{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T08:46:04Z","timestamp":1793781964995,"version":"4.6.1"},"reference-count":18,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2021,6,2]],"date-time":"2021-06-02T00:00:00Z","timestamp":1622592000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,12,18]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background and Aims<\/jats:title>\n                  <jats:p>Risankizumab, an interleukin-23 antibody, demonstrated efficacy and acceptable safety in a phase 2 study of patients with moderate-to-severe refractory Crohn\u2019s disease. This open-label extension investigated the long-term safety, pharmacokinetics, immunogenicity and efficacy of risankizumab in responders to risankizumab in the parent phase 2 study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Enrolled patients had achieved clinical response [decrease in Crohn\u2019s Disease Activity Index from baseline \u2265100] without clinical remission [Crohn\u2019s Disease Activity Index &amp;lt;150] at Week 26, or clinical response and\/or remission at Week 52 in the parent phase 2 study and received open-label subcutaneous risankizumab 180 mg every 8 weeks.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Sixty-five patients were enrolled, including four who had lost response in the parent study and were first reinduced with risankizumab 600 mg every 4 weeks [three infusions]. Patients received risankizumab for a median of 33 months [total: 167.0 patient-years]. The rate of serious adverse events was 24.6 events\/100 patient-years; the majority were gastrointestinal in nature. Rates of serious infections, opportunistic infections and fungal infections were 4.2, 1.8, and 6.6 events\/100 patient-years, respectively. No deaths, malignancies, adjudicated major adverse cardiovascular events, latent\/active tuberculosis or herpes zoster were reported. Treatment-emergent anti-drug antibodies developed in eight patients [12.3%]; none were neutralizing. Efficacy outcomes were maintained during the study, including the proportions of patients [observed analysis] with clinical remission [&amp;gt;71%] and endoscopic remission [&amp;gt;42%].<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Long-term maintenance treatment with subcutaneous risankizumab 180 mg every 8 weeks was well tolerated by patients with Crohn\u2019s disease, with no new safety signals.<\/jats:p>\n                  <jats:p>Clinical trial registration number: NCT02513459<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjab093","type":"journal-article","created":{"date-parts":[[2021,6,1]],"date-time":"2021-06-01T21:12:15Z","timestamp":1622581935000},"page":"2001-2010","source":"Crossref","is-referenced-by-count":65,"title":["Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn\u2019s Disease: Results from the Phase 2 Open-Label Extension Study"],"prefix":"10.1093","volume":"15","author":[{"given":"Marc","family":"Ferrante","sequence":"first","affiliation":[{"name":"University Hospitals Leuven, KU Leuven, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian G","family":"Feagan","sequence":"additional","affiliation":[{"name":"University of Western Ontario, London, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4971-6902","authenticated-orcid":false,"given":"Juli\u00e1n","family":"Pan\u00e9s","sequence":"additional","affiliation":[{"name":"Hospital Clinic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Filip","family":"Baert","sequence":"additional","affiliation":[{"name":"AZ Delta Roeselare-Menen, Roeselare, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edouard","family":"Louis","sequence":"additional","affiliation":[{"name":"University of Li\u00e8ge and CHU, Li\u00e8ge, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivier","family":"Dewit","sequence":"additional","affiliation":[{"name":"Cliniques Universitaires Saint-Luc, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arthur","family":"Kaser","sequence":"additional","affiliation":[{"name":"University of Cambridge and Cambridge University Hospitals \u2013 Addenbrooke\u2019s Hospital, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W Rachel","family":"Duan","sequence":"additional","affiliation":[{"name":"AbbVie Inc., North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yinuo","family":"Pang","sequence":"additional","affiliation":[{"name":"AbbVie Inc., North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wan-Ju","family":"Lee","sequence":"additional","affiliation":[{"name":"AbbVie Inc., North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dawn","family":"Gustafson","sequence":"additional","affiliation":[{"name":"AbbVie Inc., North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaomei","family":"Liao","sequence":"additional","affiliation":[{"name":"AbbVie Inc., North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kori","family":"Wallace","sequence":"additional","affiliation":[{"name":"AbbVie Inc., North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jasmina","family":"Kalabic","sequence":"additional","affiliation":[{"name":"AbbVie Deutschland GmbH & Co. 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