{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T18:15:37Z","timestamp":1793643337766,"version":"4.5.1"},"reference-count":40,"publisher":"The Journal of Rheumatology","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Rheumatol"],"published-print":{"date-parts":[[2010,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objective.<\/jats:title>\n                    <jats:p>To evaluate the longterm safety of rituximab in clinical trials in patients with rheumatoid arthritis (RA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods.<\/jats:title>\n                    <jats:p>Pooled analysis of safety data, including adverse events (AE) and infections, from patients treated with rituximab in combination with methotrexate in a global clinical trial program.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results.<\/jats:title>\n                    <jats:p>A total of 2578 patients with RA received at least 1 course of rituximab. Safety analyses were based on 5013 patient-years of rituximab exposure. The most frequent AE was infusion-related reactions (25% of patients during the first infusion of Course 1). Less than 1% of infusion-related reactions were considered serious. Rates of AE and serious AE (SAE; 17.85 events\/100 patient-yrs, 95% CI 16.72, 19.06) were stable following each course. The overall serious infection rate was 4.31\/100 patient-years (95% CI 3.77, 4.92). Infections and serious infections over time remained stable across 5 courses at 4\u20136 events\/100 patient-years. Compared with other patients with RA and with the general US population, there was no increased risk of malignancy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion.<\/jats:title>\n                    <jats:p>In this longterm safety update in RA clinical trial patients, rituximab remained well tolerated over multiple courses. SAE and infections remained stable over time and by treatment course.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3899\/jrheum.090856","type":"journal-article","created":{"date-parts":[[2010,1,28]],"date-time":"2010-01-28T22:30:43Z","timestamp":1264717843000},"page":"558-567","source":"Crossref","is-referenced-by-count":262,"title":["Longterm Safety of Patients Receiving Rituximab in Rheumatoid Arthritis Clinical Trials"],"prefix":"10.3899","volume":"37","author":[{"given":"RONALD F.","family":"van VOLLENHOVEN","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"PAUL","family":"EMERY","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"III","given":"CLIFTON O.","family":"BINGHAM","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"EDWARD C.","family":"KEYSTONE","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"ROY","family":"FLEISCHMANN","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"DANIEL E.","family":"FURST","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"KATHERINE","family":"MACEY","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"MARIANNE","family":"SWEETSER","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"ARIELLA","family":"KELMAN","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"RAVI","family":"RAO","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2262","published-online":{"date-parts":[[2010,1,28]]},"reference":[{"key":"2018112909221089000_37.3.558.1","first-page":"1232","article-title":"Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis","volume":"32","author":"Genovese","year":"2005","journal-title":"J Rheumatol"},{"key":"2018112909221089000_37.3.558.2","doi-asserted-by":"publisher","DOI":"10.1002\/art.20159"},{"key":"2018112909221089000_37.3.558.3","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2005.043166"},{"key":"2018112909221089000_37.3.558.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2008.01.001"},{"key":"2018112909221089000_37.3.558.5","doi-asserted-by":"publisher","DOI":"10.1001\/jama.295.19.2275"},{"key":"2018112909221089000_37.3.558.6","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keg263"},{"key":"2018112909221089000_37.3.558.7","doi-asserted-by":"publisher","DOI":"10.1002\/art.21675"},{"key":"2018112909221089000_37.3.558.8","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2003.09.039"},{"key":"2018112909221089000_37.3.558.9","doi-asserted-by":"publisher","DOI":"10.1016\/0049-0172(78)90008-2"},{"key":"2018112909221089000_37.3.558.10","doi-asserted-by":"crossref","first-page":"2188","DOI":"10.1182\/blood.V90.6.2188","article-title":"IDEC-C2B8 (Rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin\u2019s lymphoma","volume":"90","author":"Maloney","year":"1997","journal-title":"Blood"},{"key":"2018112909221089000_37.3.558.11","doi-asserted-by":"publisher","DOI":"10.1002\/art.22025"},{"key":"2018112909221089000_37.3.558.12","doi-asserted-by":"publisher","DOI":"10.1002\/art.21778"},{"key":"2018112909221089000_37.3.558.13","doi-asserted-by":"publisher","DOI":"10.1002\/art.23059"},{"key":"2018112909221089000_37.3.558.14","doi-asserted-by":"crossref","unstructured":"Sell S Max EE . All about B cells. In: Immunology, immunopathology, and immunity. Herndon, VA: ASM Press; 2001:101.","DOI":"10.1128\/9781555818012.ch4"},{"key":"2018112909221089000_37.3.558.15","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa032534"},{"key":"2018112909221089000_37.3.558.16","unstructured":"Emery P Rigby WF Combe B Latinis K Szczepanski LJ Roschmann RA Efficacy and safety of rituximab (RTX) as first line biologic therapy in patients with active rheumatoid arthritis. Results of a phase III randomized, controlled study (SERENE) [abstract]. Arthritis Rheum 2008;Suppl 58:S302."