Jeff Evans

The U.S. Food and Drug Administration has approved the biosimilar adalimumab-aaty (Yuflyma) in a citrate-free, high-concentration formulation, the manufacturer, Celltrion USA, announced today. It is the ninth biosimilar of adalimumab (Humira) to be approved in the United States.
 

Yuflyma is approved for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. It is also approved for polyarticular juvenile idiopathic arthritis for patients aged 2 years or older, as well as for Crohn’s disease in adults and in pediatric patients aged 6 years or older.

fda_icon2_web.jpg

The formulation was approved on the basis of a comprehensive data package of analytic, preclinical, and clinical studies, according to Celltrion USA, “demonstrating that Yuflyma is comparable to the reference product Humira in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and 1 year following treatment.”

The company conducted a double-blind, randomized phase 3 trial that compared switching from reference adalimumab to Yuflyma with continuing either reference adalimumab or Yuflyma for patients with active rheumatoid arthritis. In that trial, the efficacy, pharmacokinetics, safety, and immunogenicity of Yuflyma and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to Yuflyma.

“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Jonathan Kay, MD, of the University of Massachusetts, Worcester, in the press release.

The citrate-free formulation is thought to lead to less pain on injection.

Yuflyma will be available in prefilled syringe and autoinjector administration options.

Celltrion USA plans to market the drug in the United States in July 2023. Following the initial launch of 40 mg/0.4 mL, the company plans to launch dose forms of 80 mg/0.8 mL and 20 mg/0.2 mL.

Celltrion USA is also seeking an interchangeability designation from the FDA following the completion of an interchangeability trial of 366 patients with chronic plaque psoriasis. The interchangeability designation would mean that patients successfully switched from Humira to Yuflyma multiple times in the trial. The interchangeability designation would allow pharmacists to autosubstitute Humira with Yuflyma. In these cases, individual state laws control how and whether physicians will be notified of this switch.

If interchangeability is approved for Yuflyma, which the company tentatively expects in the fourth quarter of 2024, it would be just the third interchangeable biosimilar approved by the FDA overall and the second adalimumab biosimilar to be designated as such, after adalimumab-adbm (Cyltezo) in October 2021.

Yuflyma was approved in Canada in December 2021 for 10 indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and pediatric uveitis.

In February 2022, the European Commission granted marketing authorization for Yuflyma across those 10 indications, as well as for nonradiographic axial spondyloarthritis, pediatric plaque psoriasis, and pediatric Crohn’s disease.

In April 2022, Celltrion USA signed a licensing agreement with AbbVie, the manufacturer of Humira. Under that agreement, Celltrion will pay royalties to AbbVie on sales of their individual biosimilars, and AbbVie agreed to drop all patent litigation.

The full prescribing information for Yuflyma is available here.

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

The U.S. Food and Drug Administration has approved the biosimilar adalimumab-aaty (Yuflyma) in a citrate-free, high-concentration formulation, the manufacturer, Celltrion USA, announced today. It is the ninth biosimilar of adalimumab (Humira) to be approved in the United States.
 

Yuflyma is approved for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. It is also approved for polyarticular juvenile idiopathic arthritis for patients aged 2 years or older, as well as for Crohn’s disease in adults and in pediatric patients aged 6 years or older.

fda_icon2_web.jpg

The formulation was approved on the basis of a comprehensive data package of analytic, preclinical, and clinical studies, according to Celltrion USA, “demonstrating that Yuflyma is comparable to the reference product Humira in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and 1 year following treatment.”

The company conducted a double-blind, randomized phase 3 trial that compared switching from reference adalimumab to Yuflyma with continuing either reference adalimumab or Yuflyma for patients with active rheumatoid arthritis. In that trial, the efficacy, pharmacokinetics, safety, and immunogenicity of Yuflyma and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to Yuflyma.

“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Jonathan Kay, MD, of the University of Massachusetts, Worcester, in the press release.

The citrate-free formulation is thought to lead to less pain on injection.

Yuflyma will be available in prefilled syringe and autoinjector administration options.

Celltrion USA plans to market the drug in the United States in July 2023. Following the initial launch of 40 mg/0.4 mL, the company plans to launch dose forms of 80 mg/0.8 mL and 20 mg/0.2 mL.

Celltrion USA is also seeking an interchangeability designation from the FDA following the completion of an interchangeability trial of 366 patients with chronic plaque psoriasis. The interchangeability designation would mean that patients successfully switched from Humira to Yuflyma multiple times in the trial. The interchangeability designation would allow pharmacists to autosubstitute Humira with Yuflyma. In these cases, individual state laws control how and whether physicians will be notified of this switch.

If interchangeability is approved for Yuflyma, which the company tentatively expects in the fourth quarter of 2024, it would be just the third interchangeable biosimilar approved by the FDA overall and the second adalimumab biosimilar to be designated as such, after adalimumab-adbm (Cyltezo) in October 2021.

Yuflyma was approved in Canada in December 2021 for 10 indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and pediatric uveitis.

In February 2022, the European Commission granted marketing authorization for Yuflyma across those 10 indications, as well as for nonradiographic axial spondyloarthritis, pediatric plaque psoriasis, and pediatric Crohn’s disease.

In April 2022, Celltrion USA signed a licensing agreement with AbbVie, the manufacturer of Humira. Under that agreement, Celltrion will pay royalties to AbbVie on sales of their individual biosimilars, and AbbVie agreed to drop all patent litigation.

The full prescribing information for Yuflyma is available here.

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

The U.S. Food and Drug Administration has approved the biosimilar adalimumab-aaty (Yuflyma) in a citrate-free, high-concentration formulation, the manufacturer, Celltrion USA, announced today. It is the ninth biosimilar of adalimumab (Humira) to be approved in the United States.
 

Yuflyma is approved for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. It is also approved for polyarticular juvenile idiopathic arthritis for patients aged 2 years or older, as well as for Crohn’s disease in adults and in pediatric patients aged 6 years or older.

fda_icon2_web.jpg

The formulation was approved on the basis of a comprehensive data package of analytic, preclinical, and clinical studies, according to Celltrion USA, “demonstrating that Yuflyma is comparable to the reference product Humira in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and 1 year following treatment.”

The company conducted a double-blind, randomized phase 3 trial that compared switching from reference adalimumab to Yuflyma with continuing either reference adalimumab or Yuflyma for patients with active rheumatoid arthritis. In that trial, the efficacy, pharmacokinetics, safety, and immunogenicity of Yuflyma and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to Yuflyma.

“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Jonathan Kay, MD, of the University of Massachusetts, Worcester, in the press release.

The citrate-free formulation is thought to lead to less pain on injection.

Yuflyma will be available in prefilled syringe and autoinjector administration options.

Celltrion USA plans to market the drug in the United States in July 2023. Following the initial launch of 40 mg/0.4 mL, the company plans to launch dose forms of 80 mg/0.8 mL and 20 mg/0.2 mL.

Celltrion USA is also seeking an interchangeability designation from the FDA following the completion of an interchangeability trial of 366 patients with chronic plaque psoriasis. The interchangeability designation would mean that patients successfully switched from Humira to Yuflyma multiple times in the trial. The interchangeability designation would allow pharmacists to autosubstitute Humira with Yuflyma. In these cases, individual state laws control how and whether physicians will be notified of this switch.

If interchangeability is approved for Yuflyma, which the company tentatively expects in the fourth quarter of 2024, it would be just the third interchangeable biosimilar approved by the FDA overall and the second adalimumab biosimilar to be designated as such, after adalimumab-adbm (Cyltezo) in October 2021.

Yuflyma was approved in Canada in December 2021 for 10 indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and pediatric uveitis.

In February 2022, the European Commission granted marketing authorization for Yuflyma across those 10 indications, as well as for nonradiographic axial spondyloarthritis, pediatric plaque psoriasis, and pediatric Crohn’s disease.

In April 2022, Celltrion USA signed a licensing agreement with AbbVie, the manufacturer of Humira. Under that agreement, Celltrion will pay royalties to AbbVie on sales of their individual biosimilars, and AbbVie agreed to drop all patent litigation.

The full prescribing information for Yuflyma is available here.

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

The investigational interleukin-17A inhibitor izokibep showed higher response rates across a number of symptoms in adults with psoriatic arthritis (PsA) in an extension of its phase 2 trial out to 46 weeks, according to an announcement reporting some of the long-term data by the drug’s developer, Acelyrin.

Izokibep is an antibody mimetic designed to inhibit IL-17A that the company says has “high potency and the potential for robust tissue penetration due to its small molecular size, about one-tenth the size of a monoclonal antibody.”

“Patients want both rapid and meaningful improvement of their symptoms, as well as lasting – and ideally improving – resolution of disease over time. Building on the 16-week data for izokibep reported at EULAR and ACR [American College of Rheumatology] last year, the 46-week data now show not only continued but marked improvements over time in key areas of psoriatic arthritis including joint pain, skin psoriasis, and enthesitis,” Philip J. Mease, MD, director of rheumatology research at the Swedish Medical Center and clinical professor at the University of Washington, both in Seattle, and an investigator in the izokibep PsA program, said in the announcement.

The phase 2 trial tested two doses of izokibep – 40 mg and 80 mg – given by subcutaneous injection every 2 weeks – against placebo in 135 adult patients with active PsA. For inclusion in the trial, patients had to have at least three swollen and at least three tender joints and an inadequate response to prior therapy including NSAIDs, conventional synthetic disease-modifying antirheumatic drugs, or tumor necrosis factor inhibitors. At week 16, the placebo group transitioned to 80 mg izokibep every 2 weeks and the trial treatment period continued for up to 46 weeks.

