Asthma

This transcript has been edited for clarity.

Akshay B. Jain, MD: Welcome back to Medscape at ADA 2024, where Dr. James Kim, primary care physician from Calgary, Alberta, will be joining me in deciphering the key highlights at the ADA conference and bringing our own clinical twist into what the relevance would be for people like you and I to take back to our clinics.

Welcome back, Dr. Kim. 

James Kim, MBBCh, PgDip, MScCH: Thank you very much. It’s nice to be back. 

Dr. Jain: This was a diabetes conference, so obviously we are very pancreas focused. At this conference, we went outside our general area of territory, going outside of the pancreas and delving into other organ states. What I found fascinating were some data regarding the effects of incretin therapy on the lung, and in particular, some of the restrictive lung disorders.

Dr. Kim, you attended these sessions as well. Can you tell us a little bit more about the results that were discussed? 

Dr. Kim: This is an interesting field. The moderator of the session went up and said that there has been no time in any previous ADA sessions where the lung issue was actually discussed. This was the first time ever.

They had some of the world leaders in this field, so it was really awesome to see them. Just to paint a picture of these obese asthmatic patients, they are challenging cases because, as you know, the main therapy for any asthmatic patient is inhaled corticosteroid.

Patients who are obese have quite a bit of a steroid resistance. Therefore, they end up being on many medications that sometimes are off label, and many end up on biologics as well. Therefore, the respiratory world has been seeking therapies for these obese asthmatic patients who are likely to be steroid resistant because these people are also likely to end up on an oral steroid as well.

Dr. Jain, you know the effect of the steroids much better than I do, and it’s like a laundry list. We really don’t want our patients to be on oral steroids. 

In the past few years, GLP-1 has been studied quite extensively in the lung, especially in the world of asthma, and also in COPD. What’s really fascinating is that the GLP-1 receptors have been found to be quite abundant in the airway. Some studies show that the highest concentration of GLP-1 lies in the airway, whereas some studies have said that it’s the third most common area to find the GLP-1. 

It is not a surprise that GLP-1 is being studied in managing the airway, especially airway inflammation in asthma and COPD patients. The preliminary data have been quite encouraging. They also discussed that there are new medications coming out that seem to be incretin based, so we’ll wait to see what those studies show.

There are two current phase 3 trials being held at the moment. One is using semaglutide 2.4 mg subcutaneous and another one is using metformin to reduce the airway inflammation in these asthmatic patients and also in some COPD patients. We’ll look forward to these results.

Dr. Jain: That’s really important to note because we see that there is a high density of these receptors in the airways, and hitherto we had no idea about the overall effect. Now, we’re looking at, as you mentioned, individuals with obesity who have asthma, so there are both the restrictive and obstructive components in the lung coming into play here.

From an endocrinology perspective, I’m thinking that this could be multiple effects of the GLP-1 receptor agonists, where on one hand you’re managing the obesity and you’re working along that line, and on the other hand, it could have local anti-inflammatory effects in the lung. Hence, there could be potential improvement in the overall pulmonary function of these individuals. 

Dr. Kim: We are seeing this in primary care. Ever since I found out this information, I have started numerous patients, who are obese, asthmatic patients who do not have diabetes, on GLP-1 therapies, and their pulmonary function tests have improved significantly.

As a matter of fact, one of my personal friends is a severe asthmatic patient. She ends up being on oral steroids about three times a year. There was even one day when I saw her in one of my classes and she was dyspneic. She was short of breath. 

I introduced her to one of my colleagues who’s a respirologist and very much into the impact of the incretins and asthma, and she was started on a GLP-1 receptor agonist. She lost about 30 pounds of weight, but now she is labeled as a mild asthmatic. Her pulmonary function test is completely normal. She hasn’t touched an oral steroid for a couple of years now.

That is a huge success story and I’m seeing that even in my own clinic as well. It’s a huge win for the respiratory world.

Dr. Jain: I think from an endocrinology perspective as well, if we are initiating GLP-1 receptor agonists or medications in that class, where we use it for management of obesity, sooner or later we do hit a stage where people will plateau with their weight loss. They won’t have any additional weight loss.

We tell individuals at that time that the fact that they’re able to maintain the weight loss still means that the medication is working from the obesity perspective. For individuals who also have asthma, it would be a good point to tell them that it could still have potential effects on reducing inflammation ongoing. Hence, even though they may not be losing any additional weight, it would still be helpful to continue on these medications from a pulmonary perspective. 

Dr. Kim: Right now these pleiotropic effects of GLP-1 agents are absolutely mind-blowing. I mentioned in one of my respiratory presentations to a bunch of respirologists that diabetes is taking over the world, including the respiratory world. Well, you can imagine what their faces were like. However, they were quite impressed at that, and they were very excited with what these two phase 3 trials will show. 

Dr. Jain: I think, based on the ADA 2024 conference, GLP-1 receptor agonists continue to be the gift that keeps giving. We have the effects on diabetes, obesity, kidney function, liver protection, lungs, and Alzheimer’s. We saw some sessions about potential use in people with alcohol misuse disorder or gambling problems. Clearly, there’s a large amount of research that›s being done with these agents. 

Perhaps when you and I talk about ADA 2025, we might be able to talk about some more pleiotropic benefits outside the pancreas. Until then, please do check out our other videos from ADA 2024. Thanks for joining us again, Dr. Kim.

Dr. Kim: Thank you very much for having me.
 

Dr. Jain, clinical instructor, Department of Endocrinology, University of British Columbia, and endocrinologist, TLC Diabetes and Endocrinology, Vancouver, British Columbia, Canada, has disclosed ties with Abbott, Acerus, AstraZeneca, Amgen, Bausch Healthcare, Bayer, Boehringer Ingelheim, Care to Know, CCRN, Connected in Motion, CPD Network, Dexcom, Diabetes Canada, Eli Lilly, GSK, HLS Therapeutics, Janssen, Master Clinician Alliance, MDBriefcase, Merck, Medtronic, Moderna, Novartis, Novo Nordisk, Partners in Progressive Medical Education, Pfizer, Sanofi Aventis, Timed Right, WebMD, Gilead Sciences, Insulet, PocketPills, Roche, and Takeda. Dr. Kim, clinical assistant professor, Department of Family Medicine, University of Calgary, Alberta, has disclosed ties with Abbott, AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Eisai, Embecta, Eli Lilly, GSK, Janssen, Linpharma, Novo Nordisk, Miravo, Otsuka, Pfizer, Teva, Takeda, and Sanofi, and Partners in Progressive Medical Education.
 

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Akshay B. Jain, MD: Welcome back to Medscape at ADA 2024, where Dr. James Kim, primary care physician from Calgary, Alberta, will be joining me in deciphering the key highlights at the ADA conference and bringing our own clinical twist into what the relevance would be for people like you and I to take back to our clinics.

Welcome back, Dr. Kim. 

James Kim, MBBCh, PgDip, MScCH: Thank you very much. It’s nice to be back. 

Dr. Jain: This was a diabetes conference, so obviously we are very pancreas focused. At this conference, we went outside our general area of territory, going outside of the pancreas and delving into other organ states. What I found fascinating were some data regarding the effects of incretin therapy on the lung, and in particular, some of the restrictive lung disorders.

Dr. Kim, you attended these sessions as well. Can you tell us a little bit more about the results that were discussed? 

Dr. Kim: This is an interesting field. The moderator of the session went up and said that there has been no time in any previous ADA sessions where the lung issue was actually discussed. This was the first time ever.

They had some of the world leaders in this field, so it was really awesome to see them. Just to paint a picture of these obese asthmatic patients, they are challenging cases because, as you know, the main therapy for any asthmatic patient is inhaled corticosteroid.

Patients who are obese have quite a bit of a steroid resistance. Therefore, they end up being on many medications that sometimes are off label, and many end up on biologics as well. Therefore, the respiratory world has been seeking therapies for these obese asthmatic patients who are likely to be steroid resistant because these people are also likely to end up on an oral steroid as well.

Dr. Jain, you know the effect of the steroids much better than I do, and it’s like a laundry list. We really don’t want our patients to be on oral steroids. 

In the past few years, GLP-1 has been studied quite extensively in the lung, especially in the world of asthma, and also in COPD. What’s really fascinating is that the GLP-1 receptors have been found to be quite abundant in the airway. Some studies show that the highest concentration of GLP-1 lies in the airway, whereas some studies have said that it’s the third most common area to find the GLP-1. 

It is not a surprise that GLP-1 is being studied in managing the airway, especially airway inflammation in asthma and COPD patients. The preliminary data have been quite encouraging. They also discussed that there are new medications coming out that seem to be incretin based, so we’ll wait to see what those studies show.

There are two current phase 3 trials being held at the moment. One is using semaglutide 2.4 mg subcutaneous and another one is using metformin to reduce the airway inflammation in these asthmatic patients and also in some COPD patients. We’ll look forward to these results.

Dr. Jain: That’s really important to note because we see that there is a high density of these receptors in the airways, and hitherto we had no idea about the overall effect. Now, we’re looking at, as you mentioned, individuals with obesity who have asthma, so there are both the restrictive and obstructive components in the lung coming into play here.

From an endocrinology perspective, I’m thinking that this could be multiple effects of the GLP-1 receptor agonists, where on one hand you’re managing the obesity and you’re working along that line, and on the other hand, it could have local anti-inflammatory effects in the lung. Hence, there could be potential improvement in the overall pulmonary function of these individuals. 

Dr. Kim: We are seeing this in primary care. Ever since I found out this information, I have started numerous patients, who are obese, asthmatic patients who do not have diabetes, on GLP-1 therapies, and their pulmonary function tests have improved significantly.

As a matter of fact, one of my personal friends is a severe asthmatic patient. She ends up being on oral steroids about three times a year. There was even one day when I saw her in one of my classes and she was dyspneic. She was short of breath. 

I introduced her to one of my colleagues who’s a respirologist and very much into the impact of the incretins and asthma, and she was started on a GLP-1 receptor agonist. She lost about 30 pounds of weight, but now she is labeled as a mild asthmatic. Her pulmonary function test is completely normal. She hasn’t touched an oral steroid for a couple of years now.

That is a huge success story and I’m seeing that even in my own clinic as well. It’s a huge win for the respiratory world.

Dr. Jain: I think from an endocrinology perspective as well, if we are initiating GLP-1 receptor agonists or medications in that class, where we use it for management of obesity, sooner or later we do hit a stage where people will plateau with their weight loss. They won’t have any additional weight loss.

We tell individuals at that time that the fact that they’re able to maintain the weight loss still means that the medication is working from the obesity perspective. For individuals who also have asthma, it would be a good point to tell them that it could still have potential effects on reducing inflammation ongoing. Hence, even though they may not be losing any additional weight, it would still be helpful to continue on these medications from a pulmonary perspective. 

Dr. Kim: Right now these pleiotropic effects of GLP-1 agents are absolutely mind-blowing. I mentioned in one of my respiratory presentations to a bunch of respirologists that diabetes is taking over the world, including the respiratory world. Well, you can imagine what their faces were like. However, they were quite impressed at that, and they were very excited with what these two phase 3 trials will show. 

Dr. Jain: I think, based on the ADA 2024 conference, GLP-1 receptor agonists continue to be the gift that keeps giving. We have the effects on diabetes, obesity, kidney function, liver protection, lungs, and Alzheimer’s. We saw some sessions about potential use in people with alcohol misuse disorder or gambling problems. Clearly, there’s a large amount of research that›s being done with these agents. 

Perhaps when you and I talk about ADA 2025, we might be able to talk about some more pleiotropic benefits outside the pancreas. Until then, please do check out our other videos from ADA 2024. Thanks for joining us again, Dr. Kim.

Dr. Kim: Thank you very much for having me.
 

Dr. Jain, clinical instructor, Department of Endocrinology, University of British Columbia, and endocrinologist, TLC Diabetes and Endocrinology, Vancouver, British Columbia, Canada, has disclosed ties with Abbott, Acerus, AstraZeneca, Amgen, Bausch Healthcare, Bayer, Boehringer Ingelheim, Care to Know, CCRN, Connected in Motion, CPD Network, Dexcom, Diabetes Canada, Eli Lilly, GSK, HLS Therapeutics, Janssen, Master Clinician Alliance, MDBriefcase, Merck, Medtronic, Moderna, Novartis, Novo Nordisk, Partners in Progressive Medical Education, Pfizer, Sanofi Aventis, Timed Right, WebMD, Gilead Sciences, Insulet, PocketPills, Roche, and Takeda. Dr. Kim, clinical assistant professor, Department of Family Medicine, University of Calgary, Alberta, has disclosed ties with Abbott, AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Eisai, Embecta, Eli Lilly, GSK, Janssen, Linpharma, Novo Nordisk, Miravo, Otsuka, Pfizer, Teva, Takeda, and Sanofi, and Partners in Progressive Medical Education.
 

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Akshay B. Jain, MD: Welcome back to Medscape at ADA 2024, where Dr. James Kim, primary care physician from Calgary, Alberta, will be joining me in deciphering the key highlights at the ADA conference and bringing our own clinical twist into what the relevance would be for people like you and I to take back to our clinics.

Welcome back, Dr. Kim. 

James Kim, MBBCh, PgDip, MScCH: Thank you very much. It’s nice to be back. 

Dr. Jain: This was a diabetes conference, so obviously we are very pancreas focused. At this conference, we went outside our general area of territory, going outside of the pancreas and delving into other organ states. What I found fascinating were some data regarding the effects of incretin therapy on the lung, and in particular, some of the restrictive lung disorders.

Dr. Kim, you attended these sessions as well. Can you tell us a little bit more about the results that were discussed? 

Dr. Kim: This is an interesting field. The moderator of the session went up and said that there has been no time in any previous ADA sessions where the lung issue was actually discussed. This was the first time ever.

They had some of the world leaders in this field, so it was really awesome to see them. Just to paint a picture of these obese asthmatic patients, they are challenging cases because, as you know, the main therapy for any asthmatic patient is inhaled corticosteroid.

Patients who are obese have quite a bit of a steroid resistance. Therefore, they end up being on many medications that sometimes are off label, and many end up on biologics as well. Therefore, the respiratory world has been seeking therapies for these obese asthmatic patients who are likely to be steroid resistant because these people are also likely to end up on an oral steroid as well.

Dr. Jain, you know the effect of the steroids much better than I do, and it’s like a laundry list. We really don’t want our patients to be on oral steroids. 

In the past few years, GLP-1 has been studied quite extensively in the lung, especially in the world of asthma, and also in COPD. What’s really fascinating is that the GLP-1 receptors have been found to be quite abundant in the airway. Some studies show that the highest concentration of GLP-1 lies in the airway, whereas some studies have said that it’s the third most common area to find the GLP-1. 

It is not a surprise that GLP-1 is being studied in managing the airway, especially airway inflammation in asthma and COPD patients. The preliminary data have been quite encouraging. They also discussed that there are new medications coming out that seem to be incretin based, so we’ll wait to see what those studies show.

There are two current phase 3 trials being held at the moment. One is using semaglutide 2.4 mg subcutaneous and another one is using metformin to reduce the airway inflammation in these asthmatic patients and also in some COPD patients. We’ll look forward to these results.

Dr. Jain: That’s really important to note because we see that there is a high density of these receptors in the airways, and hitherto we had no idea about the overall effect. Now, we’re looking at, as you mentioned, individuals with obesity who have asthma, so there are both the restrictive and obstructive components in the lung coming into play here.

From an endocrinology perspective, I’m thinking that this could be multiple effects of the GLP-1 receptor agonists, where on one hand you’re managing the obesity and you’re working along that line, and on the other hand, it could have local anti-inflammatory effects in the lung. Hence, there could be potential improvement in the overall pulmonary function of these individuals. 

Dr. Kim: We are seeing this in primary care. Ever since I found out this information, I have started numerous patients, who are obese, asthmatic patients who do not have diabetes, on GLP-1 therapies, and their pulmonary function tests have improved significantly.

As a matter of fact, one of my personal friends is a severe asthmatic patient. She ends up being on oral steroids about three times a year. There was even one day when I saw her in one of my classes and she was dyspneic. She was short of breath. 

I introduced her to one of my colleagues who’s a respirologist and very much into the impact of the incretins and asthma, and she was started on a GLP-1 receptor agonist. She lost about 30 pounds of weight, but now she is labeled as a mild asthmatic. Her pulmonary function test is completely normal. She hasn’t touched an oral steroid for a couple of years now.

That is a huge success story and I’m seeing that even in my own clinic as well. It’s a huge win for the respiratory world.

Dr. Jain: I think from an endocrinology perspective as well, if we are initiating GLP-1 receptor agonists or medications in that class, where we use it for management of obesity, sooner or later we do hit a stage where people will plateau with their weight loss. They won’t have any additional weight loss.

We tell individuals at that time that the fact that they’re able to maintain the weight loss still means that the medication is working from the obesity perspective. For individuals who also have asthma, it would be a good point to tell them that it could still have potential effects on reducing inflammation ongoing. Hence, even though they may not be losing any additional weight, it would still be helpful to continue on these medications from a pulmonary perspective. 

Dr. Kim: Right now these pleiotropic effects of GLP-1 agents are absolutely mind-blowing. I mentioned in one of my respiratory presentations to a bunch of respirologists that diabetes is taking over the world, including the respiratory world. Well, you can imagine what their faces were like. However, they were quite impressed at that, and they were very excited with what these two phase 3 trials will show. 

Dr. Jain: I think, based on the ADA 2024 conference, GLP-1 receptor agonists continue to be the gift that keeps giving. We have the effects on diabetes, obesity, kidney function, liver protection, lungs, and Alzheimer’s. We saw some sessions about potential use in people with alcohol misuse disorder or gambling problems. Clearly, there’s a large amount of research that›s being done with these agents. 

Perhaps when you and I talk about ADA 2025, we might be able to talk about some more pleiotropic benefits outside the pancreas. Until then, please do check out our other videos from ADA 2024. Thanks for joining us again, Dr. Kim.

Dr. Kim: Thank you very much for having me.
 

Dr. Jain, clinical instructor, Department of Endocrinology, University of British Columbia, and endocrinologist, TLC Diabetes and Endocrinology, Vancouver, British Columbia, Canada, has disclosed ties with Abbott, Acerus, AstraZeneca, Amgen, Bausch Healthcare, Bayer, Boehringer Ingelheim, Care to Know, CCRN, Connected in Motion, CPD Network, Dexcom, Diabetes Canada, Eli Lilly, GSK, HLS Therapeutics, Janssen, Master Clinician Alliance, MDBriefcase, Merck, Medtronic, Moderna, Novartis, Novo Nordisk, Partners in Progressive Medical Education, Pfizer, Sanofi Aventis, Timed Right, WebMD, Gilead Sciences, Insulet, PocketPills, Roche, and Takeda. Dr. Kim, clinical assistant professor, Department of Family Medicine, University of Calgary, Alberta, has disclosed ties with Abbott, AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Eisai, Embecta, Eli Lilly, GSK, Janssen, Linpharma, Novo Nordisk, Miravo, Otsuka, Pfizer, Teva, Takeda, and Sanofi, and Partners in Progressive Medical Education.
 

