Conference Coverage

LAS VEGAS – An automated cleaning system outperformed manual cleaning of duodenoscopes in a comparative study. The results included measurements of residual proteins and carbohydrates in all duodenoscope working channels and elevators.

The new automated cleaning system, called the MACH 1, can be added to existing reprocessing areas and is about the size of a commercial washing machine. Cleaning alone takes about 30 minutes, and clean plus high-level disinfection (HLD) takes about an hour, according to Michael O’Donnell, MD, who is a gastroenterology fellow at NYU Langone Health. “Data from prior studies of other automated endoscope reprocessors indicate that MACH 1 more consistently delivers cleaning results that meet or exceed Food and Drug Administration/AAMI (Association for the Advancement of Medical Instrumentation) guidelines,” Dr. O’Donnell said in an interview. He presented the study at the annual meeting of the American College of Gastroenterology.

Outbreaks of multidrug resistant organism (MDRO) transmission have been linked to inadequately cleaned duodenoscopes, which has led to greater attention being paid to duodenoscope reprocessing, including prewash, manual cleaning, and disinfection or sterilization, according to Dr. O’Donnell. Postmarketing surveillance by duodenoscope manufacturers Fujifilm, Olympus, and Pentax found a contamination rate of 5.4% for any high-concern organisms – far higher than the initially assumed 0.4%.

The researchers used FDA standard maximum allowed contaminant threshold of < 6.4 mcg/cm² protein and < 2.2 mcg/cm² carbohydrate. Sampling sites on the duodenoscopes included the elevator wire channel port when present, the biopsy port, the elevator wire channel, the instrument channel, and the elevator recess.

The study included Olympic TJF-Q180V duodenoscopes used in 48 endoscopic retrograde cholangiopancreatography (ERCP) procedures. Each instrument went through standard bedside precleaning; 21 were then cleaned manually by trained technicians following manufacturing instructions, and 27 were cleaned using the automated cleaning system.

In the manually cleaned duodenoscopes, the average level of residual protein was 4.88 mcg/cm², versus 0.16 mcg/cm² in the automated clean group. The average carbohydrate residues were 1.09 mcg/cm² and 0.14 mcg/cm², respectively. In all, 2 of the 21 manually cleaned devices had protein levels higher than the FDA threshold, versus none in the automated clean group. In addition, 3 of 21 in the manually cleaned group had higher than threshold carbohydrate levels, versus none in the automated clean group. Overall, 4 of the 27 manually cleaned devices and none of the 21 automated clean devices had protein or carbohydrate levels above FDA thresholds.
 

Removing variability from cleaning

The cleaning step is critical because failure to remove bioburden can reduce the efficacy of later HLD or sterilization. Cleaning is typically done manually, but the physical complexity of the duodenoscope makes it challenging to do it thoroughly. Manual cleaning is also susceptible to human error or insufficient training, and an observational study found that at least one error occurred in more than 90% of observed cleaning operations.

The MACH 1 uses turbulent flow and resultant shearing forces to clean the duodenoscope. The device is currently used at the medical device company Parametrik as part of a program that delivers clean duodenoscopes and ultrasound scopes to its customers. The service is currently available only in the New York metro area, but the company intends to expand to other cities in 2022. The company also has plans to sell the MACH 1 in the near future at prices comparable to automated endoscope reprocessors that don’t clean, according to Dr. O’Donnell.

“This is a huge issue, not only practically for patient care, but it’s very much in the public eye. As people who do ERCP, this is a question that patients will come to us with, so we want to be as diligent as possible to drive the bioburden in the scope as low as we can. At least intuitively, that makes sense,” said Patrick Young, MD, who comoderated the session and is a professor of medicine at the Uniformed Services University, Bethesda, Md.

He noted that the system has an advantage in that it can be applied to duodenoscopes already in house. Other approaches to the issue of improperly cleaned duodenoscopes include scopes that can be returned to the manufacturer for cleaning, or removable end cap to facilitate access to difficult to clean parts. And then there are disposal duodenoscopes. “If you’re throwing a scope away every time you use it, you worry about landfill issues and some of the long term effects of that,” said Dr. Young.

Perhaps the most important attribute of the automated cleaning device is that it allows the user to eliminate variation in the cleaning procedure. High-reliability organizations aspire to eliminating variability. “This will probably make it easier to be consistent across technicians – for example, maybe there’s one tech that cleans great and one tech that doesn’t. This may take some of that out of the equation and give you a more thorough cleaning regardless of circumstance or personnel working on it. So I think it’s exciting to have another option that might be less costly than buying new scopes,” said Dr. Young.

Dr. O’Donnell and Dr. Young have no relevant financial disclosures.

LAS VEGAS – An automated cleaning system outperformed manual cleaning of duodenoscopes in a comparative study. The results included measurements of residual proteins and carbohydrates in all duodenoscope working channels and elevators.

The new automated cleaning system, called the MACH 1, can be added to existing reprocessing areas and is about the size of a commercial washing machine. Cleaning alone takes about 30 minutes, and clean plus high-level disinfection (HLD) takes about an hour, according to Michael O’Donnell, MD, who is a gastroenterology fellow at NYU Langone Health. “Data from prior studies of other automated endoscope reprocessors indicate that MACH 1 more consistently delivers cleaning results that meet or exceed Food and Drug Administration/AAMI (Association for the Advancement of Medical Instrumentation) guidelines,” Dr. O’Donnell said in an interview. He presented the study at the annual meeting of the American College of Gastroenterology.

Outbreaks of multidrug resistant organism (MDRO) transmission have been linked to inadequately cleaned duodenoscopes, which has led to greater attention being paid to duodenoscope reprocessing, including prewash, manual cleaning, and disinfection or sterilization, according to Dr. O’Donnell. Postmarketing surveillance by duodenoscope manufacturers Fujifilm, Olympus, and Pentax found a contamination rate of 5.4% for any high-concern organisms – far higher than the initially assumed 0.4%.

The researchers used FDA standard maximum allowed contaminant threshold of < 6.4 mcg/cm² protein and < 2.2 mcg/cm² carbohydrate. Sampling sites on the duodenoscopes included the elevator wire channel port when present, the biopsy port, the elevator wire channel, the instrument channel, and the elevator recess.

The study included Olympic TJF-Q180V duodenoscopes used in 48 endoscopic retrograde cholangiopancreatography (ERCP) procedures. Each instrument went through standard bedside precleaning; 21 were then cleaned manually by trained technicians following manufacturing instructions, and 27 were cleaned using the automated cleaning system.

In the manually cleaned duodenoscopes, the average level of residual protein was 4.88 mcg/cm², versus 0.16 mcg/cm² in the automated clean group. The average carbohydrate residues were 1.09 mcg/cm² and 0.14 mcg/cm², respectively. In all, 2 of the 21 manually cleaned devices had protein levels higher than the FDA threshold, versus none in the automated clean group. In addition, 3 of 21 in the manually cleaned group had higher than threshold carbohydrate levels, versus none in the automated clean group. Overall, 4 of the 27 manually cleaned devices and none of the 21 automated clean devices had protein or carbohydrate levels above FDA thresholds.
 

Removing variability from cleaning

The cleaning step is critical because failure to remove bioburden can reduce the efficacy of later HLD or sterilization. Cleaning is typically done manually, but the physical complexity of the duodenoscope makes it challenging to do it thoroughly. Manual cleaning is also susceptible to human error or insufficient training, and an observational study found that at least one error occurred in more than 90% of observed cleaning operations.

The MACH 1 uses turbulent flow and resultant shearing forces to clean the duodenoscope. The device is currently used at the medical device company Parametrik as part of a program that delivers clean duodenoscopes and ultrasound scopes to its customers. The service is currently available only in the New York metro area, but the company intends to expand to other cities in 2022. The company also has plans to sell the MACH 1 in the near future at prices comparable to automated endoscope reprocessors that don’t clean, according to Dr. O’Donnell.

“This is a huge issue, not only practically for patient care, but it’s very much in the public eye. As people who do ERCP, this is a question that patients will come to us with, so we want to be as diligent as possible to drive the bioburden in the scope as low as we can. At least intuitively, that makes sense,” said Patrick Young, MD, who comoderated the session and is a professor of medicine at the Uniformed Services University, Bethesda, Md.

He noted that the system has an advantage in that it can be applied to duodenoscopes already in house. Other approaches to the issue of improperly cleaned duodenoscopes include scopes that can be returned to the manufacturer for cleaning, or removable end cap to facilitate access to difficult to clean parts. And then there are disposal duodenoscopes. “If you’re throwing a scope away every time you use it, you worry about landfill issues and some of the long term effects of that,” said Dr. Young.

Perhaps the most important attribute of the automated cleaning device is that it allows the user to eliminate variation in the cleaning procedure. High-reliability organizations aspire to eliminating variability. “This will probably make it easier to be consistent across technicians – for example, maybe there’s one tech that cleans great and one tech that doesn’t. This may take some of that out of the equation and give you a more thorough cleaning regardless of circumstance or personnel working on it. So I think it’s exciting to have another option that might be less costly than buying new scopes,” said Dr. Young.

Dr. O’Donnell and Dr. Young have no relevant financial disclosures.

LAS VEGAS – An automated cleaning system outperformed manual cleaning of duodenoscopes in a comparative study. The results included measurements of residual proteins and carbohydrates in all duodenoscope working channels and elevators.

The new automated cleaning system, called the MACH 1, can be added to existing reprocessing areas and is about the size of a commercial washing machine. Cleaning alone takes about 30 minutes, and clean plus high-level disinfection (HLD) takes about an hour, according to Michael O’Donnell, MD, who is a gastroenterology fellow at NYU Langone Health. “Data from prior studies of other automated endoscope reprocessors indicate that MACH 1 more consistently delivers cleaning results that meet or exceed Food and Drug Administration/AAMI (Association for the Advancement of Medical Instrumentation) guidelines,” Dr. O’Donnell said in an interview. He presented the study at the annual meeting of the American College of Gastroenterology.

Outbreaks of multidrug resistant organism (MDRO) transmission have been linked to inadequately cleaned duodenoscopes, which has led to greater attention being paid to duodenoscope reprocessing, including prewash, manual cleaning, and disinfection or sterilization, according to Dr. O’Donnell. Postmarketing surveillance by duodenoscope manufacturers Fujifilm, Olympus, and Pentax found a contamination rate of 5.4% for any high-concern organisms – far higher than the initially assumed 0.4%.

The researchers used FDA standard maximum allowed contaminant threshold of < 6.4 mcg/cm² protein and < 2.2 mcg/cm² carbohydrate. Sampling sites on the duodenoscopes included the elevator wire channel port when present, the biopsy port, the elevator wire channel, the instrument channel, and the elevator recess.

The study included Olympic TJF-Q180V duodenoscopes used in 48 endoscopic retrograde cholangiopancreatography (ERCP) procedures. Each instrument went through standard bedside precleaning; 21 were then cleaned manually by trained technicians following manufacturing instructions, and 27 were cleaned using the automated cleaning system.

In the manually cleaned duodenoscopes, the average level of residual protein was 4.88 mcg/cm², versus 0.16 mcg/cm² in the automated clean group. The average carbohydrate residues were 1.09 mcg/cm² and 0.14 mcg/cm², respectively. In all, 2 of the 21 manually cleaned devices had protein levels higher than the FDA threshold, versus none in the automated clean group. In addition, 3 of 21 in the manually cleaned group had higher than threshold carbohydrate levels, versus none in the automated clean group. Overall, 4 of the 27 manually cleaned devices and none of the 21 automated clean devices had protein or carbohydrate levels above FDA thresholds.
 

Removing variability from cleaning

The cleaning step is critical because failure to remove bioburden can reduce the efficacy of later HLD or sterilization. Cleaning is typically done manually, but the physical complexity of the duodenoscope makes it challenging to do it thoroughly. Manual cleaning is also susceptible to human error or insufficient training, and an observational study found that at least one error occurred in more than 90% of observed cleaning operations.

The MACH 1 uses turbulent flow and resultant shearing forces to clean the duodenoscope. The device is currently used at the medical device company Parametrik as part of a program that delivers clean duodenoscopes and ultrasound scopes to its customers. The service is currently available only in the New York metro area, but the company intends to expand to other cities in 2022. The company also has plans to sell the MACH 1 in the near future at prices comparable to automated endoscope reprocessors that don’t clean, according to Dr. O’Donnell.

“This is a huge issue, not only practically for patient care, but it’s very much in the public eye. As people who do ERCP, this is a question that patients will come to us with, so we want to be as diligent as possible to drive the bioburden in the scope as low as we can. At least intuitively, that makes sense,” said Patrick Young, MD, who comoderated the session and is a professor of medicine at the Uniformed Services University, Bethesda, Md.

He noted that the system has an advantage in that it can be applied to duodenoscopes already in house. Other approaches to the issue of improperly cleaned duodenoscopes include scopes that can be returned to the manufacturer for cleaning, or removable end cap to facilitate access to difficult to clean parts. And then there are disposal duodenoscopes. “If you’re throwing a scope away every time you use it, you worry about landfill issues and some of the long term effects of that,” said Dr. Young.

Perhaps the most important attribute of the automated cleaning device is that it allows the user to eliminate variation in the cleaning procedure. High-reliability organizations aspire to eliminating variability. “This will probably make it easier to be consistent across technicians – for example, maybe there’s one tech that cleans great and one tech that doesn’t. This may take some of that out of the equation and give you a more thorough cleaning regardless of circumstance or personnel working on it. So I think it’s exciting to have another option that might be less costly than buying new scopes,” said Dr. Young.

Dr. O’Donnell and Dr. Young have no relevant financial disclosures.

Clinicians who are stumped on how to counsel patients asking about whether cannabinoids benefit various skin-related ailments are not alone.

“When you walk into places like CVS or Walgreens, you see lots of displays for CBD creams and oils,” Todd S. Anhalt, MD, said during the annual meeting of the Pacific Dermatologic Association. “The problem is, we don’t know what’s in them or who made them or how good they are. That’s going to be a problem for a while.”

According to Dr. Anhalt, clinical professor emeritus of dermatology at Stanford (Calif.) University, there are about 140 active cannabinoid compounds in cannabis, but the most important ones are THC and cannabidiol (CBD). There are three types of cannabinoids, based on where the cannabidiol is produced: endocannabinoids, which are produced in the human body; phytocannabinoids, which are derived from plants such as marijuana and hemp; and synthetic cannabinoids, which are derived in labs.

Dr. Anhalt described the endocannabinoid system as a conserved network of molecular signaling made of several components: signaling molecules (endocannabinoids), endocannabinoid receptors (CB-1 and CB-2), enzymes, and transporters. There is also overlap between cannabinoids and terpenes, which are responsible for flavor and aroma in plants and marijuana and can enhance the effects of CBD.

“For the most part, CB-1 receptors are in the central nervous system and CB-2 [receptors] are mostly in the periphery,” including the skin and digestive system, said Dr. Anhalt, who practices at the California Skin Institute in Los Altos, Calif. “This is interesting because one of the main conditions I recommend cannabidiol for is in patients with peripheral neuropathy, despite the fact they may be on all sorts of medications such as Neurontin and Lyrica or tricyclic antidepressants. Sometimes they don’t get much relief from those. I have had many patients tell me that they have had reduction of pain and increased functionality using the CBD creams.” CB-2 receptors, he noted, are located in keratinocytes, sensory receptors, sweat glands, fibroblasts, Langerhans cells, melanocytes, and sebaceous glands.

Recent research shows that the endocannabinoid system is involved in modulation of the CNS and in immune function, particularly skin homeostasis and barrier function. “We know that barrier function can be affected by the generation of oxidative species,” he said. “The stress that it causes can decrease barrier function and lead to cytokine release and itch. CBDs have been shown to enter cells, target and upregulate genes with decreased oxidation and inflammation, and protect membrane integrity in skin cells. Therefore, this might be helpful in atopic dermatitis.” Other potential uses in dermatology include wound healing, acne, hair growth modulation, skin and hair pigmentation, skin infections, psoriasis, and cutaneous malignancies, as well as neuropathic pain.

Evidence is strongest for neuropathic pain, he said, which is mediated by CB-1 receptors peripherally, followed by itch and atopic dermatitis. The authors of a 2017 systematic review concluded that “low-strength” evidence exists to suggest that cannabis alleviates neuropathic pain, with insufficient evidence for other types of pain.

Topical CBD comes in various forms: oils (usually hemp oil), creams, and lotions, Dr. Anhalt said. “I advise patients to apply it 2-4 times per day depending on how anxious or uncomfortable they are. It takes my patients 10 days to 2 weeks before they notice anything at all.”

For atopic dermatitis, it could be useful “not to use it instead of a moisturizer, but as a moisturizer,” Dr. Anhalt advised. “You can have a patient get big jars of CBD creams and lotions. They may have to try a few before they find one that they really like, but you can replace all of the other moisturizers that you’re using right now in patients who have a lot of itch.”

As for CBD’s effect on peripheral neuropathy, the medical literature is lacking, but some studies show low to moderate evidence of efficacy. For example, a Cochrane Review found that a 30% or greater pain reduction was achieved by 39% of patients who used cannabis-based treatments, vs. 33% of those on placebo.

“I would not suggest CBD as a first-line drug unless it’s very mild peripheral neuropathy, but for patients who are on gabapentin who are better but not better enough, this is an excellent adjunct,” Dr. Anhalt said. “It’s worth trying. It’s not too expensive and it’s really safe.”

