{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T12:42:56Z","timestamp":1770986576061,"version":"3.50.1"},"reference-count":15,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2021,2,1]],"date-time":"2021-02-01T00:00:00Z","timestamp":1612137600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis Care &amp;amp; Research"],"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Adalimumab is approved for treatment of Crohn\u2019s disease and ulcerative colitis. Thus, we postulated that exacerbation or new\u2010onset of inflammatory bowel disease (IBD) would be rare events in patients treated with adalimumab for non\u2010IBD indications. The objective was to evaluate the incidence of IBD adverse events (AEs) across adalimumab trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>IBD AE rates in 75 adalimumab clinical trials in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, pediatric enthesitis\u2010related arthritis, uveitis, hidradenitis suppurativa, adult and pediatric psoriasis, psoriatic arthritis, nonpsoriatic arthritis peripheral spondyloarthritis (SpA), axial SpA, including nonradiographic axial SpA, and ankylosing spondylitis, were analyzed. Search terms for IBD AEs (new onset or worsening\/flare) included IBD, ulcerative colitis, Crohn\u2019s disease, and ulcerative proctitis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>This analysis included 24,114 patients, representing 36,508 patient\u2010years of adalimumab exposure. The overall rate of IBD AEs in adalimumab\u2010treated patients was 0.1 (95% confidence interval [95% CI] 0.1\u20130.2)\/100 patient\u2010years (41 events), ranging from no events (psoriatic arthritis, uveitis, and pediatric trials) to 0.8 (95% CI 0.2\u20132.2)\/100 patient\u2010years in peripheral SpA. The rate of IBD in axial SpA was 0.6 (95% CI 0.4\u20131.0)\/100 patient\u2010years. During placebo\u2010controlled trials, the overall IBD rate was 0.1 (95% CI 0.0\u20130.3)\/100 patient\u2010years for adalimumab groups (3 events in 6,781 patients; 2,752 patient\u2010years of exposure) and 0.1 (95% CI 0.0\u20130.4)\/100 patient\u2010years for placebo groups (1 event in 3,493 patients; 1,246 patient\u2010years of exposure). IBD rates in axial SpA were 0.5 (95% CI 0.1\u20131.4)\/100 patient\u2010years for adalimumab and 0.6 (95% CI 0.0\u20133.1)\/100 patient\u2010years for placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The rates of IBD AEs in adalimumab clinical trials were generally low across the evaluated diseases, including axial SpA; all events occurred in adult patients.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acr.24175","type":"journal-article","created":{"date-parts":[[2020,2,26]],"date-time":"2020-02-26T06:24:27Z","timestamp":1582698267000},"page":"289-295","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Low Incidence of Inflammatory Bowel Disease Adverse Events in Adalimumab Clinical Trials Across Nine Different Diseases"],"prefix":"10.1002","volume":"73","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7468-974X","authenticated-orcid":false,"given":"Dirk","family":"Elewaut","sequence":"first","affiliation":[{"name":"Ghent University Hospital and Ghent University  Ghent Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00fcrgen","family":"Braun","sequence":"additional","affiliation":[{"name":"Rheumazentrum Ruhrgebiet, Herne, and Ruhr Universit\u00e4t Bochum  Bochum Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jaclyn K.","family":"Anderson","sequence":"additional","affiliation":[{"name":"AbbVie  North Chicago Illinois"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dilek","family":"Arikan","sequence":"additional","affiliation":[{"name":"AbbVie  North Chicago Illinois"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Su","family":"Chen","sequence":"additional","affiliation":[{"name":"AbbVie  North Chicago Illinois"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maja","family":"Hojnik","sequence":"additional","affiliation":[{"name":"AbbVie  Ljubljana Slovenia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann-Sophie","family":"De Craemer","sequence":"additional","affiliation":[{"name":"Ghent University Hospital and Ghent University  Ghent Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8907-8976","authenticated-orcid":false,"given":"Jeffrey R.","family":"Curtis","sequence":"additional","affiliation":[{"name":"University of Alabama at Birmingham"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,2]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar3150"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms18102020"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210770"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1155\/2012\/389404"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2011-301668"},{"key":"e_1_2_7_7_1","unstructured":"Cosentyx (secukinumab) full prescribing information.East Hanover (NJ):Novartis Pharmaceuticals Corporation;2016."},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/1759720X12458372"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202135"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10067-014-2652-9"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.14528"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.22669"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.40551"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2018.06.024"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2018-214273"},{"issue":"10","key":"e_1_2_7_16_1","article-title":"Secukinumab demonstrates consistent safety over long\u2010term exposure (up to 3 years) in patients with active ankylosing spondylitis: pooled analysis of three phase 3 trials [abstract]. 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