A version of this article first appeared on Medscape.com.

As more data show potentially dangerous effects of climate and weather on individuals with chronic medical conditions, CVS Health has introduced an initiative that uses technology to provide weather alerts and targeted outreach to those at increased risk, according to a press release from the company. Ultimately, the goals of the initiative are to improve health, reduce emergency department visits, hospital stays, and medical costs, according to the press release.

Extreme weather events such as heat waves are becoming more frequent and severe, but most heat-related deaths are preventable with outreach and intervention, Dan Knecht, MD, vice president and chief clinical innovation officer for CVS Caremark, a division of CVS Health, said in an interview. The approach will combine the company’s services, including care managers, health centers, and data, to aid patients vulnerable to severe weather.

The initiative is starting with a focus on extreme heat events and will expand this fall with alerts about high levels of air pollution for individuals with vulnerability to reduced lung function, asthma, and cardiac problems as a result of exposure to high air-pollution levels, according to Dr. Knecht.

For now, the initiative is available to members of Aetna Medicare, according to Dr. Knecht. “Our goal is to expand to other consumers, including those who visit MinuteClinic and CVS Pharmacy locations, where we can provide timely environment-related recommendations at time of care,” he said.

The alert system uses environmental data analytics to pair highly localized forecasts and real-time insights about air quality, wildfires, and high heat with medical and pharmacy data for high-risk patients in areas affected by extreme weather.

For example, for individuals who are at risk and living in areas facing extreme heat, “registered nurse care managers proactively reach out to vulnerable patients up to several days in advance of an extreme weather event and provide them personalized tips and resources,” said Dr. Knecht.

In addition, he added, “we talk to patients about how to manage their medications during periods of extreme heat and, when delivering medications, take weather data into account to determine appropriate packaging materials for shipments.”

These interventions direct patients to CVS Health–linked resources, such as Oak Street Health clinics available as cooling centers, health services provided at MinuteClinic locations, and medication management at CVS pharmacies. Other interventions include virtual or in-person mental health counseling through MinuteClinic.

Dr. Knecht offered additional guidance for clinicians and patients to help manage heat waves. “Heat and certain medications can impair heat tolerance and the ability to regulate body temperature,” he told this news organization. Extreme heat may affect the performance of some medications and their devices, such as inhalers and diabetes supplies, he added.
 

Health Alerts Have Potential, But Comprehensive Approach is Needed

“Patients with chronic lung conditions are highly susceptible to the impact of climate change,” MeiLan K. Han, MD, a pulmonologist and professor of internal medicine at the University of Michigan, Ann Arbor, said in an interview. “Increasing dust, hotter temperatures, and higher levels of air pollution make it more difficult for patients to breathe,” she said. Data also suggest that higher levels of air pollution may not only cause chronic lung disease but also cause worsening symptoms among those with existing disease, she added.

A weather-related health alert could be useful for patients so they can be prepared, Dr. Han told this news organization.

“For a patient with chronic lung disease, a hot weather alert may mean that it will be harder for patients to breathe, and [they] may [be] more susceptible to heat stroke and dehydration if they do not have access to air conditioning,” she said. “At a minimum, patients should ensure they are on their controller medications, which often means a daily inhaler for patients with conditions such as asthma and chronic obstructive pulmonary disease (COPD). However, patients also should have access to their short-term reliever medications so they can be prepared for increased shortness of breath that may accompany a hot weather day,” Dr. Han explained.

However, not all patients have access to technology such as smartphones or other devices that will alert them to impending weather events, such as heat waves, said Dr. Han. “For these patients, a standard phone call may be beneficial,” she said.

Looking ahead, “programs for weather-related health alerts will need to be comprehensive, focusing not only on access to needed medications but also climate-controlled settings for temporary relief of heat,” said Dr. Han. “For some of our most vulnerable patients, while they may have air conditioning, they may not be able to afford to run it, so this needs to be considered in developing a comprehensive program,” she emphasized.

Dr. Knecht had no financial conflicts to disclose. Dr. Han disclosed ties with Aerogen, Altesa BioSciences, American Lung Association, Amgen, Apreo Health, AstraZeneca, Biodesix, Boehringer Ingelheim, Chiesi, Cipla, COPD Foundation, DevPro, Gala Therapeutics, Genentech, GlaxoSmithKline, Integrity, MDBriefcase, Medscape, Medtronic, Medwiz, Meissa Vaccines, Merck, Mylan, NACE, National Institutes of Health, Novartis, Nuvaira, Polarian, Pulmonx, Regeneron, Roche, RS Biotherapeutics, Sanofi, Sunovion, Teva, UpToDate, and Verona..
 

A version of this article first appeared on Medscape.com.

As more data show potentially dangerous effects of climate and weather on individuals with chronic medical conditions, CVS Health has introduced an initiative that uses technology to provide weather alerts and targeted outreach to those at increased risk, according to a press release from the company. Ultimately, the goals of the initiative are to improve health, reduce emergency department visits, hospital stays, and medical costs, according to the press release.

Extreme weather events such as heat waves are becoming more frequent and severe, but most heat-related deaths are preventable with outreach and intervention, Dan Knecht, MD, vice president and chief clinical innovation officer for CVS Caremark, a division of CVS Health, said in an interview. The approach will combine the company’s services, including care managers, health centers, and data, to aid patients vulnerable to severe weather.

The initiative is starting with a focus on extreme heat events and will expand this fall with alerts about high levels of air pollution for individuals with vulnerability to reduced lung function, asthma, and cardiac problems as a result of exposure to high air-pollution levels, according to Dr. Knecht.

For now, the initiative is available to members of Aetna Medicare, according to Dr. Knecht. “Our goal is to expand to other consumers, including those who visit MinuteClinic and CVS Pharmacy locations, where we can provide timely environment-related recommendations at time of care,” he said.

The alert system uses environmental data analytics to pair highly localized forecasts and real-time insights about air quality, wildfires, and high heat with medical and pharmacy data for high-risk patients in areas affected by extreme weather.

For example, for individuals who are at risk and living in areas facing extreme heat, “registered nurse care managers proactively reach out to vulnerable patients up to several days in advance of an extreme weather event and provide them personalized tips and resources,” said Dr. Knecht.

In addition, he added, “we talk to patients about how to manage their medications during periods of extreme heat and, when delivering medications, take weather data into account to determine appropriate packaging materials for shipments.”

These interventions direct patients to CVS Health–linked resources, such as Oak Street Health clinics available as cooling centers, health services provided at MinuteClinic locations, and medication management at CVS pharmacies. Other interventions include virtual or in-person mental health counseling through MinuteClinic.

Dr. Knecht offered additional guidance for clinicians and patients to help manage heat waves. “Heat and certain medications can impair heat tolerance and the ability to regulate body temperature,” he told this news organization. Extreme heat may affect the performance of some medications and their devices, such as inhalers and diabetes supplies, he added.
 

Health Alerts Have Potential, But Comprehensive Approach is Needed

“Patients with chronic lung conditions are highly susceptible to the impact of climate change,” MeiLan K. Han, MD, a pulmonologist and professor of internal medicine at the University of Michigan, Ann Arbor, said in an interview. “Increasing dust, hotter temperatures, and higher levels of air pollution make it more difficult for patients to breathe,” she said. Data also suggest that higher levels of air pollution may not only cause chronic lung disease but also cause worsening symptoms among those with existing disease, she added.

A weather-related health alert could be useful for patients so they can be prepared, Dr. Han told this news organization.

“For a patient with chronic lung disease, a hot weather alert may mean that it will be harder for patients to breathe, and [they] may [be] more susceptible to heat stroke and dehydration if they do not have access to air conditioning,” she said. “At a minimum, patients should ensure they are on their controller medications, which often means a daily inhaler for patients with conditions such as asthma and chronic obstructive pulmonary disease (COPD). However, patients also should have access to their short-term reliever medications so they can be prepared for increased shortness of breath that may accompany a hot weather day,” Dr. Han explained.

However, not all patients have access to technology such as smartphones or other devices that will alert them to impending weather events, such as heat waves, said Dr. Han. “For these patients, a standard phone call may be beneficial,” she said.

Looking ahead, “programs for weather-related health alerts will need to be comprehensive, focusing not only on access to needed medications but also climate-controlled settings for temporary relief of heat,” said Dr. Han. “For some of our most vulnerable patients, while they may have air conditioning, they may not be able to afford to run it, so this needs to be considered in developing a comprehensive program,” she emphasized.

Dr. Knecht had no financial conflicts to disclose. Dr. Han disclosed ties with Aerogen, Altesa BioSciences, American Lung Association, Amgen, Apreo Health, AstraZeneca, Biodesix, Boehringer Ingelheim, Chiesi, Cipla, COPD Foundation, DevPro, Gala Therapeutics, Genentech, GlaxoSmithKline, Integrity, MDBriefcase, Medscape, Medtronic, Medwiz, Meissa Vaccines, Merck, Mylan, NACE, National Institutes of Health, Novartis, Nuvaira, Polarian, Pulmonx, Regeneron, Roche, RS Biotherapeutics, Sanofi, Sunovion, Teva, UpToDate, and Verona..
 

A version of this article first appeared on Medscape.com.

As more data show potentially dangerous effects of climate and weather on individuals with chronic medical conditions, CVS Health has introduced an initiative that uses technology to provide weather alerts and targeted outreach to those at increased risk, according to a press release from the company. Ultimately, the goals of the initiative are to improve health, reduce emergency department visits, hospital stays, and medical costs, according to the press release.

Extreme weather events such as heat waves are becoming more frequent and severe, but most heat-related deaths are preventable with outreach and intervention, Dan Knecht, MD, vice president and chief clinical innovation officer for CVS Caremark, a division of CVS Health, said in an interview. The approach will combine the company’s services, including care managers, health centers, and data, to aid patients vulnerable to severe weather.

The initiative is starting with a focus on extreme heat events and will expand this fall with alerts about high levels of air pollution for individuals with vulnerability to reduced lung function, asthma, and cardiac problems as a result of exposure to high air-pollution levels, according to Dr. Knecht.

For now, the initiative is available to members of Aetna Medicare, according to Dr. Knecht. “Our goal is to expand to other consumers, including those who visit MinuteClinic and CVS Pharmacy locations, where we can provide timely environment-related recommendations at time of care,” he said.

The alert system uses environmental data analytics to pair highly localized forecasts and real-time insights about air quality, wildfires, and high heat with medical and pharmacy data for high-risk patients in areas affected by extreme weather.

For example, for individuals who are at risk and living in areas facing extreme heat, “registered nurse care managers proactively reach out to vulnerable patients up to several days in advance of an extreme weather event and provide them personalized tips and resources,” said Dr. Knecht.

In addition, he added, “we talk to patients about how to manage their medications during periods of extreme heat and, when delivering medications, take weather data into account to determine appropriate packaging materials for shipments.”

These interventions direct patients to CVS Health–linked resources, such as Oak Street Health clinics available as cooling centers, health services provided at MinuteClinic locations, and medication management at CVS pharmacies. Other interventions include virtual or in-person mental health counseling through MinuteClinic.

Dr. Knecht offered additional guidance for clinicians and patients to help manage heat waves. “Heat and certain medications can impair heat tolerance and the ability to regulate body temperature,” he told this news organization. Extreme heat may affect the performance of some medications and their devices, such as inhalers and diabetes supplies, he added.
 

Health Alerts Have Potential, But Comprehensive Approach is Needed

“Patients with chronic lung conditions are highly susceptible to the impact of climate change,” MeiLan K. Han, MD, a pulmonologist and professor of internal medicine at the University of Michigan, Ann Arbor, said in an interview. “Increasing dust, hotter temperatures, and higher levels of air pollution make it more difficult for patients to breathe,” she said. Data also suggest that higher levels of air pollution may not only cause chronic lung disease but also cause worsening symptoms among those with existing disease, she added.

A weather-related health alert could be useful for patients so they can be prepared, Dr. Han told this news organization.

“For a patient with chronic lung disease, a hot weather alert may mean that it will be harder for patients to breathe, and [they] may [be] more susceptible to heat stroke and dehydration if they do not have access to air conditioning,” she said. “At a minimum, patients should ensure they are on their controller medications, which often means a daily inhaler for patients with conditions such as asthma and chronic obstructive pulmonary disease (COPD). However, patients also should have access to their short-term reliever medications so they can be prepared for increased shortness of breath that may accompany a hot weather day,” Dr. Han explained.

However, not all patients have access to technology such as smartphones or other devices that will alert them to impending weather events, such as heat waves, said Dr. Han. “For these patients, a standard phone call may be beneficial,” she said.

Looking ahead, “programs for weather-related health alerts will need to be comprehensive, focusing not only on access to needed medications but also climate-controlled settings for temporary relief of heat,” said Dr. Han. “For some of our most vulnerable patients, while they may have air conditioning, they may not be able to afford to run it, so this needs to be considered in developing a comprehensive program,” she emphasized.

Dr. Knecht had no financial conflicts to disclose. Dr. Han disclosed ties with Aerogen, Altesa BioSciences, American Lung Association, Amgen, Apreo Health, AstraZeneca, Biodesix, Boehringer Ingelheim, Chiesi, Cipla, COPD Foundation, DevPro, Gala Therapeutics, Genentech, GlaxoSmithKline, Integrity, MDBriefcase, Medscape, Medtronic, Medwiz, Meissa Vaccines, Merck, Mylan, NACE, National Institutes of Health, Novartis, Nuvaira, Polarian, Pulmonx, Regeneron, Roche, RS Biotherapeutics, Sanofi, Sunovion, Teva, UpToDate, and Verona..
 

A version of this article first appeared on Medscape.com.

In one of several recently published studies on the relationship between COVID-19 infection and asthma, asthma symptoms in children declined as the proportion of the US population vaccinated against COVID-19 increased, according to data drawn from the National Survey of Children’s Health (NSCH).

The inverse correlation between symptoms and vaccination was strong and statistically significant, according to investigators led by Matthew M. Davis, MD, Physician in Chief and Chief Scientific Officer, Nemours Children’s Health, Wilmington, Delaware.

“With each increase of 10 percentage points in COVID-19 vaccination coverage, the parent-reported child asthma symptoms prevalence decreased by 0.36 percentage points (P < .05),” Dr. Davis and his coinvestigators reported in a research letter published in JAMA Network Open.
 

Studies Explore Relationship of COVID and Asthma

The reduced risk of asthma symptoms with COVID-19 vaccination in children at the population level is just one of several recently published studies exploring the interaction between COVID-19 infection and asthma, but two studies that posed the same question did not reach the same conclusion.

In one, COVID-19 infection in children was not found to be a trigger for new-onset asthma, but the second found that it was. In a third study, the preponderance of evidence from a meta-analysis found that patients with asthma – whether children or adults – did not necessarily experience a more severe course of COVID-19 infection than in those without asthma.

The NSCH database study calculated state-level change in scores for patient-reported childhood asthma symptoms in the years in the years 2018-2019, which preceded the pandemic and the years 2020-2021, when the pandemic began. The hypothesis was that the proportion of the population 5 years of age or older who completed the COVID-19 primary vaccination would be inversely related to asthma symptom prevalence.

Relative to the 2018-2019 years, the mean rate of parent-reported asthma symptoms was 0.85% lower (6.93% vs 7.77%; P < .001) in 2020-2021, when the mean primary series COVID-19 vaccination rate was 72.3%.

The study was not able to evaluate the impact of COVID-19 vaccination specifically in children with asthma, because history of asthma is not captured in the NSCH data, but Dr. Davis contended that the reduction in symptomatic asthma among children with increased vaccination offers validation for the state-level findings.

“Moreover, the absence of an association of COVID-19 vaccination administered predominantly in 2021 with population-level COVID-19 mortality in 2020 serves as a negative control,” he and his colleagues wrote in their research letter.
 

Protection from Respiratory Viruses Seen for Asthma Patients

In an interview, Dr. Davis reported that these data are consistent with previous evidence that immunization against influenza also reduces risk of asthma symptoms. In a meta-analysis published in 2017, it was estimated that live vaccines reduced risk of influenza by 81% and prevented 59%-72% of asthma attacks leading to hospitalizations or emergency room visits.

“The similarity of our findings regarding COVID-19 vaccination to prior data regarding influenza vaccination underscores the importance of preventing viral illnesses in individuals with a history of asthma,” Dr. Davis said. It is not yet clear if this is true of respiratory syncytial virus (RSV). Because of the short time that the RSV vaccine has been available, it is too soon to conduct an analysis.

One message from this study is that “clinicians should continue to encourage COVID-19 vaccination for children because of its general benefits in preventing coronavirus-related illness and the apparent specific benefits for children with a history of asthma,” he said.

While vaccination appears to reduce asthmatic symptoms related to COVID-19 infection, one study suggests that COVID-19 does not trigger new-onset asthma. In a retrospective study published in Pediatrics, no association between COVID-19 infection and new-onset asthma could be made in an analysis of 27,423 children (ages, 1-16 years) from the Children’s Hospital of Philadelphia (CHOP) Care Network.

Across all the pediatric age groups evaluated, the consistent finding was “SARS-CoV-2 positivity does not confer an additional risk for asthma diagnosis at least within the first 18 months after a [polymerase chain reaction] test,” concluded the investigators, led by David A. Hill, MD, PhD, Division of Allergy and Immunology, CHOP, Philadelphia, Pennsylvania.
 

Risk of Asthma Doubled After COVID-19 Infection

However, the opposite conclusion was reached by investigators evaluating data from two cohorts of children ages 5-18 drawn from the TriNetX database, a global health research network with data on more than 250 million individuals. Cohort 1 included more than 250,000 children. These children had never received COVID-19 vaccination. The 50,000 patients in cohort 2 had all received COVID19 vaccination.

To compare the impact of COVID-19 infection on new-onset asthma, the patients who were infected with COVID-19 were compared with those who were not infected after propensity score matching over 18 months of follow-up.

In cohort 1, the rate of new onset asthma was more than twofold greater among those with COVID-19 infection (4.7% vs 2.0%). The hazard ratio (HR) of 2.25 had tight confidence intervals (95% CI, 2.158-2.367).

In cohort 2, the risk of new-onset asthma at 18 months among those who had a COVID-19 infection relative to those without was even greater (8.3% vs 3.1%). The relative risk approached a 3-fold increase (HR 2.745; 95% CI, 2.521-2.99).

The conclusion of these investigators, led by Chia-Chi Lung, PhD, Department of Public Health, Chung Shan Medical University, Taichung City, Taiwan, was that there is “a critical need for ongoing monitoring and customized healthcare strategies to mitigate the long-term respiratory impacts of COVID-19 in children.”

These health risks might not be as significant as once feared. In the recently published study from Environmental Health Insights, the goal of a meta-analysis was to determine if patients with asthma relative to those without asthma face a higher risk of serious disease from COVID-19 infection. The meta-analysis included studies of children and adults. The answer, according an in-depth analysis of 21 articles in a “scoping review,” was a qualified no.

