Tofacitinib meets Phase II ulcerative colitis endpoint

Data published Wednesday in the New England Journal of Medicine showed that the highest dose of oral tofacitinib from Pfizer Inc. (NYSE:PFE) met the primary endpoint in a Phase II trial to treat moderate to severe active ulcerative colitis. A twice-daily 15 mg dose of the oral pan-Janus kinase (JAK) inhibitor significantly improved clinical response rate from baseline to week eight vs. placebo (78% vs. 42%, p<0.001). However, twice-daily 0.5, 3 and 10 mg doses of tofacitinib missed the endpoint. Two patients receiving the 10 mg dose of tofacitinib had serious adverse events from infection. Tofacitinib is in Phase III testing to treat UC. ...