Tofacitinib 20 vs 30 mg in acute severe ulcerative colitis: a double-blind randomized controlled trial
In brief
A 30-mg tofacitinib dose did not outperform 20 mg in severe colitis
In this 72-patient pilot trial, day-7 clinical response was about 92% with 20 mg and 86% with 30 mg of tofacitinib, both given with intravenous steroids; the difference was not statistically significant. Outcomes at 90 days were also similar, but the small trial cannot establish that the doses are equivalent or rule out uncommon harms.
- Journal
- Journal of Crohn's & colitis (Q1)
- Published
- 9 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Arshdeep Singh, Aakash Garg, Arshia Bhardwaj, Dharmatma Singh, Aman Thakur, Lagandeep Kaur, et al.
- PMID
- 42880720
- DOI
- 10.1093/ecco-jcc/jjag147
Why clinicians should know about it
- Picked for Gastroenterology (paper of the day, 18 October 2026): Tofacitinib 30 mg not superior to 20 mg in ASUC
Abstract
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. RESULTS: Seventy-two patients were randomized, with 36 allocated to each treatment group. At day 7, clinical response was achieved in 33/36 (91.7%) patients in Group 1 and 31/36 (86.1%) in Group 2(RR 1.06, 95% CI 0.90-1.25; P = .46). The absolute difference in response rates was 5.6% (95% CI -9.98% to 21.34%). Rescue therapy was required in 3 patients in Group 1 (all received infliximab) and 5 patients in Group 2 (2 underwent colectomy and 3 received infliximab). Event-free survival at 90 days, defined as the absence of rescue therapy, treatment escalation, or colectomy, was similar between groups (83.3% vs 80.2%; log-rank P = .74). Adverse events were predominantly mild, with no reported venous thromboembolism or major adverse cardiovascular events. CONCLUSIONS: In this exploratory pilot trial, no statistically significant differences were observed with tofacitinib 30 mg/day compared with 20 mg/day when administered with IVCS. CLINICAL TRIAL REGISTRATION NUMBER: Clinical Trials Registry-India: CTRI/2024/10/075098.
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.