Mixed Ph III data for Pfizer's tofacitinib vs Enbrel in plaque psoriasis

US pharma giant Pfizer (NYSE:PFE) has announced detailed results from OPT Compare (A3921080), a Phase III study of tofacitinib (trade name Xeljanz), the first in a new class of treatment, oral Janus kinase (JAK) inhibitors, the safety and efficacy of which are being investigated for the treatment of adults with moderate-to-severe chronic plaque psoriasis.

Top-line results from OPT Compare were previously announced in October 2013. This is the first of five studies from the Phase III Oral treatment Psoriasis Trial (OPT) Program, one of the largest global clinical trial programs in moderate-to-severe chronic plaque psoriasis to date, Pfizer noted.

The results of OPT Compare showed that in a step-down procedure design, tofacitinib 10mg twice daily (BID) was non-inferior to high-dose Enbrel (etanercept, marketed by Pfizer and Amgen) 50mg twice weekly (BIW), and tofacitinib 5mg twice daily did not meet the non-inferiority criteria compared to high-dose Enbrel. No new safety signals for tofacitinib were observed in the OPT Compare study. Detailed results of this study were being presented as an oral presentation during the Latest in Dermatology Research Symposium at the 72nd American Academy of Dermatology (AAD) Annual Meeting held in Denver.