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Tofacitinib is an oral Janus kinase inhibitor. In two industry-funded phase III trials, patients with moderate-to-severe ulcerative colitis (UC) were randomized in a double-blinded manner to receive tofacitinib 10 mg twice daily for 8 weeks (approximately 450 patients per study) or placebo (approximately 120 patients per study). After 8 weeks, patients who had responded could participate in a maintenance trial of tofacitinib 5 mg versus 10 mg versus placebo that continued through 52 weeks (approximately 200 patients per group).
The remission rates (total Mayo score ≤2, no subscore >1, and rectal bleeding subscore =0) at 8 weeks were 18.5% and 16.6% in the two trials, versus 8.2% and 3.6% with placebo, respectively. In the maintenance trial, …