J Gastroenterol (2017) 52:1031–1040 DOI 10.1007/s00535-017-1325-2 ORI G INAL ARTI CL E—ALIMENTARY T R ACT Four-year maintenance treatment with adalimumab in Japanese patients with moderately to severely active ulcerative colitis 1 2 3 4 • • • • Yasuo Suzuki Satoshi Motoya Hiroyuki Hanai Toshifumi Hibi 5 6 7 7 • • • • Shiro Nakamura Andreas Lazar Anne Martin Robinson Martha Skup 7 7 7 8 • • • Nael Mohamed Mostafa Bidan Huang Roopal Thakkar Mamoru Watanabe Received: 30 September 2016 / Accepted: 26 February 2017 / Published online: 20 March 2017 The Author(s) 2017. This article is an open access publication Abstract hybrid nonresponder imputation (hNRI) method. Nonre- Background The 52-week safety and efﬁcacy of adali- sponder imputation was used for missing data up to the mumab in Japanese patients with moderately to severely latest possible follow-up date for each patient, followed by active ulcerative colitis were demonstrated in a placebo- observed case. Adalimumab trough concentrations were controlled phase 2/3 trial. Data from patients who enrolled reported from week 52 to week 196 of treatment. Treat- in the open-label extension study are presented. ment-emergent adverse events were reported for all adali- Methods Remission and response per
Journal of Gastroenterology – Springer Journals
Published: Mar 20, 2017
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