{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T15:10:54Z","timestamp":1779289854809,"version":"3.51.4"},"reference-count":36,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2015,7,14]],"date-time":"2015-07-14T00:00:00Z","timestamp":1436832000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Cadila Healthcare Limited, the Zydus Group Company, India"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Rheum Dis"],"published-print":{"date-parts":[[2016,11]]},"abstract":"Abstract<\/jats:title>Aim<\/jats:title>In this study, efficacy, tolerability and safety of biosimilar adalimumab (Exemptia; Zydus Cadila) was compared with reference adalimumab (Humira; AbbVie) in patients with moderate to severe rheumatoid arthritis (RA<\/jats:styled-content>).<\/jats:p><\/jats:sec>Method<\/jats:title>In this multicentre, prospective, randomized, double\u2010blind, active controlled parallel arm study, 120 patients with moderate to severeRA<\/jats:styled-content>were given 40\u00a0mg of either test adalimumab (Exemptia) or reference adalimumab (Humira) by subcutaneous route every other week for 12\u00a0weeks. The primary endpoint was proportion of responders in two tretament groups by American College of Rheumatology 20 (ACR<\/jats:styled-content>20) at week 12. The secondary endpoints were change in Disease Activity Score of 28 joints \u2013 C\u2010reactive protein (DAS<\/jats:styled-content>28\u2010CRP<\/jats:styled-content>) and proportion of patients with anACR<\/jats:styled-content>50 andACR<\/jats:styled-content>70 response in two treatment groups at week 12. Safety outcomes were also assessed.<\/jats:p><\/jats:sec>Results<\/jats:title>After 12\u00a0weeks, patients treated every other week with test adalimumab (Zydus Cadila) had statistically similar response rates as compared to reference adalimumab (AbbVie):ACR<\/jats:styled-content>20 (82%vs<\/jats:italic>. 79.2%;P\u00a0<\/jats:italic>>\u00a0<\/jats:italic>0.7);ACR<\/jats:styled-content>50 (46%,vs<\/jats:italic>. 43.4%;P\u00a0<\/jats:italic>>\u00a0<\/jats:italic>0.7);ACR<\/jats:styled-content>70 (14%vs<\/jats:italic>. 15.1%;P\u00a0<\/jats:italic>>\u00a0<\/jats:italic>0.8). The change inDAS<\/jats:styled-content>28\u2010CRP<\/jats:styled-content>score was \u22122.1\u00a0\u00b1\u00a01.09 and \u22122.1\u00a0\u00b1\u00a01.21, in test and reference products, respectively. It was statistically significant compared to baseline, but not significantly different between the two products. Three serious adverse events and no death was reported during the study. Both adalimumab preparations were safe and well tolerated in this study.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>The results demonstrated biosimilarity with respect to efficacy, tolerability and safety of test adalimumab (Exemptia) and reference adalimumab (Humira) in patients with moderate to severeRA<\/jats:styled-content>.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1756-185x.12711","type":"journal-article","created":{"date-parts":[[2015,7,14]],"date-time":"2015-07-14T23:05:22Z","timestamp":1436915122000},"page":"1157-1168","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":55,"title":["A prospective, randomized, double\u2010blind, multicentre, parallel\u2010group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia;ZRC<\/scp>\u20103197) and adalimumab (Humira) in patients with rheumatoid arthritis"],"prefix":"10.1111","volume":"19","author":[{"given":"Rajendrakumar H.","family":"Jani","sequence":"first","affiliation":[{"name":"Clinical R & D Cadila Healthcare Limited The Zydus Group Ahmedabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajiv","family":"Gupta","sequence":"additional","affiliation":[{"name":"Malpani Multispecialty Hospital Jaipur India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Girish","family":"Bhatia","sequence":"additional","affiliation":[{"name":"Medipoint Hospital Pvt. 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