{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T21:02:40Z","timestamp":1791838960318,"version":"4.3.4"},"reference-count":19,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2018,5,25]],"date-time":"2018-05-25T00:00:00Z","timestamp":1527206400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004628","name":"MedImmune","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004628","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":[[2018,7]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the safety and potential efficacy of <jats:styled-content style=\"fixed-case\">AMG<\/jats:styled-content>\u00a0557, a fully human antibody directed against the inducible T cell costimulator ligand (ICOSL) in patients with systemic lupus erythematosus (<jats:styled-content style=\"fixed-case\">SLE<\/jats:styled-content>) with arthritis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this phase Ib, randomized, double\u2010blind, placebo\u2010controlled study, patients received <jats:styled-content style=\"fixed-case\">AMG<\/jats:styled-content>\u00a0557 210 mg (n = 10) or placebo (n = 10) weekly for 3 weeks, then every other week for 10 additional doses. The corticosteroid dosage was tapered to \u22647.5 mg\/day by day 85, and immunosuppressants were discontinued by day 29. Primary end points on day 169 were safety, immunogenicity, the Lupus Arthritis Response Index (<jats:styled-content style=\"fixed-case\">LARI<\/jats:styled-content>; defined by a reduction in the tender and swollen joint counts), \u22651\u2010letter improvement in the musculoskeletal domain of the British Isles Lupus Assessment Group (<jats:styled-content style=\"fixed-case\">BILAG<\/jats:styled-content>) index, and medication discontinuation. The secondary\/exploratory end points were changes in the tender and swollen joint counts, <jats:styled-content style=\"fixed-case\">BILAG<\/jats:styled-content> index scores (musculoskeletal, global), and the Systemic Lupus Erythematosus Disease Activity Index (<jats:styled-content style=\"fixed-case\">SLEDAI<\/jats:styled-content>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The incidence of adverse events, most of which were mild, was similar between groups. <jats:styled-content style=\"fixed-case\">LARI<\/jats:styled-content> responses occurred in 3 of 10 patients receiving <jats:styled-content style=\"fixed-case\">AMG<\/jats:styled-content>\u00a0557 and 1 of 10 patients receiving placebo (<jats:italic>P =<\/jats:italic> 0.58). More patients in the <jats:styled-content style=\"fixed-case\">AMG<\/jats:styled-content>\u00a0557 group achieved a \u22654\u2010point improvement in the <jats:styled-content style=\"fixed-case\">SLEDAI<\/jats:styled-content> score on day 169 (7 of 10 patients) compared with the placebo group (2 of 10 patients) (<jats:italic>P =<\/jats:italic> 0.07). Patients treated with <jats:styled-content style=\"fixed-case\">AMG<\/jats:styled-content>\u00a0557 (versus placebo) had greater improvements from baseline in the global <jats:styled-content style=\"fixed-case\">BILAG<\/jats:styled-content> index scores (\u201336.3% versus \u201324.7%) and the <jats:styled-content style=\"fixed-case\">SLEDAI<\/jats:styled-content> score (\u201347.8% versus \u201310.7%) and in tender (\u201322.8% versus \u201313.5%) and swollen (\u201362.1% versus \u20137.8%) joint counts on day 169.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">AMG<\/jats:styled-content>\u00a0557 showed safety and potential efficacy, supporting further evaluation of the clinical efficacy of <jats:styled-content style=\"fixed-case\">ICOSL<\/jats:styled-content> blockade in patients with <jats:styled-content style=\"fixed-case\">SLE<\/jats:styled-content>.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.40479","type":"journal-article","created":{"date-parts":[[2018,3,7]],"date-time":"2018-03-07T12:44:12Z","timestamp":1520426652000},"page":"1071-1076","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":77,"title":["Brief Report: A Randomized, Double\u2010Blind, Parallel\u2010Group, Placebo\u2010Controlled, Multiple\u2010Dose Study to Evaluate <scp>AMG<\/scp> 557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis"],"prefix":"10.1002","volume":"70","author":[{"given":"Laurence E.","family":"Cheng","sequence":"first","affiliation":[{"name":"Amgen Thousand Oaks California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zahir","family":"Amoura","sequence":"additional","affiliation":[{"name":"H\u00f4pital Piti\u00e9\u2010Salp\u00eatri\u00e8re Paris 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