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AAP issues guidelines to combat rise in respiratory illness
Updated guidance from the group outlines measures to optimize resources to manage a surge of patients filling hospital beds, emergency departments, and physicians’ practices.
A separate document from the AAP endorses giving extra doses of palivizumab, a monoclonal antibody used to prevent severe infection in infants at high risk of respiratory syncytial virus (RSV), as long as the illness is prevalent in the community.
Upticks in rates of RSV and influenza, along with a crisis in children’s mental health, prompted the AAP and the Children’s Hospital Association to petition the Biden administration on Nov. 14 to declare an emergency. Such a move would free up extra funding and waivers to allow physicians and hospitals to pool resources, the organizations said.
Despite those challenges, the AAP stressed in its new guidance that routine care, such as immunizations and chronic disease management, “cannot be neglected.”
Shifting resources
Officials at some children’s hospitals said that they have already implemented many of the AAP’s recommended measures for providing care during a surge, such as cross-training staff who usually treat adults, expanding telehealth and urgent care, and optimizing the use of ancillary care spaces.
“A lot of this is just reinforcing the things that I think children’s hospitals have been doing,” Lindsay Ragsdale, MD, chief medical officer for Kentucky Children’s Hospital, Lexington, said. “Can we shift adults around? Can we use an adult unit? Can we use an occupied space creatively? We’re really thinking outside the box.”
Andrew Pavia, MD, chief of the division of pediatric infectious diseases at University of Utah Health, Salt Lake City, said large children’s hospitals have been actively sharing practices for handling a surge through various channels, but the new guidance could be a useful “checklist” for small hospitals and physician practices that lack well-developed plans.
The AAP’s suggestions for pediatricians in outpatient settings include stocking up on personal protective equipment, using social media and office staff to increase communication with families, and keeping abreast of wait times at local emergency departments.
Addressing a subset of kids
In updated guidance for palivizumab, the AAP noted that earlier-than-usual circulation of RSV prompted pediatricians in some areas to begin administering the drug in the summer and early fall.
Palivizumab is typically given in five consecutive monthly intramuscular injections during RSV season, starting in November. Eligible infants and young children include those born prematurely or who have conditions such as chronic lung disease, hemodynamically significant congenital heart disease, or a suppressed immune system.
The AAP said it supports giving extra doses if RSV activity “persists at high levels in a given region through the fall and winter.” Published studies are sparse but contain “no evidence of increased frequency or severity of adverse events with later doses in a five-dose series nor with doses beyond five doses,” the group added.
The guidance may encourage payers to pick up the tab for extra doses, which are priced at more than $1,800 for cash customers, Dr. Pavia said. However, that recommendation addresses “a pretty small part of the problem overall because the injections are used for a very small subset of kids who are at the highest risk, and more than 80% of hospitalizations for RSV are among healthy kids,” he added.
Dr. Ragsdale and Dr. Pavia have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Updated guidance from the group outlines measures to optimize resources to manage a surge of patients filling hospital beds, emergency departments, and physicians’ practices.
A separate document from the AAP endorses giving extra doses of palivizumab, a monoclonal antibody used to prevent severe infection in infants at high risk of respiratory syncytial virus (RSV), as long as the illness is prevalent in the community.
Upticks in rates of RSV and influenza, along with a crisis in children’s mental health, prompted the AAP and the Children’s Hospital Association to petition the Biden administration on Nov. 14 to declare an emergency. Such a move would free up extra funding and waivers to allow physicians and hospitals to pool resources, the organizations said.
Despite those challenges, the AAP stressed in its new guidance that routine care, such as immunizations and chronic disease management, “cannot be neglected.”
Shifting resources
Officials at some children’s hospitals said that they have already implemented many of the AAP’s recommended measures for providing care during a surge, such as cross-training staff who usually treat adults, expanding telehealth and urgent care, and optimizing the use of ancillary care spaces.
“A lot of this is just reinforcing the things that I think children’s hospitals have been doing,” Lindsay Ragsdale, MD, chief medical officer for Kentucky Children’s Hospital, Lexington, said. “Can we shift adults around? Can we use an adult unit? Can we use an occupied space creatively? We’re really thinking outside the box.”
Andrew Pavia, MD, chief of the division of pediatric infectious diseases at University of Utah Health, Salt Lake City, said large children’s hospitals have been actively sharing practices for handling a surge through various channels, but the new guidance could be a useful “checklist” for small hospitals and physician practices that lack well-developed plans.
The AAP’s suggestions for pediatricians in outpatient settings include stocking up on personal protective equipment, using social media and office staff to increase communication with families, and keeping abreast of wait times at local emergency departments.
Addressing a subset of kids
In updated guidance for palivizumab, the AAP noted that earlier-than-usual circulation of RSV prompted pediatricians in some areas to begin administering the drug in the summer and early fall.
Palivizumab is typically given in five consecutive monthly intramuscular injections during RSV season, starting in November. Eligible infants and young children include those born prematurely or who have conditions such as chronic lung disease, hemodynamically significant congenital heart disease, or a suppressed immune system.
The AAP said it supports giving extra doses if RSV activity “persists at high levels in a given region through the fall and winter.” Published studies are sparse but contain “no evidence of increased frequency or severity of adverse events with later doses in a five-dose series nor with doses beyond five doses,” the group added.
The guidance may encourage payers to pick up the tab for extra doses, which are priced at more than $1,800 for cash customers, Dr. Pavia said. However, that recommendation addresses “a pretty small part of the problem overall because the injections are used for a very small subset of kids who are at the highest risk, and more than 80% of hospitalizations for RSV are among healthy kids,” he added.
Dr. Ragsdale and Dr. Pavia have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Updated guidance from the group outlines measures to optimize resources to manage a surge of patients filling hospital beds, emergency departments, and physicians’ practices.
A separate document from the AAP endorses giving extra doses of palivizumab, a monoclonal antibody used to prevent severe infection in infants at high risk of respiratory syncytial virus (RSV), as long as the illness is prevalent in the community.
Upticks in rates of RSV and influenza, along with a crisis in children’s mental health, prompted the AAP and the Children’s Hospital Association to petition the Biden administration on Nov. 14 to declare an emergency. Such a move would free up extra funding and waivers to allow physicians and hospitals to pool resources, the organizations said.
Despite those challenges, the AAP stressed in its new guidance that routine care, such as immunizations and chronic disease management, “cannot be neglected.”
Shifting resources
Officials at some children’s hospitals said that they have already implemented many of the AAP’s recommended measures for providing care during a surge, such as cross-training staff who usually treat adults, expanding telehealth and urgent care, and optimizing the use of ancillary care spaces.
“A lot of this is just reinforcing the things that I think children’s hospitals have been doing,” Lindsay Ragsdale, MD, chief medical officer for Kentucky Children’s Hospital, Lexington, said. “Can we shift adults around? Can we use an adult unit? Can we use an occupied space creatively? We’re really thinking outside the box.”
Andrew Pavia, MD, chief of the division of pediatric infectious diseases at University of Utah Health, Salt Lake City, said large children’s hospitals have been actively sharing practices for handling a surge through various channels, but the new guidance could be a useful “checklist” for small hospitals and physician practices that lack well-developed plans.
The AAP’s suggestions for pediatricians in outpatient settings include stocking up on personal protective equipment, using social media and office staff to increase communication with families, and keeping abreast of wait times at local emergency departments.
Addressing a subset of kids
In updated guidance for palivizumab, the AAP noted that earlier-than-usual circulation of RSV prompted pediatricians in some areas to begin administering the drug in the summer and early fall.
