GlaxoSmithKline says both co-primary endpoints and all secondary endpoints were met in a pivotal phase III study investigating the efficacy and safety of mepolizumab, an IL-5 antagonist, in patients with relapsing and refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA), a rare disease characterised by widespread inflammation in the walls of small blood vessels (vasculitis).
A key goal of treatment for EGPA is to induce and maintain remission while reducing the use of corticosteroids and other immunosuppressive therapies.
The co-primary endpoints for this 52-week study assessed the total duration of remission and the proportion of patients that achieved sustained remission following treatment with mepolizumab compared to treatment with placebo, both on top of standard of care.
Remission for these two endpoints was defined by a Birmingham Vasculitis Activity Score (BVAS), a scoring system to assess disease activity, of 0 and corticosteroid dose <4mg/day prednisolone/prednisone.
The study also included six secondary endpoints investigating relapse, remission and corticosteroid use, all considered clinically relevant for patients with EGPA. Patients demonstrated statistically significant differences, in favour of mepolizumab, for all secondary endpoints compared to placebo.
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