Amgen psoriasis drug tops J&J's Stelara in Phase III study
Nov 11 (Reuters) - Amgen Inc said on Tuesday that its experimental psoriasis drug, brodalumab, met all the goals of a late-stage study, clearing the rough skin patches associated with the disease more thoroughly than Johnson & Johnson's Stelara and a placebo.
Amgen is developing brodalumab under a multi-drug collaboration with AstraZeneca that involves splitting costs and eventual profits.
After 12 weeks of treatment of 1,881 patients with moderate to severe plaque psoriasis, 36.7 percent who received the 210 milligram dose of brodalumab and 27 percent treated with 140 mg of the Amgen drug achieved total clearance of the skin disease. That compared with 18.5 percent of those treated with Stelara and 0.3 percent in the placebo group.
On a secondary measure, 85.1 percent in the higher-dose brodalumab group and 69.2 percent who got the lower dose achieved at least a 75 percent improvement in disease severity at week 12 versus 69.3 for J&J's Stelara and 6 percent of the placebo group.
"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," Amgen research and development chief Sean Harper said in a statement.
The most common adverse side effects seen with brodalumab were common cold symptoms, joint pain, upper respiratory tract infection and headache. There were more adverse side effects deemed to be serious with the Amgen antibody than with Stelara.
Serious adverse events were reported in 1.4 percent for the higher dose of brodalumab and 1.6 percent in the 140 mg group, compared with just 0.6 percent for Stelara and 1 percent in the placebo group.
(Reporting by Bill Berkrot; Editing by Lisa Von Ahn)
