Xeljanz tofacitinib: Phase III data

Top-line data from the double-blind, placebo-controlled, international Phase III OPT Compare (A3921080) trial in 1,106 patients showed that twice-daily 10 mg tofactinib met the co-primary endpoints of non-inferiority to twice-weekly 50 mg Enbrel etanercept in the proportion of patients who achieved a PGA of "clear" or "almost clear" at week 12 and a PASI 75 response at week 12. The twice-daily 5 mg dose of tofactinib missed the co-primary endpoints. No new safety signals for tofacitinib were reported. The trial enrolled patients with moderate to severe chronic plaque psoriasis who had an inadequate response to, intolerance to or contraindication to systemic therapy.

The Phase III OPT program of tofactinib to treat moderate to severe plaque psoriasis consists of 5 trials. Pfizer also reported top-line data from the Phase III OPT Retreatment trial. Top-line data from the Phase III OPT Pivotal 1 (A3921078) and OPT Pivotal 2 (A3921079) trials are expected in 2Q14. Pfizer is also conducting the Phase III OPT Extend (A3921061) extension trial of tofacitinib in which patients who have completed any of the other Phase III trials are eligible to enroll. ...