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. Graphical showing the comparison between tofacitinib and vedolizumab to achieve steroid‐free clinical remission, endoscopic improvement and histological healing at week 16 in patients with ulcerative colitis exposed to at least one anti‐TNF agent