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Taking 2021’s rheumatology advocacy momentum into 2022

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Fri, 11/12/2021 - 10:20

As 2021 winds down, I reflect on the achievements the rheumatology community has had in the realm of advocacy throughout the year. And there were many: Seven states signed accumulator program bans into law, five states reformed the use of step therapy protocols, Texas passed an innovative “gold carding” law to reduce the burden of prior authorization, and West Virginia passed a rebate pass-through law to directly assist patients with high out-of-pocket costs – the first of its kind in the nation.

Dr. Madelaine Feldman

Of course, the close of another year also means gearing up for the year ahead. The majority of state legislatures are getting ready to open legislative sessions in the New Year. This means a year of new opportunities and new challenges. As a community, there are some key areas rheumatology will need to focus on during the course of the upcoming year as policy makers return to the business of policy making.

Many in the rheumatology community are aware that the buy and bill acquisition system has come under threat in recent years, mainly from payer mandates to use the alternative white bagging model. In some cases, payers have gone as far as to mandate the practice of “brown bagging,” or home infusion. These practices can endanger patient safety and overall quality of care. A study led by Matthew Baker, MD, of Stanford (Calif.) University found that biologic infusions administered at home, compared with those administered at a facility, were associated with increased adverse events requiring escalation of care; specifically, home infusions were associated with 25% increased odds of ED or hospital admission on the same or next day after infusion, compared with facility infusions, and 28% increased odds of permanent discontinuation of the biologic after emergency department or hospital admission. Additionally, site-of-care research by Paul Fronstin, PhD, at Employee Benefit Research Institute clearly shows that in-office infusion with physician supervision is far more cost effective than hospital and, in some cases, home infusion as well.

Further, the metastasis of these payer mandates is likely to severely limit availability of and access to care. It is unclear whether outpatient infusion, especially in private rheumatology practices, will prove sustainable in a world of white bagging. The net result of an expansion of the white-bagging requirements may well be broad access challenges that inconvenience patients deeply and irresponsibly.

The expansion of these mandates has not come without pushback, and rheumatologists should be prepared to advocate for policy that prohibits payers from mandating the use of white bagging, brown bagging, and home infusion. It is abundantly clear that arguments of safety and cost effectiveness are sufficient grounds for policy makers to curtail the mandatory use of these practices.



Similar to white bagging, another key issue in the year ahead is formulary construction based on the rebate system and proposed policies to address its attendant problems. Propagated by pharmacy benefit managers (PBMs), the rebate-based, or kickback, system of formulary construction often rewards higher-priced drugs with preferred placement regardless of whether they are the best and most affordable medications for our patients. A few states are beginning to address the affordability issue by mandating that the rebate/kickback acquired by the PBM be passed back to the patient at the point of sale. West Virginia passed a first-of-its-kind law to ensure that patients who generate drug rebates benefit from them by requiring that their cost shares are reduced by an amount equivalent to the rebate received by a health plan. This policy does not get at the root of the formulary construction problem, but if it is adopted more broadly across the country, it will deliver direct relief to patients who are struggling with out-of-pocket costs associated with prescription drugs. I anticipate that this will be a prominent issue nationwide during the upcoming year with opportunity for rheumatologists to lend their voices.

Many of the rheumatology community’s longstanding issues persist, and while progress has been made, more work remains to be done. Whether it’s accumulator programs, prior authorization, nonmedical switching, or step therapy, there will be opportunities in almost every state to engage in improving our ability to provide excellent care to our patients.

We tend to be motivated into action when one of these individual issues appear in our own state’s legislature; however, consistency of engagement is also important. While it is important to talk to your legislators when you need them to vote a certain way on a certain bill, scheduling a meeting with them or sending them a message detailing some of the issues that the rheumatology community faces before legislatures return in full swing is equally important to establish the relationship.

By making “rheum for action” now, you’ll have more impact when legislation relevant to our daily work does appear in the state legislatures. You can find your state representatives at the Coalition for State Rheumatology Organization’s Action Center.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

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As 2021 winds down, I reflect on the achievements the rheumatology community has had in the realm of advocacy throughout the year. And there were many: Seven states signed accumulator program bans into law, five states reformed the use of step therapy protocols, Texas passed an innovative “gold carding” law to reduce the burden of prior authorization, and West Virginia passed a rebate pass-through law to directly assist patients with high out-of-pocket costs – the first of its kind in the nation.

Dr. Madelaine Feldman

Of course, the close of another year also means gearing up for the year ahead. The majority of state legislatures are getting ready to open legislative sessions in the New Year. This means a year of new opportunities and new challenges. As a community, there are some key areas rheumatology will need to focus on during the course of the upcoming year as policy makers return to the business of policy making.

Many in the rheumatology community are aware that the buy and bill acquisition system has come under threat in recent years, mainly from payer mandates to use the alternative white bagging model. In some cases, payers have gone as far as to mandate the practice of “brown bagging,” or home infusion. These practices can endanger patient safety and overall quality of care. A study led by Matthew Baker, MD, of Stanford (Calif.) University found that biologic infusions administered at home, compared with those administered at a facility, were associated with increased adverse events requiring escalation of care; specifically, home infusions were associated with 25% increased odds of ED or hospital admission on the same or next day after infusion, compared with facility infusions, and 28% increased odds of permanent discontinuation of the biologic after emergency department or hospital admission. Additionally, site-of-care research by Paul Fronstin, PhD, at Employee Benefit Research Institute clearly shows that in-office infusion with physician supervision is far more cost effective than hospital and, in some cases, home infusion as well.

Further, the metastasis of these payer mandates is likely to severely limit availability of and access to care. It is unclear whether outpatient infusion, especially in private rheumatology practices, will prove sustainable in a world of white bagging. The net result of an expansion of the white-bagging requirements may well be broad access challenges that inconvenience patients deeply and irresponsibly.

The expansion of these mandates has not come without pushback, and rheumatologists should be prepared to advocate for policy that prohibits payers from mandating the use of white bagging, brown bagging, and home infusion. It is abundantly clear that arguments of safety and cost effectiveness are sufficient grounds for policy makers to curtail the mandatory use of these practices.



Similar to white bagging, another key issue in the year ahead is formulary construction based on the rebate system and proposed policies to address its attendant problems. Propagated by pharmacy benefit managers (PBMs), the rebate-based, or kickback, system of formulary construction often rewards higher-priced drugs with preferred placement regardless of whether they are the best and most affordable medications for our patients. A few states are beginning to address the affordability issue by mandating that the rebate/kickback acquired by the PBM be passed back to the patient at the point of sale. West Virginia passed a first-of-its-kind law to ensure that patients who generate drug rebates benefit from them by requiring that their cost shares are reduced by an amount equivalent to the rebate received by a health plan. This policy does not get at the root of the formulary construction problem, but if it is adopted more broadly across the country, it will deliver direct relief to patients who are struggling with out-of-pocket costs associated with prescription drugs. I anticipate that this will be a prominent issue nationwide during the upcoming year with opportunity for rheumatologists to lend their voices.

