B-Cell Lymphoma ICYMI

For the first time, the majority of people dying from COVID-19 in America have been vaccinated.

“We can no longer say this is a pandemic of the unvaccinated,” Kaiser Family Foundation Vice President Cynthia Cox, who conducted the analysis, told The Washington Post.

People who had been vaccinated or boosted made up 58% of COVID-19 deaths in August, the analysis showed. The rate has been on the rise: 23% of coronavirus deaths were among vaccinated people in September 2021, and the vaccinated made up 42% of deaths in January and February 2022, the Post reported.

Research continues to show that people who are vaccinated or boosted have a lower risk of death. The rise in deaths among the vaccinated is the result of three factors, Ms. Cox said.

• A large majority of people in the United States have been vaccinated (267 million people, the  said).
• People who are at the greatest risk of dying from COVID-19 are more likely to be vaccinated and boosted, such as the elderly.
• Vaccines lose their effectiveness over time; the virus changes to avoid vaccines; and people need to choose to get boosters to continue to be protected.

The case for the effectiveness of vaccines and boosters versus skipping the shots remains strong. People age 6 months and older who are unvaccinated are six times more likely to die of COVID-19, compared to those who got the primary series of shots, the Post reported. Survival rates were even better with additional booster shots, particularly among older people.

“I feel very confident that if people continue to get vaccinated at good numbers, if people get boosted, we can absolutely have a very safe and healthy holiday season,” Ashish Jha, White House coronavirus czar, said on Nov. 22.

The number of Americans who have gotten the most recent booster has been increasing ahead of the holidays. CDC data show that 12% of the U.S. population age 5 and older has received a booster.

A new study by a team of researchers from Harvard University and Yale University estimates that 94% of the U.S. population has been infected with COVID-19 at least once, leaving just 1 in 20 people who have never had the virus.

“Despite these high exposure numbers, there is still substantial population susceptibility to infection with an Omicron variant,” the authors wrote.

They said that if all states achieved the vaccination levels of Vermont, where 55% of people had at least one booster and 22% got a second one, there would be “an appreciable improvement in population immunity, with greater relative impact for protection against infection versus severe disease. This additional protection results from both the recovery of immunity lost due to waning and the increased effectiveness of the bivalent booster against Omicron infections.”

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

For the first time, the majority of people dying from COVID-19 in America have been vaccinated.

“We can no longer say this is a pandemic of the unvaccinated,” Kaiser Family Foundation Vice President Cynthia Cox, who conducted the analysis, told The Washington Post.

People who had been vaccinated or boosted made up 58% of COVID-19 deaths in August, the analysis showed. The rate has been on the rise: 23% of coronavirus deaths were among vaccinated people in September 2021, and the vaccinated made up 42% of deaths in January and February 2022, the Post reported.

Research continues to show that people who are vaccinated or boosted have a lower risk of death. The rise in deaths among the vaccinated is the result of three factors, Ms. Cox said.

• A large majority of people in the United States have been vaccinated (267 million people, the  said).
• People who are at the greatest risk of dying from COVID-19 are more likely to be vaccinated and boosted, such as the elderly.
• Vaccines lose their effectiveness over time; the virus changes to avoid vaccines; and people need to choose to get boosters to continue to be protected.

The case for the effectiveness of vaccines and boosters versus skipping the shots remains strong. People age 6 months and older who are unvaccinated are six times more likely to die of COVID-19, compared to those who got the primary series of shots, the Post reported. Survival rates were even better with additional booster shots, particularly among older people.

“I feel very confident that if people continue to get vaccinated at good numbers, if people get boosted, we can absolutely have a very safe and healthy holiday season,” Ashish Jha, White House coronavirus czar, said on Nov. 22.

The number of Americans who have gotten the most recent booster has been increasing ahead of the holidays. CDC data show that 12% of the U.S. population age 5 and older has received a booster.

A new study by a team of researchers from Harvard University and Yale University estimates that 94% of the U.S. population has been infected with COVID-19 at least once, leaving just 1 in 20 people who have never had the virus.

“Despite these high exposure numbers, there is still substantial population susceptibility to infection with an Omicron variant,” the authors wrote.

They said that if all states achieved the vaccination levels of Vermont, where 55% of people had at least one booster and 22% got a second one, there would be “an appreciable improvement in population immunity, with greater relative impact for protection against infection versus severe disease. This additional protection results from both the recovery of immunity lost due to waning and the increased effectiveness of the bivalent booster against Omicron infections.”

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

For the first time, the majority of people dying from COVID-19 in America have been vaccinated.

“We can no longer say this is a pandemic of the unvaccinated,” Kaiser Family Foundation Vice President Cynthia Cox, who conducted the analysis, told The Washington Post.

People who had been vaccinated or boosted made up 58% of COVID-19 deaths in August, the analysis showed. The rate has been on the rise: 23% of coronavirus deaths were among vaccinated people in September 2021, and the vaccinated made up 42% of deaths in January and February 2022, the Post reported.

Research continues to show that people who are vaccinated or boosted have a lower risk of death. The rise in deaths among the vaccinated is the result of three factors, Ms. Cox said.

• A large majority of people in the United States have been vaccinated (267 million people, the  said).
• People who are at the greatest risk of dying from COVID-19 are more likely to be vaccinated and boosted, such as the elderly.
• Vaccines lose their effectiveness over time; the virus changes to avoid vaccines; and people need to choose to get boosters to continue to be protected.

The case for the effectiveness of vaccines and boosters versus skipping the shots remains strong. People age 6 months and older who are unvaccinated are six times more likely to die of COVID-19, compared to those who got the primary series of shots, the Post reported. Survival rates were even better with additional booster shots, particularly among older people.

“I feel very confident that if people continue to get vaccinated at good numbers, if people get boosted, we can absolutely have a very safe and healthy holiday season,” Ashish Jha, White House coronavirus czar, said on Nov. 22.

The number of Americans who have gotten the most recent booster has been increasing ahead of the holidays. CDC data show that 12% of the U.S. population age 5 and older has received a booster.

A new study by a team of researchers from Harvard University and Yale University estimates that 94% of the U.S. population has been infected with COVID-19 at least once, leaving just 1 in 20 people who have never had the virus.

