Lucy Hicks

Patients with granulomatosis with polyangiitis (GPA) who scored high on a sinonasal symptom test are nearly three times as likely to relapse, according to a new study.

These patients reported higher scores months and up to 2 years before a disease flare, despite having low disease activity otherwise.

The study uses a different approach to try to predict relapse, compared with measuring biomarkers in lab tests, said Zachary Wallace, MD, a rheumatologist at Massachusetts General Hospital in Boston, Massachusetts. He was not involved with the study.

“It’s exciting because it might suggest that we could use something as simple as a survey to stratify someone’s risk of relapse,” he told this news organization.

Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a rare disease, with an estimated prevalence of 200-400 cases per million people. It is also heterogeneous, which makes it difficult to predict the risk for relapse for a given patient.

“Investigators have long searched for a reliable prognostic marker that identifies patients at high vs low risk of relapse in AAV but, except for ANCA type, no prognostic biomarker is routinely used to inform treatment decision-making,” wrote lead author Ellen Romich, MD, a rheumatology fellow at the University of Pennsylvania in Philadelphia, Pennsylvania, and colleagues.

Proteinase 3-ANCA (compared with myeloperoxidase-ANCA) has been tied to a higher risk for relapse, as well as gastrointestinal complications, sinonasal disease, and patient global assessment scores. In this new study, Dr. Romich and colleagues evaluated if patient-reported outcomes of sinonasal disease could predict AAV disease activity and relapse.

Researchers used data from a prospective, longitudinal cohort study through the University of Pennsylvania Vasculitis Center from 2016 to 2022. They included 107 patients with GPA, 40 patients with eosinophilic granulomatosis with polyangiitis (EGPA), 21 patients with microscopic polyangiitis (MPA), and 51 healthy controls.

Patients completed a median of four clinic visits during the duration of the study.

During each visit, patients filled out the 22-item SinoNasal Outcome Test (SNOT-22), a validated questionnaire that assesses rhinosinusitis. The tool asks patients to rate a list of symptoms from 0 to 5 in five categories: Rhinologic, extra-nasal, ear and face, psychologic, and sleep. The possible total score ranges from 0 to 110.

Disease activity was measured via the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis. The results were published online in Arthritis Care & Research.

Patients were, on average, 55 years old with an AAV duration of 3 years. (The mean age of healthy participants was 59.) More than half (58%) of patients were female, and 95% were White. The majority had a history of a flare (54%), and 60% of those flares had sinonasal involvement.

Even in remission, patients with AAV generally had on average higher SNOT-22 scores than healthy comparators (20 vs 5). Higher disease activity also correlated with higher SNOT-22 scores.

In patients with GPA, a high SNOT-22 score (total score of 41 or above) was associated with an increased risk for relapse within 2 years (hazard ratio, 2.7; P = .02). This association was not found for EGPA or MPA. This higher risk remained in a sensitivity analysis that included only patients with no history of sinonasal disease.

“Interestingly, among patients with GPA, SNOT-22 scores are elevated months to years prior to onset of systemic relapse but remain low in patients in sustained remission,” the authors wrote.

While other patient-reported outcomes have been validated for AAV, SNOT-22 may provide more detail on upper airway disease, commented Paul Monach, MD, PhD, an adjunct associate professor of medicine at the Boston University Chobanian & Avedisian School of Medicine and a rheumatologist at the VA Boston Healthcare System, Boston, Massachusetts.

“Upper airway GPA has not been studied as much as systemic GPA and MPA,” he told this news organization. “There are very few clinical trials, and we need better outcome measures like this.”

Dr. Romich noted that this work is still in the “early stages,” and SNOT-22 will need to be further studied and validated in other patient cohorts before its inclusion in clinical practice.

“There’s certainly more work that needs to be done to understand how the SNOT-22 questionnaire works in this patient population,” she said, including its predictive value compared with other known risk factors for relapse. “But I think it’s something that’s promising that we could use as a patient-reported outcome to try to, visit-to-visit, track their sinonasal symptoms.”

This study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and an NIH Rheumatology Research Training Grant. Dr. Romich, Dr. Wallace, and Monach reported no other relevant disclosures.

A version of this article appeared on Medscape.com.

Patients with granulomatosis with polyangiitis (GPA) who scored high on a sinonasal symptom test are nearly three times as likely to relapse, according to a new study.

These patients reported higher scores months and up to 2 years before a disease flare, despite having low disease activity otherwise.

The study uses a different approach to try to predict relapse, compared with measuring biomarkers in lab tests, said Zachary Wallace, MD, a rheumatologist at Massachusetts General Hospital in Boston, Massachusetts. He was not involved with the study.

“It’s exciting because it might suggest that we could use something as simple as a survey to stratify someone’s risk of relapse,” he told this news organization.

Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a rare disease, with an estimated prevalence of 200-400 cases per million people. It is also heterogeneous, which makes it difficult to predict the risk for relapse for a given patient.

“Investigators have long searched for a reliable prognostic marker that identifies patients at high vs low risk of relapse in AAV but, except for ANCA type, no prognostic biomarker is routinely used to inform treatment decision-making,” wrote lead author Ellen Romich, MD, a rheumatology fellow at the University of Pennsylvania in Philadelphia, Pennsylvania, and colleagues.

Proteinase 3-ANCA (compared with myeloperoxidase-ANCA) has been tied to a higher risk for relapse, as well as gastrointestinal complications, sinonasal disease, and patient global assessment scores. In this new study, Dr. Romich and colleagues evaluated if patient-reported outcomes of sinonasal disease could predict AAV disease activity and relapse.

Researchers used data from a prospective, longitudinal cohort study through the University of Pennsylvania Vasculitis Center from 2016 to 2022. They included 107 patients with GPA, 40 patients with eosinophilic granulomatosis with polyangiitis (EGPA), 21 patients with microscopic polyangiitis (MPA), and 51 healthy controls.

Patients completed a median of four clinic visits during the duration of the study.

During each visit, patients filled out the 22-item SinoNasal Outcome Test (SNOT-22), a validated questionnaire that assesses rhinosinusitis. The tool asks patients to rate a list of symptoms from 0 to 5 in five categories: Rhinologic, extra-nasal, ear and face, psychologic, and sleep. The possible total score ranges from 0 to 110.

Disease activity was measured via the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis. The results were published online in Arthritis Care & Research.

Patients were, on average, 55 years old with an AAV duration of 3 years. (The mean age of healthy participants was 59.) More than half (58%) of patients were female, and 95% were White. The majority had a history of a flare (54%), and 60% of those flares had sinonasal involvement.

Even in remission, patients with AAV generally had on average higher SNOT-22 scores than healthy comparators (20 vs 5). Higher disease activity also correlated with higher SNOT-22 scores.

In patients with GPA, a high SNOT-22 score (total score of 41 or above) was associated with an increased risk for relapse within 2 years (hazard ratio, 2.7; P = .02). This association was not found for EGPA or MPA. This higher risk remained in a sensitivity analysis that included only patients with no history of sinonasal disease.

“Interestingly, among patients with GPA, SNOT-22 scores are elevated months to years prior to onset of systemic relapse but remain low in patients in sustained remission,” the authors wrote.

While other patient-reported outcomes have been validated for AAV, SNOT-22 may provide more detail on upper airway disease, commented Paul Monach, MD, PhD, an adjunct associate professor of medicine at the Boston University Chobanian & Avedisian School of Medicine and a rheumatologist at the VA Boston Healthcare System, Boston, Massachusetts.

“Upper airway GPA has not been studied as much as systemic GPA and MPA,” he told this news organization. “There are very few clinical trials, and we need better outcome measures like this.”

Dr. Romich noted that this work is still in the “early stages,” and SNOT-22 will need to be further studied and validated in other patient cohorts before its inclusion in clinical practice.

“There’s certainly more work that needs to be done to understand how the SNOT-22 questionnaire works in this patient population,” she said, including its predictive value compared with other known risk factors for relapse. “But I think it’s something that’s promising that we could use as a patient-reported outcome to try to, visit-to-visit, track their sinonasal symptoms.”

This study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and an NIH Rheumatology Research Training Grant. Dr. Romich, Dr. Wallace, and Monach reported no other relevant disclosures.

A version of this article appeared on Medscape.com.

Patients with granulomatosis with polyangiitis (GPA) who scored high on a sinonasal symptom test are nearly three times as likely to relapse, according to a new study.

These patients reported higher scores months and up to 2 years before a disease flare, despite having low disease activity otherwise.

The study uses a different approach to try to predict relapse, compared with measuring biomarkers in lab tests, said Zachary Wallace, MD, a rheumatologist at Massachusetts General Hospital in Boston, Massachusetts. He was not involved with the study.

“It’s exciting because it might suggest that we could use something as simple as a survey to stratify someone’s risk of relapse,” he told this news organization.

Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a rare disease, with an estimated prevalence of 200-400 cases per million people. It is also heterogeneous, which makes it difficult to predict the risk for relapse for a given patient.

“Investigators have long searched for a reliable prognostic marker that identifies patients at high vs low risk of relapse in AAV but, except for ANCA type, no prognostic biomarker is routinely used to inform treatment decision-making,” wrote lead author Ellen Romich, MD, a rheumatology fellow at the University of Pennsylvania in Philadelphia, Pennsylvania, and colleagues.

Proteinase 3-ANCA (compared with myeloperoxidase-ANCA) has been tied to a higher risk for relapse, as well as gastrointestinal complications, sinonasal disease, and patient global assessment scores. In this new study, Dr. Romich and colleagues evaluated if patient-reported outcomes of sinonasal disease could predict AAV disease activity and relapse.

Researchers used data from a prospective, longitudinal cohort study through the University of Pennsylvania Vasculitis Center from 2016 to 2022. They included 107 patients with GPA, 40 patients with eosinophilic granulomatosis with polyangiitis (EGPA), 21 patients with microscopic polyangiitis (MPA), and 51 healthy controls.

Patients completed a median of four clinic visits during the duration of the study.

During each visit, patients filled out the 22-item SinoNasal Outcome Test (SNOT-22), a validated questionnaire that assesses rhinosinusitis. The tool asks patients to rate a list of symptoms from 0 to 5 in five categories: Rhinologic, extra-nasal, ear and face, psychologic, and sleep. The possible total score ranges from 0 to 110.

Disease activity was measured via the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis. The results were published online in Arthritis Care & Research.

Patients were, on average, 55 years old with an AAV duration of 3 years. (The mean age of healthy participants was 59.) More than half (58%) of patients were female, and 95% were White. The majority had a history of a flare (54%), and 60% of those flares had sinonasal involvement.

Even in remission, patients with AAV generally had on average higher SNOT-22 scores than healthy comparators (20 vs 5). Higher disease activity also correlated with higher SNOT-22 scores.

In patients with GPA, a high SNOT-22 score (total score of 41 or above) was associated with an increased risk for relapse within 2 years (hazard ratio, 2.7; P = .02). This association was not found for EGPA or MPA. This higher risk remained in a sensitivity analysis that included only patients with no history of sinonasal disease.

“Interestingly, among patients with GPA, SNOT-22 scores are elevated months to years prior to onset of systemic relapse but remain low in patients in sustained remission,” the authors wrote.

While other patient-reported outcomes have been validated for AAV, SNOT-22 may provide more detail on upper airway disease, commented Paul Monach, MD, PhD, an adjunct associate professor of medicine at the Boston University Chobanian & Avedisian School of Medicine and a rheumatologist at the VA Boston Healthcare System, Boston, Massachusetts.

“Upper airway GPA has not been studied as much as systemic GPA and MPA,” he told this news organization. “There are very few clinical trials, and we need better outcome measures like this.”

Dr. Romich noted that this work is still in the “early stages,” and SNOT-22 will need to be further studied and validated in other patient cohorts before its inclusion in clinical practice.

“There’s certainly more work that needs to be done to understand how the SNOT-22 questionnaire works in this patient population,” she said, including its predictive value compared with other known risk factors for relapse. “But I think it’s something that’s promising that we could use as a patient-reported outcome to try to, visit-to-visit, track their sinonasal symptoms.”

This study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and an NIH Rheumatology Research Training Grant. Dr. Romich, Dr. Wallace, and Monach reported no other relevant disclosures.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.

This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. 

Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release. 

“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. 

The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. 

The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.

Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.

This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. 

Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release. 

“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. 

The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. 

The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.

Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.

This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. 

Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release. 

“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. 

The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. 

The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.

Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson. 

A version of this article appeared on Medscape.com.

Patients with rheumatoid arthritis (RA) in remission who tapered and then fully stopped either conventional synthetic disease-modifying antirheumatic drug (csDMARD) or tumor necrosis factor (TNF)–inhibitor therapy experienced more disease flares than those who received stable dose treatment in an open-label, randomized trial.

In the 3-year trial, called ARCTIC REWIND, 80% of patients taking stable doses of only csMARDs remained flare-free compared with 38% in another treatment arm taking only csDMARDs who tapered to a half dose and then discontinued all after 1 year. In patients who continued to receive half-dose csDMARDs for the entire study period, 57% remained flare-free.

ODell_James_UNMC_ 2012_web.jpg

A separate two treatment arms of the study that assessed the effect of tapering TNF-inhibitor treatment to withdrawal showed that only 25% of patients who tapered TNF inhibitor to withdrawal remained flare-free over 3 years compared with 85% who remained on a stable TNF-inhibitor dose.

Though the risk for flare was higher in both the half-dose csDMARD and drug-free groups, the results also suggested that tapering medication “could be a realistic option for some patients with rheumatoid arthritis in sustained remission on csDMARDs,” wrote Kaja Kjørholt, MD, of the Center for Treatment of Rheumatic and Musculoskeletal Diseases at Diakonhjemmet Hospital in Oslo, Norway, and colleagues.

The 3-year results for the csDMARD-only arms of the trial were published in The Lancet Rheumatology. The 3-year results of the TNF-inhibitor arms of the study were presented as an abstract at the annual meeting of the American College of Rheumatology (ACR).
 