Many of the rheumatology community’s longstanding issues persist, and while progress has been made, more work remains to be done. Whether it’s accumulator programs, prior authorization, nonmedical switching, or step therapy, there will be opportunities in almost every state to engage in improving our ability to provide excellent care to our patients.

We tend to be motivated into action when one of these individual issues appear in our own state’s legislature; however, consistency of engagement is also important. While it is important to talk to your legislators when you need them to vote a certain way on a certain bill, scheduling a meeting with them or sending them a message detailing some of the issues that the rheumatology community faces before legislatures return in full swing is equally important to establish the relationship.

By making “rheum for action” now, you’ll have more impact when legislation relevant to our daily work does appear in the state legislatures. You can find your state representatives at the Coalition for State Rheumatology Organization’s Action Center.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

As 2021 winds down, I reflect on the achievements the rheumatology community has had in the realm of advocacy throughout the year. And there were many: Seven states signed accumulator program bans into law, five states reformed the use of step therapy protocols, Texas passed an innovative “gold carding” law to reduce the burden of prior authorization, and West Virginia passed a rebate pass-through law to directly assist patients with high out-of-pocket costs – the first of its kind in the nation.

Dr. Madelaine Feldman

Of course, the close of another year also means gearing up for the year ahead. The majority of state legislatures are getting ready to open legislative sessions in the New Year. This means a year of new opportunities and new challenges. As a community, there are some key areas rheumatology will need to focus on during the course of the upcoming year as policy makers return to the business of policy making.

Many in the rheumatology community are aware that the buy and bill acquisition system has come under threat in recent years, mainly from payer mandates to use the alternative white bagging model. In some cases, payers have gone as far as to mandate the practice of “brown bagging,” or home infusion. These practices can endanger patient safety and overall quality of care. A study led by Matthew Baker, MD, of Stanford (Calif.) University found that biologic infusions administered at home, compared with those administered at a facility, were associated with increased adverse events requiring escalation of care; specifically, home infusions were associated with 25% increased odds of ED or hospital admission on the same or next day after infusion, compared with facility infusions, and 28% increased odds of permanent discontinuation of the biologic after emergency department or hospital admission. Additionally, site-of-care research by Paul Fronstin, PhD, at Employee Benefit Research Institute clearly shows that in-office infusion with physician supervision is far more cost effective than hospital and, in some cases, home infusion as well.

Further, the metastasis of these payer mandates is likely to severely limit availability of and access to care. It is unclear whether outpatient infusion, especially in private rheumatology practices, will prove sustainable in a world of white bagging. The net result of an expansion of the white-bagging requirements may well be broad access challenges that inconvenience patients deeply and irresponsibly.

The expansion of these mandates has not come without pushback, and rheumatologists should be prepared to advocate for policy that prohibits payers from mandating the use of white bagging, brown bagging, and home infusion. It is abundantly clear that arguments of safety and cost effectiveness are sufficient grounds for policy makers to curtail the mandatory use of these practices.



Similar to white bagging, another key issue in the year ahead is formulary construction based on the rebate system and proposed policies to address its attendant problems. Propagated by pharmacy benefit managers (PBMs), the rebate-based, or kickback, system of formulary construction often rewards higher-priced drugs with preferred placement regardless of whether they are the best and most affordable medications for our patients. A few states are beginning to address the affordability issue by mandating that the rebate/kickback acquired by the PBM be passed back to the patient at the point of sale. West Virginia passed a first-of-its-kind law to ensure that patients who generate drug rebates benefit from them by requiring that their cost shares are reduced by an amount equivalent to the rebate received by a health plan. This policy does not get at the root of the formulary construction problem, but if it is adopted more broadly across the country, it will deliver direct relief to patients who are struggling with out-of-pocket costs associated with prescription drugs. I anticipate that this will be a prominent issue nationwide during the upcoming year with opportunity for rheumatologists to lend their voices.

Many of the rheumatology community’s longstanding issues persist, and while progress has been made, more work remains to be done. Whether it’s accumulator programs, prior authorization, nonmedical switching, or step therapy, there will be opportunities in almost every state to engage in improving our ability to provide excellent care to our patients.

We tend to be motivated into action when one of these individual issues appear in our own state’s legislature; however, consistency of engagement is also important. While it is important to talk to your legislators when you need them to vote a certain way on a certain bill, scheduling a meeting with them or sending them a message detailing some of the issues that the rheumatology community faces before legislatures return in full swing is equally important to establish the relationship.

By making “rheum for action” now, you’ll have more impact when legislation relevant to our daily work does appear in the state legislatures. You can find your state representatives at the Coalition for State Rheumatology Organization’s Action Center.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

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COVID-19 vaccine mandates are working, public health experts say

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Thu, 11/11/2021 - 16:06

While COVID-19 vaccine mandates have sparked lawsuits and protests, the data shows that they’re working and increasing vaccination rates.

Some organizations have reported vaccination rates that jumped from less than 50% to more than 90%, according to ABC News. Workplace mandates have especially encouraged employees who were on the fence to get a shot.

“In general, vaccine mandates work,” James Colgrove, a public health professor at Columbia University’s Mailman School of Public Health, told ABC News.

For decades, the United States has monitored the effectiveness of vaccine mandates in schools, he noted, which have successfully required shots against measles, mumps, and other illnesses that used to be widespread. Certain employees, such as hospital workers, must take vaccines for their jobs, he said, and those requirements have also been effective over the years.

“The more normalized it becomes, the more people [know] someone else who is vaccinated, the more people will comply,” he said. “With any vaccine, the longer it’s been around, the more people get with it.”

With the widespread and contagious nature of COVID-19, workplaces have been forced to consider vaccine mandates to protect their employees and prevent worker shortages, Dr. Colgrove said.

Some companies began to issue vaccine rules this summer as the Delta variant caused a jump in cases, hospitalizations, and deaths. Major companies, including Google, Tyson Foods, United Airlines, and the Walt Disney Company, required in-person employees to get a shot. So far, the results from those mandates have been strong, ABC News reported.

For instance, Tyson announced a mandate in August, when less than half of its 140,000 employees were vaccinated. When the deadline came at the end of October, more than 60,000 additional employees had been vaccinated, and the vaccination rate was 96%.

“Has this made a difference in the health and safety of our team members? Absolutely. We’ve seen a significant decline in the number of active cases companywide,” Donnie King, CEO and president of Tyson Foods, said in a statement.

United Airlines has also shared that 99.7% of its 67,000 employees are vaccinated. Within 48 hours of announcing its mandate, the number of unvaccinated staffers fell from 593 to 320 people, ABC News reported.

Vaccine mandates appear to be working in the public sector as well. State health department officials in Washington told ABC News that the percentage of public employees who were vaccinated jumped from 49% in September to 96% by the vaccine mandate deadline in October.

