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GEN News Highlights : Mar 4, 2011

Second Phase III Trial Demonstrates Promise for Pfizer’s RA Drug

Tofacitinib is being evaluated in six studies, being undertaken in 35 countries.

Pfizer’s tofacitinib showed statistically significant changes versus placebo in reducing signs and symptoms of moderate-to-severe rheumatoid arthritis (RA), according to a new Phase IIII trial. Tofacitinib, formerly known as tasocitinib, is an oral JAK inhibitor.

A full analysis of efficacy and safety data will be submitted to a future scientific meeting. Data released last year from an ORAL Solo (1045) study also showed tasocitinib significantly reduced the signs and symptoms of moderate-to-severe RA. The Phase III ORAL clinical program for tofacitinib includes six studies with more than 350 locations in 35 countries worldwide. More than 4,000 RA patients have been treated with tofacitinib in clinical trials to date.

Data from an ORAL Sync study (A3921046) cited measurement by ACR20 response rates at six months (i.e., a 20% improvement from baseline in the American College of Rheumatology scale); improvement in physical function, as measured by mean change in HAQ DI (Health Assessment Questionnaire Disability Index) at three months; and in attainment of a Disease Activity Score using the erythrocyte sedimentation rate of DAS28-4(ESR) <2.6 at six months.

The ORAL Sync study evaluated tofacitinib doses 5 mg and 10 mg given twice-daily compared to placebo in patients with moderatetosevere RA who had an inadequate response to a previous disease-modifying antirheumatic drug (DMARD). The pateints continued to receive background traditional DMARD therapy throughout the study.