Of the 21 articles, 4 concluded that asthma is a risk factor for serious COVID-19 infection, but 17 did not, according to Chukwudi S. Ubah, PhD, Department of Public Health, Brody School of Medicine, East Caroline University, Greenville, North Carolina.
 

None of These Questions are Fully Resolved

However, given the disparity in the results and the fact that many of the studies included in this analysis had small sample sizes, Dr. Ubah called for larger studies and studies with better controls. He noted, for example, that the studies did not consistently evaluate mitigating factors, such as used of inhaled or oral corticosteroids, which might affect risk of the severity of a COVID-19 infection.

Rather, “our findings pointed out that the type of medication prescribed for asthma may have implications for the severity of COVID-19 infection in these patients,” Dr. Ubah said in an interview.

Overall, the data do not support a major interaction between asthma and COVID-19, even if the data are not conclusive. Each of the senior authors of these studies called for larger and better investigations to further explore whether COVID-19 infection and preexisting asthma interact. So far, the data indicate that if COVID-19 infection poses a risk of precipitating new-onset asthma or inducing a more severe infection in children with asthma, it is low, but the degree of risk, if any, remains unresolved in subgroups defined by asthma treatment or asthma severity.

Dr. Davis, Dr. Hill, Dr. Lung, and Dr. Ubah reported no potential conflicts of interest. None of these studies received funding from commercial interests.

In one of several recently published studies on the relationship between COVID-19 infection and asthma, asthma symptoms in children declined as the proportion of the US population vaccinated against COVID-19 increased, according to data drawn from the National Survey of Children’s Health (NSCH).

The inverse correlation between symptoms and vaccination was strong and statistically significant, according to investigators led by Matthew M. Davis, MD, Physician in Chief and Chief Scientific Officer, Nemours Children’s Health, Wilmington, Delaware.

“With each increase of 10 percentage points in COVID-19 vaccination coverage, the parent-reported child asthma symptoms prevalence decreased by 0.36 percentage points (P < .05),” Dr. Davis and his coinvestigators reported in a research letter published in JAMA Network Open.
 

Studies Explore Relationship of COVID and Asthma

The reduced risk of asthma symptoms with COVID-19 vaccination in children at the population level is just one of several recently published studies exploring the interaction between COVID-19 infection and asthma, but two studies that posed the same question did not reach the same conclusion.

In one, COVID-19 infection in children was not found to be a trigger for new-onset asthma, but the second found that it was. In a third study, the preponderance of evidence from a meta-analysis found that patients with asthma – whether children or adults – did not necessarily experience a more severe course of COVID-19 infection than in those without asthma.

The NSCH database study calculated state-level change in scores for patient-reported childhood asthma symptoms in the years in the years 2018-2019, which preceded the pandemic and the years 2020-2021, when the pandemic began. The hypothesis was that the proportion of the population 5 years of age or older who completed the COVID-19 primary vaccination would be inversely related to asthma symptom prevalence.

Relative to the 2018-2019 years, the mean rate of parent-reported asthma symptoms was 0.85% lower (6.93% vs 7.77%; P < .001) in 2020-2021, when the mean primary series COVID-19 vaccination rate was 72.3%.

The study was not able to evaluate the impact of COVID-19 vaccination specifically in children with asthma, because history of asthma is not captured in the NSCH data, but Dr. Davis contended that the reduction in symptomatic asthma among children with increased vaccination offers validation for the state-level findings.

“Moreover, the absence of an association of COVID-19 vaccination administered predominantly in 2021 with population-level COVID-19 mortality in 2020 serves as a negative control,” he and his colleagues wrote in their research letter.
 

Protection from Respiratory Viruses Seen for Asthma Patients

In an interview, Dr. Davis reported that these data are consistent with previous evidence that immunization against influenza also reduces risk of asthma symptoms. In a meta-analysis published in 2017, it was estimated that live vaccines reduced risk of influenza by 81% and prevented 59%-72% of asthma attacks leading to hospitalizations or emergency room visits.

“The similarity of our findings regarding COVID-19 vaccination to prior data regarding influenza vaccination underscores the importance of preventing viral illnesses in individuals with a history of asthma,” Dr. Davis said. It is not yet clear if this is true of respiratory syncytial virus (RSV). Because of the short time that the RSV vaccine has been available, it is too soon to conduct an analysis.

One message from this study is that “clinicians should continue to encourage COVID-19 vaccination for children because of its general benefits in preventing coronavirus-related illness and the apparent specific benefits for children with a history of asthma,” he said.

While vaccination appears to reduce asthmatic symptoms related to COVID-19 infection, one study suggests that COVID-19 does not trigger new-onset asthma. In a retrospective study published in Pediatrics, no association between COVID-19 infection and new-onset asthma could be made in an analysis of 27,423 children (ages, 1-16 years) from the Children’s Hospital of Philadelphia (CHOP) Care Network.

Across all the pediatric age groups evaluated, the consistent finding was “SARS-CoV-2 positivity does not confer an additional risk for asthma diagnosis at least within the first 18 months after a [polymerase chain reaction] test,” concluded the investigators, led by David A. Hill, MD, PhD, Division of Allergy and Immunology, CHOP, Philadelphia, Pennsylvania.
 

Risk of Asthma Doubled After COVID-19 Infection

However, the opposite conclusion was reached by investigators evaluating data from two cohorts of children ages 5-18 drawn from the TriNetX database, a global health research network with data on more than 250 million individuals. Cohort 1 included more than 250,000 children. These children had never received COVID-19 vaccination. The 50,000 patients in cohort 2 had all received COVID19 vaccination.

To compare the impact of COVID-19 infection on new-onset asthma, the patients who were infected with COVID-19 were compared with those who were not infected after propensity score matching over 18 months of follow-up.

In cohort 1, the rate of new onset asthma was more than twofold greater among those with COVID-19 infection (4.7% vs 2.0%). The hazard ratio (HR) of 2.25 had tight confidence intervals (95% CI, 2.158-2.367).

In cohort 2, the risk of new-onset asthma at 18 months among those who had a COVID-19 infection relative to those without was even greater (8.3% vs 3.1%). The relative risk approached a 3-fold increase (HR 2.745; 95% CI, 2.521-2.99).

The conclusion of these investigators, led by Chia-Chi Lung, PhD, Department of Public Health, Chung Shan Medical University, Taichung City, Taiwan, was that there is “a critical need for ongoing monitoring and customized healthcare strategies to mitigate the long-term respiratory impacts of COVID-19 in children.”

These health risks might not be as significant as once feared. In the recently published study from Environmental Health Insights, the goal of a meta-analysis was to determine if patients with asthma relative to those without asthma face a higher risk of serious disease from COVID-19 infection. The meta-analysis included studies of children and adults. The answer, according an in-depth analysis of 21 articles in a “scoping review,” was a qualified no.

Of the 21 articles, 4 concluded that asthma is a risk factor for serious COVID-19 infection, but 17 did not, according to Chukwudi S. Ubah, PhD, Department of Public Health, Brody School of Medicine, East Caroline University, Greenville, North Carolina.
 

None of These Questions are Fully Resolved

However, given the disparity in the results and the fact that many of the studies included in this analysis had small sample sizes, Dr. Ubah called for larger studies and studies with better controls. He noted, for example, that the studies did not consistently evaluate mitigating factors, such as used of inhaled or oral corticosteroids, which might affect risk of the severity of a COVID-19 infection.

Rather, “our findings pointed out that the type of medication prescribed for asthma may have implications for the severity of COVID-19 infection in these patients,” Dr. Ubah said in an interview.

Overall, the data do not support a major interaction between asthma and COVID-19, even if the data are not conclusive. Each of the senior authors of these studies called for larger and better investigations to further explore whether COVID-19 infection and preexisting asthma interact. So far, the data indicate that if COVID-19 infection poses a risk of precipitating new-onset asthma or inducing a more severe infection in children with asthma, it is low, but the degree of risk, if any, remains unresolved in subgroups defined by asthma treatment or asthma severity.

Dr. Davis, Dr. Hill, Dr. Lung, and Dr. Ubah reported no potential conflicts of interest. None of these studies received funding from commercial interests.

In one of several recently published studies on the relationship between COVID-19 infection and asthma, asthma symptoms in children declined as the proportion of the US population vaccinated against COVID-19 increased, according to data drawn from the National Survey of Children’s Health (NSCH).

The inverse correlation between symptoms and vaccination was strong and statistically significant, according to investigators led by Matthew M. Davis, MD, Physician in Chief and Chief Scientific Officer, Nemours Children’s Health, Wilmington, Delaware.

“With each increase of 10 percentage points in COVID-19 vaccination coverage, the parent-reported child asthma symptoms prevalence decreased by 0.36 percentage points (P < .05),” Dr. Davis and his coinvestigators reported in a research letter published in JAMA Network Open.
 

Studies Explore Relationship of COVID and Asthma

The reduced risk of asthma symptoms with COVID-19 vaccination in children at the population level is just one of several recently published studies exploring the interaction between COVID-19 infection and asthma, but two studies that posed the same question did not reach the same conclusion.

In one, COVID-19 infection in children was not found to be a trigger for new-onset asthma, but the second found that it was. In a third study, the preponderance of evidence from a meta-analysis found that patients with asthma – whether children or adults – did not necessarily experience a more severe course of COVID-19 infection than in those without asthma.

The NSCH database study calculated state-level change in scores for patient-reported childhood asthma symptoms in the years in the years 2018-2019, which preceded the pandemic and the years 2020-2021, when the pandemic began. The hypothesis was that the proportion of the population 5 years of age or older who completed the COVID-19 primary vaccination would be inversely related to asthma symptom prevalence.

Relative to the 2018-2019 years, the mean rate of parent-reported asthma symptoms was 0.85% lower (6.93% vs 7.77%; P < .001) in 2020-2021, when the mean primary series COVID-19 vaccination rate was 72.3%.

The study was not able to evaluate the impact of COVID-19 vaccination specifically in children with asthma, because history of asthma is not captured in the NSCH data, but Dr. Davis contended that the reduction in symptomatic asthma among children with increased vaccination offers validation for the state-level findings.

“Moreover, the absence of an association of COVID-19 vaccination administered predominantly in 2021 with population-level COVID-19 mortality in 2020 serves as a negative control,” he and his colleagues wrote in their research letter.
 

Protection from Respiratory Viruses Seen for Asthma Patients

In an interview, Dr. Davis reported that these data are consistent with previous evidence that immunization against influenza also reduces risk of asthma symptoms. In a meta-analysis published in 2017, it was estimated that live vaccines reduced risk of influenza by 81% and prevented 59%-72% of asthma attacks leading to hospitalizations or emergency room visits.

“The similarity of our findings regarding COVID-19 vaccination to prior data regarding influenza vaccination underscores the importance of preventing viral illnesses in individuals with a history of asthma,” Dr. Davis said. It is not yet clear if this is true of respiratory syncytial virus (RSV). Because of the short time that the RSV vaccine has been available, it is too soon to conduct an analysis.

One message from this study is that “clinicians should continue to encourage COVID-19 vaccination for children because of its general benefits in preventing coronavirus-related illness and the apparent specific benefits for children with a history of asthma,” he said.

While vaccination appears to reduce asthmatic symptoms related to COVID-19 infection, one study suggests that COVID-19 does not trigger new-onset asthma. In a retrospective study published in Pediatrics, no association between COVID-19 infection and new-onset asthma could be made in an analysis of 27,423 children (ages, 1-16 years) from the Children’s Hospital of Philadelphia (CHOP) Care Network.

Across all the pediatric age groups evaluated, the consistent finding was “SARS-CoV-2 positivity does not confer an additional risk for asthma diagnosis at least within the first 18 months after a [polymerase chain reaction] test,” concluded the investigators, led by David A. Hill, MD, PhD, Division of Allergy and Immunology, CHOP, Philadelphia, Pennsylvania.
 

Risk of Asthma Doubled After COVID-19 Infection

However, the opposite conclusion was reached by investigators evaluating data from two cohorts of children ages 5-18 drawn from the TriNetX database, a global health research network with data on more than 250 million individuals. Cohort 1 included more than 250,000 children. These children had never received COVID-19 vaccination. The 50,000 patients in cohort 2 had all received COVID19 vaccination.

To compare the impact of COVID-19 infection on new-onset asthma, the patients who were infected with COVID-19 were compared with those who were not infected after propensity score matching over 18 months of follow-up.

In cohort 1, the rate of new onset asthma was more than twofold greater among those with COVID-19 infection (4.7% vs 2.0%). The hazard ratio (HR) of 2.25 had tight confidence intervals (95% CI, 2.158-2.367).

In cohort 2, the risk of new-onset asthma at 18 months among those who had a COVID-19 infection relative to those without was even greater (8.3% vs 3.1%). The relative risk approached a 3-fold increase (HR 2.745; 95% CI, 2.521-2.99).

The conclusion of these investigators, led by Chia-Chi Lung, PhD, Department of Public Health, Chung Shan Medical University, Taichung City, Taiwan, was that there is “a critical need for ongoing monitoring and customized healthcare strategies to mitigate the long-term respiratory impacts of COVID-19 in children.”

These health risks might not be as significant as once feared. In the recently published study from Environmental Health Insights, the goal of a meta-analysis was to determine if patients with asthma relative to those without asthma face a higher risk of serious disease from COVID-19 infection. The meta-analysis included studies of children and adults. The answer, according an in-depth analysis of 21 articles in a “scoping review,” was a qualified no.

Of the 21 articles, 4 concluded that asthma is a risk factor for serious COVID-19 infection, but 17 did not, according to Chukwudi S. Ubah, PhD, Department of Public Health, Brody School of Medicine, East Caroline University, Greenville, North Carolina.
 

None of These Questions are Fully Resolved

However, given the disparity in the results and the fact that many of the studies included in this analysis had small sample sizes, Dr. Ubah called for larger studies and studies with better controls. He noted, for example, that the studies did not consistently evaluate mitigating factors, such as used of inhaled or oral corticosteroids, which might affect risk of the severity of a COVID-19 infection.

Rather, “our findings pointed out that the type of medication prescribed for asthma may have implications for the severity of COVID-19 infection in these patients,” Dr. Ubah said in an interview.

Overall, the data do not support a major interaction between asthma and COVID-19, even if the data are not conclusive. Each of the senior authors of these studies called for larger and better investigations to further explore whether COVID-19 infection and preexisting asthma interact. So far, the data indicate that if COVID-19 infection poses a risk of precipitating new-onset asthma or inducing a more severe infection in children with asthma, it is low, but the degree of risk, if any, remains unresolved in subgroups defined by asthma treatment or asthma severity.

Dr. Davis, Dr. Hill, Dr. Lung, and Dr. Ubah reported no potential conflicts of interest. None of these studies received funding from commercial interests.

Children with asthma who were insured by Medicaid were significantly less likely to receive specialist care over a 1-year period than children with private insurance, based on claims data from nearly 200,000 children.

Primary care clinicians successfully manage many children with asthma, but data on specialist care according to insurance coverage are lacking, wrote Kimberley H. Geissler, PhD, of the University of Massachusetts Chan Medical School–Baystate, Springfield, Massachusetts, and colleagues.

Despite many interventions over time, “low-income children insured by Medicaid, many of whom are from minoritized racial and ethnic groups, continue to have worse outcomes and higher rates of poorly controlled asthma than children who are privately insured,” Dr. Geissler said in an interview.

“Because differences in whether a child sees an asthma specialist could contribute to these disparities, better understanding specialist use among both groups of kids may help inform potential solutions,” she said.

In a study published in JAMA Network Open, the researchers identified children with asthma aged 2-17 years using data from the Massachusetts All-Payer Claims Database for the years 2015-2020. The study population included 198,101 children and 432,455 child-year observations from children with asthma during a year when they met at least one of three criteria with any asthma diagnosis: One or more hospital visits, two or more outpatient visits, or at least one outpatient visit and at least one asthma medication.
 

Outpatient Visit Outcome

The primary outcome of asthma specialist care was defined as at least one outpatient visit with any asthma diagnosis to a clinician with a code of allergy and immunology, pulmonology, or otolaryngology.

A total of 66.2% of the child-year observations involved Medicaid and 33.8% involved private insurance. Approximately 15% of the children received asthma specialist care. However, nearly twice as many children with private insurance received asthma specialty care compared with those with Medicaid (20.6% vs 11.9%). In a full logistic regression analysis, children with Medicaid insurance were 55% less likely to receive asthma specialist treatment than children with private insurance.

Allergy and immunology was the most common specialty used, and the child-years for this specialty among children with Medicaid were less than half of those among children with private insurance (7.1% vs 15.9%).

Rates of persistent asthma were 20.0% and 16.9% in children with Medicaid and private insurance, respectively. Overall, children with persistent asthma were nearly four times as likely to receive asthma specialist care (adjusted odds ratio, 3.96). However, the difference in odds of receiving specialty care based on insurance type in favor of private insurance was greater among children with persistent asthma than among those without persistent asthma (−24.0 percentage points vs −20.8 percentage points).

The researchers found a similar pattern of difference in asthma specialty care in a sensitivity analysis limiting the results to child-year observations with at least one outpatient visit with any asthma diagnosis in a calendar year, although they also found a slight narrowing of the difference between the groups over time.

“Contrary to expectations, disparities in specialist care by insurance type were even more striking in children with persistent asthma,” the researchers wrote in their discussion. Notably, the growth of specialty drugs such as biologics for moderate to severe asthma are mainly prescribed by specialists, and ensuring access to specialists for children with Medicaid may reduce disparities in asthma control for those with severe or poorly controlled disease, they added.

The study findings were limited by several factors including the use only of data from Massachusetts, which may not generalize to other states, and the use of completed specialist visits without data on referrals, the researchers noted. Other limitations included a lack of data on asthma symptom frequency or control and on the setting in which an asthma diagnosis was made.

However, the results suggest a need for more attention to disparities in asthma care by insurance type, and more research is needed to determine whether these disparities persist in subsets of children with asthma, such as those with allergies or chronic medical conditions, they concluded.
 

Takeaways and Next Steps

“Perhaps unsurprisingly, children with private insurance were more likely to receive asthma specialist care than children with Medicaid,” Dr. Geissler told this news organization. The researchers expected a smaller gap between insurance types among children with persistent asthma, a marker for asthma severity, she said. However, “we found that the gap between those with Medicaid and those with private insurance is actually larger” for children with persistent asthma, she added.

As improved treatments for hard-to-control asthma become more available, pediatricians and primary care clinicians should follow the latest clinical guidelines for referring children to specialists for asthma care, said Dr. Geissler.

“Additionally, asthma specialists should ensure that their practices are accessible to children with Medicaid, as these families may face higher barriers to care; for example, transportation needs or scheduling challenges,” she said. Other strategies to overcome barriers to care might include electronic consultations with specialists or primary care–oriented interdisciplinary asthma clinics, which may be useful for all children with asthma but may particularly benefit those insured by Medicaid, she noted.

