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Detailed Results:
In this study, treatment with brodalumab every other week resulted in mean improvements in PASI scores of 85.9 percent (140 mg), 86.3 percent (210 mg) and 45.0 percent (70 mg) versus 16.0 percent with placebo (all p<0.001). A monthly dose of brodalumab at 280 mg was associated with a mean PASI improvement of 76 percent. Approximately 30 percent of patients in the placebo group had worsening psoriasis.
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.
Study Design:
The study was a Phase 2, randomized, double-blind, placebo-controlled, dose-ranging trial designed to assess the efficacy and safety of brodalumab in moderate to severe plaque psoriasis. Patients with a PASI >12 and affected body surface area >10 percent were randomized to receive brodalumab (70, 140 or 210 mg at day one and weeks 1, 2, 4, 6, 8 and 10 or 280 mg monthly) or placebo.
About Brodalumab (AMG 827)
Brodalumab (AMG 827) is a highly-selective human monoclonal antibody that binds to and blocks signaling via the IL-17 receptor. The IL-17 pathway plays an important role in inducing and promoting inflammatory disease processes.
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).
Source: amgen.com
In this study, treatment with brodalumab every other week resulted in mean improvements in PASI scores of 85.9 percent (140 mg), 86.3 percent (210 mg) and 45.0 percent (70 mg) versus 16.0 percent with placebo (all p<0.001). A monthly dose of brodalumab at 280 mg was associated with a mean PASI improvement of 76 percent. Approximately 30 percent of patients in the placebo group had worsening psoriasis.
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.
Study Design:
The study was a Phase 2, randomized, double-blind, placebo-controlled, dose-ranging trial designed to assess the efficacy and safety of brodalumab in moderate to severe plaque psoriasis. Patients with a PASI >12 and affected body surface area >10 percent were randomized to receive brodalumab (70, 140 or 210 mg at day one and weeks 1, 2, 4, 6, 8 and 10 or 280 mg monthly) or placebo.
About Brodalumab (AMG 827)
Brodalumab (AMG 827) is a highly-selective human monoclonal antibody that binds to and blocks signaling via the IL-17 receptor. The IL-17 pathway plays an important role in inducing and promoting inflammatory disease processes.
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).
Source: amgen.com