Pfizer reports Phase III tofacitinib psoriasis data

Pfizer Inc. (NYSE:PFE) reported data on Wednesday from a pair of double-blind Phase III trials evaluating twice-daily tofacitinib, an oral pan-Janus kinase (JAK) inhibitor, to treat chronic moderate to severe plaque psoriasis. In the 1,106-patient OPT Compare trial, twice-daily 10 mg tofacitinib met the co-primary endpoints of non-inferiority to twice-weekly Enbrel etanercept from Pfizer and Amgen Inc. (NASDAQ:AMGN) in the proportion of patients who achieved a Physician's Global Assessment (PGA) of "clear" or "almost clear" at week 12 and a PASI 75 response at week 12. The twice-daily 5 mg dose missed the co-primary endpoints.

In the placebo-controlled, 674-patient OPT Retreatment trial, low- and high-dose tofacitinib each met the co-primary endpoints of a PASI 75 response and a PGA of "clear" or "almost clear" in both the withdrawal and retreatment periods of the trial. The Phase III OPT program of tofacitinib for plaque psoriasis consists of five trials. Top-line data from the Phase III OPT Pivotal 1 and OPT Pivotal 2 trials are expected in 2Q14. Pfizer is also conducting the Phase III OPT Extend extension trial. ...