“Based on data limitations, we could not examine why we observed such big differences in specialist use by insurance type; for example, whether pediatricians were referring to specialists less for Medicaid-insured kids, or whether kids with Medicaid were less likely to see a specialist after a referral was made,” Dr. Geissler said. More research is needed to examine not only these factors but also the appropriateness of specialty care based on clinical guidelines to ensure high-quality evidence-based care for children with asthma who are insured by Medicaid, she said.
 

Improve Access and Expand Analysis

Asthma is a chronic and prevalent disease and requires a comprehensive approach that sometimes calls for specialist care, Anne Coates, MD, a pediatric pulmonologist in Portland, Maine, said in an interview.

Dr. Coates said she was surprised by the results of the current study but commended the authors for highlighting the limitations of the study, which illustrate areas for additional research. Notably, “the authors couldn’t observe referrals to specialists from primary care physicians; they used completed visits as a proxy,” Dr. Coates said.

More studies are needed to assess the completion of referral visits regardless of children’s insurance in order to better understand and address the barriers to specialty care, she added.

The current study is important because of the extent of asthma coupled with the significant number of children across the United States who are insured by Medicaid, especially underserved populations, she said.

“The burden of asthma differentially affects people of color who are living in lower resourced areas, and it is important in further research to understanding the barriers to helping people get the care they need,” Dr. Coates told this news organization. Some alternatives might include telehealth visits or even a hybrid visit to a primary care provider (PCP) who has high-speed internet, and the specialist could then conduct a telehealth visit from the PCP’s office, with the PCP acting as on-site eyes and ears, said Dr. Coates, who has used this strategy in her practice in Maine, where many patients live far from specialist care.

The study was supported by the National Heart, Lung, and Blood Institute and the University of Massachusetts Center for Clinical and Translational Science-Biostatistics, Epidemiology & Research Design Component. Dr. Geissler and Dr. Coates had no financial conflicts to disclose.
 

A version of this article first appeared on Medscape.com.

Children with asthma who were insured by Medicaid were significantly less likely to receive specialist care over a 1-year period than children with private insurance, based on claims data from nearly 200,000 children.

Primary care clinicians successfully manage many children with asthma, but data on specialist care according to insurance coverage are lacking, wrote Kimberley H. Geissler, PhD, of the University of Massachusetts Chan Medical School–Baystate, Springfield, Massachusetts, and colleagues.

Despite many interventions over time, “low-income children insured by Medicaid, many of whom are from minoritized racial and ethnic groups, continue to have worse outcomes and higher rates of poorly controlled asthma than children who are privately insured,” Dr. Geissler said in an interview.

“Because differences in whether a child sees an asthma specialist could contribute to these disparities, better understanding specialist use among both groups of kids may help inform potential solutions,” she said.

In a study published in JAMA Network Open, the researchers identified children with asthma aged 2-17 years using data from the Massachusetts All-Payer Claims Database for the years 2015-2020. The study population included 198,101 children and 432,455 child-year observations from children with asthma during a year when they met at least one of three criteria with any asthma diagnosis: One or more hospital visits, two or more outpatient visits, or at least one outpatient visit and at least one asthma medication.
 

Outpatient Visit Outcome

The primary outcome of asthma specialist care was defined as at least one outpatient visit with any asthma diagnosis to a clinician with a code of allergy and immunology, pulmonology, or otolaryngology.

A total of 66.2% of the child-year observations involved Medicaid and 33.8% involved private insurance. Approximately 15% of the children received asthma specialist care. However, nearly twice as many children with private insurance received asthma specialty care compared with those with Medicaid (20.6% vs 11.9%). In a full logistic regression analysis, children with Medicaid insurance were 55% less likely to receive asthma specialist treatment than children with private insurance.

Allergy and immunology was the most common specialty used, and the child-years for this specialty among children with Medicaid were less than half of those among children with private insurance (7.1% vs 15.9%).

Rates of persistent asthma were 20.0% and 16.9% in children with Medicaid and private insurance, respectively. Overall, children with persistent asthma were nearly four times as likely to receive asthma specialist care (adjusted odds ratio, 3.96). However, the difference in odds of receiving specialty care based on insurance type in favor of private insurance was greater among children with persistent asthma than among those without persistent asthma (−24.0 percentage points vs −20.8 percentage points).

The researchers found a similar pattern of difference in asthma specialty care in a sensitivity analysis limiting the results to child-year observations with at least one outpatient visit with any asthma diagnosis in a calendar year, although they also found a slight narrowing of the difference between the groups over time.

“Contrary to expectations, disparities in specialist care by insurance type were even more striking in children with persistent asthma,” the researchers wrote in their discussion. Notably, the growth of specialty drugs such as biologics for moderate to severe asthma are mainly prescribed by specialists, and ensuring access to specialists for children with Medicaid may reduce disparities in asthma control for those with severe or poorly controlled disease, they added.

The study findings were limited by several factors including the use only of data from Massachusetts, which may not generalize to other states, and the use of completed specialist visits without data on referrals, the researchers noted. Other limitations included a lack of data on asthma symptom frequency or control and on the setting in which an asthma diagnosis was made.

However, the results suggest a need for more attention to disparities in asthma care by insurance type, and more research is needed to determine whether these disparities persist in subsets of children with asthma, such as those with allergies or chronic medical conditions, they concluded.
 

Takeaways and Next Steps

“Perhaps unsurprisingly, children with private insurance were more likely to receive asthma specialist care than children with Medicaid,” Dr. Geissler told this news organization. The researchers expected a smaller gap between insurance types among children with persistent asthma, a marker for asthma severity, she said. However, “we found that the gap between those with Medicaid and those with private insurance is actually larger” for children with persistent asthma, she added.

As improved treatments for hard-to-control asthma become more available, pediatricians and primary care clinicians should follow the latest clinical guidelines for referring children to specialists for asthma care, said Dr. Geissler.

“Additionally, asthma specialists should ensure that their practices are accessible to children with Medicaid, as these families may face higher barriers to care; for example, transportation needs or scheduling challenges,” she said. Other strategies to overcome barriers to care might include electronic consultations with specialists or primary care–oriented interdisciplinary asthma clinics, which may be useful for all children with asthma but may particularly benefit those insured by Medicaid, she noted.

“Based on data limitations, we could not examine why we observed such big differences in specialist use by insurance type; for example, whether pediatricians were referring to specialists less for Medicaid-insured kids, or whether kids with Medicaid were less likely to see a specialist after a referral was made,” Dr. Geissler said. More research is needed to examine not only these factors but also the appropriateness of specialty care based on clinical guidelines to ensure high-quality evidence-based care for children with asthma who are insured by Medicaid, she said.
 

Improve Access and Expand Analysis

Asthma is a chronic and prevalent disease and requires a comprehensive approach that sometimes calls for specialist care, Anne Coates, MD, a pediatric pulmonologist in Portland, Maine, said in an interview.

Dr. Coates said she was surprised by the results of the current study but commended the authors for highlighting the limitations of the study, which illustrate areas for additional research. Notably, “the authors couldn’t observe referrals to specialists from primary care physicians; they used completed visits as a proxy,” Dr. Coates said.

More studies are needed to assess the completion of referral visits regardless of children’s insurance in order to better understand and address the barriers to specialty care, she added.

The current study is important because of the extent of asthma coupled with the significant number of children across the United States who are insured by Medicaid, especially underserved populations, she said.

“The burden of asthma differentially affects people of color who are living in lower resourced areas, and it is important in further research to understanding the barriers to helping people get the care they need,” Dr. Coates told this news organization. Some alternatives might include telehealth visits or even a hybrid visit to a primary care provider (PCP) who has high-speed internet, and the specialist could then conduct a telehealth visit from the PCP’s office, with the PCP acting as on-site eyes and ears, said Dr. Coates, who has used this strategy in her practice in Maine, where many patients live far from specialist care.

The study was supported by the National Heart, Lung, and Blood Institute and the University of Massachusetts Center for Clinical and Translational Science-Biostatistics, Epidemiology & Research Design Component. Dr. Geissler and Dr. Coates had no financial conflicts to disclose.
 

A version of this article first appeared on Medscape.com.

Children with asthma who were insured by Medicaid were significantly less likely to receive specialist care over a 1-year period than children with private insurance, based on claims data from nearly 200,000 children.

Primary care clinicians successfully manage many children with asthma, but data on specialist care according to insurance coverage are lacking, wrote Kimberley H. Geissler, PhD, of the University of Massachusetts Chan Medical School–Baystate, Springfield, Massachusetts, and colleagues.

Despite many interventions over time, “low-income children insured by Medicaid, many of whom are from minoritized racial and ethnic groups, continue to have worse outcomes and higher rates of poorly controlled asthma than children who are privately insured,” Dr. Geissler said in an interview.

“Because differences in whether a child sees an asthma specialist could contribute to these disparities, better understanding specialist use among both groups of kids may help inform potential solutions,” she said.

In a study published in JAMA Network Open, the researchers identified children with asthma aged 2-17 years using data from the Massachusetts All-Payer Claims Database for the years 2015-2020. The study population included 198,101 children and 432,455 child-year observations from children with asthma during a year when they met at least one of three criteria with any asthma diagnosis: One or more hospital visits, two or more outpatient visits, or at least one outpatient visit and at least one asthma medication.
 

Outpatient Visit Outcome

The primary outcome of asthma specialist care was defined as at least one outpatient visit with any asthma diagnosis to a clinician with a code of allergy and immunology, pulmonology, or otolaryngology.

A total of 66.2% of the child-year observations involved Medicaid and 33.8% involved private insurance. Approximately 15% of the children received asthma specialist care. However, nearly twice as many children with private insurance received asthma specialty care compared with those with Medicaid (20.6% vs 11.9%). In a full logistic regression analysis, children with Medicaid insurance were 55% less likely to receive asthma specialist treatment than children with private insurance.

Allergy and immunology was the most common specialty used, and the child-years for this specialty among children with Medicaid were less than half of those among children with private insurance (7.1% vs 15.9%).

Rates of persistent asthma were 20.0% and 16.9% in children with Medicaid and private insurance, respectively. Overall, children with persistent asthma were nearly four times as likely to receive asthma specialist care (adjusted odds ratio, 3.96). However, the difference in odds of receiving specialty care based on insurance type in favor of private insurance was greater among children with persistent asthma than among those without persistent asthma (−24.0 percentage points vs −20.8 percentage points).

The researchers found a similar pattern of difference in asthma specialty care in a sensitivity analysis limiting the results to child-year observations with at least one outpatient visit with any asthma diagnosis in a calendar year, although they also found a slight narrowing of the difference between the groups over time.

“Contrary to expectations, disparities in specialist care by insurance type were even more striking in children with persistent asthma,” the researchers wrote in their discussion. Notably, the growth of specialty drugs such as biologics for moderate to severe asthma are mainly prescribed by specialists, and ensuring access to specialists for children with Medicaid may reduce disparities in asthma control for those with severe or poorly controlled disease, they added.

The study findings were limited by several factors including the use only of data from Massachusetts, which may not generalize to other states, and the use of completed specialist visits without data on referrals, the researchers noted. Other limitations included a lack of data on asthma symptom frequency or control and on the setting in which an asthma diagnosis was made.

However, the results suggest a need for more attention to disparities in asthma care by insurance type, and more research is needed to determine whether these disparities persist in subsets of children with asthma, such as those with allergies or chronic medical conditions, they concluded.
 

Takeaways and Next Steps

“Perhaps unsurprisingly, children with private insurance were more likely to receive asthma specialist care than children with Medicaid,” Dr. Geissler told this news organization. The researchers expected a smaller gap between insurance types among children with persistent asthma, a marker for asthma severity, she said. However, “we found that the gap between those with Medicaid and those with private insurance is actually larger” for children with persistent asthma, she added.

As improved treatments for hard-to-control asthma become more available, pediatricians and primary care clinicians should follow the latest clinical guidelines for referring children to specialists for asthma care, said Dr. Geissler.

“Additionally, asthma specialists should ensure that their practices are accessible to children with Medicaid, as these families may face higher barriers to care; for example, transportation needs or scheduling challenges,” she said. Other strategies to overcome barriers to care might include electronic consultations with specialists or primary care–oriented interdisciplinary asthma clinics, which may be useful for all children with asthma but may particularly benefit those insured by Medicaid, she noted.

“Based on data limitations, we could not examine why we observed such big differences in specialist use by insurance type; for example, whether pediatricians were referring to specialists less for Medicaid-insured kids, or whether kids with Medicaid were less likely to see a specialist after a referral was made,” Dr. Geissler said. More research is needed to examine not only these factors but also the appropriateness of specialty care based on clinical guidelines to ensure high-quality evidence-based care for children with asthma who are insured by Medicaid, she said.
 

Improve Access and Expand Analysis

Asthma is a chronic and prevalent disease and requires a comprehensive approach that sometimes calls for specialist care, Anne Coates, MD, a pediatric pulmonologist in Portland, Maine, said in an interview.

Dr. Coates said she was surprised by the results of the current study but commended the authors for highlighting the limitations of the study, which illustrate areas for additional research. Notably, “the authors couldn’t observe referrals to specialists from primary care physicians; they used completed visits as a proxy,” Dr. Coates said.

More studies are needed to assess the completion of referral visits regardless of children’s insurance in order to better understand and address the barriers to specialty care, she added.

The current study is important because of the extent of asthma coupled with the significant number of children across the United States who are insured by Medicaid, especially underserved populations, she said.

“The burden of asthma differentially affects people of color who are living in lower resourced areas, and it is important in further research to understanding the barriers to helping people get the care they need,” Dr. Coates told this news organization. Some alternatives might include telehealth visits or even a hybrid visit to a primary care provider (PCP) who has high-speed internet, and the specialist could then conduct a telehealth visit from the PCP’s office, with the PCP acting as on-site eyes and ears, said Dr. Coates, who has used this strategy in her practice in Maine, where many patients live far from specialist care.

The study was supported by the National Heart, Lung, and Blood Institute and the University of Massachusetts Center for Clinical and Translational Science-Biostatistics, Epidemiology & Research Design Component. Dr. Geissler and Dr. Coates had no financial conflicts to disclose.
 

A version of this article first appeared on Medscape.com.

AIRWAYS DISORDERS NETWORK

Asthma and COPD Section

Respiratory syncytial virus (RSV) has been increasingly recognized as a prevalent cause of lower respiratory tract infection (LRTI) among adults in the United States. The risk of hospitalization and mortality from RSV-associated respiratory failure is higher in those with chronic lung disease. In adults aged 65 years or older, RSV has shown to cause up to 160,000 hospitalizations and 10,000 deaths annually.

CHEST

In 2023, the US Food and Drug Administration approved the adjuvanted RSVPreF3 vaccine (Arexvy, GSK) and the bivalent RSVPreF vaccine (Abrysvo, Pfizer). Both vaccines have been shown to significantly reduce the risk of developing RSV LRTI and are currently recommended for single-dose administration in adults 60 years or older—irrespective of comorbidities.

RSV has been well established as a major cause of LRTI and morbidity among infants. Maternal vaccination with RSVPreF in patients who are pregnant is suggested between 32 0/7 and 36 6/7 weeks of gestation if the date of delivery falls during RSV season to prevent severe illness in young infants in their first months of life. At present, there are no data supporting vaccine administration to patients who are pregnant delivering outside of the RSV season.

CHEST

Resources

1. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(29):793-801.

2. Healthcare Providers: RSV Vaccination for Adults 60 Years of Age and Over. Centers for Disease Control and Prevention. Updated March 1, 2024. https://www.cdc.gov/vaccines/vpd/rsv/hcp/older-adults.html

3. Ault KA, Hughes BL, Riley LE. Maternal Respiratory Syncytial Virus Vaccination. The American College of Obstetricians and Gynecologists. Updated December 11, 2023. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccination

AIRWAYS DISORDERS NETWORK

Asthma and COPD Section

Respiratory syncytial virus (RSV) has been increasingly recognized as a prevalent cause of lower respiratory tract infection (LRTI) among adults in the United States. The risk of hospitalization and mortality from RSV-associated respiratory failure is higher in those with chronic lung disease. In adults aged 65 years or older, RSV has shown to cause up to 160,000 hospitalizations and 10,000 deaths annually.

CHEST

In 2023, the US Food and Drug Administration approved the adjuvanted RSVPreF3 vaccine (Arexvy, GSK) and the bivalent RSVPreF vaccine (Abrysvo, Pfizer). Both vaccines have been shown to significantly reduce the risk of developing RSV LRTI and are currently recommended for single-dose administration in adults 60 years or older—irrespective of comorbidities.

RSV has been well established as a major cause of LRTI and morbidity among infants. Maternal vaccination with RSVPreF in patients who are pregnant is suggested between 32 0/7 and 36 6/7 weeks of gestation if the date of delivery falls during RSV season to prevent severe illness in young infants in their first months of life. At present, there are no data supporting vaccine administration to patients who are pregnant delivering outside of the RSV season.

CHEST

Resources

1. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(29):793-801.

2. Healthcare Providers: RSV Vaccination for Adults 60 Years of Age and Over. Centers for Disease Control and Prevention. Updated March 1, 2024. https://www.cdc.gov/vaccines/vpd/rsv/hcp/older-adults.html

3. Ault KA, Hughes BL, Riley LE. Maternal Respiratory Syncytial Virus Vaccination. The American College of Obstetricians and Gynecologists. Updated December 11, 2023. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccination

AIRWAYS DISORDERS NETWORK

Asthma and COPD Section

Respiratory syncytial virus (RSV) has been increasingly recognized as a prevalent cause of lower respiratory tract infection (LRTI) among adults in the United States. The risk of hospitalization and mortality from RSV-associated respiratory failure is higher in those with chronic lung disease. In adults aged 65 years or older, RSV has shown to cause up to 160,000 hospitalizations and 10,000 deaths annually.

CHEST

In 2023, the US Food and Drug Administration approved the adjuvanted RSVPreF3 vaccine (Arexvy, GSK) and the bivalent RSVPreF vaccine (Abrysvo, Pfizer). Both vaccines have been shown to significantly reduce the risk of developing RSV LRTI and are currently recommended for single-dose administration in adults 60 years or older—irrespective of comorbidities.

RSV has been well established as a major cause of LRTI and morbidity among infants. Maternal vaccination with RSVPreF in patients who are pregnant is suggested between 32 0/7 and 36 6/7 weeks of gestation if the date of delivery falls during RSV season to prevent severe illness in young infants in their first months of life. At present, there are no data supporting vaccine administration to patients who are pregnant delivering outside of the RSV season.

CHEST

Resources

1. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(29):793-801.

