{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:31:27Z","timestamp":1786977087572,"version":"build-2736575974"},"reference-count":33,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2018,8,6]],"date-time":"2018-08-06T00:00:00Z","timestamp":1533513600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005614","name":"Biogen","doi-asserted-by":"publisher","award":["142861_14"],"award-info":[{"award-number":["142861_14"]}],"id":[{"id":"10.13039\/100005614","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":[[2018,9]]},"abstract":"\n Objective<\/jats:title>\n \n To evaluate the effects of non\u2010mandatory transitioning from the originator biologic drug etanercept (\n ETN<\/jats:styled-content>\n ) to its biosimilar,\n SB<\/jats:styled-content>\n 4, on drug survival and effectiveness in a controlled cohort study of patients with an inflammatory rheumatic disease.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n In 2016, 642 patients were asked to transition their treatment from originator\n ETN<\/jats:styled-content>\n to biosimilar\n SB<\/jats:styled-content>\n 4 by a structured communication strategy with opt\u2010out option. Patients who consented to switch to\n SB<\/jats:styled-content>\n 4 were considered eligible for inclusion in the transition cohort, while patients being treated with originator ETN in 2014 were recruited as the historical cohort. Drug survival was compared between the 2 cohorts using Cox regression analyses, which were adjusted for age, sex, diagnosis,\n ETN<\/jats:styled-content>\n treatment duration,\n ETN<\/jats:styled-content>\n dose interval, conventional synthetic disease\u2010modifying antirheumatic drug usage, and C\u2010reactive protein (\n CRP<\/jats:styled-content>\n ) level, with a robust variance estimator applied to account for repeated subjects (i.e., patients who were included in both the transition cohort and the historical cohort). Adjusted differences in the 6\u2010month change in\n CRP<\/jats:styled-content>\n level, Disease Activity Score in 28 joints using\n CRP<\/jats:styled-content>\n level (\n DAS<\/jats:styled-content>\n 28\u2010\n CRP<\/jats:styled-content>\n ), and Bath Ankylosing Spondylitis Disease Activity Index were also assessed.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of the 642\n ETN<\/jats:styled-content>\n \u2010treated patients, 635 (99%) agreed to transition from originator\n ETN<\/jats:styled-content>\n to biosimilar\n SB<\/jats:styled-content>\n 4, of whom 625 patients (433 with rheumatoid arthritis, 128 with psoriatic arthritis, and 64 with ankylosing spondylitis) were included in the transition cohort, and 600\n ETN<\/jats:styled-content>\n \u2010treated patients from 2014 were included in the historical cohort. The crude treatment persistence rate for biosimilar\n SB<\/jats:styled-content>\n 4 over 6 months was 90% (95% confidence interval [95%\n CI<\/jats:styled-content>\n ] 88\u201393%), compared to a 6\u2010month treatment persistence rate of 92% (95%\n CI<\/jats:styled-content>\n 90\u201394%) for originator\n ETN<\/jats:styled-content>\n . Patients in the transition cohort, compared to the historical cohort, had a statistically significantly higher relative risk of treatment discontinuation (adjusted hazard ratio 1.57, 95%\n CI<\/jats:styled-content>\n 1.05\u20132.36) and showed smaller decreases in the\n CRP<\/jats:styled-content>\n level (adjusted difference 1.8, 95%\n CI<\/jats:styled-content>\n 0.3\u20133.2) and\n DAS<\/jats:styled-content>\n 28\u2010\n CRP<\/jats:styled-content>\n (adjusted difference 0.15, 95%\n CI<\/jats:styled-content>\n 0.05\u20130.25) over 6 months.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n Non\u2010mandatory transitioning from originator\n ETN<\/jats:styled-content>\n to biosimilar\n SB<\/jats:styled-content>\n 4 using a specifically designed communication strategy resulted in a slightly lower 6\u2010month treatment persistence rate and smaller decreases in disease activity in the transition cohort compared to the historical cohort, but these differences were not considered clinically relevant.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/art.40516","type":"journal-article","created":{"date-parts":[[2018,4,2]],"date-time":"2018-04-02T18:54:17Z","timestamp":1522695257000},"page":"1408-1418","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":90,"title":["Open\u2010Label, Non\u2010Mandatory Transitioning From Originator Etanercept to Biosimilar\n SB<\/scp>\n 4"],"prefix":"10.1002","volume":"70","author":[{"given":"Lieke","family":"Tweehuysen","sequence":"first","affiliation":[{"name":"Sint Maartenskliniek Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor J. B.","family":"Huiskes","sequence":"additional","affiliation":[{"name":"Sint Maartenskliniek Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bart J. F","family":"van den Bemt","sequence":"additional","affiliation":[{"name":"Sint Maartenskliniek and Radboud University Medical Center, Nijmegen, The Netherlands and Maastricht University Medical Center Maastricht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johanna E.","family":"Vriezekolk","sequence":"additional","affiliation":[{"name":"Sint Maartenskliniek Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Teerenstra","sequence":"additional","affiliation":[{"name":"Radboud University Medical Center Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank H. J.","family":"van den Hoogen","sequence":"additional","affiliation":[{"name":"Sint Maartenskliniek and Radboud University Medical Center Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cornelia H.","family":"van den Ende","sequence":"additional","affiliation":[{"name":"Sint Maartenskliniek and Radboud University Medical Center Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfons A.","family":"den Broeder","sequence":"additional","affiliation":[{"name":"Sint Maartenskliniek and Radboud University Medical Center Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,8,6]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"US Food & Drug Administration. Biosimilar and interchangeable products. 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