The application of topical CBD to treat cutaneous malignancies has not yet shown evidence of significant efficacy, while using CBDs for acne holds promise. “The endogenous cannabinoid system is involved in the production of lipids,” he said. “Cannabinoids have an antilipogenic activity, so they decrease sebum production. CBD could help patients with mild acne who are reluctant to use other types of medications. For this and other potential dermatologic applications, lots more studies need to be done.”

Dr. Anhalt reported having no financial disclosures.

dbrunk@mdedge.com

Clinicians who are stumped on how to counsel patients asking about whether cannabinoids benefit various skin-related ailments are not alone.

“When you walk into places like CVS or Walgreens, you see lots of displays for CBD creams and oils,” Todd S. Anhalt, MD, said during the annual meeting of the Pacific Dermatologic Association. “The problem is, we don’t know what’s in them or who made them or how good they are. That’s going to be a problem for a while.”

According to Dr. Anhalt, clinical professor emeritus of dermatology at Stanford (Calif.) University, there are about 140 active cannabinoid compounds in cannabis, but the most important ones are THC and cannabidiol (CBD). There are three types of cannabinoids, based on where the cannabidiol is produced: endocannabinoids, which are produced in the human body; phytocannabinoids, which are derived from plants such as marijuana and hemp; and synthetic cannabinoids, which are derived in labs.

Dr. Anhalt described the endocannabinoid system as a conserved network of molecular signaling made of several components: signaling molecules (endocannabinoids), endocannabinoid receptors (CB-1 and CB-2), enzymes, and transporters. There is also overlap between cannabinoids and terpenes, which are responsible for flavor and aroma in plants and marijuana and can enhance the effects of CBD.

“For the most part, CB-1 receptors are in the central nervous system and CB-2 [receptors] are mostly in the periphery,” including the skin and digestive system, said Dr. Anhalt, who practices at the California Skin Institute in Los Altos, Calif. “This is interesting because one of the main conditions I recommend cannabidiol for is in patients with peripheral neuropathy, despite the fact they may be on all sorts of medications such as Neurontin and Lyrica or tricyclic antidepressants. Sometimes they don’t get much relief from those. I have had many patients tell me that they have had reduction of pain and increased functionality using the CBD creams.” CB-2 receptors, he noted, are located in keratinocytes, sensory receptors, sweat glands, fibroblasts, Langerhans cells, melanocytes, and sebaceous glands.

Recent research shows that the endocannabinoid system is involved in modulation of the CNS and in immune function, particularly skin homeostasis and barrier function. “We know that barrier function can be affected by the generation of oxidative species,” he said. “The stress that it causes can decrease barrier function and lead to cytokine release and itch. CBDs have been shown to enter cells, target and upregulate genes with decreased oxidation and inflammation, and protect membrane integrity in skin cells. Therefore, this might be helpful in atopic dermatitis.” Other potential uses in dermatology include wound healing, acne, hair growth modulation, skin and hair pigmentation, skin infections, psoriasis, and cutaneous malignancies, as well as neuropathic pain.

Evidence is strongest for neuropathic pain, he said, which is mediated by CB-1 receptors peripherally, followed by itch and atopic dermatitis. The authors of a 2017 systematic review concluded that “low-strength” evidence exists to suggest that cannabis alleviates neuropathic pain, with insufficient evidence for other types of pain.

Topical CBD comes in various forms: oils (usually hemp oil), creams, and lotions, Dr. Anhalt said. “I advise patients to apply it 2-4 times per day depending on how anxious or uncomfortable they are. It takes my patients 10 days to 2 weeks before they notice anything at all.”

For atopic dermatitis, it could be useful “not to use it instead of a moisturizer, but as a moisturizer,” Dr. Anhalt advised. “You can have a patient get big jars of CBD creams and lotions. They may have to try a few before they find one that they really like, but you can replace all of the other moisturizers that you’re using right now in patients who have a lot of itch.”

As for CBD’s effect on peripheral neuropathy, the medical literature is lacking, but some studies show low to moderate evidence of efficacy. For example, a Cochrane Review found that a 30% or greater pain reduction was achieved by 39% of patients who used cannabis-based treatments, vs. 33% of those on placebo.

“I would not suggest CBD as a first-line drug unless it’s very mild peripheral neuropathy, but for patients who are on gabapentin who are better but not better enough, this is an excellent adjunct,” Dr. Anhalt said. “It’s worth trying. It’s not too expensive and it’s really safe.”

The application of topical CBD to treat cutaneous malignancies has not yet shown evidence of significant efficacy, while using CBDs for acne holds promise. “The endogenous cannabinoid system is involved in the production of lipids,” he said. “Cannabinoids have an antilipogenic activity, so they decrease sebum production. CBD could help patients with mild acne who are reluctant to use other types of medications. For this and other potential dermatologic applications, lots more studies need to be done.”

Dr. Anhalt reported having no financial disclosures.

dbrunk@mdedge.com

Clinicians who are stumped on how to counsel patients asking about whether cannabinoids benefit various skin-related ailments are not alone.

“When you walk into places like CVS or Walgreens, you see lots of displays for CBD creams and oils,” Todd S. Anhalt, MD, said during the annual meeting of the Pacific Dermatologic Association. “The problem is, we don’t know what’s in them or who made them or how good they are. That’s going to be a problem for a while.”

According to Dr. Anhalt, clinical professor emeritus of dermatology at Stanford (Calif.) University, there are about 140 active cannabinoid compounds in cannabis, but the most important ones are THC and cannabidiol (CBD). There are three types of cannabinoids, based on where the cannabidiol is produced: endocannabinoids, which are produced in the human body; phytocannabinoids, which are derived from plants such as marijuana and hemp; and synthetic cannabinoids, which are derived in labs.

Dr. Anhalt described the endocannabinoid system as a conserved network of molecular signaling made of several components: signaling molecules (endocannabinoids), endocannabinoid receptors (CB-1 and CB-2), enzymes, and transporters. There is also overlap between cannabinoids and terpenes, which are responsible for flavor and aroma in plants and marijuana and can enhance the effects of CBD.

“For the most part, CB-1 receptors are in the central nervous system and CB-2 [receptors] are mostly in the periphery,” including the skin and digestive system, said Dr. Anhalt, who practices at the California Skin Institute in Los Altos, Calif. “This is interesting because one of the main conditions I recommend cannabidiol for is in patients with peripheral neuropathy, despite the fact they may be on all sorts of medications such as Neurontin and Lyrica or tricyclic antidepressants. Sometimes they don’t get much relief from those. I have had many patients tell me that they have had reduction of pain and increased functionality using the CBD creams.” CB-2 receptors, he noted, are located in keratinocytes, sensory receptors, sweat glands, fibroblasts, Langerhans cells, melanocytes, and sebaceous glands.

Recent research shows that the endocannabinoid system is involved in modulation of the CNS and in immune function, particularly skin homeostasis and barrier function. “We know that barrier function can be affected by the generation of oxidative species,” he said. “The stress that it causes can decrease barrier function and lead to cytokine release and itch. CBDs have been shown to enter cells, target and upregulate genes with decreased oxidation and inflammation, and protect membrane integrity in skin cells. Therefore, this might be helpful in atopic dermatitis.” Other potential uses in dermatology include wound healing, acne, hair growth modulation, skin and hair pigmentation, skin infections, psoriasis, and cutaneous malignancies, as well as neuropathic pain.

Evidence is strongest for neuropathic pain, he said, which is mediated by CB-1 receptors peripherally, followed by itch and atopic dermatitis. The authors of a 2017 systematic review concluded that “low-strength” evidence exists to suggest that cannabis alleviates neuropathic pain, with insufficient evidence for other types of pain.

Topical CBD comes in various forms: oils (usually hemp oil), creams, and lotions, Dr. Anhalt said. “I advise patients to apply it 2-4 times per day depending on how anxious or uncomfortable they are. It takes my patients 10 days to 2 weeks before they notice anything at all.”

For atopic dermatitis, it could be useful “not to use it instead of a moisturizer, but as a moisturizer,” Dr. Anhalt advised. “You can have a patient get big jars of CBD creams and lotions. They may have to try a few before they find one that they really like, but you can replace all of the other moisturizers that you’re using right now in patients who have a lot of itch.”

As for CBD’s effect on peripheral neuropathy, the medical literature is lacking, but some studies show low to moderate evidence of efficacy. For example, a Cochrane Review found that a 30% or greater pain reduction was achieved by 39% of patients who used cannabis-based treatments, vs. 33% of those on placebo.

“I would not suggest CBD as a first-line drug unless it’s very mild peripheral neuropathy, but for patients who are on gabapentin who are better but not better enough, this is an excellent adjunct,” Dr. Anhalt said. “It’s worth trying. It’s not too expensive and it’s really safe.”

The application of topical CBD to treat cutaneous malignancies has not yet shown evidence of significant efficacy, while using CBDs for acne holds promise. “The endogenous cannabinoid system is involved in the production of lipids,” he said. “Cannabinoids have an antilipogenic activity, so they decrease sebum production. CBD could help patients with mild acne who are reluctant to use other types of medications. For this and other potential dermatologic applications, lots more studies need to be done.”

Dr. Anhalt reported having no financial disclosures.

dbrunk@mdedge.com

LAS VEGAS – Over the course of the COVID-19 pandemic, alcohol-related liver disease has increased in severity, a finding that is likely related to higher consumption of alcohol and reduced care. The difference was notable in higher Model for End-Stage Liver Disease–sodium (MELD-Na) scores, more signs of hepatic decompensation, and higher mortality rates.

“Alcohol consumption during the COVID-19 pandemic led to increased morbidity and mortality, specifically in patients that already had underlying liver disease. The importance of alcohol cessation, counseling, and close physician monitoring is emphasized, given continued or relapsed alcohol consumption can significantly affect quality of life, life expectancy, and liver transplantation candidacy,” research team member Lindsay A. Sobotka, DO, said in an interview. Dr. Sobotka is an assistant professor of gastroenterology, hepatology, and nutrition at the Ohio State University Wexner Medical Center, Columbus.

The research was presented by Ayushi Jain, MD, at the annual meeting of the American College of Gastroenterology. Dr. Jain is a resident at the Ohio State University Wexner Medical Center.

Dr. Jain noted that alcohol sales have gone up during the pandemic, with monthly sales up 14%-44% between February and September 2020, compared with the same months in previous years.
 

Decompensation rates rose

The researchers analyzed data from patients with alcoholic cirrhosis or alcoholic hepatitis who were seen at the Ohio State University Medical Center between March and August 2019, and between March and August 2020.

alenkadr/Thinkstock

During the pandemic, the number of hospital admissions nearly doubled among alcoholic hepatitis patients (86 to 162), but declined slightly among patients with alcoholic cirrhosis (613 to 528), possibly because of efforts to manage decompensation and avoid hospitalizations during the pandemic, according to Dr. Jain. In total, 4 of 162 patients with alcoholic hepatitis and 14 of 528 patients with alcoholic cirrhosis had COVID-19 at the time of admission.

Higher mortality rates were seen during the pandemic, although this was only significant for alcoholic cirrhosis: 14.8% versus 7% for alcoholic hepatitis (P = .06) and 13.5% versus 7.4% for alcoholic cirrhosis (P = .001).

Among those with alcoholic hepatitis, there was no significant change in median Maddrey’s Discriminant Function during the pandemic (P = .51), but the researchers noted a significant decrease in steroid use, from 27 patients to 23 (P = .001). “This may be due to a statistically significant increase in GI bleeds and renal dysfunction that we noted during the pandemic,” said Dr. Jain.

Hepatic decompensation and critical care needs increased among patients admitted with alcoholic hepatitis, including hepatic encephalopathy (P = .037), gastrointestinal bleeding (P = .01), a need for increased oxygen (P = .024), vasopressor support (P = .005), and initiation of hemodialysis (P = .007). The median highest MELD-Na score during admission was also higher during the pandemic (24 vs. 23, P = .04).

Patients with alcoholic cirrhosis had greater decompensation as measured by ascites (P = .01), therapeutic paracentesis (P = .04), titration of diuretics (P = .005), acute kidney injury (P = .005), hepatorenal syndrome (P = .002), and spontaneous bacterial peritonitis (P = .04). They also had greater need for vasopressor support (9% to 14%; P = .006), were more likely to initiate hemodialysis (7% to 11%; P = .015), and had greater mortality (7% to 14%; P = .001).

In all, 212 patients reported increased alcohol intake, 161 reported little change over the past year, and 253 said they were abstinent. MELD-Na scores were highest in the increased group (27), compared with the unchanged group (24) and abstinent group (23) (P = .001).
 

More robust support needed

“This highlights that the increase in alcohol use seems to be associated with higher rates of more severe alcoholic hepatitis, and we are going to need to all be aware of and intervene in these individuals, and try to not only make health care more accessible, but help those with alcohol use disorder to reengage in some support systems [and] harm-reduction measures, to try to reduce the number of these episodes of admissions with severe alcoholic hepatitis,” said Paul Kwo, MD, who comoderated the session. Dr. Kwo is a professor of medicine at Stanford (Calif.) University.

Dr. Kwo suggested that the pandemic has presented dual challenges to patients with alcohol-related liver disease. One is that hospitals have filled up because of an influx of COVID-19 cases, which makes it hard for them to compete for limited resources. The other is that lockdowns and social interruptions may have interfered with the support systems that normally help them to keep sober and maintain health care. “The pandemic really disrupted everybody’s ecosystem substantially, and some of these individuals, as their ecosystems crumble, they don’t have other resources to engage in care, and then they present with far more advanced comorbidities than we might have seen prior to the pandemic,” said Dr. Kwo.

The findings underscore at least one lesson that can be drawn from the pandemic. “We now know that we have to develop more robust systems to provide support for all of these individuals,” said Dr. Kwo.

Comoderator Patricia D. Jones, MD, agreed, and expressed optimism. “We were forced develop more remote or virtual networks, so I think there are a lot of people that are taking advantage maybe of virtual [Alcoholics Anonymous], and that wasn’t something that they necessarily did [before the pandemic]. And so at least we’ve developed some parallel systems that hopefully people will benefit from,” said Dr. Jones, who is an assistant professor of medicine at the University of Miami.

She suggested that physicians should make inquiries about patients with alcohol-related liver disease and their social situations, and might consider trying to connect them to a social worker if called for. “I think that really speaking to the person about where they are would be beneficial,” said Dr. Jones.

Dr. Sobotka, Dr. Jain, Dr. Kwo, and Dr. Jones have no relevant financial disclosures.

LAS VEGAS – Over the course of the COVID-19 pandemic, alcohol-related liver disease has increased in severity, a finding that is likely related to higher consumption of alcohol and reduced care. The difference was notable in higher Model for End-Stage Liver Disease–sodium (MELD-Na) scores, more signs of hepatic decompensation, and higher mortality rates.

“Alcohol consumption during the COVID-19 pandemic led to increased morbidity and mortality, specifically in patients that already had underlying liver disease. The importance of alcohol cessation, counseling, and close physician monitoring is emphasized, given continued or relapsed alcohol consumption can significantly affect quality of life, life expectancy, and liver transplantation candidacy,” research team member Lindsay A. Sobotka, DO, said in an interview. Dr. Sobotka is an assistant professor of gastroenterology, hepatology, and nutrition at the Ohio State University Wexner Medical Center, Columbus.

The research was presented by Ayushi Jain, MD, at the annual meeting of the American College of Gastroenterology. Dr. Jain is a resident at the Ohio State University Wexner Medical Center.

Dr. Jain noted that alcohol sales have gone up during the pandemic, with monthly sales up 14%-44% between February and September 2020, compared with the same months in previous years.
 

Decompensation rates rose

The researchers analyzed data from patients with alcoholic cirrhosis or alcoholic hepatitis who were seen at the Ohio State University Medical Center between March and August 2019, and between March and August 2020.

alenkadr/Thinkstock

During the pandemic, the number of hospital admissions nearly doubled among alcoholic hepatitis patients (86 to 162), but declined slightly among patients with alcoholic cirrhosis (613 to 528), possibly because of efforts to manage decompensation and avoid hospitalizations during the pandemic, according to Dr. Jain. In total, 4 of 162 patients with alcoholic hepatitis and 14 of 528 patients with alcoholic cirrhosis had COVID-19 at the time of admission.

Higher mortality rates were seen during the pandemic, although this was only significant for alcoholic cirrhosis: 14.8% versus 7% for alcoholic hepatitis (P = .06) and 13.5% versus 7.4% for alcoholic cirrhosis (P = .001).

Among those with alcoholic hepatitis, there was no significant change in median Maddrey’s Discriminant Function during the pandemic (P = .51), but the researchers noted a significant decrease in steroid use, from 27 patients to 23 (P = .001). “This may be due to a statistically significant increase in GI bleeds and renal dysfunction that we noted during the pandemic,” said Dr. Jain.

Hepatic decompensation and critical care needs increased among patients admitted with alcoholic hepatitis, including hepatic encephalopathy (P = .037), gastrointestinal bleeding (P = .01), a need for increased oxygen (P = .024), vasopressor support (P = .005), and initiation of hemodialysis (P = .007). The median highest MELD-Na score during admission was also higher during the pandemic (24 vs. 23, P = .04).