“Despite these high exposure numbers, there is still substantial population susceptibility to infection with an Omicron variant,” the authors wrote.

They said that if all states achieved the vaccination levels of Vermont, where 55% of people had at least one booster and 22% got a second one, there would be “an appreciable improvement in population immunity, with greater relative impact for protection against infection versus severe disease. This additional protection results from both the recovery of immunity lost due to waning and the increased effectiveness of the bivalent booster against Omicron infections.”

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

As usual, several provocative additions to the colorectal cancer literature were published last month, but I will review only one today: the NordICC trial. This trial evaluated the use of screening colonoscopy to reduce the incidence of colorectal cancer, death from colorectal cancer, and all-cause mortality.

We have long accepted that colonoscopy is the gold standard for detection of colorectal cancer, but until the publication of this study there has never been a prospective, randomized controlled clinical trial to evaluate the efficacy of the test. Nearly 85,000 men and women from Nordic nations were randomly assigned to receive an invitation for either screening colonoscopy or usual care (ie, no colonoscopy). In the intention-to-screen analysis, colonoscopy reduced the risk for colorectal cancer over a period of 10 years by 18% (relative risk [RR] 0.82; 95% CI 0.70-0.93). However, the reduction in risk for death from colorectal cancer failed to reach statistical significance (RR 0.90; 95% CI 0.64-1.16).

These results were especially disappointing because sigmoidoscopy, a test that evaluates only the rectum and left colon, has been shown in multiple studies to reduce risk for colorectal cancer death and all-cause mortality. It is difficult for me to think of a biologically plausible explanation for colonoscopy to be less effective than sigmoidoscopy in the prevention of cause-specific and all-cause death. However, potential explanations are hidden in the study data. Most glaringly, only 42% of the colonoscopy invitees received a colonoscopy as compared with a much larger percentage of patients (58%-87%) in the sigmoidoscopy trials. While this might be an important real-world data point, it is far less than the estimated 60% of patients in the United States who adhere to the recommendation for screening colonoscopy from ages 45 to 55. Additionally, the study had only 10 years of follow-up. It is possible that this is just not long enough for the benefits of screening colonoscopy to be fully realized. Finally, 29% of endoscopists had an adenoma detection below the recommended threshold of 25%, suggesting that poor colonoscopic technique may have played a role in the limited efficacy of colonoscopy found in the study.

Regardless of what we think of these results, the study was generally well designed and, therefore, very important. Studies like this give us critical information that we, as a nation, need to determine how best to allot our limited healthcare resources. While this study does not change my perception of the efficacy of colonoscopy, it makes me think twice about its societal utility.

As usual, several provocative additions to the colorectal cancer literature were published last month, but I will review only one today: the NordICC trial. This trial evaluated the use of screening colonoscopy to reduce the incidence of colorectal cancer, death from colorectal cancer, and all-cause mortality.

We have long accepted that colonoscopy is the gold standard for detection of colorectal cancer, but until the publication of this study there has never been a prospective, randomized controlled clinical trial to evaluate the efficacy of the test. Nearly 85,000 men and women from Nordic nations were randomly assigned to receive an invitation for either screening colonoscopy or usual care (ie, no colonoscopy). In the intention-to-screen analysis, colonoscopy reduced the risk for colorectal cancer over a period of 10 years by 18% (relative risk [RR] 0.82; 95% CI 0.70-0.93). However, the reduction in risk for death from colorectal cancer failed to reach statistical significance (RR 0.90; 95% CI 0.64-1.16).

These results were especially disappointing because sigmoidoscopy, a test that evaluates only the rectum and left colon, has been shown in multiple studies to reduce risk for colorectal cancer death and all-cause mortality. It is difficult for me to think of a biologically plausible explanation for colonoscopy to be less effective than sigmoidoscopy in the prevention of cause-specific and all-cause death. However, potential explanations are hidden in the study data. Most glaringly, only 42% of the colonoscopy invitees received a colonoscopy as compared with a much larger percentage of patients (58%-87%) in the sigmoidoscopy trials. While this might be an important real-world data point, it is far less than the estimated 60% of patients in the United States who adhere to the recommendation for screening colonoscopy from ages 45 to 55. Additionally, the study had only 10 years of follow-up. It is possible that this is just not long enough for the benefits of screening colonoscopy to be fully realized. Finally, 29% of endoscopists had an adenoma detection below the recommended threshold of 25%, suggesting that poor colonoscopic technique may have played a role in the limited efficacy of colonoscopy found in the study.

Regardless of what we think of these results, the study was generally well designed and, therefore, very important. Studies like this give us critical information that we, as a nation, need to determine how best to allot our limited healthcare resources. While this study does not change my perception of the efficacy of colonoscopy, it makes me think twice about its societal utility.

As usual, several provocative additions to the colorectal cancer literature were published last month, but I will review only one today: the NordICC trial. This trial evaluated the use of screening colonoscopy to reduce the incidence of colorectal cancer, death from colorectal cancer, and all-cause mortality.

We have long accepted that colonoscopy is the gold standard for detection of colorectal cancer, but until the publication of this study there has never been a prospective, randomized controlled clinical trial to evaluate the efficacy of the test. Nearly 85,000 men and women from Nordic nations were randomly assigned to receive an invitation for either screening colonoscopy or usual care (ie, no colonoscopy). In the intention-to-screen analysis, colonoscopy reduced the risk for colorectal cancer over a period of 10 years by 18% (relative risk [RR] 0.82; 95% CI 0.70-0.93). However, the reduction in risk for death from colorectal cancer failed to reach statistical significance (RR 0.90; 95% CI 0.64-1.16).

These results were especially disappointing because sigmoidoscopy, a test that evaluates only the rectum and left colon, has been shown in multiple studies to reduce risk for colorectal cancer death and all-cause mortality. It is difficult for me to think of a biologically plausible explanation for colonoscopy to be less effective than sigmoidoscopy in the prevention of cause-specific and all-cause death. However, potential explanations are hidden in the study data. Most glaringly, only 42% of the colonoscopy invitees received a colonoscopy as compared with a much larger percentage of patients (58%-87%) in the sigmoidoscopy trials. While this might be an important real-world data point, it is far less than the estimated 60% of patients in the United States who adhere to the recommendation for screening colonoscopy from ages 45 to 55. Additionally, the study had only 10 years of follow-up. It is possible that this is just not long enough for the benefits of screening colonoscopy to be fully realized. Finally, 29% of endoscopists had an adenoma detection below the recommended threshold of 25%, suggesting that poor colonoscopic technique may have played a role in the limited efficacy of colonoscopy found in the study.

