Mattioli Irene, Urban Maria Letizia, Padoan Roberto, Mohammad Aladdin J, Salvarani Carlo, Baldini Chiara, Berti Alvise, Cameli Paolo, Caminati Marco, Cathébras Pascal, Bianchi Fulvia Chieco, Cinetto Francesco, Cohen Tervaert Jan Willem, Coppola Angelo, Costanzo Giulia, Cottin Vincent, Crimi Claudia, Del Giacco Stefano, Desaintjean Charlene, Egan Allyson, Espigol-Frigolé Georgina, Folci Marco, Fornaro Marco, Franceschini Franco, Govoni Marcello, Groh Matthieu, Guarnieri Gabriella, Hellmich Bernhard, Iannone Florenzo, Jones Rachel, Kernder Anna, Lo Gullo Alberto, Lombardi Carlo, Lopalco Giuseppe, Losappio Laura, Marchi Maria Rita, Rivera Carlos Martinez, Marvisi Chiara, Maule Matteo, Moi Laura, Monti Sara, Moosig Frank, Moroncini Gianluca, Negrini Simone Matteo, Neumann Thomas, Nolasco Santi, Novikov Pavel, Roccatello Dario, Samson Maxime, Schroeder Jan Walter, Seeliger Benjamin, Sinico Renato Alberto, Solans Roser, Tcherakian Colas, Toniati Paola, Treppo Elena, Trivioli Giorgio, Vacca Angelo, Jayne David, Bettiol Alessandra, Vaglio Augusto, Emmi Giacomo
Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Rheumatology Unit, Department of Medicine DIMED, University of Padua, Italy.
J Autoimmun. 2025 May;153:103398. doi: 10.1016/j.jaut.2025.103398. Epub 2025 Mar 26.
Following the results of the MANDARA trial, this real-life study aimed at comparing the effectiveness and safety profile of mepolizumab versus benralizumab in a European EGPA cohort.
We conducted a retrospective observational comparative study including EGPA patients, who received mepolizumab or benralizumab at the asthma dose. Patients were matched 1:1 by sex, age, BVAS and oral corticosteroid (OCS) dosage at the treatment initiation (T0). Complete response (CR) and partial response (PR), disease activity, OCS, pulmonary parameters, eosinophil count, relapses, and safety outcomes were also compared at 3, 6 and 12 months.
Patients treated with mepolizumab or benralizumab (n = 88 each) were matched: 57 % were females, median age was 54 years (IQR 45-60), median OCS dose 10 (7.5-12.5) and 10 (7-13) mg/day, median BVAS 4 (2-7) and 3 (2-8), respectively. 45.4 % of patients in the mepolizumab group and 51.1 % in the benralizumab group achieved CR or PR at T3, with CR steadily increasing during follow-up for both treatments. At T12, a higher CR rate was found in the benralizumab group (48.1 % vs 32.4 %, p = 0.005). No differences in BVAS, OCS, and respiratory parameters were observed between groups at the different timepoints. Throughout the follow-up, both treatments reduced eosinophil count, although a deeper reduction was found in the benralizumab group at all timepoints (p < 0.0001). Safety profile was comparable between patient groups.
Mepolizumab and benralizumab showed comparable overall effectiveness and safety in EGPA. However, benralizumab achieved a higher CR rate at T12, and a deeper peripheral eosinophil reduction.
基于MANDARA试验的结果，这项真实世界研究旨在比较美泊利单抗与贝那利珠单抗在欧洲嗜酸性肉芽肿性多血管炎（EGPA）队列中的有效性和安全性。
我们开展了一项回顾性观察性比较研究，纳入接受哮喘剂量美泊利单抗或贝那利珠单抗治疗的EGPA患者。患者在治疗起始时（T0）按性别、年龄、BVAS和口服糖皮质激素（OCS）剂量进行1:1匹配。还比较了3、6和12个月时的完全缓解（CR）和部分缓解（PR）、疾病活动度、OCS、肺参数、嗜酸性粒细胞计数、复发情况及安全性结局。
接受美泊利单抗或贝那利珠单抗治疗的患者（各88例）匹配良好：57%为女性，中位年龄54岁（四分位间距45 - 60岁），美泊利单抗组和贝那利珠单抗组的OCS中位剂量分别为10（7.5 - 12.5）和10（7 - 13）mg/天，BVAS中位值分别为4（2 - 7）和3（2 - 8）。美泊利单抗组45.4%的患者和贝那利珠单抗组51.1%的患者在T3时达到CR或PR，两种治疗在随访期间CR均稳步增加。在T12时，贝那利珠单抗组的CR率更高（48.1%对32.4%，p = 0.005）。不同时间点两组间BVAS、OCS和呼吸参数无差异。在整个随访期间，两种治疗均降低了嗜酸性粒细胞计数，尽管贝那利珠单抗组在所有时间点的降低幅度更大（p < 0.0001）。患者组间安全性相当。
美泊利单抗和贝那利珠单抗在EGPA中总体有效性和安全性相当。然而，贝那利珠单抗在T12时达到了更高的CR率，且外周嗜酸性粒细胞降低幅度更大。
