Review Article

Safety and Efficacy of Mepolizumab in Patients with Eosinophilic Granulomatosis with Polyangiitis

Table 1

Key methodological characteristics of selected studies.

AuthorYearCountryJournalSample sizeStudy designInclusion criteriaExclusion criteriaPrimary end pointMepolizumab dose

Wechsler et al. [14]2017USANEJM68 versus 68RCTAge 18 years and above
Diagnosis of relapsing or refractory EGPA at least 6 months previously and had been taking stable dose of prednisolone or prednisone (≥7.5 to ≤50.0 mg per day, with or without additional immunosuppressive therapy) for at least 4 weeks before the baseline visit
Granulomatosis with polyangiitis or microscopic polyangiitis
Organ-threatening or life-threatening eosinophilic granulomatosis with polyangiitis within 3 months before screening
Accrued weeks of remission over a 52-week period
Proportion of participants in remission at both week 36 and week 48
300 mg s.c. every 4 weeks

Kim et al. [16]2010USAJournal of Allergy and Clinical Immunology7Open-label pilot studyA diagnosis of CSS as defined by the American College of Rheumatology classification criteria.
Patient to be maintained on a stable dose of at least 10 mg of prednisone daily (or equivalent) before enrollment.
Subjects receiving adjunct therapies, such as cyclophosphamide, azathioprine, or methotrexate, were required to maintain a stable dose so that medication withdrawal would not obfuscate potential drug benefits.
Patients with non-CSS hypereosinophilic syndromes, Wegener granulomatosis, malignancy, or parasitic disease.
Pregnant or nursing female patients.
Female subjects with child-bearing potential.
Whether mepolizumab safely decreased
CSS disease activity and permitted scheduled tapering of systemic
Corticosteroids.
Lowest prednisone dose achieved at the end of the treatment phase
750 mg i.v. infusion every four to six weeks

Moosig et al. [15]2011GermanyAnnals of Internal Medicine10Uncontrolled trialPatients with active refractory or relapsing active Churg–Strauss syndrome, defined by a Birmingham Vasculitis
Activity Score (BVAS) greater than 3 despite treatment with immunosuppressants plus glucocorticoids at a dosage of 12.5 mg/d or higher.
NARemission at week 32, as defined by recommendations from the European League Against Rheumatism of a BVAS of 0 and a glucocorticoid dosage of less than 7.5 mg/d.750 mg i.v. infusion every 4 weeks

Remission was defined as Birmingham Vasculitis Activity Score (BVAS) of zero and the receipt of prednisolone or prednisone at a dose of 4 mg or less per day over the 52-week period.