Long-Term Safety and Effectiveness of Mepolizumab 300 mg in Europe (Mepo LTF Study)

NCT07591753 | Completed

• 1 other identifier: 22336 _ oss
• Study Type: observational
• Target: 591
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to evaluate the long-term effectiveness and safety of mepolizumab 300 mg/4 weeks in adults with eosinophilic granulomatosis with polyangiitis (EGPA) in the European real-life setting. The main questions it aims to answer are:

• How effective is mepolizumab 300 mg/4 weeks over long-term follow-up in patients with EGPA?
• How safe is mepolizumab 300 mg/4 weeks during long-term treatment?
• What are the effects of switching mepolizumab dosage from 300 mg/4 weeks to 100 mg/4 weeks, or from 100 mg/4 weeks to 300 mg/4 weeks? Participants already receiving mepolizumab as part of routine clinical practice. Researchers will retrospectively collect demographic, clinical, laboratory, and treatment-related data from medical records. For patients starting mepolizumab 300 mg/4 weeks, data will be collected from treatment initiation and during follow-up up to 60 months. For patients who change mepolizumab dose, data will also be collected at the time of dose switch and 3 months later.

Conditions

Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA)

Keywords

Eosinophilic Granulomatosis with Polyangiitis; EGPA; Mepolizumab; Vasculitis; Real-world study

Outcome Measures

Primary Outcomes (4)

• Complete and Partial Response

  Proportion of patients achieving complete response or partial response during follow-up. Complete response is defined as no disease activity (BVAS=0) and oral corticosteroid dose ≤4.0 mg/day. Partial response is defined as no disease activity (BVAS=0) and oral corticosteroid dose \>4.0 mg/day.

  Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months)

• Change in Lung Function

  Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) during follow-up.

  Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months)

• Disease relapses

  Proportion of patients with disease relapse during follow-up. Relapse is defined as active vasculitis (BVAS\>0) and/or worsening asthma or ENT manifestations leading to oral corticosteroid increase to \>4.0 mg/day, initiation of a new immunosuppressive therapy, or hospitalization.

  Up to 60 months (assessed at 3, 6, 12, 24, 36, 48, and 60 months)

• Respiratory Exacerbations

  Proportion of patients with respiratory exacerbations during follow-up. Respiratory exacerbations are defined as asthma attack requiring an increase in oral corticosteroid dose \>30%, emergency department admission related to asthma, and/or use of acute oral corticosteroids, antibiotics, or short-acting beta-agonists.

  Up to 60 months (assessed at 3, 6, 12, 24, 36, 48, and 60 months)

Secondary Outcomes (2)

• Safety

  Up to 60 months from mepolizumab initiation (at 3, 6, 12, 24, 36, 48, and 60 months)

• Persistance

  Up to 60 months from mepolizumab initiation (at 3, 6, 12, 24, 36, 48, and 60 months)

Other Outcomes (5)

• Changes in Organ Manifestations

  Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months)

• Oral Corticosteroid-Sparing Effect

  Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months)

• DMARD-Sparing Effect

  Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months)

Study Arms (1)

EGPA Patients on Mepolizumab 300 mg/4 Weeks

Adult patients with EGPA treated with mepolizumab 300 mg/4 weeks in routine clinical practice. Retrospective data are collected from medical records through follow-up up to 60 months, including assessment after dose switching when applicable.

Biological: Mepolizumab 300 mg

Interventions

Mepolizumab 300 mg BIOLOGICAL

Mepolizumab administered subcutaneously at a dose of 300 mg every 4 weeks in routine clinical practice for adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). In this retrospective observational study, patients may receive mepolizumab 300 mg/4 weeks as the initial regimen or after dose escalation from 100 mg/4 weeks. Dose changes from 300 mg/4 weeks to 100 mg/4 weeks, or from 100 mg/4 weeks to 300 mg/4 weeks, are also evaluated when they occur during routine care; no study-specific treatment is assigned.

EGPA Patients on Mepolizumab 300 mg/4 Weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) receiving mepolizumab 300 mg/4 weeks in routine clinical practice at participating European EGPA referral centers, either as the initial mepolizumab regimen or after dose escalation from 100 mg/4 weeks.