Vaccination rates have also increased in New York City, where some employees in the fire, police, and sanitation departments protested the mandate. By the deadline, vaccination rates shifted from less than 75% to 82% in the fire department, 86% in the police department, and 91% of EMS personnel, ABC News reported.

Overall, vaccine mandates tend to reach groups who aren’t completely against the vaccine, medical experts told the news outlet. A small percentage of the population truly opposes the shot, and in most cases, unvaccinated people are on the fence or haven’t seen good enough messaging for it.

“When you look at vaccine resistance, the people who are the most opposed often make a very large amount of noise that is at odds with the actual numbers who are against vaccination,” Dr. Colgrove said.

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

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While COVID-19 vaccine mandates have sparked lawsuits and protests, the data shows that they’re working and increasing vaccination rates.

Some organizations have reported vaccination rates that jumped from less than 50% to more than 90%, according to ABC News. Workplace mandates have especially encouraged employees who were on the fence to get a shot.

“In general, vaccine mandates work,” James Colgrove, a public health professor at Columbia University’s Mailman School of Public Health, told ABC News.

For decades, the United States has monitored the effectiveness of vaccine mandates in schools, he noted, which have successfully required shots against measles, mumps, and other illnesses that used to be widespread. Certain employees, such as hospital workers, must take vaccines for their jobs, he said, and those requirements have also been effective over the years.

“The more normalized it becomes, the more people [know] someone else who is vaccinated, the more people will comply,” he said. “With any vaccine, the longer it’s been around, the more people get with it.”

With the widespread and contagious nature of COVID-19, workplaces have been forced to consider vaccine mandates to protect their employees and prevent worker shortages, Dr. Colgrove said.

Some companies began to issue vaccine rules this summer as the Delta variant caused a jump in cases, hospitalizations, and deaths. Major companies, including Google, Tyson Foods, United Airlines, and the Walt Disney Company, required in-person employees to get a shot. So far, the results from those mandates have been strong, ABC News reported.

For instance, Tyson announced a mandate in August, when less than half of its 140,000 employees were vaccinated. When the deadline came at the end of October, more than 60,000 additional employees had been vaccinated, and the vaccination rate was 96%.

“Has this made a difference in the health and safety of our team members? Absolutely. We’ve seen a significant decline in the number of active cases companywide,” Donnie King, CEO and president of Tyson Foods, said in a statement.

United Airlines has also shared that 99.7% of its 67,000 employees are vaccinated. Within 48 hours of announcing its mandate, the number of unvaccinated staffers fell from 593 to 320 people, ABC News reported.

Vaccine mandates appear to be working in the public sector as well. State health department officials in Washington told ABC News that the percentage of public employees who were vaccinated jumped from 49% in September to 96% by the vaccine mandate deadline in October.

Vaccination rates have also increased in New York City, where some employees in the fire, police, and sanitation departments protested the mandate. By the deadline, vaccination rates shifted from less than 75% to 82% in the fire department, 86% in the police department, and 91% of EMS personnel, ABC News reported.

Overall, vaccine mandates tend to reach groups who aren’t completely against the vaccine, medical experts told the news outlet. A small percentage of the population truly opposes the shot, and in most cases, unvaccinated people are on the fence or haven’t seen good enough messaging for it.

“When you look at vaccine resistance, the people who are the most opposed often make a very large amount of noise that is at odds with the actual numbers who are against vaccination,” Dr. Colgrove said.

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

While COVID-19 vaccine mandates have sparked lawsuits and protests, the data shows that they’re working and increasing vaccination rates.

Some organizations have reported vaccination rates that jumped from less than 50% to more than 90%, according to ABC News. Workplace mandates have especially encouraged employees who were on the fence to get a shot.

“In general, vaccine mandates work,” James Colgrove, a public health professor at Columbia University’s Mailman School of Public Health, told ABC News.

For decades, the United States has monitored the effectiveness of vaccine mandates in schools, he noted, which have successfully required shots against measles, mumps, and other illnesses that used to be widespread. Certain employees, such as hospital workers, must take vaccines for their jobs, he said, and those requirements have also been effective over the years.

“The more normalized it becomes, the more people [know] someone else who is vaccinated, the more people will comply,” he said. “With any vaccine, the longer it’s been around, the more people get with it.”

With the widespread and contagious nature of COVID-19, workplaces have been forced to consider vaccine mandates to protect their employees and prevent worker shortages, Dr. Colgrove said.

Some companies began to issue vaccine rules this summer as the Delta variant caused a jump in cases, hospitalizations, and deaths. Major companies, including Google, Tyson Foods, United Airlines, and the Walt Disney Company, required in-person employees to get a shot. So far, the results from those mandates have been strong, ABC News reported.

For instance, Tyson announced a mandate in August, when less than half of its 140,000 employees were vaccinated. When the deadline came at the end of October, more than 60,000 additional employees had been vaccinated, and the vaccination rate was 96%.

“Has this made a difference in the health and safety of our team members? Absolutely. We’ve seen a significant decline in the number of active cases companywide,” Donnie King, CEO and president of Tyson Foods, said in a statement.

United Airlines has also shared that 99.7% of its 67,000 employees are vaccinated. Within 48 hours of announcing its mandate, the number of unvaccinated staffers fell from 593 to 320 people, ABC News reported.

Vaccine mandates appear to be working in the public sector as well. State health department officials in Washington told ABC News that the percentage of public employees who were vaccinated jumped from 49% in September to 96% by the vaccine mandate deadline in October.

Vaccination rates have also increased in New York City, where some employees in the fire, police, and sanitation departments protested the mandate. By the deadline, vaccination rates shifted from less than 75% to 82% in the fire department, 86% in the police department, and 91% of EMS personnel, ABC News reported.

Overall, vaccine mandates tend to reach groups who aren’t completely against the vaccine, medical experts told the news outlet. A small percentage of the population truly opposes the shot, and in most cases, unvaccinated people are on the fence or haven’t seen good enough messaging for it.

“When you look at vaccine resistance, the people who are the most opposed often make a very large amount of noise that is at odds with the actual numbers who are against vaccination,” Dr. Colgrove said.

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

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Step right up, folks, for a public dissection

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The greatest autopsy on Earth?

The LOTME staff would like to apologize in advance. The following item contains historical facts.

P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.

fstop123/E+

When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.

It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.

Oh wait.

David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.

Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.

P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
 

Go ahead, have that soda before math

We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?

©sjlocke/istock.com

You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.

Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.

This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
 

 

 

Chicken nuggets and the meat paradox

Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.

Liam: Vegetable!

Olivia: Meat!

Liam: Chicken nuggets are vegetables!

Olivia: No, dorkface! They’re meat.

Caregiver: Good news, kids. You’re both right.

Olivia: How can we both be right?

At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.

Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.

pxfuel

In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.

Olivia: Did our caregiver lie to us, Dr. Scientist?

Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.

Liam: What else did they say, Dr. Scientist?

Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.

Caregiver: How did you get in here anyway? And how do you know their names?

Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.

Bedtimes aren’t just for children

There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.

Tumisu/Pixabay

Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.

Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.

So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.

“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.

Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”

So bedtimes aren’t just for children.

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The greatest autopsy on Earth?

The LOTME staff would like to apologize in advance. The following item contains historical facts.

P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.

fstop123/E+

When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.

It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.

Oh wait.

David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.

Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.

P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
 

Go ahead, have that soda before math

We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?

©sjlocke/istock.com

You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.

Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.

This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
 

 

 

Chicken nuggets and the meat paradox

Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.

Liam: Vegetable!

Olivia: Meat!

Liam: Chicken nuggets are vegetables!

Olivia: No, dorkface! They’re meat.

Caregiver: Good news, kids. You’re both right.

Olivia: How can we both be right?

At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.

Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.

pxfuel

In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.

Olivia: Did our caregiver lie to us, Dr. Scientist?

Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.

Liam: What else did they say, Dr. Scientist?

Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.

Caregiver: How did you get in here anyway? And how do you know their names?

Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.

Bedtimes aren’t just for children

There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.

Tumisu/Pixabay

Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.

Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.

So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.

“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.

Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”

So bedtimes aren’t just for children.

 

The greatest autopsy on Earth?

The LOTME staff would like to apologize in advance. The following item contains historical facts.

P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.

fstop123/E+

When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.

It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.

Oh wait.

David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.

Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.

P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
 

Go ahead, have that soda before math

We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?

©sjlocke/istock.com

You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.

Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.

This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
 

 

 

Chicken nuggets and the meat paradox

Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.

Liam: Vegetable!

Olivia: Meat!

Liam: Chicken nuggets are vegetables!

Olivia: No, dorkface! They’re meat.

Caregiver: Good news, kids. You’re both right.

Olivia: How can we both be right?

At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.

Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.

pxfuel

In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.

Olivia: Did our caregiver lie to us, Dr. Scientist?

Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.

Liam: What else did they say, Dr. Scientist?

Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.

Caregiver: How did you get in here anyway? And how do you know their names?

Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.

Bedtimes aren’t just for children

There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.

Tumisu/Pixabay

Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.

Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.

So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.

“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.

Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”

So bedtimes aren’t just for children.

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mRNA COVID vaccine response found mostly robust in RA, SLE patients

Article Type
Changed
Thu, 11/11/2021 - 09:32

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.

Dr. Ines Colmegna

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.

Dr. Jeffrey Curtis

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.

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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.

Dr. Ines Colmegna

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.

Dr. Jeffrey Curtis

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.

Dr. Ines Colmegna

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.

Dr. Jeffrey Curtis

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.

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When a JAK inhibitor fails for a patient with RA, what’s next?

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Changed
Wed, 11/10/2021 - 16:47

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.

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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.

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Pfizer seeks EUA expansion for COVID-19 booster

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Wed, 11/10/2021 - 15:11

Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.

If the request is approved, the broader use of Pfizer boosters would be a step toward President Biden’s goal of boosters for all adults. He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.

This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.

However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.

The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.

The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.

The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
 

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

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Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.

If the request is approved, the broader use of Pfizer boosters would be a step toward President Biden’s goal of boosters for all adults. He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.

This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.

However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.

The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.

The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.

The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
 

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

Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.

If the request is approved, the broader use of Pfizer boosters would be a step toward President Biden’s goal of boosters for all adults. He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.

This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.

However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.

The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.

The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.

The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
 

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

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Should you tell your doctor that you’re a doctor?

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Fri, 12/03/2021 - 12:41

Should doctors seeking healthcare disclose that they are a doctor? 

The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”

She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”

The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.

“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.” 

“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.

“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”

Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:

“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.

Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”

“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.

Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.

For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”

@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”

Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”

Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.

“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.

Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”

Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”

Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.

“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.

To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.

Still others offered suggestions on how to broach the subject more directly when presenting as a patient:

‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.

@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”

A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.

“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.

Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”

That’s typically a sign that the Tweet is relatable for a lot of people, she said.

“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.

The debate begs the question: Is there a duty or ethical reason to disclose?

“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”

If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.

 

 

“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”

Knowing how to share the information is another story.

“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”

“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested. 

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

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Should doctors seeking healthcare disclose that they are a doctor? 

The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”

She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”

The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.

“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.” 

“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.

“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”

Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:

“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.

Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”

“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.

Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.

For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”

@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”

Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”

Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.

“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.

Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”

Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”

Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.

“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.

To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.

Still others offered suggestions on how to broach the subject more directly when presenting as a patient:

‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.

@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”

A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.

“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.

Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”

That’s typically a sign that the Tweet is relatable for a lot of people, she said.

“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.

The debate begs the question: Is there a duty or ethical reason to disclose?

“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”

If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.

 

 

“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”

Knowing how to share the information is another story.

“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”

“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested. 

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

Should doctors seeking healthcare disclose that they are a doctor? 

The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”

She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”

The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.

“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.” 

“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.

“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”

Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:

“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.

Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”

“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.

Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.

For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”

@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”

Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”

Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.

“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.

Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”

Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”

Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.

“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.

To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.

Still others offered suggestions on how to broach the subject more directly when presenting as a patient:

‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.

@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”

A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.

“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.

Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”

That’s typically a sign that the Tweet is relatable for a lot of people, she said.

“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.

The debate begs the question: Is there a duty or ethical reason to disclose?

“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”

If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.

 

 

“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”

Knowing how to share the information is another story.

“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”

“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested. 

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

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Unvaccinated people 20 times more likely to die from COVID: Texas study

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Changed
Wed, 11/10/2021 - 12:25

During the month of September, Texans who weren’t vaccinated against COVID-19 were 20 times more likely to die from COVID-19 and related complications than those who were fully vaccinated, according to a new study from the Texas Department of State Health Services.

The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.

“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.

“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”

As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.

The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.

In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.

Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.

“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”

About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.

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

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During the month of September, Texans who weren’t vaccinated against COVID-19 were 20 times more likely to die from COVID-19 and related complications than those who were fully vaccinated, according to a new study from the Texas Department of State Health Services.

The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.

“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.

“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”

As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.

The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.

In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.

Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.

“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”

About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.

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

During the month of September, Texans who weren’t vaccinated against COVID-19 were 20 times more likely to die from COVID-19 and related complications than those who were fully vaccinated, according to a new study from the Texas Department of State Health Services.

The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.

“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.

“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”

As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.

The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.

In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.

Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.

“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”

About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.

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

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Drug combo at outset of polyarticular JIA benefits patients most

Article Type
Changed
Wed, 11/10/2021 - 10:37

Initiating treatment of polyarticular juvenile idiopathic arthritis (polyJIA) with both a conventional synthetic disease-modifying antirheumatic drug and a biologic DMARD resulted in more patients achieving clinical inactive disease 2 years later than did starting with only a csDMARD and stepping up to a biologic, according to data presented at the virtual annual meeting of the American College of Rheumatology.

