{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T20:30:26Z","timestamp":1791318626213,"version":"4.3.1"},"reference-count":18,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,6,23]],"date-time":"2022-06-23T00:00:00Z","timestamp":1655942400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Patients enrolled in randomised controlled trials (RCTs) may differ from the target population due to restricted eligibility criteria.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To compare treatment response to biologics in routine practice for children with inflammatory bowel diseases (IBD) who would and would not have been eligible for enrolment in the regulatory RCT of the same drug.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We enrolled children with IBD who initiated adalimumab, infliximab, vedolizumab or ustekinumab. The eligibility criteria as defined in the RCT of the corresponding biologic were applied to each patient. The primary outcome was 12\u2010month steroid\u2010free remission (SFR) without switching biologics or undergoing surgery.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We screened 289 children (198 [68%] with Crohn's disease [CD], 91 [32%] with ulcerative colitis [UC]) with 326 initiations of biologics. Only 62 of 164 (38%) children with moderate\u2013to\u2010severe disease would have been eligible for inclusion in the original RCTs. The SFR rate was higher in the eligible children (51%) than in the ineligible children (31%; OR 2.3 [95%CI 1.2\u20134.5]; <jats:italic>p<\/jats:italic>\u00a0=\u20090.01). The main exclusion criterion was prohibited previous therapies (47%). Ineligible CD patients were older, more often had a family history of IBD and had higher levels of CRP than eligible children; in UC there were no differences between the groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Most children with IBD who initiate biologics would not have been eligible to be included in the corresponding regulatory RCTs. The outcomes of ineligible patients were worse than for eligible patients. Results from RCTs should be interpreted with caution when applied to clinical practice.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.17092","type":"journal-article","created":{"date-parts":[[2022,6,23]],"date-time":"2022-06-23T12:54:27Z","timestamp":1655988867000},"page":"794-801","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Children included in randomised controlled trials of biologics in inflammatory bowel diseases do not represent the real\u2010world patient mix"],"prefix":"10.1111","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7800-1984","authenticated-orcid":false,"given":"Ohad","family":"Atia","sequence":"first","affiliation":[{"name":"Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition Shaare Zedek Medical Center  Jerusalem Israel"},{"name":"The Faculty of Medicine The Hebrew University of Jerusalem  Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gemma","family":"Pujol\u2010Muncunill","sequence":"additional","affiliation":[{"name":"Hospital Sant Joan de D\u00e9u  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V\u00edctor Manuel","family":"Navas\u2010L\u00f3pez","sequence":"additional","affiliation":[{"name":"Hospital Regional Universitario de M\u00e1laga  M\u00e1laga Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther","family":"Orlanski\u2010Meyer","sequence":"additional","affiliation":[{"name":"Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition Shaare Zedek Medical Center  Jerusalem Israel"},{"name":"The Faculty of Medicine The Hebrew University of Jerusalem  Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oren","family":"Ledder","sequence":"additional","affiliation":[{"name":"Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition Shaare Zedek Medical Center  Jerusalem Israel"},{"name":"The Faculty of Medicine The Hebrew University of Jerusalem  Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raffi","family":"Lev\u2010Tzion","sequence":"additional","affiliation":[{"name":"Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition Shaare Zedek Medical Center  Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gili","family":"Focht","sequence":"additional","affiliation":[{"name":"Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition Shaare Zedek Medical Center  Jerusalem Israel"},{"name":"The Faculty of Medicine The Hebrew University of Jerusalem  Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eyal","family":"Shteyer","sequence":"additional","affiliation":[{"name":"Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition Shaare Zedek Medical Center  Jerusalem Israel"},{"name":"The Faculty of Medicine The Hebrew University of Jerusalem  Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronen","family":"Stein","sequence":"additional","affiliation":[{"name":"Children's Hospital of Philadelphia  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina","family":"Aloi","sequence":"additional","affiliation":[{"name":"Sapienza University of Rome \u2013 Umberto I Hospital  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard K.","family":"Russell","sequence":"additional","affiliation":[{"name":"The Royal Hospital for Children &amp; 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