{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T18:43:49Z","timestamp":1793299429403,"version":"4.5.0"},"reference-count":51,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2019,6,7]],"date-time":"2019-06-07T00:00:00Z","timestamp":1559865600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis & Rheumatology"],"published-print":{"date-parts":[[2019,7]]},"abstract":"\n Objective<\/jats:title>\n \n To assess the efficacy and safety of the anti\u2013interleukin\u20101\u03b1\/\u03b2 (anti\u2013\n IL<\/jats:styled-content>\n \u20101\u03b1\/\u03b2) dual variable domain immunoglobulin lutikizumab (\n ABT<\/jats:styled-content>\n \u2010981) in patients with knee osteoarthritis (\n OA<\/jats:styled-content>\n ) and evidence of synovitis.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Patients (n = 350; 347 analyzed) with Kellgren\/Lawrence grade 2\u20133 knee\n OA<\/jats:styled-content>\n and synovitis (determined by magnetic resonance imaging [\n MRI<\/jats:styled-content>\n ] or ultrasound) were randomized to receive placebo or lutikizumab 25, 100, or 200 mg subcutaneously every 2 weeks for 50 weeks. The coprimary end points were change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (\n WOMAC<\/jats:styled-content>\n ) pain score at week 16 and change from baseline in\n MRI<\/jats:styled-content>\n \u2010assessed synovitis at week 26.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The\n WOMAC<\/jats:styled-content>\n pain score at week 16 had improved significantly versus placebo with lutikizumab 100 mg (\n P<\/jats:italic>\n = 0.050) but not with the 25 mg or 200 mg doses. Beyond week 16, the\n WOMAC<\/jats:styled-content>\n pain score was reduced in all groups but was not significantly different between lutikizumab\u2010treated and placebo\u2010treated patients. Changes from baseline in\n MRI<\/jats:styled-content>\n \u2010assessed synovitis at week 26 and other key symptom\u2010 and most structure\u2010related end points at weeks 26 and 52 were not significantly different between the lutikizumab and placebo groups. Injection site reactions, neutropenia, and discontinuations due to neutropenia were more frequent with lutikizumab versus placebo. Reductions in neutrophil and high\u2010sensitivity C\u2010reactive protein levels plateaued with lutikizumab 100 mg, with further reductions not observed with the 200 mg dose. Immunogenic response to lutikizumab did not meaningfully affect systemic lutikizumab concentrations.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n The limited improvement in the\n WOMAC<\/jats:styled-content>\n pain score and the lack of synovitis improvement with lutikizumab, together with published results from trials of other\n IL<\/jats:styled-content>\n \u20101 inhibitors, suggest that\n IL<\/jats:styled-content>\n \u20101 inhibition is not an effective analgesic\/antiinflammatory therapy in most patients with knee\n OA<\/jats:styled-content>\n and associated synovitis.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/art.40840","type":"journal-article","created":{"date-parts":[[2019,1,17]],"date-time":"2019-01-17T13:53:59Z","timestamp":1547733239000},"page":"1056-1069","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":222,"title":["A Phase\n II<\/scp>\n Trial of Lutikizumab, an Anti\u2013Interleukin\u20101\u03b1\/\u03b2 Dual Variable Domain Immunoglobulin, in Knee Osteoarthritis Patients With Synovitis"],"prefix":"10.1002","volume":"71","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6630-1477","authenticated-orcid":false,"given":"Roy M.","family":"Fleischmann","sequence":"first","affiliation":[{"name":"University of Texas Southwestern Medical Center Dallas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henning","family":"Bliddal","sequence":"additional","affiliation":[{"name":"Bispebjerg\u2010Frederiksberg Hospital and University of Copenhagen Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9821-7635","authenticated-orcid":false,"given":"Francisco J.","family":"Blanco","sequence":"additional","affiliation":[{"name":"Hospital Universitario A Coru\u00f1a La Coru\u00f1a Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas J.","family":"Schnitzer","sequence":"additional","affiliation":[{"name":"Northwestern University Feinberg School of Medicine Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Peterfy","sequence":"additional","affiliation":[{"name":"Spire Sciences, Inc. 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