Dr. Yukiko Kimura

“The 24-month results support the 12-month primary results that suggested that the early-combination group was superior and that, at 24 months, more early combination CTP [consensus treatment plan] patients achieve CID [clinical inactive disease], compared to step up,” Yukiko Kimura, MD, division chief of pediatric rheumatology at HMH Hackensack (N.J.) University Medical Center, told attendees. “This suggests that starting biologics early in polyJIA may lead to better long-term outcomes in many patients.”

Dr. Kimura noted that polyarticular JIA patients are already at risk for poor outcomes, and initial therapy can especially impact outcomes. Further, little evidence exists to suggest when the best time is to start biologics, a gap this study aimed to address.

Diane Brown, MD, PhD, a pediatric rheumatologist at Children’s Hospital Los Angeles who was not involved in the study, was pleased to see the results, which she said support her own preferences and practice patterns.

“Starting sooner with combination therapy, taking advantage of the advances with biologics and our long history with methotrexate at the same time, gives better outcomes for the long run,” Dr. Brown said in an interview. “Having studies like this to back up my own recommendations can be very powerful when talking to families, and it is absolutely invaluable when battling with insurance companies who always want you to take the cheapest road.”
 

Study details

The findings were an update of 12-month results in the CARRA STOP-JIA study that enrolled 400 untreated patients with polyJIA and compared three Childhood Arthritis and Rheumatology Research Alliance (CARRA) CTPs. Overall, 49.5% of participants received biologics within 3 months of starting the study. For these updated results, 275 participants had complete data at 24 months for the three CTPs:

  • A step-up group of 177 patients who started therapy with a csDMARD and added a biologic if needed at least 3 months later
  • An early-combination group of 73 patients who started therapy with a csDMARD and biologic together
  • A biologic-first group of 25 patients who started with biologic monotherapy, adding a csDMARD only if needed at least 3 months later.

The primary outcome was the percentage of participants who reached CID without taking glucocorticoids at 24 months. Since the participants were not randomized, the researchers made adjustments to account for baseline differences between the groups, including differences in JIA categories, number of active joints, physician global assessment of disease activity, and the clinical Juvenile Arthritis Disease Activity Score based on 10 joints (cJADAS10).

At 24 months in an intention to treat analysis, 59.4% of the early-combination group had achieved CID, compared with 48% of the biologic-first group and 40.1% of the step-up group (P = .009 for early combination vs. step up). All three groups had improved since the 12-month time point, when 37% of the early-combination group, 24% of the biologic-first group, and 32% of the step-up group had reached CID.

There were no significant differences between the groups in secondary outcomes of achieving cJADAS10 inactive disease of 2.5 or less or 70% improvement in pediatric ACR response criteria at 24 months. All groups improved in PROMIS pain interference or mobility measures from baseline. Most of the 17 severe adverse events were infections.
 

 

 

Moving from step-up therapy to early-combination treatment

Dr. Brown said that she spent many years in her practice using the step-up therapy because it was difficult to get insurance companies to pay for biologics without first showing that methotrexate was insufficient.

”But methotrexate takes so long to control the disease that you need a lot of steroids, with all of their side effects, at least temporarily, or you must simply accept a longer period of active and symptomatic disease before you get to that desired state of clinically inactive disease,” Dr. Brown said. “And during that time, you can be accumulating what may be permanent damage to joints, as well as increase in risk of contractures and deconditioning for that child who is too uncomfortable to move and exercise and play normally.”

Dr. Brown is also wary of using a biologic as an initial therapy by itself because the actions of biologics are so specific. ”I like to back up the powerful, rapid, and specific actions of a biologic with the broader, if slower, action of methotrexate to minimize chances that the immune system is going to find a way around blockade of a single cytokine by your biologic,” she said.

While patient preference will also play a role in what CTP patients with polyJIA start with, Dr. Brown said that she believes more medication upfront can result in less medication and better outcomes in the long run, as the findings of this study suggest. The results here are helpful when speaking with families who are anxious about “so much medicine” or “such powerful medicines,” she said. ”I hope it will also help ease the fears of other providers who share the same concerns about ‘so much medicine.’ ”



The study’s biggest limitation is not being a randomized, controlled trial, but Dr. Brown said the researchers demonstrated effectively that the disease burden remains similar across the groups at baseline.

”It would also be useful to have a clear breakdown of adverse events and opportunistic infections because an excess of opportunistic infections would be a key concern with early combination therapy,” she said, although she added that the study overall was a ”beautiful example of the value of registry data.”

Dr. Kimura emphasized that polyJIA remains a challenging disease to treat, with 40%-60% of participants not reaching CID at 24 months. The registry follow-up will continue for up to 10 years to hopefully provide more information about longer-term outcomes from different treatments.

The research was funded by a grant from Genentech to CARRA. Dr. Kimura reported royalties from UpToDate and salary support from CARRA. Dr. Brown had no disclosures.

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Initiating treatment of polyarticular juvenile idiopathic arthritis (polyJIA) with both a conventional synthetic disease-modifying antirheumatic drug and a biologic DMARD resulted in more patients achieving clinical inactive disease 2 years later than did starting with only a csDMARD and stepping up to a biologic, according to data presented at the virtual annual meeting of the American College of Rheumatology.

Dr. Yukiko Kimura

“The 24-month results support the 12-month primary results that suggested that the early-combination group was superior and that, at 24 months, more early combination CTP [consensus treatment plan] patients achieve CID [clinical inactive disease], compared to step up,” Yukiko Kimura, MD, division chief of pediatric rheumatology at HMH Hackensack (N.J.) University Medical Center, told attendees. “This suggests that starting biologics early in polyJIA may lead to better long-term outcomes in many patients.”

Dr. Kimura noted that polyarticular JIA patients are already at risk for poor outcomes, and initial therapy can especially impact outcomes. Further, little evidence exists to suggest when the best time is to start biologics, a gap this study aimed to address.

Diane Brown, MD, PhD, a pediatric rheumatologist at Children’s Hospital Los Angeles who was not involved in the study, was pleased to see the results, which she said support her own preferences and practice patterns.

“Starting sooner with combination therapy, taking advantage of the advances with biologics and our long history with methotrexate at the same time, gives better outcomes for the long run,” Dr. Brown said in an interview. “Having studies like this to back up my own recommendations can be very powerful when talking to families, and it is absolutely invaluable when battling with insurance companies who always want you to take the cheapest road.”
 

Study details

The findings were an update of 12-month results in the CARRA STOP-JIA study that enrolled 400 untreated patients with polyJIA and compared three Childhood Arthritis and Rheumatology Research Alliance (CARRA) CTPs. Overall, 49.5% of participants received biologics within 3 months of starting the study. For these updated results, 275 participants had complete data at 24 months for the three CTPs:

  • A step-up group of 177 patients who started therapy with a csDMARD and added a biologic if needed at least 3 months later
  • An early-combination group of 73 patients who started therapy with a csDMARD and biologic together
  • A biologic-first group of 25 patients who started with biologic monotherapy, adding a csDMARD only if needed at least 3 months later.

