Irene Mattioli , Maria Letizia Urban , Roberto Padoan , Aladdin J. Mohammad , Carlo Salvarani , Chiara Baldini , Alvise Berti , Paolo Cameli , Marco Caminati , Pascal Cathébras , Fulvia Chieco Bianchi , Francesco Cinetto , Jan Willem Cohen Tervaert , Angelo Coppola , Giulia Costanzo , Vincent Cottin , Claudia Crimi , Stefano Del Giacco , Charlene Desaintjean , Allyson Egan , Barbara Trezzi
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引用次数: 0
Abstract
Background
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.
Methods
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.
Results
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.
Conclusion
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.
在MANDARA试验结果之后,这项现实生活中的研究旨在比较mepolizumab与benralizumab在欧洲EGPA队列中的有效性和安全性。方法我们进行了一项回顾性观察性比较研究,纳入EGPA患者,接受mepolizumab或benralizumab的哮喘剂量。患者按性别、年龄、BVAS和治疗开始时口服皮质类固醇(OCS)剂量(T0)进行1:1匹配。完全缓解(CR)和部分缓解(PR)、疾病活动性、OCS、肺参数、嗜酸性粒细胞计数、复发和安全性结果也在3、6和12个月时进行了比较。结果mepolizumab或benralizumab治疗的患者(各88例)匹配:57%为女性,中位年龄为54岁(IQR 45-60),中位OCS剂量为10(7.5-12.5)和10 (7-13)mg/天,中位BVAS分别为4(2-7)和3(2-8)。45.4%的mepolizumab组患者和51.1%的benralizumab组患者在T3达到CR或PR,在两种治疗的随访期间CR稳步增加。在T12时,benralizumab组的CR率更高(48.1% vs 32.4%, p = 0.005)。各组在不同时间点的BVAS、OCS和呼吸参数均无差异。在整个随访过程中,两种治疗均降低了嗜酸性粒细胞计数,尽管贝纳利珠单抗组在所有时间点均有更深程度的降低(p <;0.0001)。患者组间的安全性具有可比性。结论mepolizumab和benralizumab在EGPA治疗中具有相当的总体有效性和安全性。然而,贝纳利珠单抗在T12时实现了更高的CR率,以及更深的外周嗜酸性粒细胞减少。
期刊介绍:
The Journal of Autoimmunity serves as the primary publication for research on various facets of autoimmunity. These include topics such as the mechanism of self-recognition, regulation of autoimmune responses, experimental autoimmune diseases, diagnostic tests for autoantibodies, as well as the epidemiology, pathophysiology, and treatment of autoimmune diseases. While the journal covers a wide range of subjects, it emphasizes papers exploring the genetic, molecular biology, and cellular aspects of the field.
The Journal of Translational Autoimmunity, on the other hand, is a subsidiary journal of the Journal of Autoimmunity. It focuses specifically on translating scientific discoveries in autoimmunity into clinical applications and practical solutions. By highlighting research that bridges the gap between basic science and clinical practice, the Journal of Translational Autoimmunity aims to advance the understanding and treatment of autoimmune diseases.