Sendai, Japan – An interim analysis of an ongoing Japanese study published in Modern Rheumatology demonstrates that mepolizumab is safe and effective in improving disease control among patients with eosinophilic granulomatosis with polyangiitis (EGPA), a form of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
Remission is typically achieved and maintained in EGPA via the administration of corticosteroids and immunosuppressants; nevertheless, relapse is common. In addition, chronic corticosteroid use results in a range of well-documented adverse effects.
Mepolizumab is a humanized monoclonal antibody targeting interleukin-5; it works by blocking the proliferation and activation of eosinophils. In 2018, this therapy was approved in Japan for use in patients with EGPA who are refractory to currently available treatments. However, there have been no studies on the long-term safety and efficacy of this therapy in patients with EGPA beyond 96 weeks anywhere in the world.
The authors of the study hence sought to assess the efficacy and safety of mepolizumab over a 96-week period in individuals who have already received this therapy at a dose of 300 mg every 4 weeks for at least 96 weeks, thereby providing data for a combined period of 144 weeks or more. Recruited participants continued to be prescribed the drug at the same dose throughout the study period.
The primary outcome was the frequency and severity of adverse events; secondary outcomes included the average daily dose of oral corticosteroids needed and the proportion of individuals who were without clinical symptoms. A relapse was defined as the worsening of EGPA symptoms accompanied by the need to initiate and/or increase the dose of corticosteroids and/or immunosuppressants, or the need for hospitalization.
One hundred eighteen patients were enrolled in the study. At week 48, an interim analysis was performed. Thirty-four patients experienced adverse events; among them, 15 experienced severe adverse events, most commonly gastrointestinal disorders, infections, and neoplasms. The median daily oral corticosteroid dose was lower at week 48 compared with baseline, while the proportion of patients without clinical symptoms increased during the same period. Only 6 patients experienced a relapse.
“These results provide further evidence of the clinically relevant, real-world benefits of mepolizumab treatment for patients with EGPA in Japan, both for symptom control and as an oral corticosteroid-sparing treatment,” the authors concluded.
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