[embed:render:related:node:255199]

The trial’s primary endpoint of a 50% or higher level of improvement in ACR response criteria (ACR 50) was achieved by 48% of those on the 40 mg dose at week 16 and by 50% at week 46. For the 80-mg group, this rate rose from 52% to 79%. In the group that went from placebo to 80 mg, the ACR 50 rose from 13% with placebo to 73% with izokibep at week 46.

Resolution of enthesitis, measured by the Leeds Enthesitis Index, among those on the 40 mg dose, was achieved by 63% at week 16 and 83% at week 46, and among those on the 80 mg dose, 88% at week 16 and 89% at week 46. Those on placebo who switched to 80 mg of izokibep at week 16 had an 80% rate of enthesitis resolution at week 46.

Total resolution of skin involvement – 100% clearance of psoriasis based on the Psoriasis Area Severity Index (PASI) – was observed at 46 weeks in 50% of those on 40 mg, 71% of those on 80 mg, and 67% of those on 80 mg after week 16.

In its announcement, Acelyrin did not report withdrawal rates from the study after 16 weeks and through 46 weeks, although the statement said that izokibep “was generally well tolerated through 46 weeks, which is in line with previous trials of izokibep.” The most common adverse event was localized injection site reactions, with the majority graded mild to moderate in severity. They were generally the size of a quarter to half-dollar, and typically presented within the first few injections, after which they declined in incidence. In the trial, a case of vulvar cancer was determined to be potentially drug related, the company said.

Acelyrin is currently conducting a phase 2b/3 trial in PsA evaluating a range of doses, including significantly higher doses than in the phase 2 trial, that the company said “could potentially result in better ACR, PASI, and enthesitis resolution responses.”

The drug has been tested at doses up to 160 mg, in some cases for up to 3 years, in more than 400 patients with psoriasis, spondyloarthritis, noninfective uveitis, and hidradenitis suppurativa.

The full 46-week data from this trial will be presented at a future scientific meeting, according to the company.

The investigational interleukin-17A inhibitor izokibep showed higher response rates across a number of symptoms in adults with psoriatic arthritis (PsA) in an extension of its phase 2 trial out to 46 weeks, according to an announcement reporting some of the long-term data by the drug’s developer, Acelyrin.

Izokibep is an antibody mimetic designed to inhibit IL-17A that the company says has “high potency and the potential for robust tissue penetration due to its small molecular size, about one-tenth the size of a monoclonal antibody.”

“Patients want both rapid and meaningful improvement of their symptoms, as well as lasting – and ideally improving – resolution of disease over time. Building on the 16-week data for izokibep reported at EULAR and ACR [American College of Rheumatology] last year, the 46-week data now show not only continued but marked improvements over time in key areas of psoriatic arthritis including joint pain, skin psoriasis, and enthesitis,” Philip J. Mease, MD, director of rheumatology research at the Swedish Medical Center and clinical professor at the University of Washington, both in Seattle, and an investigator in the izokibep PsA program, said in the announcement.

The phase 2 trial tested two doses of izokibep – 40 mg and 80 mg – given by subcutaneous injection every 2 weeks – against placebo in 135 adult patients with active PsA. For inclusion in the trial, patients had to have at least three swollen and at least three tender joints and an inadequate response to prior therapy including NSAIDs, conventional synthetic disease-modifying antirheumatic drugs, or tumor necrosis factor inhibitors. At week 16, the placebo group transitioned to 80 mg izokibep every 2 weeks and the trial treatment period continued for up to 46 weeks.

[embed:render:related:node:255199]

The trial’s primary endpoint of a 50% or higher level of improvement in ACR response criteria (ACR 50) was achieved by 48% of those on the 40 mg dose at week 16 and by 50% at week 46. For the 80-mg group, this rate rose from 52% to 79%. In the group that went from placebo to 80 mg, the ACR 50 rose from 13% with placebo to 73% with izokibep at week 46.

Resolution of enthesitis, measured by the Leeds Enthesitis Index, among those on the 40 mg dose, was achieved by 63% at week 16 and 83% at week 46, and among those on the 80 mg dose, 88% at week 16 and 89% at week 46. Those on placebo who switched to 80 mg of izokibep at week 16 had an 80% rate of enthesitis resolution at week 46.

Total resolution of skin involvement – 100% clearance of psoriasis based on the Psoriasis Area Severity Index (PASI) – was observed at 46 weeks in 50% of those on 40 mg, 71% of those on 80 mg, and 67% of those on 80 mg after week 16.

In its announcement, Acelyrin did not report withdrawal rates from the study after 16 weeks and through 46 weeks, although the statement said that izokibep “was generally well tolerated through 46 weeks, which is in line with previous trials of izokibep.” The most common adverse event was localized injection site reactions, with the majority graded mild to moderate in severity. They were generally the size of a quarter to half-dollar, and typically presented within the first few injections, after which they declined in incidence. In the trial, a case of vulvar cancer was determined to be potentially drug related, the company said.

Acelyrin is currently conducting a phase 2b/3 trial in PsA evaluating a range of doses, including significantly higher doses than in the phase 2 trial, that the company said “could potentially result in better ACR, PASI, and enthesitis resolution responses.”

The drug has been tested at doses up to 160 mg, in some cases for up to 3 years, in more than 400 patients with psoriasis, spondyloarthritis, noninfective uveitis, and hidradenitis suppurativa.

The full 46-week data from this trial will be presented at a future scientific meeting, according to the company.

The investigational interleukin-17A inhibitor izokibep showed higher response rates across a number of symptoms in adults with psoriatic arthritis (PsA) in an extension of its phase 2 trial out to 46 weeks, according to an announcement reporting some of the long-term data by the drug’s developer, Acelyrin.

Izokibep is an antibody mimetic designed to inhibit IL-17A that the company says has “high potency and the potential for robust tissue penetration due to its small molecular size, about one-tenth the size of a monoclonal antibody.”

“Patients want both rapid and meaningful improvement of their symptoms, as well as lasting – and ideally improving – resolution of disease over time. Building on the 16-week data for izokibep reported at EULAR and ACR [American College of Rheumatology] last year, the 46-week data now show not only continued but marked improvements over time in key areas of psoriatic arthritis including joint pain, skin psoriasis, and enthesitis,” Philip J. Mease, MD, director of rheumatology research at the Swedish Medical Center and clinical professor at the University of Washington, both in Seattle, and an investigator in the izokibep PsA program, said in the announcement.

The phase 2 trial tested two doses of izokibep – 40 mg and 80 mg – given by subcutaneous injection every 2 weeks – against placebo in 135 adult patients with active PsA. For inclusion in the trial, patients had to have at least three swollen and at least three tender joints and an inadequate response to prior therapy including NSAIDs, conventional synthetic disease-modifying antirheumatic drugs, or tumor necrosis factor inhibitors. At week 16, the placebo group transitioned to 80 mg izokibep every 2 weeks and the trial treatment period continued for up to 46 weeks.

[embed:render:related:node:255199]

The trial’s primary endpoint of a 50% or higher level of improvement in ACR response criteria (ACR 50) was achieved by 48% of those on the 40 mg dose at week 16 and by 50% at week 46. For the 80-mg group, this rate rose from 52% to 79%. In the group that went from placebo to 80 mg, the ACR 50 rose from 13% with placebo to 73% with izokibep at week 46.

Resolution of enthesitis, measured by the Leeds Enthesitis Index, among those on the 40 mg dose, was achieved by 63% at week 16 and 83% at week 46, and among those on the 80 mg dose, 88% at week 16 and 89% at week 46. Those on placebo who switched to 80 mg of izokibep at week 16 had an 80% rate of enthesitis resolution at week 46.

Total resolution of skin involvement – 100% clearance of psoriasis based on the Psoriasis Area Severity Index (PASI) – was observed at 46 weeks in 50% of those on 40 mg, 71% of those on 80 mg, and 67% of those on 80 mg after week 16.

In its announcement, Acelyrin did not report withdrawal rates from the study after 16 weeks and through 46 weeks, although the statement said that izokibep “was generally well tolerated through 46 weeks, which is in line with previous trials of izokibep.” The most common adverse event was localized injection site reactions, with the majority graded mild to moderate in severity. They were generally the size of a quarter to half-dollar, and typically presented within the first few injections, after which they declined in incidence. In the trial, a case of vulvar cancer was determined to be potentially drug related, the company said.

Acelyrin is currently conducting a phase 2b/3 trial in PsA evaluating a range of doses, including significantly higher doses than in the phase 2 trial, that the company said “could potentially result in better ACR, PASI, and enthesitis resolution responses.”

The drug has been tested at doses up to 160 mg, in some cases for up to 3 years, in more than 400 patients with psoriasis, spondyloarthritis, noninfective uveitis, and hidradenitis suppurativa.

The full 46-week data from this trial will be presented at a future scientific meeting, according to the company.

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.

161006_Battafarano_Daniel_web.jpg

“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.”

Jonas_Beth_NC_web.jpg

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.

[embed:render:related:node:260033]

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.

Poole_Janet_NM_web.jpg

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.

RamseyGoldman_Rosalind_ILL_web.jpg

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.

161006_Battafarano_Daniel_web.jpg

“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.”

Jonas_Beth_NC_web.jpg

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.