Regardless of what we think of these results, the study was generally well designed and, therefore, very important. Studies like this give us critical information that we, as a nation, need to determine how best to allot our limited healthcare resources. While this study does not change my perception of the efficacy of colonoscopy, it makes me think twice about its societal utility.

While having proper indoor ventilation is recognized as a way to reduce the spread of COVID-19, a new study from MIT says maintaining the proper relative humidity in indoor spaces like your residence might help keep you healthy.

The “sweet spot” associated with reduced COVID-19 cases and deaths is 40%-60% indoor relative humidity, an MIT news release said. People who maintained indoor relative humidity outside those parameters had higher rates of catching COVID-19. 

Most people are comfortable with 30%-50% relative humidity, researchers said. An airplane cabin has about 20% relative humidity.

Relative humidity is the amount of moisture in the air, compared with the total moisture the air can hold at a given temperature before saturating and forming condensation.

The study was published in The Journal of the Royal Society Interface. Researchers examined COVID-19 data and meteorological measurements from 121 countries from January 2020 through August 2020, before vaccines became available to the public. 

“When outdoor temperatures were below the typical human comfort range, they assumed indoor spaces were heated to reach that comfort range. Based on the added heating, they calculated the associated drop in indoor relative humidity,” the MIT news release said.

The research teams found that when a region reported a rise in COVID-19 cases and deaths, the region’s estimated indoor relative humidity was either lower than 40% or higher than 60%, the release said. 

“There’s potentially a protective effect of this intermediate indoor relative humidity,” said Connor Verheyen, the lead author and a PhD student in medical engineering and medical physics in the Harvard-MIT Program in Health Sciences and Technology.

Widespread use of the 40%-60% indoor humidity range could reduce the need for lockdowns and other widespread restrictions, the study concluded.

“Unlike measures that depend on individual compliance (for example, masking or hand-washing), indoor RH optimization would achieve high compliance because all occupants of a common indoor space would be exposed to similar ambient conditions,” the study said. “Compared to the long timelines and high costs of vaccine production and distribution, humidity control systems could potentially be implemented more quickly and cheaply in certain indoor settings.”

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

While having proper indoor ventilation is recognized as a way to reduce the spread of COVID-19, a new study from MIT says maintaining the proper relative humidity in indoor spaces like your residence might help keep you healthy.

The “sweet spot” associated with reduced COVID-19 cases and deaths is 40%-60% indoor relative humidity, an MIT news release said. People who maintained indoor relative humidity outside those parameters had higher rates of catching COVID-19. 

Most people are comfortable with 30%-50% relative humidity, researchers said. An airplane cabin has about 20% relative humidity.

Relative humidity is the amount of moisture in the air, compared with the total moisture the air can hold at a given temperature before saturating and forming condensation.

The study was published in The Journal of the Royal Society Interface. Researchers examined COVID-19 data and meteorological measurements from 121 countries from January 2020 through August 2020, before vaccines became available to the public. 

“When outdoor temperatures were below the typical human comfort range, they assumed indoor spaces were heated to reach that comfort range. Based on the added heating, they calculated the associated drop in indoor relative humidity,” the MIT news release said.

The research teams found that when a region reported a rise in COVID-19 cases and deaths, the region’s estimated indoor relative humidity was either lower than 40% or higher than 60%, the release said. 

“There’s potentially a protective effect of this intermediate indoor relative humidity,” said Connor Verheyen, the lead author and a PhD student in medical engineering and medical physics in the Harvard-MIT Program in Health Sciences and Technology.

Widespread use of the 40%-60% indoor humidity range could reduce the need for lockdowns and other widespread restrictions, the study concluded.

“Unlike measures that depend on individual compliance (for example, masking or hand-washing), indoor RH optimization would achieve high compliance because all occupants of a common indoor space would be exposed to similar ambient conditions,” the study said. “Compared to the long timelines and high costs of vaccine production and distribution, humidity control systems could potentially be implemented more quickly and cheaply in certain indoor settings.”

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

While having proper indoor ventilation is recognized as a way to reduce the spread of COVID-19, a new study from MIT says maintaining the proper relative humidity in indoor spaces like your residence might help keep you healthy.

The “sweet spot” associated with reduced COVID-19 cases and deaths is 40%-60% indoor relative humidity, an MIT news release said. People who maintained indoor relative humidity outside those parameters had higher rates of catching COVID-19. 

Most people are comfortable with 30%-50% relative humidity, researchers said. An airplane cabin has about 20% relative humidity.

Relative humidity is the amount of moisture in the air, compared with the total moisture the air can hold at a given temperature before saturating and forming condensation.

The study was published in The Journal of the Royal Society Interface. Researchers examined COVID-19 data and meteorological measurements from 121 countries from January 2020 through August 2020, before vaccines became available to the public. 

“When outdoor temperatures were below the typical human comfort range, they assumed indoor spaces were heated to reach that comfort range. Based on the added heating, they calculated the associated drop in indoor relative humidity,” the MIT news release said.

The research teams found that when a region reported a rise in COVID-19 cases and deaths, the region’s estimated indoor relative humidity was either lower than 40% or higher than 60%, the release said. 

“There’s potentially a protective effect of this intermediate indoor relative humidity,” said Connor Verheyen, the lead author and a PhD student in medical engineering and medical physics in the Harvard-MIT Program in Health Sciences and Technology.

Widespread use of the 40%-60% indoor humidity range could reduce the need for lockdowns and other widespread restrictions, the study concluded.

“Unlike measures that depend on individual compliance (for example, masking or hand-washing), indoor RH optimization would achieve high compliance because all occupants of a common indoor space would be exposed to similar ambient conditions,” the study said. “Compared to the long timelines and high costs of vaccine production and distribution, humidity control systems could potentially be implemented more quickly and cheaply in certain indoor settings.”

