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RISS 인기검색어
- 검색키워드
- 저자 : ( Richuan Zheng ) (검색결과 2 건)
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( Toshifumi Hibi ),( Yuya Imai ),( Yoko Murata ),( Nobuko Matsushima ),( Richuan Zheng ),( Christopher Gasink ) 대한장연구학회 2017 Intestinal Research Vol.15 No.4
Background/Aims: Efficacy and safety of ustekinumab were evaluated in a Japanese subpopulation with moderately to se verely active Crohn’s disease (CD) in UNITI-1, UNITI-2 and IM-UNITI studies and results were compared with the overall pop ulation. 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 induc tion (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 end point 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). Clin ical 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). Ef ficacy 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). (Intest Res 2017;15:475-486)
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( Tadakazu Hisamatsu ),( Hyo Jong Kim ),( Satoshi Motoya ),( Yasuo Suzuki ),( Yoshifumi Ohnishi ),( Noriyuki Fujii ),( Nobuko Matsushima ),( Richuan Zheng ),( Colleen W. Marano ) 대한장연구학회 2021 Intestinal Research Vol.19 No.4
Background/Aims: We aimed to evaluate the efficacy and safety of ustekinumab (UST) in the East-Asian population with mod-erate 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 main-tenance 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 re-ceived 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. (Intest Res 2021;19:386-397)
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