Tasocitinib: Phase II data

A double-blind, dose-ranging Phase II trial in 197 patients showed that all 3 doses of oral tasocitinib met the primary endpoint of a significantly greater proportion of patients achieving a PASI 75 response at week 12 vs. placebo. Specifically, 25%, 40.8% and 66.7% of patients receiving 2, 5 and 15 mg twice-daily tasocitinib, respectively, achieved a PASI 75 response vs. 2% for placebo (p<0.001 for all). On secondary endpoints, a significantly greater proportion of patients receiving low-, mid- and high-dose tasocitinib achieved PASI 50 (39.6%, 65.3% and 87.5%, respectively, vs. 20%; p<0.05 for all) and PASI 90 responses at week 12 vs. placebo (14.6%, 18.4% and 33.3%, respectively, vs. 0%; p<0.01 for all).

All 3 doses of tasocitinib also produced a significantly greater proportion of patients with a PGA of "clear" or "almost clear" vs. placebo (24.5%, 40.8% and 72.9%, respectively, vs. 10%; p<0.05 for all), as well as a patient global assessment (PtGA) of "clear" or "almost clear" at week 12 (35.1%, 38.5% and 74.4%, respectively, vs. 2.9%; p<0.0001 for all). Additionally, low-, mid- and high-dose tasocitinib significantly improved patient health-related quality of life as measured by mean reductions from baseline in Dermatology Life Quality Index (DLQI) scores vs. placebo (7.74, 7.26 and 9.4, respectively, vs. 2.01; p<0.0001 for all). ...