Don’t Avoid Tapering But Take an Individualized Approach

Many rheumatologists will taper patients with RA in remission to lower doses of medication, but the protocols for this study do not reflect clinical practice, noted James R. O’Dell, MD, chief of the Division of Rheumatology at the University of Nebraska Medical Center in Omaha, Nebraska. He was not involved with the research.

“I don’t know of any rheumatologist who would ever think that it was a good idea to taper somebody completely off of all DMARDs,” he told this news organization. “The only surprise is that more of them didn’t flare,” he continued, though he suspected that more patients would flare if they were followed for more time. Rheumatologists also would take a much more individualized approach when tapering to lower doses, he added, and do so at a much slower rate than what was observed in this study.

Both the ACR and the European Alliance of Associations for Rheumatology recommendations for the management of RA stated that tapering DMARDs can be considered for patients who have sustained remission, but they do not mention discontinuing medication entirely.

In the TNF-inhibitor arms of the trial, the tapering group received a half dose of a TNF inhibitor for 4 months before stopping therapy entirely, which Dr. O’Dell noted was a large dip in too short a period.

“Nobody should be surprised that these people flared a lot,” he said. However, tapering to lower doses of a TNF inhibitor can be successful, he noted, adding that more than half of his patients taking a TNF inhibitor are on less than their original dose. Completely tapering off a TNF inhibitor is less common and depends on what other DMARDs a patient is taking, he said, and complete drug-free remission in this population is highly unlikely.

Dr. O’Dell emphasized that the takeaway from these results should not be to avoid tapering medication because of flare risk but instead a tailored approach — something that is not possible with a study protocol — is needed.

“We want our patients to have all the medicine they need and no more,” he said. “That sweet spot is different for each individual patient for how much TNF inhibition or how much conventional therapy they need. If we’re thoughtful about that in the clinic, we can find that sweet spot,” he said.
 

Details of ARCTIC REWIND

The open-label ARCTIC REWIND trial enrolled patients with RA in sustained remission, determined via Disease Activity Score (DAS), from 10 different hospitals in Norway. Researchers enrolled 160 patients in the csDMARD-only arms and randomized them to receive stable dose csDMARDs for 3 years or half-dose csDMARDs for 1 year, followed by complete withdrawal for the next 2 years; withdrawal of csDMARDs was only done in patients who had not had a flare during the first year. Participants had scheduled clinic visits every 4 months, and full-dose csDMARD therapy was resumed in patients who experienced disease flares.

There was a total of 99 patients randomized in the TNF-inhibitor arms to continue stable TNF-inhibitor therapy or to taper to a half dose for 4 months before discontinuing therapy. Like the csDMARD study, clinic visits occurred every 4 months, and full-dose therapy was resumed if a flare occurred. Patients taking a TNF inhibitor could also take a csDMARD as needed.

Last year, 1-year results for the csDMARD arms were published in JAMA, and 1-year results for the TNF-inhibitor arms were reported in Annals of the Rheumatic Diseases.

At baseline, most patients across the three csDMARD groups (81%) had received methotrexate monotherapy. Triple therapy (methotrexate, sulfasalazine, and hydroxychloroquine) was used in 13% of the stable-dose group, 7% of the half-dose group, and 8% of the half-dose tapering to withdrawal group. Seven individuals in the stable-dose group, three individuals in the half-dose group, and three individuals the half-dose tapering to withdrawal group used other mono/duo therapies.

A total of 139 participants in the csDMARD-only arms completed 3 years of follow-up, with 68 in the stable-dose group, 36 in the half-dose group, and 35 in the half-dose tapering to withdrawal group.

Compared with the stable-dose group, the risk for flare was more than four times higher in the half-dose tapering to withdrawal group (hazard ratio [HR], 4.2; 95% CI, 2.2-8.2) and about three times higher in the half-dose group (HR, 2.9; 95% CI, 1.5-5.9). The flare risk between the half dose and half-dose tapering to withdrawal group was not statistically significant.

Most patients regained DAS remission status in the next clinic visit following a flare, the authors reported. Comparing the last visit to baseline, 10 patients in the taper-to-withdrawal group (27%) had increased treatment — either by adding a biologic or increasing csDMARD dose — compared with one patient (3%) in the half-dose group and 11 patients (14%) in the stable-dose group. Adverse events were common across all three groups, though were highest in the tapering to withdrawal group.

In the TNF-inhibitor arms, a total of 80 patients completed the 3-year follow-up. By the end of 3 years, 75% of the tapering group experienced a disease flare compared with 15% of the stable TNF-inhibitor group. Most patients regained DAS remission status in the next clinic visit following a flare, the authors reported. During the study, 23% of the tapering group and 13% of the stable TNF-inhibitor group used systemic glucocorticoids. Four patients in the tapering group and two patients in the stable TNF-inhibitor group switched to another TNF inhibitor during the study. An additional two patients in the stable TNF-inhibitor group switched to a Janus kinase inhibitor during the 3-year study.

Adverse events were similar in both treatment groups, but serious adverse events were more common in the tapering group (21%) than in the stable-dose group (11%).

The authors concluded that the findings did not support tapering a TNF inhibitor to withdrawal for patients in sustained remission, but they noted that additional research is needed to identify which patients would fare better or worse tapering csDMARDs.

ARCTIC REWIND was funded by grants from The Research Council of Norway and The South-Eastern Norway Regional Health Authorities. Many of the authors disclosed financial ties to pharmaceutical companies. Dr. O’Dell disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Patients with rheumatoid arthritis (RA) in remission who tapered and then fully stopped either conventional synthetic disease-modifying antirheumatic drug (csDMARD) or tumor necrosis factor (TNF)–inhibitor therapy experienced more disease flares than those who received stable dose treatment in an open-label, randomized trial.

In the 3-year trial, called ARCTIC REWIND, 80% of patients taking stable doses of only csMARDs remained flare-free compared with 38% in another treatment arm taking only csDMARDs who tapered to a half dose and then discontinued all after 1 year. In patients who continued to receive half-dose csDMARDs for the entire study period, 57% remained flare-free.

ODell_James_UNMC_ 2012_web.jpg

A separate two treatment arms of the study that assessed the effect of tapering TNF-inhibitor treatment to withdrawal showed that only 25% of patients who tapered TNF inhibitor to withdrawal remained flare-free over 3 years compared with 85% who remained on a stable TNF-inhibitor dose.

Though the risk for flare was higher in both the half-dose csDMARD and drug-free groups, the results also suggested that tapering medication “could be a realistic option for some patients with rheumatoid arthritis in sustained remission on csDMARDs,” wrote Kaja Kjørholt, MD, of the Center for Treatment of Rheumatic and Musculoskeletal Diseases at Diakonhjemmet Hospital in Oslo, Norway, and colleagues.

The 3-year results for the csDMARD-only arms of the trial were published in The Lancet Rheumatology. The 3-year results of the TNF-inhibitor arms of the study were presented as an abstract at the annual meeting of the American College of Rheumatology (ACR).
 

Don’t Avoid Tapering But Take an Individualized Approach

Many rheumatologists will taper patients with RA in remission to lower doses of medication, but the protocols for this study do not reflect clinical practice, noted James R. O’Dell, MD, chief of the Division of Rheumatology at the University of Nebraska Medical Center in Omaha, Nebraska. He was not involved with the research.

“I don’t know of any rheumatologist who would ever think that it was a good idea to taper somebody completely off of all DMARDs,” he told this news organization. “The only surprise is that more of them didn’t flare,” he continued, though he suspected that more patients would flare if they were followed for more time. Rheumatologists also would take a much more individualized approach when tapering to lower doses, he added, and do so at a much slower rate than what was observed in this study.

Both the ACR and the European Alliance of Associations for Rheumatology recommendations for the management of RA stated that tapering DMARDs can be considered for patients who have sustained remission, but they do not mention discontinuing medication entirely.

In the TNF-inhibitor arms of the trial, the tapering group received a half dose of a TNF inhibitor for 4 months before stopping therapy entirely, which Dr. O’Dell noted was a large dip in too short a period.

“Nobody should be surprised that these people flared a lot,” he said. However, tapering to lower doses of a TNF inhibitor can be successful, he noted, adding that more than half of his patients taking a TNF inhibitor are on less than their original dose. Completely tapering off a TNF inhibitor is less common and depends on what other DMARDs a patient is taking, he said, and complete drug-free remission in this population is highly unlikely.

Dr. O’Dell emphasized that the takeaway from these results should not be to avoid tapering medication because of flare risk but instead a tailored approach — something that is not possible with a study protocol — is needed.

“We want our patients to have all the medicine they need and no more,” he said. “That sweet spot is different for each individual patient for how much TNF inhibition or how much conventional therapy they need. If we’re thoughtful about that in the clinic, we can find that sweet spot,” he said.
 

Details of ARCTIC REWIND

The open-label ARCTIC REWIND trial enrolled patients with RA in sustained remission, determined via Disease Activity Score (DAS), from 10 different hospitals in Norway. Researchers enrolled 160 patients in the csDMARD-only arms and randomized them to receive stable dose csDMARDs for 3 years or half-dose csDMARDs for 1 year, followed by complete withdrawal for the next 2 years; withdrawal of csDMARDs was only done in patients who had not had a flare during the first year. Participants had scheduled clinic visits every 4 months, and full-dose csDMARD therapy was resumed in patients who experienced disease flares.

There was a total of 99 patients randomized in the TNF-inhibitor arms to continue stable TNF-inhibitor therapy or to taper to a half dose for 4 months before discontinuing therapy. Like the csDMARD study, clinic visits occurred every 4 months, and full-dose therapy was resumed if a flare occurred. Patients taking a TNF inhibitor could also take a csDMARD as needed.

Last year, 1-year results for the csDMARD arms were published in JAMA, and 1-year results for the TNF-inhibitor arms were reported in Annals of the Rheumatic Diseases.

At baseline, most patients across the three csDMARD groups (81%) had received methotrexate monotherapy. Triple therapy (methotrexate, sulfasalazine, and hydroxychloroquine) was used in 13% of the stable-dose group, 7% of the half-dose group, and 8% of the half-dose tapering to withdrawal group. Seven individuals in the stable-dose group, three individuals in the half-dose group, and three individuals the half-dose tapering to withdrawal group used other mono/duo therapies.

A total of 139 participants in the csDMARD-only arms completed 3 years of follow-up, with 68 in the stable-dose group, 36 in the half-dose group, and 35 in the half-dose tapering to withdrawal group.

Compared with the stable-dose group, the risk for flare was more than four times higher in the half-dose tapering to withdrawal group (hazard ratio [HR], 4.2; 95% CI, 2.2-8.2) and about three times higher in the half-dose group (HR, 2.9; 95% CI, 1.5-5.9). The flare risk between the half dose and half-dose tapering to withdrawal group was not statistically significant.

Most patients regained DAS remission status in the next clinic visit following a flare, the authors reported. Comparing the last visit to baseline, 10 patients in the taper-to-withdrawal group (27%) had increased treatment — either by adding a biologic or increasing csDMARD dose — compared with one patient (3%) in the half-dose group and 11 patients (14%) in the stable-dose group. Adverse events were common across all three groups, though were highest in the tapering to withdrawal group.

In the TNF-inhibitor arms, a total of 80 patients completed the 3-year follow-up. By the end of 3 years, 75% of the tapering group experienced a disease flare compared with 15% of the stable TNF-inhibitor group. Most patients regained DAS remission status in the next clinic visit following a flare, the authors reported. During the study, 23% of the tapering group and 13% of the stable TNF-inhibitor group used systemic glucocorticoids. Four patients in the tapering group and two patients in the stable TNF-inhibitor group switched to another TNF inhibitor during the study. An additional two patients in the stable TNF-inhibitor group switched to a Janus kinase inhibitor during the 3-year study.

Adverse events were similar in both treatment groups, but serious adverse events were more common in the tapering group (21%) than in the stable-dose group (11%).

The authors concluded that the findings did not support tapering a TNF inhibitor to withdrawal for patients in sustained remission, but they noted that additional research is needed to identify which patients would fare better or worse tapering csDMARDs.

ARCTIC REWIND was funded by grants from The Research Council of Norway and The South-Eastern Norway Regional Health Authorities. Many of the authors disclosed financial ties to pharmaceutical companies. Dr. O’Dell disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Patients with rheumatoid arthritis (RA) in remission who tapered and then fully stopped either conventional synthetic disease-modifying antirheumatic drug (csDMARD) or tumor necrosis factor (TNF)–inhibitor therapy experienced more disease flares than those who received stable dose treatment in an open-label, randomized trial.

In the 3-year trial, called ARCTIC REWIND, 80% of patients taking stable doses of only csMARDs remained flare-free compared with 38% in another treatment arm taking only csDMARDs who tapered to a half dose and then discontinued all after 1 year. In patients who continued to receive half-dose csDMARDs for the entire study period, 57% remained flare-free.

ODell_James_UNMC_ 2012_web.jpg

A separate two treatment arms of the study that assessed the effect of tapering TNF-inhibitor treatment to withdrawal showed that only 25% of patients who tapered TNF inhibitor to withdrawal remained flare-free over 3 years compared with 85% who remained on a stable TNF-inhibitor dose.

Though the risk for flare was higher in both the half-dose csDMARD and drug-free groups, the results also suggested that tapering medication “could be a realistic option for some patients with rheumatoid arthritis in sustained remission on csDMARDs,” wrote Kaja Kjørholt, MD, of the Center for Treatment of Rheumatic and Musculoskeletal Diseases at Diakonhjemmet Hospital in Oslo, Norway, and colleagues.

The 3-year results for the csDMARD-only arms of the trial were published in The Lancet Rheumatology. The 3-year results of the TNF-inhibitor arms of the study were presented as an abstract at the annual meeting of the American College of Rheumatology (ACR).
 

Don’t Avoid Tapering But Take an Individualized Approach

Many rheumatologists will taper patients with RA in remission to lower doses of medication, but the protocols for this study do not reflect clinical practice, noted James R. O’Dell, MD, chief of the Division of Rheumatology at the University of Nebraska Medical Center in Omaha, Nebraska. He was not involved with the research.