Palivizumab is typically given in five consecutive monthly intramuscular injections during RSV season, starting in November. Eligible infants and young children include those born prematurely or who have conditions such as chronic lung disease, hemodynamically significant congenital heart disease, or a suppressed immune system.
The AAP said it supports giving extra doses if RSV activity “persists at high levels in a given region through the fall and winter.” Published studies are sparse but contain “no evidence of increased frequency or severity of adverse events with later doses in a five-dose series nor with doses beyond five doses,” the group added.
The guidance may encourage payers to pick up the tab for extra doses, which are priced at more than $1,800 for cash customers, Dr. Pavia said. However, that recommendation addresses “a pretty small part of the problem overall because the injections are used for a very small subset of kids who are at the highest risk, and more than 80% of hospitalizations for RSV are among healthy kids,” he added.
Dr. Ragsdale and Dr. Pavia have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
HIV: Treating ‘symptom clusters’ could help improve QOL
TAMPA – People living with HIV experience many symptoms that can be grouped into “clusters” to help guide therapy and ideally treat more than one symptom at a time in an effort to improve quality of life, according to a study presented at the annual meeting of the Association of Nurses in AIDS Care.
Interestingly, these symptoms were more common among people living with HIV who are older than 45 years versus those who are younger, with one exception.
“In HIV, with exception of anxiety, we saw older people had more symptoms than younger ones,” said Natalie Wilson, PhD, assistant professor of community health systems at the University of California, San Francisco.
Dr. Wilson and colleagues performed a study that also suggests the older group experienced more distress from their symptoms than the younger cohort, again with the exception of anxiety.
Symptom clusters are two or more related symptoms that occur together with or without the same etiology. “Imagine you can’t sleep and the next day you’re tired and have no energy, you have trouble remembering someone’s name ... and then the next night you get so anxious about not getting sleep that it keeps you from sleeping.” That’s an example of a symptom cluster, Dr. Wilson said.
A high burden
“Why should we even evaluate symptom clusters?” Dr. Wilson asked. “The symptom burden is still high in people living with HIV. The medications got better but the symptoms remain.”
A high symptom burden also is linked to lower adherence to antiretrovirals. Also, considering groups of symptoms together could lead to targeted interventions that treat multiple symptoms, she said, “instead of treating one symptom at a time and increasing the pill burden for people living with HIV.”
Accelerated aging concerns
In addition, people living with HIV can experience accelerated aging, which is one reason Dr. Wilson and colleagues chose the 45-year-old cutoff in the study. Living with inflammation from HIV and the toxicity of earlier treatments likely contribute.
“Those over age 45 have higher rates of age-associated noncommunicable comorbidities developing at an earlier age than uninfected people with comparable lifestyles and demographics,” Dr. Wilson said.
In the full study, published in the Journal of Pain and Symptom Management, a total 2,000 people living with HIV completed the 20-item HIV Symptom Index. The participants reported their symptoms on their first visit to one of six national HIV Centers of Excellence. People were asked to report presence or absence of a particular symptom, and if they had it, how distressing it was on a scale of 1 “doesn’t bother me” to 4 “bothers me a lot.”
Younger people not only reported more anxiety but were also more distressed by it, Dr. Wilson said. The older group was more likely to be distressed by muscle aches and joint pain, trouble remembering things, and more.
The mean age in the younger group was 35 years, and it was 55 years in the older group. A total of 86% in the younger group and 87% in the older were men, and there were some differences by race, Dr. Wilson said.
More research needed
“These findings warrant further confirmation,” Dr. Wilson added. Future work could evaluate whether symptom clusters share etiology and how symptom clusters change over time. “We need to look at outcomes over time. Can we predict poorer outcomes, such as cardiac events, over time based on symptom clusters?”
Also, as part of HIV treatment success in recent years, “Our guidelines are moving people out further – if you’re undetectable sometimes you can come back at 6 months or 1 year.” The question, she said, is then: “Do we need to watch people with certain symptom clusters more closely?”
Limitations of the study include a lack of information on symptom causes and severity and its cross-sectional design.
‘Absolutely useful’
The study is “absolutely useful,” said session moderator Cheryl Netherly, an HIV nurse and clinical educator for CAN Community Health headquartered in Sarasota, Fla.
“One of the things that she mentioned was people with HIV, especially long-term HIV, they’re aging faster than the population without HIV. So, that is really important to look at.”
People living with HIV and dying from age-related comorbidities is something “we never thought would happen,” Ms. Netherly said. “Unfortunately, we’re now losing them to the different things like kidney issues, heart disease, and diabetes.”
The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Wilson and Ms. Netherly disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TAMPA – People living with HIV experience many symptoms that can be grouped into “clusters” to help guide therapy and ideally treat more than one symptom at a time in an effort to improve quality of life, according to a study presented at the annual meeting of the Association of Nurses in AIDS Care.
Interestingly, these symptoms were more common among people living with HIV who are older than 45 years versus those who are younger, with one exception.
“In HIV, with exception of anxiety, we saw older people had more symptoms than younger ones,” said Natalie Wilson, PhD, assistant professor of community health systems at the University of California, San Francisco.
Dr. Wilson and colleagues performed a study that also suggests the older group experienced more distress from their symptoms than the younger cohort, again with the exception of anxiety.
Symptom clusters are two or more related symptoms that occur together with or without the same etiology. “Imagine you can’t sleep and the next day you’re tired and have no energy, you have trouble remembering someone’s name ... and then the next night you get so anxious about not getting sleep that it keeps you from sleeping.” That’s an example of a symptom cluster, Dr. Wilson said.
A high burden
“Why should we even evaluate symptom clusters?” Dr. Wilson asked. “The symptom burden is still high in people living with HIV. The medications got better but the symptoms remain.”
A high symptom burden also is linked to lower adherence to antiretrovirals. Also, considering groups of symptoms together could lead to targeted interventions that treat multiple symptoms, she said, “instead of treating one symptom at a time and increasing the pill burden for people living with HIV.”
Accelerated aging concerns
In addition, people living with HIV can experience accelerated aging, which is one reason Dr. Wilson and colleagues chose the 45-year-old cutoff in the study. Living with inflammation from HIV and the toxicity of earlier treatments likely contribute.
“Those over age 45 have higher rates of age-associated noncommunicable comorbidities developing at an earlier age than uninfected people with comparable lifestyles and demographics,” Dr. Wilson said.
In the full study, published in the Journal of Pain and Symptom Management, a total 2,000 people living with HIV completed the 20-item HIV Symptom Index. The participants reported their symptoms on their first visit to one of six national HIV Centers of Excellence. People were asked to report presence or absence of a particular symptom, and if they had it, how distressing it was on a scale of 1 “doesn’t bother me” to 4 “bothers me a lot.”
Younger people not only reported more anxiety but were also more distressed by it, Dr. Wilson said. The older group was more likely to be distressed by muscle aches and joint pain, trouble remembering things, and more.
The mean age in the younger group was 35 years, and it was 55 years in the older group. A total of 86% in the younger group and 87% in the older were men, and there were some differences by race, Dr. Wilson said.
More research needed
“These findings warrant further confirmation,” Dr. Wilson added. Future work could evaluate whether symptom clusters share etiology and how symptom clusters change over time. “We need to look at outcomes over time. Can we predict poorer outcomes, such as cardiac events, over time based on symptom clusters?”
