Tofacitinib 20 vs 30 mg in acute severe ulcerative colitis: a double-blind randomized controlled trial.
Arshdeep Singh, Aakash Garg, Arshia Bhardwaj et al.
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In 30 seconds
This double-blind, pilot randomized controlled trial compared tofacitinib 20 mg/day with 30 mg/day, each given alongside intravenous corticosteroids, in adults with acute severe ulcerative colitis. Among 72 randomized patients, day-7 clinical response occurred in 33/36 (91.7%) in the 20-mg group and 31/36 (86.1%) in the 30-mg group (RR 1.06, 95% CI 0.90-1.25; P = .46). The trial found no statistically significant difference between doses. Ninety-day event-free survival was also similar, and reported adverse events were predominantly mild.
Key findings
- Day-7 response was 33/36 (91.7%) with 20 mg/day and 31/36 (86.1%) with 30 mg/day (RR 1.06, 95% CI 0.90-1.25; P = .46).
- Ninety-day event-free survival was 83.3% vs 80.2% for 20 mg/day and 30 mg/day, respectively (log-rank P = .74).
- Rescue therapy was required in 3 patients receiving 20 mg/day and 5 receiving 30 mg/day; 2 patients in the latter group underwent colectomy.
- Adverse events were predominantly mild; no venous thromboembolism or major adverse cardiovascular events were reported.
Why it matters
The trial provides a direct comparison of two tofacitinib doses when used with intravenous corticosteroids for acute severe ulcerative colitis. Its results did not show a statistically significant advantage for 30 mg/day in early response or 90-day event-free survival. These findings help characterize the evidence for dose selection, while the exploratory pilot design means they do not establish equivalence.
What to keep in mind
This was an exploratory pilot trial with 72 patients; the results do not establish equivalence between doses.