Journal of gastroenterology · 2026
Real-world outcomes of ustekinumab, vedolizumab, and tumor necrosis factor inhibitors in very-early-onset inflammatory bowel disease: a multi-center cohort study.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Nambu Ryusuke, Iwama Itaru, Takeuchi Ichiro, Hagiwara Shin-Ichiro, Etani Yuri, Kaji Emiri, Yoden Atsushi, Kakuta Fumihiko, Hoshi Yusuke, Tsumura Naoya, Mizuochi Tatsuki, Kumagai Hideki, Yokoyama Koji, Nishizawa Takuya, Usami Masaaki, Takaki Yugo, Ebana Ryo, Kurasawa Shingo, Fujikawa Hiroki, Ishige Takashi, Kudo Takahiro, Yoshida M Masashi, Shimizu Hirotaka, Arai Katsuhiro
Аннотация
BACKGROUND: Very-early-onset inflammatory bowel disease (VEO-IBD), representing cases diagnosed before age 6 years, is increasing in prevalence. Although VEO-IBD often presents as severe, treatment-resistant disease requiring biologic agents, studies showing the effectiveness of biologics, such as ustekinumab (UST) and vedolizumab (VDZ), remain limited.
METHODS: We retrospectively analyzed patients with VEO-IBD treated for at least a year from 13 institutions in Japan, evaluating clinical course including effectiveness of biologics, such as infliximab (IFX), adalimumab (ADL), UST, and VDZ. Patients with monogenic IBD were excluded. Steroid-free clinical remission (SFCR) and treatment persistence were assessed separately for first-line and for second-line or subsequent biologic therapies.
RESULTS: We studied 101 VEO-IBD patients (56% male; median age, 3.6 years), including 40 with Crohn's disease, 52 with ulcerative colitis, and 9 with unclassified IBD. Biologics were used in 67 patients, most commonly infliximab (IFX; n = 52), followed by UST (n = 38), adalimumab (ADL; n = 23), and VDZ (n = 21). As first-line therapy, IFX and ADL achieved 1-year SFCR rates of 19% and 46%, with persistence rates of 36% and 48%. Despite being used mainly as second-line or subsequent therapies, UST and VDZ showed 1-year SFCR rates of about 45% and 36%, and maintained persistence of 79% and 46%, respectively, with UST demonstrating higher persistence than TNF-α inhibitors (P < 0.01). No discontinuations due to infusion reactions or other adverse events occurred with UST or VDZ.
CONCLUSION: UST and VDZ were effective and well tolerated even when used as second-line or subsequent therapies for VEO-IBD.
METHODS: We retrospectively analyzed patients with VEO-IBD treated for at least a year from 13 institutions in Japan, evaluating clinical course including effectiveness of biologics, such as infliximab (IFX), adalimumab (ADL), UST, and VDZ. Patients with monogenic IBD were excluded. Steroid-free clinical remission (SFCR) and treatment persistence were assessed separately for first-line and for second-line or subsequent biologic therapies.
RESULTS: We studied 101 VEO-IBD patients (56% male; median age, 3.6 years), including 40 with Crohn's disease, 52 with ulcerative colitis, and 9 with unclassified IBD. Biologics were used in 67 patients, most commonly infliximab (IFX; n = 52), followed by UST (n = 38), adalimumab (ADL; n = 23), and VDZ (n = 21). As first-line therapy, IFX and ADL achieved 1-year SFCR rates of 19% and 46%, with persistence rates of 36% and 48%. Despite being used mainly as second-line or subsequent therapies, UST and VDZ showed 1-year SFCR rates of about 45% and 36%, and maintained persistence of 79% and 46%, respectively, with UST demonstrating higher persistence than TNF-α inhibitors (P < 0.01). No discontinuations due to infusion reactions or other adverse events occurred with UST or VDZ.
CONCLUSION: UST and VDZ were effective and well tolerated even when used as second-line or subsequent therapies for VEO-IBD.