ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2482

Long-Term Safety of Mepolizumab in Eosinophilic Granulomatosis with Polyangiitis (EGPA): Pooled Results from Two Open-Label Extension Studies

Gerhard Wolff1, Michael E Wechsler2, Jared Silver3, Robert Price4, Rejina Verghis5, Peter Weller6, Peter Merkel7, Thomas Corbridge8 and Paneez Khoury9, 1Clinical Development-Respiratory, GSK, Collegeville, 2Department of Medicine, National Jewish Health, Denver, CO, 3US Medical Affairs-Respiratory, GSK, Durham, 4Biostatistics, GSK, Stevenage, United Kingdom, 5Biostatistics, Development Respiratory, GSK, Brentford, United Kingdom, 6Beth Israel Deaconess Medical Center, Department of Medicine, Division of Allergy and Inflammation, Harvard Medical School, Boston, MA, 7Division of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, 8US Value Evidence and Outcomes, GSK, Durham, NC, 9National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD

Meeting: ACR Convergence 2024

Keywords: , , ,

Session Information

Date: Monday, November 18, 2024

Title: Vasculitis – ANCA-Associated Poster III

Session Type: Poster Session C

Session Time: 10:30AM-12:30PM

Background/Purpose: The 52-week Phase III MIRRA trial demonstrated the safety and efficacy of anti-IL-5 mepolizumab in patients with EGPA. However, longer-term safety data are limited. This analysis assessed the safety of mepolizumab using pooled data from two Long-term Access Programmes (LAP; NCT03298061/MEA116841, 201607), open-label extensions of MIRRA.

Methods: 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.

Supporting image 1

Table. On-treatment adverse events and serious adverse events by preferred term during the two long-term access programmes*

Disclosures: 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.

To cite this abstract in AMA style:

Wolff G, Wechsler M, Silver J, Price R, Verghis R, Weller P, Merkel P, Corbridge T, Khoury P. Long-Term Safety of Mepolizumab in Eosinophilic Granulomatosis with Polyangiitis (EGPA): Pooled Results from Two Open-Label Extension Studies [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/long-term-safety-of-mepolizumab-in-eosinophilic-granulomatosis-with-polyangiitis-egpa-pooled-results-from-two-open-label-extension-studies/. Accessed .

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