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

The U.S. Food and Drug Administration has approved etranacogene dezaparvovec (Hemgenix), the first gene therapy option for adults with hemophilia B who currently use factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.*

“Gene therapy for hemophilia has been on the horizon for more than 2 decades. Despite advancements in the treatment of hemophilia, the prevention and treatment of bleeding episodes can adversely impact individuals’ quality of life,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval provides a new treatment option for patients with hemophilia B and represents important progress in the development of innovative therapies for those experiencing a high burden of disease associated with this form of hemophilia.”

Hemophilia B is caused by a deficiency in clotting factor IX attributable to a faulty gene. The newly approved IV infusion delivers a functional gene to liver cells via an adeno-associated virus that instructs them to make the clotting factor. The genetic instructions remain in the cell but aren’t incorporated into the patient’s own DNA, according to a press release from maker CSL Behring.

The gene therapy will cost $3.5 million, making it the most expensive treatment to date -- more than Bluebird's recently approved gene therapies. A recent analysis from the Institute for Clinical and Economic Review said charging $2.93-$2.96 million would be justified because etranacogene dezaparvovec would offset the need for ongoing factor IX replacement, which can top $20 million over a lifetime.

Approval was based on the single-arm, open-label HOPE-B trial in 54 men who relied on factor IX replacement therapy; most patients with hemophilia B are male.

Over the 18 months after infusion, their adjusted annualized bleeding rate fell 64% compared with baseline (P = .0002), and factor IX–treated bleeds fell 77% (P < .0001); 98% of subjects treated with a full dose of etranacogene dezaparvovec discontinued factor IX prophylaxis.

Durability of the effect remains a concern, but data have been reassuring, with subjects having a mean factor IX activity of 39 IU/dL at 6 months – 39% of normal – and 36.9 IU/dL at 18 months, about 37% of normal. There’s been no sign so far of patients developing inhibitors against the infusion.

Adverse events were common but largely mild and included headache and influenza-like illness, both in 13% of subjects. Nine patients needed steroids for liver enzyme elevations.

The trial was temporarily halted due to a case of liver cancer, but it was ultimately deemed not to be related to treatment, based on molecular tumor characterization and vector integration analysis. A death in the trial was also not considered treatment related.

Other gene therapies are in the pipeline for hemophilia, including valoctocogene roxaparvovec (Roctavian, BioMarin) for hemophilia A. FDA’s approval decision is expected in March 2023.

This article was updated 11/23/22.

Correction, 11/23/22: The brand name Hemgenix was misstated in an earlier version of this article.

The U.S. Food and Drug Administration has approved etranacogene dezaparvovec (Hemgenix), the first gene therapy option for adults with hemophilia B who currently use factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.*

“Gene therapy for hemophilia has been on the horizon for more than 2 decades. Despite advancements in the treatment of hemophilia, the prevention and treatment of bleeding episodes can adversely impact individuals’ quality of life,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval provides a new treatment option for patients with hemophilia B and represents important progress in the development of innovative therapies for those experiencing a high burden of disease associated with this form of hemophilia.”

Hemophilia B is caused by a deficiency in clotting factor IX attributable to a faulty gene. The newly approved IV infusion delivers a functional gene to liver cells via an adeno-associated virus that instructs them to make the clotting factor. The genetic instructions remain in the cell but aren’t incorporated into the patient’s own DNA, according to a press release from maker CSL Behring.

The gene therapy will cost $3.5 million, making it the most expensive treatment to date -- more than Bluebird's recently approved gene therapies. A recent analysis from the Institute for Clinical and Economic Review said charging $2.93-$2.96 million would be justified because etranacogene dezaparvovec would offset the need for ongoing factor IX replacement, which can top $20 million over a lifetime.

Approval was based on the single-arm, open-label HOPE-B trial in 54 men who relied on factor IX replacement therapy; most patients with hemophilia B are male.

Over the 18 months after infusion, their adjusted annualized bleeding rate fell 64% compared with baseline (P = .0002), and factor IX–treated bleeds fell 77% (P < .0001); 98% of subjects treated with a full dose of etranacogene dezaparvovec discontinued factor IX prophylaxis.

Durability of the effect remains a concern, but data have been reassuring, with subjects having a mean factor IX activity of 39 IU/dL at 6 months – 39% of normal – and 36.9 IU/dL at 18 months, about 37% of normal. There’s been no sign so far of patients developing inhibitors against the infusion.

Adverse events were common but largely mild and included headache and influenza-like illness, both in 13% of subjects. Nine patients needed steroids for liver enzyme elevations.

The trial was temporarily halted due to a case of liver cancer, but it was ultimately deemed not to be related to treatment, based on molecular tumor characterization and vector integration analysis. A death in the trial was also not considered treatment related.

Other gene therapies are in the pipeline for hemophilia, including valoctocogene roxaparvovec (Roctavian, BioMarin) for hemophilia A. FDA’s approval decision is expected in March 2023.

This article was updated 11/23/22.

Correction, 11/23/22: The brand name Hemgenix was misstated in an earlier version of this article.

The U.S. Food and Drug Administration has approved etranacogene dezaparvovec (Hemgenix), the first gene therapy option for adults with hemophilia B who currently use factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.*

“Gene therapy for hemophilia has been on the horizon for more than 2 decades. Despite advancements in the treatment of hemophilia, the prevention and treatment of bleeding episodes can adversely impact individuals’ quality of life,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval provides a new treatment option for patients with hemophilia B and represents important progress in the development of innovative therapies for those experiencing a high burden of disease associated with this form of hemophilia.”

Hemophilia B is caused by a deficiency in clotting factor IX attributable to a faulty gene. The newly approved IV infusion delivers a functional gene to liver cells via an adeno-associated virus that instructs them to make the clotting factor. The genetic instructions remain in the cell but aren’t incorporated into the patient’s own DNA, according to a press release from maker CSL Behring.

The gene therapy will cost $3.5 million, making it the most expensive treatment to date -- more than Bluebird's recently approved gene therapies. A recent analysis from the Institute for Clinical and Economic Review said charging $2.93-$2.96 million would be justified because etranacogene dezaparvovec would offset the need for ongoing factor IX replacement, which can top $20 million over a lifetime.