Patients with alcoholic cirrhosis had greater decompensation as measured by ascites (P = .01), therapeutic paracentesis (P = .04), titration of diuretics (P = .005), acute kidney injury (P = .005), hepatorenal syndrome (P = .002), and spontaneous bacterial peritonitis (P = .04). They also had greater need for vasopressor support (9% to 14%; P = .006), were more likely to initiate hemodialysis (7% to 11%; P = .015), and had greater mortality (7% to 14%; P = .001).

In all, 212 patients reported increased alcohol intake, 161 reported little change over the past year, and 253 said they were abstinent. MELD-Na scores were highest in the increased group (27), compared with the unchanged group (24) and abstinent group (23) (P = .001).
 

More robust support needed

“This highlights that the increase in alcohol use seems to be associated with higher rates of more severe alcoholic hepatitis, and we are going to need to all be aware of and intervene in these individuals, and try to not only make health care more accessible, but help those with alcohol use disorder to reengage in some support systems [and] harm-reduction measures, to try to reduce the number of these episodes of admissions with severe alcoholic hepatitis,” said Paul Kwo, MD, who comoderated the session. Dr. Kwo is a professor of medicine at Stanford (Calif.) University.

Dr. Kwo suggested that the pandemic has presented dual challenges to patients with alcohol-related liver disease. One is that hospitals have filled up because of an influx of COVID-19 cases, which makes it hard for them to compete for limited resources. The other is that lockdowns and social interruptions may have interfered with the support systems that normally help them to keep sober and maintain health care. “The pandemic really disrupted everybody’s ecosystem substantially, and some of these individuals, as their ecosystems crumble, they don’t have other resources to engage in care, and then they present with far more advanced comorbidities than we might have seen prior to the pandemic,” said Dr. Kwo.

The findings underscore at least one lesson that can be drawn from the pandemic. “We now know that we have to develop more robust systems to provide support for all of these individuals,” said Dr. Kwo.

Comoderator Patricia D. Jones, MD, agreed, and expressed optimism. “We were forced develop more remote or virtual networks, so I think there are a lot of people that are taking advantage maybe of virtual [Alcoholics Anonymous], and that wasn’t something that they necessarily did [before the pandemic]. And so at least we’ve developed some parallel systems that hopefully people will benefit from,” said Dr. Jones, who is an assistant professor of medicine at the University of Miami.

She suggested that physicians should make inquiries about patients with alcohol-related liver disease and their social situations, and might consider trying to connect them to a social worker if called for. “I think that really speaking to the person about where they are would be beneficial,” said Dr. Jones.

Dr. Sobotka, Dr. Jain, Dr. Kwo, and Dr. Jones have no relevant financial disclosures.

LAS VEGAS – Over the course of the COVID-19 pandemic, alcohol-related liver disease has increased in severity, a finding that is likely related to higher consumption of alcohol and reduced care. The difference was notable in higher Model for End-Stage Liver Disease–sodium (MELD-Na) scores, more signs of hepatic decompensation, and higher mortality rates.

“Alcohol consumption during the COVID-19 pandemic led to increased morbidity and mortality, specifically in patients that already had underlying liver disease. The importance of alcohol cessation, counseling, and close physician monitoring is emphasized, given continued or relapsed alcohol consumption can significantly affect quality of life, life expectancy, and liver transplantation candidacy,” research team member Lindsay A. Sobotka, DO, said in an interview. Dr. Sobotka is an assistant professor of gastroenterology, hepatology, and nutrition at the Ohio State University Wexner Medical Center, Columbus.

The research was presented by Ayushi Jain, MD, at the annual meeting of the American College of Gastroenterology. Dr. Jain is a resident at the Ohio State University Wexner Medical Center.

Dr. Jain noted that alcohol sales have gone up during the pandemic, with monthly sales up 14%-44% between February and September 2020, compared with the same months in previous years.
 

Decompensation rates rose

The researchers analyzed data from patients with alcoholic cirrhosis or alcoholic hepatitis who were seen at the Ohio State University Medical Center between March and August 2019, and between March and August 2020.

alenkadr/Thinkstock

During the pandemic, the number of hospital admissions nearly doubled among alcoholic hepatitis patients (86 to 162), but declined slightly among patients with alcoholic cirrhosis (613 to 528), possibly because of efforts to manage decompensation and avoid hospitalizations during the pandemic, according to Dr. Jain. In total, 4 of 162 patients with alcoholic hepatitis and 14 of 528 patients with alcoholic cirrhosis had COVID-19 at the time of admission.

Higher mortality rates were seen during the pandemic, although this was only significant for alcoholic cirrhosis: 14.8% versus 7% for alcoholic hepatitis (P = .06) and 13.5% versus 7.4% for alcoholic cirrhosis (P = .001).

Among those with alcoholic hepatitis, there was no significant change in median Maddrey’s Discriminant Function during the pandemic (P = .51), but the researchers noted a significant decrease in steroid use, from 27 patients to 23 (P = .001). “This may be due to a statistically significant increase in GI bleeds and renal dysfunction that we noted during the pandemic,” said Dr. Jain.

Hepatic decompensation and critical care needs increased among patients admitted with alcoholic hepatitis, including hepatic encephalopathy (P = .037), gastrointestinal bleeding (P = .01), a need for increased oxygen (P = .024), vasopressor support (P = .005), and initiation of hemodialysis (P = .007). The median highest MELD-Na score during admission was also higher during the pandemic (24 vs. 23, P = .04).

Patients with alcoholic cirrhosis had greater decompensation as measured by ascites (P = .01), therapeutic paracentesis (P = .04), titration of diuretics (P = .005), acute kidney injury (P = .005), hepatorenal syndrome (P = .002), and spontaneous bacterial peritonitis (P = .04). They also had greater need for vasopressor support (9% to 14%; P = .006), were more likely to initiate hemodialysis (7% to 11%; P = .015), and had greater mortality (7% to 14%; P = .001).

In all, 212 patients reported increased alcohol intake, 161 reported little change over the past year, and 253 said they were abstinent. MELD-Na scores were highest in the increased group (27), compared with the unchanged group (24) and abstinent group (23) (P = .001).
 

More robust support needed

“This highlights that the increase in alcohol use seems to be associated with higher rates of more severe alcoholic hepatitis, and we are going to need to all be aware of and intervene in these individuals, and try to not only make health care more accessible, but help those with alcohol use disorder to reengage in some support systems [and] harm-reduction measures, to try to reduce the number of these episodes of admissions with severe alcoholic hepatitis,” said Paul Kwo, MD, who comoderated the session. Dr. Kwo is a professor of medicine at Stanford (Calif.) University.

Dr. Kwo suggested that the pandemic has presented dual challenges to patients with alcohol-related liver disease. One is that hospitals have filled up because of an influx of COVID-19 cases, which makes it hard for them to compete for limited resources. The other is that lockdowns and social interruptions may have interfered with the support systems that normally help them to keep sober and maintain health care. “The pandemic really disrupted everybody’s ecosystem substantially, and some of these individuals, as their ecosystems crumble, they don’t have other resources to engage in care, and then they present with far more advanced comorbidities than we might have seen prior to the pandemic,” said Dr. Kwo.

The findings underscore at least one lesson that can be drawn from the pandemic. “We now know that we have to develop more robust systems to provide support for all of these individuals,” said Dr. Kwo.

Comoderator Patricia D. Jones, MD, agreed, and expressed optimism. “We were forced develop more remote or virtual networks, so I think there are a lot of people that are taking advantage maybe of virtual [Alcoholics Anonymous], and that wasn’t something that they necessarily did [before the pandemic]. And so at least we’ve developed some parallel systems that hopefully people will benefit from,” said Dr. Jones, who is an assistant professor of medicine at the University of Miami.

She suggested that physicians should make inquiries about patients with alcohol-related liver disease and their social situations, and might consider trying to connect them to a social worker if called for. “I think that really speaking to the person about where they are would be beneficial,” said Dr. Jones.

Dr. Sobotka, Dr. Jain, Dr. Kwo, and Dr. Jones have no relevant financial disclosures.

Immunosuppressed patients with autoimmune diseases who received the Moderna mRNA-1273 SARS-CoV-2 two-dose vaccine series had a frequency of adverse events similar to the general population albeit with a somewhat reduced, but still significant, antibody response with no severe vaccine-related disease flares, results of a prospective, nonrandomized open-label comparative trial in Canada demonstrated.

At the same time, patients with RA who were taking rituximab and patients with systemic lupus erythematosus (SLE) who were taking mycophenolate mofetil seemed to have reduced humoral responses after receiving the vaccine, said Ines Colmegna, MD, reporting results of the COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Disease (COVIAAD) study as a late-breaking poster abstract at the virtual annual meeting of the American College of Rheumatology. Dr. Colmegna is an associate professor of rheumatology in the division of experimental medicine at McGill University, Montreal.

“The frequency of adverse events, specifically the reactogenicity in people with comorbid conditions regardless of their diagnosis, was similar to healthy controls in this study, and their frequency was similar also the initial studies in the general population,” Dr. Colmegna said.

COVIAAD prospectively enrolled 220 fully vaccinated patients, 162 with rheumatic disease (131 with RA, 23 with SLE, and 8 with other diseases) and 58 controls. Adverse events a week and a month after each dose was the primary outcome. The postvaccine presence of the IgG antibody against the SARS-CoV-2 spike protein and the receptor binding domain (IgG-RBD) was the secondary outcome. Dr. Colmegna said that the study will continue evaluating participants after they get a third dose.

The Canadian trial appears to validate the ACR’s COVID-19 vaccine guidance, the fourth version of which was issued in October, said Jeffrey Curtis, MD, MS, MPH, professor of immunology and rheumatology at the University of Alabama at Birmingham and lead of the ACR COVID-19 Vaccine Guidance Task Force. Specifically, the guidance recommends that patients on rituximab or other anti-CD20 B-cell–depleting agents discuss vaccine timing with their rheumatologist.

“A few things changed over time when there was a paucity of evidence for any vaccine, but as time has gone on, mostly we were more correct than we weren’t,” Dr. Curtis said of the task force’s work. “The evidence that now is in this poster with regard to systemic lupus erythematosus and mycophenolate mofetil is [that] you have impaired vaccine response. If you’re on a B-cell drug like rituximab, you really have impaired vaccine response.”

In the study, 100% of controls had immunogenicity in terms of anti-spike and anti-RBD levels after the first and second dose. The rate of immunogenicity after the first and second dose were 67% and 88% in all patients with RA, and 35% and 78% in patients with SLE who were taking mycophenolate mofetil. The subset of patients with RA on rituximab (n = 17) had rates of immunogenicity of 5.9% and 17.6%, respectively.

“Measured antibody response is not the only way in which people develop a response to a vaccine, and there are also similar responses that occur even in people who are on rituximab and have not developed antibodies,” Dr. Colmegna said. “That’s a very important message also that we need to convey to patients: The immune response really extends beyond antibody protection.”

Overall, disease activity in both patients with RA and SLE did not appreciably change from baseline within 7 days and 28 days of each vaccine dose.

The study raises important questions about the timing of the vaccine, particularly in patients on rituximab, Dr. Colmegna said in an interview. “In theory, there is no element to suggest that, if you would schedule the vaccine a month prior to the next dose of rituximab, the effect of the drug would have decreased the number of B cells, and that the possibility of developing antibodies in response to the vaccine might be better if you give rituximab a month later when the amount of the drug and the effect of the drug is maximal,” she said. The average interval between patients receiving rituximab and vaccines was 4.5 months, Dr. Colmegna said in answering a question after her presentation.

Dr. Curtis said that the effect of holding rituximab or the vaccine to boost antibodies “is somewhat yet unknown. We think it will help, but that’s not a guarantee,” he said. “We don’t have direct evidence that just because the drug impairs vaccine response, that holding that drug for a week or 2 is going to take care of the problem.”

The study does arm rheumatologists with more information for discussing COVID vaccines with vaccine-hesitant patients with autoimmune diseases, Dr. Curtis said.

“It gives them evidence that for most of our immunomodulatory drugs the vaccine works pretty well,” he said. “The poster provides evidence that, compared to healthy controls, the vaccine doesn’t work quite as well in some patients, but for most people it actually did work pretty well. That reinforces the message: Go get vaccinated because [you] will mount [an immune] response, even, if that response isn’t quite as brisk as it is in healthy people.”

Dr. Colmegna and Dr. Curtis have no relevant relationships to disclose. The study received funding from Health and Social Services Quebec.

Immunosuppressed patients with autoimmune diseases who received the Moderna mRNA-1273 SARS-CoV-2 two-dose vaccine series had a frequency of adverse events similar to the general population albeit with a somewhat reduced, but still significant, antibody response with no severe vaccine-related disease flares, results of a prospective, nonrandomized open-label comparative trial in Canada demonstrated.

At the same time, patients with RA who were taking rituximab and patients with systemic lupus erythematosus (SLE) who were taking mycophenolate mofetil seemed to have reduced humoral responses after receiving the vaccine, said Ines Colmegna, MD, reporting results of the COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Disease (COVIAAD) study as a late-breaking poster abstract at the virtual annual meeting of the American College of Rheumatology. Dr. Colmegna is an associate professor of rheumatology in the division of experimental medicine at McGill University, Montreal.

“The frequency of adverse events, specifically the reactogenicity in people with comorbid conditions regardless of their diagnosis, was similar to healthy controls in this study, and their frequency was similar also the initial studies in the general population,” Dr. Colmegna said.

COVIAAD prospectively enrolled 220 fully vaccinated patients, 162 with rheumatic disease (131 with RA, 23 with SLE, and 8 with other diseases) and 58 controls. Adverse events a week and a month after each dose was the primary outcome. The postvaccine presence of the IgG antibody against the SARS-CoV-2 spike protein and the receptor binding domain (IgG-RBD) was the secondary outcome. Dr. Colmegna said that the study will continue evaluating participants after they get a third dose.

The Canadian trial appears to validate the ACR’s COVID-19 vaccine guidance, the fourth version of which was issued in October, said Jeffrey Curtis, MD, MS, MPH, professor of immunology and rheumatology at the University of Alabama at Birmingham and lead of the ACR COVID-19 Vaccine Guidance Task Force. Specifically, the guidance recommends that patients on rituximab or other anti-CD20 B-cell–depleting agents discuss vaccine timing with their rheumatologist.

“A few things changed over time when there was a paucity of evidence for any vaccine, but as time has gone on, mostly we were more correct than we weren’t,” Dr. Curtis said of the task force’s work. “The evidence that now is in this poster with regard to systemic lupus erythematosus and mycophenolate mofetil is [that] you have impaired vaccine response. If you’re on a B-cell drug like rituximab, you really have impaired vaccine response.”

In the study, 100% of controls had immunogenicity in terms of anti-spike and anti-RBD levels after the first and second dose. The rate of immunogenicity after the first and second dose were 67% and 88% in all patients with RA, and 35% and 78% in patients with SLE who were taking mycophenolate mofetil. The subset of patients with RA on rituximab (n = 17) had rates of immunogenicity of 5.9% and 17.6%, respectively.

“Measured antibody response is not the only way in which people develop a response to a vaccine, and there are also similar responses that occur even in people who are on rituximab and have not developed antibodies,” Dr. Colmegna said. “That’s a very important message also that we need to convey to patients: The immune response really extends beyond antibody protection.”

Overall, disease activity in both patients with RA and SLE did not appreciably change from baseline within 7 days and 28 days of each vaccine dose.

The study raises important questions about the timing of the vaccine, particularly in patients on rituximab, Dr. Colmegna said in an interview. “In theory, there is no element to suggest that, if you would schedule the vaccine a month prior to the next dose of rituximab, the effect of the drug would have decreased the number of B cells, and that the possibility of developing antibodies in response to the vaccine might be better if you give rituximab a month later when the amount of the drug and the effect of the drug is maximal,” she said. The average interval between patients receiving rituximab and vaccines was 4.5 months, Dr. Colmegna said in answering a question after her presentation.

Dr. Curtis said that the effect of holding rituximab or the vaccine to boost antibodies “is somewhat yet unknown. We think it will help, but that’s not a guarantee,” he said. “We don’t have direct evidence that just because the drug impairs vaccine response, that holding that drug for a week or 2 is going to take care of the problem.”

The study does arm rheumatologists with more information for discussing COVID vaccines with vaccine-hesitant patients with autoimmune diseases, Dr. Curtis said.

“It gives them evidence that for most of our immunomodulatory drugs the vaccine works pretty well,” he said. “The poster provides evidence that, compared to healthy controls, the vaccine doesn’t work quite as well in some patients, but for most people it actually did work pretty well. That reinforces the message: Go get vaccinated because [you] will mount [an immune] response, even, if that response isn’t quite as brisk as it is in healthy people.”

Dr. Colmegna and Dr. Curtis have no relevant relationships to disclose. The study received funding from Health and Social Services Quebec.

Immunosuppressed patients with autoimmune diseases who received the Moderna mRNA-1273 SARS-CoV-2 two-dose vaccine series had a frequency of adverse events similar to the general population albeit with a somewhat reduced, but still significant, antibody response with no severe vaccine-related disease flares, results of a prospective, nonrandomized open-label comparative trial in Canada demonstrated.

At the same time, patients with RA who were taking rituximab and patients with systemic lupus erythematosus (SLE) who were taking mycophenolate mofetil seemed to have reduced humoral responses after receiving the vaccine, said Ines Colmegna, MD, reporting results of the COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Disease (COVIAAD) study as a late-breaking poster abstract at the virtual annual meeting of the American College of Rheumatology. Dr. Colmegna is an associate professor of rheumatology in the division of experimental medicine at McGill University, Montreal.

