The efficacy and safety profile of tofacitinib in this study was expected based on what was seen in the Phase 2 clinical trial and dose modeling. Rates of selected safety events of special interest in the study patient population, including serious infections, herpes zoster, non-melanoma skin cancer and cardiovascular events, were below 1 percent and similar for all active treatment groups (both tofacitinib arms and the ENBREL arm). The most frequent adverse events across active treatment groups were infections (most commonly nasopharyngitis and upper respiratory tract infections). Injection site reactions were more frequent among patients receiving active ENBREL treatment compared with the tofacitinib and placebo arms, whereas increases in cholesterol and creatine phosphokinase were more common in tofacitinib recipients.
The detailed OPT Compare study results mark the completion of the first Phase 3 trial for tofacitinib in psoriasis. Top-line results for the second completed study, OPT Retreatment (A3921111), were previously announced in October 2013, and detailed results will be presented at a future scientific meeting. Top-line 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.
About OPT Compare (A3921080)
OPT Compare was a Phase 3 randomized, double-blind, double-dummy, placebo-controlled 12-week non-inferiority study comparing the efficacy and safety of tofacitinib 5 mg and 10 mg BID to high-dose ENBREL (etanercept) 50 mg BIW and placebo (oral tablet and subcutaneous injection) for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who had an inadequate response to, intolerance to, or contraindication to conventional systemic therapy. Patients that previously failed treatment with a tumor necrosis factor (TNF) inhibitor were excluded from this study. There were 1,106 patients enrolled in this study in 23 countries outside of the U.S. and Canada (three Latin American countries, three in Asia, 16 in Europe, and one in the Middle East).