12th Nov 2014 07:32
LONDON (Alliance News) - AstraZeneca PLC and Amgen Inc Wednesday said psoriasis treatment Brodalumab met all the primary endpoints and key secondary endpoints in a phase III study into its use in patients with moderate-to-sever plaque psoriasis.
The trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, comparing it with both Stelara and placebo at week 12.
"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," AstraZeneca said in a statement.
"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," it added.
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, AstraZeneca said.
"These results are of particular importance as they are the first to demonstrate superiority to Stelara in achieving total skin clearance, and the second positive pivotal Phase III study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis," said Sean E. Harper, executive vice president of research and development at Amgen.
The pharmaceutical giants said the most common adverse events that occurred in the brodalumab arms were common cold, joint pain, upper respiratory tract infection and headache. Serious adverse events occurred in 1.4% of patients in the 210 milligram group and 1.6% of patients in the 140 milligram group compared with 0.6% for Stelara and 1% for placebo during the placebo-controlled period.
The companies said they will share the results of a second head-to-head study comparing brodalumab with Stelara later this year.
By Steve McGrath; [email protected]; @stevemcgrath1
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