Tofacitinib Versus Vedolizumab Among Bio-naive Patients With Ulcerative Colitis: A Real-World Propensity-Weighted Comparison.

Background and aims: Over the last decade, treatment options for moderate-to-severe ulcerative colitis (UC) have expanded. However, comparative studies between these agents are limited, especially among biologic-naive patients. We aimed to compare the persistence, effectiveness, and safety of tofacitinib and vedolizumab as the first advanced treatment for patients with UC.

Methods: Patients who received either tofacitinib or vedolizumab as their first advanced therapy for UC in NHS Lothian were included. We used inverse probability of treatment weighting. The probability of treatment assignment was calculated via logistic regression using age, sex, UC duration, Montreal extent, C-reactive protein, concomitant corticosteroids, and partial Mayo score at drug commencement.

Results: We included n = 158 patients, of whom n = 81 (51.3%) received vedolizumab and n = 77 (48.7%) tofacitinib. Median follow-up for vedolizumab patients was 3.1 years (interquartile range [IQR] 1.6-4.8) and for tofacitinib patients 1.5 years (IQR 0.3-2.3). The cohort was 59.5% male with a median age of 41.1 years (IQR 31.5-51.8). At 2 years, vedolizumab persistence was superior to tofacitinib (p = 0.005). At Weeks 12 and 52, clinical, biochemical, and fecal biomarker steroid-free remission were comparable between groups. Primary nonresponse and secondary loss of response were 9.9% and 17.3% for vedolizumab and 23.4% and 13% for tofacitinib, respectively. The frequency of adverse events was comparable (11 [13.6%] vedolizumab vs 19 [24.7%] tofacitinib, p = 0.629).

Conclusions: We found that the persistence and tolerability of vedolizumab were superior to tofacitinib in bio-naive UC, although the rates of clinical and biomarker remission were comparable. These data may help inform the positioning of advanced therapy.