Also, as part of HIV treatment success in recent years, “Our guidelines are moving people out further – if you’re undetectable sometimes you can come back at 6 months or 1 year.” The question, she said, is then: “Do we need to watch people with certain symptom clusters more closely?”
Limitations of the study include a lack of information on symptom causes and severity and its cross-sectional design.
‘Absolutely useful’
The study is “absolutely useful,” said session moderator Cheryl Netherly, an HIV nurse and clinical educator for CAN Community Health headquartered in Sarasota, Fla.
“One of the things that she mentioned was people with HIV, especially long-term HIV, they’re aging faster than the population without HIV. So, that is really important to look at.”
People living with HIV and dying from age-related comorbidities is something “we never thought would happen,” Ms. Netherly said. “Unfortunately, we’re now losing them to the different things like kidney issues, heart disease, and diabetes.”
The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Wilson and Ms. Netherly disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TAMPA – People living with HIV experience many symptoms that can be grouped into “clusters” to help guide therapy and ideally treat more than one symptom at a time in an effort to improve quality of life, according to a study presented at the annual meeting of the Association of Nurses in AIDS Care.
Interestingly, these symptoms were more common among people living with HIV who are older than 45 years versus those who are younger, with one exception.
“In HIV, with exception of anxiety, we saw older people had more symptoms than younger ones,” said Natalie Wilson, PhD, assistant professor of community health systems at the University of California, San Francisco.
Dr. Wilson and colleagues performed a study that also suggests the older group experienced more distress from their symptoms than the younger cohort, again with the exception of anxiety.
Symptom clusters are two or more related symptoms that occur together with or without the same etiology. “Imagine you can’t sleep and the next day you’re tired and have no energy, you have trouble remembering someone’s name ... and then the next night you get so anxious about not getting sleep that it keeps you from sleeping.” That’s an example of a symptom cluster, Dr. Wilson said.
A high burden
“Why should we even evaluate symptom clusters?” Dr. Wilson asked. “The symptom burden is still high in people living with HIV. The medications got better but the symptoms remain.”
A high symptom burden also is linked to lower adherence to antiretrovirals. Also, considering groups of symptoms together could lead to targeted interventions that treat multiple symptoms, she said, “instead of treating one symptom at a time and increasing the pill burden for people living with HIV.”
Accelerated aging concerns
In addition, people living with HIV can experience accelerated aging, which is one reason Dr. Wilson and colleagues chose the 45-year-old cutoff in the study. Living with inflammation from HIV and the toxicity of earlier treatments likely contribute.
“Those over age 45 have higher rates of age-associated noncommunicable comorbidities developing at an earlier age than uninfected people with comparable lifestyles and demographics,” Dr. Wilson said.
In the full study, published in the Journal of Pain and Symptom Management, a total 2,000 people living with HIV completed the 20-item HIV Symptom Index. The participants reported their symptoms on their first visit to one of six national HIV Centers of Excellence. People were asked to report presence or absence of a particular symptom, and if they had it, how distressing it was on a scale of 1 “doesn’t bother me” to 4 “bothers me a lot.”
Younger people not only reported more anxiety but were also more distressed by it, Dr. Wilson said. The older group was more likely to be distressed by muscle aches and joint pain, trouble remembering things, and more.
The mean age in the younger group was 35 years, and it was 55 years in the older group. A total of 86% in the younger group and 87% in the older were men, and there were some differences by race, Dr. Wilson said.
More research needed
“These findings warrant further confirmation,” Dr. Wilson added. Future work could evaluate whether symptom clusters share etiology and how symptom clusters change over time. “We need to look at outcomes over time. Can we predict poorer outcomes, such as cardiac events, over time based on symptom clusters?”
Also, as part of HIV treatment success in recent years, “Our guidelines are moving people out further – if you’re undetectable sometimes you can come back at 6 months or 1 year.” The question, she said, is then: “Do we need to watch people with certain symptom clusters more closely?”
Limitations of the study include a lack of information on symptom causes and severity and its cross-sectional design.
‘Absolutely useful’
The study is “absolutely useful,” said session moderator Cheryl Netherly, an HIV nurse and clinical educator for CAN Community Health headquartered in Sarasota, Fla.
“One of the things that she mentioned was people with HIV, especially long-term HIV, they’re aging faster than the population without HIV. So, that is really important to look at.”
People living with HIV and dying from age-related comorbidities is something “we never thought would happen,” Ms. Netherly said. “Unfortunately, we’re now losing them to the different things like kidney issues, heart disease, and diabetes.”
The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Wilson and Ms. Netherly disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Earlier diagnosis of Alzheimer’s: A good start, but then what?
In the October 2022 issue of JAMA Neurology was a research article and accompanying editorial on the ATN (amyloid/tau/neurodegeneration) framework for diagnosing and treating Alzheimer’s disease.
If the new generation of Alzheimer’s treatments can reverse pathology before the symptoms are apparent, it certainly makes sense to treat people as early as possible. In a terrible disease with only partially effective treatments now, this is encouraging news.
So this testing, as it stands now, would involve amyloid PET and tau PET scans, not to mention other screening tests such as MRI, labs, and the occasional lumbar puncture or EEG.
But it raises new questions.
Who should we be testing? If the new agents work on a presymptomatic basis, should we test everyone over 50, or 60, or 70? Or just those with memory concerns? Realistically, a lot of people come to general neurologists with memory worries, the majority of whom have nothing ominous. Those numbers are going to skyrocket as soon as the “have you been forgetting things? Ask your doctor” ads hit the airwaves. They’ll suggest, as much as the FDA will allow, that if you can’t find your car keys, you may have early dementia and need to be worked up promptly to keep from getting worse.
Who’s going to see these people? I’m sure it’s good for business, which I have no problem with, but most neurology practices are booked out a bit as it is. The influx of people panicked because they forgot their Netflix password will add to that.
How are we going to treat them? Even if we ignore aducanumab, which has more than enough baggage, lecanemab, donanemab, and gantenerumab are all waiting in the wings. Is one drug better for patients with certain scan findings? Or clearly safer? Keep in mind that, even at this early stage, we are already grappling with the potentially serious complication of ARIA [amyloid related imaging abnormalities]. The incidence is only going to go up as these new drugs enter the market. These questions rapidly move the drug outside the comfort zone of many general neurologists, and there aren’t nearly enough dementia subspecialists out there to handle the number of patients involved.
And lastly, from the more practical view, who’s going to pay for this? I’m not trying to prioritize money over people, but it’s a legitimate question that will have to be answered. PET scans aren’t cheap, and we’re talking about doing two of them. Neither are MRIs, or lumbar punctures. If we’re going to put guidelines out (like we do for mammograms and colonoscopies) for screening asymptomatic people over 70, or even mildly forgetful patients ... that’s a lot of dollars. Is there going to be some limitation on the testing based on who would benefit the most? What do we tell the patients and families outside of that range? And that’s even before we start factoring in the drug costs. In October, Forbes listed potential lecanemab prices as being anywhere from $9,000 to $35,000 per year.
I’m not trying to be Debbie Downer here. The fact that these drugs are here is, hopefully, the start of a new era in treatment of what will still be an incurable disease. Aricept (and its cousins) and Namenda were stepping stones in their day, and these are the next ones.
But these are questions that need to be answered. And soon.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
In the October 2022 issue of JAMA Neurology was a research article and accompanying editorial on the ATN (amyloid/tau/neurodegeneration) framework for diagnosing and treating Alzheimer’s disease.
