Intest Res  
Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn’s disease: a subpopulation analysis of phase 3 induction and maintenance studies
Toshifumi Hibi1, Yuya Imai2, Yoko Murata2, Nobuko Matsushima2, Richuan Zheng2, Christopher Gasink3
1Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, 2Janssen Pharmaceutical K.K., Tokyo, Japan, 3Janssen Research & Development, LLC, Spring House, PA, USA
Correspondence to: Yuya Imai, Janssen Pharmaceutical K.K., 5-2 Nishikanda 3-chome, Chiyoda-ku, Tokyo 101-0065, Japan. Tel: +81-80-1256-6377, Fax: +81-3-4411-5086, E-mail:
Received: December 31, 2016; Revised: March 10, 2017; Accepted: March 10, 2017; Published online: June 19, 2017.
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Background/Aims: Efficacy and safety of ustekinumab were evaluated in a Japanese subpopulation with moderately to severely active Crohn’s disease (CD) in UNITI-1, UNITI-2 and IM-UNITI studies and results were compared with the overall population. Methods: Overall, patients in UNITI-1 (Japan, n=56; failed response to tumor necrosis factor antagonist) and UNITI-2 (Japan, n=26; failed response to prior conventional therapy) were randomized to placebo or ustekinumab intravenous induction (130 mg or ~6 mg/kg) at week 0. Responders to ustekinumab induction therapy (Japan, n=21) were randomized to placebo or ustekinumab (90 mg, subcutaneous) maintenance (every 12 weeks [q12w] or 8 weeks [q8w]) in IM-UNITI. The primary endpoint was clinical response at week 6 for induction studies and clinical remission at week 44 for maintenance study. Results: Percentage of patients achieving clinical response at week 6 was greater in ustekinumab 130 mg and ~6 mg/kg groups than in the placebo group (UNITI-1: 36.8% and 31.6% vs. 27.8%, respectively, for Japanese; 34.3% and 33.7% vs. 21.5%, respectively, for overall; UNITI-2: 37.5% and 55.6% vs. 11.1%, respectively, for Japanese; 51.7% and 55.5% vs. 28.7%, respectively, for overall). Clinical remission rate at week 44 during maintenance was greater in the ustekinumab 90 mg SC q12w and q8w groups than in the placebo group (50.0% and 55.6% vs. 25.0%, respectively, for Japanese; 48.8% and 53.1% vs. 35.9%, respectively, for overall). Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population. Conclusions: Ustekinumab could be considered as a new therapeutic option for moderately to severely active CD in Japanese patients. Both ustekinumab induction and maintenance treatments were generally well tolerated (Clinical Trial Registration: NCT01369329, NCT01369342, NCT01369355).
Keywords: Crohn disease; Interleukin-12/23; Japan; Ustekinumab

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