“I don’t know of any rheumatologist who would ever think that it was a good idea to taper somebody completely off of all DMARDs,” he told this news organization. “The only surprise is that more of them didn’t flare,” he continued, though he suspected that more patients would flare if they were followed for more time. Rheumatologists also would take a much more individualized approach when tapering to lower doses, he added, and do so at a much slower rate than what was observed in this study.

Both the ACR and the European Alliance of Associations for Rheumatology recommendations for the management of RA stated that tapering DMARDs can be considered for patients who have sustained remission, but they do not mention discontinuing medication entirely.

In the TNF-inhibitor arms of the trial, the tapering group received a half dose of a TNF inhibitor for 4 months before stopping therapy entirely, which Dr. O’Dell noted was a large dip in too short a period.

“Nobody should be surprised that these people flared a lot,” he said. However, tapering to lower doses of a TNF inhibitor can be successful, he noted, adding that more than half of his patients taking a TNF inhibitor are on less than their original dose. Completely tapering off a TNF inhibitor is less common and depends on what other DMARDs a patient is taking, he said, and complete drug-free remission in this population is highly unlikely.

Dr. O’Dell emphasized that the takeaway from these results should not be to avoid tapering medication because of flare risk but instead a tailored approach — something that is not possible with a study protocol — is needed.

“We want our patients to have all the medicine they need and no more,” he said. “That sweet spot is different for each individual patient for how much TNF inhibition or how much conventional therapy they need. If we’re thoughtful about that in the clinic, we can find that sweet spot,” he said.
 

Details of ARCTIC REWIND

The open-label ARCTIC REWIND trial enrolled patients with RA in sustained remission, determined via Disease Activity Score (DAS), from 10 different hospitals in Norway. Researchers enrolled 160 patients in the csDMARD-only arms and randomized them to receive stable dose csDMARDs for 3 years or half-dose csDMARDs for 1 year, followed by complete withdrawal for the next 2 years; withdrawal of csDMARDs was only done in patients who had not had a flare during the first year. Participants had scheduled clinic visits every 4 months, and full-dose csDMARD therapy was resumed in patients who experienced disease flares.

There was a total of 99 patients randomized in the TNF-inhibitor arms to continue stable TNF-inhibitor therapy or to taper to a half dose for 4 months before discontinuing therapy. Like the csDMARD study, clinic visits occurred every 4 months, and full-dose therapy was resumed if a flare occurred. Patients taking a TNF inhibitor could also take a csDMARD as needed.

Last year, 1-year results for the csDMARD arms were published in JAMA, and 1-year results for the TNF-inhibitor arms were reported in Annals of the Rheumatic Diseases.

At baseline, most patients across the three csDMARD groups (81%) had received methotrexate monotherapy. Triple therapy (methotrexate, sulfasalazine, and hydroxychloroquine) was used in 13% of the stable-dose group, 7% of the half-dose group, and 8% of the half-dose tapering to withdrawal group. Seven individuals in the stable-dose group, three individuals in the half-dose group, and three individuals the half-dose tapering to withdrawal group used other mono/duo therapies.

A total of 139 participants in the csDMARD-only arms completed 3 years of follow-up, with 68 in the stable-dose group, 36 in the half-dose group, and 35 in the half-dose tapering to withdrawal group.

Compared with the stable-dose group, the risk for flare was more than four times higher in the half-dose tapering to withdrawal group (hazard ratio [HR], 4.2; 95% CI, 2.2-8.2) and about three times higher in the half-dose group (HR, 2.9; 95% CI, 1.5-5.9). The flare risk between the half dose and half-dose tapering to withdrawal group was not statistically significant.

Most patients regained DAS remission status in the next clinic visit following a flare, the authors reported. Comparing the last visit to baseline, 10 patients in the taper-to-withdrawal group (27%) had increased treatment — either by adding a biologic or increasing csDMARD dose — compared with one patient (3%) in the half-dose group and 11 patients (14%) in the stable-dose group. Adverse events were common across all three groups, though were highest in the tapering to withdrawal group.

In the TNF-inhibitor arms, a total of 80 patients completed the 3-year follow-up. By the end of 3 years, 75% of the tapering group experienced a disease flare compared with 15% of the stable TNF-inhibitor group. Most patients regained DAS remission status in the next clinic visit following a flare, the authors reported. During the study, 23% of the tapering group and 13% of the stable TNF-inhibitor group used systemic glucocorticoids. Four patients in the tapering group and two patients in the stable TNF-inhibitor group switched to another TNF inhibitor during the study. An additional two patients in the stable TNF-inhibitor group switched to a Janus kinase inhibitor during the 3-year study.

Adverse events were similar in both treatment groups, but serious adverse events were more common in the tapering group (21%) than in the stable-dose group (11%).

The authors concluded that the findings did not support tapering a TNF inhibitor to withdrawal for patients in sustained remission, but they noted that additional research is needed to identify which patients would fare better or worse tapering csDMARDs.

ARCTIC REWIND was funded by grants from The Research Council of Norway and The South-Eastern Norway Regional Health Authorities. Many of the authors disclosed financial ties to pharmaceutical companies. Dr. O’Dell disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the launch of the first clinical trial for chimeric antigen receptor (CAR) T-cell therapy in children with systemic lupus erythematosus.

The trial, called Reversing Autoimmunity through Cell Therapy (REACT-01), will take place at Seattle Children’s Hospital in Washington State and is expected to begin this summer.

The CAR-T therapy will target CD19 positive B-cells, an approach that has had promising results in a small number of adult patients. While the FDA has approved a number of clinical trials using CAR-T therapy to treat autoimmune diseases in adults, this is the first authorization for a CAR T-cell therapy trial to treat autoimmune disease in children.

REACT-01 will enroll 12 individuals under 18 years of age, Shaun W. Jackson, MD, PhD, the principal investigator of the trial and attending physician in Pediatric Nephrology and Pediatric Rheumatology at Seattle Children’s Hospital, told this news organization. 

The trial will be initiated in separate phases, using three age cohorts. The first phase will enroll three individuals aged at least 17 years, before moving to the second phase and enrolling three individuals aged 12-17 years. Then, phase 3 will also include children aged 5-12 years.

To be eligible for the trial, participants must have failed at least two standard immunosuppressive therapies as well as have evidence of active lupus disease affecting a major organ system, such as the heart, lungs, and kidneys.

“Seattle Children’s Hospital will be the only site for this study, although patients can travel to Seattle to receive the therapy and then return back to their primary center for ongoing care,” Dr. Jackson said. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the launch of the first clinical trial for chimeric antigen receptor (CAR) T-cell therapy in children with systemic lupus erythematosus.

The trial, called Reversing Autoimmunity through Cell Therapy (REACT-01), will take place at Seattle Children’s Hospital in Washington State and is expected to begin this summer.

The CAR-T therapy will target CD19 positive B-cells, an approach that has had promising results in a small number of adult patients. While the FDA has approved a number of clinical trials using CAR-T therapy to treat autoimmune diseases in adults, this is the first authorization for a CAR T-cell therapy trial to treat autoimmune disease in children.

REACT-01 will enroll 12 individuals under 18 years of age, Shaun W. Jackson, MD, PhD, the principal investigator of the trial and attending physician in Pediatric Nephrology and Pediatric Rheumatology at Seattle Children’s Hospital, told this news organization. 

The trial will be initiated in separate phases, using three age cohorts. The first phase will enroll three individuals aged at least 17 years, before moving to the second phase and enrolling three individuals aged 12-17 years. Then, phase 3 will also include children aged 5-12 years.

To be eligible for the trial, participants must have failed at least two standard immunosuppressive therapies as well as have evidence of active lupus disease affecting a major organ system, such as the heart, lungs, and kidneys.

“Seattle Children’s Hospital will be the only site for this study, although patients can travel to Seattle to receive the therapy and then return back to their primary center for ongoing care,” Dr. Jackson said. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the launch of the first clinical trial for chimeric antigen receptor (CAR) T-cell therapy in children with systemic lupus erythematosus.

The trial, called Reversing Autoimmunity through Cell Therapy (REACT-01), will take place at Seattle Children’s Hospital in Washington State and is expected to begin this summer.

The CAR-T therapy will target CD19 positive B-cells, an approach that has had promising results in a small number of adult patients. While the FDA has approved a number of clinical trials using CAR-T therapy to treat autoimmune diseases in adults, this is the first authorization for a CAR T-cell therapy trial to treat autoimmune disease in children.

REACT-01 will enroll 12 individuals under 18 years of age, Shaun W. Jackson, MD, PhD, the principal investigator of the trial and attending physician in Pediatric Nephrology and Pediatric Rheumatology at Seattle Children’s Hospital, told this news organization. 

The trial will be initiated in separate phases, using three age cohorts. The first phase will enroll three individuals aged at least 17 years, before moving to the second phase and enrolling three individuals aged 12-17 years. Then, phase 3 will also include children aged 5-12 years.

To be eligible for the trial, participants must have failed at least two standard immunosuppressive therapies as well as have evidence of active lupus disease affecting a major organ system, such as the heart, lungs, and kidneys.

“Seattle Children’s Hospital will be the only site for this study, although patients can travel to Seattle to receive the therapy and then return back to their primary center for ongoing care,” Dr. Jackson said. 

A version of this article appeared on Medscape.com.

Congress provided $10 million to fund arthritis research in the recently passed federal fiscal year 2024 budget.

The new arthritis program is part of the Department of Defense’s (DOD’s) Congressionally Directed Medical Research Programs (CDMRP), which provides dedicated funding to study certain diseases and health conditions.

This is the first stand-alone research program for arthritis of the CDMRP, though the organization had previously funded arthritis-related research through their other programs, including chronic pain management, joint warfighter medical, peer-reviewed orthopedic, peer-reviewed medical, and tick-borne disease programs.

stethoscope_on_flag_money_web.jpg

It is not yet known what specific aspects of arthritis this funding will go toward. The standard process for new programs involves speaking with researchers, clinicians, and individuals with these targeted health conditions to better understand research gaps and narrow focus, Akua Roach, PhD, the program manager for this new CDMRP arthritis research program, told this news organization.

“We’re not going to be able to solve every question,” she said, though the allocated $10 million is “a great number to do a lot of great work.”

While the CDMRP is under the DOD, research funding can go to studying patient populations outside of military personnel or veterans, she added.

“I think that is perhaps a common misconception that if you are getting funding from the DOD, that you have to have a DOD population, and that is not true,” she said.

Another misconception is that CDMRP funding only goes to military treatment facilities. In fact, on average, 92% of CDMRP funding goes to academia, industry, and other nonmilitary recipients, noted CDMRP Director Colonel Sarah Goldman.

“Anyone around the world can apply for funding,” she told this news organization. “We want to fund the best research.”

Because the funding is provided under the defense bill, there will be discussions around the military relevance of research, she added, which not only includes service members but also their families.

CDMRP anticipates that funding opportunities through this new arthritis research program will be available by July or August 2024.
 

A version of this article appeared on Medscape.com.

Congress provided $10 million to fund arthritis research in the recently passed federal fiscal year 2024 budget.

The new arthritis program is part of the Department of Defense’s (DOD’s) Congressionally Directed Medical Research Programs (CDMRP), which provides dedicated funding to study certain diseases and health conditions.

This is the first stand-alone research program for arthritis of the CDMRP, though the organization had previously funded arthritis-related research through their other programs, including chronic pain management, joint warfighter medical, peer-reviewed orthopedic, peer-reviewed medical, and tick-borne disease programs.

stethoscope_on_flag_money_web.jpg

It is not yet known what specific aspects of arthritis this funding will go toward. The standard process for new programs involves speaking with researchers, clinicians, and individuals with these targeted health conditions to better understand research gaps and narrow focus, Akua Roach, PhD, the program manager for this new CDMRP arthritis research program, told this news organization.

“We’re not going to be able to solve every question,” she said, though the allocated $10 million is “a great number to do a lot of great work.”

While the CDMRP is under the DOD, research funding can go to studying patient populations outside of military personnel or veterans, she added.

“I think that is perhaps a common misconception that if you are getting funding from the DOD, that you have to have a DOD population, and that is not true,” she said.

Another misconception is that CDMRP funding only goes to military treatment facilities. In fact, on average, 92% of CDMRP funding goes to academia, industry, and other nonmilitary recipients, noted CDMRP Director Colonel Sarah Goldman.

“Anyone around the world can apply for funding,” she told this news organization. “We want to fund the best research.”

Because the funding is provided under the defense bill, there will be discussions around the military relevance of research, she added, which not only includes service members but also their families.

CDMRP anticipates that funding opportunities through this new arthritis research program will be available by July or August 2024.
 

A version of this article appeared on Medscape.com.

Congress provided $10 million to fund arthritis research in the recently passed federal fiscal year 2024 budget.

The new arthritis program is part of the Department of Defense’s (DOD’s) Congressionally Directed Medical Research Programs (CDMRP), which provides dedicated funding to study certain diseases and health conditions.

This is the first stand-alone research program for arthritis of the CDMRP, though the organization had previously funded arthritis-related research through their other programs, including chronic pain management, joint warfighter medical, peer-reviewed orthopedic, peer-reviewed medical, and tick-borne disease programs.

stethoscope_on_flag_money_web.jpg

It is not yet known what specific aspects of arthritis this funding will go toward. The standard process for new programs involves speaking with researchers, clinicians, and individuals with these targeted health conditions to better understand research gaps and narrow focus, Akua Roach, PhD, the program manager for this new CDMRP arthritis research program, told this news organization.

“We’re not going to be able to solve every question,” she said, though the allocated $10 million is “a great number to do a lot of great work.”

While the CDMRP is under the DOD, research funding can go to studying patient populations outside of military personnel or veterans, she added.

“I think that is perhaps a common misconception that if you are getting funding from the DOD, that you have to have a DOD population, and that is not true,” she said.

Another misconception is that CDMRP funding only goes to military treatment facilities. In fact, on average, 92% of CDMRP funding goes to academia, industry, and other nonmilitary recipients, noted CDMRP Director Colonel Sarah Goldman.

“Anyone around the world can apply for funding,” she told this news organization. “We want to fund the best research.”

