Fostamatinib disodium: Phase III data
Top-line data from the 12-month, double-blind, international Phase III OSKIRA-1 trial in 923 RA patients who had an inadequate response to methotrexate showed that both regimens of fostamatinib plus methotrexate met the co-primary endpoint of improving ACR20 response rate at week 24 vs. placebo plus methotrexate, but missed the co-primary endpoint of improving mTSS from baseline to week 24 vs. placebo plus methotrexate. Specifically, ACR20 response rate at week 24 was 49% (p<0.001) in patients who received twice-daily 100 mg fostamatinib and 44% (p=0.006) in patients who received twice-daily 100 mg fostamatinib for 4 weeks followed by once-daily 150 mg fostamatinib vs. 34% for placebo. Detailed data for the mTSS endpoint were not disclosed (p=0.252 and p=0.17, respectively). The most common adverse events reported were hypertension, diarrhea, nausea, headache and nasopharyngitis. ...