Rheumatology

A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

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

A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

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

A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

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

PHILADELPHIA – New rheumatology fellowships in underserved areas. Rheumatology training for nonspecialists. Telemedicine training, tools, and resources. These are a few of the remedies the American College of Rheumatology’s new Workforce Solutions Committee has concocted to address a shrinking U.S. rheumatology workforce in the face of a rising population of patients with rheumatologic diseases.

In two sessions at the ACR’s annual meeting, committee members provided insights on current workforce projections since the most recent ACR workforce study in 2015. They also outlined the 1-year-old committee’s response to bridge the looming gap in patient care. Some projects are already underway, while others have yet to be implemented and require sustained monetary and project coordination commitments to make their impacts felt across the targeted regions.

Jeff Evans/MDedge News

“At the current pace of physician departures from the workforce, even with fellows graduating from adult and pediatric rheumatology training programs, the subspecialty cannot be sustained,” said Daniel Battafarano, DO, chair of the Workforce Solution Committee, professor of medicine at the Uniformed Services University of the Health Sciences, Bethesda, Md., and adjunct professor at the University of Texas Health Science Center, San Antonio.

The Northwest is an example of the problem at hand. “For an adult, there’s 1.65 rheumatologists per 100,000 in 2015. In 2025, there’s going to be 0.5 [adult] rheumatologists per 100,000. That’s a problem. If you look at every region in the United States, every single region is decrementing significantly,” he said.

Even the Northeast, which boasted 3.07 adult rheumatologists per 100,000 in 2015, will drop to 1.61 in 2025. Other regions are much worse off. The Southwest will drop from 1.28 to 0.64, and North Central will drop from 1.64 to 0.69, projections show.

The situation for pediatrics “has been in a crisis since 2015,” Dr. Battafarano said. It is much worse off than the situation for adult rheumatology, with 2015 figures going from 0.17 to 0.20 in the Southwest and from 0.03 to 0.04 in the South Central region by 2025, and in the Northwest from 0.67 to 0.13 and Northeast from 0.83 to 0.16.

“The ill effects of the pandemic are immeasurable to this point, but anecdotally we know we lost colleagues to part-time employment, we saw early retirements, and that happened across the full spectrum of the United States,” he said. It’s possible that up to 10% of full-time equivalents of physicians left practice in the United States since the pandemic began.

Rheumatologists largely practice in the 392 U.S. metropolitan statistical areas (MSAs), which are defined as a “core area containing a substantial population nucleus, together with adjacent communities having a high degree of economic and social integration with that core.” The smallest MSA has nearly 59,000 people. This distribution leaves many people in the Northwest, Southwest, South Central, and North Central regions with few rheumatologists. Over 86% of locations where rheumatologists train and work are in MSAs.

“By definition, if you get into a region where there’s 60,000 people or less, you can’t support a rheumatologist,” Dr. Battafarano said. He also noted that all pediatric hospitals tend to be in dense MSAs where rheumatologists might be.
 

South Central region serves as an example

People in certain MSAs of the South Central region (Oklahoma, Texas, Arkansas) such as Laredo, Tex., population 281,805 – where there is no adult rheumatologist – have to drive nearly 2.5 hours to the nearest well-served MSA (San Antonio) where there is a rheumatology fellowship program and medical school.

“Texas may have rheumatologists, but it depends on where you live,” Dr. Battafarano said. “The same applies to Waco, Texas; Texarkana, Arkansas; Lawton, Oklahoma; Pine Bluff, Arkansas; and Enid, Oklahoma, and you can see the range of traveling is between 45 minutes and 2.5 hours. That’s adult rheumatology.”

People in Laredo have an even longer drive to find a pediatric rheumatologist. In pediatrics, he said, “we don’t even look at towns, we look at pediatrics by state. You can see there’s a pediatric fellowship program in Dallas, and there’s one in Houston. There’s one or two [pediatric] rheumatologists in Austin. It just depends on how quickly they burn out and how long they stay. I’m in San Antonio. We don’t have a pediatric rheumatologist in San Antonio, the seventh-largest city in the United States.”

Pediatric rheumatologists are very often found where fellowship programs are located. “Ninety-five percent or greater of pediatric rheumatologists are housed in a pediatric hospital,” Dr. Battafarano said. “There are very few adult rheumatologists who see children, for a variety of reasons.”

In a panel discussion and question-and-answer session that took place after Dr. Battafarano outlined concerns with the numbers and distribution of rheumatologists across the United States, committee member Beth Jonas, MD, professor of medicine and chief of the division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, noted that the rheumatology specialty match is competitive and typically leaves close to 100 residents who had rheumatology as their first choice without a match because there are not enough fellowship positions for them to fill.

The Workforce Solutions Committee hopes to reduce this “bottleneck,” she said, by identifying institutions that are ripe for opening new fellowship programs or have existing programs that can expand their number of positions, as well as expanding musculoskeletal training among nonrheumatologists, such as primary care physicians, advanced practice providers, and sports medicine physicians.

“I think that we’re going to find ourselves needing to be more creative as we become overcome with events with shortages of physicians,” Dr. Battafarano said. He gave an example of a recent pediatric rheumatology fellow in Seattle who wanted to go back home to Montana to practice. At the same time, the pediatric program wanted her to become a faculty member, so they said they would bridge their program to her, rotating fellows and covering her while on vacation.

“That’s an example of a pediatric program spreading its wings,” he said. “I think that we need to think that way, whether we talk about urban, suburban, rural. It’s how can we stage rheumatologists in areas, how can we embrace our primary care providers, and have rheumatology health care teams so that we have rheumatology expertise located within arm’s length but also within telemedicine length.”
 

Interventions for 2023

As part of a report on the activities of the Workforce Solutions Committee, Dr. Jonas outlined a number of interventions that the ACR is set to launch in 2023. The committee created five intervention teams to support fellowship positions and training providers, recruitment opportunities, fostering patient-centered communities, virtual training programs, and grants for research and training. The ACR’s initial pilot interventions are focused on, but not limited to, the Northwest, Southwest, and South Central regions.

The committee identified 10 potential partner institutions to develop new fellowship programs in the Northwest, Southwest, and South Central regions: University of Nevada, Las Vegas; Texas Tech University Permian Basin Program; Baylor Scott and White Medical Center Round Rock (Tex.) Program; Texas Tech University Health Science Center El Paso Program; University of Texas at Austin Dell Medical School Program; Abrazo Health Network Program in Arizona; University of Arizona Phoenix Program; University of Arkansas (pediatric program); Oklahoma State University; and University of Texas, San Antonio (pediatric program).

Dr. Jonas explained that opening new programs in these underserved areas should help establish new rheumatologists in these areas, because studies have shown that fellows tend to stay within 100-200 miles of where they trained.

In addition to starting new programs, “if you want to grow your program, if you want to add another fellow, we can support that,” Dr. Jonas said.

To help convince institutions of the value of rheumatology care, a position paper will soon be released by the ACR that outlines the benefits of the specialty to a health care system. The paper will describe an annual preventive cost savings of $2,762 per patient who is in the care of a rheumatologist and an annual direct or downstream income of $3.5 million per rheumatologist in a community, committee members said.

To help with recruitment and retention efforts, the ACR will revise its CareerConnection website to make it more useful.

To help in developing patient-centered communities of care, there will be a discussion series with payers on topics such as access, care delivery, and financing, in which 12 payers (including Blue Cross Blue Shield, Aetna, UnitedHealthcare, and Kaiser) will discuss patient access, cost, and quality measures. An in-person payer summit is also scheduled for 2023.

Interventions to enhance rheumatology care will also keep an ongoing focus on virtual training programs for primary care physicians and advanced practice providers, including a Project ECHO (Extension for Community Healthcare Outcomes) virtual lecture and case-based training and mentoring series for nonrheumatologists, an online library of searchable topics targeted to nonrheumatologists, as well as a grand rounds podcast series on certain rheumatic diseases for residents in family medicine, internal medicine, and pediatric programs. For rheumatology educators in 2023, there also will be an online portal curated by the ACR and other sources to use as a resource for developing curriculum.

A newly revised Fundamentals of Rheumatology course started in June 2022, which can help many medical students, residents, primary care physicians, and students in rehabilitation professions to learn about rheumatologic diseases, said committee member Janet Poole, PhD, division chief, professor, and director of the occupational therapy graduate program at the University of New Mexico, Albuquerque. Grants from the Rheumatology Research Foundation are available to offset the costs of the course for attendees.

An “onboarding toolkit” for nurse practitioners and physician assistants is now available to provide advice to practices for hiring, mentoring, and conducting performance evaluations in rheumatology care teams, Dr. Poole said. And fact sheets about the roles of interprofessional team members are being revised to give nonspecialty providers a sense of what other disciplines are available to care for patients with rheumatic and musculoskeletal disorders. The Advanced Rheumatology course is also being revised and will be available in summer 2023.

Other planned interventions aim to optimize telemedicine for the rheumatology community with a telehealth curriculum for rheumatology fellows, tools to improve telehealth implementation and delivery, and educational materials for patients to optimize their participation in telehealth visits.

The committee created targeted outreach to promote all grants focused on workforce expansion. As a result, in the last year the committee noted a three- to fourfold rise in the number of grant applications, including people and programs in underserved areas that had not previously applied. The Rheumatology Research Foundation also created a baseline for measuring success of grant funding in underserved areas and earmarked funds to increase awareness of the grants and facilitate applications.

Early signs of success are evident in the Rheumatology Access Expansion initiative in the ACR’s Collaborative Initiatives (COIN) department, said committee member Rosalind Ramsey-Goldman, MD, DrPH, professor of medicine/rheumatology at Northwestern University, Chicago. A team of rheumatologists, a pharmacist, and Navajo cultural interpreters developed a 12-week rheumatoid arthritis training program for primary care physicians in the Navajo Nation American Indian reservation, where there’s a high prevalence of RA and a shortage of local rheumatology providers. Results of the pilot study were presented in a plenary session at the meeting.

COIN also worked with the ACR’s Diversity, Equity, and Inclusion task force to sponsor 2022 annual meeting attendance for 11 medical students who identify themselves as underrepresented in medicine to expose them to rheumatology early in their career, said Dr. Ramsey-Goldman. The ACR is starting a program for medical students at historically Black colleges and universities and minority-serving institutions to include mentoring, round tables, and attendance at next year’s annual meeting.

None of the rheumatologists had relevant financial disclosures.

PHILADELPHIA – New rheumatology fellowships in underserved areas. Rheumatology training for nonspecialists. Telemedicine training, tools, and resources. These are a few of the remedies the American College of Rheumatology’s new Workforce Solutions Committee has concocted to address a shrinking U.S. rheumatology workforce in the face of a rising population of patients with rheumatologic diseases.

In two sessions at the ACR’s annual meeting, committee members provided insights on current workforce projections since the most recent ACR workforce study in 2015. They also outlined the 1-year-old committee’s response to bridge the looming gap in patient care. Some projects are already underway, while others have yet to be implemented and require sustained monetary and project coordination commitments to make their impacts felt across the targeted regions.

Jeff Evans/MDedge News

“At the current pace of physician departures from the workforce, even with fellows graduating from adult and pediatric rheumatology training programs, the subspecialty cannot be sustained,” said Daniel Battafarano, DO, chair of the Workforce Solution Committee, professor of medicine at the Uniformed Services University of the Health Sciences, Bethesda, Md., and adjunct professor at the University of Texas Health Science Center, San Antonio.

The Northwest is an example of the problem at hand. “For an adult, there’s 1.65 rheumatologists per 100,000 in 2015. In 2025, there’s going to be 0.5 [adult] rheumatologists per 100,000. That’s a problem. If you look at every region in the United States, every single region is decrementing significantly,” he said.

Even the Northeast, which boasted 3.07 adult rheumatologists per 100,000 in 2015, will drop to 1.61 in 2025. Other regions are much worse off. The Southwest will drop from 1.28 to 0.64, and North Central will drop from 1.64 to 0.69, projections show.

The situation for pediatrics “has been in a crisis since 2015,” Dr. Battafarano said. It is much worse off than the situation for adult rheumatology, with 2015 figures going from 0.17 to 0.20 in the Southwest and from 0.03 to 0.04 in the South Central region by 2025, and in the Northwest from 0.67 to 0.13 and Northeast from 0.83 to 0.16.

“The ill effects of the pandemic are immeasurable to this point, but anecdotally we know we lost colleagues to part-time employment, we saw early retirements, and that happened across the full spectrum of the United States,” he said. It’s possible that up to 10% of full-time equivalents of physicians left practice in the United States since the pandemic began.

Rheumatologists largely practice in the 392 U.S. metropolitan statistical areas (MSAs), which are defined as a “core area containing a substantial population nucleus, together with adjacent communities having a high degree of economic and social integration with that core.” The smallest MSA has nearly 59,000 people. This distribution leaves many people in the Northwest, Southwest, South Central, and North Central regions with few rheumatologists. Over 86% of locations where rheumatologists train and work are in MSAs.

“By definition, if you get into a region where there’s 60,000 people or less, you can’t support a rheumatologist,” Dr. Battafarano said. He also noted that all pediatric hospitals tend to be in dense MSAs where rheumatologists might be.
 

South Central region serves as an example

People in certain MSAs of the South Central region (Oklahoma, Texas, Arkansas) such as Laredo, Tex., population 281,805 – where there is no adult rheumatologist – have to drive nearly 2.5 hours to the nearest well-served MSA (San Antonio) where there is a rheumatology fellowship program and medical school.

“Texas may have rheumatologists, but it depends on where you live,” Dr. Battafarano said. “The same applies to Waco, Texas; Texarkana, Arkansas; Lawton, Oklahoma; Pine Bluff, Arkansas; and Enid, Oklahoma, and you can see the range of traveling is between 45 minutes and 2.5 hours. That’s adult rheumatology.”

People in Laredo have an even longer drive to find a pediatric rheumatologist. In pediatrics, he said, “we don’t even look at towns, we look at pediatrics by state. You can see there’s a pediatric fellowship program in Dallas, and there’s one in Houston. There’s one or two [pediatric] rheumatologists in Austin. It just depends on how quickly they burn out and how long they stay. I’m in San Antonio. We don’t have a pediatric rheumatologist in San Antonio, the seventh-largest city in the United States.”

Pediatric rheumatologists are very often found where fellowship programs are located. “Ninety-five percent or greater of pediatric rheumatologists are housed in a pediatric hospital,” Dr. Battafarano said. “There are very few adult rheumatologists who see children, for a variety of reasons.”

In a panel discussion and question-and-answer session that took place after Dr. Battafarano outlined concerns with the numbers and distribution of rheumatologists across the United States, committee member Beth Jonas, MD, professor of medicine and chief of the division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, noted that the rheumatology specialty match is competitive and typically leaves close to 100 residents who had rheumatology as their first choice without a match because there are not enough fellowship positions for them to fill.

The Workforce Solutions Committee hopes to reduce this “bottleneck,” she said, by identifying institutions that are ripe for opening new fellowship programs or have existing programs that can expand their number of positions, as well as expanding musculoskeletal training among nonrheumatologists, such as primary care physicians, advanced practice providers, and sports medicine physicians.

“I think that we’re going to find ourselves needing to be more creative as we become overcome with events with shortages of physicians,” Dr. Battafarano said. He gave an example of a recent pediatric rheumatology fellow in Seattle who wanted to go back home to Montana to practice. At the same time, the pediatric program wanted her to become a faculty member, so they said they would bridge their program to her, rotating fellows and covering her while on vacation.

“That’s an example of a pediatric program spreading its wings,” he said. “I think that we need to think that way, whether we talk about urban, suburban, rural. It’s how can we stage rheumatologists in areas, how can we embrace our primary care providers, and have rheumatology health care teams so that we have rheumatology expertise located within arm’s length but also within telemedicine length.”
 

Interventions for 2023

As part of a report on the activities of the Workforce Solutions Committee, Dr. Jonas outlined a number of interventions that the ACR is set to launch in 2023. The committee created five intervention teams to support fellowship positions and training providers, recruitment opportunities, fostering patient-centered communities, virtual training programs, and grants for research and training. The ACR’s initial pilot interventions are focused on, but not limited to, the Northwest, Southwest, and South Central regions.

The committee identified 10 potential partner institutions to develop new fellowship programs in the Northwest, Southwest, and South Central regions: University of Nevada, Las Vegas; Texas Tech University Permian Basin Program; Baylor Scott and White Medical Center Round Rock (Tex.) Program; Texas Tech University Health Science Center El Paso Program; University of Texas at Austin Dell Medical School Program; Abrazo Health Network Program in Arizona; University of Arizona Phoenix Program; University of Arkansas (pediatric program); Oklahoma State University; and University of Texas, San Antonio (pediatric program).

Dr. Jonas explained that opening new programs in these underserved areas should help establish new rheumatologists in these areas, because studies have shown that fellows tend to stay within 100-200 miles of where they trained.

In addition to starting new programs, “if you want to grow your program, if you want to add another fellow, we can support that,” Dr. Jonas said.

To help convince institutions of the value of rheumatology care, a position paper will soon be released by the ACR that outlines the benefits of the specialty to a health care system. The paper will describe an annual preventive cost savings of $2,762 per patient who is in the care of a rheumatologist and an annual direct or downstream income of $3.5 million per rheumatologist in a community, committee members said.

To help with recruitment and retention efforts, the ACR will revise its CareerConnection website to make it more useful.

To help in developing patient-centered communities of care, there will be a discussion series with payers on topics such as access, care delivery, and financing, in which 12 payers (including Blue Cross Blue Shield, Aetna, UnitedHealthcare, and Kaiser) will discuss patient access, cost, and quality measures. An in-person payer summit is also scheduled for 2023.

Interventions to enhance rheumatology care will also keep an ongoing focus on virtual training programs for primary care physicians and advanced practice providers, including a Project ECHO (Extension for Community Healthcare Outcomes) virtual lecture and case-based training and mentoring series for nonrheumatologists, an online library of searchable topics targeted to nonrheumatologists, as well as a grand rounds podcast series on certain rheumatic diseases for residents in family medicine, internal medicine, and pediatric programs. For rheumatology educators in 2023, there also will be an online portal curated by the ACR and other sources to use as a resource for developing curriculum.

A newly revised Fundamentals of Rheumatology course started in June 2022, which can help many medical students, residents, primary care physicians, and students in rehabilitation professions to learn about rheumatologic diseases, said committee member Janet Poole, PhD, division chief, professor, and director of the occupational therapy graduate program at the University of New Mexico, Albuquerque. Grants from the Rheumatology Research Foundation are available to offset the costs of the course for attendees.

An “onboarding toolkit” for nurse practitioners and physician assistants is now available to provide advice to practices for hiring, mentoring, and conducting performance evaluations in rheumatology care teams, Dr. Poole said. And fact sheets about the roles of interprofessional team members are being revised to give nonspecialty providers a sense of what other disciplines are available to care for patients with rheumatic and musculoskeletal disorders. The Advanced Rheumatology course is also being revised and will be available in summer 2023.

Other planned interventions aim to optimize telemedicine for the rheumatology community with a telehealth curriculum for rheumatology fellows, tools to improve telehealth implementation and delivery, and educational materials for patients to optimize their participation in telehealth visits.

The committee created targeted outreach to promote all grants focused on workforce expansion. As a result, in the last year the committee noted a three- to fourfold rise in the number of grant applications, including people and programs in underserved areas that had not previously applied. The Rheumatology Research Foundation also created a baseline for measuring success of grant funding in underserved areas and earmarked funds to increase awareness of the grants and facilitate applications.