Because the funding is provided under the defense bill, there will be discussions around the military relevance of research, she added, which not only includes service members but also their families.

CDMRP anticipates that funding opportunities through this new arthritis research program will be available by July or August 2024.
 

A version of this article appeared on Medscape.com.

Researchers have identified three distinct subgroups of Sjögren syndrome (SS) with different prognoses. While previous efforts to stratify these patients were based on reported symptoms, this new analysis is the first to add clinical and biological manifestations into the equation.

The three distinct patient clusters are those with B-cell active disease with low symptom burden (BALS), those with high systemic disease activity (HSA), and those with low systemic disease activity and high symptom burden (LSAHS). Each group had distinct long-term outcomes, including disease evolution and lymphoma incidence.

The findings were published in The Lancet Rheumatology.
 

Derived and Validated in Separate Cohorts

Researchers led by Yann Nguyen, MD, PhD, of Bicêtre Hospital and Paris-Saclay University, Paris, France, identified distinct subgroups with data from the French Paris-Saclay cohort, a group of patients suspected of having SS who participated in a multidisciplinary diagnostic session at a French National Referral Center for Rare Systemic Autoimmune Diseases and were recruited between 1999 and 2022.

Nguyen_Yann_FRANCE_web.jpg

The study included only patients who met the 2002 American-European Consensus Group criteria for SS and had European Alliance of Associations for Rheumatology (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI) and EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) scores at inclusion. Researchers excluded patients with other autoimmune diseases associated with SS.

Researchers identified distinct subgroups using 26 variables, including patient-reported symptoms, clinical parameters, and biological data.

Researchers then validated the subgroups using the same methodology in the Assessment of Systemic Signs and Evolution of Sjögren’s syndrome (ASSESS) cohort, a national French multicenter prospective cohort formed in 2006. They then compared changes in disease activity (measured by ESSDAI) and patient-acceptable symptom state (measured by ESSPRI) between the groups over 5 years of follow-up, as well as differences in lymphoma incidence over 15 years of follow-up.
 

Patients With High Systemic Disease, Low Symptoms Fare Worse

The study ultimately included 534 patients from the Paris-Saclay cohort and 395 patients from the ASSESS cohort. For both groups, 94% of patients were women, and the median age was between 53 and 54 years.

In the Paris-Saclay group, 205 patients were classified as BALS, 160 were HSA, and 169 were LSAHS. In the ASSESS cohort, BALS remained the largest group (186 patients), followed by HSA (158 patients). Only 51 patients in the second cohort were classified as LSAHS.

During 5 years of follow-up in the ASSESS cohort, systemic disease activity improved in the HSA cluster and worsened in the BALS cluster, while there were no significant changes in the LSAHS cluster. The BALS cluster was the only group to experience significant changes in patient-acceptable symptom states during follow-up: 49% of patients with BALS had an ESSPRI score of less than 5 at inclusion, but this percentage dipped to 36% at month 60.

The findings “highlight the fact that even in patients who present with predominantly systemic manifestations, the symptom burden is high and should not be neglected,” the authors wrote.

The three categories established in this study did not correlate well with previous symptom-based stratification of patients with SS, the authors noted, which looked at the five most common symptoms associated with the condition: Pain, fatigue, dryness, anxiety, and depression.

“Patients from the high symptom burden, dryness dominant with fatigue, and pain dominant with fatigue subgroups were present in each of our three clusters,” they wrote. “This finding is consistent with the poor correlation between patient-reported outcomes and systemic disease activity.”

Lymphoma was diagnosed in 5 of 186 patients (3%) in the BALS cluster, diagnosed after a median of 70 months of follow-up, and 6 of 158 patients (4%) in the HSA cluster, diagnosed after a median of 23 months follow-up. There were no cases of lymphoma in the LSAHS group.

“Notably, in the BALS cluster, lymphoma occurred later than in the HSA cluster, and after 5 years, systemic manifestations in this cluster tended to be similar to those in the HSA cluster at inclusion,” the authors added. “The BALS cluster could therefore represent an earlier stage of the disease and carry the risk of progressing toward a more systemic phenotype.”
 

A ‘First Step’ to Subgrouping Patients

Alan Baer, MD, director of the Jerome Greene Sjogren’s Syndrome Center at John Hopkins Medical Center in Baltimore, Maryland, who commented on the study, noted that these three subgroups did “resonate” with what clinicians see in practice. Certain patients may have lab results that are “quite striking” even though they report minimal symptoms. The reverse is also true: Patients who have a high symptom burden without signs of systemic disease activity. Whether these patients should be managed differently “remains the key question,” he said.

Baer_Alan_MD_web.JPG

“The hope is that when you have a group of patients that’s relatively homogenous in terms of their clinical features, that also translates to similarities into the underlying pathogenesis that can then lead to treatments that are targeted to specific subgroups of patients,” he added.

Another approach could be looking directly at molecular alterations across patients with SS and seeing how they correlate to clinical features, Dr. Baer noted.

This study “is a first step” in figuring out how to best define SS subgroups, he said, adding that “there’s more work to be done.”

This research was funded by the Fondation pour la Recherche Medicale, French Ministry of Health, French Society of Rheumatology, Innovative Medicines Initiative 2 Joint Undertaking, Medical Research Council UK, and Foundation for Research in Rheumatology. The study authors disclosed financial relationships with various pharmaceutical companies. Dr. Baer had no relevant disclosures.

A version of this article appeared on Medscape.com .

Researchers have identified three distinct subgroups of Sjögren syndrome (SS) with different prognoses. While previous efforts to stratify these patients were based on reported symptoms, this new analysis is the first to add clinical and biological manifestations into the equation.

The three distinct patient clusters are those with B-cell active disease with low symptom burden (BALS), those with high systemic disease activity (HSA), and those with low systemic disease activity and high symptom burden (LSAHS). Each group had distinct long-term outcomes, including disease evolution and lymphoma incidence.

The findings were published in The Lancet Rheumatology.
 

Derived and Validated in Separate Cohorts

Researchers led by Yann Nguyen, MD, PhD, of Bicêtre Hospital and Paris-Saclay University, Paris, France, identified distinct subgroups with data from the French Paris-Saclay cohort, a group of patients suspected of having SS who participated in a multidisciplinary diagnostic session at a French National Referral Center for Rare Systemic Autoimmune Diseases and were recruited between 1999 and 2022.

Nguyen_Yann_FRANCE_web.jpg

The study included only patients who met the 2002 American-European Consensus Group criteria for SS and had European Alliance of Associations for Rheumatology (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI) and EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) scores at inclusion. Researchers excluded patients with other autoimmune diseases associated with SS.

Researchers identified distinct subgroups using 26 variables, including patient-reported symptoms, clinical parameters, and biological data.

Researchers then validated the subgroups using the same methodology in the Assessment of Systemic Signs and Evolution of Sjögren’s syndrome (ASSESS) cohort, a national French multicenter prospective cohort formed in 2006. They then compared changes in disease activity (measured by ESSDAI) and patient-acceptable symptom state (measured by ESSPRI) between the groups over 5 years of follow-up, as well as differences in lymphoma incidence over 15 years of follow-up.
 

Patients With High Systemic Disease, Low Symptoms Fare Worse

The study ultimately included 534 patients from the Paris-Saclay cohort and 395 patients from the ASSESS cohort. For both groups, 94% of patients were women, and the median age was between 53 and 54 years.

In the Paris-Saclay group, 205 patients were classified as BALS, 160 were HSA, and 169 were LSAHS. In the ASSESS cohort, BALS remained the largest group (186 patients), followed by HSA (158 patients). Only 51 patients in the second cohort were classified as LSAHS.

During 5 years of follow-up in the ASSESS cohort, systemic disease activity improved in the HSA cluster and worsened in the BALS cluster, while there were no significant changes in the LSAHS cluster. The BALS cluster was the only group to experience significant changes in patient-acceptable symptom states during follow-up: 49% of patients with BALS had an ESSPRI score of less than 5 at inclusion, but this percentage dipped to 36% at month 60.

The findings “highlight the fact that even in patients who present with predominantly systemic manifestations, the symptom burden is high and should not be neglected,” the authors wrote.

The three categories established in this study did not correlate well with previous symptom-based stratification of patients with SS, the authors noted, which looked at the five most common symptoms associated with the condition: Pain, fatigue, dryness, anxiety, and depression.

“Patients from the high symptom burden, dryness dominant with fatigue, and pain dominant with fatigue subgroups were present in each of our three clusters,” they wrote. “This finding is consistent with the poor correlation between patient-reported outcomes and systemic disease activity.”

Lymphoma was diagnosed in 5 of 186 patients (3%) in the BALS cluster, diagnosed after a median of 70 months of follow-up, and 6 of 158 patients (4%) in the HSA cluster, diagnosed after a median of 23 months follow-up. There were no cases of lymphoma in the LSAHS group.

“Notably, in the BALS cluster, lymphoma occurred later than in the HSA cluster, and after 5 years, systemic manifestations in this cluster tended to be similar to those in the HSA cluster at inclusion,” the authors added. “The BALS cluster could therefore represent an earlier stage of the disease and carry the risk of progressing toward a more systemic phenotype.”
 

A ‘First Step’ to Subgrouping Patients

Alan Baer, MD, director of the Jerome Greene Sjogren’s Syndrome Center at John Hopkins Medical Center in Baltimore, Maryland, who commented on the study, noted that these three subgroups did “resonate” with what clinicians see in practice. Certain patients may have lab results that are “quite striking” even though they report minimal symptoms. The reverse is also true: Patients who have a high symptom burden without signs of systemic disease activity. Whether these patients should be managed differently “remains the key question,” he said.

Baer_Alan_MD_web.JPG

“The hope is that when you have a group of patients that’s relatively homogenous in terms of their clinical features, that also translates to similarities into the underlying pathogenesis that can then lead to treatments that are targeted to specific subgroups of patients,” he added.

Another approach could be looking directly at molecular alterations across patients with SS and seeing how they correlate to clinical features, Dr. Baer noted.

This study “is a first step” in figuring out how to best define SS subgroups, he said, adding that “there’s more work to be done.”

This research was funded by the Fondation pour la Recherche Medicale, French Ministry of Health, French Society of Rheumatology, Innovative Medicines Initiative 2 Joint Undertaking, Medical Research Council UK, and Foundation for Research in Rheumatology. The study authors disclosed financial relationships with various pharmaceutical companies. Dr. Baer had no relevant disclosures.

A version of this article appeared on Medscape.com .

Researchers have identified three distinct subgroups of Sjögren syndrome (SS) with different prognoses. While previous efforts to stratify these patients were based on reported symptoms, this new analysis is the first to add clinical and biological manifestations into the equation.

The three distinct patient clusters are those with B-cell active disease with low symptom burden (BALS), those with high systemic disease activity (HSA), and those with low systemic disease activity and high symptom burden (LSAHS). Each group had distinct long-term outcomes, including disease evolution and lymphoma incidence.

The findings were published in The Lancet Rheumatology.
 

Derived and Validated in Separate Cohorts

Researchers led by Yann Nguyen, MD, PhD, of Bicêtre Hospital and Paris-Saclay University, Paris, France, identified distinct subgroups with data from the French Paris-Saclay cohort, a group of patients suspected of having SS who participated in a multidisciplinary diagnostic session at a French National Referral Center for Rare Systemic Autoimmune Diseases and were recruited between 1999 and 2022.

Nguyen_Yann_FRANCE_web.jpg

The study included only patients who met the 2002 American-European Consensus Group criteria for SS and had European Alliance of Associations for Rheumatology (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI) and EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) scores at inclusion. Researchers excluded patients with other autoimmune diseases associated with SS.

Researchers identified distinct subgroups using 26 variables, including patient-reported symptoms, clinical parameters, and biological data.

Researchers then validated the subgroups using the same methodology in the Assessment of Systemic Signs and Evolution of Sjögren’s syndrome (ASSESS) cohort, a national French multicenter prospective cohort formed in 2006. They then compared changes in disease activity (measured by ESSDAI) and patient-acceptable symptom state (measured by ESSPRI) between the groups over 5 years of follow-up, as well as differences in lymphoma incidence over 15 years of follow-up.
 

Patients With High Systemic Disease, Low Symptoms Fare Worse

The study ultimately included 534 patients from the Paris-Saclay cohort and 395 patients from the ASSESS cohort. For both groups, 94% of patients were women, and the median age was between 53 and 54 years.

In the Paris-Saclay group, 205 patients were classified as BALS, 160 were HSA, and 169 were LSAHS. In the ASSESS cohort, BALS remained the largest group (186 patients), followed by HSA (158 patients). Only 51 patients in the second cohort were classified as LSAHS.

During 5 years of follow-up in the ASSESS cohort, systemic disease activity improved in the HSA cluster and worsened in the BALS cluster, while there were no significant changes in the LSAHS cluster. The BALS cluster was the only group to experience significant changes in patient-acceptable symptom states during follow-up: 49% of patients with BALS had an ESSPRI score of less than 5 at inclusion, but this percentage dipped to 36% at month 60.

The findings “highlight the fact that even in patients who present with predominantly systemic manifestations, the symptom burden is high and should not be neglected,” the authors wrote.

The three categories established in this study did not correlate well with previous symptom-based stratification of patients with SS, the authors noted, which looked at the five most common symptoms associated with the condition: Pain, fatigue, dryness, anxiety, and depression.

“Patients from the high symptom burden, dryness dominant with fatigue, and pain dominant with fatigue subgroups were present in each of our three clusters,” they wrote. “This finding is consistent with the poor correlation between patient-reported outcomes and systemic disease activity.”

Lymphoma was diagnosed in 5 of 186 patients (3%) in the BALS cluster, diagnosed after a median of 70 months of follow-up, and 6 of 158 patients (4%) in the HSA cluster, diagnosed after a median of 23 months follow-up. There were no cases of lymphoma in the LSAHS group.

“Notably, in the BALS cluster, lymphoma occurred later than in the HSA cluster, and after 5 years, systemic manifestations in this cluster tended to be similar to those in the HSA cluster at inclusion,” the authors added. “The BALS cluster could therefore represent an earlier stage of the disease and carry the risk of progressing toward a more systemic phenotype.”
 

