Xeljanz tofacitinib: Additional Phase III data

Additional data from the double-blind, placebo-controlled, international Phase III OPT Compare (A3921080) trial in 1,101 patients with chronic moderate to severe plaque psoriasis showed that twice-daily 10 mg tofacitinib led to a PASI 75 response at week 12, a co-primary endpoint, of 63.6% vs. 58.8% for twice-weekly 50 mg Enbrel etanercept, 39.5 % for twice-weekly 5 mg tofacitinib and 5.6% for placebo. Additionally, 68.2% of patients receiving 10 mg tofacitinib achieved a PGA of "clear" or "almost clear" at week 12, the other co-primary endpoint, vs. 66.3% of patients receiving Enbrel, 47.1% of patients receiving 5 mg tofacitinib and 15% of patients receiving placebo. The trial enrolled patients with moderate to severe chronic plaque psoriasis who had an inadequate response to, intolerance to or contraindication to systemic therapy. Data were presented at the American Academy of Dermatology meeting in Denver. Pfizer previously reported that high-dose tofacitinib met the co-primary endpoints of non-inferiority to Enbrel, but low-dose tofacitinib missed the co-primary endpoints (see BioCentury, Oct. 14, 2013).

The Phase III OPT program of tofacitinib to treat moderate to severe plaque psoriasis consists of 5 trials. Pfizer has also previously reported top-line data from the Phase III OPT Retreatment trial (see BioCentury, Oct. 14, 2013). Top-line data from the Phase III OPT Pivotal 1 (A3921078) and OPT Pivotal 2 (A3921079) trials are expected this quarter. 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. ...