[embed:render:related:node:260033]

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.

Poole_Janet_NM_web.jpg

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.

RamseyGoldman_Rosalind_ILL_web.jpg

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.

161006_Battafarano_Daniel_web.jpg

“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.”

Jonas_Beth_NC_web.jpg

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.

[embed:render:related:node:260033]

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.

Poole_Janet_NM_web.jpg

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.

RamseyGoldman_Rosalind_ILL_web.jpg

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 – Patients with gout who underwent an intensive treat-to-target regimen of monthly up-titration of urate-lowering therapy (ULT) to reach a target serum urate level were significantly more likely to reach that goal at 1 year than were patients who received conventional gout management in a randomized, controlled trial.

These results came from the TICOG (Tight Control of Gout) trial, one of a handful of recent trials to test a treat-to-target strategy with ULT in the management of gout. Beyond the primary outcome of reaching target serum urate level of < 5 mg/dL (< 300 micromol/L), the results also showed that the tight-control strategy significantly lowered urate to a greater extent than conventional management, reduced tophus size in the first metatarsophalangeal (MTP) joint, and improved gray scale synovitis on ultrasound significantly more than with conventional management, Sarah Black, MBBS, a rheumatology trainee at Musgrave Park Hospital, Belfast, Northern Ireland, reported at the American College of Rheumatology annual meeting.

“Based on these outcomes, we question whether gout is best managed in primary or secondary care. We think there is an argument for establishing specialist gout clinics with more time to focus on patient education to help improve outcomes. These clinics could be led by allied health care professionals, such as specialist nurses and pharmacists,” Dr. Black said at the meeting.

Gout management guidelines issued by the British Society for Rheumatology in 2017 call for a target serum urate level of < 5 mg/dL, whereas the ACR’s 2020 guideline for the management of gout endorses a treat-to-target management strategy that aims for a serum urate level of < 6 mg/dL.

The single-center, nonblinded trial recruited 110 patients aged 18-85 years over a 3-year period to take ULT with allopurinol as first-line therapy starting at 100 mg/day. Everyone received the same advice regarding ULT up-titration, lifestyle changes, and gout education at baseline. The second-line agent for ULT was febuxostat (Uloric) 80 mg daily, with uricosuric drugs as third-line agents. All patients received colchicine or NSAID prophylaxis for gout flares for the first 6 months, depending on their comorbidities.

The trial excluded patients who had been treated with ULT within the past 6 months or had experienced prior hypersensitivity to ULT, severe renal impairment (creatinine clearance < 30 mL/min as measured by estimated glomerular filtration rate), significant liver impairment, or any other significant medical disease affecting life expectancy shorter than 1 year.

Conventional management consisted of urate level review at 0, 6, and 12 months with up-titration at each visit and primary care management of ULT between reviews until the target serum urate level was reached. In the tight-control group, monthly up-titrations occurred at the Musgrave Park Hospital at visits with the study team that were led by a rheumatologist and a specialist pharmacist.

A total of 48 patients in the conventional arm and 47 in the tight-control arm completed the trial. At baseline, monosodium urate crystals were detected in joint aspirates in 56% of patients receiving tight control and in 58.5% of those receiving conventional management. The mean serum urate level was 490 micromol/L (8.24 mg/dL) for tight-control patients and 470 micromol/L (7.9 mg/dL) for conventionally managed patients.

By 1 year, 89.4% of patients in the tight-control group had achieved the target urate level, compared with 39.6% in the conventional-management group (P < .001). At 6 months, serum urate had declined by 37.6% with tight control vs. 18% with conventional management. By the end of the trial, the median allopurinol dose was 400 mg with tight control (range, 200-900 mg) and 200 mg with conventional management (range, 0-400 mg). A total of 89% of patients were taking allopurinol at the end of the trial.

As expected, tight control led to more flares per month on average (0.35 vs. 0.13) in the 79 patients for whom complete data on flare frequency were available.

On blinded ultrasound evaluations, the median diameter of the first MTP tophus declined significantly more with tight control than with conventional management (–4.65 mm vs. –0.30 mm; P = .003). Gray scale synovitis in the knee improved in 63% of patients undergoing tight control, compared with 14% of conventionally managed patients (P = .043). The researchers observed no difference in resolution of the double-contour sign or in the number of erosions between the groups, although the 1-year time frame may not have been long enough to see resolution and improvement, Dr. Black said.

Dr. Black said that a follow-up study is planned with the same patient cohort at 3 years.

When asked about the feasibility of monthly ULT titration visits for gout management, audience member Tuhina Neogi, MD, professor of epidemiology at Boston University and chief of rheumatology at Boston Medical Center, told this news organization, “We don’t have a lot of data to guide us in that regard, and I also think it depends on what the increment of the dose titration is, but we generally do recognize that therapeutic inertia is bad – keeping someone on a dose for a long time. For me, I don’t think monthly is unreasonable if you have good prophylaxis [against acute flares].”

Dr. Neogi also noted that such monthly assessments don’t have to take place at a hospital. “I think there are many different practice models in which it could be implemented [that are not physician-driven].”

The study had no outside funding. Dr. Black has disclosed no relevant financial relationships. Dr. Neogi has received consulting fees from a variety of pharmaceutical companies, including Alnylam, Regeneron, Eli Lilly, EMD Serono, Novartis, Pfizer, and GlaxoSmithKline.

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

PHILADELPHIA – Patients with gout who underwent an intensive treat-to-target regimen of monthly up-titration of urate-lowering therapy (ULT) to reach a target serum urate level were significantly more likely to reach that goal at 1 year than were patients who received conventional gout management in a randomized, controlled trial.

These results came from the TICOG (Tight Control of Gout) trial, one of a handful of recent trials to test a treat-to-target strategy with ULT in the management of gout. Beyond the primary outcome of reaching target serum urate level of < 5 mg/dL (< 300 micromol/L), the results also showed that the tight-control strategy significantly lowered urate to a greater extent than conventional management, reduced tophus size in the first metatarsophalangeal (MTP) joint, and improved gray scale synovitis on ultrasound significantly more than with conventional management, Sarah Black, MBBS, a rheumatology trainee at Musgrave Park Hospital, Belfast, Northern Ireland, reported at the American College of Rheumatology annual meeting.

“Based on these outcomes, we question whether gout is best managed in primary or secondary care. We think there is an argument for establishing specialist gout clinics with more time to focus on patient education to help improve outcomes. These clinics could be led by allied health care professionals, such as specialist nurses and pharmacists,” Dr. Black said at the meeting.

Gout management guidelines issued by the British Society for Rheumatology in 2017 call for a target serum urate level of < 5 mg/dL, whereas the ACR’s 2020 guideline for the management of gout endorses a treat-to-target management strategy that aims for a serum urate level of < 6 mg/dL.

The single-center, nonblinded trial recruited 110 patients aged 18-85 years over a 3-year period to take ULT with allopurinol as first-line therapy starting at 100 mg/day. Everyone received the same advice regarding ULT up-titration, lifestyle changes, and gout education at baseline. The second-line agent for ULT was febuxostat (Uloric) 80 mg daily, with uricosuric drugs as third-line agents. All patients received colchicine or NSAID prophylaxis for gout flares for the first 6 months, depending on their comorbidities.

The trial excluded patients who had been treated with ULT within the past 6 months or had experienced prior hypersensitivity to ULT, severe renal impairment (creatinine clearance < 30 mL/min as measured by estimated glomerular filtration rate), significant liver impairment, or any other significant medical disease affecting life expectancy shorter than 1 year.

Conventional management consisted of urate level review at 0, 6, and 12 months with up-titration at each visit and primary care management of ULT between reviews until the target serum urate level was reached. In the tight-control group, monthly up-titrations occurred at the Musgrave Park Hospital at visits with the study team that were led by a rheumatologist and a specialist pharmacist.

A total of 48 patients in the conventional arm and 47 in the tight-control arm completed the trial. At baseline, monosodium urate crystals were detected in joint aspirates in 56% of patients receiving tight control and in 58.5% of those receiving conventional management. The mean serum urate level was 490 micromol/L (8.24 mg/dL) for tight-control patients and 470 micromol/L (7.9 mg/dL) for conventionally managed patients.

By 1 year, 89.4% of patients in the tight-control group had achieved the target urate level, compared with 39.6% in the conventional-management group (P < .001). At 6 months, serum urate had declined by 37.6% with tight control vs. 18% with conventional management. By the end of the trial, the median allopurinol dose was 400 mg with tight control (range, 200-900 mg) and 200 mg with conventional management (range, 0-400 mg). A total of 89% of patients were taking allopurinol at the end of the trial.

As expected, tight control led to more flares per month on average (0.35 vs. 0.13) in the 79 patients for whom complete data on flare frequency were available.

On blinded ultrasound evaluations, the median diameter of the first MTP tophus declined significantly more with tight control than with conventional management (–4.65 mm vs. –0.30 mm; P = .003). Gray scale synovitis in the knee improved in 63% of patients undergoing tight control, compared with 14% of conventionally managed patients (P = .043). The researchers observed no difference in resolution of the double-contour sign or in the number of erosions between the groups, although the 1-year time frame may not have been long enough to see resolution and improvement, Dr. Black said.

Dr. Black said that a follow-up study is planned with the same patient cohort at 3 years.

