Mepolizumab for Eosinophilic Granulomatosis With Polyangiitis: A European Multicenter Observational Study
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- Alessandra Bettiol
- University of Florence Florence Italy
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- Maria Letizia Urban
- University of Florence Florence Italy
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- Lorenzo Dagna
- San Raffaele Hospital, IRCCS, Vita‐Salute San Raffaele University Milan Italy
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- Vincent Cottin
- Hospices Civils de Lyon and University of Lyon Lyon France
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- Franco Franceschini
- ASST Spedali Civili of Brescia and University of Brescia Brescia Italy
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- Stefano Del Giacco
- University of Cagliari Cagliari Italy
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- Franco Schiavon
- Azienda Ospedaliera‐Universitaria di Padova Padova Italy
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- Thomas Neumann
- Cantonal Hospital St. Gallen, St. Gallen, Switzerland, and Jena University Hospital Jena Germany
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- Giuseppe Lopalco
- Polyclinic Hospital, University of Bari Bari Italy
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- Pavel Novikov
- Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University Moscow Russia
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- Chiara Baldini
- University of Pisa Pisa Italy
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- Carlo Lombardi
- Fondazione Poliambulanza Istituto Ospedaliero Brescia Italy
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- Alvise Berti
- Santa Chiara Hospital and University of Trento Trento Italy
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- Federico Alberici
- University of Brescia and Spedali Civili Hospital, ASST Spedali Civili di Brescia Brescia Italy
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- Marco Folci
- Humanitas Clinical and Research Center, IRCCS and Humanitas University, IRCCS Milan Italy
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- Simone Negrini
- IRCCS Ospedale Policlinico San Martino and University of Genoa Genoa Italy
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- Renato Alberto Sinico
- University of Milano Bicocca Monza Italy
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- Luca Quartuccio
- University of Udine, Azienda sanitaria universitaria Friuli Centrale Udine Udine Italy
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- Claudio Lunardi
- University of Verona Italy
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- Paola Parronchi
- University of Florence Florence Italy
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- Frank Moosig
- Rheumazentrum Schleswig‐Holstein Mitte Neumünster Germany
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- Georgina Espígol‐Frigolé
- Hospital Clínic, University of Barcelona and Institut d'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS) Barcelona Spain
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- Jan Schroeder
- ASST Grande Ospedale Metropolitano Niguarda Milan Italy
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- Anna Luise Kernder
- Heinrich Heine University Düsseldorf Düsseldorf Germany
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- Sara Monti
- Policlinico S. Matteo Fondazione, IRCCS, University of Pavia Pavia Italy
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- Ettore Silvagni
- University of Ferrara Ferrara Italy
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- Claudia Crimi
- Policlinico‐Vittorio Emanuele San Marco University Hospital Catania Italy
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- Francesco Cinetto
- University of Padova Padova Italy
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- Paolo Fraticelli
- University Hospital Ospedali Riuniti Ancona Italy
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- Dario Roccatello
- San Giovanni Bosco Hospital and University of Turin Turin Italy
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- Angelo Vacca
- Aldo Moro University of Bari Bari Italy
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- Aladdin J. Mohammad
- Lund University, Skåne University Hospital, Lund, Sweden, and University of Cambridge Cambridge UK
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- Bernhard Hellmich
- Medius Kliniken, University of Tübingen, Kirchheim unter Teck Germany
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- Maxime Samson
- Dijon University Hospital Dijon France
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- Elena Bargagli
- University of Siena Siena Italy
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- Jan Willem Cohen Tervaert
- University of Alberta, Edmonton, Alberta, Canada, and Maastricht University Maastricht The Netherlands
