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news.Pfizer has reported positive top-line results from the ORAL Start Phase 3 study of Tofacitinib in patients with moderate-to-severe active rheumatoid arthritis (RA).
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The ongoing two-year study in methotrexate (MTX)-naïve patients with moderate-to-severe active RA, randomized to receive tofacitinib 5mg or 10mg twice-daily (BID) as monotherapy or MTX, met its primary endpoints at both the 5mg and 10mg BID doses.
As measured by change from baseline in modified Total Sharp Score (mTSS), Tofacitinib was found to be superior to MTX with statistically significant changes shown in inhibiting structural damage.
As measured by ACR70 response rates Tofacitinib was found to be superior to MTX with statistically significant changes shown in reducing signs and symptoms of RA.
Both the primary endpoints assessed tofacitinib versus MTX at six months and the company reported the data from a planned analysis at one year.
The study reported that the safety profile of tofacitinib remained consistent with that seen previously in the clinical development program.