Journal of Crohn's & colitis
Dual therapy with tofacitinib and steroids for acute severe ulcerative colitis: a randomized double-blind placebo-controlled trial
Par Arora U, Verma M, Madan D et 17 autres.
Contenu en anglais
Résumé
Background
One-third of patients with acute severe ulcerative colitis (ASUC) fail intravenous corticosteroids. We evaluated whether adding tofacitinib to corticosteroids reduces treatment failure in ASUC.
Methods
In this single-center, double-blind, placebo-controlled trial, adults with ASUC were randomized 1:1 to tofacitinib (10 mg three times daily for 3 days, then twice daily) or placebo for 5 days alongside corticosteroids. Primary outcome was treatment failure at day 6 (<3-point Lichtiger reduction or total score ≥10, or colectomy). Secondary outcomes were relapse (≥3-point rise with total ≥10), rescue therapy, and colectomy at 90 days. Modified intention-to-treat analysis was performed. (CTRI/2022/11/047186).