Benralizumab Effectiveness in EGPA (BELONG-EGPA)
2026년 9월 8일 업데이트: European EGPA Study Group
Benralizumab Effectiveness in the LONG-term Real-life Setting in EGPA: The BELONG-EGPA Study
This is a multicenter, retro-prospective observational study evaluating the effectiveness and safety of benralizumab in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a real-world setting.
The study will include patients treated with benralizumab 30 mg every 4 weeks at EGPA referral centers participating in the European EGPA Study Group.
Clinical, laboratory, lung function, treatment, relapse, and safety data will be collected from medical charts at baseline and during follow-up up to 24 months.
연구 개요
상세 설명
BELONG-EGPA is a multicenter, retro-prospective observational study conducted within centers belonging to the European EGPA Study Group. The study is designed to evaluate the long-term real-world effectiveness and safety of benralizumab in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
The study population will include adult patients with EGPA who meet the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for EGPA or the criteria proposed in the MIRRA trial, and who receive benralizumab 30 mg every 4 weeks. Only patients with at least 3 months of available follow-up after starting benralizumab will be included.
Demographic, clinical, biological, lung function, and treatment-related data will be collected from medical charts through a standardized electronic case report form. Data will be collected at the start of benralizumab treatment and at 3, 6, 12, and 24 months of follow-up.
The primary effectiveness outcomes include achievement of complete response and partial response, changes in lung function measured by pre-bronchodilator FEV1, and disease relapses. Complete response is defined as no disease activity, with Birmingham Vasculitis Activity Score equal to 0, and an oral corticosteroid dose of 4.0 mg/day or less of prednisone, prednisolone, or equivalent. Partial response is defined as no disease activity with an oral corticosteroid dose greater than 4.0 mg/day.
Secondary outcomes include treatment persistence, oral corticosteroid tapering and discontinuation, effectiveness and safety in first-line patients compared with patients previously exposed to mepolizumab, outcomes after benralizumab dosage switching, and adverse events and serious adverse events during treatment.
Additional outcomes include changes in organ manifestations, discontinuation of disease-modifying antirheumatic drugs, changes in ANCA status, and variation in eosinophil count. All data will be anonymized and stored in a centralized database.
연구 유형
관찰
등록 (추정된)
100
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Giacomo Emmi, MD/PhD
- 전화번호: +393286852815
- 이메일: giacomo.emmi0105@gmail.com
연구 연락처 백업
- 이름: Irene Mattioli, PharmD/PhD
- 이메일: irene.mattioli@unifi.it
연구 장소
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Italy
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Florence, Italy, 이탈리아, 50134
- 모병
- Edoardo Biancalana
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연락하다:
- Edoardo Biancalana, MD
- 전화번호: +393287394992
- 이메일: edoardo.biancalana@unifi.it
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) treated with benralizumab 30 mg every 4 weeks at EGPA referral centers participating in the European EGPA Study Group.
Patients may be newly diagnosed or have relapsing or refractory EGPA, and will be included if at least 3 months of follow-up data after benralizumab initiation are available.
설명
Inclusion Criteria:
- Age 18 years or older.
- Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) according to the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria or the criteria proposed in the MIRRA trial.
- Treatment with benralizumab 30 mg every 4 weeks.
- At least 3 months of available follow-up data after starting benralizumab.
- Written informed consent for study participation and data collection.
Exclusion Criteria:
- Age younger than 18 years.
- No available follow-up data after starting benralizumab.
- Follow-up after benralizumab initiation shorter than 3 months.
- Lack of written informed consent, where required by local regulations.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Patients with EGPA treated with benralizumab
Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) receiving benralizumab 30 mg every 4 weeks in a real-world setting.
Patients may be newly diagnosed or have relapsing or refractory EGPA and must have at least 3 months of available follow-up after starting benralizumab.
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Benralizumab administered at a dose of 30 mg every 4 weeks in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a real-world setting.