“The frequency of adverse events, specifically the reactogenicity in people with comorbid conditions regardless of their diagnosis, was similar to healthy controls in this study, and their frequency was similar also the initial studies in the general population,” Dr. Colmegna said.

COVIAAD prospectively enrolled 220 fully vaccinated patients, 162 with rheumatic disease (131 with RA, 23 with SLE, and 8 with other diseases) and 58 controls. Adverse events a week and a month after each dose was the primary outcome. The postvaccine presence of the IgG antibody against the SARS-CoV-2 spike protein and the receptor binding domain (IgG-RBD) was the secondary outcome. Dr. Colmegna said that the study will continue evaluating participants after they get a third dose.

The Canadian trial appears to validate the ACR’s COVID-19 vaccine guidance, the fourth version of which was issued in October, said Jeffrey Curtis, MD, MS, MPH, professor of immunology and rheumatology at the University of Alabama at Birmingham and lead of the ACR COVID-19 Vaccine Guidance Task Force. Specifically, the guidance recommends that patients on rituximab or other anti-CD20 B-cell–depleting agents discuss vaccine timing with their rheumatologist.

“A few things changed over time when there was a paucity of evidence for any vaccine, but as time has gone on, mostly we were more correct than we weren’t,” Dr. Curtis said of the task force’s work. “The evidence that now is in this poster with regard to systemic lupus erythematosus and mycophenolate mofetil is [that] you have impaired vaccine response. If you’re on a B-cell drug like rituximab, you really have impaired vaccine response.”

In the study, 100% of controls had immunogenicity in terms of anti-spike and anti-RBD levels after the first and second dose. The rate of immunogenicity after the first and second dose were 67% and 88% in all patients with RA, and 35% and 78% in patients with SLE who were taking mycophenolate mofetil. The subset of patients with RA on rituximab (n = 17) had rates of immunogenicity of 5.9% and 17.6%, respectively.

“Measured antibody response is not the only way in which people develop a response to a vaccine, and there are also similar responses that occur even in people who are on rituximab and have not developed antibodies,” Dr. Colmegna said. “That’s a very important message also that we need to convey to patients: The immune response really extends beyond antibody protection.”

Overall, disease activity in both patients with RA and SLE did not appreciably change from baseline within 7 days and 28 days of each vaccine dose.

The study raises important questions about the timing of the vaccine, particularly in patients on rituximab, Dr. Colmegna said in an interview. “In theory, there is no element to suggest that, if you would schedule the vaccine a month prior to the next dose of rituximab, the effect of the drug would have decreased the number of B cells, and that the possibility of developing antibodies in response to the vaccine might be better if you give rituximab a month later when the amount of the drug and the effect of the drug is maximal,” she said. The average interval between patients receiving rituximab and vaccines was 4.5 months, Dr. Colmegna said in answering a question after her presentation.

Dr. Curtis said that the effect of holding rituximab or the vaccine to boost antibodies “is somewhat yet unknown. We think it will help, but that’s not a guarantee,” he said. “We don’t have direct evidence that just because the drug impairs vaccine response, that holding that drug for a week or 2 is going to take care of the problem.”

The study does arm rheumatologists with more information for discussing COVID vaccines with vaccine-hesitant patients with autoimmune diseases, Dr. Curtis said.

“It gives them evidence that for most of our immunomodulatory drugs the vaccine works pretty well,” he said. “The poster provides evidence that, compared to healthy controls, the vaccine doesn’t work quite as well in some patients, but for most people it actually did work pretty well. That reinforces the message: Go get vaccinated because [you] will mount [an immune] response, even, if that response isn’t quite as brisk as it is in healthy people.”

Dr. Colmegna and Dr. Curtis have no relevant relationships to disclose. The study received funding from Health and Social Services Quebec.

Virtual platforms democratized scientific meetings during the COVID-19 pandemic but, as any meeting-goer will tell you, it’s the questions from the floor and the back-and-forth of an expert panel that often reveal the importance of and/or problems with a presentation. It’s the scrutiny that makes the science resonate, especially in this postfactual era.

The all-virtual American Heart Association Scientific Sessions 2021 is looking to recreate the engagement of an in-person meeting by offering more live interactive events. They range from seven late-breaking science (LBS) sessions to Saturday’s fireside chat on the Pfizer and Moderna COVID-19 vaccines and Monday’s dive into the controversial new AHA/American College of Cardiology Chest Pain guidelines.

To help digest the latest science, attendees will be able to have their questions answered in real-time via Slido, meet with the trialists, and hear live commentary from key opinion leaders after the live events. A networking function will also allow attendees and exhibitors to chat or meet virtually.

“In this day and age, many people pretty quickly can get access to the science but it’s what I call the IC sort of phenomenon – the presentation of the information, the context of the information, putting it into how I’m going to use it in my practice, and then the critical appraisal – that’s what most people want at the Scientific Sessions,” program committee chair Manesh R. Patel, MD, of Duke University School of Medicine, said in an interview. “We’re all craving ways in which we can interact with one another to put things in context.”

Plans for a hybrid in-person meeting in Boston were scuttled in September because of the Delta variant surge, but the theme of the meeting remained: “One World. Together for Science.” Attendees will be able to access more than 500 live and on-demand sessions including 117 oral abstracts, 286 poster sessions, 59 moderated digital posters, and over a dozen sessions focused on strategies to promote health equity.

“Last year there was a Presidential Session and a statement on structural racism, so we wanted to take the next step and say, What are the ways in which people are starting to interact and do things to make a difference?” explained Dr. Patel. “So, this year, you’ll see different versions of that from the Main Event session, which has some case vignettes and a panel discussion, to other health equity sessions that describe not just COVID care, but blood pressure care, maternal-fetal medicine, and congenital kids. Wherever we can, we’ve tried to infuse it throughout the sessions and will continue to.”

Late-breaking science

The LBS sessions kick off at 9:30 a.m. ET Saturday with AVATAR, a randomized trial of aortic valve replacement vs. watchful waiting in severe aortic stenosis proved asymptomatic through exercise testing.

“The findings of that trial, depending on what they are, could certainly impact clinical practice because it’s a very common scenario in which we have elderly patients with aortic valve stenosis that might be severe but they may not be symptomatic,” he said.

It’s followed by a randomized trial from the Cardiothoracic Surgical Trials Network, examining whether tricuspid repair at the time of mitral valve surgery leads to beneficial outcomes. “I think it’s a pretty important study,” Dr. Patel said, “because it’ll again affect how we think about our clinical practice.”

Rounding out the LBS.01 session is RAPID CABG, comparing early vs. delayed coronary bypass graft surgery (CABG) in patients with acute coronary syndromes on ticagrelor, and the pivotal U.S. VEST trial of an external support device already approved in Europe for saphenous vein grafts during CABG.

Saturday’s LBS.02 at 3:00 p.m. ET is devoted to hypertension and looks at how the COVID-19 pandemic affected blood pressure control. There’s also a study of remotely delivered hypertension and lipid management in 10,000 patients across the Partners Healthcare System and a cluster randomized trial of a village doctor–led blood pressure intervention in rural China.

Sunday’s LBS.03 at 8:00 a.m. ET is focused on atrial arrhythmias, starting with the CRAVE trial examining the effect of caffeine consumption on cardiac ectopy burden in 108 patients using an N-of-1 design and 2-day blocks on and off caffeine. “There’s an ability to identify a dose response that you get arrhythmias when you increase the amount of coffee you drink vs. not in an individual, so I think that will be likely discussed a lot and worth paying attention to,” Dr. Patel said.

The session also includes GIRAF, a comparison of cognitive outcomes with dabigatran (Pradaxa) vs. warfarin (Coumadin) in nonvalvular atrial fibrillation (AF); PALACS, a randomized trial examining whether left-sided pericardiotomy prevents AF after cardiac surgery; and AMAZE, which study sponsor AtriCure revealed missed its primary efficacy endpoint of freedom from AF with the LARIAT suture delivery device for left atrial appendage closure plus pulmonary vein isolation.

LBS.04 at 3:30 p.m. ET Sunday takes on digital health, with results from the nonrandomized Fitbit Heart Study on AF notifications from 450,000 participants wearing a single-lead ECG patch. “A lot of technologies claim that they can detect things, and we should ask that people go through the rigorous evaluation to see if they in fact do. So, in that respect, I think it›s an important step,” observed Dr. Patel.

Also on tap is I-STOP-AFib, another N-of-1 study using mobile apps and the AliveCor device to identify individual AF triggers; and REVeAL-HF, a 4,000-patient study examining whether electronic alerts that provide clinicians with prognostic information on their heart failure (HF) patients will reduce mortality and 30-day HF hospitalizations.

LBS.05 at 5:00 p.m. ET provides new information from EMPEROR-Preserved in HF with preserved ejection fraction and main results from EMPULSE, also using the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) in 530 patients hospitalized for acute HF.

The session also features CHIEF-HF, a randomized trial leveraging mobile technologies to test whether 12 weeks of another SGLT2 inhibitor, canagliflozin (Invokana), is superior to placebo for improving HF symptoms; and DREAM-HF, a comparison of transendocardial delivery of allogeneic mesenchymal precursor cells vs. a sham comparator in chronic HF as a result of left ventricular systolic dysfunction.

Monday’s LBS.06 at 8:00 a.m. ET details the safety and cholesterol-lowering efficacy of MK-0616, an investigational oral PCSK9 inhibitor. “It’s just a phase 2 [trial], but there’s interest in an oral PCSK9 inhibitor, given that the current ones are subcutaneous,” Dr. Patel said.

Results will also be presented from PREPARE-IT 2, which tested icosapent ethyl vs. placebo in outpatients with COVID-19. In the recently reported PREPARE-IT 1, a loading dose of icosapent ethyl failed to reduce the risk of hospitalization with SARS-CoV-2 infection among at-risk individuals.

LBS.07 at 11:00 a.m. Monday completes the late-breakers with new results from ASCEND, this time examining the effect of aspirin on dementia and cognitive impairment in patients with diabetes.

Next up is a look at the effectiveness of P2Y12 inhibitors in hospitalized patients with COVID-19 in the adaptive ACTIV-4a trial, followed by results of the pivotal phase 3 REVERSE-IT trial of bentracimab, a recombinant human monoclonal antibody antigen fragment designed to reverse the antiplatelet activity of ticagrelor in the event of major bleeding or when urgent surgery is needed.

Closing out the session is AXIOMATIC-TKR, a double-blind comparison of the safety and efficacy of the investigational oral factor XI anticoagulant JNJ-70033093 vs. subcutaneous enoxaparin (Lovenox) in elective total knee replacement.

For those searching for more AHA-related science online, the Resuscitation Science Symposium (ReSS) will run from this Friday through Sunday and the Quality of Care and Outcomes Research (QCOR) Scientific Sessions will take the stage next Monday, Nov. 15.

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

Virtual platforms democratized scientific meetings during the COVID-19 pandemic but, as any meeting-goer will tell you, it’s the questions from the floor and the back-and-forth of an expert panel that often reveal the importance of and/or problems with a presentation. It’s the scrutiny that makes the science resonate, especially in this postfactual era.

The all-virtual American Heart Association Scientific Sessions 2021 is looking to recreate the engagement of an in-person meeting by offering more live interactive events. They range from seven late-breaking science (LBS) sessions to Saturday’s fireside chat on the Pfizer and Moderna COVID-19 vaccines and Monday’s dive into the controversial new AHA/American College of Cardiology Chest Pain guidelines.

To help digest the latest science, attendees will be able to have their questions answered in real-time via Slido, meet with the trialists, and hear live commentary from key opinion leaders after the live events. A networking function will also allow attendees and exhibitors to chat or meet virtually.

“In this day and age, many people pretty quickly can get access to the science but it’s what I call the IC sort of phenomenon – the presentation of the information, the context of the information, putting it into how I’m going to use it in my practice, and then the critical appraisal – that’s what most people want at the Scientific Sessions,” program committee chair Manesh R. Patel, MD, of Duke University School of Medicine, said in an interview. “We’re all craving ways in which we can interact with one another to put things in context.”

Plans for a hybrid in-person meeting in Boston were scuttled in September because of the Delta variant surge, but the theme of the meeting remained: “One World. Together for Science.” Attendees will be able to access more than 500 live and on-demand sessions including 117 oral abstracts, 286 poster sessions, 59 moderated digital posters, and over a dozen sessions focused on strategies to promote health equity.

“Last year there was a Presidential Session and a statement on structural racism, so we wanted to take the next step and say, What are the ways in which people are starting to interact and do things to make a difference?” explained Dr. Patel. “So, this year, you’ll see different versions of that from the Main Event session, which has some case vignettes and a panel discussion, to other health equity sessions that describe not just COVID care, but blood pressure care, maternal-fetal medicine, and congenital kids. Wherever we can, we’ve tried to infuse it throughout the sessions and will continue to.”

Late-breaking science

The LBS sessions kick off at 9:30 a.m. ET Saturday with AVATAR, a randomized trial of aortic valve replacement vs. watchful waiting in severe aortic stenosis proved asymptomatic through exercise testing.

“The findings of that trial, depending on what they are, could certainly impact clinical practice because it’s a very common scenario in which we have elderly patients with aortic valve stenosis that might be severe but they may not be symptomatic,” he said.

It’s followed by a randomized trial from the Cardiothoracic Surgical Trials Network, examining whether tricuspid repair at the time of mitral valve surgery leads to beneficial outcomes. “I think it’s a pretty important study,” Dr. Patel said, “because it’ll again affect how we think about our clinical practice.”

Rounding out the LBS.01 session is RAPID CABG, comparing early vs. delayed coronary bypass graft surgery (CABG) in patients with acute coronary syndromes on ticagrelor, and the pivotal U.S. VEST trial of an external support device already approved in Europe for saphenous vein grafts during CABG.

Saturday’s LBS.02 at 3:00 p.m. ET is devoted to hypertension and looks at how the COVID-19 pandemic affected blood pressure control. There’s also a study of remotely delivered hypertension and lipid management in 10,000 patients across the Partners Healthcare System and a cluster randomized trial of a village doctor–led blood pressure intervention in rural China.

Sunday’s LBS.03 at 8:00 a.m. ET is focused on atrial arrhythmias, starting with the CRAVE trial examining the effect of caffeine consumption on cardiac ectopy burden in 108 patients using an N-of-1 design and 2-day blocks on and off caffeine. “There’s an ability to identify a dose response that you get arrhythmias when you increase the amount of coffee you drink vs. not in an individual, so I think that will be likely discussed a lot and worth paying attention to,” Dr. Patel said.

The session also includes GIRAF, a comparison of cognitive outcomes with dabigatran (Pradaxa) vs. warfarin (Coumadin) in nonvalvular atrial fibrillation (AF); PALACS, a randomized trial examining whether left-sided pericardiotomy prevents AF after cardiac surgery; and AMAZE, which study sponsor AtriCure revealed missed its primary efficacy endpoint of freedom from AF with the LARIAT suture delivery device for left atrial appendage closure plus pulmonary vein isolation.

LBS.04 at 3:30 p.m. ET Sunday takes on digital health, with results from the nonrandomized Fitbit Heart Study on AF notifications from 450,000 participants wearing a single-lead ECG patch. “A lot of technologies claim that they can detect things, and we should ask that people go through the rigorous evaluation to see if they in fact do. So, in that respect, I think it›s an important step,” observed Dr. Patel.

Also on tap is I-STOP-AFib, another N-of-1 study using mobile apps and the AliveCor device to identify individual AF triggers; and REVeAL-HF, a 4,000-patient study examining whether electronic alerts that provide clinicians with prognostic information on their heart failure (HF) patients will reduce mortality and 30-day HF hospitalizations.

LBS.05 at 5:00 p.m. ET provides new information from EMPEROR-Preserved in HF with preserved ejection fraction and main results from EMPULSE, also using the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) in 530 patients hospitalized for acute HF.

The session also features CHIEF-HF, a randomized trial leveraging mobile technologies to test whether 12 weeks of another SGLT2 inhibitor, canagliflozin (Invokana), is superior to placebo for improving HF symptoms; and DREAM-HF, a comparison of transendocardial delivery of allogeneic mesenchymal precursor cells vs. a sham comparator in chronic HF as a result of left ventricular systolic dysfunction.

Monday’s LBS.06 at 8:00 a.m. ET details the safety and cholesterol-lowering efficacy of MK-0616, an investigational oral PCSK9 inhibitor. “It’s just a phase 2 [trial], but there’s interest in an oral PCSK9 inhibitor, given that the current ones are subcutaneous,” Dr. Patel said.

Results will also be presented from PREPARE-IT 2, which tested icosapent ethyl vs. placebo in outpatients with COVID-19. In the recently reported PREPARE-IT 1, a loading dose of icosapent ethyl failed to reduce the risk of hospitalization with SARS-CoV-2 infection among at-risk individuals.

LBS.07 at 11:00 a.m. Monday completes the late-breakers with new results from ASCEND, this time examining the effect of aspirin on dementia and cognitive impairment in patients with diabetes.

Next up is a look at the effectiveness of P2Y12 inhibitors in hospitalized patients with COVID-19 in the adaptive ACTIV-4a trial, followed by results of the pivotal phase 3 REVERSE-IT trial of bentracimab, a recombinant human monoclonal antibody antigen fragment designed to reverse the antiplatelet activity of ticagrelor in the event of major bleeding or when urgent surgery is needed.

