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Positive Results Reported From Two Phase III Trials of Tofacitinib (Xeljanz) in Adults With Plaque Psoriasis
Positive results have been reported from two pivotal phase III studies in the Oral Treatment Psoriasis Trials (OPT) program, which evaluated the efficacy and safety of tofacitinib, an oral Janus kinase (JAK) inhibitor and the first in a new class of medications being investigated for the treatment of moderate-to-severe plaque psoriasis.
The OPT Pivotal #1 and OPT Pivotal #2 studies showed that tofacitinib, as a 5-mg or 10- mg dose taken 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 in the proportion of subjects achieving at least a 75% reduction in the Psoriasis Area and Severity Index, two commonly used measures of efficacy in psoriasis.
Results from the first two studies in the OPT Program — OPT Compare and OPT Retreatment — were reported in October 2013, and these four studies, in addition to a long-term extension study, will form a planned psoriasis submission package. A supplemental new drug application (sNDA) is expected to be submitted to the FDA for the approval of tofacitinib 5 mg and 10 mg twice daily for the treatment of adults with moderate-to-severe chronic plaque psoriasis by early 2015.
OPT Pivotal #1 and OPT Pivotal #2 were phase III, 52-week, 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 were candidates for systemic therapy or phototherapy. More than 900 patients were enrolled into each study.
In addition to these trials, the OPT program includes the following phase III studies of tofacitinib in adults with moderate-to-severe chronic plaque psoriasis:
- OPT Compare: A 12-week, phase III study comparing the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily with that of high-dose etanercept (Enbrel, Amgen) 50 mg twice weekly and placebo.
- OPT Retreatment: A phase III study evaluating the efficacy and safety of the withdrawal from, and then retreatment with, tofacitinib 5 mg and 10 mg twice-daily compared with placebo.
- OPT Extend: A long-term extension study evaluating the safety and tolerability of tofacitinib.
Tofacitinib is approved in more than 20 countries for the treatment of moderate-to-severe rheumatoid arthritis (RA). In the U.S., the drug — marketed as Xeljanz — is indicated for the treatment of adults with moderately to severely active RA who have shown an inadequate response to or are intolerant of methotrexate.
It is not known whether tofacitinib is safe and effective in children or in patients with hepatitis B or C. The drug should not be used in patients with severe liver problems.
Source: Pfizer; April 22, 2014.