In a phase 2 trial of treatment for ulcerative colitis, the percentage of patients who had clinical response and remission was higher in the group treated with tofacitinib than in patients who received placebo. Sandborn and associates evaluated tofacitinib’s effectiveness in 194 adults with moderately to severely active ulcerative colitis. The primary outcome was a clinical response at 8 weeks—an absolute decrease from baseline of 3 or more in the score on the Mayo scoring system for assessment of ulcerative colitis activity (range, 0 to 12) and a relative decrease from baseline of 30% or more with an accompanying decrease in the rectal bleeding subscore of 1 point or more or an absolute rectal bleeding subscore of 0 or 1.
Clinical response at 8 weeks occurred in 32%, 48%, 61%, and 78% of patients who received tofacitinib at a dose of 0.5 mg, 3 mg, 10 mg, and 15 mg, respectively, compared with 42% of patients who received placebo. Clinical remission at 8 weeks occurred in 13%, 33%, 48%, and 41% of patients who received tofacitinib at a dose of 0.5 mg, 3 mg, 10 mg, and 15 mg, respectively, compared with 10% of patients who received placebo.