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news.Pfizer has reported that a Phase III study (A3921046) of Tofacitinib, an investigational, novel, oral JAK inhibitor, being evaluated in moderate-to-severe rheumatoid arthritis (RA), met its primary endpoints.
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In the study, Tofacitinib showed changes versus placebo in reducing signs and symptoms of RA; in improving physical function; and in reaching DAS28-4(ESR) <2.6 at six months.
The safety profile of Tofacitinib was consistent with previously seen results of clinical programme, and no new safety signal was identified.
The Phase III study evaluated the efficacy and safety of Tofacitinib doses 5mg and 10mg given twice daily compared to placebo in patients with moderately to severely active RA.