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长期嗜酸性粒细胞清除:关于倍利珠单抗治疗重度嗜酸性粒细胞性哮喘安全性和持久性的真实世界观点

Long-Term Eosinophil Depletion: A Real-World Perspective on the Safety and Durability of Benralizumab Treatment in Severe Eosinophilic Asthma.

作者信息

Menzella Francesco, Marchi Mariarita, Caminati Marco, Romagnoli Micaela, Micheletto Claudio, Bonato Matteo, Idotta Giuseppe, Nizzetto Manuele, D'Alba Giuseppina, Cavenaghi Massimiliano, Bortoli Michela, Beghè Bianca, Pini Laura, Benoni Roberto, Casoni Gianluca, Muzzolon Rodolfo, Michieletto Lucio, Bosi Annamaria, Mastrototaro Andrea, Diamandi Adela, Nalin Mara, Senna Gianenrico

机构信息

Pulmonology Unit, S. Valentino Hospital, Montebelluna (TV), AULSS2 Marca Trevigiana, 31100 Treviso, Italy.

Respiratory Unit, Cittadella Hospital, AULSS6 Euganea, 35138 Padua, Italy.

出版信息

J Clin Med. 2024 Dec 31;14(1):191. doi: 10.3390/jcm14010191.

Abstract

Benralizumab is an anti-IL-5 receptor alpha monoclonal antibody that induces the near-complete depletion of eosinophils. This study aimed to evaluate the long-term safety and effectiveness of benralizumab in patients with severe eosinophilic asthma (SEA) over an extended 48-month follow-up period, offering one of the longest real-world perspectives available. This was a single-arm, retrospective, observational, multicenter study involving 123 SEA patients treated with benralizumab at a dosage of 30 mg every 4 weeks for the first 3 doses and then every 8 weeks. The safety endpoints focused on the frequency and nature of adverse events and the likelihood that they were induced by benralizumab. The efficacy endpoints focused on lung function, asthma exacerbations and control, and oral corticosteroid use. Benralizumab, consistent with its mechanism of action, led to the rapid and nearly complete depletion of eosinophils. In total, 26 adverse events (21.1%) were observed, with 1.6% related to the treatment and 0.8% categorized as serious (vagal hypotension). Bronchitis was the most common unrelated adverse event (15.4%), occurring between months 36 and 38. Importantly, benralizumab effectiveness and safety were maintained consistently across the 48-month duration, resulting in significant improvements in lung function and reductions in oral corticosteroid use and exacerbation frequency. Benralizumab demonstrated a favorable safety profile, comparable to previously published studies, with perdurable effectiveness in controlling SEA and reducing oral corticosteroid use. Finally, this study provides evidence that near-complete eosinophil depletion does not increase long-term safety risks and supports benralizumab as a reliable treatment option for SEA patients.

摘要

贝那利珠单抗是一种抗白细胞介素-5受体α单克隆抗体,可诱导嗜酸性粒细胞近乎完全耗竭。本研究旨在评估贝那利珠单抗在重度嗜酸性粒细胞性哮喘(SEA)患者中进行长达48个月的延长随访期后的长期安全性和有效性,提供了可获得的最长时间的真实世界观察结果之一。这是一项单臂、回顾性、观察性、多中心研究,涉及123例SEA患者,前3剂每4周接受30 mg贝那利珠单抗治疗,之后每8周治疗一次。安全性终点集中于不良事件的频率和性质以及由贝那利珠单抗诱发的可能性。疗效终点集中于肺功能、哮喘加重和控制情况以及口服糖皮质激素的使用。贝那利珠单抗与其作用机制一致,导致嗜酸性粒细胞迅速且近乎完全耗竭。总共观察到26例不良事件(21.1%),其中1.6%与治疗相关,0.8%归类为严重不良事件(迷走性低血压)。支气管炎是最常见的非相关不良事件(15.4%),发生在第36至38个月之间。重要的是,在48个月的研究期间,贝那利珠单抗的有效性和安全性始终保持一致,导致肺功能显著改善,口服糖皮质激素使用减少,加重频率降低。贝那利珠单抗显示出良好的安全性,与先前发表的研究相当,在控制SEA和减少口服糖皮质激素使用方面具有持久疗效。最后,本研究提供了证据,证明嗜酸性粒细胞近乎完全耗竭不会增加长期安全风险,并支持贝那利珠单抗作为SEA患者可靠的治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f996/11722057/ae9dc0270ce0/jcm-14-00191-g001.jpg

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