Briakinumab: Phase III data

The double-blind Phase III M10-255 trial in 317 patients showed that briakinumab met the co-primary endpoints of a significantly greater proportion of patients achieving a PASI 75 response at week 24 (81.8% vs. 39.9%, p<0.001) and at week 52 vs. methotrexate (66.2% vs. 23.9%, p<0.001). Briakinumab also met the co-primary endpoints of a significantly greater proportion of patients with a PGA score of 0 or 1 at week 24 (80.5% vs. 34.4%, p<0.001) and at week 52 (63% vs. 20.2%, p<0.001) vs. methotrexate. Furthermore, a significantly greater proportion of patients achieved a PASI 90 response at weeks 24 and 52 (63.6% and 59.7%, respectively, vs. 22.7% and 17.8%; p<0.001 for both), and a PASI 100 response at both time points (42.2% and 45.5%, respectively, vs. 8.6% and 9.2%; p<0.001 for both) vs. methotrexate. ...