Evidence map›Paper›PMID 40008472›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2025

Long-Term Safety and Efficacy of Mepolizumab in Eosinophilic Granulomatosis With Polyangiitis.

Michael E Wechsler, Jared Silver, Gerhard Wolff, Robert G Price, Rejina Verghis, Peter F Weller, Peter A Merkel, Paneez Khoury, EGPA Mepolizumab Open‐Label Extension Study Group

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03298061 (Mepolizumab Long-term Access Programme for Subjects Who Participated in Study MEA115921), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03298061 phase3completednot on this map

Mepolizumab Long-term Access Programme for Subjects Who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard-of-care Therapy)

TypeinterventionalSponsorGlaxoSmithKlineRan2015 to 2023Enrolled100ConditionsChurg-Strauss Syndrome, Eosinophilic Granulomatosis With PolyangiitisArmsMepolizumab, Prednisolone
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Real-world outcomes and corticosteroid sparing with mepolizumab for EGPA or HES.The journal of allergy and clinical immunology. Global · 2026
    Article
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  6. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Michael E WechslerNational Jewish Health, Denver, Colorado.
Jared SilverGSK, Durham, North Carolina.
Gerhard WolffGSK, Collegeville, Pennsylvania.
Robert G PriceGSK, Stevenage, Hertfordshire, United Kingdom.
Rejina VerghisGSK, London, United Kingdom.
Peter F WellerBeth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Peter A MerkelUniversity of Pennsylvania, Philadelphia.
Paneez KhouryNational Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland. Members of the EGPA Mepolizumab Open-Label Extension study group are listed in Appendix A.ORCID 0000-0003-1800-0079
EGPA Mepolizumab Open‐Label Extension Study Group

Funding

Eosinophils and Eosinophil Activation in the Pathogenesis of Human DiseaseZIAAI001130 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KLION, AMY · 2010 to 2025
$22.5M
Division of Intramural Research, NIAID/NIHGSK GSK ID: MEA116841Intramural NIH HHS ZIA AI001130
6 · The paper itself

Abstract

objectiveEosinophilic granulomatosis with polyangiitis (EGPA) is a rare, relapsing, inflammatory disease. Management of EGPA predominantly relies on oral corticosteroids (OCS), which are associated with many adverse effects. The phase 3 MIRRA trial demonstrated efficacy and safety of mepolizumab, anti-interleukin-5 biologic, for EGPA. This open-label extension (OLE) of MIRRA assessed long-term safety and OCS-sparing effects of mepolizumab.

methodsThe OLE (NCT03298061) was a multicenter study that enrolled patients from MIRRA who required OCS ≥5 mg/day up to six months after the end of MIRRA. All patients received mepolizumab 300 mg subcutaneously every four weeks plus standard of care until mepolizumab was discontinued or became approved and reimbursed for EGPA in the respective country. Key outcomes included adverse events (AEs) and use of OCS.

resultsOne hundred patients were enrolled in the OLE. Mean (SD) and median (min-max) exposure during OLE was 38.5 (27.0) and 27.0 (1.0-89.0) months. On-treatment AEs were experienced by 98% of patients (43% treatment related; most frequent: injection site reaction [10%]) and serious AEs by 38% of patients (6% treatment related) with no new safety signals versus MIRRA identified. Median (Q1-Q3) OCS dose decreased from 10.0 (7.8-15.0) mg/day at OLE baseline to 5.0 (0.0-10.0) mg/day at study exit. Proportion of patients using OCS >7.5 mg/day decreased from 75% at baseline to 32% at study exit; 28% of patients discontinued OCS.

conclusionLong-term use of mepolizumab to treat EGPA was well tolerated and resulted in sustained reductions in OCS use.

Indexed as

Antibodies, Monoclonal, HumanizedChurg-Strauss SyndromeGranulomatosis with PolyangiitisAdrenal Cortex HormonesAdultAgedFemaleHumansMaleMiddle AgedTreatment OutcomeAdrenal Cortex HormonesAntibodies, Monoclonal, Humanizedmepolizumab

Identifiers

PMID40008472
PMCPMC12295670

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.