Pfizer Touts Positive Results in Phase III Psoriasis Trials

Tofacitinib met its efficacy endpoints of superiority over placebo at week 16 in adult patients with moderate-to-severe plaque psoriasis in two pivotal Phase III trials, Pfizer said Tuesday.

The multi-site, randomized, double-blind, placebo-controlled and parallel-group Oral Treatment Psoriasis Trials evaluated twice-daily oral tofacitinib for more than 52 weeks in more than 900 patients worldwide.

The trials make up two of five trials in Pfizer’s Phase III psoriasis program that follow more than 3,600 patients. The remaining three studies compare tofacitinib to Enbrel (etanercept) and placebo, evaluate withdrawal and retreatment, and safety and tolerability. The company is planning to use the results of this program to support an sNDA next year.

According to the drugmaker, 7.4 million people in the U.S. have plaque psoriasis, approximately half are dissatisfied with their treatment with ointments or oral or injected medicines, driving a need for a new class of therapies such as its Janus kinase inhibitor.

Tofacitinib is already indicated in patients with moderate-to-severe rheumatoid arthritis in more than 20 countries, including the U.S., where it is known as Xeljanz.

Spokeswoman Victoria Davis said that these studies will be used to support plaque psoriasis indications in non-U.S. markets as well. — Lena Freund

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