Tofacitinib Meets Endpoints in Two Phase 3 Psoriasis Trials
Pfizer announced top-line results from two pivotal Phase 3 trials, evaluating the efficacy and safety of Xeljanz (tofacitinib) for the treatment of moderate-to-severe plaque psoriasis.
OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079) were 52-week, multi-site, randomized, double-blind, placebo-controlled, parallel-group Phase 3 studies within the Oral treatment Psoriasis Trials (OPT) Program. The efficacy and safety of tofacitinib 5mg and 10mg twice daily in patients with moderate-to-severe chronic plaque psoriasis, who are candidates for systemic therapy or phototherapy was evaluated in over 900 patients per trial.
The primary efficacy endpoint was met in both studies of statistically significant superiority over placebo at Week 16 in the proportion of subjects achieving a Physician's Global Assessment response of “clear” or “almost clear,” and the proportion of subjects achieving at least a 75% reduction in Psoriasis Area and Severity Index.
Previously, Pfizer announced results from the first two studies of the OPT Program, OPT Compare (A3921080) and OPT Retreatment (A3921111). The Phase 3 OPT program consists of five studies including one long-term extension study, OPT Extend (A3921061) that are evaluating the use of tofacitinib in adults with moderate-to-severe chronic plaque psoriasis.
Xeljanz (tofacitinib), an oral Janus kinase (JAK) inhibitor, is already approved for moderately-to-severely active rheumatoid arthritis with inadequate response or intolerance to methotrexate.
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