Approval was based on the single-arm, open-label HOPE-B trial in 54 men who relied on factor IX replacement therapy; most patients with hemophilia B are male.

Over the 18 months after infusion, their adjusted annualized bleeding rate fell 64% compared with baseline (P = .0002), and factor IX–treated bleeds fell 77% (P < .0001); 98% of subjects treated with a full dose of etranacogene dezaparvovec discontinued factor IX prophylaxis.

Durability of the effect remains a concern, but data have been reassuring, with subjects having a mean factor IX activity of 39 IU/dL at 6 months – 39% of normal – and 36.9 IU/dL at 18 months, about 37% of normal. There’s been no sign so far of patients developing inhibitors against the infusion.

Adverse events were common but largely mild and included headache and influenza-like illness, both in 13% of subjects. Nine patients needed steroids for liver enzyme elevations.

The trial was temporarily halted due to a case of liver cancer, but it was ultimately deemed not to be related to treatment, based on molecular tumor characterization and vector integration analysis. A death in the trial was also not considered treatment related.

Other gene therapies are in the pipeline for hemophilia, including valoctocogene roxaparvovec (Roctavian, BioMarin) for hemophilia A. FDA’s approval decision is expected in March 2023.

This article was updated 11/23/22.

Correction, 11/23/22: The brand name Hemgenix was misstated in an earlier version of this article.

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

Of the more than 6 million patients with Alzheimer’s disease in the United States aged 65 or older, nearly two-thirds are women. A new study published online in Cell may help explain the gender gap – and offer clues to new treatments for helping patients of both sexes fight back.

Researchers zeroed in on a gene named USP11, found on the X chromosome. People assigned female at birth have two X chromosomes, while people assigned male at birth have one X and one Y. So while all males have one copy of USP11, females have two.
 

The body’s trash collection system

In the normal course of events, the brain creates waste that must be removed lest it becomes toxic. One waste product is the protein tau. Too little tau can damage nerve cells, explained researchers David Kang, PhD, and Jung-A “Alexa” Woo, PhD, who led the study. But too much becomes toxic and can lead to neurodegenerative diseases such as Alzheimer’s disease. In fact, new research suggests that testing for changes in tau may someday help doctors diagnose Alzheimer’s disease earlier.

To manage tau, the brain uses a regulatory protein called ubiquitin to “tag” or signal the body that extra tau should be removed.

USP11’s job is to give instructions to make an enzyme that removes the ubiquitin tag to maintain balance. But if too much of the enzyme is present, too much tau gets untagged – and not enough of it gets cleared.

“Our study showed USP11 is higher in females than males in both humans and in mice,” Dr. Kang said. “That’s already true before the onset of dementia. But once someone has Alzheimer’s disease, USP11 is much higher – regardless of sex.”

The study adds to a growing body of evidence that shows that women may be more vulnerable than men to higher levels of tau, possibly explaining why women are affected by the disease more often than men.

But what if there was a way to “turn off” or deactivate the USP11 gene? Might that help prevent Alzheimer’s disease? And could it be done safely?
 

What happened when the gene was eliminated?

To examine these questions, researchers used a method of gene manipulation to completely delete the USP11 gene in mice. They then examined the mice for changes. The result? The mice seemed fine.

“The mice bred well. Their brains looked fine,” Dr. Woo said.

It would not be possible – or ethical – to remove a gene from humans. But when a medical condition makes a certain gene unhelpful, that gene can be partially blocked or expression of the gene can be reduced with medication. In fact, medications targeting enzymes are common. Examples include statins for cardiovascular disease or HIV treatments that inhibit protease enzymes.

“If we are able to identify some type of medicine that would inhibit USP11, our study suggests it would be well tolerated and benefit women,” Dr. Woo said.

Dr. Kang also cautions that the process for creating such a therapy takes at least 10-15 years. The researchers said they’d like to shorten the timeline and plan to study currently approved FDA medications to see if any might work to target USP11 gene activity – and hopefully bring forth a new treatment for Alzheimer’s disease sooner.

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

Of the more than 6 million patients with Alzheimer’s disease in the United States aged 65 or older, nearly two-thirds are women. A new study published online in Cell may help explain the gender gap – and offer clues to new treatments for helping patients of both sexes fight back.

Researchers zeroed in on a gene named USP11, found on the X chromosome. People assigned female at birth have two X chromosomes, while people assigned male at birth have one X and one Y. So while all males have one copy of USP11, females have two.
 

The body’s trash collection system

In the normal course of events, the brain creates waste that must be removed lest it becomes toxic. One waste product is the protein tau. Too little tau can damage nerve cells, explained researchers David Kang, PhD, and Jung-A “Alexa” Woo, PhD, who led the study. But too much becomes toxic and can lead to neurodegenerative diseases such as Alzheimer’s disease. In fact, new research suggests that testing for changes in tau may someday help doctors diagnose Alzheimer’s disease earlier.

To manage tau, the brain uses a regulatory protein called ubiquitin to “tag” or signal the body that extra tau should be removed.

USP11’s job is to give instructions to make an enzyme that removes the ubiquitin tag to maintain balance. But if too much of the enzyme is present, too much tau gets untagged – and not enough of it gets cleared.

“Our study showed USP11 is higher in females than males in both humans and in mice,” Dr. Kang said. “That’s already true before the onset of dementia. But once someone has Alzheimer’s disease, USP11 is much higher – regardless of sex.”

The study adds to a growing body of evidence that shows that women may be more vulnerable than men to higher levels of tau, possibly explaining why women are affected by the disease more often than men.

But what if there was a way to “turn off” or deactivate the USP11 gene? Might that help prevent Alzheimer’s disease? And could it be done safely?
 

What happened when the gene was eliminated?

To examine these questions, researchers used a method of gene manipulation to completely delete the USP11 gene in mice. They then examined the mice for changes. The result? The mice seemed fine.

“The mice bred well. Their brains looked fine,” Dr. Woo said.