You may qualify if:

• Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). Patients who meet the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) Classification Criteria for EGPA or the criteria proposed in the MIRRA trial.
• Patients receiving mepolizumab 300 mg/4 weeks, either as the first mepolizumab regimen or after dose escalation from mepolizumab 100 mg/4 weeks.
• Availability of at least 3 months of follow-up data after mepolizumab initiation or after dose switch.
• Written informed consent.

You may not qualify if:

• \- Follow-up shorter than 3 months after mepolizumab initiation or after dose switch.

Sponsors & Collaborators

• European EGPA Study Group: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Florence

Florence, Florence, 50134, Italy

Location

Related Publications (11)

• Wechsler ME, Akuthota P, Jayne D, Khoury P, Klion A, Langford CA, Merkel PA, Moosig F, Specks U, Cid MC, Luqmani R, Brown J, Mallett S, Philipson R, Yancey SW, Steinfeld J, Weller PF, Gleich GJ; EGPA Mepolizumab Study Team. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2017 May 18;376(20):1921-1932. doi: 10.1056/NEJMoa1702079.

  PMID: 28514601 RESULT

• Vultaggio A, Nencini F, Bormioli S, Vivarelli E, Dies L, Rossi O, Parronchi P, Maggi E, Matucci A. Low-Dose Mepolizumab Effectiveness in Patients Suffering From Eosinophilic Granulomatosis With Polyangiitis. Allergy Asthma Immunol Res. 2020 Sep;12(5):885-893. doi: 10.4168/aair.2020.12.5.885.

  PMID: 32638567 RESULT

• Masi AT, Hunder GG, Lie JT, Michel BA, Bloch DA, Arend WP, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, et al. The American College of Rheumatology 1990 criteria for the classification of Churg-Strauss syndrome (allergic granulomatosis and angiitis). Arthritis Rheum. 1990 Aug;33(8):1094-100. doi: 10.1002/art.1780330806.

  PMID: 2202307 RESULT

• Lyons PA, Peters JE, Alberici F, Liley J, Coulson RMR, Astle W, Baldini C, Bonatti F, Cid MC, Elding H, Emmi G, Epplen J, Guillevin L, Jayne DRW, Jiang T, Gunnarsson I, Lamprecht P, Leslie S, Little MA, Martorana D, Moosig F, Neumann T, Ohlsson S, Quickert S, Ramirez GA, Rewerska B, Schett G, Sinico RA, Szczeklik W, Tesar V, Vukcevic D; European Vasculitis Genetics Consortium; Terrier B, Watts RA, Vaglio A, Holle JU, Wallace C, Smith KGC. Genome-wide association study of eosinophilic granulomatosis with polyangiitis reveals genomic loci stratified by ANCA status. Nat Commun. 2019 Nov 12;10(1):5120. doi: 10.1038/s41467-019-12515-9.

  PMID: 31719529 RESULT

• Grayson PC, Ponte C, Suppiah R, Robson JC, Craven A, Judge A, Khalid S, Hutchings A, Luqmani RA, Watts RA, Merkel PA; DCVAS Study Group. 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology Classification Criteria for Eosinophilic Granulomatosis With Polyangiitis. Arthritis Rheumatol. 2022 Mar;74(3):386-392. doi: 10.1002/art.41982. Epub 2022 Feb 2.

  PMID: 35106968 RESULT

• Emmi G, Bettiol A, Gelain E, Bajema IM, Berti A, Burns S, Cid MC, Cohen Tervaert JW, Cottin V, Durante E, Holle JU, Mahr AD, Del Pero MM, Marvisi C, Mills J, Moiseev S, Moosig F, Mukhtyar C, Neumann T, Olivotto I, Salvarani C, Seeliger B, Sinico RA, Taille C, Terrier B, Venhoff N, Bertsias G, Guillevin L, Jayne DRW, Vaglio A. Evidence-Based Guideline for the diagnosis and management of eosinophilic granulomatosis with polyangiitis. Nat Rev Rheumatol. 2023 Jun;19(6):378-393. doi: 10.1038/s41584-023-00958-w. Epub 2023 May 9.

