The three clinical trials below will be presented at ACR Convergence 2022, the American College of Rheumatology’s annual meeting, and published by Wiley online in Arthritis & Rheumatology. Arthritis & Rheumatology publishes the highest quality basic and clinical research related to the rheumatic diseases, encompassing a wide range of areas of investigative activity. ACR Convergence 2022 will showcase cutting-edge and timely topics in rheumatology, as well as the prevention, diagnosis, and treatment of rheumatic diseases and related comorbid conditions.

To request the full text of any these embargoed trials, please contact: Cette adresse email est protégée contre les robots des spammeurs, vous devez activer Javascript pour la voir. . To stay up to date on new research published in Wiley journals, visit the Wiley Newsroom.

Oral deucravacitinib benefits patients with lupus
Tyrosine kinases are enzymes that play central roles in signaling by cytokines involved in the pathogenesis of autoimmune diseases, including lupus. A recent phase 2 clinical trial published by Wiley in Arthritis & Rheumatology has generated promising results for deucravacitinib, an oral inhibitor of tyrosine kinase 2 (TYK2), in patients with active lupus.

In the trial, 363 patients were randomized 1:1:1:1 to placebo or deucravacitinib 3 mg twice daily, 6 mg twice daily, or 12 mg once daily. At week 32, the percentage of patients who experienced a beneficial response (as assessed by various measures of disease activity) was 34% with placebo compared with 58%, 50%, and 45% with the respective deucravacitinib regimens.

Rates of adverse events were similar across groups, except for higher rates of infections and skin-related events, including rash and acne, with deucravacitinib. Rates of serious adverse events were comparable, with no deaths, opportunistic infections, tuberculosis, major adverse cardiovascular events, or thrombotic events reported.

“TYK2 transducer signals a unique set of cytokines that are highly relevant to SLE,” said corresponding author Eric Morand, MBBS, PhD, of Monash University. “These results put TYK2 on the map as a target for lupus and encourage further development of deucravacitinib in this disease."
URL Upon Publication: https://onlinelibrary.wiley.com/doi/10.1002/art.42391

Anesthetics that block nerves around the knee relieve pain in patients with knee osteoarthritis
Results from a recent clinical trial published by Wiley in Arthritis & Rheumatology demonstrate that patients with knee osteoarthritis experience short term pain relief from genicular nerve blocks—or locally injected anesthetics that block nerves around the knee joint.

In the trial, 59 patients were randomized to receive a nerve block or a placebo injection. At baseline and weeks 2, 4, 8 and 12, participants recorded their pain on a scale of 0 to 10.

Patients who received a nerve block reported improvement in pain scores at 2, 4, 8 and 12 weeks, compared with baseline, but with diminishing effects over time. Scores for nerve block versus placebo at baseline, weeks 2, 4, 8 and 12 were: 6.2 versus 5.3, 2.7 versus 4.7, 3.2 versus 5.1, 3.9 versus 4.9, and 4.6 versus 5.1, respectively. Most patients who received the blocks felt they had improved or greatly improved from baseline during the follow up period.
“This study demonstrates that genicular nerve block is an effective short-term therapy for pain management in people with knee osteoarthritis,” said corresponding author Ernst M. Shanahan, BMBS, MPH, MHPE, PhD, FAFOEM, FRACP, of Flinders University, in Australia. “We think it may be a useful treatment option for this group of people, in particular those waiting for, or wishing to defer surgery.”

URL Upon Publication: https://onlinelibrary.wiley.com/doi/10.1002/art.42384

Anifrolumab shows long-term promise in patients with lupus
Type I interferon (IFN) is a powerful immune activator that is present at high levels in the majority of patients with lupus, an autoimmune disease. In Arthritis & Rheumatology, researchers report positive results from the first placebo-controlled long-term trial of anifrolumab—a human monoclonal antibody that targets the type I IFN receptor—in patients with lupus.

In the long-term extension trial of two earlier phase 3 trials, patients continued anifrolumab 300 mg, switched from anifrolumab 150 mg to 300 mg, or were re-randomized from placebo to either anifrolumab 300 mg or continued placebo, administered every 4 weeks, with all patients also receiving standard therapy. Anifrolumab was administered as an intravenous infusion.