Early signs of success are evident in the Rheumatology Access Expansion initiative in the ACR’s Collaborative Initiatives (COIN) department, said committee member Rosalind Ramsey-Goldman, MD, DrPH, professor of medicine/rheumatology at Northwestern University, Chicago. A team of rheumatologists, a pharmacist, and Navajo cultural interpreters developed a 12-week rheumatoid arthritis training program for primary care physicians in the Navajo Nation American Indian reservation, where there’s a high prevalence of RA and a shortage of local rheumatology providers. Results of the pilot study were presented in a plenary session at the meeting.

COIN also worked with the ACR’s Diversity, Equity, and Inclusion task force to sponsor 2022 annual meeting attendance for 11 medical students who identify themselves as underrepresented in medicine to expose them to rheumatology early in their career, said Dr. Ramsey-Goldman. The ACR is starting a program for medical students at historically Black colleges and universities and minority-serving institutions to include mentoring, round tables, and attendance at next year’s annual meeting.

None of the rheumatologists had relevant financial disclosures.

PHILADELPHIA – New rheumatology fellowships in underserved areas. Rheumatology training for nonspecialists. Telemedicine training, tools, and resources. These are a few of the remedies the American College of Rheumatology’s new Workforce Solutions Committee has concocted to address a shrinking U.S. rheumatology workforce in the face of a rising population of patients with rheumatologic diseases.

In two sessions at the ACR’s annual meeting, committee members provided insights on current workforce projections since the most recent ACR workforce study in 2015. They also outlined the 1-year-old committee’s response to bridge the looming gap in patient care. Some projects are already underway, while others have yet to be implemented and require sustained monetary and project coordination commitments to make their impacts felt across the targeted regions.

Jeff Evans/MDedge News

“At the current pace of physician departures from the workforce, even with fellows graduating from adult and pediatric rheumatology training programs, the subspecialty cannot be sustained,” said Daniel Battafarano, DO, chair of the Workforce Solution Committee, professor of medicine at the Uniformed Services University of the Health Sciences, Bethesda, Md., and adjunct professor at the University of Texas Health Science Center, San Antonio.

The Northwest is an example of the problem at hand. “For an adult, there’s 1.65 rheumatologists per 100,000 in 2015. In 2025, there’s going to be 0.5 [adult] rheumatologists per 100,000. That’s a problem. If you look at every region in the United States, every single region is decrementing significantly,” he said.

Even the Northeast, which boasted 3.07 adult rheumatologists per 100,000 in 2015, will drop to 1.61 in 2025. Other regions are much worse off. The Southwest will drop from 1.28 to 0.64, and North Central will drop from 1.64 to 0.69, projections show.

The situation for pediatrics “has been in a crisis since 2015,” Dr. Battafarano said. It is much worse off than the situation for adult rheumatology, with 2015 figures going from 0.17 to 0.20 in the Southwest and from 0.03 to 0.04 in the South Central region by 2025, and in the Northwest from 0.67 to 0.13 and Northeast from 0.83 to 0.16.

“The ill effects of the pandemic are immeasurable to this point, but anecdotally we know we lost colleagues to part-time employment, we saw early retirements, and that happened across the full spectrum of the United States,” he said. It’s possible that up to 10% of full-time equivalents of physicians left practice in the United States since the pandemic began.

Rheumatologists largely practice in the 392 U.S. metropolitan statistical areas (MSAs), which are defined as a “core area containing a substantial population nucleus, together with adjacent communities having a high degree of economic and social integration with that core.” The smallest MSA has nearly 59,000 people. This distribution leaves many people in the Northwest, Southwest, South Central, and North Central regions with few rheumatologists. Over 86% of locations where rheumatologists train and work are in MSAs.

“By definition, if you get into a region where there’s 60,000 people or less, you can’t support a rheumatologist,” Dr. Battafarano said. He also noted that all pediatric hospitals tend to be in dense MSAs where rheumatologists might be.
 

South Central region serves as an example

People in certain MSAs of the South Central region (Oklahoma, Texas, Arkansas) such as Laredo, Tex., population 281,805 – where there is no adult rheumatologist – have to drive nearly 2.5 hours to the nearest well-served MSA (San Antonio) where there is a rheumatology fellowship program and medical school.

“Texas may have rheumatologists, but it depends on where you live,” Dr. Battafarano said. “The same applies to Waco, Texas; Texarkana, Arkansas; Lawton, Oklahoma; Pine Bluff, Arkansas; and Enid, Oklahoma, and you can see the range of traveling is between 45 minutes and 2.5 hours. That’s adult rheumatology.”

People in Laredo have an even longer drive to find a pediatric rheumatologist. In pediatrics, he said, “we don’t even look at towns, we look at pediatrics by state. You can see there’s a pediatric fellowship program in Dallas, and there’s one in Houston. There’s one or two [pediatric] rheumatologists in Austin. It just depends on how quickly they burn out and how long they stay. I’m in San Antonio. We don’t have a pediatric rheumatologist in San Antonio, the seventh-largest city in the United States.”

Pediatric rheumatologists are very often found where fellowship programs are located. “Ninety-five percent or greater of pediatric rheumatologists are housed in a pediatric hospital,” Dr. Battafarano said. “There are very few adult rheumatologists who see children, for a variety of reasons.”

In a panel discussion and question-and-answer session that took place after Dr. Battafarano outlined concerns with the numbers and distribution of rheumatologists across the United States, committee member Beth Jonas, MD, professor of medicine and chief of the division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, noted that the rheumatology specialty match is competitive and typically leaves close to 100 residents who had rheumatology as their first choice without a match because there are not enough fellowship positions for them to fill.

The Workforce Solutions Committee hopes to reduce this “bottleneck,” she said, by identifying institutions that are ripe for opening new fellowship programs or have existing programs that can expand their number of positions, as well as expanding musculoskeletal training among nonrheumatologists, such as primary care physicians, advanced practice providers, and sports medicine physicians.

“I think that we’re going to find ourselves needing to be more creative as we become overcome with events with shortages of physicians,” Dr. Battafarano said. He gave an example of a recent pediatric rheumatology fellow in Seattle who wanted to go back home to Montana to practice. At the same time, the pediatric program wanted her to become a faculty member, so they said they would bridge their program to her, rotating fellows and covering her while on vacation.

“That’s an example of a pediatric program spreading its wings,” he said. “I think that we need to think that way, whether we talk about urban, suburban, rural. It’s how can we stage rheumatologists in areas, how can we embrace our primary care providers, and have rheumatology health care teams so that we have rheumatology expertise located within arm’s length but also within telemedicine length.”
 

Interventions for 2023

As part of a report on the activities of the Workforce Solutions Committee, Dr. Jonas outlined a number of interventions that the ACR is set to launch in 2023. The committee created five intervention teams to support fellowship positions and training providers, recruitment opportunities, fostering patient-centered communities, virtual training programs, and grants for research and training. The ACR’s initial pilot interventions are focused on, but not limited to, the Northwest, Southwest, and South Central regions.

The committee identified 10 potential partner institutions to develop new fellowship programs in the Northwest, Southwest, and South Central regions: University of Nevada, Las Vegas; Texas Tech University Permian Basin Program; Baylor Scott and White Medical Center Round Rock (Tex.) Program; Texas Tech University Health Science Center El Paso Program; University of Texas at Austin Dell Medical School Program; Abrazo Health Network Program in Arizona; University of Arizona Phoenix Program; University of Arkansas (pediatric program); Oklahoma State University; and University of Texas, San Antonio (pediatric program).

Dr. Jonas explained that opening new programs in these underserved areas should help establish new rheumatologists in these areas, because studies have shown that fellows tend to stay within 100-200 miles of where they trained.

In addition to starting new programs, “if you want to grow your program, if you want to add another fellow, we can support that,” Dr. Jonas said.

To help convince institutions of the value of rheumatology care, a position paper will soon be released by the ACR that outlines the benefits of the specialty to a health care system. The paper will describe an annual preventive cost savings of $2,762 per patient who is in the care of a rheumatologist and an annual direct or downstream income of $3.5 million per rheumatologist in a community, committee members said.

To help with recruitment and retention efforts, the ACR will revise its CareerConnection website to make it more useful.

To help in developing patient-centered communities of care, there will be a discussion series with payers on topics such as access, care delivery, and financing, in which 12 payers (including Blue Cross Blue Shield, Aetna, UnitedHealthcare, and Kaiser) will discuss patient access, cost, and quality measures. An in-person payer summit is also scheduled for 2023.

Interventions to enhance rheumatology care will also keep an ongoing focus on virtual training programs for primary care physicians and advanced practice providers, including a Project ECHO (Extension for Community Healthcare Outcomes) virtual lecture and case-based training and mentoring series for nonrheumatologists, an online library of searchable topics targeted to nonrheumatologists, as well as a grand rounds podcast series on certain rheumatic diseases for residents in family medicine, internal medicine, and pediatric programs. For rheumatology educators in 2023, there also will be an online portal curated by the ACR and other sources to use as a resource for developing curriculum.

A newly revised Fundamentals of Rheumatology course started in June 2022, which can help many medical students, residents, primary care physicians, and students in rehabilitation professions to learn about rheumatologic diseases, said committee member Janet Poole, PhD, division chief, professor, and director of the occupational therapy graduate program at the University of New Mexico, Albuquerque. Grants from the Rheumatology Research Foundation are available to offset the costs of the course for attendees.

An “onboarding toolkit” for nurse practitioners and physician assistants is now available to provide advice to practices for hiring, mentoring, and conducting performance evaluations in rheumatology care teams, Dr. Poole said. And fact sheets about the roles of interprofessional team members are being revised to give nonspecialty providers a sense of what other disciplines are available to care for patients with rheumatic and musculoskeletal disorders. The Advanced Rheumatology course is also being revised and will be available in summer 2023.

Other planned interventions aim to optimize telemedicine for the rheumatology community with a telehealth curriculum for rheumatology fellows, tools to improve telehealth implementation and delivery, and educational materials for patients to optimize their participation in telehealth visits.

The committee created targeted outreach to promote all grants focused on workforce expansion. As a result, in the last year the committee noted a three- to fourfold rise in the number of grant applications, including people and programs in underserved areas that had not previously applied. The Rheumatology Research Foundation also created a baseline for measuring success of grant funding in underserved areas and earmarked funds to increase awareness of the grants and facilitate applications.

Early signs of success are evident in the Rheumatology Access Expansion initiative in the ACR’s Collaborative Initiatives (COIN) department, said committee member Rosalind Ramsey-Goldman, MD, DrPH, professor of medicine/rheumatology at Northwestern University, Chicago. A team of rheumatologists, a pharmacist, and Navajo cultural interpreters developed a 12-week rheumatoid arthritis training program for primary care physicians in the Navajo Nation American Indian reservation, where there’s a high prevalence of RA and a shortage of local rheumatology providers. Results of the pilot study were presented in a plenary session at the meeting.

COIN also worked with the ACR’s Diversity, Equity, and Inclusion task force to sponsor 2022 annual meeting attendance for 11 medical students who identify themselves as underrepresented in medicine to expose them to rheumatology early in their career, said Dr. Ramsey-Goldman. The ACR is starting a program for medical students at historically Black colleges and universities and minority-serving institutions to include mentoring, round tables, and attendance at next year’s annual meeting.

None of the rheumatologists had relevant financial disclosures.

The interleukin-12/23 inhibitor ustekinumab (Stelara) is nearly as effective as a tumor necrosis factor (TNF) inhibitor for psoriatic arthritis, and patients are slightly more likely to persist with it and have a lower rate of adverse events, a 3-year, real-world study has found.

In a paper published online in Annals of the Rheumatic Diseases, researchers presented the outcomes of the prospective, observational PsABio study of 895 adults with psoriatic arthritis, who were starting treatment for the first time with either ustekinumab or a TNF inhibitor as first-, second-, or third-line treatment.

At 3 years after starting therapy, 49.9% of the 439 patients prescribed ustekinumab were still on that treatment, compared with 47.8% of the 456 patients prescribed a TNF inhibitor. However, there were differences in persistence based on clinical presentation. Patients who had severe skin involvement who were treated with ustekinumab stayed on the drug for longer than did those with severe skin involvement treated with a TNF inhibitor, and they were more likely to persist with their treatment for the 3 years of the study. However, there were numerically more patients with mild or moderate skin involvement taking a TNF inhibitor who stayed persistent with the treatment, compared with those taking ustekinumab, although the differences were not statistically significant.

“In the ustekinumab group, skin response was an important reason for prolonged persistence, with more patients in the ustekinumab group stopping/switching due to lack of effectiveness,” wrote Laure Gossec, MD, of Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and coauthors. “This is expected, as psoriasis can significantly affect morbidity, and successfully treating skin symptoms improves patients’ health-related quality of life.”

The authors also noted that patients on ustekinumab monotherapy had the highest rate of persistence and stayed on treatment longer than did those on TNF inhibitor monotherapy, or on dual therapy with either drug combined with methotrexate. They suggested this could be because patients on TNF inhibitor monotherapy may be more likely to develop antidrug antibodies than those on ustekinumab monotherapy. It could also be because adding methotrexate may increase the risk of adverse events, but without necessarily increasing the effectiveness of ustekinumab on skin involvement.

In terms of efficacy, researchers saw that 69.8% of patients in the TNF inhibitor group had achieved low disease activity and 45% had achieved remission, compared with 58.6% of patients in the ustekinumab group who achieved low disease activity and 31.4% who achieved remission.

A similar pattern was seen for minimal disease activity and very low disease activity, which were achieved by 54.2% and 26.9% respectively of those in the TNF inhibitor group, and 41.4% and 19.2% respectively of those in the ustekinumab group.

Because the study was observational and real-world, the choice of therapy was made by the treating rheumatologist rather than patients being randomized. There were some baseline differences between the ustekinumab and TNF inhibitor groups; for example, patients in ustekinumab group were generally older and with more comorbidities, and were more likely to have previous been treated with biologics. However, they were also less likely to be concurrently treated with methotrexate and NSAIDs, and more likely to have severe skin involvement.

The study saw a higher rate of adverse events in the TNF inhibitor group, compared with the ustekinumab, with 39.7% of patients treated with TNF inhibitor and 34.6% of those treated with ustekinumab reporting at least one adverse event. The rates of serious adverse events and malignancies were similar for the two groups, but overall the ustekinumab group had a lower rate of clinically-relevant adverse events including infections.

The study was sponsored by Janssen, which markets ustekinumab. Ten authors declared personal fees, grants, and nonfinancial support from the pharmaceutical sector, including Janssen. One author was an employee of Janssen, one an employee of Johnson & Johnson, and two are editorial board members of Annals of the Rheumatic Diseases.

The interleukin-12/23 inhibitor ustekinumab (Stelara) is nearly as effective as a tumor necrosis factor (TNF) inhibitor for psoriatic arthritis, and patients are slightly more likely to persist with it and have a lower rate of adverse events, a 3-year, real-world study has found.

In a paper published online in Annals of the Rheumatic Diseases, researchers presented the outcomes of the prospective, observational PsABio study of 895 adults with psoriatic arthritis, who were starting treatment for the first time with either ustekinumab or a TNF inhibitor as first-, second-, or third-line treatment.

At 3 years after starting therapy, 49.9% of the 439 patients prescribed ustekinumab were still on that treatment, compared with 47.8% of the 456 patients prescribed a TNF inhibitor. However, there were differences in persistence based on clinical presentation. Patients who had severe skin involvement who were treated with ustekinumab stayed on the drug for longer than did those with severe skin involvement treated with a TNF inhibitor, and they were more likely to persist with their treatment for the 3 years of the study. However, there were numerically more patients with mild or moderate skin involvement taking a TNF inhibitor who stayed persistent with the treatment, compared with those taking ustekinumab, although the differences were not statistically significant.

“In the ustekinumab group, skin response was an important reason for prolonged persistence, with more patients in the ustekinumab group stopping/switching due to lack of effectiveness,” wrote Laure Gossec, MD, of Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and coauthors. “This is expected, as psoriasis can significantly affect morbidity, and successfully treating skin symptoms improves patients’ health-related quality of life.”

The authors also noted that patients on ustekinumab monotherapy had the highest rate of persistence and stayed on treatment longer than did those on TNF inhibitor monotherapy, or on dual therapy with either drug combined with methotrexate. They suggested this could be because patients on TNF inhibitor monotherapy may be more likely to develop antidrug antibodies than those on ustekinumab monotherapy. It could also be because adding methotrexate may increase the risk of adverse events, but without necessarily increasing the effectiveness of ustekinumab on skin involvement.

In terms of efficacy, researchers saw that 69.8% of patients in the TNF inhibitor group had achieved low disease activity and 45% had achieved remission, compared with 58.6% of patients in the ustekinumab group who achieved low disease activity and 31.4% who achieved remission.

A similar pattern was seen for minimal disease activity and very low disease activity, which were achieved by 54.2% and 26.9% respectively of those in the TNF inhibitor group, and 41.4% and 19.2% respectively of those in the ustekinumab group.

Because the study was observational and real-world, the choice of therapy was made by the treating rheumatologist rather than patients being randomized. There were some baseline differences between the ustekinumab and TNF inhibitor groups; for example, patients in ustekinumab group were generally older and with more comorbidities, and were more likely to have previous been treated with biologics. However, they were also less likely to be concurrently treated with methotrexate and NSAIDs, and more likely to have severe skin involvement.

The study saw a higher rate of adverse events in the TNF inhibitor group, compared with the ustekinumab, with 39.7% of patients treated with TNF inhibitor and 34.6% of those treated with ustekinumab reporting at least one adverse event. The rates of serious adverse events and malignancies were similar for the two groups, but overall the ustekinumab group had a lower rate of clinically-relevant adverse events including infections.

The study was sponsored by Janssen, which markets ustekinumab. Ten authors declared personal fees, grants, and nonfinancial support from the pharmaceutical sector, including Janssen. One author was an employee of Janssen, one an employee of Johnson & Johnson, and two are editorial board members of Annals of the Rheumatic Diseases.

The interleukin-12/23 inhibitor ustekinumab (Stelara) is nearly as effective as a tumor necrosis factor (TNF) inhibitor for psoriatic arthritis, and patients are slightly more likely to persist with it and have a lower rate of adverse events, a 3-year, real-world study has found.

In a paper published online in Annals of the Rheumatic Diseases, researchers presented the outcomes of the prospective, observational PsABio study of 895 adults with psoriatic arthritis, who were starting treatment for the first time with either ustekinumab or a TNF inhibitor as first-, second-, or third-line treatment.

At 3 years after starting therapy, 49.9% of the 439 patients prescribed ustekinumab were still on that treatment, compared with 47.8% of the 456 patients prescribed a TNF inhibitor. However, there were differences in persistence based on clinical presentation. Patients who had severe skin involvement who were treated with ustekinumab stayed on the drug for longer than did those with severe skin involvement treated with a TNF inhibitor, and they were more likely to persist with their treatment for the 3 years of the study. However, there were numerically more patients with mild or moderate skin involvement taking a TNF inhibitor who stayed persistent with the treatment, compared with those taking ustekinumab, although the differences were not statistically significant.

“In the ustekinumab group, skin response was an important reason for prolonged persistence, with more patients in the ustekinumab group stopping/switching due to lack of effectiveness,” wrote Laure Gossec, MD, of Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and coauthors. “This is expected, as psoriasis can significantly affect morbidity, and successfully treating skin symptoms improves patients’ health-related quality of life.”