It would not be possible – or ethical – to remove a gene from humans. But when a medical condition makes a certain gene unhelpful, that gene can be partially blocked or expression of the gene can be reduced with medication. In fact, medications targeting enzymes are common. Examples include statins for cardiovascular disease or HIV treatments that inhibit protease enzymes.

“If we are able to identify some type of medicine that would inhibit USP11, our study suggests it would be well tolerated and benefit women,” Dr. Woo said.

Dr. Kang also cautions that the process for creating such a therapy takes at least 10-15 years. The researchers said they’d like to shorten the timeline and plan to study currently approved FDA medications to see if any might work to target USP11 gene activity – and hopefully bring forth a new treatment for Alzheimer’s disease sooner.

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

Of the more than 6 million patients with Alzheimer’s disease in the United States aged 65 or older, nearly two-thirds are women. A new study published online in Cell may help explain the gender gap – and offer clues to new treatments for helping patients of both sexes fight back.

Researchers zeroed in on a gene named USP11, found on the X chromosome. People assigned female at birth have two X chromosomes, while people assigned male at birth have one X and one Y. So while all males have one copy of USP11, females have two.
 

The body’s trash collection system

In the normal course of events, the brain creates waste that must be removed lest it becomes toxic. One waste product is the protein tau. Too little tau can damage nerve cells, explained researchers David Kang, PhD, and Jung-A “Alexa” Woo, PhD, who led the study. But too much becomes toxic and can lead to neurodegenerative diseases such as Alzheimer’s disease. In fact, new research suggests that testing for changes in tau may someday help doctors diagnose Alzheimer’s disease earlier.

To manage tau, the brain uses a regulatory protein called ubiquitin to “tag” or signal the body that extra tau should be removed.

USP11’s job is to give instructions to make an enzyme that removes the ubiquitin tag to maintain balance. But if too much of the enzyme is present, too much tau gets untagged – and not enough of it gets cleared.

“Our study showed USP11 is higher in females than males in both humans and in mice,” Dr. Kang said. “That’s already true before the onset of dementia. But once someone has Alzheimer’s disease, USP11 is much higher – regardless of sex.”

The study adds to a growing body of evidence that shows that women may be more vulnerable than men to higher levels of tau, possibly explaining why women are affected by the disease more often than men.

But what if there was a way to “turn off” or deactivate the USP11 gene? Might that help prevent Alzheimer’s disease? And could it be done safely?
 

What happened when the gene was eliminated?

To examine these questions, researchers used a method of gene manipulation to completely delete the USP11 gene in mice. They then examined the mice for changes. The result? The mice seemed fine.

“The mice bred well. Their brains looked fine,” Dr. Woo said.

It would not be possible – or ethical – to remove a gene from humans. But when a medical condition makes a certain gene unhelpful, that gene can be partially blocked or expression of the gene can be reduced with medication. In fact, medications targeting enzymes are common. Examples include statins for cardiovascular disease or HIV treatments that inhibit protease enzymes.

“If we are able to identify some type of medicine that would inhibit USP11, our study suggests it would be well tolerated and benefit women,” Dr. Woo said.

Dr. Kang also cautions that the process for creating such a therapy takes at least 10-15 years. The researchers said they’d like to shorten the timeline and plan to study currently approved FDA medications to see if any might work to target USP11 gene activity – and hopefully bring forth a new treatment for Alzheimer’s disease sooner.

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

Key clinical point: Overall, COVID-19 vaccines were well tolerated in patients with rheumatoid arthritis (RA), with the adverse event (AE) profile being comparable to that in control individuals; patients receiving methotrexate and hydroxychloroquine vs other immunosuppressants reporting fewer minor AE.

Major finding: At 7 days after vaccination, 76.9% of patients with RA reported AE, all being minor and comparable to those in the control group and similar between patients with active and inactive disease. Major AE were reported by 4.2% of patients with RA. Patients receiving methotrexate or hydroxychloroquine vs other immunosuppressants reported fewer minor AE (all P ≤ .05).

Study details: This was a cross-sectional survey-based study of 9462 respondents of an online self-reported questionnaire, including patients with RA (n = 1347), other autoimmune rheumatic diseases (n = 2305), non-rheumatic autoimmune diseases (n = 1079), and the control group (n = 4741) who received at least one dose of any COVID-19 vaccine.

Disclosures: This study did not receive any specific funding. Several authors reported receiving advisory board or speaker honoraria, consulting fees, research grant, or funding from various sources.

Source: Naveen R et al. COVID-19 vaccination in autoimmune diseases (COVAD) Study: Vaccine safety and tolerance in rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 31). Doi: 10.1093/rheumatology/keac624

Key clinical point: Overall, COVID-19 vaccines were well tolerated in patients with rheumatoid arthritis (RA), with the adverse event (AE) profile being comparable to that in control individuals; patients receiving methotrexate and hydroxychloroquine vs other immunosuppressants reporting fewer minor AE.

Major finding: At 7 days after vaccination, 76.9% of patients with RA reported AE, all being minor and comparable to those in the control group and similar between patients with active and inactive disease. Major AE were reported by 4.2% of patients with RA. Patients receiving methotrexate or hydroxychloroquine vs other immunosuppressants reported fewer minor AE (all P ≤ .05).

Study details: This was a cross-sectional survey-based study of 9462 respondents of an online self-reported questionnaire, including patients with RA (n = 1347), other autoimmune rheumatic diseases (n = 2305), non-rheumatic autoimmune diseases (n = 1079), and the control group (n = 4741) who received at least one dose of any COVID-19 vaccine.

Disclosures: This study did not receive any specific funding. Several authors reported receiving advisory board or speaker honoraria, consulting fees, research grant, or funding from various sources.

Source: Naveen R et al. COVID-19 vaccination in autoimmune diseases (COVAD) Study: Vaccine safety and tolerance in rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 31). Doi: 10.1093/rheumatology/keac624

Key clinical point: Overall, COVID-19 vaccines were well tolerated in patients with rheumatoid arthritis (RA), with the adverse event (AE) profile being comparable to that in control individuals; patients receiving methotrexate and hydroxychloroquine vs other immunosuppressants reporting fewer minor AE.