Treatment with anifrolumab was well tolerated and had an acceptable long-term safety profile, while sustaining reduction in lupus disease activity and reducing or eliminating the need for steroid medications.

“Managing systemic lupus erythematosus is challenging, due to the complexity of the disease itself, as well as from treatments like oral corticosteroids that can reduce disease activity, but also place a significant burden on patients when used in high doses long-term,” said corresponding author Hussein Al-Mossawi, MD, PhD, of AstraZeneca. “These new data from the TULIP extension trial—the longest placebo-controlled clinical trial performed in lupus to date—support the benefit-risk profile of anifrolumab seen in previous trials, now over four years.”

URL Upon Publication: https://onlinelibrary.wiley.com/doi/10.1002/art.42392
Additional Information
NOTE: The information contained in this release is protected by copyright. Please include journal attribution in all coverage. For more information or to obtain a PDF of any study, please contact Sara Henning-Stout, Cette adresse email est protégée contre les robots des spammeurs, vous devez activer Javascript pour la voir.

Full Citation 1: “Deucravacitinib, a Tyrosine Kinase 2 Inhibitor, in Systemic Lupus Erythematosus: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial.” Eric Morand, Marilyn Pike, Joan T. Merrill, Ronald van Vollenhoven, Victoria P. Werth, Coburn Hobar, Nikolay Delev, Vaishali Shah, Brian Sharkey, Thomas Wegman, Ian Catlett, Subhashis Banerjee, Shalabh Singhal. Arthritis & Rheumatology; Published Online: November 12, 2022 (DOI: 10.1002/art.42391).

URL Upon Publication: https://onlinelibrary.wiley.com/doi/10.1002/art.42391
Author Contact: Cette adresse email est protégée contre les robots des spammeurs, vous devez activer Javascript pour la voir.

Full Citation 2: ”Genicular nerve block for pain management in patients with knee osteoarthritis: A randomised placebo-controlled trial.” Ernst M. Shanahan, Lucinda Robinson, Suellen Lyne, Richard Woodman, Fin Cai, Kokum Dissanayake, Kate Paddick, Giovanna Cheung, and Frank Voyvodic. Arthritis & Rheumatology; Published Online: November 12, 2022 (DOI: 10.1002/art.42384).
URL Upon Publication: https://onlinelibrary.wiley.com/doi/10.1002/art.42384
Author Contact: Cette adresse email est protégée contre les robots des spammeurs, vous devez activer Javascript pour la voir.

Full Citation 3: “A Randomized, Placebo-controlled Phase 3 Extension Trial of the Long-term Safety & Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus.” Kenneth C. Kalunian, Richard Furie, Eric F. Morand, Ian N. Bruce, Susan Manzi, Yoshiya Tanaka, Kevin Winthrop, Ihor Hupka, Lijin (Jinny) Zhang, Shanti Werther, Gabriel Abreu, Micki Hultquist, Raj Tummala, Catharina Lindholm,and Hussein Al-Mossawi. Arthritis & Rheumatology; Published Online: November 12, 2022 (DOI: 10.1002/art.42392).

URL Upon Publication: https://onlinelibrary.wiley.com/doi/10.1002/art.42392
Author Contact: Cette adresse email est protégée contre les robots des spammeurs, vous devez activer Javascript pour la voir.

Media Registration for ACR Convergence: Details on eligibility, deadlines, and how to register can be found visit https://www.rheumatology.org/Annual-Meeting/Press.
About the Journal
Arthritis & Rheumatology is an official journal of the American College of Rheumatology (ACR) and covers all aspects of inflammatory disease. The journal is published by Wiley on behalf of the ACR. For more information, please visit http://wileyonlinelibrary.com/journal/art.

About the American College of Rheumatology
The American College of Rheumatology (www.rheumatology.org) is the professional organization whose members share a dedication to healing, preventing disability, and curing the more than 100 types of arthritis and related disabling and sometimes fatal disorders of the joints, muscles, and bones. Members include practicing physicians, research scientists, nurses, physical and occupational therapists, psychologists, and social workers.
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