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|Amgen Announces Phase 2 Study Results for Brodalumab in Moderate to Severe Plaque Psoriasis Published in the New England Journal of Medicine|
PASI score is a measure of psoriatic plaque redness, scaling and thickness and the extent of involvement in each region of the body. Treatment efficacy is often measured by the reduction of PASI from baseline (i.e., a 75 percent reduction is known as PASI 75, a 90 percent reduction is known as PASI 90 and a PASI 100 is total clearance of skin disease).
"There are a variety of treatment options available to those living with psoriasis, yet these options are unable to help many patients achieve their therapeutic goals," explained
Psoriasis affects approximately 125 million people worldwide and is a chronic disease of the immune system that causes the skin cells to grow at an accelerated rate. Although there are several types of psoriasis, approximately 80 percent of patients have plaque psoriasis, which can cause painful and itchy red, scaly patches to appear on the skin.
The study also evaluated secondary endpoints including PASI 75, PASI 90 and PASI 100, which indicate 75 percent, 90 percent and 100 percent reductions in patient PASI scores from baseline, respectively. In patients dosed with 140 mg of brodalumab, 77 percent achieved a 75 percent reduction in their PASI score, 72 percent achieved a 90 percent reduction and 38 percent experienced total clearance (PASI 100) (all p<0.001). In patients dosed with 210 mg of brodalumab, 82 percent achieved a 75 percent reduction, 75 percent achieved a 90 percent reduction and 62 percent experienced total clearance (PASI 100) (all p<0.001).
The most commonly reported adverse events in the combined brodalumab groups were common cold (eight percent), upper respiratory tract infection (eight percent) and injection site redness (six percent). Two cases of grade three neutropenia were reported in the 210 mg brodalumab group.
About Brodalumab (AMG 827)
Brodalumab is the only investigational treatment in development that blocks the IL-17 receptor, thereby blocking several of the IL-17 ligands at once from sending signals to the body. Currently, other agents in development seek to target the individual IL-17 ligands. By stopping IL-17 ligands from binding with the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation and other ailments.
Brodalumab is currently being investigated for the treatment of psoriasis (Phase 2 and planned Phase 3), psoriatic arthritis (Phase 2) and asthma (Phase 2).
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