When asked about the feasibility of monthly ULT titration visits for gout management, audience member Tuhina Neogi, MD, professor of epidemiology at Boston University and chief of rheumatology at Boston Medical Center, told this news organization, “We don’t have a lot of data to guide us in that regard, and I also think it depends on what the increment of the dose titration is, but we generally do recognize that therapeutic inertia is bad – keeping someone on a dose for a long time. For me, I don’t think monthly is unreasonable if you have good prophylaxis [against acute flares].”

Dr. Neogi also noted that such monthly assessments don’t have to take place at a hospital. “I think there are many different practice models in which it could be implemented [that are not physician-driven].”

The study had no outside funding. Dr. Black has disclosed no relevant financial relationships. Dr. Neogi has received consulting fees from a variety of pharmaceutical companies, including Alnylam, Regeneron, Eli Lilly, EMD Serono, Novartis, Pfizer, and GlaxoSmithKline.

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

PHILADELPHIA – Patients with gout who underwent an intensive treat-to-target regimen of monthly up-titration of urate-lowering therapy (ULT) to reach a target serum urate level were significantly more likely to reach that goal at 1 year than were patients who received conventional gout management in a randomized, controlled trial.

These results came from the TICOG (Tight Control of Gout) trial, one of a handful of recent trials to test a treat-to-target strategy with ULT in the management of gout. Beyond the primary outcome of reaching target serum urate level of < 5 mg/dL (< 300 micromol/L), the results also showed that the tight-control strategy significantly lowered urate to a greater extent than conventional management, reduced tophus size in the first metatarsophalangeal (MTP) joint, and improved gray scale synovitis on ultrasound significantly more than with conventional management, Sarah Black, MBBS, a rheumatology trainee at Musgrave Park Hospital, Belfast, Northern Ireland, reported at the American College of Rheumatology annual meeting.

“Based on these outcomes, we question whether gout is best managed in primary or secondary care. We think there is an argument for establishing specialist gout clinics with more time to focus on patient education to help improve outcomes. These clinics could be led by allied health care professionals, such as specialist nurses and pharmacists,” Dr. Black said at the meeting.

Gout management guidelines issued by the British Society for Rheumatology in 2017 call for a target serum urate level of < 5 mg/dL, whereas the ACR’s 2020 guideline for the management of gout endorses a treat-to-target management strategy that aims for a serum urate level of < 6 mg/dL.

The single-center, nonblinded trial recruited 110 patients aged 18-85 years over a 3-year period to take ULT with allopurinol as first-line therapy starting at 100 mg/day. Everyone received the same advice regarding ULT up-titration, lifestyle changes, and gout education at baseline. The second-line agent for ULT was febuxostat (Uloric) 80 mg daily, with uricosuric drugs as third-line agents. All patients received colchicine or NSAID prophylaxis for gout flares for the first 6 months, depending on their comorbidities.

The trial excluded patients who had been treated with ULT within the past 6 months or had experienced prior hypersensitivity to ULT, severe renal impairment (creatinine clearance < 30 mL/min as measured by estimated glomerular filtration rate), significant liver impairment, or any other significant medical disease affecting life expectancy shorter than 1 year.

Conventional management consisted of urate level review at 0, 6, and 12 months with up-titration at each visit and primary care management of ULT between reviews until the target serum urate level was reached. In the tight-control group, monthly up-titrations occurred at the Musgrave Park Hospital at visits with the study team that were led by a rheumatologist and a specialist pharmacist.

A total of 48 patients in the conventional arm and 47 in the tight-control arm completed the trial. At baseline, monosodium urate crystals were detected in joint aspirates in 56% of patients receiving tight control and in 58.5% of those receiving conventional management. The mean serum urate level was 490 micromol/L (8.24 mg/dL) for tight-control patients and 470 micromol/L (7.9 mg/dL) for conventionally managed patients.

By 1 year, 89.4% of patients in the tight-control group had achieved the target urate level, compared with 39.6% in the conventional-management group (P < .001). At 6 months, serum urate had declined by 37.6% with tight control vs. 18% with conventional management. By the end of the trial, the median allopurinol dose was 400 mg with tight control (range, 200-900 mg) and 200 mg with conventional management (range, 0-400 mg). A total of 89% of patients were taking allopurinol at the end of the trial.

As expected, tight control led to more flares per month on average (0.35 vs. 0.13) in the 79 patients for whom complete data on flare frequency were available.

On blinded ultrasound evaluations, the median diameter of the first MTP tophus declined significantly more with tight control than with conventional management (–4.65 mm vs. –0.30 mm; P = .003). Gray scale synovitis in the knee improved in 63% of patients undergoing tight control, compared with 14% of conventionally managed patients (P = .043). The researchers observed no difference in resolution of the double-contour sign or in the number of erosions between the groups, although the 1-year time frame may not have been long enough to see resolution and improvement, Dr. Black said.

Dr. Black said that a follow-up study is planned with the same patient cohort at 3 years.

When asked about the feasibility of monthly ULT titration visits for gout management, audience member Tuhina Neogi, MD, professor of epidemiology at Boston University and chief of rheumatology at Boston Medical Center, told this news organization, “We don’t have a lot of data to guide us in that regard, and I also think it depends on what the increment of the dose titration is, but we generally do recognize that therapeutic inertia is bad – keeping someone on a dose for a long time. For me, I don’t think monthly is unreasonable if you have good prophylaxis [against acute flares].”

Dr. Neogi also noted that such monthly assessments don’t have to take place at a hospital. “I think there are many different practice models in which it could be implemented [that are not physician-driven].”

The study had no outside funding. Dr. Black has disclosed no relevant financial relationships. Dr. Neogi has received consulting fees from a variety of pharmaceutical companies, including Alnylam, Regeneron, Eli Lilly, EMD Serono, Novartis, Pfizer, and GlaxoSmithKline.

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

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

[embed:render:related:node:254293]

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

FDA_icon3_web.jpg

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

[embed:render:related:node:255135]

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

[embed:render:related:node:254293]

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

FDA_icon3_web.jpg

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

[embed:render:related:node:255135]

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

[embed:render:related:node:254293]

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

FDA_icon3_web.jpg

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

[embed:render:related:node:255135]

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

Physician authors of clinical practice guidelines for psoriatic arthritis in the United States and Japan received payments from pharmaceutical companies totaling over $7 million during 2016-2018, according to a retrospective analysis of all authors on the most recent guidelines issued by the American College of Rheumatology (ACR) and the Japanese Dermatological Association (JDA).

In addition to finding that the majority of the authors of psoriatic arthritis (PsA) clinical practice guidelines (CPGs) issued by the JDA and ACR received substantial personal payments from pharmaceutical companies before and during CPG development, researchers led by Hanano Mamada and Anju Murayama of the Medical Governance Research Institute, Tokyo, wrote in Arthritis Care & Research that “several CPG authors self-cited their articles without the disclosure of NFCOI [nonfinancial conflicts of interest], and most of the recommendations were based on low or very low quality of evidence. Although the COI policies used by JDA and ACR are clearly inadequate, no significant revisions have been made for the last 3 years.”

[embed:render:related:node:217390]

Based on their findings, which were made using payment data from major Japanese pharmaceutical companies and the U.S. Open Payments Database from 2016 to 2018, the researchers suggested that the medical societies should:

• Adopt global standard COI policies from organizations such as the National Academy of Medicine and Guidelines International Network, including a 3-year lookback period for COI declaration.
• Consider a comprehensive definition and rigorous management with full disclosure of NFCOI.
• Publish a list of authors making each recommendation to grasp the implications of COI in clinical practice guidelines.
• Mention the detailed date of the COI disclosure, which should be close to the publication date as much as possible.

Financial conflicts of interest

The researchers used payment data published between 2016 and 2018 for all 83 companies belonging to the Japan Pharmaceutical Manufacturers Association, focusing on personal payments (for lecturing, writing, and consultancy) and excluding research payments, “since in Japan, the name, institution, and position of the author or researcher who received the research payment is not disclosed, which makes assessing research payments difficult.” To evaluate authors’ FCOI in the ACR’s CPG, the researchers analyzed the U.S. Open Payments Database “for all categories of general payments such as speaking, consulting, meals, and travel expenses 3 years from before the guideline’s first online publication on November 30, 2018.”

The 2018 ACR/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis had 36 authors and the JDA’s Clinical Practice Guideline for the Treatment of Psoriatic Arthritis 2019 had 23. Overall, 61% of JDA authors and half of ACR authors voluntarily declared FCOI with pharmaceutical companies; 25 of the ACR authors were U.S. physicians and could be included in the Open Payments Database search.

A total of 21 (91.3%) JDA authors and 21 (84.0%) ACR authors received at least one payment, with the combined total of $3,335,413 and $4,081,629 payments, respectively, over the 3 years. The average and median personal payments were $145,018 and $123,876 for JDA authors and $162,825 and $58,826 for ACR authors. When the payments to ACR authors were limited to lecturing, writing, and consulting fees that are required under the ACR’s COI policy, the mean was $130,102 and median was $39,375. The corresponding payments for JDA authors were $123,876 and $8,170, respectively,

The researchers found undisclosed payments for more than three-quarters of physician authors of the Japanese guideline, and nearly half of the doctors authoring the American guideline had undisclosed payments. These added up to $474,000 for the JDA, which amounted to 38% of the total for personal payments that must be reported to the JDA based on its COI policy for clinical practice guidelines, and $218,000 for the ACR, amounting to 18% of the total for personal payments that must be reported to the society based on its COI policy.