Closing out the session is AXIOMATIC-TKR, a double-blind comparison of the safety and efficacy of the investigational oral factor XI anticoagulant JNJ-70033093 vs. subcutaneous enoxaparin (Lovenox) in elective total knee replacement.

For those searching for more AHA-related science online, the Resuscitation Science Symposium (ReSS) will run from this Friday through Sunday and the Quality of Care and Outcomes Research (QCOR) Scientific Sessions will take the stage next Monday, Nov. 15.

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

Virtual platforms democratized scientific meetings during the COVID-19 pandemic but, as any meeting-goer will tell you, it’s the questions from the floor and the back-and-forth of an expert panel that often reveal the importance of and/or problems with a presentation. It’s the scrutiny that makes the science resonate, especially in this postfactual era.

The all-virtual American Heart Association Scientific Sessions 2021 is looking to recreate the engagement of an in-person meeting by offering more live interactive events. They range from seven late-breaking science (LBS) sessions to Saturday’s fireside chat on the Pfizer and Moderna COVID-19 vaccines and Monday’s dive into the controversial new AHA/American College of Cardiology Chest Pain guidelines.

To help digest the latest science, attendees will be able to have their questions answered in real-time via Slido, meet with the trialists, and hear live commentary from key opinion leaders after the live events. A networking function will also allow attendees and exhibitors to chat or meet virtually.

“In this day and age, many people pretty quickly can get access to the science but it’s what I call the IC sort of phenomenon – the presentation of the information, the context of the information, putting it into how I’m going to use it in my practice, and then the critical appraisal – that’s what most people want at the Scientific Sessions,” program committee chair Manesh R. Patel, MD, of Duke University School of Medicine, said in an interview. “We’re all craving ways in which we can interact with one another to put things in context.”

Plans for a hybrid in-person meeting in Boston were scuttled in September because of the Delta variant surge, but the theme of the meeting remained: “One World. Together for Science.” Attendees will be able to access more than 500 live and on-demand sessions including 117 oral abstracts, 286 poster sessions, 59 moderated digital posters, and over a dozen sessions focused on strategies to promote health equity.

“Last year there was a Presidential Session and a statement on structural racism, so we wanted to take the next step and say, What are the ways in which people are starting to interact and do things to make a difference?” explained Dr. Patel. “So, this year, you’ll see different versions of that from the Main Event session, which has some case vignettes and a panel discussion, to other health equity sessions that describe not just COVID care, but blood pressure care, maternal-fetal medicine, and congenital kids. Wherever we can, we’ve tried to infuse it throughout the sessions and will continue to.”

Late-breaking science

The LBS sessions kick off at 9:30 a.m. ET Saturday with AVATAR, a randomized trial of aortic valve replacement vs. watchful waiting in severe aortic stenosis proved asymptomatic through exercise testing.

“The findings of that trial, depending on what they are, could certainly impact clinical practice because it’s a very common scenario in which we have elderly patients with aortic valve stenosis that might be severe but they may not be symptomatic,” he said.

It’s followed by a randomized trial from the Cardiothoracic Surgical Trials Network, examining whether tricuspid repair at the time of mitral valve surgery leads to beneficial outcomes. “I think it’s a pretty important study,” Dr. Patel said, “because it’ll again affect how we think about our clinical practice.”

Rounding out the LBS.01 session is RAPID CABG, comparing early vs. delayed coronary bypass graft surgery (CABG) in patients with acute coronary syndromes on ticagrelor, and the pivotal U.S. VEST trial of an external support device already approved in Europe for saphenous vein grafts during CABG.

Saturday’s LBS.02 at 3:00 p.m. ET is devoted to hypertension and looks at how the COVID-19 pandemic affected blood pressure control. There’s also a study of remotely delivered hypertension and lipid management in 10,000 patients across the Partners Healthcare System and a cluster randomized trial of a village doctor–led blood pressure intervention in rural China.

Sunday’s LBS.03 at 8:00 a.m. ET is focused on atrial arrhythmias, starting with the CRAVE trial examining the effect of caffeine consumption on cardiac ectopy burden in 108 patients using an N-of-1 design and 2-day blocks on and off caffeine. “There’s an ability to identify a dose response that you get arrhythmias when you increase the amount of coffee you drink vs. not in an individual, so I think that will be likely discussed a lot and worth paying attention to,” Dr. Patel said.

The session also includes GIRAF, a comparison of cognitive outcomes with dabigatran (Pradaxa) vs. warfarin (Coumadin) in nonvalvular atrial fibrillation (AF); PALACS, a randomized trial examining whether left-sided pericardiotomy prevents AF after cardiac surgery; and AMAZE, which study sponsor AtriCure revealed missed its primary efficacy endpoint of freedom from AF with the LARIAT suture delivery device for left atrial appendage closure plus pulmonary vein isolation.

LBS.04 at 3:30 p.m. ET Sunday takes on digital health, with results from the nonrandomized Fitbit Heart Study on AF notifications from 450,000 participants wearing a single-lead ECG patch. “A lot of technologies claim that they can detect things, and we should ask that people go through the rigorous evaluation to see if they in fact do. So, in that respect, I think it›s an important step,” observed Dr. Patel.

Also on tap is I-STOP-AFib, another N-of-1 study using mobile apps and the AliveCor device to identify individual AF triggers; and REVeAL-HF, a 4,000-patient study examining whether electronic alerts that provide clinicians with prognostic information on their heart failure (HF) patients will reduce mortality and 30-day HF hospitalizations.

LBS.05 at 5:00 p.m. ET provides new information from EMPEROR-Preserved in HF with preserved ejection fraction and main results from EMPULSE, also using the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) in 530 patients hospitalized for acute HF.

The session also features CHIEF-HF, a randomized trial leveraging mobile technologies to test whether 12 weeks of another SGLT2 inhibitor, canagliflozin (Invokana), is superior to placebo for improving HF symptoms; and DREAM-HF, a comparison of transendocardial delivery of allogeneic mesenchymal precursor cells vs. a sham comparator in chronic HF as a result of left ventricular systolic dysfunction.

Monday’s LBS.06 at 8:00 a.m. ET details the safety and cholesterol-lowering efficacy of MK-0616, an investigational oral PCSK9 inhibitor. “It’s just a phase 2 [trial], but there’s interest in an oral PCSK9 inhibitor, given that the current ones are subcutaneous,” Dr. Patel said.

Results will also be presented from PREPARE-IT 2, which tested icosapent ethyl vs. placebo in outpatients with COVID-19. In the recently reported PREPARE-IT 1, a loading dose of icosapent ethyl failed to reduce the risk of hospitalization with SARS-CoV-2 infection among at-risk individuals.

LBS.07 at 11:00 a.m. Monday completes the late-breakers with new results from ASCEND, this time examining the effect of aspirin on dementia and cognitive impairment in patients with diabetes.

Next up is a look at the effectiveness of P2Y12 inhibitors in hospitalized patients with COVID-19 in the adaptive ACTIV-4a trial, followed by results of the pivotal phase 3 REVERSE-IT trial of bentracimab, a recombinant human monoclonal antibody antigen fragment designed to reverse the antiplatelet activity of ticagrelor in the event of major bleeding or when urgent surgery is needed.

Closing out the session is AXIOMATIC-TKR, a double-blind comparison of the safety and efficacy of the investigational oral factor XI anticoagulant JNJ-70033093 vs. subcutaneous enoxaparin (Lovenox) in elective total knee replacement.

For those searching for more AHA-related science online, the Resuscitation Science Symposium (ReSS) will run from this Friday through Sunday and the Quality of Care and Outcomes Research (QCOR) Scientific Sessions will take the stage next Monday, Nov. 15.

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

For patients with rheumatoid arthritis (RA) for whom a first Janus kinase inhibitor (JAKi) has failed, there appears to be no difference in treatment effectiveness whether the patient is cycled to a second JAKi or receives a biologic disease-modifying antirheumatic drug (bDMARD), a study of international patient registry data suggests.

However, patients who are prescribed a different JAKi after the first has failed them tend to have conditions that are more difficult to treat than do patients who are switched to a bDMARD after JAKi failure. In addition, adverse events that occur with the first JAKi are likely to occur again if a different agent in the same class is used, reported Manuel Pombo-Suarez, MD, PhD, adjunct professor of medicine at the University Hospital of Santiago de Compostela, Spain.

“When the first JAK inhibitor was stopped due to an adverse event, it was also more likely that the second JAK inhibitor would be stopped for the same reason,” he said in an oral abstract presentation during the American College of Rheumatology (ACR) 2021 Annual Meeting, which was held online.

The 2019 update of the European Alliance of Associations for Rheumatology (EULAR) guidelines for RA recommend that for patients for whom a first JAKi has failed, clinicians can consider a different JAKi or switch to a bDMARD. But at the time the guidelines were published, no data were available from studies in which a second JAKi was used after the failure of a first JAKi, Dr. Pombo-Suarez noted.

“We are trying to shed a light on this growing population of patients, as prescription of these drugs is increasing and new JAK inhibitors come into play, meaning that this scenario, we propose, is becoming more and more frequent in real life. We must provide a solution for these patients,” he said.
 

Pooled registry data

The investigators compared the effectiveness of the two approaches with respect to rates of drug retention and Disease Activity Score in 28 joints (DAS28).

They conducted a nested cohort study using data from 14 national registries that are part of the JAK-pot collaboration.

They pooled data from each registry on patients with RA for whom a first JAKi had failed and who were then treated with either a second JAKi or a bDMARD.

They identified a total of 708 patients for whom a JAKi had failed initially. Of these patients, 154 were given a different JAKi, and 554 were switched to a bDMARD. In each group, women accounted for a large majority of patients.

The mean age was slightly older among those who received a second JAKi (58.41 years vs. 54.74 years for patients who were given a bDMARD). The mean disease duration was 13.95 years and 11.37 years, respectively.

In each group, approximately 77% of patients received tofacitinib (Xeljanz).

At baseline, the mean DAS28 scores were similar between the groups: 4.10 in the group that received a second JAKi, and 4.17 in the group given a bDMARD.

Reasons for initially stopping use of a JAKi were as follows: adverse events (27.3% of those who took a second JAKi after they had stopped taking one initially, and 17.9% of patients who received a bDMARD); lack of efficacy (61% and 65%, respectively), and other reasons (11.7% and 17.1%, respectively).

At 2 years’ follow-up, drug survival rates were similar between the two treatment arms, although there was a nonsignificant trend toward a higher rate of discontinuation among patients who were given a second JAKi after they stopped taking the first JAKi because of adverse events. In contrast, there was also a nonsignificant trend toward lower discontinuation rates among patients who were given a second JAKi after they had stopped taking the first JAKi because of lack of efficacy.

As noted before, patients who stopped taking the first JAKi because of an adverse event were more likely to stop taking the second JAKi because of they experienced either the same or a different adverse event, whereas patients who started taking a bDMARD were equally likely to stop taking the second therapy because of either adverse events or lack of efficacy.

The treatment strategies were virtually identical with respect to improvement of DAS28 at 7 months after the start of therapy.

Dr. Pombo-Suarez acknowledged that the study was limited by the fact that heterogeneity between countries could not be assessed, owing to the small sample sizes in each nation’s registry. Other limitations include short follow-up and the fact that tofacitinib was used as the first JAKi by the large majority of patients.

What’s your practice?

In a media briefing during which Dr. Pombo-Suarez discussed the study findings, this news organization polled other speakers who were not involved in the study about their go-to strategies when JAKi therapy fails.

Silje Watterdal Syversen, MD, PhD, a consultant rheumatologist and researcher at Diakonhjemmet Hospital, Oslo, said that she would choose to switch to a tumor necrosis factor [TNF] inhibitor.

“I think it would depend on what prior treatment the patient had received,” said April Jorge, MD, a rheumatologist at Massachusetts General Hospital, Boston. “In my practice, patients receiving a JAK inhibitor typically failed on their biologics. I haven’t had many fail a JAK inhibitor – a small sample size.”

“That’s what we see in our study,” Dr. Pombo-Suarez said. “Most of the patients that cycled JAK inhibitors had higher numbers of biologics compared with switchers.”

“I can share my experience, which is a greater comfort level with cycling a TNF antagonist. I agree with Dr Jorge: I don’t use JAK inhibitors in the first line for rheumatoid arthritis, but based on the work that’s been described here and future data, I might have a greater comfort level cycling JAK inhibitors once the data support such an approach,” commented H. Michael Belmont, MD, professor of medicine at New York University, co-director of the NYU Lupus Center, and medical director of Bellevue Hospital Lupus Center, New York.

The JAK-pot study is supported by unrestricted research grants from AbbVie and Galapagos. Dr. Pombo-Suarez has received adviser and speaker honoraria from several companies other than the funders. Dr. Syversen has received honoraria from Thermo Fisher. Dr. Jorge has disclosed no relevant financial relationships. Dr. Belmont has received honoraria from Alexion.

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

For patients with rheumatoid arthritis (RA) for whom a first Janus kinase inhibitor (JAKi) has failed, there appears to be no difference in treatment effectiveness whether the patient is cycled to a second JAKi or receives a biologic disease-modifying antirheumatic drug (bDMARD), a study of international patient registry data suggests.

However, patients who are prescribed a different JAKi after the first has failed them tend to have conditions that are more difficult to treat than do patients who are switched to a bDMARD after JAKi failure. In addition, adverse events that occur with the first JAKi are likely to occur again if a different agent in the same class is used, reported Manuel Pombo-Suarez, MD, PhD, adjunct professor of medicine at the University Hospital of Santiago de Compostela, Spain.

“When the first JAK inhibitor was stopped due to an adverse event, it was also more likely that the second JAK inhibitor would be stopped for the same reason,” he said in an oral abstract presentation during the American College of Rheumatology (ACR) 2021 Annual Meeting, which was held online.

The 2019 update of the European Alliance of Associations for Rheumatology (EULAR) guidelines for RA recommend that for patients for whom a first JAKi has failed, clinicians can consider a different JAKi or switch to a bDMARD. But at the time the guidelines were published, no data were available from studies in which a second JAKi was used after the failure of a first JAKi, Dr. Pombo-Suarez noted.

“We are trying to shed a light on this growing population of patients, as prescription of these drugs is increasing and new JAK inhibitors come into play, meaning that this scenario, we propose, is becoming more and more frequent in real life. We must provide a solution for these patients,” he said.
 

Pooled registry data

The investigators compared the effectiveness of the two approaches with respect to rates of drug retention and Disease Activity Score in 28 joints (DAS28).

They conducted a nested cohort study using data from 14 national registries that are part of the JAK-pot collaboration.

They pooled data from each registry on patients with RA for whom a first JAKi had failed and who were then treated with either a second JAKi or a bDMARD.

They identified a total of 708 patients for whom a JAKi had failed initially. Of these patients, 154 were given a different JAKi, and 554 were switched to a bDMARD. In each group, women accounted for a large majority of patients.

The mean age was slightly older among those who received a second JAKi (58.41 years vs. 54.74 years for patients who were given a bDMARD). The mean disease duration was 13.95 years and 11.37 years, respectively.

In each group, approximately 77% of patients received tofacitinib (Xeljanz).

At baseline, the mean DAS28 scores were similar between the groups: 4.10 in the group that received a second JAKi, and 4.17 in the group given a bDMARD.

Reasons for initially stopping use of a JAKi were as follows: adverse events (27.3% of those who took a second JAKi after they had stopped taking one initially, and 17.9% of patients who received a bDMARD); lack of efficacy (61% and 65%, respectively), and other reasons (11.7% and 17.1%, respectively).

At 2 years’ follow-up, drug survival rates were similar between the two treatment arms, although there was a nonsignificant trend toward a higher rate of discontinuation among patients who were given a second JAKi after they stopped taking the first JAKi because of adverse events. In contrast, there was also a nonsignificant trend toward lower discontinuation rates among patients who were given a second JAKi after they had stopped taking the first JAKi because of lack of efficacy.

As noted before, patients who stopped taking the first JAKi because of an adverse event were more likely to stop taking the second JAKi because of they experienced either the same or a different adverse event, whereas patients who started taking a bDMARD were equally likely to stop taking the second therapy because of either adverse events or lack of efficacy.

The treatment strategies were virtually identical with respect to improvement of DAS28 at 7 months after the start of therapy.

Dr. Pombo-Suarez acknowledged that the study was limited by the fact that heterogeneity between countries could not be assessed, owing to the small sample sizes in each nation’s registry. Other limitations include short follow-up and the fact that tofacitinib was used as the first JAKi by the large majority of patients.

What’s your practice?

In a media briefing during which Dr. Pombo-Suarez discussed the study findings, this news organization polled other speakers who were not involved in the study about their go-to strategies when JAKi therapy fails.

Silje Watterdal Syversen, MD, PhD, a consultant rheumatologist and researcher at Diakonhjemmet Hospital, Oslo, said that she would choose to switch to a tumor necrosis factor [TNF] inhibitor.

“I think it would depend on what prior treatment the patient had received,” said April Jorge, MD, a rheumatologist at Massachusetts General Hospital, Boston. “In my practice, patients receiving a JAK inhibitor typically failed on their biologics. I haven’t had many fail a JAK inhibitor – a small sample size.”

“That’s what we see in our study,” Dr. Pombo-Suarez said. “Most of the patients that cycled JAK inhibitors had higher numbers of biologics compared with switchers.”

