Mepolizumab incompletely suppresses clinical flares in a pilot study of episodic angioedema with eosinophilia

J Allergy Clin Immunol. 2024 Mar;153(3):821-830.e6. doi: 10.1016/j.jaci.2023.11.002. Epub 2023 Nov 10.

Abstract

Background: Episodic angioedema with eosinophilia (EAE) is a rare multilineage cyclic syndrome of unknown etiology characterized by episodes of angioedema, myalgia, fatigue, and fever that occur every 3 to 8 weeks and resolve between episodes without therapy. Cyclic elevations in serum IL-5 levels and neutrophils precede the increase in absolute eosinophil count (AEC) in most patients.

Objective: We sought to assess the role of IL-5-driven eosinophilia in the clinical manifestations of EAE.

Methods: An open-label pilot study of mepolizumab (700 mg intravenously monthly for 3 months followed by sequential dose reduction to the Food and Drug Administration-approved dose of 300 mg subcutaneously monthly) was conducted. The primary end point was reduction in the number and severity of clinical symptoms as assessed by patient-reported symptom questionnaires. Secondary end points were greater than or equal to 75% reduction in peak AEC after 1 dose of mepolizumab and sustained reduction in AEC after 3 doses of mepolizumab. Exploratory end points included effects of mepolizumab treatment on other cell lineages (numbers and surface marker expression), levels of plasma mediators, and biomarkers of eosinophil activation.

Results: Four female and 1 male (median age, 45 years) participants with EAE were enrolled. None of the 5 participants experienced a reduction in the number of symptomatic flares on mepolizumab therapy, and 1 participant withdrew before study completion because of lack of improvement. Peak AEC was reduced by 75% or more in 3 participants after the first dose of mepolizumab and in 4 participants after 3 doses.

Conclusions: In a small cohort of participants with EAE, mepolizumab was unsuccessful in substantially reducing clinical symptoms despite reduction in AEC.

Keywords: Gleich syndrome; Hypereosinophilic syndrome; IL-5; biologic therapy; episodic angioedema with eosinophilia; mepolizumab.

MeSH terms

  • Angioedema*
  • Antibodies, Monoclonal, Humanized*
  • Eosinophilia* / drug therapy
  • Eosinophils
  • Female
  • Humans
  • Interleukin-5
  • Male
  • Middle Aged
  • Pilot Projects

Substances

  • mepolizumab
  • Interleukin-5
  • Antibodies, Monoclonal, Humanized