Major finding: At 7 days after vaccination, 76.9% of patients with RA reported AE, all being minor and comparable to those in the control group and similar between patients with active and inactive disease. Major AE were reported by 4.2% of patients with RA. Patients receiving methotrexate or hydroxychloroquine vs other immunosuppressants reported fewer minor AE (all P ≤ .05).

Study details: This was a cross-sectional survey-based study of 9462 respondents of an online self-reported questionnaire, including patients with RA (n = 1347), other autoimmune rheumatic diseases (n = 2305), non-rheumatic autoimmune diseases (n = 1079), and the control group (n = 4741) who received at least one dose of any COVID-19 vaccine.

Disclosures: This study did not receive any specific funding. Several authors reported receiving advisory board or speaker honoraria, consulting fees, research grant, or funding from various sources.

Source: Naveen R et al. COVID-19 vaccination in autoimmune diseases (COVAD) Study: Vaccine safety and tolerance in rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 31). Doi: 10.1093/rheumatology/keac624

Key clinical point: Filgotinib vs placebo, both with background methotrexate, significantly improved disease activity and suppressed radiographic progression in patients with rheumatoid arthritis (RA) who were methotrexate inadequate responders (IR) and had ≤4 poor prognostic factors (PPF).

Major finding: Doses of 100 and 200 mg filgotinib vs placebo led to higher American College of Rheumatology 20, 50, and 70 response rates among patients with ≤4 PPF at week 12 (all P < .05) and significantly reduced the change from baseline in modified total Sharp score at week 24 among patients with 4 PPF (both P < .01) along with similar tolerability.

Study details: This post hoc analysis of FINCH 1 included 1755 patients with RA who were methotrexate-IR and were randomly assigned to receive filgotinib, adalimumab, or placebo, all with background methotrexate.

Disclosures: This study was funded by Gilead Sciences, Inc., with support from Eisai Co., Ltd., and Gilead Sciences K.K. Seven authors declared being current or former employees of Gilead Sciences/Galapagos BV or shareholders of various sources. Several authors reported ties with various sources.

Source: Combe BG et al. Efficacy and safety of filgotinib in patients with high risk of poor prognosis who showed inadequate response to MTX: A post hoc analysis of the FINCH 1 study. Rheumatol Ther. 2022 (Oct 9). Doi: 10.1007/s40744-022-00498-x

Key clinical point: Filgotinib vs placebo, both with background methotrexate, significantly improved disease activity and suppressed radiographic progression in patients with rheumatoid arthritis (RA) who were methotrexate inadequate responders (IR) and had ≤4 poor prognostic factors (PPF).

Major finding: Doses of 100 and 200 mg filgotinib vs placebo led to higher American College of Rheumatology 20, 50, and 70 response rates among patients with ≤4 PPF at week 12 (all P < .05) and significantly reduced the change from baseline in modified total Sharp score at week 24 among patients with 4 PPF (both P < .01) along with similar tolerability.

Study details: This post hoc analysis of FINCH 1 included 1755 patients with RA who were methotrexate-IR and were randomly assigned to receive filgotinib, adalimumab, or placebo, all with background methotrexate.

Disclosures: This study was funded by Gilead Sciences, Inc., with support from Eisai Co., Ltd., and Gilead Sciences K.K. Seven authors declared being current or former employees of Gilead Sciences/Galapagos BV or shareholders of various sources. Several authors reported ties with various sources.

Source: Combe BG et al. Efficacy and safety of filgotinib in patients with high risk of poor prognosis who showed inadequate response to MTX: A post hoc analysis of the FINCH 1 study. Rheumatol Ther. 2022 (Oct 9). Doi: 10.1007/s40744-022-00498-x

Key clinical point: Filgotinib vs placebo, both with background methotrexate, significantly improved disease activity and suppressed radiographic progression in patients with rheumatoid arthritis (RA) who were methotrexate inadequate responders (IR) and had ≤4 poor prognostic factors (PPF).

Major finding: Doses of 100 and 200 mg filgotinib vs placebo led to higher American College of Rheumatology 20, 50, and 70 response rates among patients with ≤4 PPF at week 12 (all P < .05) and significantly reduced the change from baseline in modified total Sharp score at week 24 among patients with 4 PPF (both P < .01) along with similar tolerability.

Study details: This post hoc analysis of FINCH 1 included 1755 patients with RA who were methotrexate-IR and were randomly assigned to receive filgotinib, adalimumab, or placebo, all with background methotrexate.

Disclosures: This study was funded by Gilead Sciences, Inc., with support from Eisai Co., Ltd., and Gilead Sciences K.K. Seven authors declared being current or former employees of Gilead Sciences/Galapagos BV or shareholders of various sources. Several authors reported ties with various sources.

Source: Combe BG et al. Efficacy and safety of filgotinib in patients with high risk of poor prognosis who showed inadequate response to MTX: A post hoc analysis of the FINCH 1 study. Rheumatol Ther. 2022 (Oct 9). Doi: 10.1007/s40744-022-00498-x

Key clinical point: Presence of autoantibodies for cyclic citrullinated peptide (anti-CCP2), load of anticitrullinated protein antibody (ACPA) fine-specificities, and immunoglobulin M (IgM) rheumatoid factor (RF) at diagnosis of rheumatoid arthritis (RA) increased the risk for incident venous thromboembolic events (VTE) in patients with RA.

Major finding: Positivity for IgG anti-CCP2 (hazard ratio [HR] 1.33; 95% CI 1.00-1.78) and IgM RF (HR 1.38; 95% CI 1.04-1.83) increased the risk for incident VTE. Additionally, the risk increased with the number of ACPA fine-specificities expressed (P_trend = .033).

Study details: This prospective cohort study analyzed 2782 patients with newly diagnosed RA who reported 213 first-ever VTE.

Disclosures: This study was supported by the Swedish Research Council, NordForsk, and others. Four authors declared being employees or part-time employees, paid advisors, or founders of different companies. Two authors reported owning patents for peptides and their use for diagnostic purpose.

Source: Westerlind H et al. The association between autoantibodies and risk for venous thromboembolic events among patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 18). Doi: 10.1093/rheumatology/keac601

Key clinical point: Presence of autoantibodies for cyclic citrullinated peptide (anti-CCP2), load of anticitrullinated protein antibody (ACPA) fine-specificities, and immunoglobulin M (IgM) rheumatoid factor (RF) at diagnosis of rheumatoid arthritis (RA) increased the risk for incident venous thromboembolic events (VTE) in patients with RA.

