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Comparative Study
. 2025 Jul 3;19(7):jjae188.
doi: 10.1093/ecco-jcc/jjae188.

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

Beatriz Gros  1   2   3 , Nathan Constantine-Cooke  4   5 , Jake Kennedy  1 , Alexander T Elford  1   6 , Claire O'Hare  1   7 , Colin Noble  1 , Gareth-Rhys Jones  1   8 , Ian D Arnott  1 , Charlie W Lees  1   5 , Nikolas Plevris  1   5
Affiliations
Comparative Study

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

Beatriz Gros et al. J Crohns Colitis. .

Abstract

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.

Keywords: Ulcerative colitis; biologics; real-world data; small molecule.

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Conflict of interest statement

BG has served as a consultant to Galapagos and Abbvie and as a speaker for Abbvie, Roche, Janssen, Takeda, Pfizer, and Galapagos. NP has served as a speaker for Janssen, Takeda, and Pfizer. CWL has acted as a consultant to Abbvie, Janssen, Takeda, Pfizer, Galapagos, Bristol Myers Squibb, B.I., Sandoz, Novartis, GSK, Gilead, Vifor Pharma, Dr Falk, Trellus Health, and Iterative Scopes; he has received speaking fees and travel support from Pfizer, Janssen, Abbvie, Galapagos, MSD, Takeda, Shire, Ferring, Hospira, and Dr Falk. G-RJ has served as a speaker for Takeda, Janssen, Abbvie, Fresnius, and Ferring. CN has served as a speaker for Alphasigma/Galapagos and shares in Lilly. IDA has served as a speaker for Alphasigma/Galapagos, Bristol Myers Squibb, Takeda, Lilly, Pfizer, Vifor Pharma, Dr Falk, and Ferring.

Figures

Figure 1
Figure 1
Treatment persistence of vedolizumab and tofacitinib. A, Adjusted via inverse probability of treatment weighting; B, unadjusted.
Figure 2
Figure 2
Steroid-free clinical, biochemical, and fecal calprotectin remission at Weeks 12 and 52. A, Unadjusted; B, adjusted. *Statistically significant
See this image and copyright information in PMC

References

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