AstraZeneca and Amgen's brodalumab achieves primary endpoint in Phase III trial for plaque psoriasis

Anglo-Swedish drug major AstraZeneca (LSE: AZN) and USA-based Amgen (Nasdaq: AMGN), the world’s largest independent biotech firm, say that a Phase III trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, when compared with Stelara (ustekinumab) and placebo at week 12, has met its primary endpoint.

Brodalumab was shown to be superior to Stelara on the primary endpoint of achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index (PASI 100). When compared with placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% percent improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index (PASI 75). A significantly greater proportion of patients treated with brodalumab also achieved clear or almost clear skin at week 12 compared with placebo, according to the static Physician Global Assessment (sPGA 0 or 1). All key secondary endpoints comparing brodalumab with Stelara and placebo were also met.

Results showed that 36.7% of patients in the brodalumab 210 mg group, 27% of patients in the brodalumab 140 mg group, 18.5 percent of patients in the Stelara group and 0.3% of patients in the placebo group achieved total clearance of skin disease (PASI 100). In addition, 85.1% of patients in the brodalumab 210 mg group, 69.2% of patients in the brodalumab 140 mg group, 69.3% of patients in the Stelara group and 6% of patients in the placebo group achieved PASI 75.