“I can share my experience, which is a greater comfort level with cycling a TNF antagonist. I agree with Dr Jorge: I don’t use JAK inhibitors in the first line for rheumatoid arthritis, but based on the work that’s been described here and future data, I might have a greater comfort level cycling JAK inhibitors once the data support such an approach,” commented H. Michael Belmont, MD, professor of medicine at New York University, co-director of the NYU Lupus Center, and medical director of Bellevue Hospital Lupus Center, New York.

The JAK-pot study is supported by unrestricted research grants from AbbVie and Galapagos. Dr. Pombo-Suarez has received adviser and speaker honoraria from several companies other than the funders. Dr. Syversen has received honoraria from Thermo Fisher. Dr. Jorge has disclosed no relevant financial relationships. Dr. Belmont has received honoraria from Alexion.

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

For patients with rheumatoid arthritis (RA) for whom a first Janus kinase inhibitor (JAKi) has failed, there appears to be no difference in treatment effectiveness whether the patient is cycled to a second JAKi or receives a biologic disease-modifying antirheumatic drug (bDMARD), a study of international patient registry data suggests.

However, patients who are prescribed a different JAKi after the first has failed them tend to have conditions that are more difficult to treat than do patients who are switched to a bDMARD after JAKi failure. In addition, adverse events that occur with the first JAKi are likely to occur again if a different agent in the same class is used, reported Manuel Pombo-Suarez, MD, PhD, adjunct professor of medicine at the University Hospital of Santiago de Compostela, Spain.

“When the first JAK inhibitor was stopped due to an adverse event, it was also more likely that the second JAK inhibitor would be stopped for the same reason,” he said in an oral abstract presentation during the American College of Rheumatology (ACR) 2021 Annual Meeting, which was held online.

The 2019 update of the European Alliance of Associations for Rheumatology (EULAR) guidelines for RA recommend that for patients for whom a first JAKi has failed, clinicians can consider a different JAKi or switch to a bDMARD. But at the time the guidelines were published, no data were available from studies in which a second JAKi was used after the failure of a first JAKi, Dr. Pombo-Suarez noted.

“We are trying to shed a light on this growing population of patients, as prescription of these drugs is increasing and new JAK inhibitors come into play, meaning that this scenario, we propose, is becoming more and more frequent in real life. We must provide a solution for these patients,” he said.
 

Pooled registry data

The investigators compared the effectiveness of the two approaches with respect to rates of drug retention and Disease Activity Score in 28 joints (DAS28).

They conducted a nested cohort study using data from 14 national registries that are part of the JAK-pot collaboration.

They pooled data from each registry on patients with RA for whom a first JAKi had failed and who were then treated with either a second JAKi or a bDMARD.

They identified a total of 708 patients for whom a JAKi had failed initially. Of these patients, 154 were given a different JAKi, and 554 were switched to a bDMARD. In each group, women accounted for a large majority of patients.

The mean age was slightly older among those who received a second JAKi (58.41 years vs. 54.74 years for patients who were given a bDMARD). The mean disease duration was 13.95 years and 11.37 years, respectively.

In each group, approximately 77% of patients received tofacitinib (Xeljanz).

At baseline, the mean DAS28 scores were similar between the groups: 4.10 in the group that received a second JAKi, and 4.17 in the group given a bDMARD.

Reasons for initially stopping use of a JAKi were as follows: adverse events (27.3% of those who took a second JAKi after they had stopped taking one initially, and 17.9% of patients who received a bDMARD); lack of efficacy (61% and 65%, respectively), and other reasons (11.7% and 17.1%, respectively).

At 2 years’ follow-up, drug survival rates were similar between the two treatment arms, although there was a nonsignificant trend toward a higher rate of discontinuation among patients who were given a second JAKi after they stopped taking the first JAKi because of adverse events. In contrast, there was also a nonsignificant trend toward lower discontinuation rates among patients who were given a second JAKi after they had stopped taking the first JAKi because of lack of efficacy.

As noted before, patients who stopped taking the first JAKi because of an adverse event were more likely to stop taking the second JAKi because of they experienced either the same or a different adverse event, whereas patients who started taking a bDMARD were equally likely to stop taking the second therapy because of either adverse events or lack of efficacy.

The treatment strategies were virtually identical with respect to improvement of DAS28 at 7 months after the start of therapy.

Dr. Pombo-Suarez acknowledged that the study was limited by the fact that heterogeneity between countries could not be assessed, owing to the small sample sizes in each nation’s registry. Other limitations include short follow-up and the fact that tofacitinib was used as the first JAKi by the large majority of patients.

What’s your practice?

In a media briefing during which Dr. Pombo-Suarez discussed the study findings, this news organization polled other speakers who were not involved in the study about their go-to strategies when JAKi therapy fails.

Silje Watterdal Syversen, MD, PhD, a consultant rheumatologist and researcher at Diakonhjemmet Hospital, Oslo, said that she would choose to switch to a tumor necrosis factor [TNF] inhibitor.

“I think it would depend on what prior treatment the patient had received,” said April Jorge, MD, a rheumatologist at Massachusetts General Hospital, Boston. “In my practice, patients receiving a JAK inhibitor typically failed on their biologics. I haven’t had many fail a JAK inhibitor – a small sample size.”

“That’s what we see in our study,” Dr. Pombo-Suarez said. “Most of the patients that cycled JAK inhibitors had higher numbers of biologics compared with switchers.”

“I can share my experience, which is a greater comfort level with cycling a TNF antagonist. I agree with Dr Jorge: I don’t use JAK inhibitors in the first line for rheumatoid arthritis, but based on the work that’s been described here and future data, I might have a greater comfort level cycling JAK inhibitors once the data support such an approach,” commented H. Michael Belmont, MD, professor of medicine at New York University, co-director of the NYU Lupus Center, and medical director of Bellevue Hospital Lupus Center, New York.

The JAK-pot study is supported by unrestricted research grants from AbbVie and Galapagos. Dr. Pombo-Suarez has received adviser and speaker honoraria from several companies other than the funders. Dr. Syversen has received honoraria from Thermo Fisher. Dr. Jorge has disclosed no relevant financial relationships. Dr. Belmont has received honoraria from Alexion.

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

The National Institutes of Health Toolbox Cognitive Battery (NIHTB-CB), a 30-minute, automated, iPad-based battery of psychological tests, offers some key advantages over gold standard cognitive assessments in patients with relapsing-remitting multiple sclerosis (RRMS), new research shows.

An indicator of disease activity?

Cognitive deficits affecting a range of functions – including memory, attention and communication – are common in MS and affect 34% to 65% of patients with the disease, and the ability to detect and monitor such deficits has important implications.

Cognitive changes can provide a unique opportunity to identify acute disease activity in patients with MS that might be already occurring before physical manifestations become apparent, said Ms. Manglani. “If we can detect subtle changes in cognition that might foreshadow other symptoms of disease worsening, we can then allocate interventions that might stave off cognitive decline,” she explained.

While there is an array of well-established neuropsychological tests for the assessment of cognitive deficits, each has limitations, so a shorter, computerized, convenient, and reliable test could prove beneficial.

The NIHTB-CB has been validated in a large, nationally representative sample of individuals aged 8 to 85 and represents a potentially attractive option, yielding composite measures and scores corrected for age, gender, education, race, and ethnicity.
 

Comparative testing

To compare the test with other leading cognition tools used in MS, the investigators recruited 87 patients with RRMS (79% female, mean age 47.3 years). Participants were recruited to perform the full NIHTB-CB (about 30 minutes) and the full Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS), which takes about 90 minutes, as well as some subsets from the Wechsler Adult Intelligence Scale-IV (WAIS-IV) covering processing speed and working memory. All patients had an EDSS of 5.0 or below and, on average, had been living with MS for about a decade.

The results showed the normative scores for NIHTB-CB had significant concordance with the other measures in terms of processing speed (concordance correlation coefficient [CCC] range = 0.28-0.48), working memory (CCC range = 0.27-0.37), and episodic memory (CCC range = 0.21-0.32). However, agreement was not shown for executive function (CCC range = 0.096-0.11).

Ms. Manglani noted executive function included various submeasures such as planning and inhibitory control. “Perhaps our gold standard measures tapped into a different facet of executive function than measured by the NIHTB,” she said.

The investigators found the proportion of participants classified as cognitively impaired was similar between the MACFIMS and the NIHTB tests.

Further assessment of fluid cognition on the NIHTB-CB – a composite of processing speed, working memory, episodic memory, and executive function that is automatically generated by the toolbox – showed the measure was negatively associated with disease severity, as measured by the EDSS (P = .006). However, the measure was not associated with a difference in depression (P = .39) or fatigue (P = .69).

Of note, a similar association with lower disease severity on the EDSS was not observed with MACFIMS.

“Interestingly, we found that only the NIHTB-CB fluid cognition was associated with disease severity, such that it was associated with nearly 11% of the variance in EDSS scores, and we were surprised that we didn’t see this with MACFIMS,” Ms. Manglani said.
 

Key advantages

The NIHTB-CB was developed as part of the NIH Blueprint for Neuroscience Research initiative and commissioned by 16 NIH Institutes to provide brief, efficient assessment measures of cognitive function.

The battery has been validated in healthy individuals and tested in other populations with neurologic disorders, including patients who have suffered stroke and traumatic brain injury.

Ms. Manglani noted that the NIHTB-CB had key advantages over other tests. “First, it is a 30-minute iPad-based battery, which is shorter than most cognitive batteries available, and one of the few that is completely computerized. In addition, it automatically scores performance and yields a report with both composite scores and scores for each subtest,” she said.

In addition, said Ms. Manglani, “the NIH toolbox has a large validation sample of individuals between 8-85 years of age and provides normative scores that account for age, gender, education, and race/ethnicity, which allows individuals’ performances to be compared with their peers.”

The findings underscore that with further validation, the battery could have an important role in MS, she added.

“The NIH Toolbox needs to be tested in all subtypes of MS, with a full range of disease severity, and in MS clinics to gauge the clinical feasibility. Larger samples and repeated assessments are also needed to assess the test-retest reliability,” she said.

The study had no specific funding. The authors have disclosed no relevant financial relationships.

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

The National Institutes of Health Toolbox Cognitive Battery (NIHTB-CB), a 30-minute, automated, iPad-based battery of psychological tests, offers some key advantages over gold standard cognitive assessments in patients with relapsing-remitting multiple sclerosis (RRMS), new research shows.

An indicator of disease activity?

Cognitive deficits affecting a range of functions – including memory, attention and communication – are common in MS and affect 34% to 65% of patients with the disease, and the ability to detect and monitor such deficits has important implications.

Cognitive changes can provide a unique opportunity to identify acute disease activity in patients with MS that might be already occurring before physical manifestations become apparent, said Ms. Manglani. “If we can detect subtle changes in cognition that might foreshadow other symptoms of disease worsening, we can then allocate interventions that might stave off cognitive decline,” she explained.

While there is an array of well-established neuropsychological tests for the assessment of cognitive deficits, each has limitations, so a shorter, computerized, convenient, and reliable test could prove beneficial.

The NIHTB-CB has been validated in a large, nationally representative sample of individuals aged 8 to 85 and represents a potentially attractive option, yielding composite measures and scores corrected for age, gender, education, race, and ethnicity.
 

Comparative testing

To compare the test with other leading cognition tools used in MS, the investigators recruited 87 patients with RRMS (79% female, mean age 47.3 years). Participants were recruited to perform the full NIHTB-CB (about 30 minutes) and the full Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS), which takes about 90 minutes, as well as some subsets from the Wechsler Adult Intelligence Scale-IV (WAIS-IV) covering processing speed and working memory. All patients had an EDSS of 5.0 or below and, on average, had been living with MS for about a decade.

The results showed the normative scores for NIHTB-CB had significant concordance with the other measures in terms of processing speed (concordance correlation coefficient [CCC] range = 0.28-0.48), working memory (CCC range = 0.27-0.37), and episodic memory (CCC range = 0.21-0.32). However, agreement was not shown for executive function (CCC range = 0.096-0.11).

Ms. Manglani noted executive function included various submeasures such as planning and inhibitory control. “Perhaps our gold standard measures tapped into a different facet of executive function than measured by the NIHTB,” she said.

The investigators found the proportion of participants classified as cognitively impaired was similar between the MACFIMS and the NIHTB tests.

Further assessment of fluid cognition on the NIHTB-CB – a composite of processing speed, working memory, episodic memory, and executive function that is automatically generated by the toolbox – showed the measure was negatively associated with disease severity, as measured by the EDSS (P = .006). However, the measure was not associated with a difference in depression (P = .39) or fatigue (P = .69).

Of note, a similar association with lower disease severity on the EDSS was not observed with MACFIMS.

“Interestingly, we found that only the NIHTB-CB fluid cognition was associated with disease severity, such that it was associated with nearly 11% of the variance in EDSS scores, and we were surprised that we didn’t see this with MACFIMS,” Ms. Manglani said.
 

Key advantages

The NIHTB-CB was developed as part of the NIH Blueprint for Neuroscience Research initiative and commissioned by 16 NIH Institutes to provide brief, efficient assessment measures of cognitive function.

The battery has been validated in healthy individuals and tested in other populations with neurologic disorders, including patients who have suffered stroke and traumatic brain injury.

Ms. Manglani noted that the NIHTB-CB had key advantages over other tests. “First, it is a 30-minute iPad-based battery, which is shorter than most cognitive batteries available, and one of the few that is completely computerized. In addition, it automatically scores performance and yields a report with both composite scores and scores for each subtest,” she said.

In addition, said Ms. Manglani, “the NIH toolbox has a large validation sample of individuals between 8-85 years of age and provides normative scores that account for age, gender, education, and race/ethnicity, which allows individuals’ performances to be compared with their peers.”

The findings underscore that with further validation, the battery could have an important role in MS, she added.

“The NIH Toolbox needs to be tested in all subtypes of MS, with a full range of disease severity, and in MS clinics to gauge the clinical feasibility. Larger samples and repeated assessments are also needed to assess the test-retest reliability,” she said.

The study had no specific funding. The authors have disclosed no relevant financial relationships.

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

The National Institutes of Health Toolbox Cognitive Battery (NIHTB-CB), a 30-minute, automated, iPad-based battery of psychological tests, offers some key advantages over gold standard cognitive assessments in patients with relapsing-remitting multiple sclerosis (RRMS), new research shows.

An indicator of disease activity?

Cognitive deficits affecting a range of functions – including memory, attention and communication – are common in MS and affect 34% to 65% of patients with the disease, and the ability to detect and monitor such deficits has important implications.

Cognitive changes can provide a unique opportunity to identify acute disease activity in patients with MS that might be already occurring before physical manifestations become apparent, said Ms. Manglani. “If we can detect subtle changes in cognition that might foreshadow other symptoms of disease worsening, we can then allocate interventions that might stave off cognitive decline,” she explained.

While there is an array of well-established neuropsychological tests for the assessment of cognitive deficits, each has limitations, so a shorter, computerized, convenient, and reliable test could prove beneficial.

The NIHTB-CB has been validated in a large, nationally representative sample of individuals aged 8 to 85 and represents a potentially attractive option, yielding composite measures and scores corrected for age, gender, education, race, and ethnicity.
 

Comparative testing

To compare the test with other leading cognition tools used in MS, the investigators recruited 87 patients with RRMS (79% female, mean age 47.3 years). Participants were recruited to perform the full NIHTB-CB (about 30 minutes) and the full Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS), which takes about 90 minutes, as well as some subsets from the Wechsler Adult Intelligence Scale-IV (WAIS-IV) covering processing speed and working memory. All patients had an EDSS of 5.0 or below and, on average, had been living with MS for about a decade.

The results showed the normative scores for NIHTB-CB had significant concordance with the other measures in terms of processing speed (concordance correlation coefficient [CCC] range = 0.28-0.48), working memory (CCC range = 0.27-0.37), and episodic memory (CCC range = 0.21-0.32). However, agreement was not shown for executive function (CCC range = 0.096-0.11).

Ms. Manglani noted executive function included various submeasures such as planning and inhibitory control. “Perhaps our gold standard measures tapped into a different facet of executive function than measured by the NIHTB,” she said.

The investigators found the proportion of participants classified as cognitively impaired was similar between the MACFIMS and the NIHTB tests.

Further assessment of fluid cognition on the NIHTB-CB – a composite of processing speed, working memory, episodic memory, and executive function that is automatically generated by the toolbox – showed the measure was negatively associated with disease severity, as measured by the EDSS (P = .006). However, the measure was not associated with a difference in depression (P = .39) or fatigue (P = .69).

Of note, a similar association with lower disease severity on the EDSS was not observed with MACFIMS.

“Interestingly, we found that only the NIHTB-CB fluid cognition was associated with disease severity, such that it was associated with nearly 11% of the variance in EDSS scores, and we were surprised that we didn’t see this with MACFIMS,” Ms. Manglani said.
 

Key advantages

The NIHTB-CB was developed as part of the NIH Blueprint for Neuroscience Research initiative and commissioned by 16 NIH Institutes to provide brief, efficient assessment measures of cognitive function.

The battery has been validated in healthy individuals and tested in other populations with neurologic disorders, including patients who have suffered stroke and traumatic brain injury.