Of the 11 ACR authors who were not eligible for the U.S. Open Payments Database search, 5 declared FCOI with pharmaceutical companies in the guideline, meaning that 26 (72%) of the 36 authors had FCOI with pharmaceutical companies.

The ACR only required authors to declare FCOI covering 1 year before and during guideline development, and although the JDA required authors to declare their FCOI for the past 3 years of guideline development, the study authors noted that the JDA guideline disclosed them for only 2 years (between Jan. 1, 2017, and Dec. 31, 2018).

“It is true that influential doctors such as clinical practice guideline authors tend to receive various types of payments from pharmaceutical companies and that it is difficult to conduct research without funding from pharmaceutical companies. However, our current research mainly focuses on personal payments from pharmaceutical companies such as lecture fees and consulting fees. These payments are recognized as pocket money and are not used for research. Thus, it is questionable that the observed relationships are something evitable,” the researchers wrote.
 

Nonfinancial conflicts of interest

Many authors of the ACR’s CPG and the JDA’s CPG also had NFCOI, defined objectively in this study as self-citation rate. NFCOI have been more broadly defined by the International Committee of Medical Journal Editors (ICMJE) as “conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs”; the ICMJE recommends reporting NFCOI on its COI form.

The JDA guideline included self-citations by 78% of its authors, compared with 32% of the ACR guideline authors, but this weighed differently among the two guidelines in that only 12 of the 354 (3.4%) citations in the JDA guideline were self-cited, compared with 46 of 137 (34%) citations in the ACR guideline.

The researchers noted that while the self-citation rates between JDA and ACR authors “differed remarkably,” the impact of ACR authors on CPG recommendations was much more direct. Three-quarters of JDA authors’ self-cited articles were about observational studies, whereas 52% of the ACR authors’ self-cited articles were clinical trials, most of which were randomized, controlled studies, and these NFCOI were not disclosed in the guideline.

Half of the strong recommendations in the JDA guideline were based on low or very low quality of evidence, whereas the ACR guideline had no strong recommendations based on low or very low quality of evidence.

This study was supported by the nonprofit Medical Governance Research Institute, which receives donations from Ain Pharmacies Inc., other organizations, and private individuals. The study also received support from the Tansa (formerly known as the Waseda Chronicle), an independent nonprofit news organization dedicated to investigative journalism. Three authors reported receiving personal fees from several pharmaceutical companies for work outside of the scope of this study.

Physician authors of clinical practice guidelines for psoriatic arthritis in the United States and Japan received payments from pharmaceutical companies totaling over $7 million during 2016-2018, according to a retrospective analysis of all authors on the most recent guidelines issued by the American College of Rheumatology (ACR) and the Japanese Dermatological Association (JDA).

In addition to finding that the majority of the authors of psoriatic arthritis (PsA) clinical practice guidelines (CPGs) issued by the JDA and ACR received substantial personal payments from pharmaceutical companies before and during CPG development, researchers led by Hanano Mamada and Anju Murayama of the Medical Governance Research Institute, Tokyo, wrote in Arthritis Care & Research that “several CPG authors self-cited their articles without the disclosure of NFCOI [nonfinancial conflicts of interest], and most of the recommendations were based on low or very low quality of evidence. Although the COI policies used by JDA and ACR are clearly inadequate, no significant revisions have been made for the last 3 years.”

[embed:render:related:node:217390]

Based on their findings, which were made using payment data from major Japanese pharmaceutical companies and the U.S. Open Payments Database from 2016 to 2018, the researchers suggested that the medical societies should:

• Adopt global standard COI policies from organizations such as the National Academy of Medicine and Guidelines International Network, including a 3-year lookback period for COI declaration.
• Consider a comprehensive definition and rigorous management with full disclosure of NFCOI.
• Publish a list of authors making each recommendation to grasp the implications of COI in clinical practice guidelines.
• Mention the detailed date of the COI disclosure, which should be close to the publication date as much as possible.

Financial conflicts of interest

The researchers used payment data published between 2016 and 2018 for all 83 companies belonging to the Japan Pharmaceutical Manufacturers Association, focusing on personal payments (for lecturing, writing, and consultancy) and excluding research payments, “since in Japan, the name, institution, and position of the author or researcher who received the research payment is not disclosed, which makes assessing research payments difficult.” To evaluate authors’ FCOI in the ACR’s CPG, the researchers analyzed the U.S. Open Payments Database “for all categories of general payments such as speaking, consulting, meals, and travel expenses 3 years from before the guideline’s first online publication on November 30, 2018.”

The 2018 ACR/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis had 36 authors and the JDA’s Clinical Practice Guideline for the Treatment of Psoriatic Arthritis 2019 had 23. Overall, 61% of JDA authors and half of ACR authors voluntarily declared FCOI with pharmaceutical companies; 25 of the ACR authors were U.S. physicians and could be included in the Open Payments Database search.

A total of 21 (91.3%) JDA authors and 21 (84.0%) ACR authors received at least one payment, with the combined total of $3,335,413 and $4,081,629 payments, respectively, over the 3 years. The average and median personal payments were $145,018 and $123,876 for JDA authors and $162,825 and $58,826 for ACR authors. When the payments to ACR authors were limited to lecturing, writing, and consulting fees that are required under the ACR’s COI policy, the mean was $130,102 and median was $39,375. The corresponding payments for JDA authors were $123,876 and $8,170, respectively,

The researchers found undisclosed payments for more than three-quarters of physician authors of the Japanese guideline, and nearly half of the doctors authoring the American guideline had undisclosed payments. These added up to $474,000 for the JDA, which amounted to 38% of the total for personal payments that must be reported to the JDA based on its COI policy for clinical practice guidelines, and $218,000 for the ACR, amounting to 18% of the total for personal payments that must be reported to the society based on its COI policy.

Of the 11 ACR authors who were not eligible for the U.S. Open Payments Database search, 5 declared FCOI with pharmaceutical companies in the guideline, meaning that 26 (72%) of the 36 authors had FCOI with pharmaceutical companies.

The ACR only required authors to declare FCOI covering 1 year before and during guideline development, and although the JDA required authors to declare their FCOI for the past 3 years of guideline development, the study authors noted that the JDA guideline disclosed them for only 2 years (between Jan. 1, 2017, and Dec. 31, 2018).

“It is true that influential doctors such as clinical practice guideline authors tend to receive various types of payments from pharmaceutical companies and that it is difficult to conduct research without funding from pharmaceutical companies. However, our current research mainly focuses on personal payments from pharmaceutical companies such as lecture fees and consulting fees. These payments are recognized as pocket money and are not used for research. Thus, it is questionable that the observed relationships are something evitable,” the researchers wrote.
 

Nonfinancial conflicts of interest

Many authors of the ACR’s CPG and the JDA’s CPG also had NFCOI, defined objectively in this study as self-citation rate. NFCOI have been more broadly defined by the International Committee of Medical Journal Editors (ICMJE) as “conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs”; the ICMJE recommends reporting NFCOI on its COI form.

The JDA guideline included self-citations by 78% of its authors, compared with 32% of the ACR guideline authors, but this weighed differently among the two guidelines in that only 12 of the 354 (3.4%) citations in the JDA guideline were self-cited, compared with 46 of 137 (34%) citations in the ACR guideline.

The researchers noted that while the self-citation rates between JDA and ACR authors “differed remarkably,” the impact of ACR authors on CPG recommendations was much more direct. Three-quarters of JDA authors’ self-cited articles were about observational studies, whereas 52% of the ACR authors’ self-cited articles were clinical trials, most of which were randomized, controlled studies, and these NFCOI were not disclosed in the guideline.

Half of the strong recommendations in the JDA guideline were based on low or very low quality of evidence, whereas the ACR guideline had no strong recommendations based on low or very low quality of evidence.

This study was supported by the nonprofit Medical Governance Research Institute, which receives donations from Ain Pharmacies Inc., other organizations, and private individuals. The study also received support from the Tansa (formerly known as the Waseda Chronicle), an independent nonprofit news organization dedicated to investigative journalism. Three authors reported receiving personal fees from several pharmaceutical companies for work outside of the scope of this study.

Physician authors of clinical practice guidelines for psoriatic arthritis in the United States and Japan received payments from pharmaceutical companies totaling over $7 million during 2016-2018, according to a retrospective analysis of all authors on the most recent guidelines issued by the American College of Rheumatology (ACR) and the Japanese Dermatological Association (JDA).

In addition to finding that the majority of the authors of psoriatic arthritis (PsA) clinical practice guidelines (CPGs) issued by the JDA and ACR received substantial personal payments from pharmaceutical companies before and during CPG development, researchers led by Hanano Mamada and Anju Murayama of the Medical Governance Research Institute, Tokyo, wrote in Arthritis Care & Research that “several CPG authors self-cited their articles without the disclosure of NFCOI [nonfinancial conflicts of interest], and most of the recommendations were based on low or very low quality of evidence. Although the COI policies used by JDA and ACR are clearly inadequate, no significant revisions have been made for the last 3 years.”

[embed:render:related:node:217390]

Based on their findings, which were made using payment data from major Japanese pharmaceutical companies and the U.S. Open Payments Database from 2016 to 2018, the researchers suggested that the medical societies should:

• Adopt global standard COI policies from organizations such as the National Academy of Medicine and Guidelines International Network, including a 3-year lookback period for COI declaration.
• Consider a comprehensive definition and rigorous management with full disclosure of NFCOI.
• Publish a list of authors making each recommendation to grasp the implications of COI in clinical practice guidelines.
• Mention the detailed date of the COI disclosure, which should be close to the publication date as much as possible.