If the new generation of Alzheimer’s treatments can reverse pathology before the symptoms are apparent, it certainly makes sense to treat people as early as possible. In a terrible disease with only partially effective treatments now, this is encouraging news.
So this testing, as it stands now, would involve amyloid PET and tau PET scans, not to mention other screening tests such as MRI, labs, and the occasional lumbar puncture or EEG.
But it raises new questions.
Who should we be testing? If the new agents work on a presymptomatic basis, should we test everyone over 50, or 60, or 70? Or just those with memory concerns? Realistically, a lot of people come to general neurologists with memory worries, the majority of whom have nothing ominous. Those numbers are going to skyrocket as soon as the “have you been forgetting things? Ask your doctor” ads hit the airwaves. They’ll suggest, as much as the FDA will allow, that if you can’t find your car keys, you may have early dementia and need to be worked up promptly to keep from getting worse.
Who’s going to see these people? I’m sure it’s good for business, which I have no problem with, but most neurology practices are booked out a bit as it is. The influx of people panicked because they forgot their Netflix password will add to that.
How are we going to treat them? Even if we ignore aducanumab, which has more than enough baggage, lecanemab, donanemab, and gantenerumab are all waiting in the wings. Is one drug better for patients with certain scan findings? Or clearly safer? Keep in mind that, even at this early stage, we are already grappling with the potentially serious complication of ARIA [amyloid related imaging abnormalities]. The incidence is only going to go up as these new drugs enter the market. These questions rapidly move the drug outside the comfort zone of many general neurologists, and there aren’t nearly enough dementia subspecialists out there to handle the number of patients involved.
And lastly, from the more practical view, who’s going to pay for this? I’m not trying to prioritize money over people, but it’s a legitimate question that will have to be answered. PET scans aren’t cheap, and we’re talking about doing two of them. Neither are MRIs, or lumbar punctures. If we’re going to put guidelines out (like we do for mammograms and colonoscopies) for screening asymptomatic people over 70, or even mildly forgetful patients ... that’s a lot of dollars. Is there going to be some limitation on the testing based on who would benefit the most? What do we tell the patients and families outside of that range? And that’s even before we start factoring in the drug costs. In October, Forbes listed potential lecanemab prices as being anywhere from $9,000 to $35,000 per year.
I’m not trying to be Debbie Downer here. The fact that these drugs are here is, hopefully, the start of a new era in treatment of what will still be an incurable disease. Aricept (and its cousins) and Namenda were stepping stones in their day, and these are the next ones.
But these are questions that need to be answered. And soon.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
In the October 2022 issue of JAMA Neurology was a research article and accompanying editorial on the ATN (amyloid/tau/neurodegeneration) framework for diagnosing and treating Alzheimer’s disease.
If the new generation of Alzheimer’s treatments can reverse pathology before the symptoms are apparent, it certainly makes sense to treat people as early as possible. In a terrible disease with only partially effective treatments now, this is encouraging news.
So this testing, as it stands now, would involve amyloid PET and tau PET scans, not to mention other screening tests such as MRI, labs, and the occasional lumbar puncture or EEG.
But it raises new questions.
Who should we be testing? If the new agents work on a presymptomatic basis, should we test everyone over 50, or 60, or 70? Or just those with memory concerns? Realistically, a lot of people come to general neurologists with memory worries, the majority of whom have nothing ominous. Those numbers are going to skyrocket as soon as the “have you been forgetting things? Ask your doctor” ads hit the airwaves. They’ll suggest, as much as the FDA will allow, that if you can’t find your car keys, you may have early dementia and need to be worked up promptly to keep from getting worse.
Who’s going to see these people? I’m sure it’s good for business, which I have no problem with, but most neurology practices are booked out a bit as it is. The influx of people panicked because they forgot their Netflix password will add to that.
How are we going to treat them? Even if we ignore aducanumab, which has more than enough baggage, lecanemab, donanemab, and gantenerumab are all waiting in the wings. Is one drug better for patients with certain scan findings? Or clearly safer? Keep in mind that, even at this early stage, we are already grappling with the potentially serious complication of ARIA [amyloid related imaging abnormalities]. The incidence is only going to go up as these new drugs enter the market. These questions rapidly move the drug outside the comfort zone of many general neurologists, and there aren’t nearly enough dementia subspecialists out there to handle the number of patients involved.
And lastly, from the more practical view, who’s going to pay for this? I’m not trying to prioritize money over people, but it’s a legitimate question that will have to be answered. PET scans aren’t cheap, and we’re talking about doing two of them. Neither are MRIs, or lumbar punctures. If we’re going to put guidelines out (like we do for mammograms and colonoscopies) for screening asymptomatic people over 70, or even mildly forgetful patients ... that’s a lot of dollars. Is there going to be some limitation on the testing based on who would benefit the most? What do we tell the patients and families outside of that range? And that’s even before we start factoring in the drug costs. In October, Forbes listed potential lecanemab prices as being anywhere from $9,000 to $35,000 per year.
I’m not trying to be Debbie Downer here. The fact that these drugs are here is, hopefully, the start of a new era in treatment of what will still be an incurable disease. Aricept (and its cousins) and Namenda were stepping stones in their day, and these are the next ones.
But these are questions that need to be answered. And soon.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Why do women get Alzheimer’s disease more often than men? Study offers clue
. A new study published online in Cell may help explain the gender gap – and offer clues to new treatments for helping patients of both sexes fight back.
Researchers zeroed in on a gene named USP11, found on the X chromosome. People assigned female at birth have two X chromosomes, while people assigned male at birth have one X and one Y. So while all males have one copy of USP11, females have two.
The body’s trash collection system
In the normal course of events, the brain creates waste that must be removed lest it becomes toxic. One waste product is the protein tau. Too little tau can damage nerve cells, explained researchers David Kang, PhD, and Jung-A “Alexa” Woo, PhD, who led the study. But too much becomes toxic and can lead to neurodegenerative diseases such as Alzheimer’s disease. In fact, new research suggests that testing for changes in tau may someday help doctors diagnose Alzheimer’s disease earlier.
To manage tau, the brain uses a regulatory protein called ubiquitin to “tag” or signal the body that extra tau should be removed.
USP11’s job is to give instructions to make an enzyme that removes the ubiquitin tag to maintain balance. But if too much of the enzyme is present, too much tau gets untagged – and not enough of it gets cleared.
“Our study showed USP11 is higher in females than males in both humans and in mice,” Dr. Kang said. “That’s already true before the onset of dementia. But once someone has Alzheimer’s disease, USP11 is much higher – regardless of sex.”
The study adds to a growing body of evidence that shows that women may be more vulnerable than men to higher levels of tau, possibly explaining why women are affected by the disease more often than men.
But what if there was a way to “turn off” or deactivate the USP11 gene? Might that help prevent Alzheimer’s disease? And could it be done safely?
What happened when the gene was eliminated?
To examine these questions, researchers used a method of gene manipulation to completely delete the USP11 gene in mice. They then examined the mice for changes. The result? The mice seemed fine.
“The mice bred well. Their brains looked fine,” Dr. Woo said.
It would not be possible – or ethical – to remove a gene from humans. But when a medical condition makes a certain gene unhelpful, that gene can be partially blocked or expression of the gene can be reduced with medication. In fact, medications targeting enzymes are common. Examples include statins for cardiovascular disease or HIV treatments that inhibit protease enzymes.
“If we are able to identify some type of medicine that would inhibit USP11, our study suggests it would be well tolerated and benefit women,” Dr. Woo said.