Major finding: Positivity for IgG anti-CCP2 (hazard ratio [HR] 1.33; 95% CI 1.00-1.78) and IgM RF (HR 1.38; 95% CI 1.04-1.83) increased the risk for incident VTE. Additionally, the risk increased with the number of ACPA fine-specificities expressed (P_trend = .033).

Study details: This prospective cohort study analyzed 2782 patients with newly diagnosed RA who reported 213 first-ever VTE.

Disclosures: This study was supported by the Swedish Research Council, NordForsk, and others. Four authors declared being employees or part-time employees, paid advisors, or founders of different companies. Two authors reported owning patents for peptides and their use for diagnostic purpose.

Source: Westerlind H et al. The association between autoantibodies and risk for venous thromboembolic events among patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 18). Doi: 10.1093/rheumatology/keac601

Key clinical point: Presence of autoantibodies for cyclic citrullinated peptide (anti-CCP2), load of anticitrullinated protein antibody (ACPA) fine-specificities, and immunoglobulin M (IgM) rheumatoid factor (RF) at diagnosis of rheumatoid arthritis (RA) increased the risk for incident venous thromboembolic events (VTE) in patients with RA.

Major finding: Positivity for IgG anti-CCP2 (hazard ratio [HR] 1.33; 95% CI 1.00-1.78) and IgM RF (HR 1.38; 95% CI 1.04-1.83) increased the risk for incident VTE. Additionally, the risk increased with the number of ACPA fine-specificities expressed (P_trend = .033).

Study details: This prospective cohort study analyzed 2782 patients with newly diagnosed RA who reported 213 first-ever VTE.

Disclosures: This study was supported by the Swedish Research Council, NordForsk, and others. Four authors declared being employees or part-time employees, paid advisors, or founders of different companies. Two authors reported owning patents for peptides and their use for diagnostic purpose.

Source: Westerlind H et al. The association between autoantibodies and risk for venous thromboembolic events among patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 18). Doi: 10.1093/rheumatology/keac601

Key clinical point: Concomitant methotrexate significantly reduced humoral response to the third SARS-CoV-2 mRNA vaccine in older (age ≥ 64.5 years) but not younger (age < 64.5 years) patients with rheumatoid arthritis (RA).

Major finding: Patients aged ≥ 64.5 years receiving methotrexate plus biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) vs methotrexate monotherapy or b/tsDMARD monotherapy had significantly lower serum levels of immunoglobulin G antibody for SARS-CoV-2 spike protein receptor binding domain (64.8 vs 1743.8 or 1106.0 binding antibody units/mL, respectively; Kruskal-Wallis Test, P < .001), whereas patients aged < 64.5 years showed no significant difference (Kruskal-Wallis Test, P = .334).

Study details: Findings are from a retrospective analysis including 136 patients with RA treated with conventional synthetic DMARD or b/ts DMARD with or without methotrexate who received the third dose of SARS-CoV-2 mRNA vaccines BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).

Disclosures: This study did not declare any specific source of funding. No conflict of interests was declared.

Source: Stahl D et al. Reduced humoral response to a third dose (booster) of SARS-CoV-2 mRNA vaccines by concomitant methotrexate therapy in elderly patients with rheumatoid arthritis. RMD Open. 2022;8(2):e002632 (Oct 10). Doi: 10.1136/rmdopen-2022-002632

Key clinical point: Concomitant methotrexate significantly reduced humoral response to the third SARS-CoV-2 mRNA vaccine in older (age ≥ 64.5 years) but not younger (age < 64.5 years) patients with rheumatoid arthritis (RA).

Major finding: Patients aged ≥ 64.5 years receiving methotrexate plus biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) vs methotrexate monotherapy or b/tsDMARD monotherapy had significantly lower serum levels of immunoglobulin G antibody for SARS-CoV-2 spike protein receptor binding domain (64.8 vs 1743.8 or 1106.0 binding antibody units/mL, respectively; Kruskal-Wallis Test, P < .001), whereas patients aged < 64.5 years showed no significant difference (Kruskal-Wallis Test, P = .334).

Study details: Findings are from a retrospective analysis including 136 patients with RA treated with conventional synthetic DMARD or b/ts DMARD with or without methotrexate who received the third dose of SARS-CoV-2 mRNA vaccines BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).

Disclosures: This study did not declare any specific source of funding. No conflict of interests was declared.

Source: Stahl D et al. Reduced humoral response to a third dose (booster) of SARS-CoV-2 mRNA vaccines by concomitant methotrexate therapy in elderly patients with rheumatoid arthritis. RMD Open. 2022;8(2):e002632 (Oct 10). Doi: 10.1136/rmdopen-2022-002632

Key clinical point: Concomitant methotrexate significantly reduced humoral response to the third SARS-CoV-2 mRNA vaccine in older (age ≥ 64.5 years) but not younger (age < 64.5 years) patients with rheumatoid arthritis (RA).

Major finding: Patients aged ≥ 64.5 years receiving methotrexate plus biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) vs methotrexate monotherapy or b/tsDMARD monotherapy had significantly lower serum levels of immunoglobulin G antibody for SARS-CoV-2 spike protein receptor binding domain (64.8 vs 1743.8 or 1106.0 binding antibody units/mL, respectively; Kruskal-Wallis Test, P < .001), whereas patients aged < 64.5 years showed no significant difference (Kruskal-Wallis Test, P = .334).

Study details: Findings are from a retrospective analysis including 136 patients with RA treated with conventional synthetic DMARD or b/ts DMARD with or without methotrexate who received the third dose of SARS-CoV-2 mRNA vaccines BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).

Disclosures: This study did not declare any specific source of funding. No conflict of interests was declared.

Source: Stahl D et al. Reduced humoral response to a third dose (booster) of SARS-CoV-2 mRNA vaccines by concomitant methotrexate therapy in elderly patients with rheumatoid arthritis. RMD Open. 2022;8(2):e002632 (Oct 10). Doi: 10.1136/rmdopen-2022-002632