2. Healthcare Providers: RSV Vaccination for Adults 60 Years of Age and Over. Centers for Disease Control and Prevention. Updated March 1, 2024. https://www.cdc.gov/vaccines/vpd/rsv/hcp/older-adults.html

3. Ault KA, Hughes BL, Riley LE. Maternal Respiratory Syncytial Virus Vaccination. The American College of Obstetricians and Gynecologists. Updated December 11, 2023. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccination

TOPLINE:

Pediatric patients with atopic dermatitis (AD) who are prescribed dupilumab may be at a reduced risk for atopic march progression, defined as the development of asthma or allergic rhinitis.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using data from the US Collaborative Network, focusing on pediatric patients aged 18 years and younger with two AD diagnoses at least 30 days apart.
• Patients were divided into two cohorts: Those treated with dupilumab (n = 2192) and those who received conventional therapies (n = 2192), including systemic corticosteroids or conventional immunomodulators. They were stratified into three age groups: Preschoolers (< 6 years), school-aged children (6 to < 12 years), and adolescents (12-18 years).
• Both cohorts underwent 1:1 propensity score matching based on current age, age at index (first prescription of dupilumab or conventional therapy), sex, race, comorbidities, laboratory measurements, and prior medications. The primary outcome was atopic march progression, defined by incident asthma or allergic rhinitis.

TAKEAWAY:

• Over 3 years, the dupilumab-treated cohort had a significantly lower cumulative incidence of atopic march progression (20.09% vs 27.22%; P < .001), asthma (9.43% vs 14.64%; P = .001), and allergic rhinitis (13.57% vs 20.52%; P = .003) than the conventional therapy cohort.
• The risk for atopic march progression, asthma, and allergic rhinitis was also significantly reduced by 32%, 40%, and 31%, respectively, in the dupilumab vs conventional therapy cohort.
• Age-specific analyses found that the protective effect of dupilumab against allergic rhinitis was the most pronounced in adolescents (hazard ratio [HR], 0.503; 95% CI, 0.322-0.784), followed by school-aged children (HR, 0.577; 95% CI, 0.399-0.834), and preschoolers (HR, 0.623; 95% CI, 0.412-0.942).
• However, dupilumab was associated with reduced risk for asthma only in preschoolers (HR, 0.427; 95% CI, 0.247-0.738) and not in school-aged children or adolescents.

IN PRACTICE:

“Dupilumab in AD not only treats the disease but may influence atopic march mechanisms, suggesting its role as a disease-modifying atopic march drug,” the authors wrote, adding that more research “with extended follow-up and proof-of-concept is warranted.”

SOURCE:

The study was led by Teng-Li Lin, MD, Department of Dermatology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan, and was published online on June 13, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The observational nature of the study limited the ability to infer direct causality between dupilumab use and reduced atopic march risk. Lack of detailed information on AD severity, total dosage, and duration of medication treatment may affect the interpretation of the study’s findings. The demographic data suggest that the dupilumab cohort had more severe AD, so the observed risk reduction may be greater than that reported in this study.

DISCLOSURES:

The study was supported in part by the National Science and Technology Council, Taiwan, and Taichung Veterans General Hospital. The authors had no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com .

TOPLINE:

Pediatric patients with atopic dermatitis (AD) who are prescribed dupilumab may be at a reduced risk for atopic march progression, defined as the development of asthma or allergic rhinitis.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using data from the US Collaborative Network, focusing on pediatric patients aged 18 years and younger with two AD diagnoses at least 30 days apart.
• Patients were divided into two cohorts: Those treated with dupilumab (n = 2192) and those who received conventional therapies (n = 2192), including systemic corticosteroids or conventional immunomodulators. They were stratified into three age groups: Preschoolers (< 6 years), school-aged children (6 to < 12 years), and adolescents (12-18 years).
• Both cohorts underwent 1:1 propensity score matching based on current age, age at index (first prescription of dupilumab or conventional therapy), sex, race, comorbidities, laboratory measurements, and prior medications. The primary outcome was atopic march progression, defined by incident asthma or allergic rhinitis.

TAKEAWAY:

• Over 3 years, the dupilumab-treated cohort had a significantly lower cumulative incidence of atopic march progression (20.09% vs 27.22%; P < .001), asthma (9.43% vs 14.64%; P = .001), and allergic rhinitis (13.57% vs 20.52%; P = .003) than the conventional therapy cohort.
• The risk for atopic march progression, asthma, and allergic rhinitis was also significantly reduced by 32%, 40%, and 31%, respectively, in the dupilumab vs conventional therapy cohort.
• Age-specific analyses found that the protective effect of dupilumab against allergic rhinitis was the most pronounced in adolescents (hazard ratio [HR], 0.503; 95% CI, 0.322-0.784), followed by school-aged children (HR, 0.577; 95% CI, 0.399-0.834), and preschoolers (HR, 0.623; 95% CI, 0.412-0.942).
• However, dupilumab was associated with reduced risk for asthma only in preschoolers (HR, 0.427; 95% CI, 0.247-0.738) and not in school-aged children or adolescents.

IN PRACTICE:

“Dupilumab in AD not only treats the disease but may influence atopic march mechanisms, suggesting its role as a disease-modifying atopic march drug,” the authors wrote, adding that more research “with extended follow-up and proof-of-concept is warranted.”

SOURCE:

The study was led by Teng-Li Lin, MD, Department of Dermatology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan, and was published online on June 13, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The observational nature of the study limited the ability to infer direct causality between dupilumab use and reduced atopic march risk. Lack of detailed information on AD severity, total dosage, and duration of medication treatment may affect the interpretation of the study’s findings. The demographic data suggest that the dupilumab cohort had more severe AD, so the observed risk reduction may be greater than that reported in this study.

DISCLOSURES:

The study was supported in part by the National Science and Technology Council, Taiwan, and Taichung Veterans General Hospital. The authors had no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com .

TOPLINE:

Pediatric patients with atopic dermatitis (AD) who are prescribed dupilumab may be at a reduced risk for atopic march progression, defined as the development of asthma or allergic rhinitis.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using data from the US Collaborative Network, focusing on pediatric patients aged 18 years and younger with two AD diagnoses at least 30 days apart.
• Patients were divided into two cohorts: Those treated with dupilumab (n = 2192) and those who received conventional therapies (n = 2192), including systemic corticosteroids or conventional immunomodulators. They were stratified into three age groups: Preschoolers (< 6 years), school-aged children (6 to < 12 years), and adolescents (12-18 years).
• Both cohorts underwent 1:1 propensity score matching based on current age, age at index (first prescription of dupilumab or conventional therapy), sex, race, comorbidities, laboratory measurements, and prior medications. The primary outcome was atopic march progression, defined by incident asthma or allergic rhinitis.

TAKEAWAY:

• Over 3 years, the dupilumab-treated cohort had a significantly lower cumulative incidence of atopic march progression (20.09% vs 27.22%; P < .001), asthma (9.43% vs 14.64%; P = .001), and allergic rhinitis (13.57% vs 20.52%; P = .003) than the conventional therapy cohort.
• The risk for atopic march progression, asthma, and allergic rhinitis was also significantly reduced by 32%, 40%, and 31%, respectively, in the dupilumab vs conventional therapy cohort.
• Age-specific analyses found that the protective effect of dupilumab against allergic rhinitis was the most pronounced in adolescents (hazard ratio [HR], 0.503; 95% CI, 0.322-0.784), followed by school-aged children (HR, 0.577; 95% CI, 0.399-0.834), and preschoolers (HR, 0.623; 95% CI, 0.412-0.942).
• However, dupilumab was associated with reduced risk for asthma only in preschoolers (HR, 0.427; 95% CI, 0.247-0.738) and not in school-aged children or adolescents.

IN PRACTICE:

“Dupilumab in AD not only treats the disease but may influence atopic march mechanisms, suggesting its role as a disease-modifying atopic march drug,” the authors wrote, adding that more research “with extended follow-up and proof-of-concept is warranted.”

SOURCE:

The study was led by Teng-Li Lin, MD, Department of Dermatology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan, and was published online on June 13, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The observational nature of the study limited the ability to infer direct causality between dupilumab use and reduced atopic march risk. Lack of detailed information on AD severity, total dosage, and duration of medication treatment may affect the interpretation of the study’s findings. The demographic data suggest that the dupilumab cohort had more severe AD, so the observed risk reduction may be greater than that reported in this study.

DISCLOSURES:

The study was supported in part by the National Science and Technology Council, Taiwan, and Taichung Veterans General Hospital. The authors had no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com .

PARIS — Pregnancy is a period of asthma instability; it entails an increased risk for exacerbations. While therapeutic de-escalation, if not the outright cessation of maintenance treatment, is common, experts used the 19th Francophone Congress of Allergology to emphasize the importance of well-controlled asthma for the mother, the fetus, and the pregnancy.

About 12% of women of childbearing age have asthma. It is the most common chronic condition in pregnant women. Pregnancy affects asthma, and vice versa. Due to mechanical, hormonal, and immunological changes, allergic conditions, including asthma, can worsen.

First, pregnancy exerts mechanical pressure on respiratory function because of the progressive increase in uterine volume, diaphragm elevation, and various anatomical changes leading to chest expansion. The latter changes include increased subcostal angle, anteroposterior and transverse diameters, and thoracic circumference. 

Respiratory function is affected, with a decrease in functional residual capacity and expiratory reserve volume but an increase in inspiratory capacity, maximal ventilation, and tidal volume. The resulting hyperventilation manifests clinically as dyspnea, which affects up to 70% of pregnant women and can be mistaken for exacerbation symptoms.

Besides mechanical impact, hormonal changes occur during pregnancy, including elevated estrogen and progesterone levels. Placental hormones increase during the third trimester. These steroid hormones weaken the respiratory mucosa through structural changes in the bronchial wall and the activity of inflammatory cells involved in asthma, while influencing bronchial muscle tone. Estrogens have a dual effect. They are immunostimulatory at low doses and immunosuppressive at high doses (as in late pregnancy). This phenomenon suggests a role in immune tolerance toward the fetus.
 

The Rule of Thirds

Asthma progression during pregnancy is unpredictable. According to older studies, about one third of cases remain stable, one third worsen, and one third improve. In 60% of cases, the course remains similar from one pregnancy to another. Pregnancy is considered a period of asthma instability, with a doubled risk for exacerbation compared with nonpregnant women. Several pregnancy-specific factors contribute, including gastroesophageal reflux, excessive weight gain, active or passive smoking, and usual risk factors like infections. However, the main risk factor for exacerbation and loss of asthma control is insufficient maintenance treatment.

“The control of asthma during pregnancy is influenced by pregnancy itself, but especially by the severity of the disease before pregnancy and the underuse of inhaled corticosteroids,” said Mohammed Tawfik el Fassy Fihry, MD, pulmonologist at Ibn Sina Souissi Hospital in Rabat, Morocco. “This treatment insufficiency is the main cause of poor asthma control and sometimes of severe exacerbations.”
 

Inhaled Corticosteroid Often Insufficient

A 2017 study conducted in France found that one third of women had their asthma treatment reduced in the first trimester of pregnancy. Another observation was the frequent replacement of fixed combinations (such as long- and short-acting bronchodilators and inhaled corticosteroids) with simple inhaled corticosteroid therapy.

“A significant proportion of pregnant women on maintenance therapy decide to stop it as soon as they discover their pregnancy,” said Chantal Raherison-Semjen, PhD, coordinator of the Women and Lung group of the French Society of Pulmonology (SPLF) and of the pulmonology department at the University Hospital of Pointe-à-Pitre in Guadeloupe, France. “Treating physicians also often opt for therapeutic de-escalation, which involves stopping long-acting bronchodilators in favor of only inhaled corticosteroid therapy, which is usually insufficient for optimal asthma control.”

In severe exacerbations, especially during the first trimester of pregnancy, poorly controlled asthma can lead to complications in fetal development, such as low birth weight, intrauterine growth retardation, prematurity, and congenital malformations.

It can also affect maternal health by increasing the risk for gestational diabetes and affecting the course of pregnancy itself, favoring the occurrence of preeclampsia, placenta previa, placental abruption, premature rupture of membranes, spontaneous miscarriage, cesarean section, and hemorrhagic complications before and after delivery.

“When a pregnant woman presents to the emergency room due to an asthma exacerbation, physicians are often reluctant to administer optimal treatment for fear of the effects of bronchodilators and systemic corticosteroids,” said Dr. Raherison-Semjen. “As a result, these women generally receive less effective treatment in such situations, compared with nonpregnant women. This is despite the risk that severe asthma exacerbations pose to the mother and her child.”
 

‘Pregnant Woman’ Pictogram

In France, manufacturers of teratogenic or fetotoxic drugs are required to display a pictogram on the label indicating the danger for pregnant women or the fetus. The guidelines for this labeling are left to the discretion of the laboratories, however, which sometimes leads to unjustified warnings on the packaging of inhaled corticosteroids or emergency treatments. French medical societies were not consulted on this matter, which complicates prescriptions for pregnant asthmatic women, said Dr. Raherison-Semjen. The SPLF condemns the harmful effects of this decision.

Corticosteroids and Omalizumab

“Given the low, if any, risks associated with the main asthma treatments for the mother and fetus, continuing treatments started before conception is highly recommended,” said Dr. Raherison-Semjen. Inhaled corticosteroids, the cornerstone of asthma treatment, are the primary therapy, and the dosage can be adjusted as strictly necessary. “When properly managed, treatment generally allows for asthma control and reduces the risk for complications during pregnancy to the same level observed in the general population.”

Depending on asthma control levels, long-acting beta-2 agonists (eg, formoterol, salmeterol, and indacaterol) can be added, and possibly leukotriene antagonists. Before pregnancy, prescribed medications should be continued, including biologics prescribed for severe asthma. The exception is omalizumab, which can be started during pregnancy without risk.

For its part, allergen immunotherapy should also be maintained but without dose increases. Oral corticosteroids are reserved for severe exacerbations.

As specified by the GINA report of 2023, the benefits of active asthma treatment during pregnancy far outweigh the risks of usual asthma medications (Level A). This view is supported by reassuring data from the Reference Center for Teratogenic Agents. “There is no scientific-medical evidence justifying that pregnant women with asthma should not be treated the same way as when they are not pregnant,” said Dr. Raherison-Semjen.
 

Useful Links

The Asthma Control Test is a quick questionnaire that allows practitioners to ensure their patient›s asthma control. A score below 20 of 25 indicates poor asthma control. It has been specifically validated for pregnancy.

Dr. Tawfik el Fassy Fihry reported having no relevant financial relationships. Dr. Raherison-Semjen reported receiving compensation from AstraZeneca, B. Ingelheim, ALK, Novartis, Banook, GSK, and Mundi Pharma.

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

PARIS — Pregnancy is a period of asthma instability; it entails an increased risk for exacerbations. While therapeutic de-escalation, if not the outright cessation of maintenance treatment, is common, experts used the 19th Francophone Congress of Allergology to emphasize the importance of well-controlled asthma for the mother, the fetus, and the pregnancy.

About 12% of women of childbearing age have asthma. It is the most common chronic condition in pregnant women. Pregnancy affects asthma, and vice versa. Due to mechanical, hormonal, and immunological changes, allergic conditions, including asthma, can worsen.

First, pregnancy exerts mechanical pressure on respiratory function because of the progressive increase in uterine volume, diaphragm elevation, and various anatomical changes leading to chest expansion. The latter changes include increased subcostal angle, anteroposterior and transverse diameters, and thoracic circumference. 

Respiratory function is affected, with a decrease in functional residual capacity and expiratory reserve volume but an increase in inspiratory capacity, maximal ventilation, and tidal volume. The resulting hyperventilation manifests clinically as dyspnea, which affects up to 70% of pregnant women and can be mistaken for exacerbation symptoms.

Besides mechanical impact, hormonal changes occur during pregnancy, including elevated estrogen and progesterone levels. Placental hormones increase during the third trimester. These steroid hormones weaken the respiratory mucosa through structural changes in the bronchial wall and the activity of inflammatory cells involved in asthma, while influencing bronchial muscle tone. Estrogens have a dual effect. They are immunostimulatory at low doses and immunosuppressive at high doses (as in late pregnancy). This phenomenon suggests a role in immune tolerance toward the fetus.
 

The Rule of Thirds

Asthma progression during pregnancy is unpredictable. According to older studies, about one third of cases remain stable, one third worsen, and one third improve. In 60% of cases, the course remains similar from one pregnancy to another. Pregnancy is considered a period of asthma instability, with a doubled risk for exacerbation compared with nonpregnant women. Several pregnancy-specific factors contribute, including gastroesophageal reflux, excessive weight gain, active or passive smoking, and usual risk factors like infections. However, the main risk factor for exacerbation and loss of asthma control is insufficient maintenance treatment.

“The control of asthma during pregnancy is influenced by pregnancy itself, but especially by the severity of the disease before pregnancy and the underuse of inhaled corticosteroids,” said Mohammed Tawfik el Fassy Fihry, MD, pulmonologist at Ibn Sina Souissi Hospital in Rabat, Morocco. “This treatment insufficiency is the main cause of poor asthma control and sometimes of severe exacerbations.”
 

Inhaled Corticosteroid Often Insufficient

A 2017 study conducted in France found that one third of women had their asthma treatment reduced in the first trimester of pregnancy. Another observation was the frequent replacement of fixed combinations (such as long- and short-acting bronchodilators and inhaled corticosteroids) with simple inhaled corticosteroid therapy.

“A significant proportion of pregnant women on maintenance therapy decide to stop it as soon as they discover their pregnancy,” said Chantal Raherison-Semjen, PhD, coordinator of the Women and Lung group of the French Society of Pulmonology (SPLF) and of the pulmonology department at the University Hospital of Pointe-à-Pitre in Guadeloupe, France. “Treating physicians also often opt for therapeutic de-escalation, which involves stopping long-acting bronchodilators in favor of only inhaled corticosteroid therapy, which is usually insufficient for optimal asthma control.”

In severe exacerbations, especially during the first trimester of pregnancy, poorly controlled asthma can lead to complications in fetal development, such as low birth weight, intrauterine growth retardation, prematurity, and congenital malformations.

It can also affect maternal health by increasing the risk for gestational diabetes and affecting the course of pregnancy itself, favoring the occurrence of preeclampsia, placenta previa, placental abruption, premature rupture of membranes, spontaneous miscarriage, cesarean section, and hemorrhagic complications before and after delivery.

“When a pregnant woman presents to the emergency room due to an asthma exacerbation, physicians are often reluctant to administer optimal treatment for fear of the effects of bronchodilators and systemic corticosteroids,” said Dr. Raherison-Semjen. “As a result, these women generally receive less effective treatment in such situations, compared with nonpregnant women. This is despite the risk that severe asthma exacerbations pose to the mother and her child.”
 

‘Pregnant Woman’ Pictogram

In France, manufacturers of teratogenic or fetotoxic drugs are required to display a pictogram on the label indicating the danger for pregnant women or the fetus. The guidelines for this labeling are left to the discretion of the laboratories, however, which sometimes leads to unjustified warnings on the packaging of inhaled corticosteroids or emergency treatments. French medical societies were not consulted on this matter, which complicates prescriptions for pregnant asthmatic women, said Dr. Raherison-Semjen. The SPLF condemns the harmful effects of this decision.

Corticosteroids and Omalizumab

“Given the low, if any, risks associated with the main asthma treatments for the mother and fetus, continuing treatments started before conception is highly recommended,” said Dr. Raherison-Semjen. Inhaled corticosteroids, the cornerstone of asthma treatment, are the primary therapy, and the dosage can be adjusted as strictly necessary. “When properly managed, treatment generally allows for asthma control and reduces the risk for complications during pregnancy to the same level observed in the general population.”

