{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T00:56:51Z","timestamp":1792803411717,"version":"4.5.0"},"reference-count":29,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,1,5]],"date-time":"2025-01-05T00:00:00Z","timestamp":1736035200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>The objective of this study was to report 52\u2010week safety and efficacy of ianalumab from phase 2b dose\u2010finding study in patients with Sj\u00f6gren's disease (SjD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients randomly received (1:1:1:1) ianalumab (5, 50, or 300 mg) or placebo subcutaneously every 4 weeks until week 24 (treatment period [TP]1). At week 24, patients on 300\u2009mg were rerandomized to continue 300 mg or receive placebo until week 52 (TP2), patients on placebo were switched to ianalumab 150 mg, and patients on 5 and 50 mg directly entered posttreatment safety follow\u2010up. Patients who discontinued treatment early or completed treatment entered safety follow\u2010up (\u226520 weeks).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>During TP1, 190 patients were randomized (placebo = 49, 5 mg = 47, 50 mg = 47, 300 mg = 47). Of these 190 patients, 90 (47.4 %; 43 continued 300 mg and 47 received placebo) entered TP2, and 81 of 90 (90.0%) completed the study treatment. By week 52, efficacy was sustained in patients who continued 300 mg in TP2 (EULAR Sj\u00f6gren's Syndrome Disease Activity Index, EULAR Sj\u00f6gren's Syndrome Patient Reported Index, patient global assessment, and physician global assessment change from week 24: \u22121.45, \u22120.46, \u22124.69, and \u22126.86, respectively). Stimulated salivary flow rates and autoantibody levels numerically improved in the 300 mg group. Treatment\u2010emergent adverse events were not dose\u2010dependent, except for injection\u2010site reactions. Cases of decreased neutrophil counts (Common Terminology Criteria for Adverse Events v4.03 grade 3 according to laboratory listings) were observed in three patients during the posttreatment follow\u2010up, occurring at 3.5, 5.5, and 3 months, after the last ianalumab administration. None were associated with infection except one incidental finding of asymptomatic cytomegalovirus infection (IgM\u2010positive).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In patients with SjD, ianalumab 300 mg demonstrated sustained efficacy through week 52 and a favorable safety profile up to two years of follow\u2010up.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.43059","type":"journal-article","created":{"date-parts":[[2024,11,18]],"date-time":"2024-11-18T22:03:17Z","timestamp":1731967397000},"page":"560-570","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":34,"title":["Safety and Efficacy of Ianalumab in Patients With Sj\u00f6gren's Disease: 52\u2010Week Results From a Randomized, Placebo\u2010Controlled, Phase 2b Dose\u2010Ranging 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