Dr. Kang also cautions that the process for creating such a therapy takes at least 10-15 years. The researchers said they’d like to shorten the timeline and plan to study currently approved FDA medications to see if any might work to target USP11 gene activity – and hopefully bring forth a new treatment for Alzheimer’s disease sooner.
A version of this article first appeared on WebMD.com.
. A new study published online in Cell may help explain the gender gap – and offer clues to new treatments for helping patients of both sexes fight back.
Researchers zeroed in on a gene named USP11, found on the X chromosome. People assigned female at birth have two X chromosomes, while people assigned male at birth have one X and one Y. So while all males have one copy of USP11, females have two.
The body’s trash collection system
In the normal course of events, the brain creates waste that must be removed lest it becomes toxic. One waste product is the protein tau. Too little tau can damage nerve cells, explained researchers David Kang, PhD, and Jung-A “Alexa” Woo, PhD, who led the study. But too much becomes toxic and can lead to neurodegenerative diseases such as Alzheimer’s disease. In fact, new research suggests that testing for changes in tau may someday help doctors diagnose Alzheimer’s disease earlier.
To manage tau, the brain uses a regulatory protein called ubiquitin to “tag” or signal the body that extra tau should be removed.
USP11’s job is to give instructions to make an enzyme that removes the ubiquitin tag to maintain balance. But if too much of the enzyme is present, too much tau gets untagged – and not enough of it gets cleared.
“Our study showed USP11 is higher in females than males in both humans and in mice,” Dr. Kang said. “That’s already true before the onset of dementia. But once someone has Alzheimer’s disease, USP11 is much higher – regardless of sex.”
The study adds to a growing body of evidence that shows that women may be more vulnerable than men to higher levels of tau, possibly explaining why women are affected by the disease more often than men.
But what if there was a way to “turn off” or deactivate the USP11 gene? Might that help prevent Alzheimer’s disease? And could it be done safely?
What happened when the gene was eliminated?
To examine these questions, researchers used a method of gene manipulation to completely delete the USP11 gene in mice. They then examined the mice for changes. The result? The mice seemed fine.
“The mice bred well. Their brains looked fine,” Dr. Woo said.
It would not be possible – or ethical – to remove a gene from humans. But when a medical condition makes a certain gene unhelpful, that gene can be partially blocked or expression of the gene can be reduced with medication. In fact, medications targeting enzymes are common. Examples include statins for cardiovascular disease or HIV treatments that inhibit protease enzymes.
“If we are able to identify some type of medicine that would inhibit USP11, our study suggests it would be well tolerated and benefit women,” Dr. Woo said.
Dr. Kang also cautions that the process for creating such a therapy takes at least 10-15 years. The researchers said they’d like to shorten the timeline and plan to study currently approved FDA medications to see if any might work to target USP11 gene activity – and hopefully bring forth a new treatment for Alzheimer’s disease sooner.
A version of this article first appeared on WebMD.com.
. A new study published online in Cell may help explain the gender gap – and offer clues to new treatments for helping patients of both sexes fight back.
Researchers zeroed in on a gene named USP11, found on the X chromosome. People assigned female at birth have two X chromosomes, while people assigned male at birth have one X and one Y. So while all males have one copy of USP11, females have two.
The body’s trash collection system
In the normal course of events, the brain creates waste that must be removed lest it becomes toxic. One waste product is the protein tau. Too little tau can damage nerve cells, explained researchers David Kang, PhD, and Jung-A “Alexa” Woo, PhD, who led the study. But too much becomes toxic and can lead to neurodegenerative diseases such as Alzheimer’s disease. In fact, new research suggests that testing for changes in tau may someday help doctors diagnose Alzheimer’s disease earlier.
To manage tau, the brain uses a regulatory protein called ubiquitin to “tag” or signal the body that extra tau should be removed.
USP11’s job is to give instructions to make an enzyme that removes the ubiquitin tag to maintain balance. But if too much of the enzyme is present, too much tau gets untagged – and not enough of it gets cleared.
“Our study showed USP11 is higher in females than males in both humans and in mice,” Dr. Kang said. “That’s already true before the onset of dementia. But once someone has Alzheimer’s disease, USP11 is much higher – regardless of sex.”
The study adds to a growing body of evidence that shows that women may be more vulnerable than men to higher levels of tau, possibly explaining why women are affected by the disease more often than men.
But what if there was a way to “turn off” or deactivate the USP11 gene? Might that help prevent Alzheimer’s disease? And could it be done safely?
What happened when the gene was eliminated?
To examine these questions, researchers used a method of gene manipulation to completely delete the USP11 gene in mice. They then examined the mice for changes. The result? The mice seemed fine.
“The mice bred well. Their brains looked fine,” Dr. Woo said.
It would not be possible – or ethical – to remove a gene from humans. But when a medical condition makes a certain gene unhelpful, that gene can be partially blocked or expression of the gene can be reduced with medication. In fact, medications targeting enzymes are common. Examples include statins for cardiovascular disease or HIV treatments that inhibit protease enzymes.
“If we are able to identify some type of medicine that would inhibit USP11, our study suggests it would be well tolerated and benefit women,” Dr. Woo said.
Dr. Kang also cautions that the process for creating such a therapy takes at least 10-15 years. The researchers said they’d like to shorten the timeline and plan to study currently approved FDA medications to see if any might work to target USP11 gene activity – and hopefully bring forth a new treatment for Alzheimer’s disease sooner.
A version of this article first appeared on WebMD.com.
FROM CELL
Twins born from embryos frozen 30 years ago
In what is believed to be a record, twins in Oregon were born this past Halloween from embryos that were frozen in 1992.
The National Embryo Donation Center says the twins, named Lydia and Timothy Ridgeway, are the longest frozen embryos to result in live birth, CNN reported.
Lydia was born at 5 pounds, 11 ounces. Timothy was born at 6 pounds, 7 ounces.
“There is something mind-boggling about it,” Philip Ridgeway told CNN as he and wife, Rachel Ridgeway, held their newborns. “I was 5 years old when God gave life to Lydia and Timothy, and he’s been preserving that life ever since.”
The babies were a result of embryo donation, usually from parents who have extra embryos after successfully having babies via in vitro fertilization (IVF).
In the case of newborns Lydia and Timothy, their donor parents are an anonymous married couple. The husband was in his early 50s at the time, and the couple used a 34-year-old egg donor, CNN reported.
After the embryos sat in storage on the West Coast from 1992 to 2007, the donor parents donated them to the National Embryo Donation Center in Knoxville, Tenn.
“In a sense, they’re our oldest children, even though they’re our smallest children,” said Philip Ridgeway.
The couple already had four other children, ages 8, 6, 3, and one that’s almost 2. None of their other children was conceived via IVF or donors.
“We’ve never had in our minds a set number of children we’d like to have,” Philip Ridgeway said. “We’ve always thought we’ll have as many as God wants to give us, and ... when we heard about embryo adoption, we thought that’s something we would like to do.”
In an article for Harvard Medical School, fertility expert Ellen S. Glazer said there are countless IVF-created embryos whose future path has five options.
“Those embarking on an IVF cycle are often laser-focused on the baby they long for,” wrote Ms. Glazer, a clinical social worker whose practice focuses on reproductive issues. “Most hope a cycle will yield several embryos, because it frequently takes more than one embryo transfer to achieve a successful full-term pregnancy. Any remaining embryos may offer the hope of future pregnancies and additional children.”
If the embryos are not used, the five options are:
- Discard the remaining embryos.
