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Comparative effectiveness and safety of tofacitinib and filgotinib in patients with ulcerative colitis: A propensity

Fabio Salvatore Macaluso1, Walter Fries2, Anna Viola2

  • 1Inflammatory bowel disease Unit, A.O.O.R. "Villa Sofia-Cervello", Hospital, Viale Strasburgo 233, Palermo 90146, Italy.

Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
|August 27, 2025
PubMed
Abstract

Insights

Tofacitinib (TOFA) and filgotinib (FILGO) showed similar effectiveness and persistence for ulcerative colitis (UC) patients in real-world use. Both Janus kinase inhibitors (JAKi) demonstrated acceptable safety profiles for managing UC.

Area of Science:

  • Gastroenterology
  • Pharmacology
  • Clinical Medicine

Background:

  • Janus kinase inhibitors (JAKi), including tofacitinib (pan-JAK) and filgotinib (selective JAK1), are oral treatments for moderate-to-severe ulcerative colitis (UC).
  • Limited head-to-head comparative data exists for these JAKi in real-world clinical practice.

Purpose of the Study:

  • To compare the real-world effectiveness and safety of tofacitinib (TOFA) versus filgotinib (FILGO) in adult patients with ulcerative colitis (UC).

Main Methods:

  • A multicenter cohort study utilized data from the Sicilian Network for Inflammatory Bowel Diseases.
  • Included were consecutive adult UC patients treated with TOFA or FILGO with at least 16 weeks of follow-up.
  • Inverse probability of treatment weighting (IPTW) was applied to balance baseline patient characteristics.

Main Results:

  • The study included 263 UC patients (171 on TOFA, 92 on FILGO).
  • At 24 weeks, steroid-free clinical remission rates were 58.8% for TOFA and 44.9% for FILGO (IPTW-adjusted OR: 1.37; P=0.30).
  • Adverse event rates were higher with TOFA (12.7 vs. 5.4 per 100 person-years), but this difference was not statistically significant (P=0.152).

Conclusions:

  • Tofacitinib and filgotinib exhibited comparable high effectiveness and treatment persistence in a real-world UC patient cohort.
  • Both JAK inhibitors demonstrated acceptable safety profiles in this patient population.
Keywords:
EffectivenessJak-inhibitorsPropensity scoreSafety

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