Poster Session C
Vasculitis
Peter Merkel, MD,MPH
University of Pennsylvania
Philadelphia, Pennsylvania, United States
No financial relationships with ineligible companies to disclose
Patients with EGPA were enrolled in LAP if on an oral corticosteroid dose ≥5mg/day after the end of MIRRA; all patients received mepolizumab 300mg subcutaneous every 4 weeks + standard of care. Follow-up was until discontinuation or after licensing of mepolizumab for EGPA in the patient’s country. Treatment exposure, on-treatment adverse events (AEs) and serious AEs (SAEs) are reported.
Results:
In total 115 patients enrolled in two LAP. Mean (SD) age: 49.7 (13.8) years; 68% completed treatment; 3% discontinued due to an AE. Total exposure was 394.32 subject-years (median [min–max]: 28 [1–91] months). AEs and SAEs occurred in 97% (38% drug-related) and 38% (5% drug-related) of patients; 2 patients had fatal SAEs (non-drug-related). The most common SAE reported was worsening asthma (6%) (Table).
Conclusion:
Long-term safety data for mepolizumab (≤7.6 years) are consistent with its known safety profile. The high completion rate in LAP suggests mepolizumab is well tolerated with a positive benefit:risk profile.
Funding: GSK (MEA116841, 201607)
Abstract previously submitted to European Respiratory Society (ERS) 2024 Annual Scientific Meeting.
Table. On-treatment adverse events and serious adverse events by preferred term during the two long-term access programmes*
G. Wolff: GSK, 3, 12, Holds financial equities in GSK; M. Wechsler: Allakos, 1, 2, 6, Amgen, 1, 2, 6, Areteia Therapeutics, 1, 2, 6, Arrowhead Pharmaceutical, 1, 2, 6, AstraZeneca, 1, 2, 6, Avalo Therapeutics, 1, 2, 6, Celldex, 1, 2, 6, Connect Biopharma, 1, 2, 6, Eli Lilly, 1, 2, 6, Equilium, 1, 2, 6, Genetech, 2, Glaxosmithkline, 1, 2, 6, Incyte, 1, 2, 6, Kinaset, 1, 2, 6, Kymera, 1, 2, 6, Merck, 1, 2, 6, Novartis, 2, Phylaxis, 1, 2, 6, Pulmatrix, 1, 2, 6, Rapt Therapeutics, 1, 2, 6, recludix Pharma, 1, 2, 6, Regeneron, 1, 2, 6, Roche/Genentech, 1, 2, 6, Sanofi/Genzyme, 1, 2, 6, Sentien, 1, 2, 6, Sound Biologics, 1, 2, 6, Tetherex Pharmaceuticals, 1, 2, 6, Teva, 2, Uniquity Bio, 1, 2, 6, Upstream Bio, 1, 2, 6, Verona Pharma, 1, 2, 6, Zurabio, 1, 2, 6; J. Silver: GSK, 3, 12, Holds financial equites; R. Price: GSK, 3, 12, Holds financial equities; R. Verghis: GSK, 3, 12, Holds financial equities; P. Weller: AstraZeneca, 12, Data and safety monitoring boards, GSK, 12, Data and safety monitoring boards; P. Merkel: AbbVie/Abbot, 2, AstraZeneca, 2, Boehringer Ingelheim, 2, GlaxoSmithKlein(GSK), 2, Roche, 5; T. Corbridge: GlaxoSmithKlein(GSK), 3, 12, financial equities; P. Khoury: American Partnership for Eosinophilic Disorders, 5.