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Long-Term Safety and Effectiveness of Mepolizumab 300 mg in Europe (Mepo LTF Study)
Sponsor: European EGPA Study Group
Summary
This observational study aims to evaluate the long-term effectiveness and safety of mepolizumab 300 mg/4 weeks in adults with eosinophilic granulomatosis with polyangiitis (EGPA) in the European real-life setting. The main questions it aims to answer are: * How effective is mepolizumab 300 mg/4 weeks over long-term follow-up in patients with EGPA? * How safe is mepolizumab 300 mg/4 weeks during long-term treatment? * What are the effects of switching mepolizumab dosage from 300 mg/4 weeks to 100 mg/4 weeks, or from 100 mg/4 weeks to 300 mg/4 weeks? Participants already receiving mepolizumab as part of routine clinical practice. Researchers will retrospectively collect demographic, clinical, laboratory, and treatment-related data from medical records. For patients starting mepolizumab 300 mg/4 weeks, data will be collected from treatment initiation and during follow-up up to 60 months. For patients who change mepolizumab dose, data will also be collected at the time of dose switch and 3 months later.
Official title: Assessing The Long-Term Effectiveness and Safety of Mepolizumab 300mg/Month in the European Real-Life Setting (Mepo Long-term Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
591
Start Date
2025-09-18
Completion Date
2026-03-31
Last Updated
2026-09-11
Healthy Volunteers
No
Interventions
Mepolizumab 300 mg
Mepolizumab administered subcutaneously at a dose of 300 mg every 4 weeks in routine clinical practice for adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). In this retrospective observational study, patients may receive mepolizumab 300 mg/4 weeks as the initial regimen or after dose escalation from 100 mg/4 weeks. Dose changes from 300 mg/4 weeks to 100 mg/4 weeks, or from 100 mg/4 weeks to 300 mg/4 weeks, are also evaluated when they occur during routine care; no study-specific treatment is assigned.
Locations (1)
University of Florence
Florence, Florence, Italy