Top-line results from Pfizer's tofacitinib Phase 3 studies in RA

Pfizer Inc. announced today top-line results from the ORAL Standard (A3921064) and ORAL Step (A3921032) Phase 3 studies of tofacitinib (development code: CP-690,550), an investigational, novel, oral JAK inhibitor.

ORAL Standard is a completed twelve-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 5 or 10 mg BID, adalimumab 40 mg subcutaneously every other week or placebo, each of which was added to stable background MTX.

The ORAL Standard study met all primary endpoints at the 5 and 10 mg BID doses of tofacitinib, showing statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates at six months; in improving physical function, as measured by mean change in HAQ DI at three months; and in reaching DAS28-4(ESR) <2.6 at six months.

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 5 or 10 mg BID or placebo, which were added to stable background MTX.

The ORAL Step study met all primary endpoints at the 5 and 10 mg BID 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.

No new safety signals emerged in the ORAL Standard and ORAL Step studies. The efficacy and safety profile of tofacitinib in these studies remains consistent with that seen previously in the clinical program.

A detailed analysis of the ORAL Standard and ORAL Step efficacy and safety data, including secondary endpoints which are not reported here, will be submitted to a future scientific meeting.