Depending on asthma control levels, long-acting beta-2 agonists (eg, formoterol, salmeterol, and indacaterol) can be added, and possibly leukotriene antagonists. Before pregnancy, prescribed medications should be continued, including biologics prescribed for severe asthma. The exception is omalizumab, which can be started during pregnancy without risk.

For its part, allergen immunotherapy should also be maintained but without dose increases. Oral corticosteroids are reserved for severe exacerbations.

As specified by the GINA report of 2023, the benefits of active asthma treatment during pregnancy far outweigh the risks of usual asthma medications (Level A). This view is supported by reassuring data from the Reference Center for Teratogenic Agents. “There is no scientific-medical evidence justifying that pregnant women with asthma should not be treated the same way as when they are not pregnant,” said Dr. Raherison-Semjen.
 

Useful Links

The Asthma Control Test is a quick questionnaire that allows practitioners to ensure their patient›s asthma control. A score below 20 of 25 indicates poor asthma control. It has been specifically validated for pregnancy.

Dr. Tawfik el Fassy Fihry reported having no relevant financial relationships. Dr. Raherison-Semjen reported receiving compensation from AstraZeneca, B. Ingelheim, ALK, Novartis, Banook, GSK, and Mundi Pharma.

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

PARIS — Pregnancy is a period of asthma instability; it entails an increased risk for exacerbations. While therapeutic de-escalation, if not the outright cessation of maintenance treatment, is common, experts used the 19th Francophone Congress of Allergology to emphasize the importance of well-controlled asthma for the mother, the fetus, and the pregnancy.

About 12% of women of childbearing age have asthma. It is the most common chronic condition in pregnant women. Pregnancy affects asthma, and vice versa. Due to mechanical, hormonal, and immunological changes, allergic conditions, including asthma, can worsen.

First, pregnancy exerts mechanical pressure on respiratory function because of the progressive increase in uterine volume, diaphragm elevation, and various anatomical changes leading to chest expansion. The latter changes include increased subcostal angle, anteroposterior and transverse diameters, and thoracic circumference. 

Respiratory function is affected, with a decrease in functional residual capacity and expiratory reserve volume but an increase in inspiratory capacity, maximal ventilation, and tidal volume. The resulting hyperventilation manifests clinically as dyspnea, which affects up to 70% of pregnant women and can be mistaken for exacerbation symptoms.

Besides mechanical impact, hormonal changes occur during pregnancy, including elevated estrogen and progesterone levels. Placental hormones increase during the third trimester. These steroid hormones weaken the respiratory mucosa through structural changes in the bronchial wall and the activity of inflammatory cells involved in asthma, while influencing bronchial muscle tone. Estrogens have a dual effect. They are immunostimulatory at low doses and immunosuppressive at high doses (as in late pregnancy). This phenomenon suggests a role in immune tolerance toward the fetus.
 

The Rule of Thirds

Asthma progression during pregnancy is unpredictable. According to older studies, about one third of cases remain stable, one third worsen, and one third improve. In 60% of cases, the course remains similar from one pregnancy to another. Pregnancy is considered a period of asthma instability, with a doubled risk for exacerbation compared with nonpregnant women. Several pregnancy-specific factors contribute, including gastroesophageal reflux, excessive weight gain, active or passive smoking, and usual risk factors like infections. However, the main risk factor for exacerbation and loss of asthma control is insufficient maintenance treatment.

“The control of asthma during pregnancy is influenced by pregnancy itself, but especially by the severity of the disease before pregnancy and the underuse of inhaled corticosteroids,” said Mohammed Tawfik el Fassy Fihry, MD, pulmonologist at Ibn Sina Souissi Hospital in Rabat, Morocco. “This treatment insufficiency is the main cause of poor asthma control and sometimes of severe exacerbations.”
 

Inhaled Corticosteroid Often Insufficient

A 2017 study conducted in France found that one third of women had their asthma treatment reduced in the first trimester of pregnancy. Another observation was the frequent replacement of fixed combinations (such as long- and short-acting bronchodilators and inhaled corticosteroids) with simple inhaled corticosteroid therapy.

“A significant proportion of pregnant women on maintenance therapy decide to stop it as soon as they discover their pregnancy,” said Chantal Raherison-Semjen, PhD, coordinator of the Women and Lung group of the French Society of Pulmonology (SPLF) and of the pulmonology department at the University Hospital of Pointe-à-Pitre in Guadeloupe, France. “Treating physicians also often opt for therapeutic de-escalation, which involves stopping long-acting bronchodilators in favor of only inhaled corticosteroid therapy, which is usually insufficient for optimal asthma control.”

In severe exacerbations, especially during the first trimester of pregnancy, poorly controlled asthma can lead to complications in fetal development, such as low birth weight, intrauterine growth retardation, prematurity, and congenital malformations.

It can also affect maternal health by increasing the risk for gestational diabetes and affecting the course of pregnancy itself, favoring the occurrence of preeclampsia, placenta previa, placental abruption, premature rupture of membranes, spontaneous miscarriage, cesarean section, and hemorrhagic complications before and after delivery.

“When a pregnant woman presents to the emergency room due to an asthma exacerbation, physicians are often reluctant to administer optimal treatment for fear of the effects of bronchodilators and systemic corticosteroids,” said Dr. Raherison-Semjen. “As a result, these women generally receive less effective treatment in such situations, compared with nonpregnant women. This is despite the risk that severe asthma exacerbations pose to the mother and her child.”
 

‘Pregnant Woman’ Pictogram

In France, manufacturers of teratogenic or fetotoxic drugs are required to display a pictogram on the label indicating the danger for pregnant women or the fetus. The guidelines for this labeling are left to the discretion of the laboratories, however, which sometimes leads to unjustified warnings on the packaging of inhaled corticosteroids or emergency treatments. French medical societies were not consulted on this matter, which complicates prescriptions for pregnant asthmatic women, said Dr. Raherison-Semjen. The SPLF condemns the harmful effects of this decision.

Corticosteroids and Omalizumab

“Given the low, if any, risks associated with the main asthma treatments for the mother and fetus, continuing treatments started before conception is highly recommended,” said Dr. Raherison-Semjen. Inhaled corticosteroids, the cornerstone of asthma treatment, are the primary therapy, and the dosage can be adjusted as strictly necessary. “When properly managed, treatment generally allows for asthma control and reduces the risk for complications during pregnancy to the same level observed in the general population.”

Depending on asthma control levels, long-acting beta-2 agonists (eg, formoterol, salmeterol, and indacaterol) can be added, and possibly leukotriene antagonists. Before pregnancy, prescribed medications should be continued, including biologics prescribed for severe asthma. The exception is omalizumab, which can be started during pregnancy without risk.

For its part, allergen immunotherapy should also be maintained but without dose increases. Oral corticosteroids are reserved for severe exacerbations.

As specified by the GINA report of 2023, the benefits of active asthma treatment during pregnancy far outweigh the risks of usual asthma medications (Level A). This view is supported by reassuring data from the Reference Center for Teratogenic Agents. “There is no scientific-medical evidence justifying that pregnant women with asthma should not be treated the same way as when they are not pregnant,” said Dr. Raherison-Semjen.
 

Useful Links

The Asthma Control Test is a quick questionnaire that allows practitioners to ensure their patient›s asthma control. A score below 20 of 25 indicates poor asthma control. It has been specifically validated for pregnancy.

Dr. Tawfik el Fassy Fihry reported having no relevant financial relationships. Dr. Raherison-Semjen reported receiving compensation from AstraZeneca, B. Ingelheim, ALK, Novartis, Banook, GSK, and Mundi Pharma.

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Use of biologics significantly reduced exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD) and overlapping type 2 asthma inflammation, based on data from a new study presented at the American Thoracic Society’s international conference.

Patients diagnosed with COPD on maximum medical therapy may continue to have disease exacerbations that are highly morbid and are associated with worsening lung function, increased hospitalizations, and worsened mortality, said lead author Stephen Dachert, MD, Temple University Hospital, Philadelphia, in an interview.

“Biologic therapy has been shown to reduce exacerbations in type 2 airway inflammation in patients with asthma and may be a potential target in patients with COPD and type 2 inflammation,” he said. In type 2 inflammation, a systematic allergic response activates immune cells, including eosinophils, mast cells, and T cells.

Previous research has examined the association between use of individual biologics and reduction in acute exacerbations of COPD, but real-world data on the use of biologics for COPD and asthma-COPD overlap syndrome (ACOS) are lacking, Dr. Dachert and colleagues wrote in their abstract.

In the current study, the researchers reviewed data from 53 adults with COPD who were seen at a single center; 30 had ACOS, and 23 had COPD only. The mean age of the participants was 68.2 years, approximately half were White/Caucasian individuals, 26% were Black/African American individuals, 17% were Hispanic individuals, 4% were Asian individuals/Pacific Islanders, and 2% were from other races/ethnicities; 62% were women. The study population included patients with prior diagnosis codes for COPD and dupilumab, mepolizumab, benralizumab, or tezepelumab; the mean eosinophil count before biologics initiation was 471.
 

Reduction in Exacerbations and Hospitalizations

The researchers assessed change in exacerbations, hospitalizations, and spirometry from 1 year before to 1 year after initiation of treatment with biologics. Overall, after the use of biologics, patients experienced a significant mean reduction in exacerbations and hospitalizations of 1.780 and 0.944, respectively (both P < .001, using a paired T-test). 

In addition, the researchers found a mean reduction of forced expiratory volume per second percent predicted of 0.57% and a mean increase in forced vital capacity percent predicted of 1.3% after the initiation of biologics.

Increases also occurred in total lung capacity percent predicted, residual volume percent predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted (3.37%, 9.90%, and 4.58%, respectively). Of these, only DLCO percent predicted approached statistical significance, the researchers wrote.

The study findings make sense physiologically, Dr. Dachert said in an interview. “If large, randomized trials have shown a reduction in exacerbations in patients with type 2 inflammation asthma, it makes sense that we would see similar results in patients with COPD and type 2 inflammation,” he said. However, as yet only one of several large randomized trials has shown reductions in exacerbations and COPD with type 2 inflammation, he added.

“In our real-world cohort, we saw both a reduction in exacerbations and hospitalizations in the year following initiation of biologic therapy,” Dr. Dachert said. A reduction in hospitalizations, in particular, had not previously been shown in this population, he noted.

The findings were limited by the retrospective design and use of data from a single center; moreover, larger real-world studies are needed to confirm the results, said Dr. Dachert. “As we add patients to our cohort, we may be able to identify which clinical characteristics/risk factors may be associated with an even more robust reduction in exacerbations or hospitalizations,” he said.

“Our cohort of patients was more diverse than those included in prior randomized clinical trials and also has high rates of emphysema and airflow obstruction, populations typically excluded in large randomized trials,” he said.
 

Data Support the Potential of Biologics for COPD

Biologic agents have been effective in reducing asthma exacerbations, and understanding their effectiveness in reducing COPD exacerbations in a real-world setting is important, said Arianne K. Baldomero, MD, assistant professor of medicine at Minneapolis VA Health Care System, Minneapolis, in an interview.

Dr, Baldomero said she was not surprised by the current study results “as clinical trials are showing similar findings among this group of patients with elevated eosinophil counts.”

The current study adds to the growing evidence supporting the use of biologics to reduce COPD exacerbations, Dr. Baldomero told this news organization. “I anticipate that we will soon begin using biologics to manage frequent exacerbations in patients with COPD,” she said.

“For both asthma and COPD, more research is needed to guide clinicians in tapering or weaning down biologic treatment and determining whether patients still need to use inhalers,” Dr. Baldomero added.

The study received no outside funding. The researchers and Dr. Baldomero had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Use of biologics significantly reduced exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD) and overlapping type 2 asthma inflammation, based on data from a new study presented at the American Thoracic Society’s international conference.

Patients diagnosed with COPD on maximum medical therapy may continue to have disease exacerbations that are highly morbid and are associated with worsening lung function, increased hospitalizations, and worsened mortality, said lead author Stephen Dachert, MD, Temple University Hospital, Philadelphia, in an interview.

“Biologic therapy has been shown to reduce exacerbations in type 2 airway inflammation in patients with asthma and may be a potential target in patients with COPD and type 2 inflammation,” he said. In type 2 inflammation, a systematic allergic response activates immune cells, including eosinophils, mast cells, and T cells.

Previous research has examined the association between use of individual biologics and reduction in acute exacerbations of COPD, but real-world data on the use of biologics for COPD and asthma-COPD overlap syndrome (ACOS) are lacking, Dr. Dachert and colleagues wrote in their abstract.

In the current study, the researchers reviewed data from 53 adults with COPD who were seen at a single center; 30 had ACOS, and 23 had COPD only. The mean age of the participants was 68.2 years, approximately half were White/Caucasian individuals, 26% were Black/African American individuals, 17% were Hispanic individuals, 4% were Asian individuals/Pacific Islanders, and 2% were from other races/ethnicities; 62% were women. The study population included patients with prior diagnosis codes for COPD and dupilumab, mepolizumab, benralizumab, or tezepelumab; the mean eosinophil count before biologics initiation was 471.
 

Reduction in Exacerbations and Hospitalizations

The researchers assessed change in exacerbations, hospitalizations, and spirometry from 1 year before to 1 year after initiation of treatment with biologics. Overall, after the use of biologics, patients experienced a significant mean reduction in exacerbations and hospitalizations of 1.780 and 0.944, respectively (both P < .001, using a paired T-test). 

In addition, the researchers found a mean reduction of forced expiratory volume per second percent predicted of 0.57% and a mean increase in forced vital capacity percent predicted of 1.3% after the initiation of biologics.

Increases also occurred in total lung capacity percent predicted, residual volume percent predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted (3.37%, 9.90%, and 4.58%, respectively). Of these, only DLCO percent predicted approached statistical significance, the researchers wrote.

The study findings make sense physiologically, Dr. Dachert said in an interview. “If large, randomized trials have shown a reduction in exacerbations in patients with type 2 inflammation asthma, it makes sense that we would see similar results in patients with COPD and type 2 inflammation,” he said. However, as yet only one of several large randomized trials has shown reductions in exacerbations and COPD with type 2 inflammation, he added.

“In our real-world cohort, we saw both a reduction in exacerbations and hospitalizations in the year following initiation of biologic therapy,” Dr. Dachert said. A reduction in hospitalizations, in particular, had not previously been shown in this population, he noted.

The findings were limited by the retrospective design and use of data from a single center; moreover, larger real-world studies are needed to confirm the results, said Dr. Dachert. “As we add patients to our cohort, we may be able to identify which clinical characteristics/risk factors may be associated with an even more robust reduction in exacerbations or hospitalizations,” he said.

“Our cohort of patients was more diverse than those included in prior randomized clinical trials and also has high rates of emphysema and airflow obstruction, populations typically excluded in large randomized trials,” he said.
 

Data Support the Potential of Biologics for COPD

Biologic agents have been effective in reducing asthma exacerbations, and understanding their effectiveness in reducing COPD exacerbations in a real-world setting is important, said Arianne K. Baldomero, MD, assistant professor of medicine at Minneapolis VA Health Care System, Minneapolis, in an interview.

Dr, Baldomero said she was not surprised by the current study results “as clinical trials are showing similar findings among this group of patients with elevated eosinophil counts.”

The current study adds to the growing evidence supporting the use of biologics to reduce COPD exacerbations, Dr. Baldomero told this news organization. “I anticipate that we will soon begin using biologics to manage frequent exacerbations in patients with COPD,” she said.

“For both asthma and COPD, more research is needed to guide clinicians in tapering or weaning down biologic treatment and determining whether patients still need to use inhalers,” Dr. Baldomero added.

The study received no outside funding. The researchers and Dr. Baldomero had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Use of biologics significantly reduced exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD) and overlapping type 2 asthma inflammation, based on data from a new study presented at the American Thoracic Society’s international conference.

Patients diagnosed with COPD on maximum medical therapy may continue to have disease exacerbations that are highly morbid and are associated with worsening lung function, increased hospitalizations, and worsened mortality, said lead author Stephen Dachert, MD, Temple University Hospital, Philadelphia, in an interview.

“Biologic therapy has been shown to reduce exacerbations in type 2 airway inflammation in patients with asthma and may be a potential target in patients with COPD and type 2 inflammation,” he said. In type 2 inflammation, a systematic allergic response activates immune cells, including eosinophils, mast cells, and T cells.

Previous research has examined the association between use of individual biologics and reduction in acute exacerbations of COPD, but real-world data on the use of biologics for COPD and asthma-COPD overlap syndrome (ACOS) are lacking, Dr. Dachert and colleagues wrote in their abstract.

In the current study, the researchers reviewed data from 53 adults with COPD who were seen at a single center; 30 had ACOS, and 23 had COPD only. The mean age of the participants was 68.2 years, approximately half were White/Caucasian individuals, 26% were Black/African American individuals, 17% were Hispanic individuals, 4% were Asian individuals/Pacific Islanders, and 2% were from other races/ethnicities; 62% were women. The study population included patients with prior diagnosis codes for COPD and dupilumab, mepolizumab, benralizumab, or tezepelumab; the mean eosinophil count before biologics initiation was 471.
 

Reduction in Exacerbations and Hospitalizations

The researchers assessed change in exacerbations, hospitalizations, and spirometry from 1 year before to 1 year after initiation of treatment with biologics. Overall, after the use of biologics, patients experienced a significant mean reduction in exacerbations and hospitalizations of 1.780 and 0.944, respectively (both P < .001, using a paired T-test). 

In addition, the researchers found a mean reduction of forced expiratory volume per second percent predicted of 0.57% and a mean increase in forced vital capacity percent predicted of 1.3% after the initiation of biologics.

Increases also occurred in total lung capacity percent predicted, residual volume percent predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted (3.37%, 9.90%, and 4.58%, respectively). Of these, only DLCO percent predicted approached statistical significance, the researchers wrote.

The study findings make sense physiologically, Dr. Dachert said in an interview. “If large, randomized trials have shown a reduction in exacerbations in patients with type 2 inflammation asthma, it makes sense that we would see similar results in patients with COPD and type 2 inflammation,” he said. However, as yet only one of several large randomized trials has shown reductions in exacerbations and COPD with type 2 inflammation, he added.

“In our real-world cohort, we saw both a reduction in exacerbations and hospitalizations in the year following initiation of biologic therapy,” Dr. Dachert said. A reduction in hospitalizations, in particular, had not previously been shown in this population, he noted.

The findings were limited by the retrospective design and use of data from a single center; moreover, larger real-world studies are needed to confirm the results, said Dr. Dachert. “As we add patients to our cohort, we may be able to identify which clinical characteristics/risk factors may be associated with an even more robust reduction in exacerbations or hospitalizations,” he said.

“Our cohort of patients was more diverse than those included in prior randomized clinical trials and also has high rates of emphysema and airflow obstruction, populations typically excluded in large randomized trials,” he said.
 