Financial conflicts of interest

The researchers used payment data published between 2016 and 2018 for all 83 companies belonging to the Japan Pharmaceutical Manufacturers Association, focusing on personal payments (for lecturing, writing, and consultancy) and excluding research payments, “since in Japan, the name, institution, and position of the author or researcher who received the research payment is not disclosed, which makes assessing research payments difficult.” To evaluate authors’ FCOI in the ACR’s CPG, the researchers analyzed the U.S. Open Payments Database “for all categories of general payments such as speaking, consulting, meals, and travel expenses 3 years from before the guideline’s first online publication on November 30, 2018.”

The 2018 ACR/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis had 36 authors and the JDA’s Clinical Practice Guideline for the Treatment of Psoriatic Arthritis 2019 had 23. Overall, 61% of JDA authors and half of ACR authors voluntarily declared FCOI with pharmaceutical companies; 25 of the ACR authors were U.S. physicians and could be included in the Open Payments Database search.

A total of 21 (91.3%) JDA authors and 21 (84.0%) ACR authors received at least one payment, with the combined total of $3,335,413 and $4,081,629 payments, respectively, over the 3 years. The average and median personal payments were $145,018 and $123,876 for JDA authors and $162,825 and $58,826 for ACR authors. When the payments to ACR authors were limited to lecturing, writing, and consulting fees that are required under the ACR’s COI policy, the mean was $130,102 and median was $39,375. The corresponding payments for JDA authors were $123,876 and $8,170, respectively,

The researchers found undisclosed payments for more than three-quarters of physician authors of the Japanese guideline, and nearly half of the doctors authoring the American guideline had undisclosed payments. These added up to $474,000 for the JDA, which amounted to 38% of the total for personal payments that must be reported to the JDA based on its COI policy for clinical practice guidelines, and $218,000 for the ACR, amounting to 18% of the total for personal payments that must be reported to the society based on its COI policy.

Of the 11 ACR authors who were not eligible for the U.S. Open Payments Database search, 5 declared FCOI with pharmaceutical companies in the guideline, meaning that 26 (72%) of the 36 authors had FCOI with pharmaceutical companies.

The ACR only required authors to declare FCOI covering 1 year before and during guideline development, and although the JDA required authors to declare their FCOI for the past 3 years of guideline development, the study authors noted that the JDA guideline disclosed them for only 2 years (between Jan. 1, 2017, and Dec. 31, 2018).

“It is true that influential doctors such as clinical practice guideline authors tend to receive various types of payments from pharmaceutical companies and that it is difficult to conduct research without funding from pharmaceutical companies. However, our current research mainly focuses on personal payments from pharmaceutical companies such as lecture fees and consulting fees. These payments are recognized as pocket money and are not used for research. Thus, it is questionable that the observed relationships are something evitable,” the researchers wrote.
 

Nonfinancial conflicts of interest

Many authors of the ACR’s CPG and the JDA’s CPG also had NFCOI, defined objectively in this study as self-citation rate. NFCOI have been more broadly defined by the International Committee of Medical Journal Editors (ICMJE) as “conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs”; the ICMJE recommends reporting NFCOI on its COI form.

The JDA guideline included self-citations by 78% of its authors, compared with 32% of the ACR guideline authors, but this weighed differently among the two guidelines in that only 12 of the 354 (3.4%) citations in the JDA guideline were self-cited, compared with 46 of 137 (34%) citations in the ACR guideline.

The researchers noted that while the self-citation rates between JDA and ACR authors “differed remarkably,” the impact of ACR authors on CPG recommendations was much more direct. Three-quarters of JDA authors’ self-cited articles were about observational studies, whereas 52% of the ACR authors’ self-cited articles were clinical trials, most of which were randomized, controlled studies, and these NFCOI were not disclosed in the guideline.

Half of the strong recommendations in the JDA guideline were based on low or very low quality of evidence, whereas the ACR guideline had no strong recommendations based on low or very low quality of evidence.

This study was supported by the nonprofit Medical Governance Research Institute, which receives donations from Ain Pharmacies Inc., other organizations, and private individuals. The study also received support from the Tansa (formerly known as the Waseda Chronicle), an independent nonprofit news organization dedicated to investigative journalism. Three authors reported receiving personal fees from several pharmaceutical companies for work outside of the scope of this study.

The U.S. Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner Organon said in an announcement.

Hadlima is a biosimilar of the tumor necrosis factor inhibitor reference product adalimumab (Humira).

Hadlima was first approved in July 2019 in a citrated, 50-mg/mL formulation. The new citrate-free, 100-mg/mL version will be available in prefilled syringe and autoinjector options.

fda_icon2_web.jpg

The 100-mg/mL formulation is indicated for the same seven conditions as its 50-mg/mL counterpart: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, and ulcerative colitis.

[embed:render:related:node:247499]

The approval was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of the 100-mg/mL and 50-mg/mL formulations of Hadlima in healthy volunteers.

Both low- and high-concentration formulations of Humira are currently marketed in the United States. Organon said that it expects to market Hadlima in the United States on or after July 1, 2023, in accordance with a licensing agreement with AbbVie.

The prescribing information for Hadlima includes specific warnings and areas of concern. The drug should not be administered to individuals who are known to be hypersensitive to adalimumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, including serious infections leading to hospitalization or death, such as tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections attributable to other opportunistic pathogens.

[embed:render:related:node:239217]

A test for latent TB infection should be given before administration, and treatment of TB should begin before administration of Hadlima.

Patients taking Hadlima should not take a live vaccine.

The most common adverse effects (incidence > 10%) include infections (for example, upper respiratory infections, sinusitis), injection site reactions, headache, and rash.

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

The U.S. Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner Organon said in an announcement.

Hadlima is a biosimilar of the tumor necrosis factor inhibitor reference product adalimumab (Humira).

Hadlima was first approved in July 2019 in a citrated, 50-mg/mL formulation. The new citrate-free, 100-mg/mL version will be available in prefilled syringe and autoinjector options.

fda_icon2_web.jpg

The 100-mg/mL formulation is indicated for the same seven conditions as its 50-mg/mL counterpart: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, and ulcerative colitis.

[embed:render:related:node:247499]

The approval was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of the 100-mg/mL and 50-mg/mL formulations of Hadlima in healthy volunteers.

Both low- and high-concentration formulations of Humira are currently marketed in the United States. Organon said that it expects to market Hadlima in the United States on or after July 1, 2023, in accordance with a licensing agreement with AbbVie.

The prescribing information for Hadlima includes specific warnings and areas of concern. The drug should not be administered to individuals who are known to be hypersensitive to adalimumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, including serious infections leading to hospitalization or death, such as tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections attributable to other opportunistic pathogens.

[embed:render:related:node:239217]

A test for latent TB infection should be given before administration, and treatment of TB should begin before administration of Hadlima.

Patients taking Hadlima should not take a live vaccine.

The most common adverse effects (incidence > 10%) include infections (for example, upper respiratory infections, sinusitis), injection site reactions, headache, and rash.

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

The U.S. Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner Organon said in an announcement.

Hadlima is a biosimilar of the tumor necrosis factor inhibitor reference product adalimumab (Humira).

Hadlima was first approved in July 2019 in a citrated, 50-mg/mL formulation. The new citrate-free, 100-mg/mL version will be available in prefilled syringe and autoinjector options.

fda_icon2_web.jpg

The 100-mg/mL formulation is indicated for the same seven conditions as its 50-mg/mL counterpart: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, and ulcerative colitis.

[embed:render:related:node:247499]

The approval was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of the 100-mg/mL and 50-mg/mL formulations of Hadlima in healthy volunteers.

Both low- and high-concentration formulations of Humira are currently marketed in the United States. Organon said that it expects to market Hadlima in the United States on or after July 1, 2023, in accordance with a licensing agreement with AbbVie.

The prescribing information for Hadlima includes specific warnings and areas of concern. The drug should not be administered to individuals who are known to be hypersensitive to adalimumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, including serious infections leading to hospitalization or death, such as tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections attributable to other opportunistic pathogens.

[embed:render:related:node:239217]

A test for latent TB infection should be given before administration, and treatment of TB should begin before administration of Hadlima.

Patients taking Hadlima should not take a live vaccine.

The most common adverse effects (incidence > 10%) include infections (for example, upper respiratory infections, sinusitis), injection site reactions, headache, and rash.

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

The Food and Drug Administration has approved the dual interleukin-12 and IL-23 inhibitor ustekinumab (Stelara) for the treatment of juvenile psoriatic arthritis (jPsA) in patients aged 6 years and older, according to an Aug. 1 announcement from its manufacturer, Janssen.

The approval makes jPsA the sixth approved indication for ustekinumab, which include active psoriatic arthritis in adults, moderate to severe plaque psoriasis in both adults and children aged 6 years or older who are candidates for phototherapy or systemic therapy, moderately to severely active Crohn’s disease in adults, and moderately to severely active ulcerative colitis in adults.

FDA_icon3_web.jpg

In addition, ustekinumab is now the second biologic to be approved for jPsA, following the agency’s December 2021 approval of secukinumab (Cosentyx) to treat jPsA in children and adolescents aged 2 years and older as well as enthesitis-related arthritis in children and adolescents aged 4 years and older.

In pediatric patients, ustekinumab is administered as a subcutaneous injection dosed four times per year after two starter doses.

