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news.Pfizer's ORAL Scan Phase 3 study (A3921044) of tofacitinib has met all primary endpoints at the 10mg BID dose, showing prominant changes versus placebo in reducing signs and symptoms of rheumatoid arthritis (RA).
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Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for RA.
ORAL Scan is an ongoing two-year study that randomized 800 patients with moderate-to-severe active RA who had an inadequate response to MTX to receive tofacitinib 5 or 10 mg BID or placebo added to background MTX.
The study showed improvements in 5mg BID dose, versus placebo in ACR20 response rates at six months, but the difference from placebo in mTSS did not reach statistical significance at six months.
Pfizer said that the efficacy and safety profile of tofacitinib in this study remains consistent with that seen previously in the clinical program.