The primary outcome was the percentage of participants who reached CID without taking glucocorticoids at 24 months. Since the participants were not randomized, the researchers made adjustments to account for baseline differences between the groups, including differences in JIA categories, number of active joints, physician global assessment of disease activity, and the clinical Juvenile Arthritis Disease Activity Score based on 10 joints (cJADAS10).

At 24 months in an intention to treat analysis, 59.4% of the early-combination group had achieved CID, compared with 48% of the biologic-first group and 40.1% of the step-up group (P = .009 for early combination vs. step up). All three groups had improved since the 12-month time point, when 37% of the early-combination group, 24% of the biologic-first group, and 32% of the step-up group had reached CID.

There were no significant differences between the groups in secondary outcomes of achieving cJADAS10 inactive disease of 2.5 or less or 70% improvement in pediatric ACR response criteria at 24 months. All groups improved in PROMIS pain interference or mobility measures from baseline. Most of the 17 severe adverse events were infections.
 

 

 

Moving from step-up therapy to early-combination treatment

Dr. Brown said that she spent many years in her practice using the step-up therapy because it was difficult to get insurance companies to pay for biologics without first showing that methotrexate was insufficient.

”But methotrexate takes so long to control the disease that you need a lot of steroids, with all of their side effects, at least temporarily, or you must simply accept a longer period of active and symptomatic disease before you get to that desired state of clinically inactive disease,” Dr. Brown said. “And during that time, you can be accumulating what may be permanent damage to joints, as well as increase in risk of contractures and deconditioning for that child who is too uncomfortable to move and exercise and play normally.”

Dr. Brown is also wary of using a biologic as an initial therapy by itself because the actions of biologics are so specific. ”I like to back up the powerful, rapid, and specific actions of a biologic with the broader, if slower, action of methotrexate to minimize chances that the immune system is going to find a way around blockade of a single cytokine by your biologic,” she said.

While patient preference will also play a role in what CTP patients with polyJIA start with, Dr. Brown said that she believes more medication upfront can result in less medication and better outcomes in the long run, as the findings of this study suggest. The results here are helpful when speaking with families who are anxious about “so much medicine” or “such powerful medicines,” she said. ”I hope it will also help ease the fears of other providers who share the same concerns about ‘so much medicine.’ ”



The study’s biggest limitation is not being a randomized, controlled trial, but Dr. Brown said the researchers demonstrated effectively that the disease burden remains similar across the groups at baseline.

”It would also be useful to have a clear breakdown of adverse events and opportunistic infections because an excess of opportunistic infections would be a key concern with early combination therapy,” she said, although she added that the study overall was a ”beautiful example of the value of registry data.”

Dr. Kimura emphasized that polyJIA remains a challenging disease to treat, with 40%-60% of participants not reaching CID at 24 months. The registry follow-up will continue for up to 10 years to hopefully provide more information about longer-term outcomes from different treatments.

The research was funded by a grant from Genentech to CARRA. Dr. Kimura reported royalties from UpToDate and salary support from CARRA. Dr. Brown had no disclosures.

Initiating treatment of polyarticular juvenile idiopathic arthritis (polyJIA) with both a conventional synthetic disease-modifying antirheumatic drug and a biologic DMARD resulted in more patients achieving clinical inactive disease 2 years later than did starting with only a csDMARD and stepping up to a biologic, according to data presented at the virtual annual meeting of the American College of Rheumatology.

Dr. Yukiko Kimura

“The 24-month results support the 12-month primary results that suggested that the early-combination group was superior and that, at 24 months, more early combination CTP [consensus treatment plan] patients achieve CID [clinical inactive disease], compared to step up,” Yukiko Kimura, MD, division chief of pediatric rheumatology at HMH Hackensack (N.J.) University Medical Center, told attendees. “This suggests that starting biologics early in polyJIA may lead to better long-term outcomes in many patients.”

Dr. Kimura noted that polyarticular JIA patients are already at risk for poor outcomes, and initial therapy can especially impact outcomes. Further, little evidence exists to suggest when the best time is to start biologics, a gap this study aimed to address.

Diane Brown, MD, PhD, a pediatric rheumatologist at Children’s Hospital Los Angeles who was not involved in the study, was pleased to see the results, which she said support her own preferences and practice patterns.

“Starting sooner with combination therapy, taking advantage of the advances with biologics and our long history with methotrexate at the same time, gives better outcomes for the long run,” Dr. Brown said in an interview. “Having studies like this to back up my own recommendations can be very powerful when talking to families, and it is absolutely invaluable when battling with insurance companies who always want you to take the cheapest road.”
 

Study details

The findings were an update of 12-month results in the CARRA STOP-JIA study that enrolled 400 untreated patients with polyJIA and compared three Childhood Arthritis and Rheumatology Research Alliance (CARRA) CTPs. Overall, 49.5% of participants received biologics within 3 months of starting the study. For these updated results, 275 participants had complete data at 24 months for the three CTPs:

  • A step-up group of 177 patients who started therapy with a csDMARD and added a biologic if needed at least 3 months later
  • An early-combination group of 73 patients who started therapy with a csDMARD and biologic together
  • A biologic-first group of 25 patients who started with biologic monotherapy, adding a csDMARD only if needed at least 3 months later.

The primary outcome was the percentage of participants who reached CID without taking glucocorticoids at 24 months. Since the participants were not randomized, the researchers made adjustments to account for baseline differences between the groups, including differences in JIA categories, number of active joints, physician global assessment of disease activity, and the clinical Juvenile Arthritis Disease Activity Score based on 10 joints (cJADAS10).

At 24 months in an intention to treat analysis, 59.4% of the early-combination group had achieved CID, compared with 48% of the biologic-first group and 40.1% of the step-up group (P = .009 for early combination vs. step up). All three groups had improved since the 12-month time point, when 37% of the early-combination group, 24% of the biologic-first group, and 32% of the step-up group had reached CID.

There were no significant differences between the groups in secondary outcomes of achieving cJADAS10 inactive disease of 2.5 or less or 70% improvement in pediatric ACR response criteria at 24 months. All groups improved in PROMIS pain interference or mobility measures from baseline. Most of the 17 severe adverse events were infections.
 

 

 

Moving from step-up therapy to early-combination treatment

Dr. Brown said that she spent many years in her practice using the step-up therapy because it was difficult to get insurance companies to pay for biologics without first showing that methotrexate was insufficient.

”But methotrexate takes so long to control the disease that you need a lot of steroids, with all of their side effects, at least temporarily, or you must simply accept a longer period of active and symptomatic disease before you get to that desired state of clinically inactive disease,” Dr. Brown said. “And during that time, you can be accumulating what may be permanent damage to joints, as well as increase in risk of contractures and deconditioning for that child who is too uncomfortable to move and exercise and play normally.”

