Brodalumab: Phase III data

The double-blind, international Phase III AMAGINE-2 trial in >1,800 patients with moderate to severe plaque psoriasis showed that 140 and 210 mg subcutaneous brodalumab every 2 weeks each met the co-primary endpoints of improving PASI 75 response rate and of a greater proportion of patients achieving an sPGA score of “clear” or “almost clear” at week 12 vs. placebo. Additionally, high-dose brodalumab and a pre-specified brodalumab weight-based stratification arm (of patients receiving low- or high-dose brodalumab) each met the co-primary endpoint of improving PASI 100 response rate at week 12 vs. Stelara ustekinumab. Low-dose brodalumab did not significantly improve PASI 100 response rate at week 12 vs. Stelara (p=0.078).

Specifically, 66.6% of patients receiving low-dose brodalumab, 86.3% of patients receiving high-dose brodalumab and 77% of patients in the weight-based analysis achieved a PASI 75 response at week 12 vs. 70% of patients receiving Stelara and 8.1% of patients receiving placebo. Additionally, 25.7% of patients receiving low-dose brodalumab, 44.4% of patients receiving high-dose brodalumab and 33.6% of patients in the weight-based analysis achieved a PASI 100 response at week 12 vs. 21.7% of patients receiving Stelara and 0.6% of patients receiving placebo. The most common adverse events reported in the brodalumab arms were common cold, upper respiratory tract infection, headache and joint pain. There was 1 fatal event of stroke in the high-dose brodalumab arm, which was deemed unrelated to treatment. ...