Intestinal research · 2026
Efficacy and safety of ozanimod in Japanese patients with moderately to severely active ulcerative colitis naive to immunomodulators or advanced therapies: post hoc analysis of the phase 2/3 J-True North study.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Hisamatsu Tadakazu, Fujii Toshimitsu, Nakase Hiroshi, Matsuoka Katsuyoshi, Saruta Masayuki, Kobayashi Taku, Inoue Seika, Toriyama Kazuhiro, Wang Dong, Uchikawa Yoko, Fujimoto Go, Hibi Toshifumi
Аннотация
BACKGROUND/AIMS: There is limited evidence for ozanimod, an oral sphingosine 1-phosphate receptor modulator, in patients with ulcerative colitis (UC) before treatment is escalated to an immunomodulator (IM) or advanced therapy (AT), including biologics and Janus kinase inhibitors.
METHODS: We performed post hoc analyses to examine the efficacy and safety of ozanimod 0.92 mg versus placebo in a subgroup of Japanese IM-/AT-naive patients with moderately to severely active UC, without concomitant corticosteroids (CS), enrolled in the randomized J-True North study.
RESULTS: The analyses comprised 29 and 30 patients treated with ozanimod 0.92 mg and placebo, respectively. The clinical response rate was significantly greater in the ozanimod group at Week 12 (75.9% vs. 40.0%; P=0.0103) and Week 52 (62.1% vs. 16.7%; P=0.0010). Clinical remission, endoscopic improvement, and histologic remission rates at Weeks 12 and 52 were significantly better in the ozanimod group. Changes in the rectal bleeding subscore, stool frequency subscore, symptomatic response, and symptomatic remission were apparent by Week 2 in both groups, and tended to be better in the ozanimod group from Week 5 onward. Treatment-emergent adverse events occurred in 79.3% and 63.3% of patients in the ozanimod and placebo groups, respectively; the most frequent were nasopharyngitis (ozanimod vs. placebo: 17.2% vs. 13.3%) and pyrexia (13.8% vs. 10.0%, respectively).
CONCLUSIONS: This subgroup analysis demonstrated that ozanimod 0.92 mg was significantly more effective than placebo in Japanese IM-/AT-naive UC patients without concomitant CS therapy, consistent with the results of global trials. The safety profile of ozanimod 0.92 mg was consistent with prior studies. ClinicalTrials.gov (NCT03915769) and the Japan Registry of Clinical Trials (jRCT2080224654).
METHODS: We performed post hoc analyses to examine the efficacy and safety of ozanimod 0.92 mg versus placebo in a subgroup of Japanese IM-/AT-naive patients with moderately to severely active UC, without concomitant corticosteroids (CS), enrolled in the randomized J-True North study.
RESULTS: The analyses comprised 29 and 30 patients treated with ozanimod 0.92 mg and placebo, respectively. The clinical response rate was significantly greater in the ozanimod group at Week 12 (75.9% vs. 40.0%; P=0.0103) and Week 52 (62.1% vs. 16.7%; P=0.0010). Clinical remission, endoscopic improvement, and histologic remission rates at Weeks 12 and 52 were significantly better in the ozanimod group. Changes in the rectal bleeding subscore, stool frequency subscore, symptomatic response, and symptomatic remission were apparent by Week 2 in both groups, and tended to be better in the ozanimod group from Week 5 onward. Treatment-emergent adverse events occurred in 79.3% and 63.3% of patients in the ozanimod and placebo groups, respectively; the most frequent were nasopharyngitis (ozanimod vs. placebo: 17.2% vs. 13.3%) and pyrexia (13.8% vs. 10.0%, respectively).
CONCLUSIONS: This subgroup analysis demonstrated that ozanimod 0.92 mg was significantly more effective than placebo in Japanese IM-/AT-naive UC patients without concomitant CS therapy, consistent with the results of global trials. The safety profile of ozanimod 0.92 mg was consistent with prior studies. ClinicalTrials.gov (NCT03915769) and the Japan Registry of Clinical Trials (jRCT2080224654).