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May 11, 2026Open Access

Comparative Effectiveness and Safety of Tofacitinib, Filgotinib, and Upadacitinib in Ulcerative Colitis: A Multicenter Real-World Cohort Study

Key Points

This study aims to compare the effectiveness and safety of tofacitinib, filgotinib, and upadacitinib in treating ulcerative colitis.
Multicenter retrospective cohort study of adult ulcerative colitis patients from September 2020 to June 2025.
Inverse probability of treatment weighting was used to control baseline differences in a pseudo-population of 627 patients.
Clinical and biochemical remissions were assessed at predefined time points using specific scoring systems.
At week 8, clinical remission probabilities were 17.5% for upadacitinib, 11.8% for tofacitinib, and 6.7% for filgotinib (p < 0.001).
At week 52, endoscopic remission was achieved by 36.6% with upadacitinib, compared to 18.8% with tofacitinib and 19.5% with filgotinib (p = 0.039).
Overall adverse events were more frequent with tofacitinib, while filgotinib had a lower rate of non-serious side effects.

Abstract

Tofacitinib, filgotinib, and upadacitinib are Janus kinase inhibitors (JAKis) available for ulcerative colitis (UC) refractory or intolerant to at least one advanced therapy; their comparative effectiveness in clinical practice remains uncertain. We conducted a multicenter retrospective study including adult UC patients initiating tofacitinib, filgotinib, or upadacitinib (September 2020–June 2025). Clinical remission (partial Mayo score ≤ 1), steroid-free clinical remission, biochemical remission, and endoscopic remission (Mayo endoscopic score = 0) were assessed at predefined time-points. Baseline differences were controlled using inverse probability of treatment weighting (IPTW), and time-to-event and longitudinal analyses were performed. After IPTW, the pseudo-population included 627 patients (tofacitinib = 179, filgotinib = 138, upadacitinib = 310). In the weighted cohort, clinical remission probabilities at weeks 8, 24, and 52 were 17.5%, 40.7%, and 61.3% with upadacitinib, 11.8%, 33.8%, and 54.6% with tofacitinib, and 6.7%, 29.0%, and 52.0% with filgotinib, respectively; p < 0.001 at weeks 8 and 24; p = 0.040 at week 52. Steroid-free clinical remission showed a similar gradient (14.2%, 39.2%, and 59.8% with upadacitinib; 9.2%, 31.2%, and 50.8% with tofacitinib; 4.4%, 27.6%, and 49.8% with filgotinib, respectively; all p < 0.001. Biochemical remission was also achieved more frequently with upadacitinib at weeks 8 and 16, although differences between treatments were no longer significant during maintenance. At week 52, endoscopic remission was 18.8% with tofacitinib, 36.6% with upadacitinib, and 19.5% with filgotinib (p = 0.039). Overall adverse events, particularly infections and herpes zoster, were more frequent with tofacitinib, whereas filgotinib had fewer non-serious events; serious adverse events and colectomy risk were uncommon and similar across groups. All three JAKis were effective, but upadacitinib yielded the highest remission rates, while tofacitinib and filgotinib differed mainly in safety, supporting individualized drug positioning according to efficacy needs and patient-specific risks.

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