Efficacy and safety of tofacitinib in the treatment of ulcerative colitis: real-life experience in Andalusia

Tofacitinib is a Janus kinase inhibitor approved for the treatment of moderate-severe ulcerative colitis (UC). In the present study we aimed to evaluate its efficacy in a real-life setting. Retrospective and multicenter observational study including UC patients treated with tofacitinib. Short and long-term treatment effectiveness, treatment survival, need for dose escalation and safety are analyzed. Clinical response and remission were defined in accordance with the partial Mayo score. Seventy-four patients were included, 98.3% of whom had received prior biological treatment: 55.4% with 3 or more biologicals and up to 64.9% with 2 or 3 different mechanisms of action. Clinical remission and response rates were 37.8% and 77% at 8 weeks, and 41.8% and 70.1% at 16 weeks. Of non-responders at 8 weeks, 37,5% achieved a delayed clinical response at 16 weeks. Mean treatment duration was 19 months (95% CI: 16-22), with a treatment survival of 56% at 28 months, and remission and response rates at 24 months of 53.8% and 61.5%. Twenty-three treatments were withdrawn, most of them (18) during the induction period. There were adverse events in a quarter of the patients; only 4 were severe and led to treatment discontinuation. Tofacitinib demonstrates in clinical practice its efficacy to induce and maintain clinical response in treatment-refractory UC patients, with an acceptable safety profile.