The authors also noted that patients on ustekinumab monotherapy had the highest rate of persistence and stayed on treatment longer than did those on TNF inhibitor monotherapy, or on dual therapy with either drug combined with methotrexate. They suggested this could be because patients on TNF inhibitor monotherapy may be more likely to develop antidrug antibodies than those on ustekinumab monotherapy. It could also be because adding methotrexate may increase the risk of adverse events, but without necessarily increasing the effectiveness of ustekinumab on skin involvement.

In terms of efficacy, researchers saw that 69.8% of patients in the TNF inhibitor group had achieved low disease activity and 45% had achieved remission, compared with 58.6% of patients in the ustekinumab group who achieved low disease activity and 31.4% who achieved remission.

A similar pattern was seen for minimal disease activity and very low disease activity, which were achieved by 54.2% and 26.9% respectively of those in the TNF inhibitor group, and 41.4% and 19.2% respectively of those in the ustekinumab group.

Because the study was observational and real-world, the choice of therapy was made by the treating rheumatologist rather than patients being randomized. There were some baseline differences between the ustekinumab and TNF inhibitor groups; for example, patients in ustekinumab group were generally older and with more comorbidities, and were more likely to have previous been treated with biologics. However, they were also less likely to be concurrently treated with methotrexate and NSAIDs, and more likely to have severe skin involvement.

The study saw a higher rate of adverse events in the TNF inhibitor group, compared with the ustekinumab, with 39.7% of patients treated with TNF inhibitor and 34.6% of those treated with ustekinumab reporting at least one adverse event. The rates of serious adverse events and malignancies were similar for the two groups, but overall the ustekinumab group had a lower rate of clinically-relevant adverse events including infections.

The study was sponsored by Janssen, which markets ustekinumab. Ten authors declared personal fees, grants, and nonfinancial support from the pharmaceutical sector, including Janssen. One author was an employee of Janssen, one an employee of Johnson & Johnson, and two are editorial board members of Annals of the Rheumatic Diseases.

Metabolic syndrome is associated with a significantly increased risk for gout in young men, but the risk can be mitigated by improvement in individual components of the syndrome, based on data from a pair of population-based studies totaling more than 4 million individuals.

Gout remains the most common type of inflammatory arthritis in men, and the rate has been rising among younger adults, Yeonghee Eun, MD, PhD, of Sungkyunkwan University, Seoul, South Korea, and colleagues wrote. An increasing body of evidence suggests a link between gout and metabolic syndrome (MetS), but large studies have been lacking, especially in younger adults.

In a study published in Frontiers in Medicine, the researchers reviewed data from 3,569,104 men aged 20-39 years who underwent a health checkup between 2009 and 2012 in South Korea, based on the Korean National Health Insurance Service. The primary outcome of incident gout was identified using claims data. The mean age of the participants was 31.5 years.

Over a mean follow-up of 7.4 years, the incidence of gout was 3.36 per 1,000 person-years. The risk of developing gout was more than twice as high among individuals who met MetS criteria than in those who did not (adjusted hazard ratio, 2.44).

MetS was defined as the presence of at least two of the following components: hypertriglyceridemia, abdominal obesity, reduced HDL cholesterol, elevated blood pressure, and elevated fasting glucose.

Overall, individuals with all five MetS components had a fivefold increase in gout risk, compared with people who did not have MetS (aHR, 5.24). In an analysis of each component of MetS, hypertriglyceridemia and abdominal obesity showed the strongest association with gout (aHRs of 2.08 and 2.33, respectively).

The impact of MetS on risk of incident gout was greater in younger participants, which suggests that the management of MetS in young people should be emphasized, the researchers said.

In a further analysis of body mass index subgroups, MetS had the greatest impact on gout risk for individuals who were underweight (aHR, 3.82). “In particular, in the underweight group, the risk of gout increased 10-fold when abdominal obesity was present,” the researchers said.

The study was limited by several factors including potential selection bias and potential overestimation of gout incidence because of the use of diagnostic codes, the researchers noted. Other limitations included lack of control for nutritional or dietary risk factors and the inability to include cases that occurred after the study period.

However, findings were strengthened by the large number of participants with MetS who were underweight or normal weight, the researchers wrote. More research on the mechanism of action is needed, but the data suggest that MetS is a key risk factor in the development of gout in young men.

In a second study, published in Arthritis & Rheumatology, Dr. Eun and colleagues examined associations between MetS changes and incident gout in young men. Although previous studies have shown that changes in MetS status can alter the risk of cardiovascular events, atrial fibrillation, end-stage renal disease, and all-cause mortality, the impact of these changes on gout has not been well studied, they said. The researchers used the same study cohort, the National Health Insurance Service database in South Korea. They reviewed data from 1,293,166 individuals aged 20-39 years. Of these, 18,473 were diagnosed with gout for an incidence rate 3.36/1,000 person-years. The researchers compared gout incidence for men who met criteria for MetS at three health checkups and those without MetS.

Overall, patients with MetS at all three checkups had a nearly fourfold higher risk of gout than those who never had MetS, with an adjusted hazard ratio of 3.82, the researchers wrote. The development of MetS over the study period more than doubled the risk of gout, but recovery from MetS reduced incident gout risk by approximately 50% (aHR, 0.52).

In findings similar to the Frontiers in Medicine study, the greatest associations with gout were noted for changes in elevated triglycerides and changes in abdominal obesity; aHRs for development and recovery for elevated triglycerides were 1.74 and 0.56, respectively, and for abdominal obesity, 1.94 and 0.69, respectively.

More research is needed to explore the mechanism by which both abdominal obesity and elevated triglycerides drive the development of gout, the researchers wrote in their discussion.

Also similar to the Frontiers study, the associations among changes in MetS and incident gout were greater for the youngest participants (in their 20s) and in the underweight or normal weight BMI groups.

Limitations of the second study included possible selection bias because of the study population of workplace employees who participated in regular health checks and the lack of data on women or on men aged 40 years and older, the researchers noted. Other limitations included possible misclassification of MetS because of varying health checkup results and drug claims, and lack of data on serum urate, which prevented assessment of hyperuricemia as a cause of gout.

However, the results were strengthened by the large sample size and suggest that MetS is a modifiable risk factor for gout, the researchers concluded.

Neither of the studies received outside funding. The researchers had no financial conflicts to disclose.

Metabolic syndrome is associated with a significantly increased risk for gout in young men, but the risk can be mitigated by improvement in individual components of the syndrome, based on data from a pair of population-based studies totaling more than 4 million individuals.

Gout remains the most common type of inflammatory arthritis in men, and the rate has been rising among younger adults, Yeonghee Eun, MD, PhD, of Sungkyunkwan University, Seoul, South Korea, and colleagues wrote. An increasing body of evidence suggests a link between gout and metabolic syndrome (MetS), but large studies have been lacking, especially in younger adults.

In a study published in Frontiers in Medicine, the researchers reviewed data from 3,569,104 men aged 20-39 years who underwent a health checkup between 2009 and 2012 in South Korea, based on the Korean National Health Insurance Service. The primary outcome of incident gout was identified using claims data. The mean age of the participants was 31.5 years.

Over a mean follow-up of 7.4 years, the incidence of gout was 3.36 per 1,000 person-years. The risk of developing gout was more than twice as high among individuals who met MetS criteria than in those who did not (adjusted hazard ratio, 2.44).

MetS was defined as the presence of at least two of the following components: hypertriglyceridemia, abdominal obesity, reduced HDL cholesterol, elevated blood pressure, and elevated fasting glucose.

Overall, individuals with all five MetS components had a fivefold increase in gout risk, compared with people who did not have MetS (aHR, 5.24). In an analysis of each component of MetS, hypertriglyceridemia and abdominal obesity showed the strongest association with gout (aHRs of 2.08 and 2.33, respectively).

The impact of MetS on risk of incident gout was greater in younger participants, which suggests that the management of MetS in young people should be emphasized, the researchers said.

In a further analysis of body mass index subgroups, MetS had the greatest impact on gout risk for individuals who were underweight (aHR, 3.82). “In particular, in the underweight group, the risk of gout increased 10-fold when abdominal obesity was present,” the researchers said.

The study was limited by several factors including potential selection bias and potential overestimation of gout incidence because of the use of diagnostic codes, the researchers noted. Other limitations included lack of control for nutritional or dietary risk factors and the inability to include cases that occurred after the study period.

However, findings were strengthened by the large number of participants with MetS who were underweight or normal weight, the researchers wrote. More research on the mechanism of action is needed, but the data suggest that MetS is a key risk factor in the development of gout in young men.

In a second study, published in Arthritis & Rheumatology, Dr. Eun and colleagues examined associations between MetS changes and incident gout in young men. Although previous studies have shown that changes in MetS status can alter the risk of cardiovascular events, atrial fibrillation, end-stage renal disease, and all-cause mortality, the impact of these changes on gout has not been well studied, they said. The researchers used the same study cohort, the National Health Insurance Service database in South Korea. They reviewed data from 1,293,166 individuals aged 20-39 years. Of these, 18,473 were diagnosed with gout for an incidence rate 3.36/1,000 person-years. The researchers compared gout incidence for men who met criteria for MetS at three health checkups and those without MetS.

Overall, patients with MetS at all three checkups had a nearly fourfold higher risk of gout than those who never had MetS, with an adjusted hazard ratio of 3.82, the researchers wrote. The development of MetS over the study period more than doubled the risk of gout, but recovery from MetS reduced incident gout risk by approximately 50% (aHR, 0.52).

In findings similar to the Frontiers in Medicine study, the greatest associations with gout were noted for changes in elevated triglycerides and changes in abdominal obesity; aHRs for development and recovery for elevated triglycerides were 1.74 and 0.56, respectively, and for abdominal obesity, 1.94 and 0.69, respectively.

More research is needed to explore the mechanism by which both abdominal obesity and elevated triglycerides drive the development of gout, the researchers wrote in their discussion.

Also similar to the Frontiers study, the associations among changes in MetS and incident gout were greater for the youngest participants (in their 20s) and in the underweight or normal weight BMI groups.

Limitations of the second study included possible selection bias because of the study population of workplace employees who participated in regular health checks and the lack of data on women or on men aged 40 years and older, the researchers noted. Other limitations included possible misclassification of MetS because of varying health checkup results and drug claims, and lack of data on serum urate, which prevented assessment of hyperuricemia as a cause of gout.

However, the results were strengthened by the large sample size and suggest that MetS is a modifiable risk factor for gout, the researchers concluded.

Neither of the studies received outside funding. The researchers had no financial conflicts to disclose.

Metabolic syndrome is associated with a significantly increased risk for gout in young men, but the risk can be mitigated by improvement in individual components of the syndrome, based on data from a pair of population-based studies totaling more than 4 million individuals.

Gout remains the most common type of inflammatory arthritis in men, and the rate has been rising among younger adults, Yeonghee Eun, MD, PhD, of Sungkyunkwan University, Seoul, South Korea, and colleagues wrote. An increasing body of evidence suggests a link between gout and metabolic syndrome (MetS), but large studies have been lacking, especially in younger adults.

In a study published in Frontiers in Medicine, the researchers reviewed data from 3,569,104 men aged 20-39 years who underwent a health checkup between 2009 and 2012 in South Korea, based on the Korean National Health Insurance Service. The primary outcome of incident gout was identified using claims data. The mean age of the participants was 31.5 years.

Over a mean follow-up of 7.4 years, the incidence of gout was 3.36 per 1,000 person-years. The risk of developing gout was more than twice as high among individuals who met MetS criteria than in those who did not (adjusted hazard ratio, 2.44).

MetS was defined as the presence of at least two of the following components: hypertriglyceridemia, abdominal obesity, reduced HDL cholesterol, elevated blood pressure, and elevated fasting glucose.

Overall, individuals with all five MetS components had a fivefold increase in gout risk, compared with people who did not have MetS (aHR, 5.24). In an analysis of each component of MetS, hypertriglyceridemia and abdominal obesity showed the strongest association with gout (aHRs of 2.08 and 2.33, respectively).

The impact of MetS on risk of incident gout was greater in younger participants, which suggests that the management of MetS in young people should be emphasized, the researchers said.

In a further analysis of body mass index subgroups, MetS had the greatest impact on gout risk for individuals who were underweight (aHR, 3.82). “In particular, in the underweight group, the risk of gout increased 10-fold when abdominal obesity was present,” the researchers said.

The study was limited by several factors including potential selection bias and potential overestimation of gout incidence because of the use of diagnostic codes, the researchers noted. Other limitations included lack of control for nutritional or dietary risk factors and the inability to include cases that occurred after the study period.

However, findings were strengthened by the large number of participants with MetS who were underweight or normal weight, the researchers wrote. More research on the mechanism of action is needed, but the data suggest that MetS is a key risk factor in the development of gout in young men.

In a second study, published in Arthritis & Rheumatology, Dr. Eun and colleagues examined associations between MetS changes and incident gout in young men. Although previous studies have shown that changes in MetS status can alter the risk of cardiovascular events, atrial fibrillation, end-stage renal disease, and all-cause mortality, the impact of these changes on gout has not been well studied, they said. The researchers used the same study cohort, the National Health Insurance Service database in South Korea. They reviewed data from 1,293,166 individuals aged 20-39 years. Of these, 18,473 were diagnosed with gout for an incidence rate 3.36/1,000 person-years. The researchers compared gout incidence for men who met criteria for MetS at three health checkups and those without MetS.

Overall, patients with MetS at all three checkups had a nearly fourfold higher risk of gout than those who never had MetS, with an adjusted hazard ratio of 3.82, the researchers wrote. The development of MetS over the study period more than doubled the risk of gout, but recovery from MetS reduced incident gout risk by approximately 50% (aHR, 0.52).

In findings similar to the Frontiers in Medicine study, the greatest associations with gout were noted for changes in elevated triglycerides and changes in abdominal obesity; aHRs for development and recovery for elevated triglycerides were 1.74 and 0.56, respectively, and for abdominal obesity, 1.94 and 0.69, respectively.

More research is needed to explore the mechanism by which both abdominal obesity and elevated triglycerides drive the development of gout, the researchers wrote in their discussion.

Also similar to the Frontiers study, the associations among changes in MetS and incident gout were greater for the youngest participants (in their 20s) and in the underweight or normal weight BMI groups.

Limitations of the second study included possible selection bias because of the study population of workplace employees who participated in regular health checks and the lack of data on women or on men aged 40 years and older, the researchers noted. Other limitations included possible misclassification of MetS because of varying health checkup results and drug claims, and lack of data on serum urate, which prevented assessment of hyperuricemia as a cause of gout.

However, the results were strengthened by the large sample size and suggest that MetS is a modifiable risk factor for gout, the researchers concluded.

Neither of the studies received outside funding. The researchers had no financial conflicts to disclose.

Exposure to inhaled agents in the workplace could be putting people at risk of developing rheumatoid arthritis, according to research published in Annals of the Rheumatic Diseases.

In an analysis of data from the long-running Swedish Epidemiological Investigation of RA (EIRA) population-based cohort study, there was a 21% increased risk of RA and a 25% increased risk of anti–citrullinated protein antibody (ACPA)–positive RA associated with exposure to any occupationally inhaled agent.

LOOK PHOTO / Fotolia.com

“We have investigated a number of occupational airborne exposures and found that exposure for those agents infer a high risk for RA,” Lars Klareskog, MD, PhD, senior professor of rheumatology at the Karolinska Institute and Karolinska University Hospital (Solna) in Stockholm, said in an interview.

Dr. Klareskog, who is one of the lead authors of the published work, added that the risk is particularly high in individuals who had a genetic susceptibility and in those who smoked.

“The importance of this is that it further demonstrates that exposures to the lung may trigger immune reactions associated with the major subset of rheumatoid arthritis,” Dr. Klareskog said. “Second, it shows that those exposed to these agents should be very keen to not smoke.” “These findings further implicate the respiratory tract mucosa in ACPA-positive RA pathogenesis,” agreed Vanessa L. Kronzer, MD, of the Mayo Clinic in Rochester, Minn., and Jeffrey A. Sparks, MD, MMSc, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston.

They also “impress the need for public policy initiatives related to occupational inhalants to prevent RA,” they suggested in an editorial.

Multiple occupational inhalable exposures assessed

In the analysis, the researchers assessed exposure to 32 inhalable agents in people with (n = 4,033) and without RA (n = 6,485). The list of agents considered included detergents, diesel engine exhaust, fine particulate matter, solvents, and agricultural chemicals.

A total of 17 agents showed a positive association with an increased risk of ACPA-positive RA. Dr. Kronzer and Dr. Sparks noted that breathing in insecticides and fungicides at work was associated with the highest odds ratios for having ACPA-positive RA (both 2.38).

“Importantly, both the number and duration of exposures exhibited a dose-response effect on RA risk,” the editorialists said.

They also picked out that there was “a gene-environment interaction for RA risk for certain inhalants,” including diesel engine exhaust, asbestos, carbon monoxide, and quartz dust.

Smoking amplified the risk for ACPA-positive RA associated with certain agents, such as detergents, and adding in genetic susceptibility for a third exposure increased the risk still further.

A key message is that there are many agents that can affect the airways and increase the risk of RA rather than there being a specific one, Dr. Klareskog said.

“On one hand, it’s a message of public health,” he said. Many public health authorities are aware of the potential risks of inhaled agents on the lung, “but this just adds another dimension that it’s bad also for rheumatoid arthritis.” Thus, greater efforts to help protect people from being exposed at work may be needed.

From the individual’s perspective, “if you have RA or other immune diseases in your family, then you may know that you’re at increased risk,” Dr. Klareskog said. The message here is perhaps to “be aware, [protect yourself], and stop smoking.”

The EIRA study was supported by funding from the Swedish Research Foundation for Health, Working Life, and Welfare, the Swedish Research Council, the AFA foundation, Region Stockholm, King Gustaf V’s 80-year foundation, and the Swedish Rheumatic Foundation. Dr. Klareskog and coauthors had no competing interests to disclose. Dr. Kronzer and Dr. Sparks had no disclosures of relevance to their comments.

Exposure to inhaled agents in the workplace could be putting people at risk of developing rheumatoid arthritis, according to research published in Annals of the Rheumatic Diseases.

In an analysis of data from the long-running Swedish Epidemiological Investigation of RA (EIRA) population-based cohort study, there was a 21% increased risk of RA and a 25% increased risk of anti–citrullinated protein antibody (ACPA)–positive RA associated with exposure to any occupationally inhaled agent.

LOOK PHOTO / Fotolia.com

“We have investigated a number of occupational airborne exposures and found that exposure for those agents infer a high risk for RA,” Lars Klareskog, MD, PhD, senior professor of rheumatology at the Karolinska Institute and Karolinska University Hospital (Solna) in Stockholm, said in an interview.

Dr. Klareskog, who is one of the lead authors of the published work, added that the risk is particularly high in individuals who had a genetic susceptibility and in those who smoked.

“The importance of this is that it further demonstrates that exposures to the lung may trigger immune reactions associated with the major subset of rheumatoid arthritis,” Dr. Klareskog said. “Second, it shows that those exposed to these agents should be very keen to not smoke.” “These findings further implicate the respiratory tract mucosa in ACPA-positive RA pathogenesis,” agreed Vanessa L. Kronzer, MD, of the Mayo Clinic in Rochester, Minn., and Jeffrey A. Sparks, MD, MMSc, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston.

They also “impress the need for public policy initiatives related to occupational inhalants to prevent RA,” they suggested in an editorial.

