{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T17:53:21Z","timestamp":1790790801474,"version":"4.1.0"},"reference-count":36,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T00:00:00Z","timestamp":1771286400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T00:00:00Z","timestamp":1771286400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp;amp; Rheumatology"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The multinational, phase 3, double\u2010blind, placebo\u2010controlled TULIP\u2010SC trial evaluated the efficacy and safety of subcutaneous anifrolumab in adults who have moderate to severe systemic lupus erythematosus (SLE) activity, despite receiving standard therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adults with SLE received subcutaneous anifrolumab 120\u2009mg or placebo once weekly for 52\u2009weeks (1:1 randomization). Only the primary endpoint (treatment difference in BILAG\u2010based Composite Lupus Assessment [BICLA] response at 52\u2009weeks) was formally tested in a preplanned interim analysis; key secondary and other endpoints were tested in the full analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      At the interim analysis (220 patients, anifrolumab: n\u00a0=\u00a0109; placebo: n\u00a0=\u00a0111), the primary endpoint was met (anifrolumab vs placebo: 59.4% vs 43.9%; BICLA response difference\u200915.5%, 95% confidence interval [95% CI] 2.3\u201328.6;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.0211). The full analysis included 367 patients (anifrolumab: n\u00a0=\u00a0184; placebo: n\u00a0=\u00a0183). Versus placebo, more patients treated with anifrolumab attained a BICLA response while maintaining low\/reduced oral glucocorticoid doses through week 52 (56.2% vs 34.0%; difference 22.3%, 95% CI 12.3\u201332.2;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.0001), and the time to first sustained BICLA response was reduced (hazard ratio 2.2, 95% CI 1.5\u20133.2;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.0001). Treatment differences in week 52 DORIS remission and Low Lupus Disease Activity State attainment rates favored anifrolumab over placebo (14.2%, 95% CI 5.6\u201322.8;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.0012, and 14.1%, 95% CI 4.6\u201323.6;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.0038). The frequencies of serious adverse events were 11.9% with anifrolumab and 10.4% with placebo; the frequencies of herpes zoster were 3.8% and 1.1%, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Consistent with the well\u2010established profile of intravenous anifrolumab, subcutaneous anifrolumab demonstrated significant, clinically meaningful treatment benefits when added to standard therapy, and an acceptable safety profile in patients with moderate to severe SLE.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/art.70041","type":"journal-article","created":{"date-parts":[[2025,12,30]],"date-time":"2025-12-30T07:55:28Z","timestamp":1767081328000},"page":"1258-1267","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: A Randomized, Phase 3 Study"],"prefix":"10.1002","volume":"78","author":[{"given":"Susan","family":"Manzi","sequence":"first","affiliation":[{"name":"Lupus Center of Excellence, Autoimmunity Institute Allegheny Health Network  Pittsburgh Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian N.","family":"Bruce","sequence":"additional","affiliation":[{"name":"Centre for Musculoskeletal Research The University of Manchester  Manchester United Kingdom"},{"name":"Centre for Public Health, Faculty of Medicine, Health, and Life Sciences Queen's University Belfast  Belfast United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9507-3338","authenticated-orcid":false,"given":"Eric F.","family":"Morand","sequence":"additional","affiliation":[{"name":"Centre for Inflammatory Diseases Monash University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6712-1585","authenticated-orcid":false,"given":"Richard","family":"Furie","sequence":"additional","affiliation":[{"name":"Division of Rheumatology Northwell, Great Neck  New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0807-7139","authenticated-orcid":false,"given":"Yoshiya","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Molecular Targeted Therapeutics University of Occupational and Environmental Health  Japan, Kitakyushu Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth C.","family":"Kalunian","sequence":"additional","affiliation":[{"name":"Lupus Center of Excellence, Division of Rheumatology, Autoimmunity, and Inflammation University of California, San Diego School of Medicine  La Jolla California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4597-5023","authenticated-orcid":false,"given":"Anca","family":"Askanase","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Department of Medicine Columbia University College of Physicians and Surgeons  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Puzio","sequence":"additional","affiliation":[{"name":"BioPharmaceuticals R&amp;D, AstraZeneca US  Gaithersburg Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emon","family":"Khan","sequence":"additional","affiliation":[{"name":"BioPharmaceuticals R&amp;D, Late Respiratory and Immunology, AstraZeneca, Academy House  Cambridge United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenny","family":"Wissmar","sequence":"additional","affiliation":[{"name":"BioPharmaceuticals R&amp;D, Late\u2010Stage 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