論文種別	原著(症例報告除く)
言語種別	英語
査読の有無	その他(不明)
表題	Effectiveness and safety of tacrolimus versus infliximab as rescue therapy for intravenous corticosteroid-refractory acute severe ulcerative colitis: a multicenter cohort study.
掲載誌名	正式名：Journal of Crohn's & colitis 略　 称：J Crohns Colitis ISSNコード：18764479/18739946
掲載区分	国外
巻・号・頁	20(9),pp.jjag143
著者・共著者	Takahito Katano, Shinji Okabayashi, Hajime Yamazaki, Mao Matsubayashi, Kanade Serizawa, Masatoshi Nakashima, Motoki Kaneko, Katsuyoshi Matsuoka, Ryota Ogihara, Hiroki Kiyohara, Keiichi Tominaga, Koji Kaku, Mayo Tanabe, Katsuyoshi Ando, Kousaku Kawashima, Manabu Shiraki, Ruriko Nishigaki, Masato Aizawa, Tomoyuki Hayashi, Nobuaki Nishimata, Misaki Nakamura, Masaki Takao, Yuichi Shimodate, Kenji Kinoshita, Tsunaki Sawada, Yuma Hotta, Toshihiro Inokuchi, Takashi Ibuka, Akira Matsui, Yoshiharu Yamaguchi, Keisuke Itoh, Ken Kurokawa, Atsuhiro Hirayama, Kazuki Kakimoto, Yu Sasaki, Tsutomu Mizoshita, Hiroshi Nakase, Yusuke Honzawa,
発行年月	2026/09
概要	BACKGROUND & AIMS:Acute severe ulcerative colitis (ASUC) refractory to intravenous corticosteroids (IVCS) is a major clinical challenge with limited rescue therapy options. Although tacrolimus has been proposed as a potential rescue therapy, its effectiveness and safety compared with infliximab, widely used in this setting, remain unclear.METHODS:A multicenter retrospective cohort study was conducted across 34 Japanese institutions, including hospitalized patients with IVCS-refractory ASUC who received infliximab or tacrolimus as rescue therapy between January 2014 and March 2023. The primary outcome was clinical remission at day 14, using two-item patient-reported outcome scoring. Secondary outcomes included clinical response at day 3 and 7, colectomy, and adverse events within 56 days. A modified Poisson regression model was used for analysis.RESULTS:Among 300 patients (infliximab, n = 113; tacrolimus, n = 187), clinical remission at day 14 occurred in 41.6% and 33.7%, respectively, with no difference (adjusted risk ratio [RR] 0.87 [95% CI: 0.65, 1.17]). Clinical response at day 3 was lower with tacrolimus (infliximab 42.5% vs tacrolimus 24.1%; adjusted RR 0.58 [95% CI: 0.42, 0.80]) but did not differ at day 7 (infliximab 63.7% vs tacrolimus 51.9%; adjusted RR 0.83 [95% CI: 0.69, 1.01]). No difference in colectomy within 56 days was observed, although rates were higher in the tacrolimus (13.3% vs 20.3%; adjusted RR 1.58 [95% CI: 0.93, 2.67]). Adverse events were similar between groups (infliximab 8.8% vs tacrolimus 7.5%; adjusted RR 0.77 [95% CI: 0.37, 1.57]).CONCLUSIONS:Tacrolimus demonstrated comparable effectiveness and safety to infliximab as rescue therapy for IVCS-refractory ASUC, although early response was slower.
DOI	10.1093/ecco-jcc/jjag143
PMID	42768925