- Have another child anyway, even if a larger family wasn’t the original plan.
- Donate the embryos to science.
- Donate the embryos to another person or couple.
- Decide not to decide. (In this situation, clinics use the term “abandon” when a family avoids contact and stops paying storage fees.)
For the Ridgeways, when they were offered information to help them choose among donated embryos, they decided to focus on those with the lowest identification numbers on the list.
“We weren’t looking to get the embryos that have been frozen the longest in the world,” Philip Ridgeway said. “We just wanted the ones that had been waiting the longest.”
A version of this article first appeared on WebMD.com.
In what is believed to be a record, twins in Oregon were born this past Halloween from embryos that were frozen in 1992.
The National Embryo Donation Center says the twins, named Lydia and Timothy Ridgeway, are the longest frozen embryos to result in live birth, CNN reported.
Lydia was born at 5 pounds, 11 ounces. Timothy was born at 6 pounds, 7 ounces.
“There is something mind-boggling about it,” Philip Ridgeway told CNN as he and wife, Rachel Ridgeway, held their newborns. “I was 5 years old when God gave life to Lydia and Timothy, and he’s been preserving that life ever since.”
The babies were a result of embryo donation, usually from parents who have extra embryos after successfully having babies via in vitro fertilization (IVF).
In the case of newborns Lydia and Timothy, their donor parents are an anonymous married couple. The husband was in his early 50s at the time, and the couple used a 34-year-old egg donor, CNN reported.
After the embryos sat in storage on the West Coast from 1992 to 2007, the donor parents donated them to the National Embryo Donation Center in Knoxville, Tenn.
“In a sense, they’re our oldest children, even though they’re our smallest children,” said Philip Ridgeway.
The couple already had four other children, ages 8, 6, 3, and one that’s almost 2. None of their other children was conceived via IVF or donors.
“We’ve never had in our minds a set number of children we’d like to have,” Philip Ridgeway said. “We’ve always thought we’ll have as many as God wants to give us, and ... when we heard about embryo adoption, we thought that’s something we would like to do.”
In an article for Harvard Medical School, fertility expert Ellen S. Glazer said there are countless IVF-created embryos whose future path has five options.
“Those embarking on an IVF cycle are often laser-focused on the baby they long for,” wrote Ms. Glazer, a clinical social worker whose practice focuses on reproductive issues. “Most hope a cycle will yield several embryos, because it frequently takes more than one embryo transfer to achieve a successful full-term pregnancy. Any remaining embryos may offer the hope of future pregnancies and additional children.”
If the embryos are not used, the five options are:
- Discard the remaining embryos.
- Have another child anyway, even if a larger family wasn’t the original plan.
- Donate the embryos to science.
- Donate the embryos to another person or couple.
- Decide not to decide. (In this situation, clinics use the term “abandon” when a family avoids contact and stops paying storage fees.)
For the Ridgeways, when they were offered information to help them choose among donated embryos, they decided to focus on those with the lowest identification numbers on the list.
“We weren’t looking to get the embryos that have been frozen the longest in the world,” Philip Ridgeway said. “We just wanted the ones that had been waiting the longest.”
A version of this article first appeared on WebMD.com.
In what is believed to be a record, twins in Oregon were born this past Halloween from embryos that were frozen in 1992.
The National Embryo Donation Center says the twins, named Lydia and Timothy Ridgeway, are the longest frozen embryos to result in live birth, CNN reported.
Lydia was born at 5 pounds, 11 ounces. Timothy was born at 6 pounds, 7 ounces.
“There is something mind-boggling about it,” Philip Ridgeway told CNN as he and wife, Rachel Ridgeway, held their newborns. “I was 5 years old when God gave life to Lydia and Timothy, and he’s been preserving that life ever since.”
The babies were a result of embryo donation, usually from parents who have extra embryos after successfully having babies via in vitro fertilization (IVF).
In the case of newborns Lydia and Timothy, their donor parents are an anonymous married couple. The husband was in his early 50s at the time, and the couple used a 34-year-old egg donor, CNN reported.
After the embryos sat in storage on the West Coast from 1992 to 2007, the donor parents donated them to the National Embryo Donation Center in Knoxville, Tenn.
“In a sense, they’re our oldest children, even though they’re our smallest children,” said Philip Ridgeway.
The couple already had four other children, ages 8, 6, 3, and one that’s almost 2. None of their other children was conceived via IVF or donors.
“We’ve never had in our minds a set number of children we’d like to have,” Philip Ridgeway said. “We’ve always thought we’ll have as many as God wants to give us, and ... when we heard about embryo adoption, we thought that’s something we would like to do.”
In an article for Harvard Medical School, fertility expert Ellen S. Glazer said there are countless IVF-created embryos whose future path has five options.
“Those embarking on an IVF cycle are often laser-focused on the baby they long for,” wrote Ms. Glazer, a clinical social worker whose practice focuses on reproductive issues. “Most hope a cycle will yield several embryos, because it frequently takes more than one embryo transfer to achieve a successful full-term pregnancy. Any remaining embryos may offer the hope of future pregnancies and additional children.”
If the embryos are not used, the five options are:
- Discard the remaining embryos.
- Have another child anyway, even if a larger family wasn’t the original plan.
- Donate the embryos to science.
- Donate the embryos to another person or couple.
- Decide not to decide. (In this situation, clinics use the term “abandon” when a family avoids contact and stops paying storage fees.)
For the Ridgeways, when they were offered information to help them choose among donated embryos, they decided to focus on those with the lowest identification numbers on the list.
“We weren’t looking to get the embryos that have been frozen the longest in the world,” Philip Ridgeway said. “We just wanted the ones that had been waiting the longest.”
A version of this article first appeared on WebMD.com.
As STDs proliferate, companies rush to market at-home test kits. But are they reliable?
Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.
But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.
Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.
But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.
The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”
Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.
The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.
The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.
The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.
In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.
And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.
CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.
Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.
Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.
“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.
“CVS should not be selling that test,” he added.
In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.
CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.
Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.
“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”
Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.
Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.
“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”
Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.
He noted that doctors have years of experience using home collection kits.
The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.
Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.
“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.
But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.
Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”
Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.
Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.
“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.
But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.
Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.
But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.
The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”
Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.
The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.
The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.
The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.
In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.
And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.
CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.
Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.
Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.
“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.
“CVS should not be selling that test,” he added.
In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.
CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.
Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.
“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”
Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.
Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.
“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”
Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.
He noted that doctors have years of experience using home collection kits.
The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.
Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.
“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.
But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.
Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”
Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.
Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.
“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.
But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.
Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.
But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.
The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”
Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.
The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.
The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.
The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.
In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.
And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.
CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.
Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.
Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.
“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.
“CVS should not be selling that test,” he added.
In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.
CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.
Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.
“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”
Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.
Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.
“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”
Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.
He noted that doctors have years of experience using home collection kits.
The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.
Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.
“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.
But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.
Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”
Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.
Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.
“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Safety and tolerance of COVID-19 vaccines in patients with RA
Key clinical point: Overall, COVID-19 vaccines were well tolerated in patients with rheumatoid arthritis (RA), with the adverse event (AE) profile being comparable to that in control individuals; patients receiving methotrexate and hydroxychloroquine vs other immunosuppressants reporting fewer minor AE.
Major finding: At 7 days after vaccination, 76.9% of patients with RA reported AE, all being minor and comparable to those in the control group and similar between patients with active and inactive disease. Major AE were reported by 4.2% of patients with RA. Patients receiving methotrexate or hydroxychloroquine vs other immunosuppressants reported fewer minor AE (all P ≤ .05).
