Xeljanz tofacitinib: Phase III data

Top-line data from the double-blind, international Phase III OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079) trials showed that twice-daily 5 and 10 mg oral tofacitinib each met the co-primary endpoints in both trials of a greater proportion of patients achieving a PGA of "clear" or "almost clear" at week 16 and of improving PASI 75 response at week 16 vs. placebo. Each of the trials enrolled over 900 patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

The Phase III OPT program of tofacitinib to treat moderate to severe chronic plaque psoriasis consists of 5 trials in over 3,600 patients. Pfizer has previously reported top-line data from the OPT Compare (A3921080) and OPT Retreatment (A3921111) trials (see BioCentury, Oct. 14, 2013). Pfizer is also conducting the Phase III OPT Extend (A3921061) extension trial of tofacitinib in which patients who have completed a Phase II trial or any of the other Phase III trials are eligible to enroll. By early next year, Pfizer plans to submit an sNDA to FDA for both the twice-daily 5 and 10 mg doses of tofacitinib to treat moderate to severe chronic plaque psoriasis. ...