Patients may receive benralizumab as first-line biologic therapy or after previous exposure to mepolizumab.
Treatment use, persistence, dosage changes, effectiveness outcomes, and safety events will be assessed during follow-up.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Complete Response
기간: Baseline and up to 24 months (at 3, 6, 12, 24 months)
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Proportion of patients achieving complete response during follow-up.
Complete response is defined as no disease activity (BVAS=0) and oral corticosteroid dose ≤4.0 mg/day.
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Baseline and up to 24 months (at 3, 6, 12, 24 months)
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Change in Lung Function
기간: Baseline, 3, 6, 12, and 24 months
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Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline to each follow-up time point. Unit of Measure: Milliliters |
Baseline, 3, 6, 12, and 24 months
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Disease relapse
기간: 3, 6, 12, and 24 months
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Proportion of patients experiencing disease relapse after achieving complete response.
Relapse is defined as active vasculitis, BVAS >0, and/or worsening asthma or ear-nose-throat manifestations leading to an increase in oral corticosteroid dose to >4.0 mg/day, initiation of a new immunosuppressive therapy, or hospitalization.
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3, 6, 12, and 24 months
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Partial response
기간: Baseline and up to 24 months (at 3, 6, 12, 24 months)
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Proportion of patients achieving complete response during follow-up.
Partial response is defined as no disease activity (BVAS=0) and oral corticosteroid dose >4.0 mg/day.
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Baseline and up to 24 months (at 3, 6, 12, 24 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Treatment persistence
기간: 3, 6, 12, and 24 months
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Proportion of patients who continue benralizumab treatment, switch benralizumab dosage, or discontinue benralizumab for any reason.
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3, 6, 12, and 24 months
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Change in oral corticosteroid dose expressed as prednisone-equivalent dose
기간: Baseline, 3, 6, 12, and 24 months
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The daily dose of each oral corticosteroid will be converted to prednisone-equivalent mg/day using standardized glucocorticoid equivalence factors. Unit of Measure: mg/day of prednisone equivalent |
Baseline, 3, 6, 12, and 24 months
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Oral corticosteroid discontinuation
기간: 3, 6, 12, and 24 months
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Proportion of patients who discontinue oral corticosteroid therapy during follow-up.
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3, 6, 12, and 24 months
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Overall clinical benefit in first-line versus post-mepolizumab patients
기간: Baseline, 3, 6, 12, and 24 months
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A comparison of the overall clinical benefit in patients treated with benralizumab as first-line therapy versus patients switching to benralizumab following prior exposure to mepolizumab. Unit of Measure: Percentage of participants |
Baseline, 3, 6, 12, and 24 months
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Effectiveness after benralizumab dosage switching
기간: 3 months after dosage switch
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Assessment of complete response, partial response, and changes in lung function in patients switching benralizumab dosage from 30 mg every 4 weeks to 30 mg every 8 weeks or from 30 mg every 8 weeks to 30 mg every 4 weeks.
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3 months after dosage switch
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Adverse event rate
기간: 3, 6, 12, and 24 months
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Proportion of patients experiencing at least one adverse event during benralizumab treatment, regardless of causal association with treatment.
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3, 6, 12, and 24 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in organ manifestations
기간: Baseline, 3, 6, 12, and 24 months
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Change in the proportion of patients with active EGPA-related organ manifestations assessed separately from Birmingham Vasculitis Activity Score items.
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Baseline, 3, 6, 12, and 24 months
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DMARD discontinuation rate
기간: 3, 6, 12, and 24 months
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Proportion of patients discontinuing disease-modifying antirheumatic drug treatment that was ongoing or newly started at baseline.
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3, 6, 12, and 24 months
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Change in ANCA positivity
기간: Baseline, 3, 6, 12, and 24 months
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Change in the proportion of patients with positive ANCA testing and proportion of patients with ANCA negativization among those who were ANCA-positive at baseline.
