{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T21:32:50Z","timestamp":1792186370967,"version":"4.4.0"},"reference-count":43,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2023,11,29]],"date-time":"2023-11-29T00:00:00Z","timestamp":1701216000000},"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":[[2023,12]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Obexelimab is an investigational, bifunctional, noncytolytic monoclonal antibody that binds CD19 and FcyRIIb to inhibit B cells, plasmablasts, and plasma cells. This trial evaluated the efficacy and safety of obexelimab in the treatment of patients with systemic lupus erythematosus (SLE).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>During screening, patients with active, non\u2013organ\u2010threatening SLE received corticosteroid injections to ameliorate symptoms while immunosuppressants were withdrawn (\u226410 mg\/day prednisone equivalent and \u2264400 mg\/day hydroxychloroquine allowed). Patients with improved disease activity were randomized 1:1 to obexelimab 5 mg\/kg intravenously or placebo once every 2\u2009weeks until week 32 or loss of improvement (LOI).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In this study, 104 patients were randomized. Analysis of the primary endpoint, proportion of patients reaching week 32 without LOI, used an efficacy\u2010evaluable (EE) population defined as patients who completed the study or withdrew for flare or treatment\u2010related toxicity. This endpoint did not reach statistical significance: 21 of 50 obexelimab\u2010treated patients (42.0%) versus 12 of 42 patients (28.6%) treated with a placebo (<jats:italic>P =<\/jats:italic> 0.183). Time to LOI was increased in obexelimab\u2010treated patients versus patients treated with a placebo in the EE (hazard ratio [HR] 0.53, <jats:italic>P =<\/jats:italic> 0.025) and intention\u2010to\u2010treat (HR 0.59, <jats:italic>P =<\/jats:italic> 0.062) populations. In obexelimab\u2010treated patients, B cells decreased approximately 50%, and trough concentration and inclusion in baseline gene expression clusters with high B cell pathway modules were associated with increased time to LOI. Obexelimab was associated with infusion reactions but was generally safe and well\u2010tolerated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Although the primary endpoint was not reached, secondary analysis showed time to LOI was significantly increased in obexelimab\u2010treated patients, and analysis of patient subsets defined by gene expression patterns at baseline suggests a responding subpopulation.<\/jats:p><jats:p><jats:boxed-text content-type=\"graphic\" position=\"anchor\"><jats:graphic xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" mimetype=\"image\/png\" position=\"anchor\" specific-use=\"enlarged-web-image\" xlink:href=\"graphic\/art42652-toc-0001-m.png\"><jats:alt-text>image<\/jats:alt-text><\/jats:graphic><\/jats:boxed-text><\/jats:p><\/jats:sec>","DOI":"10.1002\/art.42652","type":"journal-article","created":{"date-parts":[[2023,7,17]],"date-time":"2023-07-17T12:39:57Z","timestamp":1689597597000},"page":"2185-2194","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":68,"title":["Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway <scp>Co\u2010Expression<\/scp> Patterns: A <scp>Double\u2010Blind<\/scp>, Randomized, <scp>Placebo\u2010Controlled<\/scp>, Phase 2 Trial"],"prefix":"10.1002","volume":"75","author":[{"given":"Joan T.","family":"Merrill","sequence":"first","affiliation":[{"name":"Oklahoma Medical Research Foundation  Oklahoma City 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