Dr. Brown is also wary of using a biologic as an initial therapy by itself because the actions of biologics are so specific. ”I like to back up the powerful, rapid, and specific actions of a biologic with the broader, if slower, action of methotrexate to minimize chances that the immune system is going to find a way around blockade of a single cytokine by your biologic,” she said.

While patient preference will also play a role in what CTP patients with polyJIA start with, Dr. Brown said that she believes more medication upfront can result in less medication and better outcomes in the long run, as the findings of this study suggest. The results here are helpful when speaking with families who are anxious about “so much medicine” or “such powerful medicines,” she said. ”I hope it will also help ease the fears of other providers who share the same concerns about ‘so much medicine.’ ”



The study’s biggest limitation is not being a randomized, controlled trial, but Dr. Brown said the researchers demonstrated effectively that the disease burden remains similar across the groups at baseline.

”It would also be useful to have a clear breakdown of adverse events and opportunistic infections because an excess of opportunistic infections would be a key concern with early combination therapy,” she said, although she added that the study overall was a ”beautiful example of the value of registry data.”

Dr. Kimura emphasized that polyJIA remains a challenging disease to treat, with 40%-60% of participants not reaching CID at 24 months. The registry follow-up will continue for up to 10 years to hopefully provide more information about longer-term outcomes from different treatments.

The research was funded by a grant from Genentech to CARRA. Dr. Kimura reported royalties from UpToDate and salary support from CARRA. Dr. Brown had no disclosures.

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Statins’ effects on CVD outweigh risk for diabetes in RA

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Tue, 05/03/2022 - 15:03

The use of statins by patients with rheumatoid arthritis appears to provide an overall net benefit on cardiovascular disease outcomes that outweighs the risk of type 2 diabetes mellitus (T2DM) seen with the drugs in the general population, according to evidence from a cohort study of more than 16,000 people in the United Kingdom that was presented at the virtual annual meeting of the American College of Rheumatology.

Dr. Gulsen Ozen

“Our study emphasizes that RA patients should be assessed for statin initiation to improve CVD risk,” lead study author Gulsen Ozen, MD, a third-year resident at the University of Nebraska, Omaha, said in an interview. Because the risk of T2DM with statin use is no worse in patients with RA than in the general population, statin initiation “is actually a great opportunity to address the risk factors for T2DM such as activity and exercise, obesity and weight loss, and [use of glucocorticoids], which have other important health effects,” she said.

“Also, importantly, even if [patients] develop T2DM, statins still work on CVD and mortality outcomes as in patients without diabetes,” Dr. Ozen added. “Given all, the benefits of statins way outweigh the hazards.”

Dr. Ozen said this was the first large cohort study to evaluate CVD mortality and T2DM risks with statins in patients with RA, a claim with which rheumatologist Elena Myasoedova, MD, PhD, of the Mayo Clinic in Rochester, Minn., concurred.

Dr. Elena Myasoedova

Dr. Myasoedova, professor of rheumatology and epidemiology at Mayo, said in an interview that the study was “methodologically rigorous” using time-conditional propensity score (TCPS) matching and a prevalent new-user design, “thus addressing the immortal time bias” found in the design of studies in which patients enter a cohort but do not start a treatment before developing the outcome of interest and are assigned to the untreated group or when the period of delay from when patients enter the cohort to when they are treated is excluded from the analysis. An earlier study from the same authors did not use TCPS matching, she said.

“The study findings suggest that patients with RA can benefit from statin use in terms of CVD outcomes and mortality but physicians should use vigilance regarding increased T2DM risk and discuss this possibility with patients,” Dr. Myasoedova said. “Identifying patients who are at higher risk of developing T2DM after statin initiation would be important to personalize the approach to statin therapy.”
 

Study details

The study accessed records from the U.K. Clinical Practice Research Datalink and linked Hospital Episode Statistics and Office of National Statistics databases. It analyzed adult patients with RA who were diagnosed during 1989-2018 in two cohorts: One for CVD and all-cause mortality, consisting of 1,768 statin initiators and 3,528 TCPS-matched nonusers; and a T2DM cohort with 3,608 statin initiators and 7,208 TCPS-matched nonusers.

In the entire cohort, statin use was associated with a 32% reduction in CV events (composite endpoint of the nonfatal or fatal MI, stroke, hospitalized heart failure, or CVD mortality), a 54% reduction in all-cause mortality, and a 33% increase in risk for T2DM, Dr. Ozen said. Results were similar in both sexes, although CV event reduction with statins in men did not reach statistical significance, likely because of a smaller sample size, she said.

Patients with and without a history of CVD had a similar reduction in CV events and all-cause mortality, and risk for T2DM increased with statins, but the latter reached statistical significance only in patients without a history of CVD, Dr. Ozen said.

Patients with RA who are at risk for T2DM and who are taking statins require blood glucose monitoring, which is typically done in patients with RA on disease-modifying antirheumatic drugs, and hemoglobin A1c testing when glucose levels are impaired, she said. “Any concerns for T2DM would be also communicated by the primary care providers of the patients to initiate further assessment and management,” she said.

But Dr. Ozen noted that confusion exists among primary care physicians and rheumatologists about who’s responsible for prescribing statins in these patients. “I would like to remind you that instead of assigning this role to a certain specialty, just good communication could improve this care gap of statin underutilization in RA,” she said. “Also, for rheumatologists, given that all-cause mortality reduction with statins was as high as CV event reduction, statins may be reducing other causes of mortality through improving disease activity.”

Bristol-Myers Squibb provided funding for the study. Dr. Ozen and Dr. Myasoedova have no relevant disclosures.

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The use of statins by patients with rheumatoid arthritis appears to provide an overall net benefit on cardiovascular disease outcomes that outweighs the risk of type 2 diabetes mellitus (T2DM) seen with the drugs in the general population, according to evidence from a cohort study of more than 16,000 people in the United Kingdom that was presented at the virtual annual meeting of the American College of Rheumatology.

Dr. Gulsen Ozen

“Our study emphasizes that RA patients should be assessed for statin initiation to improve CVD risk,” lead study author Gulsen Ozen, MD, a third-year resident at the University of Nebraska, Omaha, said in an interview. Because the risk of T2DM with statin use is no worse in patients with RA than in the general population, statin initiation “is actually a great opportunity to address the risk factors for T2DM such as activity and exercise, obesity and weight loss, and [use of glucocorticoids], which have other important health effects,” she said.

“Also, importantly, even if [patients] develop T2DM, statins still work on CVD and mortality outcomes as in patients without diabetes,” Dr. Ozen added. “Given all, the benefits of statins way outweigh the hazards.”