Ms. Manglani noted that the NIHTB-CB had key advantages over other tests. “First, it is a 30-minute iPad-based battery, which is shorter than most cognitive batteries available, and one of the few that is completely computerized. In addition, it automatically scores performance and yields a report with both composite scores and scores for each subtest,” she said.

In addition, said Ms. Manglani, “the NIH toolbox has a large validation sample of individuals between 8-85 years of age and provides normative scores that account for age, gender, education, and race/ethnicity, which allows individuals’ performances to be compared with their peers.”

The findings underscore that with further validation, the battery could have an important role in MS, she added.

“The NIH Toolbox needs to be tested in all subtypes of MS, with a full range of disease severity, and in MS clinics to gauge the clinical feasibility. Larger samples and repeated assessments are also needed to assess the test-retest reliability,” she said.

The study had no specific funding. The authors have disclosed no relevant financial relationships.

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

Specialty pharmacists play a key and growing role in navigating the complexities of initiating disease-modifying therapies (DMTs) for multiple sclerosis (MS), resulting in earlier treatment, new data suggest.

Aids early intervention

A report on the Kaiser Permanente Washington (KPWA) MS Pharmacy Program detailed significant reductions in the time to address patients’ needs through the use of specialty pharmacists. In an assessment of 391 referrals to the program from 2019 to 2020, the average total time spent per patient per year dropped from 145 minutes in 2019 to 109 minutes in 2020.

Services included assessment of medication adherence, adverse drug reaction consultation, lab monitoring, patient counseling on initiation of a DMT, shared decision making, and follow-up visits.

“The KPWA MS Pharmacy Program plays an integral role in the care of patients with MS. The MS clinical pharmacists ensure patients are well informed about their DMT options and are fully educated about selected treatment,” the investigators noted.

A report on an outpatient MS clinic at Emory Healthcare, Atlanta, described how use of specialty pharmacist services resulted in a 49% reduction in time to treatment initiation with fingolimod. The time decreased from 83.9 days to 42.9 days following the introduction of specialty pharmacist services.

“Integration of a clinical pharmacy specialist in the therapeutic management of MS patients is crucial to early intervention with disease-modifying therapy,” the investigators noted.

A report on the specialty pharmacy services provided at Johns Hopkins MS Precision Medicine Center of Excellence, Baltimore, described an evaluation of 708 assessments between July 2019 and June 2020. Results showed that the vast majority (98%) of patients reported no missed days from work or school due to MS-related symptoms and that 99.3% reported no hospitalizations due to MS relapses, which are both key measures of MS treatment adherence.
 

High patient satisfaction

Patients reported high satisfaction with the in-house pharmacy on the National Association of Specialty Pharmacy’s patient satisfaction survey. In the survey, the average score was 82, compared with 79 for external specialty pharmacies.

“Moreover, patients were highly satisfied with the services provided at the pharmacy and were likely to continue receiving their comprehensive pharmacy care at our institution,” the researchers reported.

The study “highlights the value of pharmacists’ involvement in patient care and supports the need for continuation of integrated clinical services in health system specialty pharmacy,” the investigators noted.

CMSC President Scott D. Newsome, DO, director of the Neurosciences Consultation and Infusion Center at Green Spring Station, Lutherville, Maryland, and associate professor of neurology at Johns Hopkins University School of Medicine, said that as a clinician, he is highly satisfied with the specialty pharmacy services for MS at Johns Hopkins.

“Our pharmacists are fantastic in communicating with the prescriber if something comes up related to medication safety or they are concerned that the patient isn’t adhering to the medication,” Dr. Newsome said.

He noted that in addition to helping to alleviate the burden of a myriad of tasks associated with prescribing for patients with MS, specialty pharmacists may have an important impact on outcomes, although more data are needed.

“Having a specialty pharmacy involved in the care of our patients can help navigate the challenges associated with the process of obtaining approval for DMTs,” he said. “We know how important it is to expedite and shorten the time frame from writing the prescription to getting the person on their DMT.”
 

Telemedicine, other models

Although integrated specialty pharmacist services may seem out of reach for smaller MS clinics, the use of telemedicine and other models may help achieve similar results.

“A model I have seen is having pharmacists split their time between a specialty pharmacy and the MS clinic,” said Dr. Montgomery.

“A telemedicine model can also be utilized, in which a pharmacist can reach out to patients by telephone or through video visits. This would allow a pharmacist to be utilized for multiple clinics or as an MS specialist within a specialty pharmacy,” she added.

Whether provided in house or through telemedicine, a key benefit for clinicians is in freeing up valuable time, which has a domino effect in improving quality all around.

“In addition to improving safety outcomes, specialty pharmacists help with the allocation of clinic staff to other clinic responsibilities, and the utilization of services by patients results in more resources allocated for their care,” Dr. Montgomery said.

Dr. Montgomery is a nonpromotional speaker for Novartis and is on its advisory board.

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

Specialty pharmacists play a key and growing role in navigating the complexities of initiating disease-modifying therapies (DMTs) for multiple sclerosis (MS), resulting in earlier treatment, new data suggest.

Aids early intervention

A report on the Kaiser Permanente Washington (KPWA) MS Pharmacy Program detailed significant reductions in the time to address patients’ needs through the use of specialty pharmacists. In an assessment of 391 referrals to the program from 2019 to 2020, the average total time spent per patient per year dropped from 145 minutes in 2019 to 109 minutes in 2020.

Services included assessment of medication adherence, adverse drug reaction consultation, lab monitoring, patient counseling on initiation of a DMT, shared decision making, and follow-up visits.

“The KPWA MS Pharmacy Program plays an integral role in the care of patients with MS. The MS clinical pharmacists ensure patients are well informed about their DMT options and are fully educated about selected treatment,” the investigators noted.

A report on an outpatient MS clinic at Emory Healthcare, Atlanta, described how use of specialty pharmacist services resulted in a 49% reduction in time to treatment initiation with fingolimod. The time decreased from 83.9 days to 42.9 days following the introduction of specialty pharmacist services.

“Integration of a clinical pharmacy specialist in the therapeutic management of MS patients is crucial to early intervention with disease-modifying therapy,” the investigators noted.

A report on the specialty pharmacy services provided at Johns Hopkins MS Precision Medicine Center of Excellence, Baltimore, described an evaluation of 708 assessments between July 2019 and June 2020. Results showed that the vast majority (98%) of patients reported no missed days from work or school due to MS-related symptoms and that 99.3% reported no hospitalizations due to MS relapses, which are both key measures of MS treatment adherence.
 

High patient satisfaction

Patients reported high satisfaction with the in-house pharmacy on the National Association of Specialty Pharmacy’s patient satisfaction survey. In the survey, the average score was 82, compared with 79 for external specialty pharmacies.

“Moreover, patients were highly satisfied with the services provided at the pharmacy and were likely to continue receiving their comprehensive pharmacy care at our institution,” the researchers reported.

The study “highlights the value of pharmacists’ involvement in patient care and supports the need for continuation of integrated clinical services in health system specialty pharmacy,” the investigators noted.

CMSC President Scott D. Newsome, DO, director of the Neurosciences Consultation and Infusion Center at Green Spring Station, Lutherville, Maryland, and associate professor of neurology at Johns Hopkins University School of Medicine, said that as a clinician, he is highly satisfied with the specialty pharmacy services for MS at Johns Hopkins.

“Our pharmacists are fantastic in communicating with the prescriber if something comes up related to medication safety or they are concerned that the patient isn’t adhering to the medication,” Dr. Newsome said.

He noted that in addition to helping to alleviate the burden of a myriad of tasks associated with prescribing for patients with MS, specialty pharmacists may have an important impact on outcomes, although more data are needed.

“Having a specialty pharmacy involved in the care of our patients can help navigate the challenges associated with the process of obtaining approval for DMTs,” he said. “We know how important it is to expedite and shorten the time frame from writing the prescription to getting the person on their DMT.”
 

Telemedicine, other models

Although integrated specialty pharmacist services may seem out of reach for smaller MS clinics, the use of telemedicine and other models may help achieve similar results.

“A model I have seen is having pharmacists split their time between a specialty pharmacy and the MS clinic,” said Dr. Montgomery.

“A telemedicine model can also be utilized, in which a pharmacist can reach out to patients by telephone or through video visits. This would allow a pharmacist to be utilized for multiple clinics or as an MS specialist within a specialty pharmacy,” she added.

Whether provided in house or through telemedicine, a key benefit for clinicians is in freeing up valuable time, which has a domino effect in improving quality all around.

“In addition to improving safety outcomes, specialty pharmacists help with the allocation of clinic staff to other clinic responsibilities, and the utilization of services by patients results in more resources allocated for their care,” Dr. Montgomery said.

Dr. Montgomery is a nonpromotional speaker for Novartis and is on its advisory board.

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

Specialty pharmacists play a key and growing role in navigating the complexities of initiating disease-modifying therapies (DMTs) for multiple sclerosis (MS), resulting in earlier treatment, new data suggest.

Aids early intervention

A report on the Kaiser Permanente Washington (KPWA) MS Pharmacy Program detailed significant reductions in the time to address patients’ needs through the use of specialty pharmacists. In an assessment of 391 referrals to the program from 2019 to 2020, the average total time spent per patient per year dropped from 145 minutes in 2019 to 109 minutes in 2020.

Services included assessment of medication adherence, adverse drug reaction consultation, lab monitoring, patient counseling on initiation of a DMT, shared decision making, and follow-up visits.

“The KPWA MS Pharmacy Program plays an integral role in the care of patients with MS. The MS clinical pharmacists ensure patients are well informed about their DMT options and are fully educated about selected treatment,” the investigators noted.

A report on an outpatient MS clinic at Emory Healthcare, Atlanta, described how use of specialty pharmacist services resulted in a 49% reduction in time to treatment initiation with fingolimod. The time decreased from 83.9 days to 42.9 days following the introduction of specialty pharmacist services.

“Integration of a clinical pharmacy specialist in the therapeutic management of MS patients is crucial to early intervention with disease-modifying therapy,” the investigators noted.

A report on the specialty pharmacy services provided at Johns Hopkins MS Precision Medicine Center of Excellence, Baltimore, described an evaluation of 708 assessments between July 2019 and June 2020. Results showed that the vast majority (98%) of patients reported no missed days from work or school due to MS-related symptoms and that 99.3% reported no hospitalizations due to MS relapses, which are both key measures of MS treatment adherence.
 

High patient satisfaction

Patients reported high satisfaction with the in-house pharmacy on the National Association of Specialty Pharmacy’s patient satisfaction survey. In the survey, the average score was 82, compared with 79 for external specialty pharmacies.

“Moreover, patients were highly satisfied with the services provided at the pharmacy and were likely to continue receiving their comprehensive pharmacy care at our institution,” the researchers reported.

The study “highlights the value of pharmacists’ involvement in patient care and supports the need for continuation of integrated clinical services in health system specialty pharmacy,” the investigators noted.

CMSC President Scott D. Newsome, DO, director of the Neurosciences Consultation and Infusion Center at Green Spring Station, Lutherville, Maryland, and associate professor of neurology at Johns Hopkins University School of Medicine, said that as a clinician, he is highly satisfied with the specialty pharmacy services for MS at Johns Hopkins.

“Our pharmacists are fantastic in communicating with the prescriber if something comes up related to medication safety or they are concerned that the patient isn’t adhering to the medication,” Dr. Newsome said.

He noted that in addition to helping to alleviate the burden of a myriad of tasks associated with prescribing for patients with MS, specialty pharmacists may have an important impact on outcomes, although more data are needed.

“Having a specialty pharmacy involved in the care of our patients can help navigate the challenges associated with the process of obtaining approval for DMTs,” he said. “We know how important it is to expedite and shorten the time frame from writing the prescription to getting the person on their DMT.”
 

Telemedicine, other models

Although integrated specialty pharmacist services may seem out of reach for smaller MS clinics, the use of telemedicine and other models may help achieve similar results.

“A model I have seen is having pharmacists split their time between a specialty pharmacy and the MS clinic,” said Dr. Montgomery.

“A telemedicine model can also be utilized, in which a pharmacist can reach out to patients by telephone or through video visits. This would allow a pharmacist to be utilized for multiple clinics or as an MS specialist within a specialty pharmacy,” she added.

Whether provided in house or through telemedicine, a key benefit for clinicians is in freeing up valuable time, which has a domino effect in improving quality all around.

“In addition to improving safety outcomes, specialty pharmacists help with the allocation of clinic staff to other clinic responsibilities, and the utilization of services by patients results in more resources allocated for their care,” Dr. Montgomery said.

Dr. Montgomery is a nonpromotional speaker for Novartis and is on its advisory board.

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

System-level changes to the way cancer care is delivered can help eliminate survival disparities between Black and White patients.

When barriers to completing radiation therapy were identified and addressed in a cohort of patients with early-stage lung and breast cancer, 5-year survival rates improved for all patients and closed the racial disparity gap, researchers reported at the annual meeting of the American Society for Radiation Oncology (ASTRO).

The findings come from the ACCURE clinical trial. This is the first prospective study designed to erase gaps in cancer treatment completion and survival among Black and White patient populations, explained lead author Matthew A. Manning, MD, a radiation oncologist and chief of oncology at Cone Health in Greensboro, N.C.

“Thousands of studies have looked at racial disparities in health care, but until recently, very few studies have implemented interventions to eliminate those disparities,” he said.

“This study shows that the implementation of ‘systems-change’ can eliminate racial disparities in cancer survival while improving survival for all,” he added.

“These results add to a growing body of evidence that health care disparities in cancer outcomes are eliminated or minimized by providing supportive, timely, and guideline-directed care,” said Lannis Hall, MD, MPH, director of radiation oncology, Siteman Cancer Center, and associate professor of radiation oncology at Washington University School of Medicine, St. Louis, who was approached for comment

“This research supports that access to care and timely treatment completion is critical to eliminating health care disparities,” she told this news organization. The system-based intervention in this trial was designed to reduce treatment delays and provide a supportive matrix for patients confronting real-world difficulties like transportation issues, childcare complications, and work absence, she explained.
 

Eliminating racial disparities

Previous findings from the ACCURE trial showed that it eliminated Black-White disparities in treatment completion rates, which was the study’s primary endpoint (Cancer Med. 2019;8:1095-1102). “It also improved treatment for all patients,” said Dr. Manning. “The current study is a follow-up on the survival of eligible patients treated during the ACCURE enrollment as compared to historical data.”

ACCURE was a multi-institutional trial designed to test a community-created intervention to reduce racial disparities. The intervention involved multiple changes to the way patients were supported while receiving cancer treatment and had four components: 

• an electronic health record with automatic alerts to flag missed appointments or unmet milestones in expected care 
• a nurse navigator trained in race-specific barriers to help patients overcome obstacles to care when alerts are flagged
• a physician champion to engage health care teams with race-related feedback on treatment completion
• regular health equity education training sessions for staff

The cohort was comprised of 1,413 patients with lung and breast cancer (stage 0-II) who were diagnosed from 2013-2015, and survival was compared to historical cases – 2,016 patients who had been treated from 2007-2011.

The results showed a significant improvement in survival for both Black and White patients with breast and lung cancer over time, and the racial gap in survival was reduced. 

The 5-year survival rate for breast cancer increased from 91% for White patients and 89% in Black patients in historical cases, to 94% for both during the study period.  

For patients with lung cancer, the 5-year survival rate improved from 43% in White patients and 37% in Black patients to 56% and 54%, respectively.

A subgroup analysis showed that patients with lung cancer who underwent surgery had 5-year survival rates of 78.5% for White and 70.1% for Black patients, whereas for those who underwent stereotactic body radiation therapy (SBRT) the rates were 41.9% and 50% respectively.

“We’ve shown it’s possible to eliminate disparities in cancer treatment completion and that this change has the potential to close cancer survival gaps downstream,” said Dr. Manning. “But we think the application can be much broader.” 

The ACCURE study was sponsored by the National Institutes of Health. Dr. Manning and Dr. Hall have disclosed no relevant financial relationships.

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

System-level changes to the way cancer care is delivered can help eliminate survival disparities between Black and White patients.

When barriers to completing radiation therapy were identified and addressed in a cohort of patients with early-stage lung and breast cancer, 5-year survival rates improved for all patients and closed the racial disparity gap, researchers reported at the annual meeting of the American Society for Radiation Oncology (ASTRO).

The findings come from the ACCURE clinical trial. This is the first prospective study designed to erase gaps in cancer treatment completion and survival among Black and White patient populations, explained lead author Matthew A. Manning, MD, a radiation oncologist and chief of oncology at Cone Health in Greensboro, N.C.

“Thousands of studies have looked at racial disparities in health care, but until recently, very few studies have implemented interventions to eliminate those disparities,” he said.

“This study shows that the implementation of ‘systems-change’ can eliminate racial disparities in cancer survival while improving survival for all,” he added.

“These results add to a growing body of evidence that health care disparities in cancer outcomes are eliminated or minimized by providing supportive, timely, and guideline-directed care,” said Lannis Hall, MD, MPH, director of radiation oncology, Siteman Cancer Center, and associate professor of radiation oncology at Washington University School of Medicine, St. Louis, who was approached for comment

“This research supports that access to care and timely treatment completion is critical to eliminating health care disparities,” she told this news organization. The system-based intervention in this trial was designed to reduce treatment delays and provide a supportive matrix for patients confronting real-world difficulties like transportation issues, childcare complications, and work absence, she explained.
 

