Hisamatsu Tadakazu, Kim Hyo Jong, Motoya Satoshi, Suzuki Yasuo, Ohnishi Yoshifumi, Fujii Noriyuki, Matsushima Nobuko, Zheng Richuan, Marano Colleen W
Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan.
Center for Crohn's and Colitis, Department of Gastroenterology, Kyung Hee University College of Medicine, Seoul, Korea.
Intest Res. 2021 Oct;19(4):386-397. doi: 10.5217/ir.2020.00080. Epub 2020 Dec 1.
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).
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.
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.
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.
背景/目的：我们旨在评估优特克单抗（UST）在东亚中度至重度活动性溃疡性结肠炎（UC）患者中的疗效和安全性。
该亚组分析基于纳入UNIFI项目（NCT02407236）的东亚患者数据进行。UNIFI包括两项双盲、安慰剂对照试验：一项为期8周的诱导研究和一项为期44周的随机撤药维持研究。
133例接受随机分组的东亚患者（日本人：107例，韩国人：26例）中，131例完成诱导研究，111例进入维持研究。在维持研究中，78例患者被随机分组。与接受安慰剂的患者（0/44，0%）相比，接受130 mg UST和6 mg/kg UST的患者在诱导研究第8周时临床缓解率在数值上更高（分别为5/44 [11.4%]和5/45 [11.1%]）。在第44周达到临床缓解的患者比例在UST 90 mg q12w组中数值上更高（10/21，47.6%），但与安慰剂组（7/31，22.6%）相比，UST 90 mg q8w组（5/26，19.2%）相似。在诱导研究至第8周时，UST 130 mg组有1例患者报告了严重不良事件，但UST 6 mg/kg组无患者报告；在维持研究中，UST 90 mg q12w组有1例患者，UST 90 mg q8w组有5例患者报告了严重不良事件。在整个研究过程中，东亚患者未报告死亡病例。
UST诱导和维持治疗对东亚中度至重度UC患者有效；疗效和安全性概况与总体人群一致。