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- Camillo Ribi
- University Hospital Center of Lausanne Lausanne Switzerland
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- Davide Fiori
- University of Florence Florence Italy
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- Federica Bello
- University of Florence Florence Italy
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- Filippo Fagni
- University of Florence Florence Italy
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- Luca Moroni
- San Raffaele Hospital, IRCCS, Vita‐Salute San Raffaele University Milan Italy
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- Giuseppe Alvise Ramirez
- San Raffaele Hospital, IRCCS, Vita‐Salute San Raffaele University Milan Italy
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- Mouhamad Nasser
- Hospices Civils de Lyon and University of Lyon Lyon France
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- Chiara Marvisi
- Azienda USL‐IRCCS di Reggio Emilia, IRCCS, and Università di Modena e Reggio Emilia Reggio Emilia Italy
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- Paola Toniati
- ASST Spedali Civili of Brescia Brescia Italy
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- Davide Firinu
- University of Cagliari Cagliari Italy
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- Roberto Padoan
- Azienda Ospedaliera‐Universitaria di Padova Padova Italy
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- Allyson Egan
- University of Cambridge Cambridge UK
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- Benjamin Seeliger
- Hannover Medical School Hannover Germany
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- Florenzo Iannone
- Polyclinic Hospital, University of Bari Bari Italy
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- Carlo Salvarani
- Azienda USL‐IRCCS di Reggio Emilia, IRCCS, and Università di Modena e Reggio Emilia Reggio Emilia Italy
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- David Jayne
- University of Cambridge Cambridge UK
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- Domenico Prisco
- University of Florence Florence Italy
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- Augusto Vaglio
- University of Florence and Meyer Children's Hospital Florence Italy
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- Giacomo Emmi
- University of Florence Florence Italy
抄録
<jats:sec><jats:title>Objective</jats:title><jats:p>Mepolizumab proved to be an efficacious treatment for eosinophilic granulomatosis with polyangiitis (EGPA) at a dose of 300 mg every 4 weeks in the randomized, controlled MIRRA trial. In a few recently reported studies, successful real‐life experiences with the approved dose for treating severe eosinophilic asthma (100 mg every 4 weeks) were observed. We undertook this study to assess the effectiveness and safety of mepolizumab 100 mg every 4 weeks and 300 mg every 4 weeks in a large European EGPA cohort.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We included all patients with EGPA treated with mepolizumab at the recruiting centers in 2015–2020. Treatment response was evaluated from 3 months to 24 months after initiation of mepolizumab. Complete response to treatment was defined as no disease activity (Birmingham Vasculitis Activity Score [BVAS] = 0) and a prednisolone or prednisone dose (or equivalent) of ≤4 mg/day. Respiratory outcomes included asthma and ear, nose, and throat (ENT) exacerbations.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Two hundred three patients, of whom 191 received a stable dose of mepolizumab (158 received 100 mg every 4 weeks and 33 received 300 mg every 4 weeks) were included. Twenty‐five patients (12.3%) had a complete response to treatment at 3 months. Complete response rates increased to 30.4% and 35.7% at 12 months and 24 months, respectively, and rates were comparable between mepolizumab 100 mg every 4 weeks and 300 mg every 4 weeks. Mepolizumab led to a significant reduction in BVAS score, prednisone dose, and eosinophil counts from 3 months to 24 months, with no significant differences observed between 100 mg every 4 weeks and 300 mg every 4 weeks. Eighty‐two patients (40.4%) experienced asthma exacerbations (57 of 158 [36%] who received 100 mg every 4 weeks; 17 of 33 [52%] who received 300 mg every 4 weeks), and 31 patients (15.3%) experienced ENT exacerbations. Forty‐four patients (21.7%) experienced adverse events (AEs), most of which were nonserious AEs (38 of 44).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Mepolizumab at both 100 mg every 4 weeks and 300 mg every 4 weeks is effective for the treatment of EGPA. The 2 doses should be compared in the setting of a controlled trial.</jats:p></jats:sec>
収録刊行物
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- Arthritis & Rheumatology
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Arthritis & Rheumatology 74 (2), 295-306, 2021-12-30
Wiley