Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy.
Personalized Medicine Center: Asthma & Allergology, Humanitas Research Hospital, Rozzano (MI), Italy.
Immunotherapy. 2024;16(14-15):913-923. doi: 10.1080/1750743X.2024.2386899. Epub 2024 Sep 17.
WHAT IS THIS SUMMARY ABOUT?: This summary outlines the findings from the ANANKE study on the treatment of patients with severe eosinophilic asthma (SEA) with benralizumab. SEA is an inflammatory disease of the lungs caused by eosinophils. Patients with SEA may experience asthma attacks (exacerbations) and decreased ability to breathe (lung function) despite taking medications. Benralizumab (Fasenra) is a biologic therapy (a medicine produced using living cells) approved for the treatment of SEA.The ANANKE study was conducted in Italy and evaluated the characteristics of patients with SEA who received benralizumab as prescribed by their doctors. It also described the effects of benralizumab on participants in terms of frequency of exacerbations, lung function and overall control of asthma, and their need to take oral corticosteroids (OCS) to control symptoms. The effects of benralizumab have been observed in participants treated for: 1) an average of 10.3 months, and 2) up to 96 weeks (approximately 2 years). The effects were also compared between different groups: 1) participants with chronic rhinosinusitis with nasal polyps (CRSwNP) and those without, and 2) participants who received other biologics before benralizumab (bio-experienced) and those who started with benralizumab as their first biologic (naïve). CRSwNP is an inflammatory condition that makes breathing even more difficult.
WHAT WERE THE KEY FINDINGS?: Before receiving benralizumab, participants showed a high blood eosinophil count (the number of eosinophils in the bloodstream), frequent exacerbations, insufficient lung function, and poor disease control (symptom management). After 96 weeks, benralizumab almost eliminated exacerbations, improved lung function, reduced the use of OCS, and increased the control of SEA symptoms while lowering blood eosinophil count. Comparable effects were observed between participants with and without CRSwNP and between naïve and bio-experienced participants.
WHAT WERE THE MAIN CONCLUSIONS REPORTED BY THE RESEARCHERS?: The ANANKE study showed that participants had frequent exacerbations and were characterized by eosinophilic inflammation before starting benralizumab. Overall, benralizumab improved the control of the disease for up to 2 years and induced similar beneficial effects regardless of the presence of CRSwNP and the use of previous biologics. These findings highlight the long-lasting and broad action of benralizumab. NCT04272463 (ANANKE) (ClinicalTrials.gov).
这篇摘要概述了 ANANKE 研究中贝那鲁肽治疗严重嗜酸性粒细胞性哮喘(SEA)患者的结果。SEA 是一种由嗜酸性粒细胞引起的肺部炎症性疾病。尽管接受了药物治疗,SEA 患者仍可能经历哮喘发作(加重)和呼吸能力下降(肺功能)。贝那鲁肽(Fasenra)是一种生物疗法(使用活细胞生产的药物),批准用于治疗 SEA。
ANANKE 研究在意大利进行,评估了按医生规定接受贝那鲁肽治疗的 SEA 患者的特征。它还描述了贝那鲁肽对参与者的影响,包括加重发作的频率、肺功能和哮喘的整体控制,以及他们控制症状所需的口服皮质类固醇(OCS)。在接受以下治疗的参与者中观察到了贝那鲁肽的作用:1)平均 10.3 个月,2)长达 96 周(约 2 年)。还比较了不同组之间的作用:1)有慢性鼻-鼻窦炎伴鼻息肉(CRSwNP)和没有 CRSwNP 的参与者,2)在接受贝那鲁肽之前接受过其他生物制剂的参与者(生物经验丰富)和作为他们的第一种生物制剂开始接受贝那鲁肽的参与者(初治)。CRSwNP 是一种使呼吸更加困难的炎症性疾病。
主要发现是什么?在接受贝那鲁肽治疗之前,参与者的血液嗜酸性粒细胞计数(血液中的嗜酸性粒细胞数量)高、加重发作频繁、肺功能不足且疾病控制不佳(症状管理)。96 周后,贝那鲁肽几乎消除了加重发作,改善了肺功能,减少了 OCS 的使用,并增加了 SEA 症状的控制,同时降低了血液嗜酸性粒细胞计数。有和没有 CRSwNP 的参与者以及初治和生物经验丰富的参与者之间观察到了类似的效果。
研究人员报告的主要结论是什么?ANANKE 研究表明,参与者在开始接受贝那鲁肽治疗之前,加重发作频繁,并且表现出嗜酸性粒细胞炎症。总的来说,贝那鲁肽改善了疾病的控制,长达 2 年,并诱导了相似的有益作用,无论是否存在 CRSwNP 和使用以前的生物制剂。这些发现突出了贝那鲁肽的持久和广泛作用。NCT04272463(ANANKE)(ClinicalTrials.gov)。