Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2025
Comparative effectiveness and safety of tofacitinib and filgotinib in patients with ulcerative colitis: A propensity score-weighted cohort study.
СтатьяМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Macaluso Fabio Salvatore, Fries Walter, Viola Anna, De Francesco Clara, Belluardo Nunzio, Giangreco Emiliano, Cappello Maria, Ajovalasit Roberto, Mocciaro Filippo, Scrivo Barbara, Privitera Antonino Carlo, Distefano Maria Emanuela, Vitello Alessandro, Ferracane Concetta, Muscarella Stefano, Li Voti Raffaele, Mistretta Giuseppe, Renna Sara, Casà Angelo, Ventimiglia Marco, Orlando Ambrogio, Sicilian Network for Inflammatory Bowel Disease (SN-IBD)
Аннотация
BACKGROUND: Janus kinase inhibitors (JAKi), including tofacitinib (TOFA, pan-JAK) and filgotinib (FILGO, selective JAK1), are oral agents approved for moderate-to-severe ulcerative colitis (UC). Head-to-head comparative data in real-world settings are limited.
AIM: To compare effectiveness and safety of TOFA and FILGO in patients with UC.
METHODS: We conducted a multicenter cohort study using data from the Sicilian Network for Inflammatory Bowel Diseases. Consecutive adult UC patients treated with TOFA or FILGO and ≥16 weeks of follow-up were included. Propensity score weighting (IPTW) was used to balance baseline characteristics.
RESULTS: 263 patients were included (TOFA: n = 171; FILGO: n = 92). At week 24, steroid-free clinical remission was observed in 58.8 % with TOFA and 44.9 % with FILGO (IPTW-adjusted OR: 1.37; 95 % CI: 0.76-2.49; P = 0.30). Clinical response rates at 24 weeks were 63.6 % for TOFA and 59.0 % for FILGO (IPTW-adjusted OR: 1.13; 95 % CI: 0.62-2.08; P = 0.69). Treatment persistence at 24 weeks was 83.5 % for TOFA vs. 76.4 % for FILGO (HR: 0.78; P = 0.30). Adverse event rates were higher with TOFA (12.7 vs. 5.4 per 100 person-years), though not statistically significant (P = 0.152).
CONCLUSION: TOFA and FILGO demonstrated similarly high effectiveness and persistence in real-world UC patients. Both had acceptable safety profiles.
AIM: To compare effectiveness and safety of TOFA and FILGO in patients with UC.
METHODS: We conducted a multicenter cohort study using data from the Sicilian Network for Inflammatory Bowel Diseases. Consecutive adult UC patients treated with TOFA or FILGO and ≥16 weeks of follow-up were included. Propensity score weighting (IPTW) was used to balance baseline characteristics.
RESULTS: 263 patients were included (TOFA: n = 171; FILGO: n = 92). At week 24, steroid-free clinical remission was observed in 58.8 % with TOFA and 44.9 % with FILGO (IPTW-adjusted OR: 1.37; 95 % CI: 0.76-2.49; P = 0.30). Clinical response rates at 24 weeks were 63.6 % for TOFA and 59.0 % for FILGO (IPTW-adjusted OR: 1.13; 95 % CI: 0.62-2.08; P = 0.69). Treatment persistence at 24 weeks was 83.5 % for TOFA vs. 76.4 % for FILGO (HR: 0.78; P = 0.30). Adverse event rates were higher with TOFA (12.7 vs. 5.4 per 100 person-years), though not statistically significant (P = 0.152).
CONCLUSION: TOFA and FILGO demonstrated similarly high effectiveness and persistence in real-world UC patients. Both had acceptable safety profiles.