{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T22:24:49Z","timestamp":1792448689666,"version":"4.5.0"},"reference-count":32,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2017,1,28]],"date-time":"2017-01-28T00:00:00Z","timestamp":1485561600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004628","name":"MedImmune","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004628","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis & Rheumatology"],"published-print":{"date-parts":[[2017,2]]},"abstract":"\n Objective<\/jats:title>\n To assess the efficacy and safety of anifrolumab, a type I interferon (IFN) receptor antagonist, in a phase IIb, randomized, double\u2010blind, placebo\u2010controlled study of adults with moderate\u2010to\u2010severe systemic lupus erythematosus (SLE).<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Patients (n\u2009=\u2009305) were randomized to receive intravenous anifrolumab (300 mg or 1,000 mg) or placebo, in addition to standard therapy, every 4 weeks for 48 weeks. Randomization was stratified by SLE Disease Activity Index 2000 score (<10 or \u226510), oral corticosteroid dosage (<10 or \u226510 mg\/day), and type I IFN gene signature test status (high or low) based on a 4\u2010gene expression assay. The primary end point was the percentage of patients achieving an SLE Responder Index (SRI[4]) response at week 24 with sustained reduction of oral corticosteroids (<10 mg\/day and less than or equal to the dose at week 1 from week 12 through 24). Other end points (including SRI[4], British Isles Lupus Assessment Group [BILAG]\u2013based Composite Lupus Assessment [BICLA], modified SRI[6], and major clinical response) were assessed at week 52. The primary end point was analyzed in the modified intent\u2010to\u2010treat (ITT) population and type I IFN\u2013high subpopulation. The study result was considered positive if the primary end point was met in either of the 2 study populations. The Type I error rate was controlled at 0.10 (2\u2010sided), within each of the 2 study populations for the primary end point analysis.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The primary end point was met by more patients treated with anifrolumab (34.3% of 99 for 300 mg and 28.8% of 104 for 1,000 mg) than placebo (17.6% of 102) (\n P<\/jats:italic>\n \u2009=\u20090.014 for 300 mg and\n P<\/jats:italic>\n \u2009=\u20090.063 for 1,000 mg, versus placebo), with greater effect size in patients with a high IFN signature at baseline (13.2% in placebo\u2010treated patients versus 36.0% [\n P<\/jats:italic>\n \u2009=\u20090.004] and 28.2% [\n P<\/jats:italic>\n \u2009=\u20090.029]) in patients treated with anifrolumab 300 mg and 1,000 mg, respectively. At week 52, patients treated with anifrolumab achieved greater responses in SRI(4) (40.2% versus 62.6% [\n P<\/jats:italic>\n \u2009<\u20090.001] and 53.8% [\n P<\/jats:italic>\n \u2009=\u20090.043] with placebo, anifrolumab 300 mg, and anifrolumab 1,000 mg, respectively), BICLA (25.7% versus 53.5% [\n P<\/jats:italic>\n \u2009<\u20090.001] and 41.2% [\n P<\/jats:italic>\n \u2009=\u20090.018], respectively), modified SRI(6) (28.4% versus 49.5% [\n P<\/jats:italic>\n \u2009=\u20090.002] and 44.7% [\n P<\/jats:italic>\n \u2009=\u20090.015], respectively), major clinical response (BILAG 2004 C or better in all organ domains from week 24 through week 52) (6.9% versus 19.2% [\n P<\/jats:italic>\n \u2009=\u20090.012] and 17.3% [\n P<\/jats:italic>\n \u2009=\u20090.025], respectively), and several other global and organ\u2010specific end points. Herpes zoster was more frequent in the anifrolumab\u2010treated patients (2.0% with placebo treatment versus 5.1% and 9.5% with anifrolumab 300 mg and 1,000 mg, respectively), as were cases reported as influenza (2.0% versus 6.1% and 7.6%, respectively), in the anifrolumab treatment groups. Incidence of serious adverse events was similar between groups (18.8% versus 16.2% and 17.1%, respectively).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n Anifrolumab substantially reduced disease activity compared with placebo across multiple clinical end points in the patients with moderate\u2010to\u2010severe SLE.<\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/art.39962","type":"journal-article","created":{"date-parts":[[2016,11,7]],"date-time":"2016-11-07T12:53:39Z","timestamp":1478523219000},"page":"376-386","source":"Crossref","is-referenced-by-count":801,"title":["Anifrolumab, an Anti\u2013Interferon\u2010\u03b1 Receptor Monoclonal Antibody, in Moderate\u2010to\u2010Severe Systemic Lupus Erythematosus"],"prefix":"10.1002","volume":"69","author":[{"given":"Richard","family":"Furie","sequence":"first","affiliation":[{"name":"Hofstra Northwell School of Medicine, Northwell Health New York New 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