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.
Comparative effectiveness and safety of tofacitinib and filgotinib in patients with ulcerative colitis: A propensity score-weighted cohort study
Vitello, Alessandro;
2025-01-01
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
