Real-World Comparison of the Effectiveness of Tofacitinib and Ustekinumab in Patients With Ulcerative Colitis: The TORUS Study.

BACKGROUND & AIMS: We compared the effectiveness of tofacitinib and ustekinumab in patients with ulcerative colitis (UC) previously exposed to at least one anti-tumor necrosis factor (TNF) agent.

METHODS

In this multicenter real-world evidence study, we consecutively included patients with UC ≥18 years old, previously exposed to anti-TNF therapy, with partial Mayo score >2 and, starting tofacitinib or ustekinumab. All the comparisons were performed using propensity score analyses.

RESULTS

Overall, 124 and 165 patients were included in the tofacitinib and ustekinumab groups, respectively. Symptomatic remission, off corticosteroids (partial Mayo score ≤2) was achieved at week 16 in 37.8% and 35.8%, among the tofacitinib and ustekinumab groups, respectively (adjusted odds ratio [OR], 1.09; 95% confidence interval [CI], 0.60-2.00; P = .75), with higher tofacitinib effectiveness in patients with prior exposure to ≥3 biologics (46.7% vs 23.1%; adjusted OR, 2.92; 95% CI, 1.02-8.39; P = .047). Primary failure to any biologic (OR, 2.88; 95% CI, 1.20-6.98) and prior exposure to ≥3 advanced therapies (OR, 2.45; 95% CI, 1.03-5.82), but not disease severity, were associated with ustekinumab failure. We did not find any significant difference between tofacitinib and ustekinumab regarding clinical remission per modified Mayo score (17.0% vs 11.7%; adjusted OR, 1.55; 95% CI, 0.65-3.68; P = .32) and histological and endoscopic improvement (4.4% vs 7.8%; adjusted OR, 0.54; 95% CI, 0.16-1.86; P = .32). After a median follow-up of 11.8 months (interquartile range, 6.1-20.5 months), we did not observe any difference regarding the risk of UC relapse-related drug discontinuation (adjusted hazard ratio, 1.44; 95% CI, 0.94-2.21; P = .10), and the risk of secondary loss of response among patients achieving CFREM at week 16 (adjusted hazard ratio, 1.88; 95% CI, 0.57-6.19; P = .30).

CONCLUSIONS

Tofacitinib and ustekinumab are similarly effective to induce and maintain corticosteroid-free remission after anti-TNF failure in UC. However, tofacitinib could be favored in case of multiple therapeutic failures (≥3 biologics) and primary failure to any biologic.