抗IL-5通路药物在嗜酸性粒细胞相关疾病中的终生应用

IF 13 1区 医学 Q1 PHARMACOLOGY & PHARMACY
Drugs Pub Date : 2024-06-01 Epub Date: 2024-06-08 DOI:10.1007/s40265-024-02037-0
Carlo Lombardi, Pasquale Comberiati, Erminia Ridolo, Marcello Cottini, Mona Rita Yacoub, Silvia Casagrande, Matteo Riccò, Marco Bottazzoli, Alvise Berti
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引用次数: 0

摘要

针对白细胞介素(IL)-5 通路的单克隆抗体彻底改变了嗜酸性粒细胞相关疾病的治疗预期,尤其是对呼吸系统受累患者的治疗。Mepolizumab(IL-5 拮抗剂单克隆抗体)、benralizumab(IL-5 受体阻断剂单克隆抗体)和 reslizumab(IL-5 拮抗剂单克隆抗体)共同促进了各种疾病负担的整体改善。嗜酸性粒细胞性哮喘目前在所有年龄组中都拥有最有力的证据:所有三种生物制剂都被批准用于成人(年龄≥18 岁);美国食品药品管理局(FDA)和欧洲药品管理局(EMA)也批准了mepolizumab 用于儿童(年龄≥6 岁),而伯纳利珠单抗最近被美国食品药品管理局批准用于年龄≥6 岁的患者。对于伴有鼻息肉的慢性鼻炎,皮下注射甲泊利珠单抗是迄今为止唯一获批的抗IL-5疗法,可用于成年患者(年龄≥18岁)。对于嗜酸性粒细胞食管炎,mepolizumab、reslizumab 和 benralizumab 的证据相互矛盾,导致这些药物未获 FDA/EMA 批准。最近,mepolizumab 被批准用于年龄≥6 岁或以上的嗜酸性粒细胞肉芽肿伴多血管炎患者和高嗜酸性粒细胞综合征成人患者。最近发表的一项III期试验证明,在嗜酸性粒细胞肉芽肿伴多血管炎的治疗中,苯拉利珠单抗与美泊珠单抗相比并无劣效,而有关雷利珠单抗的证据则很少。总体而言,目前有关抗IL-5生物制剂治疗嗜酸性粒细胞相关疾病的证据大多集中在成人身上,而针对18岁以下和65岁以上人群的数据却很少,导致在这些特定患者人群中使用抗IL-5药物缺乏证据,尤其是在疗效方面。本综述探讨了来自随机对照试验和实际上市后研究的高质量证据,这些证据涉及嗜酸性粒细胞相关性疾病的抗IL-5疗法在儿童、成年和老年各年龄段的应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Anti-IL-5 Pathway Agents in Eosinophilic-Associated Disorders Across the Lifespan.

Anti-IL-5 Pathway Agents in Eosinophilic-Associated Disorders Across the Lifespan.

Monoclonal antibodies targeting interleukin (IL)-5 pathways have revolutionized the treatment expectations for eosinophilic-associated conditions, particularly in patients with respiratory involvement. Mepolizumab (IL-5 antagonist monoclonal antibody), benralizumab (IL-5 receptor blocker monoclonal antibody), and reslizumab (IL-5 antagonist monoclonal antibody) have collectively contributed to the overall improvement of the disease burden in various conditions. Eosinophilic asthma currently boasts the most robust evidence across all age groups: all three biologics are approved for adults (aged ≥18 years); mepolizumab is approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) also in children (aged ≥ 6 years), while bernalizumab was recently approved by the FDA for patients aged ≥6 years in the USA. In chronic rhinosinusitis with nasal polyps, subcutaneous mepolizumab is the only anti-IL-5 therapy approved so far and can be used in adult patients (aged ≥18 years). For eosinophilic esophagitis, conflicting evidence surrounds both mepolizumab, reslizumab, and benralizumab, leading to non-approval of these agents by the FDA/EMA. Recently, mepolizumab was approved for eosinophilic granulomatosis with polyangiitis patients aged ≥6 years or older and for hypereosinophilic syndrome adult patients. A phase III trial proving noninferiority of benralizumab versus mepolizumab in eosinophilic granulomatosis with polyangiitis has been recently published, while evidence on reslizumab is scant. Overall, current evidence on anti-IL-5 biologics for eosinophilic-associated disorders is mostly focused on adults, whereas data for individuals aged under 18 years and over 65 years are scarce, resulting in a lack of evidence, particularly regarding efficacy, for the use of anti-IL-5 agents in these specific patient populations. This review addresses high-quality evidence from randomized controlled trials and real-world post-marketing studies regarding the use of anti-IL-5 therapies for eosinophilic-associated disorders across all age groups, spanning childhood, adulthood, and older age.

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来源期刊
Drugs
Drugs 医学-毒理学
CiteScore
22.70
自引率
0.90%
发文量
134
审稿时长
3-8 weeks
期刊介绍: Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.
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