Pfizer announced results from two of its Phase 3 studies, ORAL Standard and Oral Step, of tofacitinib (CP-690,550) for the treatment of active rheumatoid arthritis. ORAL Standard is a completed 12-month study in patients with moderate-to-severe active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX) and were randomized to receive tofacitinib 5mg or 10mg twice daily, adalimumab 40mg subcutaneously every other week or placebo, each of which was added to stable background MTX. ORAL Step is a completed six-month study in patients with moderate-to-severe active RA who had an inadequate response to a TNF inhibitor and were randomized to receive tofacitinib 5mg or 10mg twice daily or placebo, which were added to stable background MTX as well.

The ORAL Standard study met all its primary endpoints at the 5mg and 10mg twice daily doses, showing statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by the American College of Rheumatology (ACR) Criteria ACR20 response rate at six months; in improving physical function, measured by mean change in Health Assessment Questionnaire – Disease Index (HAQ DI) at three months; and in reaching DAS28-4(ESR) <2.6 at six months. ORAL Step also met all primary endpoints at the 5mg and 10mg twice daily doses, showing statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates; in improving physical function, as measured by mean change in HAQ DI; and in reaching DAS28-4(ESR) <2.6, all assessed at three months.

Tofacitinib is an oral Janus kinase (JAK) inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for RA.

For more information call (800) 438-1985 or visit www.pfizer.com.