},{"key":"2018112909221089000_37.3.558.17","unstructured":"Rubbert-Roth A Tak PP Bombardieri S Zerbini C Tremblay J Carre\u00f1o L Efficacy and safety of various dosing regimens of rituximab in patients with active RA: results of a phase III randomized study (MIRROR) [abstract]. Arthritis Rheum 2008;Suppl 58:S301."},{"key":"2018112909221089000_37.3.558.18","unstructured":"Mease PJ Cohen S Gaylis NB Chubick A Kaell AT Greenwald M Efficacy, safety, and dose frequency of retreatment with rituximab in RA: results from a randomized controlled trial (SUNRISE) [abstract]. Arthritis Rheum 2008;Suppl 58:S619."},{"key":"2018112909221089000_37.3.558.19","unstructured":"Bingham C Looney R Deodhar A Halsey N Greenwald M Codding C Results from a controlled clinical trial (SIERRA) to evaluate primary and recall responses to immunizations in RA patients treated with rituximab [abstract]. Arthritis Rheum 2008;Suppl 58:S900."},{"key":"2018112909221089000_37.3.558.20","unstructured":"Keystone EC Fleischmann R Emery P Chubick A Dougados MR Baldassare AR Efficacy and safety of repeat treatment courses of rituximab (RTX) in RA patients with inadequate response to tumor necrosis factor inhibitors; long-term experience from the REFLEX study [abstract]. Arthritis Rheum 2008;Suppl 58:S303."},{"key":"2018112909221089000_37.3.558.21","unstructured":"Centers for Disease Control\/National Center for Health Statistics . National Vital Statistics Reports. Deaths: Final data for 2005. [Internet. Accessed Dec 10, 2009.] Available from: http:\/\/www.cdc.gov\/nchs\/data\/nvsr\/nvsr56\/nvsr56_10.pdf"},{"key":"2018112909221089000_37.3.558.22","first-page":"854","article-title":"Etanercept treatment in adults with established rheumatoid arthritis: 7 years of clinical experience","volume":"33","author":"Moreland","year":"2006","journal-title":"J Rheumatol"},{"key":"2018112909221089000_37.3.558.23","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2007.074773"},{"key":"2018112909221089000_37.3.558.24","doi-asserted-by":"publisher","DOI":"10.1002\/art.23397"},{"key":"2018112909221089000_37.3.558.25","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kel328"},{"key":"2018112909221089000_37.3.558.26","doi-asserted-by":"publisher","DOI":"10.1002\/art.23112"},{"key":"2018112909221089000_37.3.558.27","doi-asserted-by":"publisher","DOI":"10.1007\/s11940-008-0019-8"},{"key":"2018112909221089000_37.3.558.28","doi-asserted-by":"publisher","DOI":"10.1001\/archneur.65.11.1538"},{"key":"2018112909221089000_37.3.558.29","doi-asserted-by":"publisher","DOI":"10.1016\/j.autrev.2008.07.006"},{"key":"2018112909221089000_37.3.558.30","doi-asserted-by":"publisher","DOI":"10.1002\/art.22967"},{"issue":"5 Suppl 1","key":"2018112909221089000_37.3.558.31","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1016\/S1081-1206(10)61142-8","article-title":"Practice parameter for the diagnosis and management of primary immunodeficiency","volume":"94","author":"Bonilla","year":"2005","journal-title":"Ann Allergy Asthma Immunol"},{"key":"2018112909221089000_37.3.558.32","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0706383"},{"key":"2018112909221089000_37.3.558.33","doi-asserted-by":"publisher","DOI":"10.1002\/ana.21363"},{"key":"2018112909221089000_37.3.558.34","doi-asserted-by":"publisher","DOI":"10.1093\/geronj\/48.6.B231"},{"key":"2018112909221089000_37.3.558.35","doi-asserted-by":"publisher","DOI":"10.1002\/art.22809"},{"key":"2018112909221089000_37.3.558.36","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2005.050377"},{"key":"2018112909221089000_37.3.558.37","doi-asserted-by":"publisher","DOI":"10.1016\/0959-8049(96)00210-9"},{"key":"2018112909221089000_37.3.558.38","doi-asserted-by":"publisher","DOI":"10.1002\/art.22579"},{"key":"2018112909221089000_37.3.558.39","doi-asserted-by":"publisher","DOI":"10.1186\/ar2404"},{"key":"2018112909221089000_37.3.558.40","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2006.066761"}],"container-title":["The Journal of Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.3899\/jrheum.090856","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,5,26]],"date-time":"2020-05-26T23:51:03Z","timestamp":1590537063000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.jrheum.org\/lookup\/doi\/10.3899\/jrheum.090856"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010,1,28]]},"references-count":40,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2010,3,2]]},"published-print":{"date-parts":[[2010,3]]}},"alternative-id":["10.3899\/jrheum.090856"],"URL":"https:\/\/doi.org\/10.3899\/jrheum.090856","relation":{},"ISSN":["0315-162X","1499-2752"],"issn-type":[{"value":"0315-162X","type":"print"},{"value":"1499-2752","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010,1,28]]}}}