Dr. Ozen said this was the first large cohort study to evaluate CVD mortality and T2DM risks with statins in patients with RA, a claim with which rheumatologist Elena Myasoedova, MD, PhD, of the Mayo Clinic in Rochester, Minn., concurred.

Dr. Elena Myasoedova

Dr. Myasoedova, professor of rheumatology and epidemiology at Mayo, said in an interview that the study was “methodologically rigorous” using time-conditional propensity score (TCPS) matching and a prevalent new-user design, “thus addressing the immortal time bias” found in the design of studies in which patients enter a cohort but do not start a treatment before developing the outcome of interest and are assigned to the untreated group or when the period of delay from when patients enter the cohort to when they are treated is excluded from the analysis. An earlier study from the same authors did not use TCPS matching, she said.

“The study findings suggest that patients with RA can benefit from statin use in terms of CVD outcomes and mortality but physicians should use vigilance regarding increased T2DM risk and discuss this possibility with patients,” Dr. Myasoedova said. “Identifying patients who are at higher risk of developing T2DM after statin initiation would be important to personalize the approach to statin therapy.”
 

Study details

The study accessed records from the U.K. Clinical Practice Research Datalink and linked Hospital Episode Statistics and Office of National Statistics databases. It analyzed adult patients with RA who were diagnosed during 1989-2018 in two cohorts: One for CVD and all-cause mortality, consisting of 1,768 statin initiators and 3,528 TCPS-matched nonusers; and a T2DM cohort with 3,608 statin initiators and 7,208 TCPS-matched nonusers.

In the entire cohort, statin use was associated with a 32% reduction in CV events (composite endpoint of the nonfatal or fatal MI, stroke, hospitalized heart failure, or CVD mortality), a 54% reduction in all-cause mortality, and a 33% increase in risk for T2DM, Dr. Ozen said. Results were similar in both sexes, although CV event reduction with statins in men did not reach statistical significance, likely because of a smaller sample size, she said.

Patients with and without a history of CVD had a similar reduction in CV events and all-cause mortality, and risk for T2DM increased with statins, but the latter reached statistical significance only in patients without a history of CVD, Dr. Ozen said.

Patients with RA who are at risk for T2DM and who are taking statins require blood glucose monitoring, which is typically done in patients with RA on disease-modifying antirheumatic drugs, and hemoglobin A1c testing when glucose levels are impaired, she said. “Any concerns for T2DM would be also communicated by the primary care providers of the patients to initiate further assessment and management,” she said.

But Dr. Ozen noted that confusion exists among primary care physicians and rheumatologists about who’s responsible for prescribing statins in these patients. “I would like to remind you that instead of assigning this role to a certain specialty, just good communication could improve this care gap of statin underutilization in RA,” she said. “Also, for rheumatologists, given that all-cause mortality reduction with statins was as high as CV event reduction, statins may be reducing other causes of mortality through improving disease activity.”

Bristol-Myers Squibb provided funding for the study. Dr. Ozen and Dr. Myasoedova have no relevant disclosures.

The use of statins by patients with rheumatoid arthritis appears to provide an overall net benefit on cardiovascular disease outcomes that outweighs the risk of type 2 diabetes mellitus (T2DM) seen with the drugs in the general population, according to evidence from a cohort study of more than 16,000 people in the United Kingdom that was presented at the virtual annual meeting of the American College of Rheumatology.

Dr. Gulsen Ozen

“Our study emphasizes that RA patients should be assessed for statin initiation to improve CVD risk,” lead study author Gulsen Ozen, MD, a third-year resident at the University of Nebraska, Omaha, said in an interview. Because the risk of T2DM with statin use is no worse in patients with RA than in the general population, statin initiation “is actually a great opportunity to address the risk factors for T2DM such as activity and exercise, obesity and weight loss, and [use of glucocorticoids], which have other important health effects,” she said.

“Also, importantly, even if [patients] develop T2DM, statins still work on CVD and mortality outcomes as in patients without diabetes,” Dr. Ozen added. “Given all, the benefits of statins way outweigh the hazards.”

Dr. Ozen said this was the first large cohort study to evaluate CVD mortality and T2DM risks with statins in patients with RA, a claim with which rheumatologist Elena Myasoedova, MD, PhD, of the Mayo Clinic in Rochester, Minn., concurred.

Dr. Elena Myasoedova

Dr. Myasoedova, professor of rheumatology and epidemiology at Mayo, said in an interview that the study was “methodologically rigorous” using time-conditional propensity score (TCPS) matching and a prevalent new-user design, “thus addressing the immortal time bias” found in the design of studies in which patients enter a cohort but do not start a treatment before developing the outcome of interest and are assigned to the untreated group or when the period of delay from when patients enter the cohort to when they are treated is excluded from the analysis. An earlier study from the same authors did not use TCPS matching, she said.

“The study findings suggest that patients with RA can benefit from statin use in terms of CVD outcomes and mortality but physicians should use vigilance regarding increased T2DM risk and discuss this possibility with patients,” Dr. Myasoedova said. “Identifying patients who are at higher risk of developing T2DM after statin initiation would be important to personalize the approach to statin therapy.”
 

Study details

The study accessed records from the U.K. Clinical Practice Research Datalink and linked Hospital Episode Statistics and Office of National Statistics databases. It analyzed adult patients with RA who were diagnosed during 1989-2018 in two cohorts: One for CVD and all-cause mortality, consisting of 1,768 statin initiators and 3,528 TCPS-matched nonusers; and a T2DM cohort with 3,608 statin initiators and 7,208 TCPS-matched nonusers.

In the entire cohort, statin use was associated with a 32% reduction in CV events (composite endpoint of the nonfatal or fatal MI, stroke, hospitalized heart failure, or CVD mortality), a 54% reduction in all-cause mortality, and a 33% increase in risk for T2DM, Dr. Ozen said. Results were similar in both sexes, although CV event reduction with statins in men did not reach statistical significance, likely because of a smaller sample size, she said.

Patients with and without a history of CVD had a similar reduction in CV events and all-cause mortality, and risk for T2DM increased with statins, but the latter reached statistical significance only in patients without a history of CVD, Dr. Ozen said.

Patients with RA who are at risk for T2DM and who are taking statins require blood glucose monitoring, which is typically done in patients with RA on disease-modifying antirheumatic drugs, and hemoglobin A1c testing when glucose levels are impaired, she said. “Any concerns for T2DM would be also communicated by the primary care providers of the patients to initiate further assessment and management,” she said.

But Dr. Ozen noted that confusion exists among primary care physicians and rheumatologists about who’s responsible for prescribing statins in these patients. “I would like to remind you that instead of assigning this role to a certain specialty, just good communication could improve this care gap of statin underutilization in RA,” she said. “Also, for rheumatologists, given that all-cause mortality reduction with statins was as high as CV event reduction, statins may be reducing other causes of mortality through improving disease activity.”

Bristol-Myers Squibb provided funding for the study. Dr. Ozen and Dr. Myasoedova have no relevant disclosures.

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