Study details: This was a cross-sectional survey-based study of 9462 respondents of an online self-reported questionnaire, including patients with RA (n = 1347), other autoimmune rheumatic diseases (n = 2305), non-rheumatic autoimmune diseases (n = 1079), and the control group (n = 4741) who received at least one dose of any COVID-19 vaccine.
Disclosures: This study did not receive any specific funding. Several authors reported receiving advisory board or speaker honoraria, consulting fees, research grant, or funding from various sources.
Source: Naveen R et al. COVID-19 vaccination in autoimmune diseases (COVAD) Study: Vaccine safety and tolerance in rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 31). Doi: 10.1093/rheumatology/keac624
Key clinical point: Overall, COVID-19 vaccines were well tolerated in patients with rheumatoid arthritis (RA), with the adverse event (AE) profile being comparable to that in control individuals; patients receiving methotrexate and hydroxychloroquine vs other immunosuppressants reporting fewer minor AE.
Major finding: At 7 days after vaccination, 76.9% of patients with RA reported AE, all being minor and comparable to those in the control group and similar between patients with active and inactive disease. Major AE were reported by 4.2% of patients with RA. Patients receiving methotrexate or hydroxychloroquine vs other immunosuppressants reported fewer minor AE (all P ≤ .05).
Study details: This was a cross-sectional survey-based study of 9462 respondents of an online self-reported questionnaire, including patients with RA (n = 1347), other autoimmune rheumatic diseases (n = 2305), non-rheumatic autoimmune diseases (n = 1079), and the control group (n = 4741) who received at least one dose of any COVID-19 vaccine.
Disclosures: This study did not receive any specific funding. Several authors reported receiving advisory board or speaker honoraria, consulting fees, research grant, or funding from various sources.
Source: Naveen R et al. COVID-19 vaccination in autoimmune diseases (COVAD) Study: Vaccine safety and tolerance in rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 31). Doi: 10.1093/rheumatology/keac624
Key clinical point: Overall, COVID-19 vaccines were well tolerated in patients with rheumatoid arthritis (RA), with the adverse event (AE) profile being comparable to that in control individuals; patients receiving methotrexate and hydroxychloroquine vs other immunosuppressants reporting fewer minor AE.
Major finding: At 7 days after vaccination, 76.9% of patients with RA reported AE, all being minor and comparable to those in the control group and similar between patients with active and inactive disease. Major AE were reported by 4.2% of patients with RA. Patients receiving methotrexate or hydroxychloroquine vs other immunosuppressants reported fewer minor AE (all P ≤ .05).
Study details: This was a cross-sectional survey-based study of 9462 respondents of an online self-reported questionnaire, including patients with RA (n = 1347), other autoimmune rheumatic diseases (n = 2305), non-rheumatic autoimmune diseases (n = 1079), and the control group (n = 4741) who received at least one dose of any COVID-19 vaccine.
Disclosures: This study did not receive any specific funding. Several authors reported receiving advisory board or speaker honoraria, consulting fees, research grant, or funding from various sources.
Source: Naveen R et al. COVID-19 vaccination in autoimmune diseases (COVAD) Study: Vaccine safety and tolerance in rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 31). Doi: 10.1093/rheumatology/keac624
Filgotinib safe and effective in patients with RA who are methotrexate-IR with high risk for poor prognosis
Key clinical point: Filgotinib vs placebo, both with background methotrexate, significantly improved disease activity and suppressed radiographic progression in patients with rheumatoid arthritis (RA) who were methotrexate inadequate responders (IR) and had ≤4 poor prognostic factors (PPF).
Major finding: Doses of 100 and 200 mg filgotinib vs placebo led to higher American College of Rheumatology 20, 50, and 70 response rates among patients with ≤4 PPF at week 12 (all P < .05) and significantly reduced the change from baseline in modified total Sharp score at week 24 among patients with 4 PPF (both P < .01) along with similar tolerability.
Study details: This post hoc analysis of FINCH 1 included 1755 patients with RA who were methotrexate-IR and were randomly assigned to receive filgotinib, adalimumab, or placebo, all with background methotrexate.
Disclosures: This study was funded by Gilead Sciences, Inc., with support from Eisai Co., Ltd., and Gilead Sciences K.K. Seven authors declared being current or former employees of Gilead Sciences/Galapagos BV or shareholders of various sources. Several authors reported ties with various sources.
Source: Combe BG et al. Efficacy and safety of filgotinib in patients with high risk of poor prognosis who showed inadequate response to MTX: A post hoc analysis of the FINCH 1 study. Rheumatol Ther. 2022 (Oct 9). Doi: 10.1007/s40744-022-00498-x
Key clinical point: Filgotinib vs placebo, both with background methotrexate, significantly improved disease activity and suppressed radiographic progression in patients with rheumatoid arthritis (RA) who were methotrexate inadequate responders (IR) and had ≤4 poor prognostic factors (PPF).
Major finding: Doses of 100 and 200 mg filgotinib vs placebo led to higher American College of Rheumatology 20, 50, and 70 response rates among patients with ≤4 PPF at week 12 (all P < .05) and significantly reduced the change from baseline in modified total Sharp score at week 24 among patients with 4 PPF (both P < .01) along with similar tolerability.
Study details: This post hoc analysis of FINCH 1 included 1755 patients with RA who were methotrexate-IR and were randomly assigned to receive filgotinib, adalimumab, or placebo, all with background methotrexate.
Disclosures: This study was funded by Gilead Sciences, Inc., with support from Eisai Co., Ltd., and Gilead Sciences K.K. Seven authors declared being current or former employees of Gilead Sciences/Galapagos BV or shareholders of various sources. Several authors reported ties with various sources.
Source: Combe BG et al. Efficacy and safety of filgotinib in patients with high risk of poor prognosis who showed inadequate response to MTX: A post hoc analysis of the FINCH 1 study. Rheumatol Ther. 2022 (Oct 9). Doi: 10.1007/s40744-022-00498-x
Key clinical point: Filgotinib vs placebo, both with background methotrexate, significantly improved disease activity and suppressed radiographic progression in patients with rheumatoid arthritis (RA) who were methotrexate inadequate responders (IR) and had ≤4 poor prognostic factors (PPF).
Major finding: Doses of 100 and 200 mg filgotinib vs placebo led to higher American College of Rheumatology 20, 50, and 70 response rates among patients with ≤4 PPF at week 12 (all P < .05) and significantly reduced the change from baseline in modified total Sharp score at week 24 among patients with 4 PPF (both P < .01) along with similar tolerability.
Study details: This post hoc analysis of FINCH 1 included 1755 patients with RA who were methotrexate-IR and were randomly assigned to receive filgotinib, adalimumab, or placebo, all with background methotrexate.
Disclosures: This study was funded by Gilead Sciences, Inc., with support from Eisai Co., Ltd., and Gilead Sciences K.K. Seven authors declared being current or former employees of Gilead Sciences/Galapagos BV or shareholders of various sources. Several authors reported ties with various sources.
Source: Combe BG et al. Efficacy and safety of filgotinib in patients with high risk of poor prognosis who showed inadequate response to MTX: A post hoc analysis of the FINCH 1 study. Rheumatol Ther. 2022 (Oct 9). Doi: 10.1007/s40744-022-00498-x
Positivity for autoantibodies at RA diagnosis ups risk for incident VTE
Key clinical point: Presence of autoantibodies for cyclic citrullinated peptide (anti-CCP2), load of anticitrullinated protein antibody (ACPA) fine-specificities, and immunoglobulin M (IgM) rheumatoid factor (RF) at diagnosis of rheumatoid arthritis (RA) increased the risk for incident venous thromboembolic events (VTE) in patients with RA.
