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자료유형
학술저널
저자정보
Tadakazu Hisamatsu (Kyorin University School of Medicine) 김효종 (경희대학교) Satoshi Motoya (Sapporo-Kosei General Hospital) Yasuo Suzuki (Toho University Sakura Medical Center) Yoshifumi Ohnishi (Division of Gastroenterology Shizuoka Medical Center) Noriyuki Fujii (Janssen Pharmaceutical K.K.) Nobuko Matsushima (Janssen Pharmaceutical K.K. Tokyo) Richuan Zheng (Janssen Pharmaceutical K.K. Tokyo) Colleen W. Marano (Janssen Research & Development LLC)
저널정보
대한장연구학회 Intestinal research Intestinal research Vol.19 No.4
발행연도
2021.10
수록면
386 - 397 (12page)
DOI
10.5217/ir.2020.00080

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Background/Aims: We aimed to evaluate the efficacy and safety of ustekinumab (UST) in the East-Asian population with moderate to severely active ulcerative colitis (UC).Methods: This sub-analysis was conducted on data from East-Asian patients included in the UNIFI program (NCT02407236). UNIFI consisted of two double-blind, placebo-controlled trials: an 8-week induction study and a 44-week randomized withdrawal maintenance study.Results: Of 133 East-Asian patients (Japanese: 107, Korean: 26) who underwent randomization, 131 completed induction study and 111 entered maintenance study. In the maintenance study, 78 patients were randomized. Patients who received UST 130 mg and UST 6 mg/kg showed numerically higher clinical remission at week 8 in the induction study (5/44 [11.4%] and 5/45 [11.1%], respectively) compared with those who received placebo (0/44, 0%). The proportion of patients achieved clinical remission at week 44 was numerically higher in the UST 90 mg q12w group (10/21, 47.6%), but similar in the UST 90 mg q8w group (5/26, 19.2%) compared to placebo (7/31, 22.6%). Serious adverse events were reported in 1 patient in UST 130 mg group, but no patient in UST 6 mg/kg group through week 8 in the induction study, and 1 patient in UST 90 mg q12w group and 5 patients in the UST 90 mg q8w group in the maintenance study. No deaths were reported in East-Asian patients throughout the study.Conclusions: UST induction and maintenance treatments were effective in East-Asian patients with moderate to severe UC; the efficacy and safety profiles were consistent with the overall population.

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