{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,7]],"date-time":"2026-06-07T06:43:03Z","timestamp":1780814583336,"version":"3.54.1"},"reference-count":21,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2019,8,12]],"date-time":"2019-08-12T00:00:00Z","timestamp":1565568000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["ACR Open Rheumatology"],"published-print":{"date-parts":[[2019,10]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Adalimumab is a well\u2010established anti\u2013tumor necrosis factor therapy for patients with ankylosing spondylitis (AS). An indigenously developed biosimilar adalimumab (bADA) (ZRC\u20103197; Exemptia) is approved for prescribing in India. In this article, we present the effectiveness and tolerability of this bADA in real\u2010life Indian patients with AS from the Adalimumab Biosimilar Patient Registry (ASPIRE) (ISRCTN: 16838474).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>ASPIRE is a postmarketing observational registry for evaluating the real\u2010world experiences of patients with autoimmune inflammatory disorders across multiple centers in India who were prescribed 40 mg of Exemptia subcutaneously every fortnight. For this report, data available until 24 weeks of bADA treatment for patients with AS who were included in the registry were evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Data from 308 patients with AS from the registry (median age of 35.0 [range 17\u201068] years, 19% women) were analyzed. In analyzable patients with complete data, there was a gradual and significant decrease (<jats:italic>P<\/jats:italic> &lt; 0.001) in the primary disease outcome scores (the mean Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score [n = 107] improved from 6.2 \u00b1 1.54 to 2.1 \u00b1 0.64, and the median visual analogue scale [VAS] score [n = 101] improved from 8 to 2) after 24 weeks of bADA therapy. BASDAI score was lower than\u00a04 in about\u00a094% of patients after 24 weeks of therapy, and 95% of patients achieved BASDAI50 response. The overall global assessment for efficacy and tolerability was \u2018good\u2019 to \u2018excellent\u2019 for a majority of the patients (\u226598%), as rated by physicians as well as patients. The therapy was tolerated well, and there were no new unexpected adverse reactions with the biosimilar's use during this study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This report demonstrates the tolerability and effectiveness of bADA (Exemptia) after its clinical use for 24 weeks in real\u2010world patients with AS from Indian clinical practice.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acr2.11067","type":"journal-article","created":{"date-parts":[[2019,8,13]],"date-time":"2019-08-13T02:04:36Z","timestamp":1565661876000},"page":"480-484","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Real\u2010life Tolerability and Effectiveness of Adalimumab Biosimilar in Ankylosing Spondylitis: the Adalimumab Biosimilar Patient Registry Data"],"prefix":"10.1002","volume":"1","author":[{"given":"Sanjiv","family":"Kapoor","sequence":"first","affiliation":[{"name":"Indian Spinal Injuries Centre New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viswanath V.","family":"Kaushik","sequence":"additional","affiliation":[{"name":"Arthritis and Rheumatism Centre Chennai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rahul","family":"Jain","sequence":"additional","affiliation":[{"name":"Narayana Multispeciality Hospital Jaipur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vijay K.R.","family":"Rao","sequence":"additional","affiliation":[{"name":"Manipal Hospital Bangalore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8321-7966","authenticated-orcid":false,"given":"Mihir","family":"Gharia","sequence":"additional","affiliation":[{"name":"Medical Affairs, Zydus Biovation Cadila Healthcare Ltd. Ahmedabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,8,12]]},"reference":[{"key":"e_1_2_8_2_1","first-page":"83","article-title":"Efficacy and safety of adalimumab in ankylosing spondylitis","volume":"6","author":"Mounach A","year":"2014","journal-title":"Open Access Rheumatol"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.8.6.831"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.21913"},{"key":"e_1_2_8_5_1","first-page":"1346","article-title":"Adalimumab reduces pain, fatigue, and stiffness in patients with ankylosing spondylitis: results from the adalimumab trial evaluating long\u2010term safety and efficacy for ankylosing spondylitis (ATLAS) [published erratum appears in J Rheumatol 2011;38:788]","volume":"35","author":"Revicki DA","year":"2008","journal-title":"J Rheumatol"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.081048"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biologicals.2011.06.018"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.autrev.2013.02.005"},{"key":"e_1_2_8_9_1","unstructured":"Business Standard.Zydus Cadila launches biosimilar of adalimumab.2014. 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