Major finding: Positivity for IgG anti-CCP2 (hazard ratio [HR] 1.33; 95% CI 1.00-1.78) and IgM RF (HR 1.38; 95% CI 1.04-1.83) increased the risk for incident VTE. Additionally, the risk increased with the number of ACPA fine-specificities expressed (Ptrend = .033).
Study details: This prospective cohort study analyzed 2782 patients with newly diagnosed RA who reported 213 first-ever VTE.
Disclosures: This study was supported by the Swedish Research Council, NordForsk, and others. Four authors declared being employees or part-time employees, paid advisors, or founders of different companies. Two authors reported owning patents for peptides and their use for diagnostic purpose.
Source: Westerlind H et al. The association between autoantibodies and risk for venous thromboembolic events among patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 18). Doi: 10.1093/rheumatology/keac601
Key clinical point: Presence of autoantibodies for cyclic citrullinated peptide (anti-CCP2), load of anticitrullinated protein antibody (ACPA) fine-specificities, and immunoglobulin M (IgM) rheumatoid factor (RF) at diagnosis of rheumatoid arthritis (RA) increased the risk for incident venous thromboembolic events (VTE) in patients with RA.
Major finding: Positivity for IgG anti-CCP2 (hazard ratio [HR] 1.33; 95% CI 1.00-1.78) and IgM RF (HR 1.38; 95% CI 1.04-1.83) increased the risk for incident VTE. Additionally, the risk increased with the number of ACPA fine-specificities expressed (Ptrend = .033).
Study details: This prospective cohort study analyzed 2782 patients with newly diagnosed RA who reported 213 first-ever VTE.
Disclosures: This study was supported by the Swedish Research Council, NordForsk, and others. Four authors declared being employees or part-time employees, paid advisors, or founders of different companies. Two authors reported owning patents for peptides and their use for diagnostic purpose.
Source: Westerlind H et al. The association between autoantibodies and risk for venous thromboembolic events among patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 18). Doi: 10.1093/rheumatology/keac601
Key clinical point: Presence of autoantibodies for cyclic citrullinated peptide (anti-CCP2), load of anticitrullinated protein antibody (ACPA) fine-specificities, and immunoglobulin M (IgM) rheumatoid factor (RF) at diagnosis of rheumatoid arthritis (RA) increased the risk for incident venous thromboembolic events (VTE) in patients with RA.
Major finding: Positivity for IgG anti-CCP2 (hazard ratio [HR] 1.33; 95% CI 1.00-1.78) and IgM RF (HR 1.38; 95% CI 1.04-1.83) increased the risk for incident VTE. Additionally, the risk increased with the number of ACPA fine-specificities expressed (Ptrend = .033).
Study details: This prospective cohort study analyzed 2782 patients with newly diagnosed RA who reported 213 first-ever VTE.
Disclosures: This study was supported by the Swedish Research Council, NordForsk, and others. Four authors declared being employees or part-time employees, paid advisors, or founders of different companies. Two authors reported owning patents for peptides and their use for diagnostic purpose.
Source: Westerlind H et al. The association between autoantibodies and risk for venous thromboembolic events among patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 18). Doi: 10.1093/rheumatology/keac601
Concomitant methotrexate hampers third SARS-CoV-2 vaccine response in elderly patients with RA
Key clinical point: Concomitant methotrexate significantly reduced humoral response to the third SARS-CoV-2 mRNA vaccine in older (age ≥ 64.5 years) but not younger (age < 64.5 years) patients with rheumatoid arthritis (RA).
Major finding: Patients aged ≥ 64.5 years receiving methotrexate plus biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) vs methotrexate monotherapy or b/tsDMARD monotherapy had significantly lower serum levels of immunoglobulin G antibody for SARS-CoV-2 spike protein receptor binding domain (64.8 vs 1743.8 or 1106.0 binding antibody units/mL, respectively; Kruskal-Wallis Test, P < .001), whereas patients aged < 64.5 years showed no significant difference (Kruskal-Wallis Test, P = .334).
Study details: Findings are from a retrospective analysis including 136 patients with RA treated with conventional synthetic DMARD or b/ts DMARD with or without methotrexate who received the third dose of SARS-CoV-2 mRNA vaccines BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).
Disclosures: This study did not declare any specific source of funding. No conflict of interests was declared.
Source: Stahl D et al. Reduced humoral response to a third dose (booster) of SARS-CoV-2 mRNA vaccines by concomitant methotrexate therapy in elderly patients with rheumatoid arthritis. RMD Open. 2022;8(2):e002632 (Oct 10). Doi: 10.1136/rmdopen-2022-002632
Key clinical point: Concomitant methotrexate significantly reduced humoral response to the third SARS-CoV-2 mRNA vaccine in older (age ≥ 64.5 years) but not younger (age < 64.5 years) patients with rheumatoid arthritis (RA).
Major finding: Patients aged ≥ 64.5 years receiving methotrexate plus biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) vs methotrexate monotherapy or b/tsDMARD monotherapy had significantly lower serum levels of immunoglobulin G antibody for SARS-CoV-2 spike protein receptor binding domain (64.8 vs 1743.8 or 1106.0 binding antibody units/mL, respectively; Kruskal-Wallis Test, P < .001), whereas patients aged < 64.5 years showed no significant difference (Kruskal-Wallis Test, P = .334).
Study details: Findings are from a retrospective analysis including 136 patients with RA treated with conventional synthetic DMARD or b/ts DMARD with or without methotrexate who received the third dose of SARS-CoV-2 mRNA vaccines BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).
Disclosures: This study did not declare any specific source of funding. No conflict of interests was declared.
Source: Stahl D et al. Reduced humoral response to a third dose (booster) of SARS-CoV-2 mRNA vaccines by concomitant methotrexate therapy in elderly patients with rheumatoid arthritis. RMD Open. 2022;8(2):e002632 (Oct 10). Doi: 10.1136/rmdopen-2022-002632
Key clinical point: Concomitant methotrexate significantly reduced humoral response to the third SARS-CoV-2 mRNA vaccine in older (age ≥ 64.5 years) but not younger (age < 64.5 years) patients with rheumatoid arthritis (RA).
Major finding: Patients aged ≥ 64.5 years receiving methotrexate plus biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) vs methotrexate monotherapy or b/tsDMARD monotherapy had significantly lower serum levels of immunoglobulin G antibody for SARS-CoV-2 spike protein receptor binding domain (64.8 vs 1743.8 or 1106.0 binding antibody units/mL, respectively; Kruskal-Wallis Test, P < .001), whereas patients aged < 64.5 years showed no significant difference (Kruskal-Wallis Test, P = .334).
Study details: Findings are from a retrospective analysis including 136 patients with RA treated with conventional synthetic DMARD or b/ts DMARD with or without methotrexate who received the third dose of SARS-CoV-2 mRNA vaccines BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).
Disclosures: This study did not declare any specific source of funding. No conflict of interests was declared.
Source: Stahl D et al. Reduced humoral response to a third dose (booster) of SARS-CoV-2 mRNA vaccines by concomitant methotrexate therapy in elderly patients with rheumatoid arthritis. RMD Open. 2022;8(2):e002632 (Oct 10). Doi: 10.1136/rmdopen-2022-002632