It has been unusual for companies to risk direct comparisons of new agents with recent vintage competitors, but that is beginning to happen in the crowded market for biologic agents in psoriasis. It is also important to note that the trend toward a higher bar for efficacy assessment of treatments for this disease is continuing with a 100% reduction in the psoriasis area-and-severity index score (PASI 100) being used as the benchmark for efficacy.
In two phase III studies (AMAGINE-2 and AMAGINE-3), patients with moderate-to-severe psoriasis were randomized to brodalumab, ustekinumab, or placebo.
The primary aims were to evaluate the superiority of brodalumab over placebo at week 12 with the primary endpoint being the percent of patients achieving at least a 75% reduction in the psoriasis area-and-severity index score (PASI 75) and a static physician’s global assessment (sPGA) score of 0 or 1 (clear or almost clear skin), as well as the superiority of brodalumab over ustekinumab at week 12 with respect to PASI 100.
At week 12, PASI 100 response rates were significantly higher with 210 mg of brodalumab than with ustekinumab (AMAGINE-2, 44% vs 22%; AMAGINE-3, 37% vs 19%; P<0.001).
Rates of neutropenia were higher with brodalumab and with ustekinumab than with placebo and mild or moderate candida infections were more frequent with brodalumab than with ustekinumab or placebo (Lebwohl, 2015).
Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373:1318-28.