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.

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

Ettore Silvagni;
2022

Abstract

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.
2022
Bettiol, Alessandra; Letizia Urban, Maria; Dagna, Lorenzo; Cottin, Vincent; Franceschini, Franco; Del Giacco, Stefano; Schiavon, Franco; Neumann, Thomas; Lopalco, Giuseppe; Novikov, Pavel; Baldini, Chiara; Lombardi, Carlo; Berti, Alvise; Alberici, Federico; Folci, Marco; Negrini, Simone; Alberto Sinico, Renato; Quartuccio, Luca; Lunardi, Claudio; Parronchi, Paola; Moosig, Frank; Espígol-Frigolé, Georgina; Schroeder, Jan; Luise Kernder, Anna; Monti, Sara; Silvagni, Ettore; Crimi, Claudia; Cinetto, Francesco; Fraticelli, Paolo; Roccatello, Dario; Vacca, Angelo; J Mohammad, Aladdin; Hellmich, Bernhard; Samson, Maxime; Bargagli, Elena; Willem Cohen Tervaert, Jan; Ribi, Camillo; Fiori, Davide; Bello, Federica; Fagni, Filippo; Moroni, Luca; Alvise Ramirez, Giuseppe; Nasser, Mouhamad; Marvisi, Chiara; Toniati, Paola; Firinu, Davide; Padoan, Roberto; Egan, Allyson; Seeliger, Benjamin; Iannone, Florenzo; Salvarani, Carlo; Jayne, David; Prisco, Domenico; Vaglio, Augusto; Emmi, Giacomo
File in questo prodotto:
File Dimensione Formato  
Arthritis Rheumatology - 2021 - Bettiol - Mepolizumab for Eosinophilic Granulomatosis With Polyangiitis A European (1).pdf

accesso aperto

Descrizione: Full text editoriale
Tipologia: Full text (versione editoriale)
Licenza: Creative commons
Dimensione 703.94 kB
Formato Adobe PDF
703.94 kB Adobe PDF Visualizza/Apri
Bettiol et al. - Mepolizumab for Eosinophilic Granulomatosis with P.pdf

solo gestori archivio

Descrizione: Post-print
Tipologia: Post-print
Licenza: NON PUBBLICO - Accesso privato/ristretto
Dimensione 12.52 MB
Formato Adobe PDF
12.52 MB Adobe PDF   Visualizza/Apri   Richiedi una copia

I documenti in SFERA sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11392/2497314
Citazioni
  • ???jsp.display-item.citation.pmc??? 35
  • Scopus 72
  • ???jsp.display-item.citation.isi??? 68
social impact