Multiple occupational inhalable exposures assessed

In the analysis, the researchers assessed exposure to 32 inhalable agents in people with (n = 4,033) and without RA (n = 6,485). The list of agents considered included detergents, diesel engine exhaust, fine particulate matter, solvents, and agricultural chemicals.

A total of 17 agents showed a positive association with an increased risk of ACPA-positive RA. Dr. Kronzer and Dr. Sparks noted that breathing in insecticides and fungicides at work was associated with the highest odds ratios for having ACPA-positive RA (both 2.38).

“Importantly, both the number and duration of exposures exhibited a dose-response effect on RA risk,” the editorialists said.

They also picked out that there was “a gene-environment interaction for RA risk for certain inhalants,” including diesel engine exhaust, asbestos, carbon monoxide, and quartz dust.

Smoking amplified the risk for ACPA-positive RA associated with certain agents, such as detergents, and adding in genetic susceptibility for a third exposure increased the risk still further.

A key message is that there are many agents that can affect the airways and increase the risk of RA rather than there being a specific one, Dr. Klareskog said.

“On one hand, it’s a message of public health,” he said. Many public health authorities are aware of the potential risks of inhaled agents on the lung, “but this just adds another dimension that it’s bad also for rheumatoid arthritis.” Thus, greater efforts to help protect people from being exposed at work may be needed.

From the individual’s perspective, “if you have RA or other immune diseases in your family, then you may know that you’re at increased risk,” Dr. Klareskog said. The message here is perhaps to “be aware, [protect yourself], and stop smoking.”

The EIRA study was supported by funding from the Swedish Research Foundation for Health, Working Life, and Welfare, the Swedish Research Council, the AFA foundation, Region Stockholm, King Gustaf V’s 80-year foundation, and the Swedish Rheumatic Foundation. Dr. Klareskog and coauthors had no competing interests to disclose. Dr. Kronzer and Dr. Sparks had no disclosures of relevance to their comments.

Exposure to inhaled agents in the workplace could be putting people at risk of developing rheumatoid arthritis, according to research published in Annals of the Rheumatic Diseases.

In an analysis of data from the long-running Swedish Epidemiological Investigation of RA (EIRA) population-based cohort study, there was a 21% increased risk of RA and a 25% increased risk of anti–citrullinated protein antibody (ACPA)–positive RA associated with exposure to any occupationally inhaled agent.

LOOK PHOTO / Fotolia.com

“We have investigated a number of occupational airborne exposures and found that exposure for those agents infer a high risk for RA,” Lars Klareskog, MD, PhD, senior professor of rheumatology at the Karolinska Institute and Karolinska University Hospital (Solna) in Stockholm, said in an interview.

Dr. Klareskog, who is one of the lead authors of the published work, added that the risk is particularly high in individuals who had a genetic susceptibility and in those who smoked.

“The importance of this is that it further demonstrates that exposures to the lung may trigger immune reactions associated with the major subset of rheumatoid arthritis,” Dr. Klareskog said. “Second, it shows that those exposed to these agents should be very keen to not smoke.” “These findings further implicate the respiratory tract mucosa in ACPA-positive RA pathogenesis,” agreed Vanessa L. Kronzer, MD, of the Mayo Clinic in Rochester, Minn., and Jeffrey A. Sparks, MD, MMSc, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston.

They also “impress the need for public policy initiatives related to occupational inhalants to prevent RA,” they suggested in an editorial.

Multiple occupational inhalable exposures assessed

In the analysis, the researchers assessed exposure to 32 inhalable agents in people with (n = 4,033) and without RA (n = 6,485). The list of agents considered included detergents, diesel engine exhaust, fine particulate matter, solvents, and agricultural chemicals.

A total of 17 agents showed a positive association with an increased risk of ACPA-positive RA. Dr. Kronzer and Dr. Sparks noted that breathing in insecticides and fungicides at work was associated with the highest odds ratios for having ACPA-positive RA (both 2.38).

“Importantly, both the number and duration of exposures exhibited a dose-response effect on RA risk,” the editorialists said.

They also picked out that there was “a gene-environment interaction for RA risk for certain inhalants,” including diesel engine exhaust, asbestos, carbon monoxide, and quartz dust.

Smoking amplified the risk for ACPA-positive RA associated with certain agents, such as detergents, and adding in genetic susceptibility for a third exposure increased the risk still further.

A key message is that there are many agents that can affect the airways and increase the risk of RA rather than there being a specific one, Dr. Klareskog said.

“On one hand, it’s a message of public health,” he said. Many public health authorities are aware of the potential risks of inhaled agents on the lung, “but this just adds another dimension that it’s bad also for rheumatoid arthritis.” Thus, greater efforts to help protect people from being exposed at work may be needed.

From the individual’s perspective, “if you have RA or other immune diseases in your family, then you may know that you’re at increased risk,” Dr. Klareskog said. The message here is perhaps to “be aware, [protect yourself], and stop smoking.”

The EIRA study was supported by funding from the Swedish Research Foundation for Health, Working Life, and Welfare, the Swedish Research Council, the AFA foundation, Region Stockholm, King Gustaf V’s 80-year foundation, and the Swedish Rheumatic Foundation. Dr. Klareskog and coauthors had no competing interests to disclose. Dr. Kronzer and Dr. Sparks had no disclosures of relevance to their comments.

Use of a tumor necrosis factor inhibitor (TNFi) or triple therapy with conventional, synthetic disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis have similar beneficial effects in reducing patients’ vascular inflammation and cardiovascular (CV) risk, according to results from a randomized, active comparator trial.

“The good news is, providers can rest assured that aggressive treatment for RA does reduce vascular inflammation and therefore cardiovascular risk,” lead author Daniel H. Solomon, MD, MPH, of Brigham and Women’s Hospital in Boston, told this news organization. “Part of the reason that treating people with potent disease-modifying agents is important is not only because of reductions in pain and improvements in function on the level of arthritis, but also because of the vascular impact.”

The small study, published in Annals of the Rheumatic Diseases, randomly assigned 115 patients with active RA despite methotrexate use to one of two treatment protocols for 24 weeks: addition of a TNFi or triple therapy with the addition of sulfasalazine and hydroxychloroquine. Participants had 18F-fluorodeoxyglucose (FDG)–PET/CT scans at baseline and 24 weeks to assess change in arterial inflammation, measured as an arterial target-to-background ratio (TBR) in the carotid arteries and aorta. The study achieved its outcomes despite a low 56.5% rate of adherence to 80% or more of randomized treatments.

Dr. Solomon said this is the first randomized trial comparing the effects of DMARDs on vascular inflammation in RA. The researchers hypothesized that TNFi would be superior to triple therapy for reducing vascular inflammation. “We found that they both reduced vascular inflammation on PET scanning to the same degree,” Dr. Solomon said.

Study results

In the TNFi group, the mean of the maximum of the TBR in the most diseased segment (MDS) of the index vessel declined from 2.72 to 2.47 for a delta of –0.24. In the triple-therapy patients, MDS declined from 2.62 to 2.43 for a delta of –0.19 (difference in deltas –0.02; 95% confidence interval, –0.19 to 0.15; P = .79).

Dr. Solomon explained the choice of FDG-PET/CT scanning to evaluate vascular inflammation in the study participants. “We know that FDG-PET/CT scanning correlates with CV risk, and we know that treatments like statins that impact CV risk reduce the inflammation as observed on FDG-PET/CT,” he said.

Although the study found no difference between the TNFi and triple therapy in terms of vascular outcomes, the conclusion is “a bit more nuanced,” Dr. Solomon said. “It tells us first that reducing inflammation with different strategies in rheumatoid arthritis can similarly impact vascular inflammation. That’s great news. These are aggressive treatment strategies, so if you can reduce vascular inflammation in a significant manner, that should result in reduced cardiovascular risk over time.” 

Although the choice of TNFi or triple therapy may not matter for reducing CV risk, Dr. Solomon said, “It matters that you choose something that’s aggressive and that you use it in people who have active disease. That’s another part of the story: People who have active disease have worse vascular inflammation, which translates into a reduction in cardiovascular risk – but it’s not differentially reduced.”

Underlying mechanisms of CVD in RA

Commenting on the research for this news organization, Lihi Eder, MD, PhD, codirector of the cardio-rheumatology program at Women’s College Hospital in Toronto, said the study findings build on what’s known about some of the underlying mechanisms of cardiovascular diseases in RA and how to optimize treatments to reduce the risk.

“Importantly,” she said, “none of these treatment strategies was superior, suggesting that both treatment options are acceptable when considering cardiovascular risk reduction, in addition to controlling RA activity.”

The strengths of the study are its randomized, controlled design “conducted by a strong team of investigators,” and that it addressed questions relevant to routine practice, said Dr. Eder, who was not involved with the study.

The study’s use of FDG-PET/CT as a surrogate outcome is a limitation, she noted. “Although it would have been very challenging to perform a similar study that will include clinical events as a study outcome.” Another limitation, she said, was the low adherence rate to randomized treatments.

“Additional studies that will compare other modes of action [for example, interleukin-6 inhibitors, Janus kinase inhibitors, anti-CD20 monoclonal antibodies] could broaden our understanding regarding the inflammatory pathways driving CV risk in RA,” Dr. Eder added.

The study received funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. AbbVie and Amgen supplied drugs used in the study. Dr. Solomon disclosed receiving research support from AbbVie, Amgen, CorEvitas, and Moderna, and royalties from UpToDate. Dr. Eder reports no relevant financial relationships.

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

Use of a tumor necrosis factor inhibitor (TNFi) or triple therapy with conventional, synthetic disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis have similar beneficial effects in reducing patients’ vascular inflammation and cardiovascular (CV) risk, according to results from a randomized, active comparator trial.

“The good news is, providers can rest assured that aggressive treatment for RA does reduce vascular inflammation and therefore cardiovascular risk,” lead author Daniel H. Solomon, MD, MPH, of Brigham and Women’s Hospital in Boston, told this news organization. “Part of the reason that treating people with potent disease-modifying agents is important is not only because of reductions in pain and improvements in function on the level of arthritis, but also because of the vascular impact.”

The small study, published in Annals of the Rheumatic Diseases, randomly assigned 115 patients with active RA despite methotrexate use to one of two treatment protocols for 24 weeks: addition of a TNFi or triple therapy with the addition of sulfasalazine and hydroxychloroquine. Participants had 18F-fluorodeoxyglucose (FDG)–PET/CT scans at baseline and 24 weeks to assess change in arterial inflammation, measured as an arterial target-to-background ratio (TBR) in the carotid arteries and aorta. The study achieved its outcomes despite a low 56.5% rate of adherence to 80% or more of randomized treatments.

Dr. Solomon said this is the first randomized trial comparing the effects of DMARDs on vascular inflammation in RA. The researchers hypothesized that TNFi would be superior to triple therapy for reducing vascular inflammation. “We found that they both reduced vascular inflammation on PET scanning to the same degree,” Dr. Solomon said.

Study results

In the TNFi group, the mean of the maximum of the TBR in the most diseased segment (MDS) of the index vessel declined from 2.72 to 2.47 for a delta of –0.24. In the triple-therapy patients, MDS declined from 2.62 to 2.43 for a delta of –0.19 (difference in deltas –0.02; 95% confidence interval, –0.19 to 0.15; P = .79).

Dr. Solomon explained the choice of FDG-PET/CT scanning to evaluate vascular inflammation in the study participants. “We know that FDG-PET/CT scanning correlates with CV risk, and we know that treatments like statins that impact CV risk reduce the inflammation as observed on FDG-PET/CT,” he said.

Although the study found no difference between the TNFi and triple therapy in terms of vascular outcomes, the conclusion is “a bit more nuanced,” Dr. Solomon said. “It tells us first that reducing inflammation with different strategies in rheumatoid arthritis can similarly impact vascular inflammation. That’s great news. These are aggressive treatment strategies, so if you can reduce vascular inflammation in a significant manner, that should result in reduced cardiovascular risk over time.” 

Although the choice of TNFi or triple therapy may not matter for reducing CV risk, Dr. Solomon said, “It matters that you choose something that’s aggressive and that you use it in people who have active disease. That’s another part of the story: People who have active disease have worse vascular inflammation, which translates into a reduction in cardiovascular risk – but it’s not differentially reduced.”

Underlying mechanisms of CVD in RA

Commenting on the research for this news organization, Lihi Eder, MD, PhD, codirector of the cardio-rheumatology program at Women’s College Hospital in Toronto, said the study findings build on what’s known about some of the underlying mechanisms of cardiovascular diseases in RA and how to optimize treatments to reduce the risk.

“Importantly,” she said, “none of these treatment strategies was superior, suggesting that both treatment options are acceptable when considering cardiovascular risk reduction, in addition to controlling RA activity.”

The strengths of the study are its randomized, controlled design “conducted by a strong team of investigators,” and that it addressed questions relevant to routine practice, said Dr. Eder, who was not involved with the study.

The study’s use of FDG-PET/CT as a surrogate outcome is a limitation, she noted. “Although it would have been very challenging to perform a similar study that will include clinical events as a study outcome.” Another limitation, she said, was the low adherence rate to randomized treatments.

“Additional studies that will compare other modes of action [for example, interleukin-6 inhibitors, Janus kinase inhibitors, anti-CD20 monoclonal antibodies] could broaden our understanding regarding the inflammatory pathways driving CV risk in RA,” Dr. Eder added.

The study received funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. AbbVie and Amgen supplied drugs used in the study. Dr. Solomon disclosed receiving research support from AbbVie, Amgen, CorEvitas, and Moderna, and royalties from UpToDate. Dr. Eder reports no relevant financial relationships.

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

Use of a tumor necrosis factor inhibitor (TNFi) or triple therapy with conventional, synthetic disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis have similar beneficial effects in reducing patients’ vascular inflammation and cardiovascular (CV) risk, according to results from a randomized, active comparator trial.

“The good news is, providers can rest assured that aggressive treatment for RA does reduce vascular inflammation and therefore cardiovascular risk,” lead author Daniel H. Solomon, MD, MPH, of Brigham and Women’s Hospital in Boston, told this news organization. “Part of the reason that treating people with potent disease-modifying agents is important is not only because of reductions in pain and improvements in function on the level of arthritis, but also because of the vascular impact.”

The small study, published in Annals of the Rheumatic Diseases, randomly assigned 115 patients with active RA despite methotrexate use to one of two treatment protocols for 24 weeks: addition of a TNFi or triple therapy with the addition of sulfasalazine and hydroxychloroquine. Participants had 18F-fluorodeoxyglucose (FDG)–PET/CT scans at baseline and 24 weeks to assess change in arterial inflammation, measured as an arterial target-to-background ratio (TBR) in the carotid arteries and aorta. The study achieved its outcomes despite a low 56.5% rate of adherence to 80% or more of randomized treatments.

Dr. Solomon said this is the first randomized trial comparing the effects of DMARDs on vascular inflammation in RA. The researchers hypothesized that TNFi would be superior to triple therapy for reducing vascular inflammation. “We found that they both reduced vascular inflammation on PET scanning to the same degree,” Dr. Solomon said.

Study results

In the TNFi group, the mean of the maximum of the TBR in the most diseased segment (MDS) of the index vessel declined from 2.72 to 2.47 for a delta of –0.24. In the triple-therapy patients, MDS declined from 2.62 to 2.43 for a delta of –0.19 (difference in deltas –0.02; 95% confidence interval, –0.19 to 0.15; P = .79).

Dr. Solomon explained the choice of FDG-PET/CT scanning to evaluate vascular inflammation in the study participants. “We know that FDG-PET/CT scanning correlates with CV risk, and we know that treatments like statins that impact CV risk reduce the inflammation as observed on FDG-PET/CT,” he said.

Although the study found no difference between the TNFi and triple therapy in terms of vascular outcomes, the conclusion is “a bit more nuanced,” Dr. Solomon said. “It tells us first that reducing inflammation with different strategies in rheumatoid arthritis can similarly impact vascular inflammation. That’s great news. These are aggressive treatment strategies, so if you can reduce vascular inflammation in a significant manner, that should result in reduced cardiovascular risk over time.” 

Although the choice of TNFi or triple therapy may not matter for reducing CV risk, Dr. Solomon said, “It matters that you choose something that’s aggressive and that you use it in people who have active disease. That’s another part of the story: People who have active disease have worse vascular inflammation, which translates into a reduction in cardiovascular risk – but it’s not differentially reduced.”

Underlying mechanisms of CVD in RA

Commenting on the research for this news organization, Lihi Eder, MD, PhD, codirector of the cardio-rheumatology program at Women’s College Hospital in Toronto, said the study findings build on what’s known about some of the underlying mechanisms of cardiovascular diseases in RA and how to optimize treatments to reduce the risk.

“Importantly,” she said, “none of these treatment strategies was superior, suggesting that both treatment options are acceptable when considering cardiovascular risk reduction, in addition to controlling RA activity.”

The strengths of the study are its randomized, controlled design “conducted by a strong team of investigators,” and that it addressed questions relevant to routine practice, said Dr. Eder, who was not involved with the study.

The study’s use of FDG-PET/CT as a surrogate outcome is a limitation, she noted. “Although it would have been very challenging to perform a similar study that will include clinical events as a study outcome.” Another limitation, she said, was the low adherence rate to randomized treatments.

“Additional studies that will compare other modes of action [for example, interleukin-6 inhibitors, Janus kinase inhibitors, anti-CD20 monoclonal antibodies] could broaden our understanding regarding the inflammatory pathways driving CV risk in RA,” Dr. Eder added.

The study received funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. AbbVie and Amgen supplied drugs used in the study. Dr. Solomon disclosed receiving research support from AbbVie, Amgen, CorEvitas, and Moderna, and royalties from UpToDate. Dr. Eder reports no relevant financial relationships.

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

Asking knee osteoarthritis patients a simple question – do you have difficulty climbing stairs? – may predict the risk of future functional limitation, according to research presented at the annual meeting of the American College of Rheumatology. Finding out that the patient has difficulty also opens avenues for further evaluation and intervention, said Jason Jakiela, a PhD candidate at the University of Delaware, Newark, who led the study. “We like to view it as a kind of yellow flag,” Mr. Jakiela said in an interview.

Another expert agreed. “I think this is useful for clinical rheumatologists,” said C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona, Tucson, and director of the University of Arizona Arthritis Center. He commented on the study findings but was not involved in the study. Another common question asked of OA patients, about pain, may not be as useful as asking about difficulty climbing stairs, he said. “Their pain level can go up and down and can be quite varied.”

decade3d/Thinkstock

Study details, results

Mr. Jakiela and his team, including Daniel White, PT, ScD, MSC, associate professor of physical therapy at the University of Delaware, Newark, used data from the Osteoarthritis Initiative (OAI). They assessed stair climbing difficulty at baseline with the question: Does your health now limit you in climbing several flights of stairs? Respondents could answer that they were limited a lot, a little, or not at all.

The researchers evaluated functional limitation using two measures: Walking speed and Western Ontario and McMaster Universities Osteoarthritis Index physical function (WOMAC-PF) scores. A walking speed of < 1.22 m/s over 20 meters, the speed needed to safely cross a timed intersection, represented poor function. A WOMAC-PF score of 28/68 or more was also used to define low functioning.

The analyses included only people free of functional limitations at baseline. Each measure was conducted at the start and then at 12, 24, 36, 48, 72, and 96 months’ follow-up visits.