Eliminating racial disparities

Previous findings from the ACCURE trial showed that it eliminated Black-White disparities in treatment completion rates, which was the study’s primary endpoint (Cancer Med. 2019;8:1095-1102). “It also improved treatment for all patients,” said Dr. Manning. “The current study is a follow-up on the survival of eligible patients treated during the ACCURE enrollment as compared to historical data.”

ACCURE was a multi-institutional trial designed to test a community-created intervention to reduce racial disparities. The intervention involved multiple changes to the way patients were supported while receiving cancer treatment and had four components: 

• an electronic health record with automatic alerts to flag missed appointments or unmet milestones in expected care 
• a nurse navigator trained in race-specific barriers to help patients overcome obstacles to care when alerts are flagged
• a physician champion to engage health care teams with race-related feedback on treatment completion
• regular health equity education training sessions for staff

The cohort was comprised of 1,413 patients with lung and breast cancer (stage 0-II) who were diagnosed from 2013-2015, and survival was compared to historical cases – 2,016 patients who had been treated from 2007-2011.

The results showed a significant improvement in survival for both Black and White patients with breast and lung cancer over time, and the racial gap in survival was reduced. 

The 5-year survival rate for breast cancer increased from 91% for White patients and 89% in Black patients in historical cases, to 94% for both during the study period.  

For patients with lung cancer, the 5-year survival rate improved from 43% in White patients and 37% in Black patients to 56% and 54%, respectively.

A subgroup analysis showed that patients with lung cancer who underwent surgery had 5-year survival rates of 78.5% for White and 70.1% for Black patients, whereas for those who underwent stereotactic body radiation therapy (SBRT) the rates were 41.9% and 50% respectively.

“We’ve shown it’s possible to eliminate disparities in cancer treatment completion and that this change has the potential to close cancer survival gaps downstream,” said Dr. Manning. “But we think the application can be much broader.” 

The ACCURE study was sponsored by the National Institutes of Health. Dr. Manning and Dr. Hall have disclosed no relevant financial relationships.

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

System-level changes to the way cancer care is delivered can help eliminate survival disparities between Black and White patients.

When barriers to completing radiation therapy were identified and addressed in a cohort of patients with early-stage lung and breast cancer, 5-year survival rates improved for all patients and closed the racial disparity gap, researchers reported at the annual meeting of the American Society for Radiation Oncology (ASTRO).

The findings come from the ACCURE clinical trial. This is the first prospective study designed to erase gaps in cancer treatment completion and survival among Black and White patient populations, explained lead author Matthew A. Manning, MD, a radiation oncologist and chief of oncology at Cone Health in Greensboro, N.C.

“Thousands of studies have looked at racial disparities in health care, but until recently, very few studies have implemented interventions to eliminate those disparities,” he said.

“This study shows that the implementation of ‘systems-change’ can eliminate racial disparities in cancer survival while improving survival for all,” he added.

“These results add to a growing body of evidence that health care disparities in cancer outcomes are eliminated or minimized by providing supportive, timely, and guideline-directed care,” said Lannis Hall, MD, MPH, director of radiation oncology, Siteman Cancer Center, and associate professor of radiation oncology at Washington University School of Medicine, St. Louis, who was approached for comment

“This research supports that access to care and timely treatment completion is critical to eliminating health care disparities,” she told this news organization. The system-based intervention in this trial was designed to reduce treatment delays and provide a supportive matrix for patients confronting real-world difficulties like transportation issues, childcare complications, and work absence, she explained.
 

Eliminating racial disparities

Previous findings from the ACCURE trial showed that it eliminated Black-White disparities in treatment completion rates, which was the study’s primary endpoint (Cancer Med. 2019;8:1095-1102). “It also improved treatment for all patients,” said Dr. Manning. “The current study is a follow-up on the survival of eligible patients treated during the ACCURE enrollment as compared to historical data.”

ACCURE was a multi-institutional trial designed to test a community-created intervention to reduce racial disparities. The intervention involved multiple changes to the way patients were supported while receiving cancer treatment and had four components: 

• an electronic health record with automatic alerts to flag missed appointments or unmet milestones in expected care 
• a nurse navigator trained in race-specific barriers to help patients overcome obstacles to care when alerts are flagged
• a physician champion to engage health care teams with race-related feedback on treatment completion
• regular health equity education training sessions for staff

The cohort was comprised of 1,413 patients with lung and breast cancer (stage 0-II) who were diagnosed from 2013-2015, and survival was compared to historical cases – 2,016 patients who had been treated from 2007-2011.

The results showed a significant improvement in survival for both Black and White patients with breast and lung cancer over time, and the racial gap in survival was reduced. 

The 5-year survival rate for breast cancer increased from 91% for White patients and 89% in Black patients in historical cases, to 94% for both during the study period.  

For patients with lung cancer, the 5-year survival rate improved from 43% in White patients and 37% in Black patients to 56% and 54%, respectively.

A subgroup analysis showed that patients with lung cancer who underwent surgery had 5-year survival rates of 78.5% for White and 70.1% for Black patients, whereas for those who underwent stereotactic body radiation therapy (SBRT) the rates were 41.9% and 50% respectively.

“We’ve shown it’s possible to eliminate disparities in cancer treatment completion and that this change has the potential to close cancer survival gaps downstream,” said Dr. Manning. “But we think the application can be much broader.” 

The ACCURE study was sponsored by the National Institutes of Health. Dr. Manning and Dr. Hall have disclosed no relevant financial relationships.

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

Although genomic testing is useful when an interstitial lung disease diagnosis is uncertain, the testing results themselves aren’t sufficient to make the diagnosis, Daniel Dilling, MD, FCCP, said in a presentation at the annual meeting of the American College of Chest Physicians, which was held virtually.

The genomic classifier (Envisia, Veracyte) helps differentiate idiopathic pulmonary fibrosis (IPF) by detecting usual interstitial pneumonia (UIP), the hallmark pattern of this interstitial lung disease.

However, UIP is just one piece of the larger diagnostic puzzle, according to Dr. Dilling, professor of medicine in the interstitial lung disease program at Loyola University Medical Center in Maywood, Ill.

“Remember, it’s just a pattern, and not a diagnosis of IPF,” Dr. Dilling said in his presentation.

Genomic classifier results correlate well with both histologic and radiographic UIP pattern, studies show.

However, Dr. Dilling said the value of the genomic classifier is not in isolation.

“We don’t use this in a vacuum,” he said. “It increases our confidence and consensus, but it has to be incorporated into a multidisciplinary discussion group.”
 

Part of the diagnostic pathway

Dr. Dilling said the genomic classifier should be considered part of a diagnostic pathway in uncertain cases, particularly when the risk of surgical lung biopsy is high.

Current clinical practice guidelines recommend surgical lung biopsy for histopathologic diagnosis when clinical and radiologic findings are not definitive for IPF, the speaker said.

However, surgical lung biopsy carries some risk, and sometimes it can’t be done, he added.

In his presentation, Dr. Dilling cited a systematic review and meta-analysis of 23 studies looking at surgical lung biopsy for the diagnosis of interstitial lung diseases.

The postoperative mortality rate was 3.6% in that meta-analysis, published in 2015 in the Journal of Thoracic and Cardiovascular Surgery.

“The final decision regarding whether or not to perform a [surgical lung biopsy] must be based on the balance between benefits to establish a secure diagnosis and the potential risks,” authors wrote at the time.

Mortality risk is higher in immunocompromised and acutely ill patient populations, according to Dr. Dilling, who added that as many of 19% of patients will have complications from surgical lung biopsy.
 

Genomic classifier studies

In a proof-of-principle study, published in 2017 in the Annals of the American Thoracic Society, authors described how they used machine learning to train an algorithm to distinguish UIP from non-UIP pattern in tissue obtained by transbronchial biopsy (TBB).

The top-performing algorithm distinguished UIP from non-UIP conditions in single TBB samples with specificity of 86% and sensitivity of 63%, according to investigators, who said at the time that independent validation would be needed before the genomic classifier could be applied in clinical settings.

In a prospective validation study, published in 2019 in The Lancet Respiratory Medicine, the genomic classifier identified UIP in TBB samples from 49 patients with a specificity of 88% and sensitivity of 70%.

Excluding patients with definite or probable UIP as shown on high-resolution computed tomography, results show that the classifier had a sensitivity of 76%, specificity of 88%, and positive predictive value of 81%.

“The performance of the test is good, even in that scenario,” Dr. Dilling said.
 

Real-world results

Dr. Dilling also highlighted a “real-world” study, published earlier in 2021, demonstrating that UIP pattern recognized by a genomic classifier had encouraging sensitivity and specificity when combined with high-resolution CT and clinical factors.

That study included 96 patients who had both diagnostic lung pathology and a transbronchial lung biopsy for molecular testing with the classifier.

The classifier had a sensitivity of 60.3% and a specificity of 92.1% for histology-proven UIP pattern, investigators said in their report, which appears in the American Journal of Respiratory and Critical Care Medicine.

Local radiologists identified UIP with a sensitivity of 34.0% and specificity of 96.9%. But adding genomic classifier testing to local radiology testing increased the diagnostic yield, investigators said, with a sensitivity of 79.2% and specificity of 90.6%.

“This might suggest that the implementation of this into a local [multidisciplinary discussion] with your local radiology expertise might really improve your recognition of UIP,” Dr. Dilling said.

Dr. Dilling reported disclosures related to Bellerophon, Boehringer Ingelheim, Genentech, Nitto Denko, and Lung Bioengineering.

Although genomic testing is useful when an interstitial lung disease diagnosis is uncertain, the testing results themselves aren’t sufficient to make the diagnosis, Daniel Dilling, MD, FCCP, said in a presentation at the annual meeting of the American College of Chest Physicians, which was held virtually.

The genomic classifier (Envisia, Veracyte) helps differentiate idiopathic pulmonary fibrosis (IPF) by detecting usual interstitial pneumonia (UIP), the hallmark pattern of this interstitial lung disease.

However, UIP is just one piece of the larger diagnostic puzzle, according to Dr. Dilling, professor of medicine in the interstitial lung disease program at Loyola University Medical Center in Maywood, Ill.

“Remember, it’s just a pattern, and not a diagnosis of IPF,” Dr. Dilling said in his presentation.

Genomic classifier results correlate well with both histologic and radiographic UIP pattern, studies show.

However, Dr. Dilling said the value of the genomic classifier is not in isolation.

“We don’t use this in a vacuum,” he said. “It increases our confidence and consensus, but it has to be incorporated into a multidisciplinary discussion group.”
 

Part of the diagnostic pathway

Dr. Dilling said the genomic classifier should be considered part of a diagnostic pathway in uncertain cases, particularly when the risk of surgical lung biopsy is high.

Current clinical practice guidelines recommend surgical lung biopsy for histopathologic diagnosis when clinical and radiologic findings are not definitive for IPF, the speaker said.

However, surgical lung biopsy carries some risk, and sometimes it can’t be done, he added.

In his presentation, Dr. Dilling cited a systematic review and meta-analysis of 23 studies looking at surgical lung biopsy for the diagnosis of interstitial lung diseases.

The postoperative mortality rate was 3.6% in that meta-analysis, published in 2015 in the Journal of Thoracic and Cardiovascular Surgery.

“The final decision regarding whether or not to perform a [surgical lung biopsy] must be based on the balance between benefits to establish a secure diagnosis and the potential risks,” authors wrote at the time.

Mortality risk is higher in immunocompromised and acutely ill patient populations, according to Dr. Dilling, who added that as many of 19% of patients will have complications from surgical lung biopsy.
 

Genomic classifier studies

In a proof-of-principle study, published in 2017 in the Annals of the American Thoracic Society, authors described how they used machine learning to train an algorithm to distinguish UIP from non-UIP pattern in tissue obtained by transbronchial biopsy (TBB).

The top-performing algorithm distinguished UIP from non-UIP conditions in single TBB samples with specificity of 86% and sensitivity of 63%, according to investigators, who said at the time that independent validation would be needed before the genomic classifier could be applied in clinical settings.

In a prospective validation study, published in 2019 in The Lancet Respiratory Medicine, the genomic classifier identified UIP in TBB samples from 49 patients with a specificity of 88% and sensitivity of 70%.

Excluding patients with definite or probable UIP as shown on high-resolution computed tomography, results show that the classifier had a sensitivity of 76%, specificity of 88%, and positive predictive value of 81%.

“The performance of the test is good, even in that scenario,” Dr. Dilling said.
 

Real-world results

Dr. Dilling also highlighted a “real-world” study, published earlier in 2021, demonstrating that UIP pattern recognized by a genomic classifier had encouraging sensitivity and specificity when combined with high-resolution CT and clinical factors.

That study included 96 patients who had both diagnostic lung pathology and a transbronchial lung biopsy for molecular testing with the classifier.

The classifier had a sensitivity of 60.3% and a specificity of 92.1% for histology-proven UIP pattern, investigators said in their report, which appears in the American Journal of Respiratory and Critical Care Medicine.

Local radiologists identified UIP with a sensitivity of 34.0% and specificity of 96.9%. But adding genomic classifier testing to local radiology testing increased the diagnostic yield, investigators said, with a sensitivity of 79.2% and specificity of 90.6%.

“This might suggest that the implementation of this into a local [multidisciplinary discussion] with your local radiology expertise might really improve your recognition of UIP,” Dr. Dilling said.

Dr. Dilling reported disclosures related to Bellerophon, Boehringer Ingelheim, Genentech, Nitto Denko, and Lung Bioengineering.

Although genomic testing is useful when an interstitial lung disease diagnosis is uncertain, the testing results themselves aren’t sufficient to make the diagnosis, Daniel Dilling, MD, FCCP, said in a presentation at the annual meeting of the American College of Chest Physicians, which was held virtually.

The genomic classifier (Envisia, Veracyte) helps differentiate idiopathic pulmonary fibrosis (IPF) by detecting usual interstitial pneumonia (UIP), the hallmark pattern of this interstitial lung disease.

However, UIP is just one piece of the larger diagnostic puzzle, according to Dr. Dilling, professor of medicine in the interstitial lung disease program at Loyola University Medical Center in Maywood, Ill.

“Remember, it’s just a pattern, and not a diagnosis of IPF,” Dr. Dilling said in his presentation.

Genomic classifier results correlate well with both histologic and radiographic UIP pattern, studies show.

However, Dr. Dilling said the value of the genomic classifier is not in isolation.

“We don’t use this in a vacuum,” he said. “It increases our confidence and consensus, but it has to be incorporated into a multidisciplinary discussion group.”
 

Part of the diagnostic pathway

Dr. Dilling said the genomic classifier should be considered part of a diagnostic pathway in uncertain cases, particularly when the risk of surgical lung biopsy is high.

Current clinical practice guidelines recommend surgical lung biopsy for histopathologic diagnosis when clinical and radiologic findings are not definitive for IPF, the speaker said.

However, surgical lung biopsy carries some risk, and sometimes it can’t be done, he added.

In his presentation, Dr. Dilling cited a systematic review and meta-analysis of 23 studies looking at surgical lung biopsy for the diagnosis of interstitial lung diseases.

The postoperative mortality rate was 3.6% in that meta-analysis, published in 2015 in the Journal of Thoracic and Cardiovascular Surgery.

“The final decision regarding whether or not to perform a [surgical lung biopsy] must be based on the balance between benefits to establish a secure diagnosis and the potential risks,” authors wrote at the time.

Mortality risk is higher in immunocompromised and acutely ill patient populations, according to Dr. Dilling, who added that as many of 19% of patients will have complications from surgical lung biopsy.
 

Genomic classifier studies

In a proof-of-principle study, published in 2017 in the Annals of the American Thoracic Society, authors described how they used machine learning to train an algorithm to distinguish UIP from non-UIP pattern in tissue obtained by transbronchial biopsy (TBB).

The top-performing algorithm distinguished UIP from non-UIP conditions in single TBB samples with specificity of 86% and sensitivity of 63%, according to investigators, who said at the time that independent validation would be needed before the genomic classifier could be applied in clinical settings.

In a prospective validation study, published in 2019 in The Lancet Respiratory Medicine, the genomic classifier identified UIP in TBB samples from 49 patients with a specificity of 88% and sensitivity of 70%.

Excluding patients with definite or probable UIP as shown on high-resolution computed tomography, results show that the classifier had a sensitivity of 76%, specificity of 88%, and positive predictive value of 81%.

“The performance of the test is good, even in that scenario,” Dr. Dilling said.
 

Real-world results

Dr. Dilling also highlighted a “real-world” study, published earlier in 2021, demonstrating that UIP pattern recognized by a genomic classifier had encouraging sensitivity and specificity when combined with high-resolution CT and clinical factors.

That study included 96 patients who had both diagnostic lung pathology and a transbronchial lung biopsy for molecular testing with the classifier.

The classifier had a sensitivity of 60.3% and a specificity of 92.1% for histology-proven UIP pattern, investigators said in their report, which appears in the American Journal of Respiratory and Critical Care Medicine.

Local radiologists identified UIP with a sensitivity of 34.0% and specificity of 96.9%. But adding genomic classifier testing to local radiology testing increased the diagnostic yield, investigators said, with a sensitivity of 79.2% and specificity of 90.6%.

“This might suggest that the implementation of this into a local [multidisciplinary discussion] with your local radiology expertise might really improve your recognition of UIP,” Dr. Dilling said.

Dr. Dilling reported disclosures related to Bellerophon, Boehringer Ingelheim, Genentech, Nitto Denko, and Lung Bioengineering.