Xeljanz Demonstrates Efficacy in Chronic Plaque Psoriasis

Pfizer announced results from OPT Compare (A3921080), a Phase 3 study of Xeljanz (tofacitinib) for the treatment of adults with moderate-to-severe chronic plaque psoriasis. Xeljanz is the first in a new class of treatment, oral Janus kinase (JAK) inhibitor.

OPT Compare is a randomized, double-blind, double-dummy, placebo-controlled, 12-week, non-inferiority study comparing the efficacy and safety of tofacitinib 5mg and 10mg twice daily (BID) to high-dose Enbrel 50mg twice weekly (BIW), the approved starting dose for Enbrel (entanercept) for the first 12 weeks, and placebo for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis.

The results of OPT Compare demonstrated that tofacitinib 10mg BID was non-inferior to high-dose Enbrel 50mg BIW as measured by Psoriasis Area and Severity Index (PASI) 75 response and Physician’s Global Assessment (PGA) response. The proportion of patients that achieved a PASI75 response at week 12 was: tofacitinib 10mg BID (63.6%); Enbrel 50mg BIW (58.8%); tofacitinib 5mg BID (39.5%); placebo (5.6%). The proportion of patients that achieved “clear” or “almost clear” in PGA at week 12 were: tofacitinib 10mg BID (68.2%); Enbrel 50mg BIW (66.3%); tofacitinib 5mg BID (47.1%); placebo (15.0%). Tofacitinib 5mg BID did not meet the non-inferiority criterion of 15% difference compared to high-dose Enbrel as measured by PASI75.

Results for the second completed study, OPT Retreatment (A3921111), were previously announced in October 2013. Results from two of the three remaining trials in the Phase 3 Oral treatment Psoriasis Trial (OPT) Program, the OPT Pivotal 1 and OPT Pivotal 2 trials (A3921078 and A3921079), are anticipated in the second quarter of 2014, and these four studies, in addition to a long-term extension study, will form the planned psoriasis submission package to regulatory authorities.

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