While 2,952 participants (mean age 60.1, 54% female, mean body mass index 27.9) were in the walking speed sample, 3,983 participants (mean age 61.2, 57% female, mean BMI 28.2) were in the WOMAC-PF sample.

Starting the conversation

The question about stair climbing difficulty is a good “jumping-off point,” Mr. Jakiela said. “It opens up a line of questioning.” With knee OA, stair climbing difficulty is often the first reported limitation. That difficulty could capture a variety of issues, he said. Patients could be struggling with strength issues, cardiovascular problems, or balance deficits, for instance.

It signals there may be a trajectory of slow decline coming in this patient, Mr. Jakiela said.

“It’s a signal that something is not right,” Dr. White said in an interview. “We don’t know what is wrong.” While questions about stairs have routinely been asked of OA patients, the study findings suggest the answer to the question about having difficulty could help predict a patient’s future course, he said.

After patients reported a little or a lot of difficulty with stair climbing, the average time to reach functional limitation status was about 3 years, Mr. Jakiela said. That gives health care providers time to ask more questions about the patient’s condition and potentially intervene, depending on the details of the difficulty. If it’s a balance issue, physical therapy might help, for example.

While gait speed is a tried-and-true indication, collecting answers about stair climbing difficulty is easier and quicker for clinicians than assessing gait speed, which requires more time as well as office space, Mr. Jakiela said. It’s also intuitive for the patients to recall, the researchers said.
 

More practical takeaways

Finding out whether functional limitation is likely, based on the stair question, can help health care providers consider nonpharmacologic interventions, Dr. Kwoh agreed, such as physical therapy or braces. “It doesn’t have to be drugs. We have limited drugs for OA at the moment. We don’t have a so-called DMARD drug [for OA].”

NSAIDs have side effects, and people are very familiar with the issues of opioids, he said. It’s important, he added, for the health care provider, if referring to a physical therapist, to find the right one. To help those dealing with knee OA, a PT in sports medicine might be a good choice, he said.

Mr. Jakiela has no disclosures. Dr. Kwoh and Dr. White have no relevant disclosures.

Asking knee osteoarthritis patients a simple question – do you have difficulty climbing stairs? – may predict the risk of future functional limitation, according to research presented at the annual meeting of the American College of Rheumatology. Finding out that the patient has difficulty also opens avenues for further evaluation and intervention, said Jason Jakiela, a PhD candidate at the University of Delaware, Newark, who led the study. “We like to view it as a kind of yellow flag,” Mr. Jakiela said in an interview.

Another expert agreed. “I think this is useful for clinical rheumatologists,” said C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona, Tucson, and director of the University of Arizona Arthritis Center. He commented on the study findings but was not involved in the study. Another common question asked of OA patients, about pain, may not be as useful as asking about difficulty climbing stairs, he said. “Their pain level can go up and down and can be quite varied.”

decade3d/Thinkstock

Study details, results

Mr. Jakiela and his team, including Daniel White, PT, ScD, MSC, associate professor of physical therapy at the University of Delaware, Newark, used data from the Osteoarthritis Initiative (OAI). They assessed stair climbing difficulty at baseline with the question: Does your health now limit you in climbing several flights of stairs? Respondents could answer that they were limited a lot, a little, or not at all.

The researchers evaluated functional limitation using two measures: Walking speed and Western Ontario and McMaster Universities Osteoarthritis Index physical function (WOMAC-PF) scores. A walking speed of < 1.22 m/s over 20 meters, the speed needed to safely cross a timed intersection, represented poor function. A WOMAC-PF score of 28/68 or more was also used to define low functioning.

The analyses included only people free of functional limitations at baseline. Each measure was conducted at the start and then at 12, 24, 36, 48, 72, and 96 months’ follow-up visits.

While 2,952 participants (mean age 60.1, 54% female, mean body mass index 27.9) were in the walking speed sample, 3,983 participants (mean age 61.2, 57% female, mean BMI 28.2) were in the WOMAC-PF sample.

Starting the conversation

The question about stair climbing difficulty is a good “jumping-off point,” Mr. Jakiela said. “It opens up a line of questioning.” With knee OA, stair climbing difficulty is often the first reported limitation. That difficulty could capture a variety of issues, he said. Patients could be struggling with strength issues, cardiovascular problems, or balance deficits, for instance.

It signals there may be a trajectory of slow decline coming in this patient, Mr. Jakiela said.

“It’s a signal that something is not right,” Dr. White said in an interview. “We don’t know what is wrong.” While questions about stairs have routinely been asked of OA patients, the study findings suggest the answer to the question about having difficulty could help predict a patient’s future course, he said.

After patients reported a little or a lot of difficulty with stair climbing, the average time to reach functional limitation status was about 3 years, Mr. Jakiela said. That gives health care providers time to ask more questions about the patient’s condition and potentially intervene, depending on the details of the difficulty. If it’s a balance issue, physical therapy might help, for example.

While gait speed is a tried-and-true indication, collecting answers about stair climbing difficulty is easier and quicker for clinicians than assessing gait speed, which requires more time as well as office space, Mr. Jakiela said. It’s also intuitive for the patients to recall, the researchers said.
 

More practical takeaways

Finding out whether functional limitation is likely, based on the stair question, can help health care providers consider nonpharmacologic interventions, Dr. Kwoh agreed, such as physical therapy or braces. “It doesn’t have to be drugs. We have limited drugs for OA at the moment. We don’t have a so-called DMARD drug [for OA].”

NSAIDs have side effects, and people are very familiar with the issues of opioids, he said. It’s important, he added, for the health care provider, if referring to a physical therapist, to find the right one. To help those dealing with knee OA, a PT in sports medicine might be a good choice, he said.

Mr. Jakiela has no disclosures. Dr. Kwoh and Dr. White have no relevant disclosures.

Asking knee osteoarthritis patients a simple question – do you have difficulty climbing stairs? – may predict the risk of future functional limitation, according to research presented at the annual meeting of the American College of Rheumatology. Finding out that the patient has difficulty also opens avenues for further evaluation and intervention, said Jason Jakiela, a PhD candidate at the University of Delaware, Newark, who led the study. “We like to view it as a kind of yellow flag,” Mr. Jakiela said in an interview.

Another expert agreed. “I think this is useful for clinical rheumatologists,” said C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona, Tucson, and director of the University of Arizona Arthritis Center. He commented on the study findings but was not involved in the study. Another common question asked of OA patients, about pain, may not be as useful as asking about difficulty climbing stairs, he said. “Their pain level can go up and down and can be quite varied.”

decade3d/Thinkstock

Study details, results

Mr. Jakiela and his team, including Daniel White, PT, ScD, MSC, associate professor of physical therapy at the University of Delaware, Newark, used data from the Osteoarthritis Initiative (OAI). They assessed stair climbing difficulty at baseline with the question: Does your health now limit you in climbing several flights of stairs? Respondents could answer that they were limited a lot, a little, or not at all.

The researchers evaluated functional limitation using two measures: Walking speed and Western Ontario and McMaster Universities Osteoarthritis Index physical function (WOMAC-PF) scores. A walking speed of < 1.22 m/s over 20 meters, the speed needed to safely cross a timed intersection, represented poor function. A WOMAC-PF score of 28/68 or more was also used to define low functioning.

The analyses included only people free of functional limitations at baseline. Each measure was conducted at the start and then at 12, 24, 36, 48, 72, and 96 months’ follow-up visits.

While 2,952 participants (mean age 60.1, 54% female, mean body mass index 27.9) were in the walking speed sample, 3,983 participants (mean age 61.2, 57% female, mean BMI 28.2) were in the WOMAC-PF sample.

Starting the conversation

The question about stair climbing difficulty is a good “jumping-off point,” Mr. Jakiela said. “It opens up a line of questioning.” With knee OA, stair climbing difficulty is often the first reported limitation. That difficulty could capture a variety of issues, he said. Patients could be struggling with strength issues, cardiovascular problems, or balance deficits, for instance.

It signals there may be a trajectory of slow decline coming in this patient, Mr. Jakiela said.

“It’s a signal that something is not right,” Dr. White said in an interview. “We don’t know what is wrong.” While questions about stairs have routinely been asked of OA patients, the study findings suggest the answer to the question about having difficulty could help predict a patient’s future course, he said.

After patients reported a little or a lot of difficulty with stair climbing, the average time to reach functional limitation status was about 3 years, Mr. Jakiela said. That gives health care providers time to ask more questions about the patient’s condition and potentially intervene, depending on the details of the difficulty. If it’s a balance issue, physical therapy might help, for example.

While gait speed is a tried-and-true indication, collecting answers about stair climbing difficulty is easier and quicker for clinicians than assessing gait speed, which requires more time as well as office space, Mr. Jakiela said. It’s also intuitive for the patients to recall, the researchers said.
 

More practical takeaways

Finding out whether functional limitation is likely, based on the stair question, can help health care providers consider nonpharmacologic interventions, Dr. Kwoh agreed, such as physical therapy or braces. “It doesn’t have to be drugs. We have limited drugs for OA at the moment. We don’t have a so-called DMARD drug [for OA].”

NSAIDs have side effects, and people are very familiar with the issues of opioids, he said. It’s important, he added, for the health care provider, if referring to a physical therapist, to find the right one. To help those dealing with knee OA, a PT in sports medicine might be a good choice, he said.

Mr. Jakiela has no disclosures. Dr. Kwoh and Dr. White have no relevant disclosures.

Patients with rheumatic disease are at least half as likely to develop long COVID after a SARS-CoV-2 infection if they have been fully vaccinated against COVID-19, according to research published in Annals of the Rheumatic Diseases (2022 Nov 28. doi: 10.1136/ard-2022-223439).

“Moreover, those who were vaccinated prior to getting COVID-19 had less pain and fatigue after their infection,” Zachary S. Wallace, MD, MSc, an assistant professor of medicine at Harvard Medical School, Boston, and a study author, said in an interview. “These findings reinforce the importance of vaccination in this population.”

Messaging around the value of COVID vaccination has been confusing for some with rheumatic disease “because our concern regarding a blunted response to vaccination has led many patients to think that they do not provide much benefit if they are on immunosuppression,” Dr. Wallace said. “In our cohort, which included many patients on immunosuppression of varying degrees, being vaccinated was quite beneficial.”

Leonard H. Calabrese, DO, director of the R.J. Fasenmyer Center for Clinical Immunology and a professor of medicine at the Cleveland Clinic, said in an interview that the study is an “extremely important contribution to our understanding of COVID-19 and its pattern of recovery in patients with immune-mediated inflammatory diseases [IMIDs].” Remaining unanswered questions are “whether patients with IMIDs develop more frequent PASC [post–acute sequelae of COVID-19] from COVID-19 and, if so, is it milder or more severe, and does it differ in its clinical phenotype?”
 

Long COVID risk assessed at 4 weeks and 3 months after infection

The researchers prospectively tracked 280 adult patients in the Mass General Brigham health care system in the greater Boston area who had systemic autoimmune rheumatic diseases and had an acute COVID-19 infection between March 2020 and July 2022. Patients were an average 53 years old, and most were White (82%) and female (80%). More than half (59%) had inflammatory arthritis, a quarter (24%) had connective tissue disease, and most others had a vasculitis condition or multiple conditions.

filadendron/E+/Getty Images

A total of 11% of patients were unvaccinated, 28% were partially vaccinated with one mRNA COVID-19 vaccine dose, and 41% were fully vaccinated with two mRNA vaccine doses or one Johnson & Johnson dose. The 116 fully vaccinated patients were considered to have a breakthrough infection while the other 164 were considered to have a nonbreakthrough infection. The breakthrough and nonbreakthrough groups were similar in terms of age, sex, race, ethnicity, smoking status, and type of rheumatic disease. Comorbidities were also similar, except obesity, which was more common in the non–breakthrough infection group (25%) than the breakthrough infection group (10%).

The researchers queried patients on their COVID-19 symptoms, how long symptoms lasted, treatments they received, and hospitalization details. COVID-19 symptoms assessed included fever, sore throat, new cough, nasal congestion/rhinorrhea, dyspnea, chest pain, rash, myalgia, fatigue/malaise, headache, nausea/vomiting, diarrhea, anosmia, dysgeusia, and joint pain.

Patients completed surveys about symptoms at 4 weeks and 3 months after infection. Long COVID, or PASC, was defined as any persistent symptom at the times assessed.
 

Vaccinated patients fared better across outcomes

At 4 weeks after infection, 41% of fully vaccinated patients had at least one persistent symptom, compared with 54% of unvaccinated or partially vaccinated patients (P = .04). At 3 months after infection, 21% of fully vaccinated patients had at least one persistent symptom, compared with 41% of unvaccinated or partially vaccinated patients (P < .0001).

Vaccinated patients were half as likely to have long COVID at 4 weeks after infection (adjusted odds ratio, 0.49) and 90% less likely to have long COVID 3 months after infection (aOR, 0.1), after adjustment for age, sex, race, comorbidities, and use of any of four immune-suppressing medications (anti-CD20 monoclonal antibodies, methotrexate, mycophenolate, or glucocorticoids).

Fully vaccinated patients with breakthrough infections had an average 21 additional days without symptoms during follow-up, compared with unvaccinated and partially vaccinated patients (P = .04).

Reduced risk of long COVID did not change for vaccinated patients after sensitivity analyses for those who did not receive nirmatrelvir/ritonavir (Paxlovid) or monoclonal antibodies, those who didn’t receive any COVID-19-related treatment, those who completed their questionnaires within 6 months after infection, and those who were not hospitalized.

“One important message is that among those who did get PASC, the severity appears similar among those with and without a breakthrough infection,” Dr. Wallace said. “This highlights the need for ongoing research to improve recognition, diagnosis, and treatment of PASC.”

Many more breakthrough infections (72%) than nonbreakthrough infections (2%) occurred during Omicron. The authors acknowledged that different variants might play a role in different long COVID risks but said such potential confounding is unlikely to fully explain the results.

“Even with data suggesting that the Omicron variants may be intrinsically less severe, vaccination still has an impact on severity of infection, rates of hospitalization, and other outcomes and thus may play a role in the risk of PASC,” lead author Naomi Patel, MD, an instructor at Harvard Medical School and a rheumatologist at Massachusetts General Hospital, said in an interview. “A study evaluating the proportions with PASC by vaccination status during the time in which a single variant is predominant, such as the early Omicron era, could help to better assess the more isolated impact of vaccination on PASC.”

Dr. Calabrese said he is convinced that Omicron infections are less likely to result in more severe forms of acute COVID than pre-Omicron infections, and he suspects Omicron infections are also less likely to result in long COVID, although less evidence currently supports this hypothesis.

Hospitalization was more common in unvaccinated/partly vaccinated patients than in vaccinated patients (27% vs. 5%; P = .001). Although pain and fatigue were lower in those with breakthrough infections, functional scores and health-related quality of life were similar in both groups.

Some symptoms significantly differed between vaccinated and unvaccinated/partly vaccinated groups, possibly caused partly by different variants. Nasal congestion was more common (73%) in those with breakthrough infections than in those with nonbreakthrough infections (46%; P < .0001). Those who were unvaccinated/partly vaccinated were significantly more likely to have loss of smell (46% vs. 22%) or taste (45% vs. 28%) or to have joint pain (11% vs. 4%).

Treatment with nirmatrelvir/ritonavir was also more common in vaccinated patients (12%) than in unvaccinated/partly vaccinated patients (1%; P < .0001), as was treatment with monoclonal antibodies (34% vs. 8%; P < .0001).

The study was limited by its low diversity and being at a single health care system, the authors said. Study coauthor Jeffrey A. Sparks, MD, MMSc, an assistant professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, said in an interview that the group is planning additional studies as their cohort grows, including “investigating the relationships between COVID-19 and specific rheumatic diseases and immunomodulating medications, expansion of autoimmunity and systemic inflammation, and lung damage among specific patient populations.”

Dr. Calabrese said it will be important for follow-up study of the symptomatic patients to “determine how many of these patients will fit the clinical picture of long COVID or long-haul phenotypes over the months and years ahead, including documenting exertional malaise and quality of life.

This study only assessed patients who received zero, one, or two doses of a vaccine, but many patients with rheumatic disease today will likely have received booster doses. However, Dr. Calabrese said it would be difficult to quantify whether a third, fourth, or fifth dose offers additional protection from long-term COVID complications after full vaccination or hybrid vaccination.

The research was funded by the Rheumatology Research Foundation, the National Institutes of Health, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Wallace has received research support from Bristol-Myers Squibb and Principia/Sanofi and consulting fees from Zenas BioPharma, Horizon, Sanofi, Shionogi, Viela Bio, and Medpace. Dr. Sparks has received research support from Bristol-Myers Squibb and consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer. Dr. Patel has received consulting fees from FVC Health. Calabrese has consulted for Genentech, Sanofi-Regeneron, AstraZeneca, and GlaxoSmithKline.

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

Patients with rheumatic disease are at least half as likely to develop long COVID after a SARS-CoV-2 infection if they have been fully vaccinated against COVID-19, according to research published in Annals of the Rheumatic Diseases (2022 Nov 28. doi: 10.1136/ard-2022-223439).

“Moreover, those who were vaccinated prior to getting COVID-19 had less pain and fatigue after their infection,” Zachary S. Wallace, MD, MSc, an assistant professor of medicine at Harvard Medical School, Boston, and a study author, said in an interview. “These findings reinforce the importance of vaccination in this population.”

Messaging around the value of COVID vaccination has been confusing for some with rheumatic disease “because our concern regarding a blunted response to vaccination has led many patients to think that they do not provide much benefit if they are on immunosuppression,” Dr. Wallace said. “In our cohort, which included many patients on immunosuppression of varying degrees, being vaccinated was quite beneficial.”

Leonard H. Calabrese, DO, director of the R.J. Fasenmyer Center for Clinical Immunology and a professor of medicine at the Cleveland Clinic, said in an interview that the study is an “extremely important contribution to our understanding of COVID-19 and its pattern of recovery in patients with immune-mediated inflammatory diseases [IMIDs].” Remaining unanswered questions are “whether patients with IMIDs develop more frequent PASC [post–acute sequelae of COVID-19] from COVID-19 and, if so, is it milder or more severe, and does it differ in its clinical phenotype?”
 

Long COVID risk assessed at 4 weeks and 3 months after infection

The researchers prospectively tracked 280 adult patients in the Mass General Brigham health care system in the greater Boston area who had systemic autoimmune rheumatic diseases and had an acute COVID-19 infection between March 2020 and July 2022. Patients were an average 53 years old, and most were White (82%) and female (80%). More than half (59%) had inflammatory arthritis, a quarter (24%) had connective tissue disease, and most others had a vasculitis condition or multiple conditions.

filadendron/E+/Getty Images

A total of 11% of patients were unvaccinated, 28% were partially vaccinated with one mRNA COVID-19 vaccine dose, and 41% were fully vaccinated with two mRNA vaccine doses or one Johnson & Johnson dose. The 116 fully vaccinated patients were considered to have a breakthrough infection while the other 164 were considered to have a nonbreakthrough infection. The breakthrough and nonbreakthrough groups were similar in terms of age, sex, race, ethnicity, smoking status, and type of rheumatic disease. Comorbidities were also similar, except obesity, which was more common in the non–breakthrough infection group (25%) than the breakthrough infection group (10%).

The researchers queried patients on their COVID-19 symptoms, how long symptoms lasted, treatments they received, and hospitalization details. COVID-19 symptoms assessed included fever, sore throat, new cough, nasal congestion/rhinorrhea, dyspnea, chest pain, rash, myalgia, fatigue/malaise, headache, nausea/vomiting, diarrhea, anosmia, dysgeusia, and joint pain.

