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Positive results from two phase 3 trials of Tofacitinib in adults with moderate-to-severe chronic plaque psoriasis


Pfizer has announced top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials ( OPT ) Program, OPT Pivotal #1 ( A3921078 ) and OPT Pivotal #2 ( A3921079 ), evaluating the efficacy and safety of Tofacitinib ( Xeljanz ), an oral Janus kinase ( JAK ) inhibitor, the first in a new class of medicines being investigated for the treatment of moderate-to-severe plaque psoriasis.
The OPT Pivotal #1 and OPT Pivotal #2 studies have shown that Tofacitinib, as a 5 mg or a 10 mg dose taken as a pill twice-daily, met the primary efficacy endpoints 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 PASI ( Psoriasis Area and Severity Index ), two commonly used measures of efficacy in psoriasis.

No new safety signals for Tofacitinib were observed in the OPT Pivotal #1 or OPT Pivotal #2 studies.

OPT Pivotal #1 and OPT Pivotal #2 were phase 3, 52-week, multi-site, randomized, double-blind, placebo-controlled, parallel-group studies evaluating the safety and efficacy of Tofacitinib 5 mg and 10 mg twice-daily in patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. There were over 900 patients randomized into each of the studies.

OPT clinical trial program

The phase 3 OPT clinical trial program consists of five studies ( including one long-term extension study ) evaluating oral Tofacitinib 5 mg and 10 mg twice-daily in adults with moderate-to-severe chronic plaque psoriasis. It is a global, comprehensive clinical development program that includes over 3,600 patients in 36 countries, and is one of the largest global clinical trial programs in moderate-to-severe chronic plaque psoriasis to date. In addition to the OPT Pivotal #1 and OPT Pivotal #2 studies, the OPT Program includes the following phase 3 studies of Tofacitinib in adults with moderate-to-severe chronic plaque psoriasis:

OPT Compare ( A3921080 ): a 12-week, phase 3 study comparing the efficacy and safety of Tofacitinib 5 mg and 10 mg twice-daily to high-dose Etanercept ( Enbrel ) 50 mg twice-weekly as well as to placebo;

OPT Retreatment ( A3921111 ): a phase 3 study evaluating the efficacy and safety of the withdrawal from, and then the retreatment with, Tofacitinib 5 mg and 10 mg twice-daily compared to placebo;

OPT Extend ( A3921061 ): a long-term extension study evaluating the safety and tolerability of Tofacitinib. Patients who participated in the phase 2 trial or any of the other phase 3 studies had the option, if eligible, to enroll in this study.

Psoriasis is a chronic, immune-mediated disease, affecting the skin and other organs, such as nails and joints. It affects approximately two-to-three percent of people worldwide and 7.4 million people in the United States.
Due to inconsistent response to treatment, adverse effects, and the limited persistence of therapeutic effects of some therapies, a need for additional therapies for patients with moderate-to-severe chronic plaque psoriasis still remains.
According to recently published surveys, approximately 50% of patients with psoriasis are dissatisfied with their treatment, and under-treatment represents a significant problem.
Even though guidelines typically state that moderate-to-severe patients are candidates for systemic therapy many treated adult plaque psoriasis patients appear to be undertreated, with approximately 30% of treated moderate patients and 22% of treated severe patients receiving only topical therapies, like ointments and creams, in the U.S. ( Xagena )

Source: Pfizer, 2014

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