A ‘First Step’ to Subgrouping Patients

Alan Baer, MD, director of the Jerome Greene Sjogren’s Syndrome Center at John Hopkins Medical Center in Baltimore, Maryland, who commented on the study, noted that these three subgroups did “resonate” with what clinicians see in practice. Certain patients may have lab results that are “quite striking” even though they report minimal symptoms. The reverse is also true: Patients who have a high symptom burden without signs of systemic disease activity. Whether these patients should be managed differently “remains the key question,” he said.

Baer_Alan_MD_web.JPG

“The hope is that when you have a group of patients that’s relatively homogenous in terms of their clinical features, that also translates to similarities into the underlying pathogenesis that can then lead to treatments that are targeted to specific subgroups of patients,” he added.

Another approach could be looking directly at molecular alterations across patients with SS and seeing how they correlate to clinical features, Dr. Baer noted.

This study “is a first step” in figuring out how to best define SS subgroups, he said, adding that “there’s more work to be done.”

This research was funded by the Fondation pour la Recherche Medicale, French Ministry of Health, French Society of Rheumatology, Innovative Medicines Initiative 2 Joint Undertaking, Medical Research Council UK, and Foundation for Research in Rheumatology. The study authors disclosed financial relationships with various pharmaceutical companies. Dr. Baer had no relevant disclosures.

A version of this article appeared on Medscape.com .

Physiotherapy conducted via video conference is noninferior to in-person sessions for the treatment of chronic knee pain, according to new research.

In the trial, participants assigned to in-person or telehealth sessions had similar improvements in knee pain and physical function over 3 months, while the online group had better session attendance and reported higher convenience.

While the COVID-19 pandemic increased the use of telerehabilitation physiotherapy services, it is not clear how these teleservices will be utilized moving forward, the study authors wrote. There is some research suggesting that both in-person and online physiotherapy are equally effective, but surveys suggest that both providers and patients remain unconvinced.

“Based on pandemic telerehabilitation experiences, less than half of allied health clinicians believe telerehabilitation is as effective as in-person care and almost half of patients think video conferencing with a physiotherapist provides lower quality care,” study first author Rana Hinman, PhD, professor of physiotherapy at the University of Melbourne, Australia, and colleagues wrote in their report published online in The Lancet.
 

‘A Game Changer’ for Physical Therapy

Commenting on the study for this news organization, Daniel White, ScD, an associate professor in the department of physical therapy at the University of Delaware in Newark, Delaware, called the research “a game changer” for physical therapy. 

“It’s showing that in-person care can be replicated in terms of efficacy,” in telehealth settings, he said. “From a telehealth perspective, it really opens the doors to access to people who have difficulty reaching physical therapists,” he added, “and puts us on stage with other modes of telehealth that are given as part of modern medicine.”

Dr. White noted that physical therapy treatment for knee osteoarthritis is underused, with just 10% of patients seeing a physical therapist prior to undergoing knee replacement. While knee replacements are effective interventions, he said, access to physical therapy could allow many patients to put off having surgery.

The findings not only provide solutions for access issues but also assuage concerns “that you’re going to get ‘physical therapy lite’” with telehealth, Dr. White added. 

“You can deliver physical therapy to this group that typically is not getting enough of it,” he said, “and it is just as effective when delivered online than if it were to be delivered in person.”
 

Noninferiority Maintained at 9 Months’ Follow-up

To understand how video conferencing physiotherapy consultations compared to in-person care, the researchers designed a non-inferiority randomized controlled trial. 

For the trial, researchers enrolled 394 adults with chronic knee pain who were aged ≥ 45 years, had activity-related joint pain, and either had no morning stiffness or morning stiffness lasting < 30 minutes. Other inclusion criteria were history of knee pain of ≥ 3 months, knee pain most days of the previous month, average walking pain score of four or more on the 11-point numeric rating scale (NRS) over the previous week, and difficulty walking and climbing stairs.

Participants also needed access to a computer device with internet as well as the ability to travel to the nearest trial physiotherapist.

The study recruited 15 physiotherapists across 27 practices in metropolitan Queensland and Victoria, Australia, of which 60% had no previous telerehabilitation experience. Physiotherapists were trained to conduct video sessions via e-learning, practice video consultations, and a competency video conferencing evaluation.

Participants were randomly assigned to in-person or video physiotherapist consultations, with both groups receiving five consultations over 3 months. All clients were prescribed a home-based strength training program and physical activity plan.

The primary outcomes were changes at 3 months in patient-reported knee pain (on a scale of 0-10), with an inferiority margin of 0.95, and physical function — assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) — with an inferiority margin of −5.44.

From December 10, 2019, to June 17, 2022, 204 participants were assigned to in-person sessions and 190 were assigned to telerehabilitation. At 3 months, both groups reported improved pain and physical function, with no significant differences between the two groups with either measure. The mean between-group difference was 0.16 (95% CI, −0.26 to 0.57) for knee pain and 1.65 (−0.23 to 3.53) for physical function. Noninferiority was also maintained at 9 months’ follow-up.

The trial took place over the COVID-19 pandemic, which limited participant ability to attend in-person consultations. In total, 84% of participants assigned to in-person rehabilitation attended at least three or more consultations compared with 96% of those assigned to telerehabilitation. In an additional analysis including only participants attending three or more sessions, improvement in knee pain and physical function was similar between the in-person or tele-rehabilitation groups “showing that the findings are robust,” the authors noted.

At 3 months, the telerehabilitation group ranked their sessions as more convenient that their in-person counterparts and reported greater adherence to their strengthening program. At 9 months’ follow-up, the telerehabilitation group had higher physical activity scores than the in-person group.

This research was funded by the Australian National Health and Medical Research Council. Two authors reported grant funding paid to the University of Melbourne from the National Health & Medical Research Council, Australian Research Council, Medical Research Future Fund, and Medibank for research. Dr. White has been a paid speaker for Viatris.

A version of this article appeared on Medscape.com.

Physiotherapy conducted via video conference is noninferior to in-person sessions for the treatment of chronic knee pain, according to new research.

In the trial, participants assigned to in-person or telehealth sessions had similar improvements in knee pain and physical function over 3 months, while the online group had better session attendance and reported higher convenience.

While the COVID-19 pandemic increased the use of telerehabilitation physiotherapy services, it is not clear how these teleservices will be utilized moving forward, the study authors wrote. There is some research suggesting that both in-person and online physiotherapy are equally effective, but surveys suggest that both providers and patients remain unconvinced.

“Based on pandemic telerehabilitation experiences, less than half of allied health clinicians believe telerehabilitation is as effective as in-person care and almost half of patients think video conferencing with a physiotherapist provides lower quality care,” study first author Rana Hinman, PhD, professor of physiotherapy at the University of Melbourne, Australia, and colleagues wrote in their report published online in The Lancet.
 

‘A Game Changer’ for Physical Therapy

Commenting on the study for this news organization, Daniel White, ScD, an associate professor in the department of physical therapy at the University of Delaware in Newark, Delaware, called the research “a game changer” for physical therapy. 

“It’s showing that in-person care can be replicated in terms of efficacy,” in telehealth settings, he said. “From a telehealth perspective, it really opens the doors to access to people who have difficulty reaching physical therapists,” he added, “and puts us on stage with other modes of telehealth that are given as part of modern medicine.”

Dr. White noted that physical therapy treatment for knee osteoarthritis is underused, with just 10% of patients seeing a physical therapist prior to undergoing knee replacement. While knee replacements are effective interventions, he said, access to physical therapy could allow many patients to put off having surgery.

The findings not only provide solutions for access issues but also assuage concerns “that you’re going to get ‘physical therapy lite’” with telehealth, Dr. White added. 

“You can deliver physical therapy to this group that typically is not getting enough of it,” he said, “and it is just as effective when delivered online than if it were to be delivered in person.”
 

Noninferiority Maintained at 9 Months’ Follow-up

To understand how video conferencing physiotherapy consultations compared to in-person care, the researchers designed a non-inferiority randomized controlled trial. 

For the trial, researchers enrolled 394 adults with chronic knee pain who were aged ≥ 45 years, had activity-related joint pain, and either had no morning stiffness or morning stiffness lasting < 30 minutes. Other inclusion criteria were history of knee pain of ≥ 3 months, knee pain most days of the previous month, average walking pain score of four or more on the 11-point numeric rating scale (NRS) over the previous week, and difficulty walking and climbing stairs.

Participants also needed access to a computer device with internet as well as the ability to travel to the nearest trial physiotherapist.

The study recruited 15 physiotherapists across 27 practices in metropolitan Queensland and Victoria, Australia, of which 60% had no previous telerehabilitation experience. Physiotherapists were trained to conduct video sessions via e-learning, practice video consultations, and a competency video conferencing evaluation.

Participants were randomly assigned to in-person or video physiotherapist consultations, with both groups receiving five consultations over 3 months. All clients were prescribed a home-based strength training program and physical activity plan.

The primary outcomes were changes at 3 months in patient-reported knee pain (on a scale of 0-10), with an inferiority margin of 0.95, and physical function — assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) — with an inferiority margin of −5.44.

From December 10, 2019, to June 17, 2022, 204 participants were assigned to in-person sessions and 190 were assigned to telerehabilitation. At 3 months, both groups reported improved pain and physical function, with no significant differences between the two groups with either measure. The mean between-group difference was 0.16 (95% CI, −0.26 to 0.57) for knee pain and 1.65 (−0.23 to 3.53) for physical function. Noninferiority was also maintained at 9 months’ follow-up.

The trial took place over the COVID-19 pandemic, which limited participant ability to attend in-person consultations. In total, 84% of participants assigned to in-person rehabilitation attended at least three or more consultations compared with 96% of those assigned to telerehabilitation. In an additional analysis including only participants attending three or more sessions, improvement in knee pain and physical function was similar between the in-person or tele-rehabilitation groups “showing that the findings are robust,” the authors noted.

At 3 months, the telerehabilitation group ranked their sessions as more convenient that their in-person counterparts and reported greater adherence to their strengthening program. At 9 months’ follow-up, the telerehabilitation group had higher physical activity scores than the in-person group.

This research was funded by the Australian National Health and Medical Research Council. Two authors reported grant funding paid to the University of Melbourne from the National Health & Medical Research Council, Australian Research Council, Medical Research Future Fund, and Medibank for research. Dr. White has been a paid speaker for Viatris.

A version of this article appeared on Medscape.com.

Physiotherapy conducted via video conference is noninferior to in-person sessions for the treatment of chronic knee pain, according to new research.

In the trial, participants assigned to in-person or telehealth sessions had similar improvements in knee pain and physical function over 3 months, while the online group had better session attendance and reported higher convenience.

While the COVID-19 pandemic increased the use of telerehabilitation physiotherapy services, it is not clear how these teleservices will be utilized moving forward, the study authors wrote. There is some research suggesting that both in-person and online physiotherapy are equally effective, but surveys suggest that both providers and patients remain unconvinced.

“Based on pandemic telerehabilitation experiences, less than half of allied health clinicians believe telerehabilitation is as effective as in-person care and almost half of patients think video conferencing with a physiotherapist provides lower quality care,” study first author Rana Hinman, PhD, professor of physiotherapy at the University of Melbourne, Australia, and colleagues wrote in their report published online in The Lancet.
 

‘A Game Changer’ for Physical Therapy

Commenting on the study for this news organization, Daniel White, ScD, an associate professor in the department of physical therapy at the University of Delaware in Newark, Delaware, called the research “a game changer” for physical therapy. 

“It’s showing that in-person care can be replicated in terms of efficacy,” in telehealth settings, he said. “From a telehealth perspective, it really opens the doors to access to people who have difficulty reaching physical therapists,” he added, “and puts us on stage with other modes of telehealth that are given as part of modern medicine.”

Dr. White noted that physical therapy treatment for knee osteoarthritis is underused, with just 10% of patients seeing a physical therapist prior to undergoing knee replacement. While knee replacements are effective interventions, he said, access to physical therapy could allow many patients to put off having surgery.

The findings not only provide solutions for access issues but also assuage concerns “that you’re going to get ‘physical therapy lite’” with telehealth, Dr. White added. 

“You can deliver physical therapy to this group that typically is not getting enough of it,” he said, “and it is just as effective when delivered online than if it were to be delivered in person.”
 

Noninferiority Maintained at 9 Months’ Follow-up

To understand how video conferencing physiotherapy consultations compared to in-person care, the researchers designed a non-inferiority randomized controlled trial. 

For the trial, researchers enrolled 394 adults with chronic knee pain who were aged ≥ 45 years, had activity-related joint pain, and either had no morning stiffness or morning stiffness lasting < 30 minutes. Other inclusion criteria were history of knee pain of ≥ 3 months, knee pain most days of the previous month, average walking pain score of four or more on the 11-point numeric rating scale (NRS) over the previous week, and difficulty walking and climbing stairs.

Participants also needed access to a computer device with internet as well as the ability to travel to the nearest trial physiotherapist.

The study recruited 15 physiotherapists across 27 practices in metropolitan Queensland and Victoria, Australia, of which 60% had no previous telerehabilitation experience. Physiotherapists were trained to conduct video sessions via e-learning, practice video consultations, and a competency video conferencing evaluation.

Participants were randomly assigned to in-person or video physiotherapist consultations, with both groups receiving five consultations over 3 months. All clients were prescribed a home-based strength training program and physical activity plan.

The primary outcomes were changes at 3 months in patient-reported knee pain (on a scale of 0-10), with an inferiority margin of 0.95, and physical function — assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) — with an inferiority margin of −5.44.

From December 10, 2019, to June 17, 2022, 204 participants were assigned to in-person sessions and 190 were assigned to telerehabilitation. At 3 months, both groups reported improved pain and physical function, with no significant differences between the two groups with either measure. The mean between-group difference was 0.16 (95% CI, −0.26 to 0.57) for knee pain and 1.65 (−0.23 to 3.53) for physical function. Noninferiority was also maintained at 9 months’ follow-up.