Patients completed surveys about symptoms at 4 weeks and 3 months after infection. Long COVID, or PASC, was defined as any persistent symptom at the times assessed.
 

Vaccinated patients fared better across outcomes

At 4 weeks after infection, 41% of fully vaccinated patients had at least one persistent symptom, compared with 54% of unvaccinated or partially vaccinated patients (P = .04). At 3 months after infection, 21% of fully vaccinated patients had at least one persistent symptom, compared with 41% of unvaccinated or partially vaccinated patients (P < .0001).

Vaccinated patients were half as likely to have long COVID at 4 weeks after infection (adjusted odds ratio, 0.49) and 90% less likely to have long COVID 3 months after infection (aOR, 0.1), after adjustment for age, sex, race, comorbidities, and use of any of four immune-suppressing medications (anti-CD20 monoclonal antibodies, methotrexate, mycophenolate, or glucocorticoids).

Fully vaccinated patients with breakthrough infections had an average 21 additional days without symptoms during follow-up, compared with unvaccinated and partially vaccinated patients (P = .04).

Reduced risk of long COVID did not change for vaccinated patients after sensitivity analyses for those who did not receive nirmatrelvir/ritonavir (Paxlovid) or monoclonal antibodies, those who didn’t receive any COVID-19-related treatment, those who completed their questionnaires within 6 months after infection, and those who were not hospitalized.

“One important message is that among those who did get PASC, the severity appears similar among those with and without a breakthrough infection,” Dr. Wallace said. “This highlights the need for ongoing research to improve recognition, diagnosis, and treatment of PASC.”

Many more breakthrough infections (72%) than nonbreakthrough infections (2%) occurred during Omicron. The authors acknowledged that different variants might play a role in different long COVID risks but said such potential confounding is unlikely to fully explain the results.

“Even with data suggesting that the Omicron variants may be intrinsically less severe, vaccination still has an impact on severity of infection, rates of hospitalization, and other outcomes and thus may play a role in the risk of PASC,” lead author Naomi Patel, MD, an instructor at Harvard Medical School and a rheumatologist at Massachusetts General Hospital, said in an interview. “A study evaluating the proportions with PASC by vaccination status during the time in which a single variant is predominant, such as the early Omicron era, could help to better assess the more isolated impact of vaccination on PASC.”

Dr. Calabrese said he is convinced that Omicron infections are less likely to result in more severe forms of acute COVID than pre-Omicron infections, and he suspects Omicron infections are also less likely to result in long COVID, although less evidence currently supports this hypothesis.

Hospitalization was more common in unvaccinated/partly vaccinated patients than in vaccinated patients (27% vs. 5%; P = .001). Although pain and fatigue were lower in those with breakthrough infections, functional scores and health-related quality of life were similar in both groups.

Some symptoms significantly differed between vaccinated and unvaccinated/partly vaccinated groups, possibly caused partly by different variants. Nasal congestion was more common (73%) in those with breakthrough infections than in those with nonbreakthrough infections (46%; P < .0001). Those who were unvaccinated/partly vaccinated were significantly more likely to have loss of smell (46% vs. 22%) or taste (45% vs. 28%) or to have joint pain (11% vs. 4%).

Treatment with nirmatrelvir/ritonavir was also more common in vaccinated patients (12%) than in unvaccinated/partly vaccinated patients (1%; P < .0001), as was treatment with monoclonal antibodies (34% vs. 8%; P < .0001).

The study was limited by its low diversity and being at a single health care system, the authors said. Study coauthor Jeffrey A. Sparks, MD, MMSc, an assistant professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, said in an interview that the group is planning additional studies as their cohort grows, including “investigating the relationships between COVID-19 and specific rheumatic diseases and immunomodulating medications, expansion of autoimmunity and systemic inflammation, and lung damage among specific patient populations.”

Dr. Calabrese said it will be important for follow-up study of the symptomatic patients to “determine how many of these patients will fit the clinical picture of long COVID or long-haul phenotypes over the months and years ahead, including documenting exertional malaise and quality of life.

This study only assessed patients who received zero, one, or two doses of a vaccine, but many patients with rheumatic disease today will likely have received booster doses. However, Dr. Calabrese said it would be difficult to quantify whether a third, fourth, or fifth dose offers additional protection from long-term COVID complications after full vaccination or hybrid vaccination.

The research was funded by the Rheumatology Research Foundation, the National Institutes of Health, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Wallace has received research support from Bristol-Myers Squibb and Principia/Sanofi and consulting fees from Zenas BioPharma, Horizon, Sanofi, Shionogi, Viela Bio, and Medpace. Dr. Sparks has received research support from Bristol-Myers Squibb and consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer. Dr. Patel has received consulting fees from FVC Health. Calabrese has consulted for Genentech, Sanofi-Regeneron, AstraZeneca, and GlaxoSmithKline.

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

Patients with rheumatic disease are at least half as likely to develop long COVID after a SARS-CoV-2 infection if they have been fully vaccinated against COVID-19, according to research published in Annals of the Rheumatic Diseases (2022 Nov 28. doi: 10.1136/ard-2022-223439).

“Moreover, those who were vaccinated prior to getting COVID-19 had less pain and fatigue after their infection,” Zachary S. Wallace, MD, MSc, an assistant professor of medicine at Harvard Medical School, Boston, and a study author, said in an interview. “These findings reinforce the importance of vaccination in this population.”

Messaging around the value of COVID vaccination has been confusing for some with rheumatic disease “because our concern regarding a blunted response to vaccination has led many patients to think that they do not provide much benefit if they are on immunosuppression,” Dr. Wallace said. “In our cohort, which included many patients on immunosuppression of varying degrees, being vaccinated was quite beneficial.”

Leonard H. Calabrese, DO, director of the R.J. Fasenmyer Center for Clinical Immunology and a professor of medicine at the Cleveland Clinic, said in an interview that the study is an “extremely important contribution to our understanding of COVID-19 and its pattern of recovery in patients with immune-mediated inflammatory diseases [IMIDs].” Remaining unanswered questions are “whether patients with IMIDs develop more frequent PASC [post–acute sequelae of COVID-19] from COVID-19 and, if so, is it milder or more severe, and does it differ in its clinical phenotype?”
 

Long COVID risk assessed at 4 weeks and 3 months after infection

The researchers prospectively tracked 280 adult patients in the Mass General Brigham health care system in the greater Boston area who had systemic autoimmune rheumatic diseases and had an acute COVID-19 infection between March 2020 and July 2022. Patients were an average 53 years old, and most were White (82%) and female (80%). More than half (59%) had inflammatory arthritis, a quarter (24%) had connective tissue disease, and most others had a vasculitis condition or multiple conditions.

filadendron/E+/Getty Images

A total of 11% of patients were unvaccinated, 28% were partially vaccinated with one mRNA COVID-19 vaccine dose, and 41% were fully vaccinated with two mRNA vaccine doses or one Johnson & Johnson dose. The 116 fully vaccinated patients were considered to have a breakthrough infection while the other 164 were considered to have a nonbreakthrough infection. The breakthrough and nonbreakthrough groups were similar in terms of age, sex, race, ethnicity, smoking status, and type of rheumatic disease. Comorbidities were also similar, except obesity, which was more common in the non–breakthrough infection group (25%) than the breakthrough infection group (10%).

The researchers queried patients on their COVID-19 symptoms, how long symptoms lasted, treatments they received, and hospitalization details. COVID-19 symptoms assessed included fever, sore throat, new cough, nasal congestion/rhinorrhea, dyspnea, chest pain, rash, myalgia, fatigue/malaise, headache, nausea/vomiting, diarrhea, anosmia, dysgeusia, and joint pain.

Patients completed surveys about symptoms at 4 weeks and 3 months after infection. Long COVID, or PASC, was defined as any persistent symptom at the times assessed.
 

Vaccinated patients fared better across outcomes

At 4 weeks after infection, 41% of fully vaccinated patients had at least one persistent symptom, compared with 54% of unvaccinated or partially vaccinated patients (P = .04). At 3 months after infection, 21% of fully vaccinated patients had at least one persistent symptom, compared with 41% of unvaccinated or partially vaccinated patients (P < .0001).

Vaccinated patients were half as likely to have long COVID at 4 weeks after infection (adjusted odds ratio, 0.49) and 90% less likely to have long COVID 3 months after infection (aOR, 0.1), after adjustment for age, sex, race, comorbidities, and use of any of four immune-suppressing medications (anti-CD20 monoclonal antibodies, methotrexate, mycophenolate, or glucocorticoids).

Fully vaccinated patients with breakthrough infections had an average 21 additional days without symptoms during follow-up, compared with unvaccinated and partially vaccinated patients (P = .04).

Reduced risk of long COVID did not change for vaccinated patients after sensitivity analyses for those who did not receive nirmatrelvir/ritonavir (Paxlovid) or monoclonal antibodies, those who didn’t receive any COVID-19-related treatment, those who completed their questionnaires within 6 months after infection, and those who were not hospitalized.

“One important message is that among those who did get PASC, the severity appears similar among those with and without a breakthrough infection,” Dr. Wallace said. “This highlights the need for ongoing research to improve recognition, diagnosis, and treatment of PASC.”

Many more breakthrough infections (72%) than nonbreakthrough infections (2%) occurred during Omicron. The authors acknowledged that different variants might play a role in different long COVID risks but said such potential confounding is unlikely to fully explain the results.

“Even with data suggesting that the Omicron variants may be intrinsically less severe, vaccination still has an impact on severity of infection, rates of hospitalization, and other outcomes and thus may play a role in the risk of PASC,” lead author Naomi Patel, MD, an instructor at Harvard Medical School and a rheumatologist at Massachusetts General Hospital, said in an interview. “A study evaluating the proportions with PASC by vaccination status during the time in which a single variant is predominant, such as the early Omicron era, could help to better assess the more isolated impact of vaccination on PASC.”

Dr. Calabrese said he is convinced that Omicron infections are less likely to result in more severe forms of acute COVID than pre-Omicron infections, and he suspects Omicron infections are also less likely to result in long COVID, although less evidence currently supports this hypothesis.

Hospitalization was more common in unvaccinated/partly vaccinated patients than in vaccinated patients (27% vs. 5%; P = .001). Although pain and fatigue were lower in those with breakthrough infections, functional scores and health-related quality of life were similar in both groups.

Some symptoms significantly differed between vaccinated and unvaccinated/partly vaccinated groups, possibly caused partly by different variants. Nasal congestion was more common (73%) in those with breakthrough infections than in those with nonbreakthrough infections (46%; P < .0001). Those who were unvaccinated/partly vaccinated were significantly more likely to have loss of smell (46% vs. 22%) or taste (45% vs. 28%) or to have joint pain (11% vs. 4%).

Treatment with nirmatrelvir/ritonavir was also more common in vaccinated patients (12%) than in unvaccinated/partly vaccinated patients (1%; P < .0001), as was treatment with monoclonal antibodies (34% vs. 8%; P < .0001).

The study was limited by its low diversity and being at a single health care system, the authors said. Study coauthor Jeffrey A. Sparks, MD, MMSc, an assistant professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, said in an interview that the group is planning additional studies as their cohort grows, including “investigating the relationships between COVID-19 and specific rheumatic diseases and immunomodulating medications, expansion of autoimmunity and systemic inflammation, and lung damage among specific patient populations.”

Dr. Calabrese said it will be important for follow-up study of the symptomatic patients to “determine how many of these patients will fit the clinical picture of long COVID or long-haul phenotypes over the months and years ahead, including documenting exertional malaise and quality of life.

This study only assessed patients who received zero, one, or two doses of a vaccine, but many patients with rheumatic disease today will likely have received booster doses. However, Dr. Calabrese said it would be difficult to quantify whether a third, fourth, or fifth dose offers additional protection from long-term COVID complications after full vaccination or hybrid vaccination.

The research was funded by the Rheumatology Research Foundation, the National Institutes of Health, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Wallace has received research support from Bristol-Myers Squibb and Principia/Sanofi and consulting fees from Zenas BioPharma, Horizon, Sanofi, Shionogi, Viela Bio, and Medpace. Dr. Sparks has received research support from Bristol-Myers Squibb and consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer. Dr. Patel has received consulting fees from FVC Health. Calabrese has consulted for Genentech, Sanofi-Regeneron, AstraZeneca, and GlaxoSmithKline.

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

For patients with severe arthritis, joint replacement is considered when more conservative treatments have failed. Because patients with obesity have a higher risk of complications during and after surgery, some surgeons, hospitals, and insurance companies have adopted body mass index cutoffs as a basis for deciding whether to offer patients these elective surgeries. But some experts argue that these cutoffs are arbitrary, exclude patients who can still benefit from the surgery, and can increase disparities in care.

“By enforcing cutoffs in general, you’re losing the ability for each surgeon to determine who they want to operate on,” said Daniel Wiznia, MD, assistant professor of orthopedic surgery at Yale University, New Haven, Conn. He is on the leadership committee of the Movement Is Life Caucus, a nonprofit group focused on eliminating disparities in musculoskeletal health. “For every surgeon, it’s up to them to decide if they feel comfortable doing the surgery,” he noted in an interview. “My guidance for that would be, don’t just say no because of the number – look at the patient’s entire medical profile.”

According to the Centers for Disease Control and Prevention, nearly 42% of adults in the United States have a BMI over 30, and 9.2% of adults have a BMI over 40. This excess weight puts additional stress on joints: When a person is walking, experts estimate that the force on the knees can be two to three times someone’s body weight. Over time, this pressure can wear down the cartilage on joints.

As a result, people who are overweight or obese are more likely to develop osteoarthritis and to need joint replacements. According to a Canadian study, patients with a BMI of 30-35 are 3.4 times as likely to require a hip replacement and are 8.5 times as likely to require a knee replacement compared to individuals with a BMI in the “healthy weight” range. With a BMI above 40, individuals were 8.5 times more likely to need a hip replacement and were 32.7 times as likely to need a knee replacement.
 

More complications, greater expense

While there are no universally recommended BMI cutoffs for joint replacement surgery, it is not uncommon for institutions to require that patients have a BMI below a certain value (usually 35-40) to proceed with surgery. A 2013 survey of physicians from the American Association of Hip and Knee Surgeons found that 52% of surgeons required a BMI below 40 to qualify for surgery.

One of the main reasons for these cutoffs is the elevated risk of complications during and after surgery. Research suggests that obesity is associated with higher rates of wound dehiscence, prosthetic joint infection (PJI), and revision total joint arthroplasty. One 2016 study suggests that patients with a BMI of 35-39.9 are twice as likely to experience PJI compared to patients with a BMI below 35. For patients with a BMI of 40 or higher, PJI is four times as likely.

Another study found that patients whose BMI is 35-40 and who undergo total joint arthroplasty have a 6.4-fold greater risk of deep incision infection. For those with a BMI over 40, that rises to a 12.9-fold increased risk compared to patients with a BMI of 18.5-25. Patients with obesity tend to have other comorbidities that can increase the risk of complications during surgery, such as type 2 diabetes, coronary artery disease, and chronic kidney disease.

Because of the increased risk of complications, health care costs tend to be higher for patients with obesity. The growing popularity of bundled health payments can discourage operating on patients who are more likely to experience complications, such as patients with high BMIs, noted Dr. Wiznia.

Research suggests that minorities and people with lower socioeconomic status are disproportionately affected by these cutoffs. According to the CDC, among non-Hispanic Black Americans and Hispanic Americans, rates of obesity are higher than among their White counterparts, and these patients are less likely to undergo joint replacement. Strictly enforcing this eligibility criterion can worsen those disparities. A study involving 21,294 adults over age 50 from the National Health and Nutrition Examination Survey (NHANES) found that requiring a BMI of under 35 for total joint arthroplasty resulted in Black patients being 39% less likely to be eligible for surgery than White patients. And individuals with an annual household income under $45,000 were 19% less likely to qualify for surgery than those with a household income above $45,000.
 

BMI no better than other risk factors

Although high BMI is independently associated with a higher risk of complications, the increased risk of complications conferred by a BMI at or above 40 is similar to or lower than those of other comorbidities that surgeons generally accept, said Nicholas Giori, MD, PhD, professor of orthopedic surgery at Stanford (Calif.) University, and chief of orthopedic surgery at the VA Palo Alto Health Care System. These other comorbidities include age older than 75, hypertension that requires medication, and insulin-controlled diabetes. “The independent risk of just having the diagnosis of insulin-dependent diabetes is actually comparable to the independent risk of having obesity by itself,” he told this news organization, “and all of us operate on [patients with] diabetes.”

Also, there is no BMI at which the risk of complications suddenly increases, according to the American Academy of Orthopaedic Surgeons. “It’s a rising complication rate as you go into higher BMIs,” Dr. Giori said. “If you operate on someone with a BMI of 39 vs. 41, you’re not going to find that much of a difference [in risk].” But if a medical system enforced a hard BMI cutoff of 40, one patient would qualify for surgery while the other would be barred.
 

Weight not as “modifiable” as previously thought

Weight is often considered a “modifiable factor” for a person considering undergoing total joint arthroplasty, but research suggests that the issue is more complicated. “Obesity is tricky, because some people are successful [in weight loss],” said Dr. Giori. Those tend to be the more memorable stories. “But a large majority have a really hard time losing substantial weight – enough to make a difference in risk,” he continued.

A study conducted in North Carolina found that restricting patients with a BMI over 40 from having elective total joint arthroplasty procedures until their weight was optimized did not result in successful weight loss. Only 20% of patients who originally presented with a BMI above this limit eventually underwent surgery after 2 years, and fewer than half of these patients had achieved a BMI of less than 40 at the time of their surgery. A third of all patients in the study did not return to the orthopedic office after their first visit.

“To hold a hard cutoff when it’s very, very hard to modify ... is essentially telling people that they are not going to ever have surgery,” Dr. Giori said; “I think that can be unfair to some patients.”

Bariatric surgery is often suggested for patients with obesity who have not experienced successful weight loss with diet and lifestyle changes alone, but bariatric surgery comes with its own complications. Research on outcomes from total joint arthroplasty among patients with who have lost weight with bariatric surgery has yielded mixed results. “I rarely push anyone hard to go that route but present it as an option for certain patients,” said Benjamin M. Stronach, MD, an orthopedic surgeon at the University of Arkansas for Medical Sciences, in Little Rock. He usually brings up bariatric surgery with patients with a BMI in the high 40s or higher to gauge their interest. If patients are already considering weight loss surgery, his office provides referrals.

But even bariatric surgery does not result in successful long-term weight loss for every patient, Dr. Stronach said. He’s seeing more and more patients who come for consultations after having undergone bariatric surgery 10 to 15 years ago. These patients lost a significant amount of weight, but then gained the weight back. He noted that bariatric surgery can be very successful for some patients who adhere to their postbariatric regimen. “We typically see fairly impressive results in the short term,” he said.
 

Patients with obesity benefit from joint replacement

Although patients with obesity are at higher risk for complications from joint replacement surgery, research suggests that these patients can still benefit greatly from these surgeries and that these surgeries remain cost-effective. Some studies have found that patients with obesity tend to have worse outcomes after surgery than patients who are not obese, but often, patients with high BMIs are starting from a lower point, with greater joint pain and limited mobility, Dr. Giori said. But the improvements – that is, net change in measured outcomes – can be greater for obese patients.