Ustekinumab’s approval is based on “an extrapolation of the established data and existing safety profile” of ustekinumab in multiple phase 3 studies in adult and pediatric patients with moderate to severe plaque psoriasis and adult patients with active PsA, according to Janssen.

“With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population,” according to the October 2021 announcement from the company that the Biologics License Application had been submitted to the FDA.

Juvenile arthritis occurs in an estimated 20-45 children per 100,000 in the United States, with about 5% of those children having jPsA, according to the National Psoriasis Foundation.

[embed:render:related:node:241602]

The prescribing information for ustekinumab includes specific warnings and areas of concern. The drug should not be administered to individuals with known hypersensitivity to ustekinumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, sometimes serious, and a test for tuberculosis infection should be given before administration.

Patients taking ustekinumab should not be given a live vaccine, and their doctors should be informed if anyone in their household needs a live vaccine. They also should not receive the BCG vaccine during the 1 year before receiving the drug or 1 year after they stop taking it, according to Johnson & Johnson.

The most common adverse effects include nasal congestion, sore throat, runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain.

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

The Food and Drug Administration has approved the dual interleukin-12 and IL-23 inhibitor ustekinumab (Stelara) for the treatment of juvenile psoriatic arthritis (jPsA) in patients aged 6 years and older, according to an Aug. 1 announcement from its manufacturer, Janssen.

The approval makes jPsA the sixth approved indication for ustekinumab, which include active psoriatic arthritis in adults, moderate to severe plaque psoriasis in both adults and children aged 6 years or older who are candidates for phototherapy or systemic therapy, moderately to severely active Crohn’s disease in adults, and moderately to severely active ulcerative colitis in adults.

FDA_icon3_web.jpg

In addition, ustekinumab is now the second biologic to be approved for jPsA, following the agency’s December 2021 approval of secukinumab (Cosentyx) to treat jPsA in children and adolescents aged 2 years and older as well as enthesitis-related arthritis in children and adolescents aged 4 years and older.

In pediatric patients, ustekinumab is administered as a subcutaneous injection dosed four times per year after two starter doses.

Ustekinumab’s approval is based on “an extrapolation of the established data and existing safety profile” of ustekinumab in multiple phase 3 studies in adult and pediatric patients with moderate to severe plaque psoriasis and adult patients with active PsA, according to Janssen.

“With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population,” according to the October 2021 announcement from the company that the Biologics License Application had been submitted to the FDA.

Juvenile arthritis occurs in an estimated 20-45 children per 100,000 in the United States, with about 5% of those children having jPsA, according to the National Psoriasis Foundation.

[embed:render:related:node:241602]

The prescribing information for ustekinumab includes specific warnings and areas of concern. The drug should not be administered to individuals with known hypersensitivity to ustekinumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, sometimes serious, and a test for tuberculosis infection should be given before administration.

Patients taking ustekinumab should not be given a live vaccine, and their doctors should be informed if anyone in their household needs a live vaccine. They also should not receive the BCG vaccine during the 1 year before receiving the drug or 1 year after they stop taking it, according to Johnson & Johnson.

The most common adverse effects include nasal congestion, sore throat, runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain.

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

The Food and Drug Administration has approved the dual interleukin-12 and IL-23 inhibitor ustekinumab (Stelara) for the treatment of juvenile psoriatic arthritis (jPsA) in patients aged 6 years and older, according to an Aug. 1 announcement from its manufacturer, Janssen.

The approval makes jPsA the sixth approved indication for ustekinumab, which include active psoriatic arthritis in adults, moderate to severe plaque psoriasis in both adults and children aged 6 years or older who are candidates for phototherapy or systemic therapy, moderately to severely active Crohn’s disease in adults, and moderately to severely active ulcerative colitis in adults.

FDA_icon3_web.jpg

In addition, ustekinumab is now the second biologic to be approved for jPsA, following the agency’s December 2021 approval of secukinumab (Cosentyx) to treat jPsA in children and adolescents aged 2 years and older as well as enthesitis-related arthritis in children and adolescents aged 4 years and older.

In pediatric patients, ustekinumab is administered as a subcutaneous injection dosed four times per year after two starter doses.

Ustekinumab’s approval is based on “an extrapolation of the established data and existing safety profile” of ustekinumab in multiple phase 3 studies in adult and pediatric patients with moderate to severe plaque psoriasis and adult patients with active PsA, according to Janssen.

“With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population,” according to the October 2021 announcement from the company that the Biologics License Application had been submitted to the FDA.

Juvenile arthritis occurs in an estimated 20-45 children per 100,000 in the United States, with about 5% of those children having jPsA, according to the National Psoriasis Foundation.

[embed:render:related:node:241602]

The prescribing information for ustekinumab includes specific warnings and areas of concern. The drug should not be administered to individuals with known hypersensitivity to ustekinumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, sometimes serious, and a test for tuberculosis infection should be given before administration.

Patients taking ustekinumab should not be given a live vaccine, and their doctors should be informed if anyone in their household needs a live vaccine. They also should not receive the BCG vaccine during the 1 year before receiving the drug or 1 year after they stop taking it, according to Johnson & Johnson.

The most common adverse effects include nasal congestion, sore throat, runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain.

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

In the last 2 decades, the number of women receiving awards from the American College of Rheumatology, European Alliance of Associations for Rheumatology, and the British Society for Rheumatology has steadily increased, but the absolute percentage of female prize winners remains lower than male winners across the 41 total awards given by the three organizations, according to Thorsten Halling and colleagues at Heinrich-Heine-University in Düsseldorf, Germany.

[embed:render:related:node:227619]

The overall number of awards given by the three groups rose by 10% over the past 2 years. In 2021, 40% of awards given by the ACR went to females, compared with 48% by EULAR, and 50% by the BSR. However, the most prestigious prizes awarded by these groups were given less often to women, according to the researchers, who published their results online July 27, 2022, in The Lancet Rheumatology. They noted that during 2017-2021, just one in five top prizes from ACR went to a woman; once (20%) for the Presidential Gold Medal, and 26 times (23%) for the ACR Master Designation. During the same time period, only one woman (11%) received the EULAR Meritorious Service Award. In 2022, the EULAR Health Professionals in Rheumatology Lifetime Achievement Award was inaugurated and given to Christina Opava. As for the most important prizes of the BSR, the corresponding numbers for female recipients are 25% for the Michael Mason Award and 33% for the Garrod Award.” This pattern did not seem to change in 2022 at the BSR and EULAR annual meetings; the 2022 ACR annual meeting is in November.

championship_award_web.jpg

The trend is also seen in others fields, noted the researchers, who cited only one woman winning mathematics’ Fields Medal since it began in 1936 and female scientists winning only 7% of the Nobel Prize awards in the categories physiology or medicine, physics, and chemistry. In one larger study of 141 international research prizes that were awarded 3,445 times during 2001-2020, only 262 recipients were women.

[embed:render:related:node:218175]

Changing the status quo begins with awareness, according to the authors, who propose three strategies for prize juries to follow to raise the number of female awardees. “First, it is important to stimulate diversity among both nominees and the members of prize committees. Efforts to diversify the pool of nominees have already been initiated by large science prize players, such as the Royal Academy of Sciences in Sweden and the Wolf Foundation in Israel. This diversity should not only take gender into account, but also geographical region, ethnicity, and age. In the prize statutes, we recommend that the biological age of the applicants should no longer play a role for young scientist awards, but only the academic age. Second, if prizes are to be named after a person or people, we suggest that they should increasingly honor rheumatologists who are women to further increase their visibility in the field of rheumatology. We can note that, so far, no single award is named after a rheumatologist who is a woman. Third, we are convinced that more transparency around the nomination procedure will promote gender equity among the future prize winners.”

The authors had no conflicts of interest to declare.

In the last 2 decades, the number of women receiving awards from the American College of Rheumatology, European Alliance of Associations for Rheumatology, and the British Society for Rheumatology has steadily increased, but the absolute percentage of female prize winners remains lower than male winners across the 41 total awards given by the three organizations, according to Thorsten Halling and colleagues at Heinrich-Heine-University in Düsseldorf, Germany.

[embed:render:related:node:227619]

The overall number of awards given by the three groups rose by 10% over the past 2 years. In 2021, 40% of awards given by the ACR went to females, compared with 48% by EULAR, and 50% by the BSR. However, the most prestigious prizes awarded by these groups were given less often to women, according to the researchers, who published their results online July 27, 2022, in The Lancet Rheumatology. They noted that during 2017-2021, just one in five top prizes from ACR went to a woman; once (20%) for the Presidential Gold Medal, and 26 times (23%) for the ACR Master Designation. During the same time period, only one woman (11%) received the EULAR Meritorious Service Award. In 2022, the EULAR Health Professionals in Rheumatology Lifetime Achievement Award was inaugurated and given to Christina Opava. As for the most important prizes of the BSR, the corresponding numbers for female recipients are 25% for the Michael Mason Award and 33% for the Garrod Award.” This pattern did not seem to change in 2022 at the BSR and EULAR annual meetings; the 2022 ACR annual meeting is in November.

championship_award_web.jpg

The trend is also seen in others fields, noted the researchers, who cited only one woman winning mathematics’ Fields Medal since it began in 1936 and female scientists winning only 7% of the Nobel Prize awards in the categories physiology or medicine, physics, and chemistry. In one larger study of 141 international research prizes that were awarded 3,445 times during 2001-2020, only 262 recipients were women.

