Tofacitinib: Phase II data

A double-blind, international Phase II trial in 194 patients with moderate to severe active UC showed that twice-daily 15 mg oral tofacitinib met the primary endpoint of improving clinical response rate from baseline to week 8 vs. placebo (78% vs. 42%, p<0.001). However, the twice-daily 0.5, 3 and 10 mg doses of tofacitinib missed the endpoint (32%, 48% and 61%, respectively; p=0.39, p=0.55 and p=0.1). The 3, 10 and 15 mg doses of tofacitinib met the secondary endpoint of improving clinical remission rates from baseline to week 8 vs. placebo (33%. 48% and 41%, respectively, vs. 10%; p=0.01, p<0.001 and p<0.001), but the 0.5 mg dose of tofacitinib did not (13%, p=0.76). Two patients receiving the 10 mg dose of tofacitinib had serious adverse events from infection - post-operative abscess and anal abscess. Tofacitinib was also associated with dose-dependent increases in low- and high-density lipoprotein cholesterol levels. Data were published in the New England Journal of Medicine. Tofacitinib is in Phase III testing to treat UC. ...