“Several studies have shown equal or greater improvements in validated outcome scores, function, and satisfaction compared with nonobese patients after surgery,” authors wrote in a recent review article in which they discuss how to optimize joint replacement surgery for patients with obesity. The article, published in the November 2022 issue of the Journal of the American Academy of Orthopaedic Surgeon (JAAOS), is part of a collection of review articles by the Movement Is Life Caucus.

Encourage weight loss, but look beyond the number

Rather than adhering to strict BMI cutoffs, some experts urge surgeons to consider the patient as a whole and to evaluate each individual’s overall health and potential risk. Dr. Giori generally considers high BMI as just another comorbidity when assessing a patient’s overall risk. “For a person who only has a high BMI but is otherwise healthy, I see no reason not to go ahead and schedule that person for surgery, because reducing the patient’s BMI will not substantially reduce the patient’s complication risk, and a delay in surgery may adversely affect the patient’s quality of life and ability to earn a living,” he said.

“If someone is between a BMI of 40 and 45, we are definitely going to have a discussion about weight,” Dr. Stronach said. He generally counsels against surgery for any patient with a BMI at 45 or above. He wants patients to have a BMI below 40 before surgery but considers individual cases for exceptions. “We will still move forward at times with someone with a BMI of 41, as an example, who is otherwise healthy,” he said. Similarly, if a patient has lost a significant amount of weight (e.g., the patient’s BMI was reduced from 50 to 41), the patient is actively engaged in improving their health, and surgeons believe the patient has significantly reduced their risk, “a lot of time, we’re not going to draw a line in the sand right at [a BMI of] 40,” he said.

While using a BMI of under 35 or 40 as a guideline when starting to work with patients is reasonable, working toward a weight loss of 5%-10% of total body weight is another goal to consider, authors advise in the JAAOS obesity review article. Research suggests that even a 5% reduction in overall body weight can reduce surgical complications and can improve a patient’s glucose and lipid levels and cardiac profile. Referrals to dietitians and weight loss programs, as well as behavioral counseling, can also be useful in initiating weight loss and keeping patients engaged in the process, the authors wrote.
 

Consider a patient’s comorbidities

Many patients with obesity have comorbidities, such as type 2 diabetes and hypertension, that can also be optimized for surgery so as to lower a patient’s overall risk profile. For patients with diabetes, achieving an A1c of 8% or lower can be a reasonable goal and can reduce risk. “We’ve found that an HbA1c level of 8% or less is something that virtually all diabetics (though not everybody) can reach, and it’s something that can be reached in a reasonable amount of time,” Dr. Giori said. Preoperative use of beta-blockers, continued use of ACE inhibitors or angiotensin receptor blockers, and behavioral modifications can improve a patient’s cardiac health before surgery.

Malnutrition can be a correctable problem for patients, regardless of BMI. In the Movement Is Life collection of optimization articles, experts recommend that orthopedists screen for malnutrition with blood tests for albumin, vitamin D, transferrin, and total lymphocyte count. Patients with malnutrition should be screened for food insecurity, experts advise, and surgical candidates with deficiencies can be given supplements of omega-3 fatty acids, arginine, and protein shakes.

Surgeon comfort and shared decision-making

Dr. Wiznia emphasized that the patient and surgeon need to discuss the risks of surgery, concerns about potential complications, and how a complication could affect the patient’s life moving forward. “Ultimately, the surgeon needs to make the decision [of whether or not to proceed [with surgery] with the patient,” he said, “but not every surgeon is going to feel comfortable operating on these patients, and not every medical institution is going to have the equipment and the investments to support surgeons doing it.”

Dr. Giori agreed that surgeons should proceed only with surgical cases they feel comfortable with. Certain surgeons may decide not to operate on individuals with higher BMIs because of the potential complications and can refer these patients to more specialized care centers. Operating on larger patients is more difficult and requires surgical skills and expertise that the surgeon may not have, he noted. “What I do object to is a system-wide BMI cutoff – for example, if an insurance company won’t pay for you to have a joint replacement, regardless of where you go or who your surgeon is,” Dr. Giori added. “I think that’s wrong, because it’s not patient centered and it’s basically excluding people from having a life-altering operation.”

Dr. Giori and Dr. Wiznia report no relevant financial relationships. Dr. Stronach is a consultant for DJ Orthopaedics, Johnson & Johnson, and MiCare Path.

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

For patients with severe arthritis, joint replacement is considered when more conservative treatments have failed. Because patients with obesity have a higher risk of complications during and after surgery, some surgeons, hospitals, and insurance companies have adopted body mass index cutoffs as a basis for deciding whether to offer patients these elective surgeries. But some experts argue that these cutoffs are arbitrary, exclude patients who can still benefit from the surgery, and can increase disparities in care.

“By enforcing cutoffs in general, you’re losing the ability for each surgeon to determine who they want to operate on,” said Daniel Wiznia, MD, assistant professor of orthopedic surgery at Yale University, New Haven, Conn. He is on the leadership committee of the Movement Is Life Caucus, a nonprofit group focused on eliminating disparities in musculoskeletal health. “For every surgeon, it’s up to them to decide if they feel comfortable doing the surgery,” he noted in an interview. “My guidance for that would be, don’t just say no because of the number – look at the patient’s entire medical profile.”

According to the Centers for Disease Control and Prevention, nearly 42% of adults in the United States have a BMI over 30, and 9.2% of adults have a BMI over 40. This excess weight puts additional stress on joints: When a person is walking, experts estimate that the force on the knees can be two to three times someone’s body weight. Over time, this pressure can wear down the cartilage on joints.

As a result, people who are overweight or obese are more likely to develop osteoarthritis and to need joint replacements. According to a Canadian study, patients with a BMI of 30-35 are 3.4 times as likely to require a hip replacement and are 8.5 times as likely to require a knee replacement compared to individuals with a BMI in the “healthy weight” range. With a BMI above 40, individuals were 8.5 times more likely to need a hip replacement and were 32.7 times as likely to need a knee replacement.
 

More complications, greater expense

While there are no universally recommended BMI cutoffs for joint replacement surgery, it is not uncommon for institutions to require that patients have a BMI below a certain value (usually 35-40) to proceed with surgery. A 2013 survey of physicians from the American Association of Hip and Knee Surgeons found that 52% of surgeons required a BMI below 40 to qualify for surgery.

One of the main reasons for these cutoffs is the elevated risk of complications during and after surgery. Research suggests that obesity is associated with higher rates of wound dehiscence, prosthetic joint infection (PJI), and revision total joint arthroplasty. One 2016 study suggests that patients with a BMI of 35-39.9 are twice as likely to experience PJI compared to patients with a BMI below 35. For patients with a BMI of 40 or higher, PJI is four times as likely.

Another study found that patients whose BMI is 35-40 and who undergo total joint arthroplasty have a 6.4-fold greater risk of deep incision infection. For those with a BMI over 40, that rises to a 12.9-fold increased risk compared to patients with a BMI of 18.5-25. Patients with obesity tend to have other comorbidities that can increase the risk of complications during surgery, such as type 2 diabetes, coronary artery disease, and chronic kidney disease.

Because of the increased risk of complications, health care costs tend to be higher for patients with obesity. The growing popularity of bundled health payments can discourage operating on patients who are more likely to experience complications, such as patients with high BMIs, noted Dr. Wiznia.

Research suggests that minorities and people with lower socioeconomic status are disproportionately affected by these cutoffs. According to the CDC, among non-Hispanic Black Americans and Hispanic Americans, rates of obesity are higher than among their White counterparts, and these patients are less likely to undergo joint replacement. Strictly enforcing this eligibility criterion can worsen those disparities. A study involving 21,294 adults over age 50 from the National Health and Nutrition Examination Survey (NHANES) found that requiring a BMI of under 35 for total joint arthroplasty resulted in Black patients being 39% less likely to be eligible for surgery than White patients. And individuals with an annual household income under $45,000 were 19% less likely to qualify for surgery than those with a household income above $45,000.
 

BMI no better than other risk factors

Although high BMI is independently associated with a higher risk of complications, the increased risk of complications conferred by a BMI at or above 40 is similar to or lower than those of other comorbidities that surgeons generally accept, said Nicholas Giori, MD, PhD, professor of orthopedic surgery at Stanford (Calif.) University, and chief of orthopedic surgery at the VA Palo Alto Health Care System. These other comorbidities include age older than 75, hypertension that requires medication, and insulin-controlled diabetes. “The independent risk of just having the diagnosis of insulin-dependent diabetes is actually comparable to the independent risk of having obesity by itself,” he told this news organization, “and all of us operate on [patients with] diabetes.”

Also, there is no BMI at which the risk of complications suddenly increases, according to the American Academy of Orthopaedic Surgeons. “It’s a rising complication rate as you go into higher BMIs,” Dr. Giori said. “If you operate on someone with a BMI of 39 vs. 41, you’re not going to find that much of a difference [in risk].” But if a medical system enforced a hard BMI cutoff of 40, one patient would qualify for surgery while the other would be barred.
 

Weight not as “modifiable” as previously thought

Weight is often considered a “modifiable factor” for a person considering undergoing total joint arthroplasty, but research suggests that the issue is more complicated. “Obesity is tricky, because some people are successful [in weight loss],” said Dr. Giori. Those tend to be the more memorable stories. “But a large majority have a really hard time losing substantial weight – enough to make a difference in risk,” he continued.

A study conducted in North Carolina found that restricting patients with a BMI over 40 from having elective total joint arthroplasty procedures until their weight was optimized did not result in successful weight loss. Only 20% of patients who originally presented with a BMI above this limit eventually underwent surgery after 2 years, and fewer than half of these patients had achieved a BMI of less than 40 at the time of their surgery. A third of all patients in the study did not return to the orthopedic office after their first visit.

“To hold a hard cutoff when it’s very, very hard to modify ... is essentially telling people that they are not going to ever have surgery,” Dr. Giori said; “I think that can be unfair to some patients.”

Bariatric surgery is often suggested for patients with obesity who have not experienced successful weight loss with diet and lifestyle changes alone, but bariatric surgery comes with its own complications. Research on outcomes from total joint arthroplasty among patients with who have lost weight with bariatric surgery has yielded mixed results. “I rarely push anyone hard to go that route but present it as an option for certain patients,” said Benjamin M. Stronach, MD, an orthopedic surgeon at the University of Arkansas for Medical Sciences, in Little Rock. He usually brings up bariatric surgery with patients with a BMI in the high 40s or higher to gauge their interest. If patients are already considering weight loss surgery, his office provides referrals.

But even bariatric surgery does not result in successful long-term weight loss for every patient, Dr. Stronach said. He’s seeing more and more patients who come for consultations after having undergone bariatric surgery 10 to 15 years ago. These patients lost a significant amount of weight, but then gained the weight back. He noted that bariatric surgery can be very successful for some patients who adhere to their postbariatric regimen. “We typically see fairly impressive results in the short term,” he said.
 

Patients with obesity benefit from joint replacement

Although patients with obesity are at higher risk for complications from joint replacement surgery, research suggests that these patients can still benefit greatly from these surgeries and that these surgeries remain cost-effective. Some studies have found that patients with obesity tend to have worse outcomes after surgery than patients who are not obese, but often, patients with high BMIs are starting from a lower point, with greater joint pain and limited mobility, Dr. Giori said. But the improvements – that is, net change in measured outcomes – can be greater for obese patients.

“Several studies have shown equal or greater improvements in validated outcome scores, function, and satisfaction compared with nonobese patients after surgery,” authors wrote in a recent review article in which they discuss how to optimize joint replacement surgery for patients with obesity. The article, published in the November 2022 issue of the Journal of the American Academy of Orthopaedic Surgeon (JAAOS), is part of a collection of review articles by the Movement Is Life Caucus.

Encourage weight loss, but look beyond the number

Rather than adhering to strict BMI cutoffs, some experts urge surgeons to consider the patient as a whole and to evaluate each individual’s overall health and potential risk. Dr. Giori generally considers high BMI as just another comorbidity when assessing a patient’s overall risk. “For a person who only has a high BMI but is otherwise healthy, I see no reason not to go ahead and schedule that person for surgery, because reducing the patient’s BMI will not substantially reduce the patient’s complication risk, and a delay in surgery may adversely affect the patient’s quality of life and ability to earn a living,” he said.

“If someone is between a BMI of 40 and 45, we are definitely going to have a discussion about weight,” Dr. Stronach said. He generally counsels against surgery for any patient with a BMI at 45 or above. He wants patients to have a BMI below 40 before surgery but considers individual cases for exceptions. “We will still move forward at times with someone with a BMI of 41, as an example, who is otherwise healthy,” he said. Similarly, if a patient has lost a significant amount of weight (e.g., the patient’s BMI was reduced from 50 to 41), the patient is actively engaged in improving their health, and surgeons believe the patient has significantly reduced their risk, “a lot of time, we’re not going to draw a line in the sand right at [a BMI of] 40,” he said.

While using a BMI of under 35 or 40 as a guideline when starting to work with patients is reasonable, working toward a weight loss of 5%-10% of total body weight is another goal to consider, authors advise in the JAAOS obesity review article. Research suggests that even a 5% reduction in overall body weight can reduce surgical complications and can improve a patient’s glucose and lipid levels and cardiac profile. Referrals to dietitians and weight loss programs, as well as behavioral counseling, can also be useful in initiating weight loss and keeping patients engaged in the process, the authors wrote.
 

Consider a patient’s comorbidities

Many patients with obesity have comorbidities, such as type 2 diabetes and hypertension, that can also be optimized for surgery so as to lower a patient’s overall risk profile. For patients with diabetes, achieving an A1c of 8% or lower can be a reasonable goal and can reduce risk. “We’ve found that an HbA1c level of 8% or less is something that virtually all diabetics (though not everybody) can reach, and it’s something that can be reached in a reasonable amount of time,” Dr. Giori said. Preoperative use of beta-blockers, continued use of ACE inhibitors or angiotensin receptor blockers, and behavioral modifications can improve a patient’s cardiac health before surgery.

Malnutrition can be a correctable problem for patients, regardless of BMI. In the Movement Is Life collection of optimization articles, experts recommend that orthopedists screen for malnutrition with blood tests for albumin, vitamin D, transferrin, and total lymphocyte count. Patients with malnutrition should be screened for food insecurity, experts advise, and surgical candidates with deficiencies can be given supplements of omega-3 fatty acids, arginine, and protein shakes.

Surgeon comfort and shared decision-making

Dr. Wiznia emphasized that the patient and surgeon need to discuss the risks of surgery, concerns about potential complications, and how a complication could affect the patient’s life moving forward. “Ultimately, the surgeon needs to make the decision [of whether or not to proceed [with surgery] with the patient,” he said, “but not every surgeon is going to feel comfortable operating on these patients, and not every medical institution is going to have the equipment and the investments to support surgeons doing it.”

Dr. Giori agreed that surgeons should proceed only with surgical cases they feel comfortable with. Certain surgeons may decide not to operate on individuals with higher BMIs because of the potential complications and can refer these patients to more specialized care centers. Operating on larger patients is more difficult and requires surgical skills and expertise that the surgeon may not have, he noted. “What I do object to is a system-wide BMI cutoff – for example, if an insurance company won’t pay for you to have a joint replacement, regardless of where you go or who your surgeon is,” Dr. Giori added. “I think that’s wrong, because it’s not patient centered and it’s basically excluding people from having a life-altering operation.”

Dr. Giori and Dr. Wiznia report no relevant financial relationships. Dr. Stronach is a consultant for DJ Orthopaedics, Johnson & Johnson, and MiCare Path.

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

For patients with severe arthritis, joint replacement is considered when more conservative treatments have failed. Because patients with obesity have a higher risk of complications during and after surgery, some surgeons, hospitals, and insurance companies have adopted body mass index cutoffs as a basis for deciding whether to offer patients these elective surgeries. But some experts argue that these cutoffs are arbitrary, exclude patients who can still benefit from the surgery, and can increase disparities in care.

“By enforcing cutoffs in general, you’re losing the ability for each surgeon to determine who they want to operate on,” said Daniel Wiznia, MD, assistant professor of orthopedic surgery at Yale University, New Haven, Conn. He is on the leadership committee of the Movement Is Life Caucus, a nonprofit group focused on eliminating disparities in musculoskeletal health. “For every surgeon, it’s up to them to decide if they feel comfortable doing the surgery,” he noted in an interview. “My guidance for that would be, don’t just say no because of the number – look at the patient’s entire medical profile.”

According to the Centers for Disease Control and Prevention, nearly 42% of adults in the United States have a BMI over 30, and 9.2% of adults have a BMI over 40. This excess weight puts additional stress on joints: When a person is walking, experts estimate that the force on the knees can be two to three times someone’s body weight. Over time, this pressure can wear down the cartilage on joints.

As a result, people who are overweight or obese are more likely to develop osteoarthritis and to need joint replacements. According to a Canadian study, patients with a BMI of 30-35 are 3.4 times as likely to require a hip replacement and are 8.5 times as likely to require a knee replacement compared to individuals with a BMI in the “healthy weight” range. With a BMI above 40, individuals were 8.5 times more likely to need a hip replacement and were 32.7 times as likely to need a knee replacement.
 

More complications, greater expense

While there are no universally recommended BMI cutoffs for joint replacement surgery, it is not uncommon for institutions to require that patients have a BMI below a certain value (usually 35-40) to proceed with surgery. A 2013 survey of physicians from the American Association of Hip and Knee Surgeons found that 52% of surgeons required a BMI below 40 to qualify for surgery.

One of the main reasons for these cutoffs is the elevated risk of complications during and after surgery. Research suggests that obesity is associated with higher rates of wound dehiscence, prosthetic joint infection (PJI), and revision total joint arthroplasty. One 2016 study suggests that patients with a BMI of 35-39.9 are twice as likely to experience PJI compared to patients with a BMI below 35. For patients with a BMI of 40 or higher, PJI is four times as likely.

Another study found that patients whose BMI is 35-40 and who undergo total joint arthroplasty have a 6.4-fold greater risk of deep incision infection. For those with a BMI over 40, that rises to a 12.9-fold increased risk compared to patients with a BMI of 18.5-25. Patients with obesity tend to have other comorbidities that can increase the risk of complications during surgery, such as type 2 diabetes, coronary artery disease, and chronic kidney disease.

Because of the increased risk of complications, health care costs tend to be higher for patients with obesity. The growing popularity of bundled health payments can discourage operating on patients who are more likely to experience complications, such as patients with high BMIs, noted Dr. Wiznia.

Research suggests that minorities and people with lower socioeconomic status are disproportionately affected by these cutoffs. According to the CDC, among non-Hispanic Black Americans and Hispanic Americans, rates of obesity are higher than among their White counterparts, and these patients are less likely to undergo joint replacement. Strictly enforcing this eligibility criterion can worsen those disparities. A study involving 21,294 adults over age 50 from the National Health and Nutrition Examination Survey (NHANES) found that requiring a BMI of under 35 for total joint arthroplasty resulted in Black patients being 39% less likely to be eligible for surgery than White patients. And individuals with an annual household income under $45,000 were 19% less likely to qualify for surgery than those with a household income above $45,000.
 

BMI no better than other risk factors

Although high BMI is independently associated with a higher risk of complications, the increased risk of complications conferred by a BMI at or above 40 is similar to or lower than those of other comorbidities that surgeons generally accept, said Nicholas Giori, MD, PhD, professor of orthopedic surgery at Stanford (Calif.) University, and chief of orthopedic surgery at the VA Palo Alto Health Care System. These other comorbidities include age older than 75, hypertension that requires medication, and insulin-controlled diabetes. “The independent risk of just having the diagnosis of insulin-dependent diabetes is actually comparable to the independent risk of having obesity by itself,” he told this news organization, “and all of us operate on [patients with] diabetes.”

