Filgotinib: Phase IIb final data

Final data from the double-blind, international Phase IIb DARWIN 1 trial in 594 patients with moderate to severe RA who had an inadequate response to methotrexate showed that once-daily 200 mg and twice-daily 100 mg filgotinib as an add-on to methotrexate each significantly improved ACR20 response rate at week 24 vs. placebo as an add-on to methotrexate (73% and 80%, respectively, vs. 42%, p<0.001 for both). The once-daily 50 and 100 mg doses of filgotinib and twice-daily 25 and 50 mg doses of filgotinib as an add-on to methotrexate led to ACR20 response rates at week 24 of 55%, 60%, 56% and 60%, respectively.

Additionally, once-daily filgotinib led to ACR50 response rates at week 24 of 35% at the 50 mg dose (p<0.05), 46% at the 100 mg dose (p<0.001) and 50% at the 200 mg dose (p<0.001) and twice-daily filgotinib led to ACR50 response rates at week 24 of 35% at the 25 mg dose (p<0.05), 35% at the 50 mg dose (p<0.05) and 55% at the 100 mg dose (p<0.001) vs. 17% for placebo. Once-daily filgotinib led to ACR70 response rates at week 24 of 22% at the 50 mg dose (p<0.05), 33% at the 100 mg dose (p<0.01) and 29% at the 200 mg dose (p<0.01) and twice-daily filgotinib led to ACR70 response rates at week 24 of 21% at the 25 mg dose (p<0.05), 24% at the 50 mg dose (p<0.05) and 39% at the 100 mg dose (p<0.001) vs. 9% for placebo. ...