Spataro Federico, Solimando Antonio Giovanni, Di Girolamo Attilio, Vacca Angelo, Ria Roberto
Post Graduate School in Allergology and Internal Medicine "Guido Baccelli", Department of Precision and Regenerative Medicine and Ionian Area-(DiMePRe-J), School of Medicine, University of Bari Aldo Moro, Bari, Italy.
Guido Baccelli Unit of Internal Medicine, Department of Precision and Regenerative Medicine and Ionian Area-(DiMePRe-J), School of Medicine, University of Bari Aldo Moro, Bari, Italy.
Eur J Clin Invest. 2025 Feb;55(2):e14333. doi: 10.1111/eci.14333. Epub 2024 Oct 10.
Eosinophilic granulomatous polyangiitis (EGPA) is a rare autoimmune disease characterized by multisystemic inflammation, with eosinophils playing a central role in its pathogenesis. Traditional management relies heavily on corticosteroids and immunosuppressants, which are associated with significant side effects. The emergence of biologic agents, such as benralizumab, offers targeted therapeutic options by inhibiting the interleukin-5 receptor α, thereby reducing eosinophilic inflammation.
This systematic review and meta-analysis comprehensively evaluate the efficacy and safety of benralizumab in EGPA patients, focusing on its ability to reduce oral corticosteroid (OCS) use, facilitate remission and spare immunosuppressants. We searched MEDLINE, LILACS and ISI Web of Science databases for relevant studies up to July 2024.
Eight studies, including both randomized controlled trials (RCTs) and observational studies, were included in the meta-analysis, involving a total of 396 EGPA patients. The pooled analysis demonstrated a significant reduction in OCS dose, with an overall estimated effect of -8.25 mg/day (95% CI, -9.39 to -7.10). Complete remission was achieved in 56.8% of patients, and immunosuppressants were reduced or discontinued in 28.1% of cases. Adverse events (AEs) were reported in 21.9% of patients, with only one discontinuation due to an AE.
These findings provide robust evidence supporting the use of benralizumab as an effective and well-tolerated treatment option for EGPA, significantly reducing OCS requirements and offering promising remission rates. Future research should focus on larger, multicentre RCTs to confirm these findings and further elucidate the long-term benefits and safety profile of benralizumab in EGPA.
嗜酸性肉芽肿性多血管炎（EGPA）是一种罕见的自身免疫性疾病，其特征为多系统炎症，嗜酸性粒细胞在其发病机制中起核心作用。传统治疗严重依赖糖皮质激素和免疫抑制剂，这些药物有显著的副作用。诸如贝那利珠单抗等生物制剂的出现，通过抑制白细胞介素-5受体α提供了靶向治疗选择，从而减轻嗜酸性粒细胞炎症。
本系统评价和荟萃分析全面评估了贝那利珠单抗在EGPA患者中的疗效和安全性，重点关注其减少口服糖皮质激素（OCS）使用、促进缓解以及减少免疫抑制剂使用的能力。我们检索了MEDLINE、LILACS和ISI科学网数据库，以查找截至2024年7月的相关研究。
荟萃分析纳入了8项研究，包括随机对照试验（RCT）和观察性研究，共涉及396例EGPA患者。汇总分析显示OCS剂量显著降低，总体估计效应为-8.25毫克/天（95%可信区间，-9.39至-7.10）。56.8% 的患者实现了完全缓解，28.1% 的病例中免疫抑制剂减少或停用。21.9% 的患者报告了不良事件（AE），仅有1例因AE停药。
这些发现提供了有力证据，支持将贝那利珠单抗作为EGPA一种有效且耐受性良好的治疗选择，显著降低OCS需求并提供可观的缓解率。未来研究应聚焦于更大规模的多中心RCT，以证实这些发现并进一步阐明贝那利珠单抗在EGPA中的长期益处和安全性。
