{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T17:42:52Z","timestamp":1790185372734,"version":"4.1.0"},"reference-count":40,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2017,1,28]],"date-time":"2017-01-28T00:00:00Z","timestamp":1485561600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Sanofi and Regeneron Pharmaceuticals"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2017,2]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy and safety of sarilumab plus conventional synthetic disease\u2010modifying antirheumatic drugs (DMARDs) in patients with active moderate\u2010to\u2010severe rheumatoid arthritis (RA) who had an inadequate response or intolerance to anti\u2013tumor necrosis factor (anti\u2010TNF) therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients were randomly allocated to receive sarilumab 150 mg, sarilumab 200 mg, or placebo every 2 weeks for 24 weeks with background conventional synthetic DMARDs. The co\u2010primary end points were the proportion of patients achieving a response according to the American College of Rheumatology 20% criteria for improvement (ACR20) at week 24, and change from baseline in the Health Assessment Questionnaire disability index (HAQ DI) at week 12. Each sarilumab dose was evaluated against placebo; differences between the 2 sarilumab doses were not assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The baseline characteristics of the treatment groups were similar. The ACR20 response rate at week 24 was significantly higher with sarilumab 150 mg and sarilumab 200 mg every 2 weeks compared with placebo (55.8%, 60.9%, and 33.7%, respectively; <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001). The mean change from baseline in the HAQ DI score at week 12 was significantly greater for sarilumab (least squares mean change: for 150 mg, \u22120.46 [<jats:italic>P<\/jats:italic>\u2009=\u20090.0007]; for 200 mg, \u22120.47 [<jats:italic>P<\/jats:italic>\u2009=\u20090.0004]) versus placebo (\u22120.26). Infections were the most frequently reported treatment\u2010emergent adverse events. Serious infections occurred in 1.1%, 0.6%, and 1.1% of patients receiving placebo, sarilumab 150 mg, and sarilumab 200 mg, respectively. Laboratory abnormalities included decreased absolute neutrophil count and increased transaminase levels in both sarilumab groups compared with placebo. In this study, reductions in the absolute neutrophil count were not associated with an increased incidence of infections or serious infections.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Sarilumab 150 mg and sarilumab 200 mg every 2 weeks plus conventional synthetic DMARDs improved the signs and symptoms of RA and physical function in patients with an inadequate response or intolerance to anti\u2010TNF agents. Safety data were consistent with interleukin\u20106 receptor blockade and the known safety profile of sarilumab.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.39944","type":"journal-article","created":{"date-parts":[[2016,11,17]],"date-time":"2016-11-17T12:16:50Z","timestamp":1479385010000},"page":"277-290","source":"Crossref","is-referenced-by-count":177,"title":["Sarilumab and Nonbiologic Disease\u2010Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Tumor Necrosis Factor Inhibitors"],"prefix":"10.1002","volume":"69","author":[{"given":"Roy","family":"Fleischmann","sequence":"first","affiliation":[{"name":"Metroplex Clinical Research Center and University of Texas Southwestern Medical Center Dallas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet","family":"van Adelsberg","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals Tarrytown New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yong","family":"Lin","sequence":"additional","affiliation":[{"name":"Sanofi Bridgewater New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geraldo da Rocha","family":"Castelar\u2010Pinheiro","sequence":"additional","affiliation":[{"name":"Rio de Janeiro State University Rio de Janeiro Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Brzezicki","sequence":"additional","affiliation":[{"name":"Centrum Kliniczno\u2010Badawcze Elblag Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pawel","family":"Hrycaj","sequence":"additional","affiliation":[{"name":"Pozna\u0144 University of Medical Sciences Pozna\u0144 Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil M. H.","family":"Graham","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals Tarrytown New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hubert","family":"van Hoogstraten","sequence":"additional","affiliation":[{"name":"Sanofi Bridgewater New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah","family":"Bauer","sequence":"additional","affiliation":[{"name":"Sanofi Bridgewater New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerd R.","family":"Burmester","sequence":"additional","affiliation":[{"name":"Charit\u00e9 University Medicine Free University, and Humboldt University, Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,1,28]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204573"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.39480"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kes115"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.22331"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2015.8"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar1917"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1158\/2326-6066.CIR-14-0022"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.59.suppl_1.i21"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/1759720X10378372"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/38.3.202"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00296-006-0143-2"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/00124743-199504000-00006"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.24781"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar1916"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.092932"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202470"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.23940"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.30158"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2011-200395"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.39093"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204405"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.27584"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780360601"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380602"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780230202"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380107"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(200007)43:7<1478::AID-ANR10>3.0.CO;2-M"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61424-X"},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa050524"},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204920"},{"key":"e_1_2_7_32_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keq343"},{"key":"e_1_2_7_33_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-205137"},{"key":"e_1_2_7_34_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204760"},{"key":"e_1_2_7_35_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.101378"},{"key":"e_1_2_7_36_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.105197"},{"key":"e_1_2_7_37_1","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/698313"},{"key":"e_1_2_7_38_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2009.122374"},{"key":"e_1_2_7_39_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.berh.2007.05.007"},{"key":"e_1_2_7_40_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.120573"},{"issue":"10","key":"e_1_2_7_41_1","article-title":"Evaluation of bone and joint proteins for prognostic association with radiographic progression and disease activity in methotrexate inadequate responder rheumatoid arthritis patients in a sarilumab phase 3 study [abstract]","volume":"67","author":"Boyapati A","year":"2015","journal-title":"Arthritis Rheumatol"}],"container-title":["Arthritis &amp; Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fart.39944","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.39944","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T11:57:08Z","timestamp":1759924628000},"score":1,"resource":{"primary":{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/10.1002\/art.39944"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,1,28]]},"references-count":40,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2017,2]]}},"alternative-id":["10.1002\/art.39944"],"URL":"https:\/\/doi.org\/10.1002\/art.39944","archive":["Portico"],"relation":{},"ISSN":["2326-5191","2326-5205"],"issn-type":[{"value":"2326-5191","type":"print"},{"value":"2326-5205","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,1,28]]}}}