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Oct 01, 2012
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Tofacitinib: Additional Phase III data

Additional data from the double-blind, international Phase III ORAL Start (A3921069) trial in 952 methotrexate-naïve patients with moderate to severe active RA showed that twice-daily 5 and 10 mg oral tofacitinib significantly inhibited structural damage as measured by the change from baseline in mTSS on radiographic scans at 6 months, a co-primary endpoint, vs. methotrexate (0.18 and 0.04 points, respectively, vs. 0.84 points; p<0.001 and p<0.0001). ACR70 response rates, also a co-primary endpoint, were 25.5% for low-dose tofacitinib and 37.7% for high-dose tofacitinib vs. 12% for methotrexate (p<0.0001 for both). In July, Pfizer reported top-line data from the trial showing that both doses of tofacitinib met...

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