Data Support the Potential of Biologics for COPD

Biologic agents have been effective in reducing asthma exacerbations, and understanding their effectiveness in reducing COPD exacerbations in a real-world setting is important, said Arianne K. Baldomero, MD, assistant professor of medicine at Minneapolis VA Health Care System, Minneapolis, in an interview.

Dr, Baldomero said she was not surprised by the current study results “as clinical trials are showing similar findings among this group of patients with elevated eosinophil counts.”

The current study adds to the growing evidence supporting the use of biologics to reduce COPD exacerbations, Dr. Baldomero told this news organization. “I anticipate that we will soon begin using biologics to manage frequent exacerbations in patients with COPD,” she said.

“For both asthma and COPD, more research is needed to guide clinicians in tapering or weaning down biologic treatment and determining whether patients still need to use inhalers,” Dr. Baldomero added.

The study received no outside funding. The researchers and Dr. Baldomero had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Dupilumab significantly reduced exacerbations and improved lung function in adults with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation, based on data from more than 900 individuals.

Data from a phase 3 trial known as NOTUS were presented at the American Thoracic Society’s international conference and published simultaneously in The New England Journal of Medicine.

Dupilumab, a fully human monoclonal antibody, works by inhibiting the signaling of the interleukin 4 (IL-4) and IL-13 pathways and is approved for many conditions characterized by type 2 inflammation, wrote Surya P. Bhatt, MD, of The University of Alabama at Birmingham, and colleagues in the NEJM study.

“Last year, we showed in the BOREAS trial that dupilumab was very effective in lowering exacerbation frequency in patients with COPD who continued to have frequent exacerbations despite being on maximal inhaled therapy,” Dr. Bhatt said in an interview.

12 Months of COPD, Triple Inhaler Therapy

In the NOTUS study, the researchers randomized 470 adults with uncontrolled COPD and type 2 inflammation (defined as a blood eosinophil count of ≥ 300 cells/µL) to 300-mg subcutaneous dupilumab and 465 to a placebo every 2 weeks. Patients were enrolled between July 2020 and May 2023.

The study population included adults aged 40-85 years with physician-diagnosed COPD for at least 12 months who had received background triple inhaler therapy (an inhaled glucocorticoid agent plus long-acting muscarinic antagonist [LAMA]–long-acting beta-agonist [LABA] or LAMA-LABA alone) for at least 3 months and at a stable dose for at least 1 month. All participants were current or former smokers with a smoking history of at least 10 pack-years.

The primary endpoint was a reduction in the annualized rate of moderate or severe COPD exacerbations at 52 weeks.

At 52 weeks, the annualized rate of moderate or severe exacerbations was significantly lower (34%) in the dupilumab group than in the placebo group (0.86 vs 1.30, P < .001).

Patients in the dupilumab group also saw a significantly greater improvement in lung function compared with individuals in the placebo group based on prebronchodilator forced expiratory volume in 1 second from baseline to 12 weeks (least squares mean change of 139 mL vs 57 mL). This improvement was sustained at 52 weeks (least squares mean change of 115 mL vs 54 mL).

Improvement in respiratory symptom severity based on the St. George’s Respiratory Questionnaire was another secondary endpoint, and changes in total score were greater in the dupilumab group than in the placebo group (least squares mean change of 9.8 vs 6.4).

Safety outcomes were similar between the dupilumab and placebo groups, with approximately 66% of patients in each group reporting adverse events during the 52-week study period. Serious adverse events occurred in 13% and 15.9% of dupilumab and placebo patients, respectively, and adverse events resulting in death occurred in 2.6% and 1.5%, respectively. The most common adverse events were COVID-19, which occurred in 9.4% and 8.2% of the dupilumab and placebo patients, respectively, followed by headache, COPD, and nasopharyngitis. Major adverse cardiovascular events occurred in three patients in the dupilumab group and seven patients in the placebo group.

The findings were limited by several factors including the reduced sample size for 52-week endpoints because of the earlier analysis and the primarily White study population, the researchers noted. The study was conducted in part during the COVID-19 pandemic period, which contributed to healthcare disruptions and behavior changes that decreased exposure to viral respiratory infections, they wrote in their discussion. However, the results were strengthened by the large numbers and international population without other major pulmonary diseases, such as asthma, and the 34% reduction in exacerbations with dupilumab vs placebo is clinically significant, they said.

Data May Drive US Food and Drug Administration (FDA) Approval

In the BOREAS trial, dupilumab also improved lung function and quality of life, with no notable safety concerns. “As with any trial evaluating the efficacy and safety of a medication, it is important to confirm the findings in a replicative study,” said Dr. Bhatt. “With NOTUS, we confirmed the findings of BOREAS,” and the researchers were reassured by the substantial reduction in exacerbation frequency and the replication of key secondary outcomes, he said.

With the NOTUS study, “two randomized trials have now shown near identical reductions in exacerbation frequency in a difficult-to-treat population of patients with COPD with type 2 inflammation and frequent exacerbations,” as well as a significant and meaningful improvement in lung function, Dr. Bhatt said in an interview. “We hope these trials pave for the way for regulatory body approval of dupilumab for clinical use,” he said. Looking ahead, more studies are needed to test the potential disease modification effects of dupilumab in patients with COPD, he added.

Potential Change in Patient Management

Approximately 20%-40% of patients with COPD have type 2 inflammation with elevated blood eosinophil count, and this subset of patients has an increased risk for exacerbations, with worsening lung function and quality of life, Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, said in an interview.

Prior phase 3 studies have shown that dupilumab, a blocker of IL-4 and IL-13 pathways, could effectively reduce exacerbations and improve lung function in these patients, and the NOTUS study aimed to confirm the findings in a larger, more diverse population, said Dr. Narendra, who was not involved in the study.

The NOTUS study represents a paradigm shift in the management of COPD patients with type 2 inflammation, said Narendra. “This study validates the previous BOREAS trial and has shown that dupilumab reduces exacerbations, improves lung function and quality of life, and potentially slows disease progression,” she said.

If approved, potential barriers to the use of dupilumab in practice include cost and insurance coverage, education and dissemination of study findings, and limited data on side effects, said Dr. Narendra.

“While the NOTUS study provides valuable insights into the efficacy and safety of dupilumab over 52 weeks, longer-term studies are needed to understand the sustained benefits and risks of continued treatment,” Dr. Narendra told this news organization. “Studies comparing dupilumab with other biological agents and newer COPD treatments could provide insights into its relative efficacy and position in treatment protocols,” she said.

In addition, further research into dupilumab’s underlying mechanisms could provide deeper insights into the pathophysiology of type 2 inflammation in COPD and inform the development of new treatments, Dr. Narendra said. “These steps will help integrate dupilumab more effectively into clinical practice and optimize its use for COPD patients with type 2 inflammation,” she noted.

Dupilumab is undergoing Priority Review by the FDA as an add-on maintenance therapy for adults with uncontrolled COPD and type 2 inflammation, with a target action date of June 27, 2024, according to a company press release.

The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Narendra had no financial conflicts to disclose but serves on the Editorial Advisory Board of CHEST Physician.

A version of this article appeared on Medscape.com.

Dupilumab significantly reduced exacerbations and improved lung function in adults with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation, based on data from more than 900 individuals.

Data from a phase 3 trial known as NOTUS were presented at the American Thoracic Society’s international conference and published simultaneously in The New England Journal of Medicine.

Dupilumab, a fully human monoclonal antibody, works by inhibiting the signaling of the interleukin 4 (IL-4) and IL-13 pathways and is approved for many conditions characterized by type 2 inflammation, wrote Surya P. Bhatt, MD, of The University of Alabama at Birmingham, and colleagues in the NEJM study.

“Last year, we showed in the BOREAS trial that dupilumab was very effective in lowering exacerbation frequency in patients with COPD who continued to have frequent exacerbations despite being on maximal inhaled therapy,” Dr. Bhatt said in an interview.

12 Months of COPD, Triple Inhaler Therapy

In the NOTUS study, the researchers randomized 470 adults with uncontrolled COPD and type 2 inflammation (defined as a blood eosinophil count of ≥ 300 cells/µL) to 300-mg subcutaneous dupilumab and 465 to a placebo every 2 weeks. Patients were enrolled between July 2020 and May 2023.

The study population included adults aged 40-85 years with physician-diagnosed COPD for at least 12 months who had received background triple inhaler therapy (an inhaled glucocorticoid agent plus long-acting muscarinic antagonist [LAMA]–long-acting beta-agonist [LABA] or LAMA-LABA alone) for at least 3 months and at a stable dose for at least 1 month. All participants were current or former smokers with a smoking history of at least 10 pack-years.

The primary endpoint was a reduction in the annualized rate of moderate or severe COPD exacerbations at 52 weeks.

At 52 weeks, the annualized rate of moderate or severe exacerbations was significantly lower (34%) in the dupilumab group than in the placebo group (0.86 vs 1.30, P < .001).

Patients in the dupilumab group also saw a significantly greater improvement in lung function compared with individuals in the placebo group based on prebronchodilator forced expiratory volume in 1 second from baseline to 12 weeks (least squares mean change of 139 mL vs 57 mL). This improvement was sustained at 52 weeks (least squares mean change of 115 mL vs 54 mL).

Improvement in respiratory symptom severity based on the St. George’s Respiratory Questionnaire was another secondary endpoint, and changes in total score were greater in the dupilumab group than in the placebo group (least squares mean change of 9.8 vs 6.4).

Safety outcomes were similar between the dupilumab and placebo groups, with approximately 66% of patients in each group reporting adverse events during the 52-week study period. Serious adverse events occurred in 13% and 15.9% of dupilumab and placebo patients, respectively, and adverse events resulting in death occurred in 2.6% and 1.5%, respectively. The most common adverse events were COVID-19, which occurred in 9.4% and 8.2% of the dupilumab and placebo patients, respectively, followed by headache, COPD, and nasopharyngitis. Major adverse cardiovascular events occurred in three patients in the dupilumab group and seven patients in the placebo group.

The findings were limited by several factors including the reduced sample size for 52-week endpoints because of the earlier analysis and the primarily White study population, the researchers noted. The study was conducted in part during the COVID-19 pandemic period, which contributed to healthcare disruptions and behavior changes that decreased exposure to viral respiratory infections, they wrote in their discussion. However, the results were strengthened by the large numbers and international population without other major pulmonary diseases, such as asthma, and the 34% reduction in exacerbations with dupilumab vs placebo is clinically significant, they said.

Data May Drive US Food and Drug Administration (FDA) Approval

In the BOREAS trial, dupilumab also improved lung function and quality of life, with no notable safety concerns. “As with any trial evaluating the efficacy and safety of a medication, it is important to confirm the findings in a replicative study,” said Dr. Bhatt. “With NOTUS, we confirmed the findings of BOREAS,” and the researchers were reassured by the substantial reduction in exacerbation frequency and the replication of key secondary outcomes, he said.

With the NOTUS study, “two randomized trials have now shown near identical reductions in exacerbation frequency in a difficult-to-treat population of patients with COPD with type 2 inflammation and frequent exacerbations,” as well as a significant and meaningful improvement in lung function, Dr. Bhatt said in an interview. “We hope these trials pave for the way for regulatory body approval of dupilumab for clinical use,” he said. Looking ahead, more studies are needed to test the potential disease modification effects of dupilumab in patients with COPD, he added.

Potential Change in Patient Management

Approximately 20%-40% of patients with COPD have type 2 inflammation with elevated blood eosinophil count, and this subset of patients has an increased risk for exacerbations, with worsening lung function and quality of life, Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, said in an interview.

Prior phase 3 studies have shown that dupilumab, a blocker of IL-4 and IL-13 pathways, could effectively reduce exacerbations and improve lung function in these patients, and the NOTUS study aimed to confirm the findings in a larger, more diverse population, said Dr. Narendra, who was not involved in the study.

The NOTUS study represents a paradigm shift in the management of COPD patients with type 2 inflammation, said Narendra. “This study validates the previous BOREAS trial and has shown that dupilumab reduces exacerbations, improves lung function and quality of life, and potentially slows disease progression,” she said.

If approved, potential barriers to the use of dupilumab in practice include cost and insurance coverage, education and dissemination of study findings, and limited data on side effects, said Dr. Narendra.

“While the NOTUS study provides valuable insights into the efficacy and safety of dupilumab over 52 weeks, longer-term studies are needed to understand the sustained benefits and risks of continued treatment,” Dr. Narendra told this news organization. “Studies comparing dupilumab with other biological agents and newer COPD treatments could provide insights into its relative efficacy and position in treatment protocols,” she said.

In addition, further research into dupilumab’s underlying mechanisms could provide deeper insights into the pathophysiology of type 2 inflammation in COPD and inform the development of new treatments, Dr. Narendra said. “These steps will help integrate dupilumab more effectively into clinical practice and optimize its use for COPD patients with type 2 inflammation,” she noted.

Dupilumab is undergoing Priority Review by the FDA as an add-on maintenance therapy for adults with uncontrolled COPD and type 2 inflammation, with a target action date of June 27, 2024, according to a company press release.

The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Narendra had no financial conflicts to disclose but serves on the Editorial Advisory Board of CHEST Physician.

A version of this article appeared on Medscape.com.

Dupilumab significantly reduced exacerbations and improved lung function in adults with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation, based on data from more than 900 individuals.

Data from a phase 3 trial known as NOTUS were presented at the American Thoracic Society’s international conference and published simultaneously in The New England Journal of Medicine.

Dupilumab, a fully human monoclonal antibody, works by inhibiting the signaling of the interleukin 4 (IL-4) and IL-13 pathways and is approved for many conditions characterized by type 2 inflammation, wrote Surya P. Bhatt, MD, of The University of Alabama at Birmingham, and colleagues in the NEJM study.

“Last year, we showed in the BOREAS trial that dupilumab was very effective in lowering exacerbation frequency in patients with COPD who continued to have frequent exacerbations despite being on maximal inhaled therapy,” Dr. Bhatt said in an interview.

12 Months of COPD, Triple Inhaler Therapy

In the NOTUS study, the researchers randomized 470 adults with uncontrolled COPD and type 2 inflammation (defined as a blood eosinophil count of ≥ 300 cells/µL) to 300-mg subcutaneous dupilumab and 465 to a placebo every 2 weeks. Patients were enrolled between July 2020 and May 2023.

The study population included adults aged 40-85 years with physician-diagnosed COPD for at least 12 months who had received background triple inhaler therapy (an inhaled glucocorticoid agent plus long-acting muscarinic antagonist [LAMA]–long-acting beta-agonist [LABA] or LAMA-LABA alone) for at least 3 months and at a stable dose for at least 1 month. All participants were current or former smokers with a smoking history of at least 10 pack-years.

The primary endpoint was a reduction in the annualized rate of moderate or severe COPD exacerbations at 52 weeks.

At 52 weeks, the annualized rate of moderate or severe exacerbations was significantly lower (34%) in the dupilumab group than in the placebo group (0.86 vs 1.30, P < .001).

Patients in the dupilumab group also saw a significantly greater improvement in lung function compared with individuals in the placebo group based on prebronchodilator forced expiratory volume in 1 second from baseline to 12 weeks (least squares mean change of 139 mL vs 57 mL). This improvement was sustained at 52 weeks (least squares mean change of 115 mL vs 54 mL).

Improvement in respiratory symptom severity based on the St. George’s Respiratory Questionnaire was another secondary endpoint, and changes in total score were greater in the dupilumab group than in the placebo group (least squares mean change of 9.8 vs 6.4).

Safety outcomes were similar between the dupilumab and placebo groups, with approximately 66% of patients in each group reporting adverse events during the 52-week study period. Serious adverse events occurred in 13% and 15.9% of dupilumab and placebo patients, respectively, and adverse events resulting in death occurred in 2.6% and 1.5%, respectively. The most common adverse events were COVID-19, which occurred in 9.4% and 8.2% of the dupilumab and placebo patients, respectively, followed by headache, COPD, and nasopharyngitis. Major adverse cardiovascular events occurred in three patients in the dupilumab group and seven patients in the placebo group.

The findings were limited by several factors including the reduced sample size for 52-week endpoints because of the earlier analysis and the primarily White study population, the researchers noted. The study was conducted in part during the COVID-19 pandemic period, which contributed to healthcare disruptions and behavior changes that decreased exposure to viral respiratory infections, they wrote in their discussion. However, the results were strengthened by the large numbers and international population without other major pulmonary diseases, such as asthma, and the 34% reduction in exacerbations with dupilumab vs placebo is clinically significant, they said.

Data May Drive US Food and Drug Administration (FDA) Approval

In the BOREAS trial, dupilumab also improved lung function and quality of life, with no notable safety concerns. “As with any trial evaluating the efficacy and safety of a medication, it is important to confirm the findings in a replicative study,” said Dr. Bhatt. “With NOTUS, we confirmed the findings of BOREAS,” and the researchers were reassured by the substantial reduction in exacerbation frequency and the replication of key secondary outcomes, he said.

With the NOTUS study, “two randomized trials have now shown near identical reductions in exacerbation frequency in a difficult-to-treat population of patients with COPD with type 2 inflammation and frequent exacerbations,” as well as a significant and meaningful improvement in lung function, Dr. Bhatt said in an interview. “We hope these trials pave for the way for regulatory body approval of dupilumab for clinical use,” he said. Looking ahead, more studies are needed to test the potential disease modification effects of dupilumab in patients with COPD, he added.

Potential Change in Patient Management

Approximately 20%-40% of patients with COPD have type 2 inflammation with elevated blood eosinophil count, and this subset of patients has an increased risk for exacerbations, with worsening lung function and quality of life, Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, said in an interview.

Prior phase 3 studies have shown that dupilumab, a blocker of IL-4 and IL-13 pathways, could effectively reduce exacerbations and improve lung function in these patients, and the NOTUS study aimed to confirm the findings in a larger, more diverse population, said Dr. Narendra, who was not involved in the study.

The NOTUS study represents a paradigm shift in the management of COPD patients with type 2 inflammation, said Narendra. “This study validates the previous BOREAS trial and has shown that dupilumab reduces exacerbations, improves lung function and quality of life, and potentially slows disease progression,” she said.

If approved, potential barriers to the use of dupilumab in practice include cost and insurance coverage, education and dissemination of study findings, and limited data on side effects, said Dr. Narendra.

“While the NOTUS study provides valuable insights into the efficacy and safety of dupilumab over 52 weeks, longer-term studies are needed to understand the sustained benefits and risks of continued treatment,” Dr. Narendra told this news organization. “Studies comparing dupilumab with other biological agents and newer COPD treatments could provide insights into its relative efficacy and position in treatment protocols,” she said.

In addition, further research into dupilumab’s underlying mechanisms could provide deeper insights into the pathophysiology of type 2 inflammation in COPD and inform the development of new treatments, Dr. Narendra said. “These steps will help integrate dupilumab more effectively into clinical practice and optimize its use for COPD patients with type 2 inflammation,” she noted.