The trial took place over the COVID-19 pandemic, which limited participant ability to attend in-person consultations. In total, 84% of participants assigned to in-person rehabilitation attended at least three or more consultations compared with 96% of those assigned to telerehabilitation. In an additional analysis including only participants attending three or more sessions, improvement in knee pain and physical function was similar between the in-person or tele-rehabilitation groups “showing that the findings are robust,” the authors noted.

At 3 months, the telerehabilitation group ranked their sessions as more convenient that their in-person counterparts and reported greater adherence to their strengthening program. At 9 months’ follow-up, the telerehabilitation group had higher physical activity scores than the in-person group.

This research was funded by the Australian National Health and Medical Research Council. Two authors reported grant funding paid to the University of Melbourne from the National Health & Medical Research Council, Australian Research Council, Medical Research Future Fund, and Medibank for research. Dr. White has been a paid speaker for Viatris.

A version of this article appeared on Medscape.com.

The number of clinically active rheumatology providers in the United States grew more than 20% from 2009 to 2019, according to a new analysis.

The number of advanced practice providers (APPs) in rheumatology more than doubled during that same time. However, these numerical increases are not enough to meet the projected demand in care, the authors reported.

Mannion_Melissa_AL_web.jpg

“Even though we found growth, and if that same growth continued, we’d still be well below the projected needs for the overall aging population of the United States,” lead author Melissa Mannion, MD, MSPH, a pediatric rheumatologist at the University of Alabama at Birmingham, said in an interview.

In a 2015 workforce study by the American College of Rheumatology (ACR), researchers projected that the supply of rheumatologists would decrease by 25% from 2015 to 2030, with an estimated shortage of over 4000 clinical full-time equivalent (cFTE) rheumatology providers.

While the previous study’s findings seem to contrast with this newest analysis, Dr. Dr. Mannion said the findings are complementary, with both studies using different data sources.

The newest findings were published online on February 24 in Arthritis & Rheumatology.

Leveraging Medicare Data

The ACR study estimated the adult rheumatology workforce and cFTEs using both primary and secondary sources, including published data from the American Medical Association and other professional societies, as well as electronic surveys of ACR members and rheumatology fellows in training.

By contrast, this newest study identified rheumatology providers using Medicare administrative data from 2006 to 2020, supplemented by national provider identifier taxonomy codes. Rheumatologists were considered “clinically active” if they provided care for at least five patients in 1 year. To account for rheumatology fellows, who can be categorized as internal medicine physicians, researchers also included internists who prescribed biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) to more than 10 patients a year.

The count also included APPs, both nurse practitioners (NPs) and physician assistants (PAs), who were attached to practices with only rheumatologists, internists, or one other specialty. Like physicians, APPs were included in the count if they prescribed more than 10 patients biologic or targeted synthetic DMARDs in a calendar year and billed at least five patients with a rheumatic condition per year.

Researchers also estimated the number of cFTEs for 2019, using a variety of assumptions to generate an upper and lower range.

Different Numbers, Complementary Conclusions

For the 2019 calendar year, researchers counted 5667 clinically active rheumatologists and 379 NPs/PAs.

This represented a 23% increase in rheumatologists and a 141% increase in the number of APPs in the rheumatology workforce from 2009. The active rheumatology workforce increased by about 100 providers per year over the study period, although growth flattened off in more recent years.

The estimated cFTEs for 2019 ranged from 3457 to 5396, which are “comparable” to the projected 2020 cFTE estimates made in the ACR 2015 workforce study: 3888 to 5777 cFTEs.

Battafarano_Daniel_TX_web.jpg

Daniel Battafarano, DO, chair of the ACR Workforce Solutions Committee, agreed with Dr. Mannion that these findings complement each other, telling a similar story “but with different numbers,” he told this news organization. Dr. Battafarano, a professor of medicine at the Uniformed Services University of the Health Sciences, Bethesda, Maryland, led the ACR workforce study.

“Both studies project estimates of rheumatology providers and workforce trends, but neither study can claim accurate numbers of rheumatology providers due to the true limitation of either workforce study model,” he said.

The ACR study began with a higher count of rheumatologists, estimating 6013 practicing providers in 2015, while Dr. Mannion’s team calculated 5474 providers for the same year. The ACR study projected that provider numbers would fall to 5886 by 2020, which was higher than the 2019 count in this most recent study.

Dr. Battafarano noted that the studies also dealt with different time frames: While the ACR study used 2015 data to project trends in 5-year increments, this most recent study looked trends in the previous decade.

“We found an increase over time, although toward the end of our study — from 2019 to 2020 — we did have a drop off in number of providers, so maybe we are finding the beginning of what [the ACR researchers] anticipated, or maybe that will be corrected in the future,” Dr. Dr. Mannion said. “I think that our estimates really coordinate with what they found just using a different data source.”

Geographic Disparities and Solutions

The new study also highlighted the scarcity of rheumatology providers in rural counties, which was also an important take away from the 2015 ACR study. In the new analysis, researchers found that 95% of rheumatology practices were in urban settings, which did not change over the study period. Most counties in the United States had fewer than 30 rheumatologists per 1 million adults, with 93% of rural counties having zero adult rheumatologists. In comparison, 48% of urban counties had no adult rheumatologists.

“There’s not enough people, and they’re in very specific locations,” Dr. Dr. Mannion said. “Both things make it harder for people to get care.”

Dr. Battafarano noted that leveraging APPs would be key to increasing patient access to care moving forward — a resource that has more than doubled in the past decade, according to Dr. Dr. Mannion’s analysis.

“Recruiting a significant number of APPs into rheumatology practice should be a primary goal to increase the rheumatology workforce,” he said. Other potential solutions, he added, include employing telemedicine and educating primary care providers on rheumatic disease to help them comanage these conditions with rheumatologists.

This study was partially funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Mannion was supported by the Rheumatology Research Foundation Norman B. Gaylis, MD Clinical Research Award, paid to her institution. Dr. Battafarano had no relevant disclosures.

A version of this article appeared on Medscape.com.

The number of clinically active rheumatology providers in the United States grew more than 20% from 2009 to 2019, according to a new analysis.

The number of advanced practice providers (APPs) in rheumatology more than doubled during that same time. However, these numerical increases are not enough to meet the projected demand in care, the authors reported.

Mannion_Melissa_AL_web.jpg

“Even though we found growth, and if that same growth continued, we’d still be well below the projected needs for the overall aging population of the United States,” lead author Melissa Mannion, MD, MSPH, a pediatric rheumatologist at the University of Alabama at Birmingham, said in an interview.

In a 2015 workforce study by the American College of Rheumatology (ACR), researchers projected that the supply of rheumatologists would decrease by 25% from 2015 to 2030, with an estimated shortage of over 4000 clinical full-time equivalent (cFTE) rheumatology providers.

While the previous study’s findings seem to contrast with this newest analysis, Dr. Dr. Mannion said the findings are complementary, with both studies using different data sources.

The newest findings were published online on February 24 in Arthritis & Rheumatology.

Leveraging Medicare Data

The ACR study estimated the adult rheumatology workforce and cFTEs using both primary and secondary sources, including published data from the American Medical Association and other professional societies, as well as electronic surveys of ACR members and rheumatology fellows in training.

By contrast, this newest study identified rheumatology providers using Medicare administrative data from 2006 to 2020, supplemented by national provider identifier taxonomy codes. Rheumatologists were considered “clinically active” if they provided care for at least five patients in 1 year. To account for rheumatology fellows, who can be categorized as internal medicine physicians, researchers also included internists who prescribed biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) to more than 10 patients a year.

The count also included APPs, both nurse practitioners (NPs) and physician assistants (PAs), who were attached to practices with only rheumatologists, internists, or one other specialty. Like physicians, APPs were included in the count if they prescribed more than 10 patients biologic or targeted synthetic DMARDs in a calendar year and billed at least five patients with a rheumatic condition per year.

Researchers also estimated the number of cFTEs for 2019, using a variety of assumptions to generate an upper and lower range.

Different Numbers, Complementary Conclusions

For the 2019 calendar year, researchers counted 5667 clinically active rheumatologists and 379 NPs/PAs.

This represented a 23% increase in rheumatologists and a 141% increase in the number of APPs in the rheumatology workforce from 2009. The active rheumatology workforce increased by about 100 providers per year over the study period, although growth flattened off in more recent years.

The estimated cFTEs for 2019 ranged from 3457 to 5396, which are “comparable” to the projected 2020 cFTE estimates made in the ACR 2015 workforce study: 3888 to 5777 cFTEs.

Battafarano_Daniel_TX_web.jpg

Daniel Battafarano, DO, chair of the ACR Workforce Solutions Committee, agreed with Dr. Mannion that these findings complement each other, telling a similar story “but with different numbers,” he told this news organization. Dr. Battafarano, a professor of medicine at the Uniformed Services University of the Health Sciences, Bethesda, Maryland, led the ACR workforce study.

“Both studies project estimates of rheumatology providers and workforce trends, but neither study can claim accurate numbers of rheumatology providers due to the true limitation of either workforce study model,” he said.

The ACR study began with a higher count of rheumatologists, estimating 6013 practicing providers in 2015, while Dr. Mannion’s team calculated 5474 providers for the same year. The ACR study projected that provider numbers would fall to 5886 by 2020, which was higher than the 2019 count in this most recent study.

Dr. Battafarano noted that the studies also dealt with different time frames: While the ACR study used 2015 data to project trends in 5-year increments, this most recent study looked trends in the previous decade.

“We found an increase over time, although toward the end of our study — from 2019 to 2020 — we did have a drop off in number of providers, so maybe we are finding the beginning of what [the ACR researchers] anticipated, or maybe that will be corrected in the future,” Dr. Dr. Mannion said. “I think that our estimates really coordinate with what they found just using a different data source.”

Geographic Disparities and Solutions

The new study also highlighted the scarcity of rheumatology providers in rural counties, which was also an important take away from the 2015 ACR study. In the new analysis, researchers found that 95% of rheumatology practices were in urban settings, which did not change over the study period. Most counties in the United States had fewer than 30 rheumatologists per 1 million adults, with 93% of rural counties having zero adult rheumatologists. In comparison, 48% of urban counties had no adult rheumatologists.

“There’s not enough people, and they’re in very specific locations,” Dr. Dr. Mannion said. “Both things make it harder for people to get care.”

Dr. Battafarano noted that leveraging APPs would be key to increasing patient access to care moving forward — a resource that has more than doubled in the past decade, according to Dr. Dr. Mannion’s analysis.

“Recruiting a significant number of APPs into rheumatology practice should be a primary goal to increase the rheumatology workforce,” he said. Other potential solutions, he added, include employing telemedicine and educating primary care providers on rheumatic disease to help them comanage these conditions with rheumatologists.

This study was partially funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Mannion was supported by the Rheumatology Research Foundation Norman B. Gaylis, MD Clinical Research Award, paid to her institution. Dr. Battafarano had no relevant disclosures.

A version of this article appeared on Medscape.com.

The number of clinically active rheumatology providers in the United States grew more than 20% from 2009 to 2019, according to a new analysis.

The number of advanced practice providers (APPs) in rheumatology more than doubled during that same time. However, these numerical increases are not enough to meet the projected demand in care, the authors reported.

Mannion_Melissa_AL_web.jpg

“Even though we found growth, and if that same growth continued, we’d still be well below the projected needs for the overall aging population of the United States,” lead author Melissa Mannion, MD, MSPH, a pediatric rheumatologist at the University of Alabama at Birmingham, said in an interview.

In a 2015 workforce study by the American College of Rheumatology (ACR), researchers projected that the supply of rheumatologists would decrease by 25% from 2015 to 2030, with an estimated shortage of over 4000 clinical full-time equivalent (cFTE) rheumatology providers.

While the previous study’s findings seem to contrast with this newest analysis, Dr. Dr. Mannion said the findings are complementary, with both studies using different data sources.

The newest findings were published online on February 24 in Arthritis & Rheumatology.

Leveraging Medicare Data

The ACR study estimated the adult rheumatology workforce and cFTEs using both primary and secondary sources, including published data from the American Medical Association and other professional societies, as well as electronic surveys of ACR members and rheumatology fellows in training.

By contrast, this newest study identified rheumatology providers using Medicare administrative data from 2006 to 2020, supplemented by national provider identifier taxonomy codes. Rheumatologists were considered “clinically active” if they provided care for at least five patients in 1 year. To account for rheumatology fellows, who can be categorized as internal medicine physicians, researchers also included internists who prescribed biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) to more than 10 patients a year.

The count also included APPs, both nurse practitioners (NPs) and physician assistants (PAs), who were attached to practices with only rheumatologists, internists, or one other specialty. Like physicians, APPs were included in the count if they prescribed more than 10 patients biologic or targeted synthetic DMARDs in a calendar year and billed at least five patients with a rheumatic condition per year.

Researchers also estimated the number of cFTEs for 2019, using a variety of assumptions to generate an upper and lower range.

Different Numbers, Complementary Conclusions

For the 2019 calendar year, researchers counted 5667 clinically active rheumatologists and 379 NPs/PAs.

This represented a 23% increase in rheumatologists and a 141% increase in the number of APPs in the rheumatology workforce from 2009. The active rheumatology workforce increased by about 100 providers per year over the study period, although growth flattened off in more recent years.

The estimated cFTEs for 2019 ranged from 3457 to 5396, which are “comparable” to the projected 2020 cFTE estimates made in the ACR 2015 workforce study: 3888 to 5777 cFTEs.

Battafarano_Daniel_TX_web.jpg

Daniel Battafarano, DO, chair of the ACR Workforce Solutions Committee, agreed with Dr. Mannion that these findings complement each other, telling a similar story “but with different numbers,” he told this news organization. Dr. Battafarano, a professor of medicine at the Uniformed Services University of the Health Sciences, Bethesda, Maryland, led the ACR workforce study.

“Both studies project estimates of rheumatology providers and workforce trends, but neither study can claim accurate numbers of rheumatology providers due to the true limitation of either workforce study model,” he said.