  PMID: 37161084 RESULT

• Canzian A, Venhoff N, Urban ML, Sartorelli S, Ruppert AM, Groh M, Girszyn N, Taille C, Maurier F, Cottin V, de Moreuil C, Germain V, Samson M, Jachiet M, Denis L, Rieu V, Smets P, Pugnet G, Deroux A, Durel CA, Aouba A, Cathebras P, Deligny C, Faguer S, Gil H, Godeau B, Lifermann F, Phin-Huynh S, Ruivard M, Bonniaud P, Puechal X, Kahn JE, Thiel J, Dagna L, Guillevin L, Vaglio A, Emmi G, Terrier B; French Vasculitis Study Group and the European EGPA Study Group. Use of Biologics to Treat Relapsing and/or Refractory Eosinophilic Granulomatosis With Polyangiitis: Data From a European Collaborative Study. Arthritis Rheumatol. 2021 Mar;73(3):498-503. doi: 10.1002/art.41534. Epub 2021 Jan 23.

  PMID: 33001543 RESULT

• Caminati M, Crisafulli E, Lunardi C, Micheletto C, Festi G, Maule M, Giollo A, Orsolini G, Senna G. Mepolizumab 100 mg in severe asthmatic patients with EGPA in remission phase. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1386-1388. doi: 10.1016/j.jaip.2020.09.025. Epub 2020 Oct 1. No abstract available.

  PMID: 33011303 RESULT

• Bettiol A, Urban ML, Padoan R, Groh M, Lopalco G, Egan A, Cottin V, Fraticelli P, Crimi C, Del Giacco S, Losappio L, Moi L, Cinetto F, Caminati M, Novikov P, Berti A, Cameli P, Cathebras P, Coppola A, Durel CA, Folci M, Lo Gullo A, Lombardi C, Monti S, Parronchi P, Rivera CM, Solans R, Vacca A, Espigol-Frigole G, Guarnieri G, Bianchi FC, Marchi MR, Tcherakian C, Kahn JE, Iannone F, Venerito V, Desaintjean C, Moroncini G, Nolasco S, Costanzo GAML, Schroeder JW, Ribi C, Tesi M, Gelain E, Mattioli I, Bello F, Jayne D, Prisco D, Vaglio A, Emmi G; European EGPA Study Group. Benralizumab for eosinophilic granulomatosis with polyangiitis: a retrospective, multicentre, cohort study. Lancet Rheumatol. 2023 Dec;5(12):e707-e715. doi: 10.1016/S2665-9913(23)00243-6. Epub 2023 Nov 6.

  PMID: 38251561 RESULT

• Bettiol A, Urban ML, Dagna L, Cottin V, Franceschini F, Del Giacco S, Schiavon F, Neumann T, Lopalco G, Novikov P, Baldini C, Lombardi C, Berti A, Alberici F, Folci M, Negrini S, Sinico RA, Quartuccio L, Lunardi C, Parronchi P, Moosig F, Espigol-Frigole G, Schroeder J, Kernder AL, Monti S, Silvagni E, Crimi C, Cinetto F, Fraticelli P, Roccatello D, Vacca A, Mohammad AJ, Hellmich B, Samson M, Bargagli E, Cohen Tervaert JW, Ribi C, Fiori D, Bello F, Fagni F, Moroni L, Ramirez GA, Nasser M, Marvisi C, Toniati P, Firinu D, Padoan R, Egan A, Seeliger B, Iannone F, Salvarani C, Jayne D, Prisco D, Vaglio A, Emmi G; European EGPA Study Group. Mepolizumab for Eosinophilic Granulomatosis With Polyangiitis: A European Multicenter Observational Study. Arthritis Rheumatol. 2022 Feb;74(2):295-306. doi: 10.1002/art.41943. Epub 2021 Dec 30.

  PMID: 34347947 RESULT

• Bettiol A, Urban ML, Bello F, Fiori D, Mattioli I, Lopalco G, Iannone F, Egan A, Dagna L, Caminati M, Negrini S, Bargagli E, Folci M, Franceschini F, Padoan R, Flossmann O, Solans R, Schroeder J, Andre M, Moi L, Parronchi P, Roccatello D, Sciascia S, Jayne D, Prisco D, Vaglio A, Emmi G; European EGPA Study Group. Sequential rituximab and mepolizumab in eosinophilic granulomatosis with polyangiitis (EGPA): a European multicentre observational study. Ann Rheum Dis. 2022 Dec;81(12):1769-1772. doi: 10.1136/ard-2022-222776. Epub 2022 Jul 18. No abstract available.

  PMID: 35850947 RESULT

MeSH Terms

Conditions

Churg-Strauss Syndrome; Vasculitis

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: September 18, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)