Dupilumab is undergoing Priority Review by the FDA as an add-on maintenance therapy for adults with uncontrolled COPD and type 2 inflammation, with a target action date of June 27, 2024, according to a company press release.

The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Narendra had no financial conflicts to disclose but serves on the Editorial Advisory Board of CHEST Physician.

A version of this article appeared on Medscape.com.

SAN DIEGO — You can’t treat patients if you can’t find them. But as investigators in a randomized controlled trial showed, a case-finding method based on spirometry results can identify individuals in the community with undiagnosed chronic obstructive pulmonary disease (COPD) or asthma whose lives could be significantly improved with proper care.

Once they have been identified and randomly assigned to be treated by a pulmonologist and asthma-COPD educator according to clinical guidelines, these previously undiagnosed patients have significant improvements in health care utilization, lung function, symptoms, and quality of life compared with patients randomly assigned to treatment by a general practitioner.

“By diagnosing people early and treating them intensively, you can really improve their quality of life,” said lead investigator Shawn D. Aaron, MD, from the Ottawa Hospital Research Institute and University of Ottawa, Ontario, Canada.

Even those patients in the study who were randomly assigned to receive care from a general practice physician had improvements in lung function and quality of life, although on a smaller scale than patients assigned to a specialty team, Dr. Aaron said at the American Thoracic Society’s international conference.

He reported results of the study in a late-breaking oral abstract session. The study findings were also published online in The New England Journal of Medicine.
 

Undiagnosed diseases

“The simple problem is that 70% of individuals with asthma or COPD are likely undiagnosed,” Dr. Aaron said.

He noted that the 2007-2012 US National Health and Nutritional Examination Survey found obstructive lung disease in 13% of randomly selected US adults, but 71% of these people had never been diagnosed with asthma or COPD.

“So our questions were in this study: One, can we find adults with undiagnosed asthma or COPD in the community? The second question was: If we find them, are they sick? And the third and most important question was: Can we treat them early and improve their health outcomes?” he said.

Asthma and COPD both present with similar respiratory symptoms, including dyspnea, cough, wheeze, and/or chest tightness, and the two conditions share expiratory airflow obstruction as a common physiologic impairment that can be detected with spirometry.
 

Study details

To identify participants, the investigators hired a commercial survey firm to contact households asking whether any member aged 18 years or older had respiratory symptoms such as shortness of breath, wheezing, increased mucus or sputum production, or prolonged cough in the past 6 months. Those who responded yes were then contacted by a trial coordinator, and the symptomatic household member was asked to complete the Asthma Screening Questionnaire over the phone. Participants aged 60 years or older and those younger than 60 years with a score of 6 or higher on the asthma screen also completed the COPD Diagnostic Questionnaire.

Those with a score of 6 or higher on the asthma screen or 20 or higher on the COPD screen were invited to undergo spirometry at a trial site.

The investigators ultimately identified 508 adults with undiagnosed asthma or COPD and randomly assigned them on an equal basis to an intervention group (253 patients) or control group (255 patients).

In the intervention group treatment was provided by a study pulmonologist and asthma-COPD educator who started guideline-based care. Patients were prescribed inhalers and were taught how to use them, and many were given action plans that included smoking cessation aids, exercise and weight counseling, and vaccinations against influenza and pneumonia.

Participants assigned to the control group would receive usual care provided by their primary care practitioner.
 

Improvements abound

During the 12 months of the study, 92% of patients in the intervention group and 60% in the control group were started on new medications for their condition. 

Only 13.4% of those in the intervention group received either no respiratory treatments or a short-acting beta 2 agonist only during the entire trial period compared with 49.8% of controls, “so the usual care arm was undertreated relative to the intervention arm, and because of that under-treatment we saw a tremendous difference in the primary outcome,” Dr. Aaron said.

The primary outcome, the annualized rate of patient-initiated healthcare utilization for respiratory illness, was significantly lower in the intervention group, translating into an incidence rate ratio of 0.48 (P < .001).

Secondary outcomes were also better in the intervention group. For example, total scores on the St. George Respiratory Questionnaire (SGRQ) declined by 10.2 points from baseline in intervention group compared with a 6.8-point drop in the usual-care group. The mean difference was 3.5 points (P = .009). Lower scores on the 0-100 SGRQ scale indicate better health status.

Similarly, total scores on the COPD Assessment Test, a scale of 0-40 with lower scores indicating better health, declined by 3.8 points and 2.6 points, respectively, over 12 months, for a mean difference of 1.3 points (P = .03).

In addition, those in the intervention arm had a 119-mL improvement in forced expiratory volume in 1 second over the 12 months of the study compared with only a 22-mL improvement in the usual-care group.
 

Translatable results?

Dr. Aaron acknowledged that the investigators could have chosen to keep those who were assigned to the control group unaware of their diagnosis during the study but because all patients enrolled were symptomatic, it would have been unethical to do so. All participants were informed of their diagnosis at randomization, and the information was conveyed to each patient’s primary care practitioner as well.

In fact, many patients in the control group decided to seek treatment for either asthma or COPD after learning of their diagnosis, which may have contributed to improved outcomes in the control arm, he said.

“What this means is if you make the diagnosis early in the community, and at least have them see a primary care practitioner, they will improve their quality of life and their health status,” he concluded.

Ravi Kalhan, MD, MS, from the Northwestern University Feinberg School Of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the case-finding model used in the trial would be difficult to replicate elsewhere.

“This idea of seeking out undiagnosed people by doing spirometry, so-called ‘case finding’ as they described it, testing highly symptomatic people with spirometry, is really challenging in the US, because symptoms are not collected proactively very much,” he said.

Persons with acute respiratory symptoms in the US typically seek healthcare at urgent-care clinics or have unscheduled visits with their primary care physicians, “and by all accounts those people should have spirometry, but they just don’t in the US, as best as I can tell,” he added.

He agreed that getting patients to a specialist can result in better outcomes but said that implementing a systematic approach such as the one described in the study would be extremely difficult in the fragmented US healthcare system.

Dr. Kalhan’s co-moderator, Nuala J. Meyer, MD, MS, from the Hospital of the University of Pennsylvania, Philadelphia, told Chest Physician that “it was interesting that even those who were not in the intervention group but had these details passed on to their primary care physicians still had improvements,” and that it would be beneficial if primary care practitioners were routinely informed about the results of urgent care visits.

She added, however, that in the US the flow of information between urgent care clinics, primary care offices, and specialty clinics is problematic, suggesting that symptomatic patients may not always receive the additional care that they need.

The study was supported by the Canadian Institutes of Health Research. Dr. Aaron, Dr. Kalhan, and Dr. Meyer all reported having no relevant disclosures. 

A version of this article appeared on Medscape.com.

SAN DIEGO — You can’t treat patients if you can’t find them. But as investigators in a randomized controlled trial showed, a case-finding method based on spirometry results can identify individuals in the community with undiagnosed chronic obstructive pulmonary disease (COPD) or asthma whose lives could be significantly improved with proper care.

Once they have been identified and randomly assigned to be treated by a pulmonologist and asthma-COPD educator according to clinical guidelines, these previously undiagnosed patients have significant improvements in health care utilization, lung function, symptoms, and quality of life compared with patients randomly assigned to treatment by a general practitioner.

“By diagnosing people early and treating them intensively, you can really improve their quality of life,” said lead investigator Shawn D. Aaron, MD, from the Ottawa Hospital Research Institute and University of Ottawa, Ontario, Canada.

Even those patients in the study who were randomly assigned to receive care from a general practice physician had improvements in lung function and quality of life, although on a smaller scale than patients assigned to a specialty team, Dr. Aaron said at the American Thoracic Society’s international conference.

He reported results of the study in a late-breaking oral abstract session. The study findings were also published online in The New England Journal of Medicine.
 

Undiagnosed diseases

“The simple problem is that 70% of individuals with asthma or COPD are likely undiagnosed,” Dr. Aaron said.

He noted that the 2007-2012 US National Health and Nutritional Examination Survey found obstructive lung disease in 13% of randomly selected US adults, but 71% of these people had never been diagnosed with asthma or COPD.

“So our questions were in this study: One, can we find adults with undiagnosed asthma or COPD in the community? The second question was: If we find them, are they sick? And the third and most important question was: Can we treat them early and improve their health outcomes?” he said.

Asthma and COPD both present with similar respiratory symptoms, including dyspnea, cough, wheeze, and/or chest tightness, and the two conditions share expiratory airflow obstruction as a common physiologic impairment that can be detected with spirometry.
 

Study details

To identify participants, the investigators hired a commercial survey firm to contact households asking whether any member aged 18 years or older had respiratory symptoms such as shortness of breath, wheezing, increased mucus or sputum production, or prolonged cough in the past 6 months. Those who responded yes were then contacted by a trial coordinator, and the symptomatic household member was asked to complete the Asthma Screening Questionnaire over the phone. Participants aged 60 years or older and those younger than 60 years with a score of 6 or higher on the asthma screen also completed the COPD Diagnostic Questionnaire.

Those with a score of 6 or higher on the asthma screen or 20 or higher on the COPD screen were invited to undergo spirometry at a trial site.

The investigators ultimately identified 508 adults with undiagnosed asthma or COPD and randomly assigned them on an equal basis to an intervention group (253 patients) or control group (255 patients).

In the intervention group treatment was provided by a study pulmonologist and asthma-COPD educator who started guideline-based care. Patients were prescribed inhalers and were taught how to use them, and many were given action plans that included smoking cessation aids, exercise and weight counseling, and vaccinations against influenza and pneumonia.

Participants assigned to the control group would receive usual care provided by their primary care practitioner.
 

Improvements abound

During the 12 months of the study, 92% of patients in the intervention group and 60% in the control group were started on new medications for their condition. 

Only 13.4% of those in the intervention group received either no respiratory treatments or a short-acting beta 2 agonist only during the entire trial period compared with 49.8% of controls, “so the usual care arm was undertreated relative to the intervention arm, and because of that under-treatment we saw a tremendous difference in the primary outcome,” Dr. Aaron said.

The primary outcome, the annualized rate of patient-initiated healthcare utilization for respiratory illness, was significantly lower in the intervention group, translating into an incidence rate ratio of 0.48 (P < .001).

Secondary outcomes were also better in the intervention group. For example, total scores on the St. George Respiratory Questionnaire (SGRQ) declined by 10.2 points from baseline in intervention group compared with a 6.8-point drop in the usual-care group. The mean difference was 3.5 points (P = .009). Lower scores on the 0-100 SGRQ scale indicate better health status.

Similarly, total scores on the COPD Assessment Test, a scale of 0-40 with lower scores indicating better health, declined by 3.8 points and 2.6 points, respectively, over 12 months, for a mean difference of 1.3 points (P = .03).

In addition, those in the intervention arm had a 119-mL improvement in forced expiratory volume in 1 second over the 12 months of the study compared with only a 22-mL improvement in the usual-care group.
 

Translatable results?

Dr. Aaron acknowledged that the investigators could have chosen to keep those who were assigned to the control group unaware of their diagnosis during the study but because all patients enrolled were symptomatic, it would have been unethical to do so. All participants were informed of their diagnosis at randomization, and the information was conveyed to each patient’s primary care practitioner as well.

In fact, many patients in the control group decided to seek treatment for either asthma or COPD after learning of their diagnosis, which may have contributed to improved outcomes in the control arm, he said.

“What this means is if you make the diagnosis early in the community, and at least have them see a primary care practitioner, they will improve their quality of life and their health status,” he concluded.

Ravi Kalhan, MD, MS, from the Northwestern University Feinberg School Of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the case-finding model used in the trial would be difficult to replicate elsewhere.

“This idea of seeking out undiagnosed people by doing spirometry, so-called ‘case finding’ as they described it, testing highly symptomatic people with spirometry, is really challenging in the US, because symptoms are not collected proactively very much,” he said.

Persons with acute respiratory symptoms in the US typically seek healthcare at urgent-care clinics or have unscheduled visits with their primary care physicians, “and by all accounts those people should have spirometry, but they just don’t in the US, as best as I can tell,” he added.

He agreed that getting patients to a specialist can result in better outcomes but said that implementing a systematic approach such as the one described in the study would be extremely difficult in the fragmented US healthcare system.

Dr. Kalhan’s co-moderator, Nuala J. Meyer, MD, MS, from the Hospital of the University of Pennsylvania, Philadelphia, told Chest Physician that “it was interesting that even those who were not in the intervention group but had these details passed on to their primary care physicians still had improvements,” and that it would be beneficial if primary care practitioners were routinely informed about the results of urgent care visits.

She added, however, that in the US the flow of information between urgent care clinics, primary care offices, and specialty clinics is problematic, suggesting that symptomatic patients may not always receive the additional care that they need.

The study was supported by the Canadian Institutes of Health Research. Dr. Aaron, Dr. Kalhan, and Dr. Meyer all reported having no relevant disclosures. 

A version of this article appeared on Medscape.com.

SAN DIEGO — You can’t treat patients if you can’t find them. But as investigators in a randomized controlled trial showed, a case-finding method based on spirometry results can identify individuals in the community with undiagnosed chronic obstructive pulmonary disease (COPD) or asthma whose lives could be significantly improved with proper care.

Once they have been identified and randomly assigned to be treated by a pulmonologist and asthma-COPD educator according to clinical guidelines, these previously undiagnosed patients have significant improvements in health care utilization, lung function, symptoms, and quality of life compared with patients randomly assigned to treatment by a general practitioner.

“By diagnosing people early and treating them intensively, you can really improve their quality of life,” said lead investigator Shawn D. Aaron, MD, from the Ottawa Hospital Research Institute and University of Ottawa, Ontario, Canada.

Even those patients in the study who were randomly assigned to receive care from a general practice physician had improvements in lung function and quality of life, although on a smaller scale than patients assigned to a specialty team, Dr. Aaron said at the American Thoracic Society’s international conference.

He reported results of the study in a late-breaking oral abstract session. The study findings were also published online in The New England Journal of Medicine.
 

Undiagnosed diseases

“The simple problem is that 70% of individuals with asthma or COPD are likely undiagnosed,” Dr. Aaron said.

He noted that the 2007-2012 US National Health and Nutritional Examination Survey found obstructive lung disease in 13% of randomly selected US adults, but 71% of these people had never been diagnosed with asthma or COPD.

“So our questions were in this study: One, can we find adults with undiagnosed asthma or COPD in the community? The second question was: If we find them, are they sick? And the third and most important question was: Can we treat them early and improve their health outcomes?” he said.

Asthma and COPD both present with similar respiratory symptoms, including dyspnea, cough, wheeze, and/or chest tightness, and the two conditions share expiratory airflow obstruction as a common physiologic impairment that can be detected with spirometry.
 

Study details

To identify participants, the investigators hired a commercial survey firm to contact households asking whether any member aged 18 years or older had respiratory symptoms such as shortness of breath, wheezing, increased mucus or sputum production, or prolonged cough in the past 6 months. Those who responded yes were then contacted by a trial coordinator, and the symptomatic household member was asked to complete the Asthma Screening Questionnaire over the phone. Participants aged 60 years or older and those younger than 60 years with a score of 6 or higher on the asthma screen also completed the COPD Diagnostic Questionnaire.

Those with a score of 6 or higher on the asthma screen or 20 or higher on the COPD screen were invited to undergo spirometry at a trial site.

The investigators ultimately identified 508 adults with undiagnosed asthma or COPD and randomly assigned them on an equal basis to an intervention group (253 patients) or control group (255 patients).

In the intervention group treatment was provided by a study pulmonologist and asthma-COPD educator who started guideline-based care. Patients were prescribed inhalers and were taught how to use them, and many were given action plans that included smoking cessation aids, exercise and weight counseling, and vaccinations against influenza and pneumonia.

Participants assigned to the control group would receive usual care provided by their primary care practitioner.
 

Improvements abound

During the 12 months of the study, 92% of patients in the intervention group and 60% in the control group were started on new medications for their condition. 

Only 13.4% of those in the intervention group received either no respiratory treatments or a short-acting beta 2 agonist only during the entire trial period compared with 49.8% of controls, “so the usual care arm was undertreated relative to the intervention arm, and because of that under-treatment we saw a tremendous difference in the primary outcome,” Dr. Aaron said.

The primary outcome, the annualized rate of patient-initiated healthcare utilization for respiratory illness, was significantly lower in the intervention group, translating into an incidence rate ratio of 0.48 (P < .001).

Secondary outcomes were also better in the intervention group. For example, total scores on the St. George Respiratory Questionnaire (SGRQ) declined by 10.2 points from baseline in intervention group compared with a 6.8-point drop in the usual-care group. The mean difference was 3.5 points (P = .009). Lower scores on the 0-100 SGRQ scale indicate better health status.

Similarly, total scores on the COPD Assessment Test, a scale of 0-40 with lower scores indicating better health, declined by 3.8 points and 2.6 points, respectively, over 12 months, for a mean difference of 1.3 points (P = .03).

In addition, those in the intervention arm had a 119-mL improvement in forced expiratory volume in 1 second over the 12 months of the study compared with only a 22-mL improvement in the usual-care group.
 

Translatable results?

Dr. Aaron acknowledged that the investigators could have chosen to keep those who were assigned to the control group unaware of their diagnosis during the study but because all patients enrolled were symptomatic, it would have been unethical to do so. All participants were informed of their diagnosis at randomization, and the information was conveyed to each patient’s primary care practitioner as well.

In fact, many patients in the control group decided to seek treatment for either asthma or COPD after learning of their diagnosis, which may have contributed to improved outcomes in the control arm, he said.

“What this means is if you make the diagnosis early in the community, and at least have them see a primary care practitioner, they will improve their quality of life and their health status,” he concluded.

Ravi Kalhan, MD, MS, from the Northwestern University Feinberg School Of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the case-finding model used in the trial would be difficult to replicate elsewhere.

“This idea of seeking out undiagnosed people by doing spirometry, so-called ‘case finding’ as they described it, testing highly symptomatic people with spirometry, is really challenging in the US, because symptoms are not collected proactively very much,” he said.

Persons with acute respiratory symptoms in the US typically seek healthcare at urgent-care clinics or have unscheduled visits with their primary care physicians, “and by all accounts those people should have spirometry, but they just don’t in the US, as best as I can tell,” he added.

He agreed that getting patients to a specialist can result in better outcomes but said that implementing a systematic approach such as the one described in the study would be extremely difficult in the fragmented US healthcare system.

Dr. Kalhan’s co-moderator, Nuala J. Meyer, MD, MS, from the Hospital of the University of Pennsylvania, Philadelphia, told Chest Physician that “it was interesting that even those who were not in the intervention group but had these details passed on to their primary care physicians still had improvements,” and that it would be beneficial if primary care practitioners were routinely informed about the results of urgent care visits.

She added, however, that in the US the flow of information between urgent care clinics, primary care offices, and specialty clinics is problematic, suggesting that symptomatic patients may not always receive the additional care that they need.

The study was supported by the Canadian Institutes of Health Research. Dr. Aaron, Dr. Kalhan, and Dr. Meyer all reported having no relevant disclosures. 

A version of this article appeared on Medscape.com.