The ACR study began with a higher count of rheumatologists, estimating 6013 practicing providers in 2015, while Dr. Mannion’s team calculated 5474 providers for the same year. The ACR study projected that provider numbers would fall to 5886 by 2020, which was higher than the 2019 count in this most recent study.

Dr. Battafarano noted that the studies also dealt with different time frames: While the ACR study used 2015 data to project trends in 5-year increments, this most recent study looked trends in the previous decade.

“We found an increase over time, although toward the end of our study — from 2019 to 2020 — we did have a drop off in number of providers, so maybe we are finding the beginning of what [the ACR researchers] anticipated, or maybe that will be corrected in the future,” Dr. Dr. Mannion said. “I think that our estimates really coordinate with what they found just using a different data source.”

Geographic Disparities and Solutions

The new study also highlighted the scarcity of rheumatology providers in rural counties, which was also an important take away from the 2015 ACR study. In the new analysis, researchers found that 95% of rheumatology practices were in urban settings, which did not change over the study period. Most counties in the United States had fewer than 30 rheumatologists per 1 million adults, with 93% of rural counties having zero adult rheumatologists. In comparison, 48% of urban counties had no adult rheumatologists.

“There’s not enough people, and they’re in very specific locations,” Dr. Dr. Mannion said. “Both things make it harder for people to get care.”

Dr. Battafarano noted that leveraging APPs would be key to increasing patient access to care moving forward — a resource that has more than doubled in the past decade, according to Dr. Dr. Mannion’s analysis.

“Recruiting a significant number of APPs into rheumatology practice should be a primary goal to increase the rheumatology workforce,” he said. Other potential solutions, he added, include employing telemedicine and educating primary care providers on rheumatic disease to help them comanage these conditions with rheumatologists.

This study was partially funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Mannion was supported by the Rheumatology Research Foundation Norman B. Gaylis, MD Clinical Research Award, paid to her institution. Dr. Battafarano had no relevant disclosures.

A version of this article appeared on Medscape.com.

Patients diagnosed with rheumatoid arthritis (RA) and co-occurring anxiety or depression are less likely to achieve low disease activity (LDA) and better symptom control after 3 months of treatment, according to new research presented at the at the annual meeting of the Canadian Rheumatology Association.

The findings emphasized the importance of taking a multidisciplinary approach to RA treatment, said presenter Susan Bartlett, PhD, a professor in the Divisions of Clinical Epidemiology, Rheumatology, and Respiratory Epidemiology at McGill University in Montreal, Quebec, Canada.

Bartlett_Susan_CANADA_2_web.jpg

“In the absence of directly addressing anxiety and depression, people are not going to improve to the same extent we hope that they will,” she told this news organization.
 

Symptom Clusters in RA

In her research, presented on February 29, Dr. Bartlett explored how certain symptom clusters in RA predicted prognosis.

Symptom clusters are related symptoms that occur together and can be associated with worse outcomes than one symptom alone. Symptom science has been a growing interest in precision medicine, particularly for cancer, Dr. Bartlett noted, and this same approach could help pinpoint RA subtypes, disease trajectories, and personalized treatment.

In the study, Dr. Bartlett and colleagues used data from the Canadian Early Arthritis Cohort (CATCH), a multisite prospective research study following individuals with new-onset RA. They identified patients starting methotrexate (MTX) therapy who also had clinical and patient-reported outcome measures available. Individuals included in the analysis may have also been taking additional disease-modifying antirheumatic drugs beyond MTX.

Across the 310 selected individuals, researchers identified four key symptoms: Pain, fatigue, anxiety, and depression. Pain and fatigue were defined as physical symptoms, while anxiety and depression were classified as emotional symptoms. Results showed that the patients could be sorted into four distinct symptom clusters: Minimal symptoms (12%), mild physical and emotional symptoms (11%), moderate to severe pain and fatigue (40%), and moderate to severe physical and emotional symptoms (37%).

Researchers then followed patients during the first 6 months of treatment to evaluate if patients’ symptoms improved.

Symptom improvement mostly occurred during the first 3 months of treatment and remained consistent at 6 months. Overall, patients with moderate to severe emotional symptoms had a worse prognosis and were less likely to achieve milder symptoms than those who had only pain and fatigue or mild emotional symptoms. While 64% of patients in the moderate to severe physical symptoms group achieved minimal symptoms after 3 months of treatment, only 13% of patients with moderate to severe physical and emotional systems reported minimal symptoms during this same time frame.

The study builds on previous work that “suggests that there are different factors that we can identify around the time of diagnosis that point to how well a person is likely to respond,” Dr. Bartlett added. “What our work is showing pretty clearly [is that] the presence of anxiety and depression is one of those important markers.”
 

Patients With Depression Report Worse Disease Activity

In a related study, researchers from the University of Ottawa explored how depression in RA affected subjective and objective disease measures.

The study included patients from the Ottawa Rheumatology Comprehensive Treatment and Assessment (ORCHESTRA) clinic at The Ottawa Hospital, Ottawa, Ontario, Canada, which sees patients with inflammatory arthritis who are starting biologic therapy or switching to another biologic. The clinic is designed to take a more comprehensive approach to managing inflammatory arthritis, including addressing comorbidities such as cardiac disease, depression, and cancer. Patients seen at the clinic can opt to be included in the ORCHESTRA cohort to be a part of ongoing research.

From this cohort, researchers identified 98 patients with RA. At enrollment, patients were screened for depression using patient health questionnaire scores and asked about duration of morning stiffness and tender joint counts. Swollen joint counts, ultrasound, and clinical scores were used to evaluate disease activity.

In the study group, 47 patients had no depression, 21 patients had mild depression, and 30 patients had moderate to severe depression. Researchers found that subjective disease measures, including visual analog pain scale, health assessment questionnaire, and disease activity score in 28 joints were all higher in patients with depression; however, depression did not appear to affect objective disease measures, such as the Global OMERACT-EULAR Synovitis Score or Doppler scores.

While there is a known link between inflammation and depression, these findings suggest that depression is “a concomitant comorbidity just like cardiovascular disease, just like fibromyalgia, just like some other comorbidity that also needs to be addressed in its own right to improve the outcomes,” noted Elliot Hepworth, MD, a rheumatologist and ORCHESTRA clinic lead at The Ottawa Hospital, in an interview.

Dr. Hepworth presented the findings on March 1.

Hepworth_Elliot_CANADA_web.jpg

The data also suggested that patients with depression had poorer outcomes. For the 79 patients who had 3-month follow-up visit data, 43.9% of patients with no or mild depression achieved LDA and remission compared with 21.7% of patients with moderate to severe depression, though this difference was not statistically significant (P = .064). There was a similar trend for the 39 patients with 6-month follow-up data: Only 20% of patients with moderate to severe depression had reached LDA and remission compared with 37.9% of patients with no or mild depression (P = .445). The researchers noted this could be an issue with a smaller sample size.

“Every time more patients get added we approach closer to significance,” Dr. Hepworth added.
 

Some Disagreement, Same Takeaway

Commenting on the Ottawa study, Dr. Bartlett was skeptical of the conclusion that depression may not directly influence disease activity. “There’s just too much good evidence these days that [depression] very much coexists with worse disease activity,” she said. “It is not in the person’s head.”

Dr. Hepworth added that patient-reported outcomes are important for clinicians to address during treatment.

“There’s the tender joints, there’s the pain, there’s the fatigue, there’s the patient global assessment, which are subjective,” he said, “but that does not mean that they are not important. Those are important to the patient: That is how they’re living their life, and that is how they’re experiencing their disease.”

This is why efforts to treat depression in patients with RA such as cognitive behavioral therapy are so important, he said, to which Dr. Bartlett agreed.

“A comprehensive approach is required, which includes addressing depression,” she said. Otherwise, data show “that people just never make it to remission.”

The studies looked at different patient populations but ultimately complement each other, added Sibel Aydin, MD, a professor of medicine in the Division of Rheumatology at the University of Ottawa, Ottawa, Ontario, Canada, and senior author of the Ottawa study.

Aydin_Sibel_CANADA_web.jpg

“Two different cohorts with different patient populations still reached the same result,” she said. “If you don’t address the emotional aspect, you are not going to achieve the good outcomes.”

“It’s remarkable when you have two independent researchers coming to the same conclusion without ever talking to each other,” added Dr. Hepworth. “That really shows that this is something that’s pervasive, and it’s not just within our patient population.”

CATCH is funded by unrestricted research grants from programs with Pfizer, AbbVie, Roche, Sandoz, Fresenius Kabi, Organon, Viatris, JAMP, and Celltrion. Dr. Bartlett is president of the PROMIS Health Organization. She is a member of speakers bureaus or has consulted for Pfizer, Sandoz, Merck, Janssen, and Organon. Dr. Hepworth and Dr. Aydin declared no conflicts of interest.

A version of this article appeared on Medscape.com .

Patients diagnosed with rheumatoid arthritis (RA) and co-occurring anxiety or depression are less likely to achieve low disease activity (LDA) and better symptom control after 3 months of treatment, according to new research presented at the at the annual meeting of the Canadian Rheumatology Association.

The findings emphasized the importance of taking a multidisciplinary approach to RA treatment, said presenter Susan Bartlett, PhD, a professor in the Divisions of Clinical Epidemiology, Rheumatology, and Respiratory Epidemiology at McGill University in Montreal, Quebec, Canada.

Bartlett_Susan_CANADA_2_web.jpg

“In the absence of directly addressing anxiety and depression, people are not going to improve to the same extent we hope that they will,” she told this news organization.
 

Symptom Clusters in RA

In her research, presented on February 29, Dr. Bartlett explored how certain symptom clusters in RA predicted prognosis.

Symptom clusters are related symptoms that occur together and can be associated with worse outcomes than one symptom alone. Symptom science has been a growing interest in precision medicine, particularly for cancer, Dr. Bartlett noted, and this same approach could help pinpoint RA subtypes, disease trajectories, and personalized treatment.

In the study, Dr. Bartlett and colleagues used data from the Canadian Early Arthritis Cohort (CATCH), a multisite prospective research study following individuals with new-onset RA. They identified patients starting methotrexate (MTX) therapy who also had clinical and patient-reported outcome measures available. Individuals included in the analysis may have also been taking additional disease-modifying antirheumatic drugs beyond MTX.

Across the 310 selected individuals, researchers identified four key symptoms: Pain, fatigue, anxiety, and depression. Pain and fatigue were defined as physical symptoms, while anxiety and depression were classified as emotional symptoms. Results showed that the patients could be sorted into four distinct symptom clusters: Minimal symptoms (12%), mild physical and emotional symptoms (11%), moderate to severe pain and fatigue (40%), and moderate to severe physical and emotional symptoms (37%).

Researchers then followed patients during the first 6 months of treatment to evaluate if patients’ symptoms improved.

Symptom improvement mostly occurred during the first 3 months of treatment and remained consistent at 6 months. Overall, patients with moderate to severe emotional symptoms had a worse prognosis and were less likely to achieve milder symptoms than those who had only pain and fatigue or mild emotional symptoms. While 64% of patients in the moderate to severe physical symptoms group achieved minimal symptoms after 3 months of treatment, only 13% of patients with moderate to severe physical and emotional systems reported minimal symptoms during this same time frame.

The study builds on previous work that “suggests that there are different factors that we can identify around the time of diagnosis that point to how well a person is likely to respond,” Dr. Bartlett added. “What our work is showing pretty clearly [is that] the presence of anxiety and depression is one of those important markers.”
 

Patients With Depression Report Worse Disease Activity

In a related study, researchers from the University of Ottawa explored how depression in RA affected subjective and objective disease measures.

The study included patients from the Ottawa Rheumatology Comprehensive Treatment and Assessment (ORCHESTRA) clinic at The Ottawa Hospital, Ottawa, Ontario, Canada, which sees patients with inflammatory arthritis who are starting biologic therapy or switching to another biologic. The clinic is designed to take a more comprehensive approach to managing inflammatory arthritis, including addressing comorbidities such as cardiac disease, depression, and cancer. Patients seen at the clinic can opt to be included in the ORCHESTRA cohort to be a part of ongoing research.

From this cohort, researchers identified 98 patients with RA. At enrollment, patients were screened for depression using patient health questionnaire scores and asked about duration of morning stiffness and tender joint counts. Swollen joint counts, ultrasound, and clinical scores were used to evaluate disease activity.

In the study group, 47 patients had no depression, 21 patients had mild depression, and 30 patients had moderate to severe depression. Researchers found that subjective disease measures, including visual analog pain scale, health assessment questionnaire, and disease activity score in 28 joints were all higher in patients with depression; however, depression did not appear to affect objective disease measures, such as the Global OMERACT-EULAR Synovitis Score or Doppler scores.

While there is a known link between inflammation and depression, these findings suggest that depression is “a concomitant comorbidity just like cardiovascular disease, just like fibromyalgia, just like some other comorbidity that also needs to be addressed in its own right to improve the outcomes,” noted Elliot Hepworth, MD, a rheumatologist and ORCHESTRA clinic lead at The Ottawa Hospital, in an interview.

Dr. Hepworth presented the findings on March 1.

Hepworth_Elliot_CANADA_web.jpg

The data also suggested that patients with depression had poorer outcomes. For the 79 patients who had 3-month follow-up visit data, 43.9% of patients with no or mild depression achieved LDA and remission compared with 21.7% of patients with moderate to severe depression, though this difference was not statistically significant (P = .064). There was a similar trend for the 39 patients with 6-month follow-up data: Only 20% of patients with moderate to severe depression had reached LDA and remission compared with 37.9% of patients with no or mild depression (P = .445). The researchers noted this could be an issue with a smaller sample size.

“Every time more patients get added we approach closer to significance,” Dr. Hepworth added.
 

Some Disagreement, Same Takeaway

Commenting on the Ottawa study, Dr. Bartlett was skeptical of the conclusion that depression may not directly influence disease activity. “There’s just too much good evidence these days that [depression] very much coexists with worse disease activity,” she said. “It is not in the person’s head.”

Dr. Hepworth added that patient-reported outcomes are important for clinicians to address during treatment.

