Effectiveness and safety of tacrolimus versus infliximab as rescue therapy for intravenous corticosteroid-refractory acute severe ulcerative colitis: a multicenter cohort study.
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Katano Takahito, Okabayashi Shinji, Yamazaki Hajime, Matsubayashi Mao, Serizawa Kanade, Nakashima Masatoshi, Kaneko Motoki, Matsuoka Katsuyoshi, Ogihara Ryota, Kiyohara Hiroki, Tominaga Keiichi, Kaku Koji, Tanabe Mayo, Ando Katsuyoshi, Kawashima Kousaku, Shiraki Manabu, Nishigaki Ruriko, Aizawa Masato, Hayashi Tomoyuki, Nishimata Nobuaki, Nakamura Misaki, Takao Masaki, Shimodate Yuichi, Kinoshita Kenji, Sawada Tsunaki, Hotta Yuma, Inokuchi Toshihiro, Ibuka Takashi, Matsui Akira, Yamaguchi Yoshiharu, Itoh Keisuke, Kurokawa Ken, Hirayama Atsuhiro, Kakimoto Kazuki, Sasaki Yu, Mizoshita Tsutomu, Nakase Hiroshi, Honzawa Yusuke, IBD Terakoya Group
Аннотация
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.