Real‐world comparison of effectiveness between tofacitinib and vedolizumab in patients with ulcerative colitis exposed to at least one anti‐TNF agent.

Summary: Background: Data comparing tofacitinib and vedolizumab in ulcerative colitis (UC) are lacking. Aims: To compare the effectiveness of tofacitinib and vedolizumab in patients with UC who had prior exposure to anti‐TNF therapy Methods: In this multicentre study, we included consecutive patients with UC ≥18 years old with partial Mayo score >2 and prior anti‐TNF exposure, who started tofacitinib or vedolizumab between January 2019 and June 2021. Comparisons were performed using propensity score analyses (inverse probability of treatment weighting). Results: Overall, 126 and 178 patients received tofacitinib and vedolizumab, respectively. Intensified induction (vedolizumab infusion at week 10 or tofacitinib 10 mg b.d until week 16) was performed in 28.5% and 41.5% of patients, respectively. After propensity‐score analysis, corticosteroid‐free clinical remission (partial Mayo score ≤2) was achieved at week 16 in 45.1% and 40.2% of patients receiving tofacitinib and vedolizumab, respectively (aOR = 0.82 [0.35–1.91], p = 0.64). Endoscopic improvement (corticosteroid‐free clinical remission and endoscopic Mayo score ≤1) (aOR = 0.23[0.08–0.65], p = 0.0032) and histological healing (endoscopic improvement + Nancy histological index ≤1) (13.4% vs 3.2%, aOR = 0.21[0.05–0.91], p = 0.023) were higher at week 16 in patients treated with tofacitinib. No factor was predictive of tofacitinib effectiveness. At least one primary failure to a biologic (OR = 0.46[0.22–0.99], p = 0.049), partial Mayo score >6 (OR = 0.39[0.17–0.90], p = 0.029) and CRP level > 30 mg/L at baseline (OR = 0.08[0.01–0.85], p = 0.036) were associated with vedolizumab failure. Conclusion: Tofacitinib and vedolizumab are effective in UC after failure of anti‐TNF agents. However, tofacitinib seems more effective, especially in severe disease and primary failure to biologics. [ABSTRACT FROM AUTHOR]