“There’s the tender joints, there’s the pain, there’s the fatigue, there’s the patient global assessment, which are subjective,” he said, “but that does not mean that they are not important. Those are important to the patient: That is how they’re living their life, and that is how they’re experiencing their disease.”

This is why efforts to treat depression in patients with RA such as cognitive behavioral therapy are so important, he said, to which Dr. Bartlett agreed.

“A comprehensive approach is required, which includes addressing depression,” she said. Otherwise, data show “that people just never make it to remission.”

The studies looked at different patient populations but ultimately complement each other, added Sibel Aydin, MD, a professor of medicine in the Division of Rheumatology at the University of Ottawa, Ottawa, Ontario, Canada, and senior author of the Ottawa study.

Aydin_Sibel_CANADA_web.jpg

“Two different cohorts with different patient populations still reached the same result,” she said. “If you don’t address the emotional aspect, you are not going to achieve the good outcomes.”

“It’s remarkable when you have two independent researchers coming to the same conclusion without ever talking to each other,” added Dr. Hepworth. “That really shows that this is something that’s pervasive, and it’s not just within our patient population.”

CATCH is funded by unrestricted research grants from programs with Pfizer, AbbVie, Roche, Sandoz, Fresenius Kabi, Organon, Viatris, JAMP, and Celltrion. Dr. Bartlett is president of the PROMIS Health Organization. She is a member of speakers bureaus or has consulted for Pfizer, Sandoz, Merck, Janssen, and Organon. Dr. Hepworth and Dr. Aydin declared no conflicts of interest.

A version of this article appeared on Medscape.com .

Patients diagnosed with rheumatoid arthritis (RA) and co-occurring anxiety or depression are less likely to achieve low disease activity (LDA) and better symptom control after 3 months of treatment, according to new research presented at the at the annual meeting of the Canadian Rheumatology Association.

The findings emphasized the importance of taking a multidisciplinary approach to RA treatment, said presenter Susan Bartlett, PhD, a professor in the Divisions of Clinical Epidemiology, Rheumatology, and Respiratory Epidemiology at McGill University in Montreal, Quebec, Canada.

Bartlett_Susan_CANADA_2_web.jpg

“In the absence of directly addressing anxiety and depression, people are not going to improve to the same extent we hope that they will,” she told this news organization.
 

Symptom Clusters in RA

In her research, presented on February 29, Dr. Bartlett explored how certain symptom clusters in RA predicted prognosis.

Symptom clusters are related symptoms that occur together and can be associated with worse outcomes than one symptom alone. Symptom science has been a growing interest in precision medicine, particularly for cancer, Dr. Bartlett noted, and this same approach could help pinpoint RA subtypes, disease trajectories, and personalized treatment.

In the study, Dr. Bartlett and colleagues used data from the Canadian Early Arthritis Cohort (CATCH), a multisite prospective research study following individuals with new-onset RA. They identified patients starting methotrexate (MTX) therapy who also had clinical and patient-reported outcome measures available. Individuals included in the analysis may have also been taking additional disease-modifying antirheumatic drugs beyond MTX.

Across the 310 selected individuals, researchers identified four key symptoms: Pain, fatigue, anxiety, and depression. Pain and fatigue were defined as physical symptoms, while anxiety and depression were classified as emotional symptoms. Results showed that the patients could be sorted into four distinct symptom clusters: Minimal symptoms (12%), mild physical and emotional symptoms (11%), moderate to severe pain and fatigue (40%), and moderate to severe physical and emotional symptoms (37%).

Researchers then followed patients during the first 6 months of treatment to evaluate if patients’ symptoms improved.

Symptom improvement mostly occurred during the first 3 months of treatment and remained consistent at 6 months. Overall, patients with moderate to severe emotional symptoms had a worse prognosis and were less likely to achieve milder symptoms than those who had only pain and fatigue or mild emotional symptoms. While 64% of patients in the moderate to severe physical symptoms group achieved minimal symptoms after 3 months of treatment, only 13% of patients with moderate to severe physical and emotional systems reported minimal symptoms during this same time frame.

The study builds on previous work that “suggests that there are different factors that we can identify around the time of diagnosis that point to how well a person is likely to respond,” Dr. Bartlett added. “What our work is showing pretty clearly [is that] the presence of anxiety and depression is one of those important markers.”
 

Patients With Depression Report Worse Disease Activity

In a related study, researchers from the University of Ottawa explored how depression in RA affected subjective and objective disease measures.

The study included patients from the Ottawa Rheumatology Comprehensive Treatment and Assessment (ORCHESTRA) clinic at The Ottawa Hospital, Ottawa, Ontario, Canada, which sees patients with inflammatory arthritis who are starting biologic therapy or switching to another biologic. The clinic is designed to take a more comprehensive approach to managing inflammatory arthritis, including addressing comorbidities such as cardiac disease, depression, and cancer. Patients seen at the clinic can opt to be included in the ORCHESTRA cohort to be a part of ongoing research.

From this cohort, researchers identified 98 patients with RA. At enrollment, patients were screened for depression using patient health questionnaire scores and asked about duration of morning stiffness and tender joint counts. Swollen joint counts, ultrasound, and clinical scores were used to evaluate disease activity.

In the study group, 47 patients had no depression, 21 patients had mild depression, and 30 patients had moderate to severe depression. Researchers found that subjective disease measures, including visual analog pain scale, health assessment questionnaire, and disease activity score in 28 joints were all higher in patients with depression; however, depression did not appear to affect objective disease measures, such as the Global OMERACT-EULAR Synovitis Score or Doppler scores.

While there is a known link between inflammation and depression, these findings suggest that depression is “a concomitant comorbidity just like cardiovascular disease, just like fibromyalgia, just like some other comorbidity that also needs to be addressed in its own right to improve the outcomes,” noted Elliot Hepworth, MD, a rheumatologist and ORCHESTRA clinic lead at The Ottawa Hospital, in an interview.

Dr. Hepworth presented the findings on March 1.

Hepworth_Elliot_CANADA_web.jpg

The data also suggested that patients with depression had poorer outcomes. For the 79 patients who had 3-month follow-up visit data, 43.9% of patients with no or mild depression achieved LDA and remission compared with 21.7% of patients with moderate to severe depression, though this difference was not statistically significant (P = .064). There was a similar trend for the 39 patients with 6-month follow-up data: Only 20% of patients with moderate to severe depression had reached LDA and remission compared with 37.9% of patients with no or mild depression (P = .445). The researchers noted this could be an issue with a smaller sample size.

“Every time more patients get added we approach closer to significance,” Dr. Hepworth added.
 

Some Disagreement, Same Takeaway

Commenting on the Ottawa study, Dr. Bartlett was skeptical of the conclusion that depression may not directly influence disease activity. “There’s just too much good evidence these days that [depression] very much coexists with worse disease activity,” she said. “It is not in the person’s head.”

Dr. Hepworth added that patient-reported outcomes are important for clinicians to address during treatment.

“There’s the tender joints, there’s the pain, there’s the fatigue, there’s the patient global assessment, which are subjective,” he said, “but that does not mean that they are not important. Those are important to the patient: That is how they’re living their life, and that is how they’re experiencing their disease.”

This is why efforts to treat depression in patients with RA such as cognitive behavioral therapy are so important, he said, to which Dr. Bartlett agreed.

“A comprehensive approach is required, which includes addressing depression,” she said. Otherwise, data show “that people just never make it to remission.”

The studies looked at different patient populations but ultimately complement each other, added Sibel Aydin, MD, a professor of medicine in the Division of Rheumatology at the University of Ottawa, Ottawa, Ontario, Canada, and senior author of the Ottawa study.

Aydin_Sibel_CANADA_web.jpg

“Two different cohorts with different patient populations still reached the same result,” she said. “If you don’t address the emotional aspect, you are not going to achieve the good outcomes.”

“It’s remarkable when you have two independent researchers coming to the same conclusion without ever talking to each other,” added Dr. Hepworth. “That really shows that this is something that’s pervasive, and it’s not just within our patient population.”

CATCH is funded by unrestricted research grants from programs with Pfizer, AbbVie, Roche, Sandoz, Fresenius Kabi, Organon, Viatris, JAMP, and Celltrion. Dr. Bartlett is president of the PROMIS Health Organization. She is a member of speakers bureaus or has consulted for Pfizer, Sandoz, Merck, Janssen, and Organon. Dr. Hepworth and Dr. Aydin declared no conflicts of interest.

A version of this article appeared on Medscape.com .

The US Food and Drug Administration (FDA) has approved the biosimilar tocilizumab-aazg (Tyenne), Fresenius Kabi, the drug’s manufacturer, announced on March 7.

This is the second tocilizumab biosimilar approved by the regulatory agency and the first to be approved in both intravenous (IV) and subcutaneous formulations that are available with the reference product, Actemra, the company said in a press release. 

fda_icon2_web.jpg

Tocilizumab-aazg is an interleukin-6 (IL-6) receptor antagonist indicated for:

• Adults with moderate to severe rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs
• Adults with giant cell arteritis
• Patients aged 2 years or older with active polyarticular juvenile idiopathic arthritis
• Patients aged 2 years or older with active systemic juvenile idiopathic arthritis

“Fresenius Kabi is leading the way as the first company to receive FDA approval for both IV and subcutaneous formulations of its tocilizumab biosimilar and is available in prefilled syringe, pen injector, and vial presentations,” Fabrice Romanet, senior vice president of innovation and development at Fresenius Kabi Biopharma, said in a statement.

The FDA approved the first tocilizumab biosimilar, manufactured by Biogen, in late September 2023. It is administered by IV infusion.

Tocilizumab-aazg’s approval was based on outcome and safety data from a dozen clinical studies. The drug can be administered via intravenous formulation (20 mg/mL) or subcutaneously via a single-dose 162-mg/0.9-mL prefilled syringe or single-dose prefilled autoinjector. 

The most common side effects for tocilizumab-aazg include upper respiratory tract infections, headache, hypertension, and injection site reactions. The most serious side effects include serious infections, perforation of the stomach or intestines, hepatotoxicity, and changes in certain lab results.

Tocilizumab-aazg has already launched in 10 countries, Fresenius Kabi shared in the press release, and plans to launch in additional countries in 2024 and 2025. It is not clear when tocilizumab-aazg will be made available in the United States.

“In accordance with its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its tocilizumab products in the United States commencing on the license dates, which are confidential,” the company noted.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar tocilizumab-aazg (Tyenne), Fresenius Kabi, the drug’s manufacturer, announced on March 7.

This is the second tocilizumab biosimilar approved by the regulatory agency and the first to be approved in both intravenous (IV) and subcutaneous formulations that are available with the reference product, Actemra, the company said in a press release. 

fda_icon2_web.jpg

Tocilizumab-aazg is an interleukin-6 (IL-6) receptor antagonist indicated for:

• Adults with moderate to severe rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs
• Adults with giant cell arteritis
• Patients aged 2 years or older with active polyarticular juvenile idiopathic arthritis
• Patients aged 2 years or older with active systemic juvenile idiopathic arthritis

“Fresenius Kabi is leading the way as the first company to receive FDA approval for both IV and subcutaneous formulations of its tocilizumab biosimilar and is available in prefilled syringe, pen injector, and vial presentations,” Fabrice Romanet, senior vice president of innovation and development at Fresenius Kabi Biopharma, said in a statement.

The FDA approved the first tocilizumab biosimilar, manufactured by Biogen, in late September 2023. It is administered by IV infusion.

Tocilizumab-aazg’s approval was based on outcome and safety data from a dozen clinical studies. The drug can be administered via intravenous formulation (20 mg/mL) or subcutaneously via a single-dose 162-mg/0.9-mL prefilled syringe or single-dose prefilled autoinjector. 

The most common side effects for tocilizumab-aazg include upper respiratory tract infections, headache, hypertension, and injection site reactions. The most serious side effects include serious infections, perforation of the stomach or intestines, hepatotoxicity, and changes in certain lab results.

Tocilizumab-aazg has already launched in 10 countries, Fresenius Kabi shared in the press release, and plans to launch in additional countries in 2024 and 2025. It is not clear when tocilizumab-aazg will be made available in the United States.

“In accordance with its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its tocilizumab products in the United States commencing on the license dates, which are confidential,” the company noted.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar tocilizumab-aazg (Tyenne), Fresenius Kabi, the drug’s manufacturer, announced on March 7.

This is the second tocilizumab biosimilar approved by the regulatory agency and the first to be approved in both intravenous (IV) and subcutaneous formulations that are available with the reference product, Actemra, the company said in a press release. 

fda_icon2_web.jpg

Tocilizumab-aazg is an interleukin-6 (IL-6) receptor antagonist indicated for:

• Adults with moderate to severe rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs
• Adults with giant cell arteritis
• Patients aged 2 years or older with active polyarticular juvenile idiopathic arthritis
• Patients aged 2 years or older with active systemic juvenile idiopathic arthritis

“Fresenius Kabi is leading the way as the first company to receive FDA approval for both IV and subcutaneous formulations of its tocilizumab biosimilar and is available in prefilled syringe, pen injector, and vial presentations,” Fabrice Romanet, senior vice president of innovation and development at Fresenius Kabi Biopharma, said in a statement.

The FDA approved the first tocilizumab biosimilar, manufactured by Biogen, in late September 2023. It is administered by IV infusion.

Tocilizumab-aazg’s approval was based on outcome and safety data from a dozen clinical studies. The drug can be administered via intravenous formulation (20 mg/mL) or subcutaneously via a single-dose 162-mg/0.9-mL prefilled syringe or single-dose prefilled autoinjector. 

The most common side effects for tocilizumab-aazg include upper respiratory tract infections, headache, hypertension, and injection site reactions. The most serious side effects include serious infections, perforation of the stomach or intestines, hepatotoxicity, and changes in certain lab results.

Tocilizumab-aazg has already launched in 10 countries, Fresenius Kabi shared in the press release, and plans to launch in additional countries in 2024 and 2025. It is not clear when tocilizumab-aazg will be made available in the United States.

“In accordance with its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its tocilizumab products in the United States commencing on the license dates, which are confidential,” the company noted.
 

A version of this article appeared on Medscape.com.