Tofacitinib 20 vs 30 mg in acute severe ulcerative colitis: a double-blind randomized controlled trial

Background & aims: Tofacitinib has emerged as a promising therapy for acute severe ulcerative colitis (ASUC) due to its rapid onset of action. We compared the efficacy and safety of tofacitinib 20 mg/day vs 30 mg/day, both administered with intravenous corticosteroids (IVCS), in patients with ASUC.

Methods

This was a double-blind, pilot, randomized controlled trial. Adult patients with ASUC were randomized to receive either tofacitinib 20 mg/day (Group 1) or 30 mg/day (Group 2) along with IVCS (hydrocortisone, 100 mg IV every 6 hours). The primary endpoint was clinical response by day 7. The secondary outcome was the cumulative probability of medical rescue therapy or post discharge escalation of therapy or colectomy within 90 days.