Dual therapy with tofacitinib and steroids for acute severe ulcerative colitis: a randomized double-blind placebo-controlled trial
In brief
Tofacitinib plus steroids reduced rescue therapy by 73%, but trial was small
In a 58-patient trial stopped early for slow recruitment, day 6 treatment failure was lower with tofacitinib only after adjustment for baseline differences; the unadjusted result was not significant. Rescue therapy was less frequent over 90 days, but colectomy rates were nearly identical. Larger trials are needed to confirm whether the treatment improves outcomes.
- Journal
- Journal of Crohn's & colitis (Q1)
- Published
- 9 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Umang Arora, Mahak Verma, Divya Madan, Mukesh Singh, Devasenathipathy Kandasamy, Himanshu Narang, et al.
- PMID
- 42909466
- DOI
- 10.1093/ecco-jcc/jjag149
Why clinicians should know about it
- Picked for Gastroenterology (paper of the day, 25 October 2026): Dual therapy trial in acute severe ulcerative colitis
Abstract
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). RESULTS: Of 62 randomized patients, 58 were analyzed: 33 in the tofacitinib arm and 25 in the placebo arm. The trial was terminated early because of slow recruitment and did not reach the planned sample size of 98. Day 6 treatment failure was numerically lower with tofacitinib in unadjusted analysis (24.2% vs 36.0%; RR 0.67, 95% CI 0.30-1.51; P = .33) and significantly lower after adjustment for baseline covariate imbalance (adjusted RR 0.47, 95% CI 0.24-0.93; P = .03). At 90 days, colectomy rates were similar (12.1% vs 12.0%; P = 1.0), but more tofacitinib-treated patients remained on assigned therapy (84.4% vs 54.2%) and rescue therapy was lower (HR 0.27, 95% CI 0.09-0.78; P = .01). Serious adverse events occurred in one versus three patients. No deaths occurred with tofacitinib versus two deaths with placebo. CONCLUSION: Dual therapy with tofacitinib and steroids in ASUC did not significantly reduce treatment failure at day 6, unless adjustment for baseline imbalance in serum albumin was taken into account. It reduced the need for rescue therapy over 90 days without affecting colectomy risk. Larger clinical trials are required to confirm these findings.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.