Mepolizumab for Eosinophilic Granulomatosis With Polyangiitis: A European Multicenter Observational Study.

Autor: Bettiol A; University of Florence, Florence, Italy., Urban ML; University of Florence, Florence, Italy., Dagna L; San Raffaele Hospital, IRCCS, Vita-Salute San Raffaele University, Milan, Italy., Cottin V; Hospices Civils de Lyon and University of Lyon, Lyon, France., Franceschini F; ASST Spedali Civili of Brescia and University of Brescia, Brescia, Italy., Del Giacco S; University of Cagliari, Cagliari, Italy., Schiavon F; Azienda Ospedaliera-Universitaria di Padova, Padova, Italy., Neumann T; Cantonal Hospital St. Gallen, St. Gallen, Switzerland, and Jena University Hospital, Jena, Germany., Lopalco G; Polyclinic Hospital, University of Bari, Bari, Italy., Novikov P; Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia., Baldini C; University of Pisa, Pisa, Italy., Lombardi C; Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy., Berti A; Santa Chiara Hospital and University of Trento, Trento, Italy., Alberici F; University of Brescia and Spedali Civili Hospital, ASST Spedali Civili di Brescia, Brescia, Italy., Folci M; Humanitas Clinical and Research Center, IRCCS and Humanitas University, IRCCS, Milan, Italy., Negrini S; IRCCS Ospedale Policlinico San Martino and University of Genoa, Genoa, Italy., Sinico RA; University of Milano Bicocca, Monza, Italy., Quartuccio L; University of Udine, Azienda sanitaria universitaria Friuli Centrale Udine, Udine, Italy., Lunardi C; University of Verona, Italy., Parronchi P; University of Florence, Florence, Italy., Moosig F; Rheumazentrum Schleswig-Holstein Mitte, Neumünster, Germany., Espígol-Frigolé G; Hospital Clínic, University of Barcelona and Institut d'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain., Schroeder J; ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy., Kernder AL; Heinrich Heine University Düsseldorf, Düsseldorf, Germany., Monti S; Policlinico S. Matteo Fondazione, IRCCS, University of Pavia, Pavia, Italy., Silvagni E; University of Ferrara, Ferrara, Italy., Crimi C; Policlinico-Vittorio Emanuele San Marco University Hospital, Catania, Italy., Cinetto F; University of Padova, Padova, Italy., Fraticelli P; University Hospital Ospedali Riuniti, Ancona, Italy., Roccatello D; San Giovanni Bosco Hospital and University of Turin, Turin, Italy., Vacca A; Aldo Moro University of Bari, Bari, Italy., Mohammad AJ; Lund University, Skåne University Hospital, Lund, Sweden, and University of Cambridge, Cambridge, UK., Hellmich B; Medius Kliniken, University of Tübingen, Kirchheim unter Teck, Germany., Samson M; Dijon University Hospital, Dijon, France., Bargagli E; University of Siena, Siena, Italy., Cohen Tervaert JW; University of Alberta, Edmonton, Alberta, Canada, and Maastricht University, Maastricht, The Netherlands., Ribi C; University Hospital Center of Lausanne, Lausanne, Switzerland., Fiori D; University of Florence, Florence, Italy., Bello F; University of Florence, Florence, Italy., Fagni F; University of Florence, Florence, Italy., Moroni L; San Raffaele Hospital, IRCCS, Vita-Salute San Raffaele University, Milan, Italy., Ramirez GA; San Raffaele Hospital, IRCCS, Vita-Salute San Raffaele University, Milan, Italy., Nasser M; Hospices Civils de Lyon and University of Lyon, Lyon, France., Marvisi C; Azienda USL-IRCCS di Reggio Emilia, IRCCS, and Università di Modena e Reggio Emilia, Reggio Emilia, Italy., Toniati P; ASST Spedali Civili of Brescia, Brescia, Italy., Firinu D; University of Cagliari, Cagliari, Italy., Padoan R; Azienda Ospedaliera-Universitaria di Padova, Padova, Italy., Egan A; University of Cambridge, Cambridge, UK., Seeliger B; Hannover Medical School, Hannover, Germany., Iannone F; Polyclinic Hospital, University of Bari, Bari, Italy., Salvarani C; Azienda USL-IRCCS di Reggio Emilia, IRCCS, and Università di Modena e Reggio Emilia, Reggio Emilia, Italy., Jayne D; University of Cambridge, Cambridge, UK., Prisco D; University of Florence, Florence, Italy., Vaglio A; University of Florence and Meyer Children's Hospital, Florence, Italy., Emmi G; University of Florence, Florence, Italy.
Jazyk: angličtina
Zdroj: Arthritis & rheumatology (Hoboken, N.J.) [Arthritis Rheumatol] 2022 Feb; Vol. 74 (2), pp. 295-306. Date of Electronic Publication: 2021 Dec 30.
DOI: 10.1002/art.41943
Abstrakt: Objective: 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.
Methods: 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.
Results: 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).
Conclusion: 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.
(© 2021 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
Databáze: MEDLINE
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