Also, there is no BMI at which the risk of complications suddenly increases, according to the American Academy of Orthopaedic Surgeons. “It’s a rising complication rate as you go into higher BMIs,” Dr. Giori said. “If you operate on someone with a BMI of 39 vs. 41, you’re not going to find that much of a difference [in risk].” But if a medical system enforced a hard BMI cutoff of 40, one patient would qualify for surgery while the other would be barred.
 

Weight not as “modifiable” as previously thought

Weight is often considered a “modifiable factor” for a person considering undergoing total joint arthroplasty, but research suggests that the issue is more complicated. “Obesity is tricky, because some people are successful [in weight loss],” said Dr. Giori. Those tend to be the more memorable stories. “But a large majority have a really hard time losing substantial weight – enough to make a difference in risk,” he continued.

A study conducted in North Carolina found that restricting patients with a BMI over 40 from having elective total joint arthroplasty procedures until their weight was optimized did not result in successful weight loss. Only 20% of patients who originally presented with a BMI above this limit eventually underwent surgery after 2 years, and fewer than half of these patients had achieved a BMI of less than 40 at the time of their surgery. A third of all patients in the study did not return to the orthopedic office after their first visit.

“To hold a hard cutoff when it’s very, very hard to modify ... is essentially telling people that they are not going to ever have surgery,” Dr. Giori said; “I think that can be unfair to some patients.”

Bariatric surgery is often suggested for patients with obesity who have not experienced successful weight loss with diet and lifestyle changes alone, but bariatric surgery comes with its own complications. Research on outcomes from total joint arthroplasty among patients with who have lost weight with bariatric surgery has yielded mixed results. “I rarely push anyone hard to go that route but present it as an option for certain patients,” said Benjamin M. Stronach, MD, an orthopedic surgeon at the University of Arkansas for Medical Sciences, in Little Rock. He usually brings up bariatric surgery with patients with a BMI in the high 40s or higher to gauge their interest. If patients are already considering weight loss surgery, his office provides referrals.

But even bariatric surgery does not result in successful long-term weight loss for every patient, Dr. Stronach said. He’s seeing more and more patients who come for consultations after having undergone bariatric surgery 10 to 15 years ago. These patients lost a significant amount of weight, but then gained the weight back. He noted that bariatric surgery can be very successful for some patients who adhere to their postbariatric regimen. “We typically see fairly impressive results in the short term,” he said.
 

Patients with obesity benefit from joint replacement

Although patients with obesity are at higher risk for complications from joint replacement surgery, research suggests that these patients can still benefit greatly from these surgeries and that these surgeries remain cost-effective. Some studies have found that patients with obesity tend to have worse outcomes after surgery than patients who are not obese, but often, patients with high BMIs are starting from a lower point, with greater joint pain and limited mobility, Dr. Giori said. But the improvements – that is, net change in measured outcomes – can be greater for obese patients.

“Several studies have shown equal or greater improvements in validated outcome scores, function, and satisfaction compared with nonobese patients after surgery,” authors wrote in a recent review article in which they discuss how to optimize joint replacement surgery for patients with obesity. The article, published in the November 2022 issue of the Journal of the American Academy of Orthopaedic Surgeon (JAAOS), is part of a collection of review articles by the Movement Is Life Caucus.

Encourage weight loss, but look beyond the number

Rather than adhering to strict BMI cutoffs, some experts urge surgeons to consider the patient as a whole and to evaluate each individual’s overall health and potential risk. Dr. Giori generally considers high BMI as just another comorbidity when assessing a patient’s overall risk. “For a person who only has a high BMI but is otherwise healthy, I see no reason not to go ahead and schedule that person for surgery, because reducing the patient’s BMI will not substantially reduce the patient’s complication risk, and a delay in surgery may adversely affect the patient’s quality of life and ability to earn a living,” he said.

“If someone is between a BMI of 40 and 45, we are definitely going to have a discussion about weight,” Dr. Stronach said. He generally counsels against surgery for any patient with a BMI at 45 or above. He wants patients to have a BMI below 40 before surgery but considers individual cases for exceptions. “We will still move forward at times with someone with a BMI of 41, as an example, who is otherwise healthy,” he said. Similarly, if a patient has lost a significant amount of weight (e.g., the patient’s BMI was reduced from 50 to 41), the patient is actively engaged in improving their health, and surgeons believe the patient has significantly reduced their risk, “a lot of time, we’re not going to draw a line in the sand right at [a BMI of] 40,” he said.

While using a BMI of under 35 or 40 as a guideline when starting to work with patients is reasonable, working toward a weight loss of 5%-10% of total body weight is another goal to consider, authors advise in the JAAOS obesity review article. Research suggests that even a 5% reduction in overall body weight can reduce surgical complications and can improve a patient’s glucose and lipid levels and cardiac profile. Referrals to dietitians and weight loss programs, as well as behavioral counseling, can also be useful in initiating weight loss and keeping patients engaged in the process, the authors wrote.
 

Consider a patient’s comorbidities

Many patients with obesity have comorbidities, such as type 2 diabetes and hypertension, that can also be optimized for surgery so as to lower a patient’s overall risk profile. For patients with diabetes, achieving an A1c of 8% or lower can be a reasonable goal and can reduce risk. “We’ve found that an HbA1c level of 8% or less is something that virtually all diabetics (though not everybody) can reach, and it’s something that can be reached in a reasonable amount of time,” Dr. Giori said. Preoperative use of beta-blockers, continued use of ACE inhibitors or angiotensin receptor blockers, and behavioral modifications can improve a patient’s cardiac health before surgery.

Malnutrition can be a correctable problem for patients, regardless of BMI. In the Movement Is Life collection of optimization articles, experts recommend that orthopedists screen for malnutrition with blood tests for albumin, vitamin D, transferrin, and total lymphocyte count. Patients with malnutrition should be screened for food insecurity, experts advise, and surgical candidates with deficiencies can be given supplements of omega-3 fatty acids, arginine, and protein shakes.

Surgeon comfort and shared decision-making

Dr. Wiznia emphasized that the patient and surgeon need to discuss the risks of surgery, concerns about potential complications, and how a complication could affect the patient’s life moving forward. “Ultimately, the surgeon needs to make the decision [of whether or not to proceed [with surgery] with the patient,” he said, “but not every surgeon is going to feel comfortable operating on these patients, and not every medical institution is going to have the equipment and the investments to support surgeons doing it.”

Dr. Giori agreed that surgeons should proceed only with surgical cases they feel comfortable with. Certain surgeons may decide not to operate on individuals with higher BMIs because of the potential complications and can refer these patients to more specialized care centers. Operating on larger patients is more difficult and requires surgical skills and expertise that the surgeon may not have, he noted. “What I do object to is a system-wide BMI cutoff – for example, if an insurance company won’t pay for you to have a joint replacement, regardless of where you go or who your surgeon is,” Dr. Giori added. “I think that’s wrong, because it’s not patient centered and it’s basically excluding people from having a life-altering operation.”

Dr. Giori and Dr. Wiznia report no relevant financial relationships. Dr. Stronach is a consultant for DJ Orthopaedics, Johnson & Johnson, and MiCare Path.

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

CHICAGO – Taking NSAIDs for knee osteoarthritis may worsen inflammation and pain over time, suggest new data revealed at the annual meeting of the Radiological Society of North America.

Johanna Luitjens, MD, a postdoctoral scholar in the department of radiology and biomedical Imaging at the University of California, San Francisco, told this news organization that NSAIDs are frequently used to treat OA pain because inflammation is one of the main drivers of OA, but whether they actually help outcomes has been unclear. Her study suggests that they don’t help – and may actually worsen – outcomes.

Denise Fulton/MDedge News

In particular, this study looked at the impact of NSAIDs on synovitis – the inflammation of the membrane lining the knee joint – by using MRI-based structural biomarkers.

OA, the most common form of arthritis, affects more than 32 million adults in the United States and more than 500 million people worldwide.
 

No approved therapy to reduce OA progression

Little is known of the long-term effects of NSAIDs on OA progression. Currently, there’s no approved therapy to cure OA or to reduce its advance.

Dr. Luitjens noted, however, that the synovial membrane mediates development and progression of OA and may be a good therapeutic target.

Researchers studied participants from the Osteoarthritis Initiative (OAI) cohort with moderate to severe OA who used NSAIDs regularly for at least 1 year between baseline and 4-year follow-up. All participants had high-quality 3T MRI of the knee at baseline and after 4 years. Images were scored for biomarkers of inflammation, including cartilage thickness and composition.

Dr. Luitjens and associates studied 721 participants who matched the inclusion criteria (129 with and 592 participants without regular NSAID use). The available data did not further specify amounts of NSAIDs used.

At baseline, significantly higher signal intensity in the infrapatellar fat pad (IFP) was seen in patients who used NSAID, compared with controls (adjusted difference in score, 0.26; 95% confidence interval, –0.5 to –0.129; P = .039).

In addition, at the end of the study period, there was a significantly greater increase in signal intensity of IFP (adjusted difference in score, 0.46; 95% CI, 0.2-0.72; P < .001) and higher increase in effusion synovitis (adjusted difference in score, 0.27; 95% CI, 0.06-0.47;  P = .01) in NSAID users, compared with controls.

IFP size and synovial proliferation score did not different significantly between groups at the start of the study and showed no significant change over time.

The results showed no long-term benefit of NSAID use. Joint inflammation and cartilage quality were worse at baseline in the participants taking NSAIDs, compared with the control group, and worsened at 4-year follow-up.

Design limits strength

Amanda E. Nelson, MD, associate professor of medicine, division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, cautioned against assuming causality, pointing out that the OAI is an observational cohort study. (Dr. Nelson was not involved in the OAI or Dr. Luitjens’ analysis.)

“[The OAI is] large and well known, but it wasn’t designed to compare these groups, and this was a small subset,” she said in an interview. Without randomization, it’s hard to judge the results.

“It may be that people on NSAIDs for the duration of the study had more pain and had more disease to begin with, or had more symptoms or had failed other treatments,” she said, adding that the effect sizes were small.

Measures such as the IFP are ranked 0-3, so “the clinical difference of a 0.26 difference on a 0-3 scale is a bit uncertain,” she said.

Dr. Luitjens said that the researchers tried to adjust for potential confounders but agreed that randomized controlled trials are needed to better advise physicians and patients on the benefits or harms of using NSAIDs for OA.

Weighing the risks in older adults

Una Makris, MD, associate professor of internal medicine in the division of rheumatic diseases at the University of Texas Southwestern Medical Center, Dallas, noted that NSAIDs are “not always the safest option.”

“We are still in desperate need of disease-modifying drugs in OA with rigorous randomized trials to show efficacy for outcomes that are most meaningful to patients,” Dr. Makris, who was not involved in the study, told this news organization.

“OA is most common in older adults, those often with multiple comorbidities, so we must always weigh the risks – including known adverse effects which can be amplified in older adults – and benefits with the goal of improved function and less pain,” Dr. Makris said.

NSAID use also should be considered in the context of body mass index, cardiovascular risk, prior trauma or injury, other medication use, and behavioral factors, including physical activity, she said.

Dr. Luitjens, Dr. Nelson, and Dr. Makris reported no relevant financial relationships.

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

CHICAGO – Taking NSAIDs for knee osteoarthritis may worsen inflammation and pain over time, suggest new data revealed at the annual meeting of the Radiological Society of North America.

Johanna Luitjens, MD, a postdoctoral scholar in the department of radiology and biomedical Imaging at the University of California, San Francisco, told this news organization that NSAIDs are frequently used to treat OA pain because inflammation is one of the main drivers of OA, but whether they actually help outcomes has been unclear. Her study suggests that they don’t help – and may actually worsen – outcomes.

Denise Fulton/MDedge News

In particular, this study looked at the impact of NSAIDs on synovitis – the inflammation of the membrane lining the knee joint – by using MRI-based structural biomarkers.

OA, the most common form of arthritis, affects more than 32 million adults in the United States and more than 500 million people worldwide.
 

No approved therapy to reduce OA progression

Little is known of the long-term effects of NSAIDs on OA progression. Currently, there’s no approved therapy to cure OA or to reduce its advance.

Dr. Luitjens noted, however, that the synovial membrane mediates development and progression of OA and may be a good therapeutic target.

Researchers studied participants from the Osteoarthritis Initiative (OAI) cohort with moderate to severe OA who used NSAIDs regularly for at least 1 year between baseline and 4-year follow-up. All participants had high-quality 3T MRI of the knee at baseline and after 4 years. Images were scored for biomarkers of inflammation, including cartilage thickness and composition.

Dr. Luitjens and associates studied 721 participants who matched the inclusion criteria (129 with and 592 participants without regular NSAID use). The available data did not further specify amounts of NSAIDs used.

At baseline, significantly higher signal intensity in the infrapatellar fat pad (IFP) was seen in patients who used NSAID, compared with controls (adjusted difference in score, 0.26; 95% confidence interval, –0.5 to –0.129; P = .039).

In addition, at the end of the study period, there was a significantly greater increase in signal intensity of IFP (adjusted difference in score, 0.46; 95% CI, 0.2-0.72; P < .001) and higher increase in effusion synovitis (adjusted difference in score, 0.27; 95% CI, 0.06-0.47;  P = .01) in NSAID users, compared with controls.

IFP size and synovial proliferation score did not different significantly between groups at the start of the study and showed no significant change over time.

The results showed no long-term benefit of NSAID use. Joint inflammation and cartilage quality were worse at baseline in the participants taking NSAIDs, compared with the control group, and worsened at 4-year follow-up.

Design limits strength

Amanda E. Nelson, MD, associate professor of medicine, division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, cautioned against assuming causality, pointing out that the OAI is an observational cohort study. (Dr. Nelson was not involved in the OAI or Dr. Luitjens’ analysis.)

“[The OAI is] large and well known, but it wasn’t designed to compare these groups, and this was a small subset,” she said in an interview. Without randomization, it’s hard to judge the results.

“It may be that people on NSAIDs for the duration of the study had more pain and had more disease to begin with, or had more symptoms or had failed other treatments,” she said, adding that the effect sizes were small.

Measures such as the IFP are ranked 0-3, so “the clinical difference of a 0.26 difference on a 0-3 scale is a bit uncertain,” she said.

Dr. Luitjens said that the researchers tried to adjust for potential confounders but agreed that randomized controlled trials are needed to better advise physicians and patients on the benefits or harms of using NSAIDs for OA.

Weighing the risks in older adults

Una Makris, MD, associate professor of internal medicine in the division of rheumatic diseases at the University of Texas Southwestern Medical Center, Dallas, noted that NSAIDs are “not always the safest option.”

“We are still in desperate need of disease-modifying drugs in OA with rigorous randomized trials to show efficacy for outcomes that are most meaningful to patients,” Dr. Makris, who was not involved in the study, told this news organization.

“OA is most common in older adults, those often with multiple comorbidities, so we must always weigh the risks – including known adverse effects which can be amplified in older adults – and benefits with the goal of improved function and less pain,” Dr. Makris said.

NSAID use also should be considered in the context of body mass index, cardiovascular risk, prior trauma or injury, other medication use, and behavioral factors, including physical activity, she said.

Dr. Luitjens, Dr. Nelson, and Dr. Makris reported no relevant financial relationships.

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

CHICAGO – Taking NSAIDs for knee osteoarthritis may worsen inflammation and pain over time, suggest new data revealed at the annual meeting of the Radiological Society of North America.

Johanna Luitjens, MD, a postdoctoral scholar in the department of radiology and biomedical Imaging at the University of California, San Francisco, told this news organization that NSAIDs are frequently used to treat OA pain because inflammation is one of the main drivers of OA, but whether they actually help outcomes has been unclear. Her study suggests that they don’t help – and may actually worsen – outcomes.

Denise Fulton/MDedge News

In particular, this study looked at the impact of NSAIDs on synovitis – the inflammation of the membrane lining the knee joint – by using MRI-based structural biomarkers.

OA, the most common form of arthritis, affects more than 32 million adults in the United States and more than 500 million people worldwide.
 

No approved therapy to reduce OA progression

Little is known of the long-term effects of NSAIDs on OA progression. Currently, there’s no approved therapy to cure OA or to reduce its advance.

Dr. Luitjens noted, however, that the synovial membrane mediates development and progression of OA and may be a good therapeutic target.

Researchers studied participants from the Osteoarthritis Initiative (OAI) cohort with moderate to severe OA who used NSAIDs regularly for at least 1 year between baseline and 4-year follow-up. All participants had high-quality 3T MRI of the knee at baseline and after 4 years. Images were scored for biomarkers of inflammation, including cartilage thickness and composition.

Dr. Luitjens and associates studied 721 participants who matched the inclusion criteria (129 with and 592 participants without regular NSAID use). The available data did not further specify amounts of NSAIDs used.

At baseline, significantly higher signal intensity in the infrapatellar fat pad (IFP) was seen in patients who used NSAID, compared with controls (adjusted difference in score, 0.26; 95% confidence interval, –0.5 to –0.129; P = .039).

In addition, at the end of the study period, there was a significantly greater increase in signal intensity of IFP (adjusted difference in score, 0.46; 95% CI, 0.2-0.72; P < .001) and higher increase in effusion synovitis (adjusted difference in score, 0.27; 95% CI, 0.06-0.47;  P = .01) in NSAID users, compared with controls.

IFP size and synovial proliferation score did not different significantly between groups at the start of the study and showed no significant change over time.

The results showed no long-term benefit of NSAID use. Joint inflammation and cartilage quality were worse at baseline in the participants taking NSAIDs, compared with the control group, and worsened at 4-year follow-up.

Design limits strength

Amanda E. Nelson, MD, associate professor of medicine, division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, cautioned against assuming causality, pointing out that the OAI is an observational cohort study. (Dr. Nelson was not involved in the OAI or Dr. Luitjens’ analysis.)

“[The OAI is] large and well known, but it wasn’t designed to compare these groups, and this was a small subset,” she said in an interview. Without randomization, it’s hard to judge the results.

“It may be that people on NSAIDs for the duration of the study had more pain and had more disease to begin with, or had more symptoms or had failed other treatments,” she said, adding that the effect sizes were small.

Measures such as the IFP are ranked 0-3, so “the clinical difference of a 0.26 difference on a 0-3 scale is a bit uncertain,” she said.

Dr. Luitjens said that the researchers tried to adjust for potential confounders but agreed that randomized controlled trials are needed to better advise physicians and patients on the benefits or harms of using NSAIDs for OA.

Weighing the risks in older adults

Una Makris, MD, associate professor of internal medicine in the division of rheumatic diseases at the University of Texas Southwestern Medical Center, Dallas, noted that NSAIDs are “not always the safest option.”

“We are still in desperate need of disease-modifying drugs in OA with rigorous randomized trials to show efficacy for outcomes that are most meaningful to patients,” Dr. Makris, who was not involved in the study, told this news organization.

“OA is most common in older adults, those often with multiple comorbidities, so we must always weigh the risks – including known adverse effects which can be amplified in older adults – and benefits with the goal of improved function and less pain,” Dr. Makris said.

NSAID use also should be considered in the context of body mass index, cardiovascular risk, prior trauma or injury, other medication use, and behavioral factors, including physical activity, she said.

Dr. Luitjens, Dr. Nelson, and Dr. Makris reported no relevant financial relationships.

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