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Baseline, 3, 6, 12, and 24 months
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Change in eosinophil count
기간: Baseline, 3, 6, 12, and 24 months
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Change in blood eosinophil count from baseline to each follow-up time point.
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Baseline, 3, 6, 12, and 24 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Giacomo Emmi, MD/PhD, University of Trieste, Italy
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Hellmich B, Sanchez-Alamo B, Schirmer JH, Berti A, Blockmans D, Cid MC, Holle JU, Hollinger N, Karadag O, Kronbichler A, Little MA, Luqmani RA, Mahr A, Merkel PA, Mohammad AJ, Monti S, Mukhtyar CB, Musial J, Price-Kuehne F, Segelmark M, Teng YKO, Terrier B, Tomasson G, Vaglio A, Vassilopoulos D, Verhoeven P, Jayne D. EULAR recommendations for the management of ANCA-associated vasculitis: 2022 update. Ann Rheum Dis. 2024 Jan 2;83(1):30-47. doi: 10.1136/ard-2022-223764.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Mattioli I, Urban ML, Padoan R, Mohammad AJ, Salvarani C, Baldini C, Berti A, Cameli P, Caminati M, Cathebras P, Bianchi FC, Cinetto F, Cohen Tervaert JW, Coppola A, Costanzo G, Cottin V, Crimi C, Del Giacco S, Desaintjean C, Egan A, Espigol-Frigole G, Folci M, Fornaro M, Franceschini F, Govoni M, Groh M, Guarnieri G, Hellmich B, Iannone F, Jones R, Kernder A, Lo Gullo A, Lombardi C, Lopalco G, Losappio L, Marchi MR, Rivera CM, Marvisi C, Maule M, Moi L, Monti S, Moosig F, Moroncini G, Negrini SM, Neumann T, Nolasco S, Novikov P, Roccatello D, Samson M, Schroeder JW, Seeliger B, Sinico RA, Solans R, Tcherakian C, Toniati P, Treppo E, Trivioli G, Vacca A, Jayne D, Bettiol A, Vaglio A, Emmi G; European EGPA Study Group. Mepolizumab versus benralizumab for eosinophilic granulomatosis with polyangiitis (EGPA): A European real-life retrospective comparative study. J Autoimmun. 2025 May;153:103398. doi: 10.1016/j.jaut.2025.103398. Epub 2025 Mar 26.
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- Nolasco S, Portacci A, Campisi R, Buonamico E, Pelaia C, Benfante A, Triggiani M, Spadaro G, Caiaffa MF, Scioscia G, Detoraki A, Valenti G, Papia F, Tomasello A, Crimi N, Scichilone N, Pelaia G, Carpagnano GE, Crimi C. Effectiveness and safety of anti-IL-5/Ralpha biologics in eosinophilic granulomatosis with polyangiitis: a two-year multicenter observational study. Front Immunol. 2023 Jun 30;14:1204444. doi: 10.3389/fimmu.2023.1204444. eCollection 2023.
- Guntur VP, Manka LA, Denson JL, Dunn RM, Dollin YT, Gill M, Kolakowski C, Strand MJ, Wechsler ME. Benralizumab as a Steroid-Sparing Treatment Option in Eosinophilic Granulomatosis with Polyangiitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1186-1193.e1. doi: 10.1016/j.jaip.2020.09.054. Epub 2020 Oct 14.
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유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 2월 11일
기본 완료 (추정된)
2027년 2월 11일
연구 완료 (추정된)
2028년 2월 11일
연구 등록 날짜
최초 제출
2026년 5월 27일
QC 기준을 충족하는 최초 제출
2026년 9월 8일
처음 게시됨 (실제)
2026년 9월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 8일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BENRA_22336_oss
- 22336_oss (레지스트리 식별자: Ethics Committee of the Tuscany Region - Central Area (CEAVC))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .