Benralizumab for eosinophilic granulomatosis with polyangiitis: a retrospective, multicentre, cohort study.
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Bettiol Alessandra, Urban Maria Letizia, Padoan Roberto, Groh Matthieu, Lopalco Giuseppe, Egan Allyson, Cottin Vincent, Fraticelli Paolo, Crimi Claudia, Del Giacco Stefano, Losappio Laura, Moi Laura, Cinetto Francesco, Caminati Marco, Novikov Pavel, Berti Alvise, Cameli Paolo, Cathébras Pascal, Coppola Angelo, Durel Cécile-Audrey, Folci Marco, Lo Gullo Alberto, Lombardi Carlo, Monti Sara, Parronchi Paola, Rivera Carlos Martinez, Solans Roser, Vacca Angelo, Espígol-Frigolé Georgina, Guarnieri Gabriella, Bianchi Fulvia Chieco, Marchi Maria Rita, Tcherakian Colas, Kahn Jean-Emmanuel, Iannone Florenzo, Venerito Vincenzo, Desaintjean Charlene, Moroncini Gianluca, Nolasco Santi, Costanzo Giulia Anna Maria Luigia, Schroeder Jan Walter, Ribi Camillo, Tesi Michelangelo, Gelain Elena, Mattioli Irene, Bello Federica, Jayne David, Prisco Domenico, Vaglio Augusto, Emmi Giacomo, European EGPA Study Group
Аннотация
METHODS: This retrospective cohort study included patients with EGPA from 28 European referral centres of the European EGPA Study Group across six countries (Italy, France, UK, Russia, Spain, and Switzerland) who received benralizumab as any line of treatment between Jan 1, 2019, and Sep 30, 2022. We assessed the rates of complete response, defined as no disease activity (Birmingham Vasculitis Activity Score [BVAS] of 0) and a prednisone dose of up to 4 mg/day, in contrast to partial response, defined as a BVAS of 0 and a prednisone dose greater than 4 mg/day. Active disease manifestations, pulmonary function, variation in glucocorticoid dose, and safety outcomes were also assessed over a 12-month follow-up.
FINDINGS: 121 patients with relapsing-refractory EGPA treated with benralizumab at the dose approved for eosinophilic asthma were included (64 [53%] women and 57 [47%] men; median age at the time of beginning benralizumab treatment 54·1 years [IQR 44·2-62·2]). Complete response was reported in 15 (12·4%, 95% CI 7·1-19·6) of 121 patients at month 3, 25 (28·7%, 19·5-39·4) of 87 patients at month 6, and 32 (46·4%, 34·3-58·8) of 69 patients at month 12; partial response was observed in an additional 43 (35·5%, 27·0-44·8) patients at month 3, 23 (26·4%, 17·6-37·0) at month 6, and 13 (18·8%, 10·4-30·1) at month 12. BVAS dropped from 3·0 (IQR 2·0-8·0) at baseline to 0·0 (0·0-2·0) at months 3 and 6, and to 0·0 (0·0-1·0) at month 12. The proportion of patients with systemic manifestations, active peripheral neurological disease, ear, nose, and throat involvement, and pulmonary involvement decreased, with an improvement in lung function tests. Six patients relapsed after having a complete response. The oral prednisone (or equivalent) dose decreased from 10·0 mg/day (5·0-12·5) at baseline to 5·0 mg/day (3·6-8·5) at month 3 (p<0·01), to 5·0 mg/day (2·5-6·3) at month 6, and to 2·5 mg/day (0·0-5·0) at month 12 (p<0·0001). 19 (16%) of 121 patients had adverse events and 16 (13%) discontinued benralizumab.
INTERPRETATION: These data suggest that benralizumab could be an effective treatment for EGPA in real-life clinical practice. Further clinical trials are required to confirm the efficacy of benralizumab in patients with a higher baseline disease activity.
FUNDING: None.