{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T06:38:22Z","timestamp":1787639902074,"version":"build-2736575974"},"reference-count":18,"publisher":"The Journal of Rheumatology","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Rheumatol"],"published-print":{"date-parts":[[2013,5]]},"abstract":"<jats:sec><jats:title>Objective.<\/jats:title><jats:p>To characterize the safety of rituximab (RTX) in combination with biologic disease-modifying antirheumatic drugs (DMARD) in patients with rheumatoid arthritis (RA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods.<\/jats:title><jats:p>We did an open-label study of the safety and efficacy of RTX in adult patients with active RA and an inadequate response to \u2265 1 biologic for \u2265 12 weeks (stable dose \u2265 4 weeks). RTX (2 \u00d7 500 mg) was added to patients\u2019 current biologic and nonbiologic DMARD treatment. After 24 weeks, patients with 28-joint Disease Activity Score \u2265 2.6 were eligible for RTX retreatment. The primary endpoint was the proportion of patients developing a serious adverse event (SAE) within 24 weeks of initiating RTX.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results.<\/jats:title><jats:p>Patients (n = 176) received RTX with 18 different biologic\/DMARD combinations. Adalimumab alone (n = 46; 26.1%) or etanercept alone (n = 37; 21.0%) plus RTX were the most common combinations. Overall, 90.9% and 76.1% of patients completed 24 and 48 weeks, respectively; 147 patients (83.5%) received a second course of RTX. Over 24 weeks, 9.1% of patients reported SAE (24.3 events\/100 patient-yrs, 95% CI 15.5\u201338.1). The SAE rate was similar over 48 weeks (22.4 events\/100 patient-yrs, 95% CI 15.9\u201331.5). Four serious infections were reported over 48 weeks (2.7 events\/100 patient-yrs, 95% CI 1.0\u20137.2). No SAE occurred within 24 h of any RTX infusion. Efficacy responses improved numerically at Week 48 compared with Week 24.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion.<\/jats:title><jats:p>The overall safety profile of RTX in combination with 1 other biologic was consistent with that previously reported for RTX plus methotrexate or other nonbiologic DMARD. (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"Clinicaltrials.gov\" ext-link-type=\"uri\" xlink:type=\"simple\">Clinicaltrials.gov<\/jats:ext-link><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT00443651\">NCT00443651<\/jats:ext-link>)<\/jats:p><\/jats:sec>","DOI":"10.3899\/jrheum.120924","type":"journal-article","created":{"date-parts":[[2013,4,2]],"date-time":"2013-04-02T00:59:34Z","timestamp":1364864374000},"page":"599-604","source":"Crossref","is-referenced-by-count":27,"title":["Safety of Rituximab in Combination with Other Biologic Disease-modifying Antirheumatic Drugs in Rheumatoid Arthritis: An Open-label Study"],"prefix":"10.3899","volume":"40","author":[{"given":"William F.C.","family":"Rigby","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip J.","family":"Mease","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ewa","family":"Olech","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Ashby","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Swati","family":"Tole","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2262","published-online":{"date-parts":[[2013,4,1]]},"reference":[{"key":"2018112909313182000_40.5.599.1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2009.182"},{"key":"2018112909313182000_40.5.599.2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199901283400401"},{"key":"2018112909313182000_40.5.599.3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200011303432202"},{"key":"2018112909313182000_40.5.599.4","doi-asserted-by":"publisher","DOI":"10.1002\/art.10697"},{"key":"2018112909313182000_40.5.599.5","doi-asserted-by":"publisher","DOI":"10.1002\/art.20019"},{"key":"2018112909313182000_40.5.599.6","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2007.080002"},{"key":"2018112909313182000_40.5.599.7","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.2010.01099.x"},{"key":"2018112909313182000_40.5.599.8","doi-asserted-by":"publisher","DOI":"10.1002\/art.20221"},{"key":"2018112909313182000_40.5.599.9","doi-asserted-by":"publisher","DOI":"10.1002\/art.22070"},{"key":"2018112909313182000_40.5.599.10","doi-asserted-by":"publisher","DOI":"10.1002\/art.22025"},{"key":"2018112909313182000_40.5.599.11","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2009.119222"},{"key":"2018112909313182000_40.5.599.12","doi-asserted-by":"publisher","DOI":"10.1002\/art.21778"},{"key":"2018112909313182000_40.5.599.13","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2009.119933"},{"key":"2018112909313182000_40.5.599.14","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.090442"},{"key":"2018112909313182000_40.5.599.15","doi-asserted-by":"publisher","DOI":"10.1002\/art.30194"},{"issue":"Suppl","key":"2018112909313182000_40.5.599.16","first-page":"S1660","article-title":"An open-label, prospective study (SUNDIAL) of the safety of rituximab in combination with disease-modifying anti-rheumatic drugs in patients with active rheumatoid arthritis (SUNDIAL) [abstract]","volume":"60","author":"Loveless","year":"2009","journal-title":"Arthritis Rheum"},{"key":"2018112909313182000_40.5.599.17","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.137703"},{"key":"2018112909313182000_40.5.599.18","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.090856"}],"container-title":["The Journal of Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.3899\/jrheum.120924","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2018,11,29]],"date-time":"2018-11-29T18:26:27Z","timestamp":1543515987000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.jrheum.org\/lookup\/doi\/10.3899\/jrheum.120924"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,4,1]]},"references-count":18,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2013,5,1]]},"published-print":{"date-parts":[[2013,5]]}},"alternative-id":["10.3899\/jrheum.120924"],"URL":"https:\/\/doi.org\/10.3899\/jrheum.120924","relation":{},"ISSN":["0315-162X","1499-2752"],"issn-type":[{"value":"0315-162X","type":"print"},{"value":"1499-2752","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,4,1]]}}}