Pfizer Reports Top-Line Trial Results For Tofacitinib

Pfizer reported positive top-line results from two pivotal Phase III trials OPT (Oral treatment Psoriasis Trials) assessing tofacitinib in adults with moderate to severe cases of chronic plaque psoriasis. The company announced plans to submit a supplemental New Drug Application (sNDA) for tofacitinib by early 2015.

OPT Pivotal #1 and OPT Pivotal #2 trials were multi-site, double-blind, placebo controlled, randomized, 52 week, Phase III parallel-group studies investigating the safety and efficacy of tofacitinib 5 mg and 10 mg twice daily in patients who are candidates for systemic therapy or phototherapy. More than 900 patients were randomized into each of the studies.

The study met its primary endpoints . The drug significantly reduced psoriasis-affected areas in patients according to the Psoriasis Area and Severity Index, two commonly used measures of efficacy in psoriasis.

Dr. Steven Romano, Global Medicines Development Lead for the Pfizer Global Innovative Pharmaceutical business, said, “Psoriasis is a long-term disease with no cure that can have a significant impact on patients. Although it is one of the most common chronic inflammatory diseases, many psoriasis patients remain untreated, undertreated, or dissatisfied with their treatment, according to recently published surveys. Tofacitinib is the first in a new class of investigational psoriasis treatments, and I am encouraged by our Phase 3 results to-date that demonstrate the potential of tofacitinib to be an important new treatment option for adults with moderate-to-severe chronic plaque psoriasis.”

Plaque psoriasis is a chronic immune-mediated disease that affects the skin and other organs. is the disease affects two to three percent of people worldwide, with 7.4 million patients in the U.S. alone.

Tofacitinib is a Janus kinase (JAK) inhibitor currently approved for the treatment of moderate to severe rheumatoid arthritis in over 20 countries worldwide. The drug is marketed under the brand name XELJANZ in the U.S.

The company said detailed analysis of the studies, including additional data on the safety and efficacy of tofacitinib, will be presented at a future scientific meeting.