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 / Bettiol, A.; Urban, M. L.; 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, R. A.; Quartuccio, L.; Lunardi, C.; Parronchi, P.; Moosig, F.; Espigol-Frigole, G.; Schroeder, J.; Kernder, A. L.; Monti, S.; Silvagni, E.; Crimi, C.; Cinetto, F.; Fraticelli, P.; Roccatello, D.; Vacca, A.; Mohammad, A. J.; Hellmich, B.; Samson, M.; Bargagli, E.; Cohen Tervaert, J. W.; Ribi, C.; Fiori, D.; Bello, F.; Fagni, F.; Moroni, L.; Ramirez, G. A.; 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.; Ahmad, K.; Beccalli, M.; Bonnotte, B.; Bortolotti, R.; Cariddi, A.; Caminati, M.; Cid, M. C.; Deidda, M.; Delvino, P.; Scal, a G. D.; Felicetti, M.; Ferro, F.; Furini, F.; Gelain, E.; Ghirelli, G.; Holle, J.; Losappio, L. M.; Mahr, A.; Malandrino, D.; Marhhold, J.; Mattioli, I.; Moi, L.; Moiseev, S.; Muratore, F.; Nolasco, S.; Olivieri, B.; Palermo, A.; Regola, F.; Sander, O.; Scarpa, R.; Sciascia, S.; Silvestri, E.; Susca, N.; Terrier, B.; Treppo, E.; Trezzi, B.; Uzzo, M.; Vitiello, G.; Yacyshyn, E.. - In: ARTHRITIS & RHEUMATOLOGY. - ISSN 2326-5191. - 74:2(2022), pp. 295-306. [10.1002/art.41943]

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

Franceschini, F.;Berti, A.;Vaglio, A.;Ahmad, K.;Felicetti, M.;Ferro, F.;Ghirelli ,G.;Palermo, A.;Scarpa, R.;
2022-01-01

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
2
Bettiol, A.; Urban, M. L.; Dagna, L.; Cottin, V.; Franceschini, F.; Del Giacco, S.; Schiavon, F.; Neumann, T.; Lopalco, G.; Novikov, P.; Baldini, C.; ...espandi
Mepolizumab for Eosinophilic Granulomatosis With Polyangiitis: A European Multicenter Observational Study / Bettiol, A.; Urban, M. L.; 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, R. A.; Quartuccio, L.; Lunardi, C.; Parronchi, P.; Moosig, F.; Espigol-Frigole, G.; Schroeder, J.; Kernder, A. L.; Monti, S.; Silvagni, E.; Crimi, C.; Cinetto, F.; Fraticelli, P.; Roccatello, D.; Vacca, A.; Mohammad, A. J.; Hellmich, B.; Samson, M.; Bargagli, E.; Cohen Tervaert, J. W.; Ribi, C.; Fiori, D.; Bello, F.; Fagni, F.; Moroni, L.; Ramirez, G. A.; 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.; Ahmad, K.; Beccalli, M.; Bonnotte, B.; Bortolotti, R.; Cariddi, A.; Caminati, M.; Cid, M. C.; Deidda, M.; Delvino, P.; Scal, a G. D.; Felicetti, M.; Ferro, F.; Furini, F.; Gelain, E.; Ghirelli, G.; Holle, J.; Losappio, L. M.; Mahr, A.; Malandrino, D.; Marhhold, J.; Mattioli, I.; Moi, L.; Moiseev, S.; Muratore, F.; Nolasco, S.; Olivieri, B.; Palermo, A.; Regola, F.; Sander, O.; Scarpa, R.; Sciascia, S.; Silvestri, E.; Susca, N.; Terrier, B.; Treppo, E.; Trezzi, B.; Uzzo, M.; Vitiello, G.; Yacyshyn, E.. - In: ARTHRITIS & RHEUMATOLOGY. - ISSN 2326-5191. - 74:2(2022), pp. 295-306. [10.1002/art.41943]
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