{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T22:43:21Z","timestamp":1791931401000,"version":"4.3.4"},"reference-count":37,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T00:00:00Z","timestamp":1740096000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008021","name":"Bristol-Myers Squibb Canada","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008021","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Our objective was to evaluate the efficacy and safety of subcutaneous (SC) abatacept and standard of care (SOC) for the treatment of idiopathic inflammatory myopathy (IIM) over 52 weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this randomized, double\u2010blind, placebo\u2010controlled phase III trial, patients with treatment\u2010refractory IIM received SC abatacept (at 125 mg weekly) with SOC (abatacept group) or a placebo with SOC (placebo group). A 24\u2010week double\u2010blind period was followed by an open\u2010label period to assess outcomes from continued therapy with abatacept and initiation with abatacept (placebo\u2010to\u2010abatacept switch group) from 24 to 52 weeks. The primary end point was International Myositis Assessment and Clinical Studies definition of improvement (IMACS DOI) at week 24. Secondary efficacy and safety end points were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 148 (double\u2010blind) and 133 (open\u2010label) patients were treated. Baseline demographics were well\u2010balanced between treatment groups and disease subtypes. At 24 weeks, improvement per IMACS DOI was 56.0% for the abatacept group and 42.5% for the placebo group (<jats:italic>P<\/jats:italic> = 0.083); at 52 weeks, improvement was 69.8% (continued abatacept) and 69.0% (placebo\u2010to\u2010abatacept switch). The IMACS DOI rate at 24 weeks was greater in the nondermatomyositis (non\u2010DM) group (abatacept: 57.1%; placebo: 32.3%; <jats:italic>P<\/jats:italic> = 0.040) than the DM group (abatacept: 55.0%; placebo: 50.0%; <jats:italic>P<\/jats:italic> = 0.679). The observed safety profile was similar in both groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The proportion of patients who met improvement criteria after 24 weeks was similar between abatacept and placebo groups. However, analysis by IIM subtype suggested there may be a sustained benefit of SC abatacept for patients with non\u2010DM subtypes.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.43066","type":"journal-article","created":{"date-parts":[[2024,11,28]],"date-time":"2024-11-28T21:33:08Z","timestamp":1732829588000},"page":"765-776","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Efficacy and Safety of Subcutaneous Abatacept Plus Standard Treatment for Active Idiopathic Inflammatory Myopathy: Phase 3 Randomized Controlled Trial"],"prefix":"10.1002","volume":"77","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7531-8038","authenticated-orcid":false,"given":"Rohit","family":"Aggarwal","sequence":"first","affiliation":[{"name":"University of Pittsburgh  Pittsburgh 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P.","family":"Werth","sequence":"additional","affiliation":[{"name":"Pennsylvania Medical School  Philadelphia Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael A.","family":"Maldonado","sequence":"additional","affiliation":[{"name":"Immunology and Fibrosis Research and Development Bristol Myers Squibb  Princeton New 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