[embed:render:related:node:218175]

Changing the status quo begins with awareness, according to the authors, who propose three strategies for prize juries to follow to raise the number of female awardees. “First, it is important to stimulate diversity among both nominees and the members of prize committees. Efforts to diversify the pool of nominees have already been initiated by large science prize players, such as the Royal Academy of Sciences in Sweden and the Wolf Foundation in Israel. This diversity should not only take gender into account, but also geographical region, ethnicity, and age. In the prize statutes, we recommend that the biological age of the applicants should no longer play a role for young scientist awards, but only the academic age. Second, if prizes are to be named after a person or people, we suggest that they should increasingly honor rheumatologists who are women to further increase their visibility in the field of rheumatology. We can note that, so far, no single award is named after a rheumatologist who is a woman. Third, we are convinced that more transparency around the nomination procedure will promote gender equity among the future prize winners.”

The authors had no conflicts of interest to declare.

In the last 2 decades, the number of women receiving awards from the American College of Rheumatology, European Alliance of Associations for Rheumatology, and the British Society for Rheumatology has steadily increased, but the absolute percentage of female prize winners remains lower than male winners across the 41 total awards given by the three organizations, according to Thorsten Halling and colleagues at Heinrich-Heine-University in Düsseldorf, Germany.

[embed:render:related:node:227619]

The overall number of awards given by the three groups rose by 10% over the past 2 years. In 2021, 40% of awards given by the ACR went to females, compared with 48% by EULAR, and 50% by the BSR. However, the most prestigious prizes awarded by these groups were given less often to women, according to the researchers, who published their results online July 27, 2022, in The Lancet Rheumatology. They noted that during 2017-2021, just one in five top prizes from ACR went to a woman; once (20%) for the Presidential Gold Medal, and 26 times (23%) for the ACR Master Designation. During the same time period, only one woman (11%) received the EULAR Meritorious Service Award. In 2022, the EULAR Health Professionals in Rheumatology Lifetime Achievement Award was inaugurated and given to Christina Opava. As for the most important prizes of the BSR, the corresponding numbers for female recipients are 25% for the Michael Mason Award and 33% for the Garrod Award.” This pattern did not seem to change in 2022 at the BSR and EULAR annual meetings; the 2022 ACR annual meeting is in November.

championship_award_web.jpg

The trend is also seen in others fields, noted the researchers, who cited only one woman winning mathematics’ Fields Medal since it began in 1936 and female scientists winning only 7% of the Nobel Prize awards in the categories physiology or medicine, physics, and chemistry. In one larger study of 141 international research prizes that were awarded 3,445 times during 2001-2020, only 262 recipients were women.

[embed:render:related:node:218175]

Changing the status quo begins with awareness, according to the authors, who propose three strategies for prize juries to follow to raise the number of female awardees. “First, it is important to stimulate diversity among both nominees and the members of prize committees. Efforts to diversify the pool of nominees have already been initiated by large science prize players, such as the Royal Academy of Sciences in Sweden and the Wolf Foundation in Israel. This diversity should not only take gender into account, but also geographical region, ethnicity, and age. In the prize statutes, we recommend that the biological age of the applicants should no longer play a role for young scientist awards, but only the academic age. Second, if prizes are to be named after a person or people, we suggest that they should increasingly honor rheumatologists who are women to further increase their visibility in the field of rheumatology. We can note that, so far, no single award is named after a rheumatologist who is a woman. Third, we are convinced that more transparency around the nomination procedure will promote gender equity among the future prize winners.”

The authors had no conflicts of interest to declare.

Upadacitinib may soon be used for the treatment of nonradiographic axial spondyloarthritis (nr-axSpA) after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave it its stamp of approval.

AbbVie, the drug’s manufacturer, announced on June 27 that the committee approved the use on June 23. The recommendation to approve market authorization for upadacitinib for nr-axSpA now goes to the European Commission, which is expected to make a decision by the third quarter of 2022.

“The CHMP’s recommendation to approve upadacitinib for patients with nr-axSpA is an important milestone in providing a new treatment option to patients in need,” said Neil Gallagher, MD, vice president of development and chief medical officer of AbbVie. He noted that currently, there are few options to treat symptoms such as inflammation, back pain, and stiffness for these patients.

Officially, the new indication for upadacitinib (Rinvoq) 15 mg once daily is for the treatment of active nr-axSpA in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein and/or MRI, whose condition has responded inadequately to NSAIDs.

Upadacitinib is a selective Janus kinase (JAK) inhibitor that in human cellular assays preferentially inhibits signaling by JAK1 or JAK1/3.

In the European Union, upadacitinib is currently approved for use in patients with moderate to severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe atopic dermatitis. In addition to these indications, it is approved in the United States for ulcerative colitis but not for nr-axSpA.

The committee based its decision on the results of the nr-axSpA study within the SELECT-AXIS-2 trial, recently reported at the European Alliance of Associations for Rheumatology (EULAR) 2022 annual meeting.

The nr-axSpA study met the primary endpoint of a 40% improvement in Assessment of SpondyloArthritis International Society response criteria (ASAS40) and the first 12 of 14 ranked secondary endpoints, according to AbbVie.

The most commonly reported adverse reactions with upadacitinib 15 mg were upper respiratory tract infections, elevated blood creatine phosphokinase levels, elevated alanine transaminase levels, bronchitis, nausea, cough, elevated aspartate transaminase levels, and hypercholesterolemia. These occurred in 2% or more of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis in clinical trials.

The safety profile of upadacitinib with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications, AbbVie said.

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

Upadacitinib may soon be used for the treatment of nonradiographic axial spondyloarthritis (nr-axSpA) after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave it its stamp of approval.

AbbVie, the drug’s manufacturer, announced on June 27 that the committee approved the use on June 23. The recommendation to approve market authorization for upadacitinib for nr-axSpA now goes to the European Commission, which is expected to make a decision by the third quarter of 2022.

“The CHMP’s recommendation to approve upadacitinib for patients with nr-axSpA is an important milestone in providing a new treatment option to patients in need,” said Neil Gallagher, MD, vice president of development and chief medical officer of AbbVie. He noted that currently, there are few options to treat symptoms such as inflammation, back pain, and stiffness for these patients.

Officially, the new indication for upadacitinib (Rinvoq) 15 mg once daily is for the treatment of active nr-axSpA in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein and/or MRI, whose condition has responded inadequately to NSAIDs.

Upadacitinib is a selective Janus kinase (JAK) inhibitor that in human cellular assays preferentially inhibits signaling by JAK1 or JAK1/3.

In the European Union, upadacitinib is currently approved for use in patients with moderate to severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe atopic dermatitis. In addition to these indications, it is approved in the United States for ulcerative colitis but not for nr-axSpA.

The committee based its decision on the results of the nr-axSpA study within the SELECT-AXIS-2 trial, recently reported at the European Alliance of Associations for Rheumatology (EULAR) 2022 annual meeting.

The nr-axSpA study met the primary endpoint of a 40% improvement in Assessment of SpondyloArthritis International Society response criteria (ASAS40) and the first 12 of 14 ranked secondary endpoints, according to AbbVie.

The most commonly reported adverse reactions with upadacitinib 15 mg were upper respiratory tract infections, elevated blood creatine phosphokinase levels, elevated alanine transaminase levels, bronchitis, nausea, cough, elevated aspartate transaminase levels, and hypercholesterolemia. These occurred in 2% or more of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis in clinical trials.

The safety profile of upadacitinib with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications, AbbVie said.

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

Upadacitinib may soon be used for the treatment of nonradiographic axial spondyloarthritis (nr-axSpA) after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave it its stamp of approval.

AbbVie, the drug’s manufacturer, announced on June 27 that the committee approved the use on June 23. The recommendation to approve market authorization for upadacitinib for nr-axSpA now goes to the European Commission, which is expected to make a decision by the third quarter of 2022.

“The CHMP’s recommendation to approve upadacitinib for patients with nr-axSpA is an important milestone in providing a new treatment option to patients in need,” said Neil Gallagher, MD, vice president of development and chief medical officer of AbbVie. He noted that currently, there are few options to treat symptoms such as inflammation, back pain, and stiffness for these patients.

Officially, the new indication for upadacitinib (Rinvoq) 15 mg once daily is for the treatment of active nr-axSpA in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein and/or MRI, whose condition has responded inadequately to NSAIDs.

Upadacitinib is a selective Janus kinase (JAK) inhibitor that in human cellular assays preferentially inhibits signaling by JAK1 or JAK1/3.

In the European Union, upadacitinib is currently approved for use in patients with moderate to severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe atopic dermatitis. In addition to these indications, it is approved in the United States for ulcerative colitis but not for nr-axSpA.

The committee based its decision on the results of the nr-axSpA study within the SELECT-AXIS-2 trial, recently reported at the European Alliance of Associations for Rheumatology (EULAR) 2022 annual meeting.

The nr-axSpA study met the primary endpoint of a 40% improvement in Assessment of SpondyloArthritis International Society response criteria (ASAS40) and the first 12 of 14 ranked secondary endpoints, according to AbbVie.

The most commonly reported adverse reactions with upadacitinib 15 mg were upper respiratory tract infections, elevated blood creatine phosphokinase levels, elevated alanine transaminase levels, bronchitis, nausea, cough, elevated aspartate transaminase levels, and hypercholesterolemia. These occurred in 2% or more of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis in clinical trials.

The safety profile of upadacitinib with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications, AbbVie said.

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