Depemokimab在未控制的重度哮喘中的定位。
完整摘要 · 中文译文
哮喘是一种影响全球超过3亿人的慢性气道炎症性疾病。据估计，其中3%至10%患有重度哮喘。Depemokimab是首个为2型呼吸系统疾病开发的超长效抗IL-5单克隆抗体，可实现每26周给药一次。它能快速且持续地降低血嗜酸性粒细胞计数。这种每年两次的给药方案显著减少了注射频率，并可能减轻治疗负担。在重复开展的3期SWIFT-1和SWIFT-2试验中，与安慰剂相比，depemokimab使12岁及以上重度嗜酸性粒细胞性哮喘患者的合并年化临床显著急性发作率降低了54%，需要住院或急诊处理的急性发作率降低了72%。在慢性鼻窦炎伴鼻息肉（CRSwNP）中，depemokimab在重复开展的3期ANCHOR-1和ANCHOR-2试验中接受了评估。两项共同主要终点均已达到，这些研究提供了证据，表明每年两次的depemokimab在52周内可降低内镜下鼻息肉评分并改善鼻塞，适用于控制不佳的CRSwNP。Depemokimab已被批准用于伴有2型炎症的重度哮喘和重度CRSwNP，使其成为两种疾病并存时的一种治疗选择。基于目前可获得的证据，depemokimab为重度嗜酸性粒细胞性哮喘患者提供了一个额外选择，对于这些患者，预防急性发作是主要治疗目标。当减轻治疗负担是患者的主要考量时，每年两次的给药方案也可能具有相关性。 nt优先级，尽管这种减少对依从性和持续性的影响仍有待证实。
完整摘要 · 英文原文
Asthma is a chronic inflammatory disease of the airways affecting more than 300 million people worldwide. It is estimated that between 3% and 10% have severe asthma. Depemokimab is the first ultra-long-acting anti-IL-5 monoclonal antibody developed for type 2 respiratory disease, enabling administration every 26 weeks. It produces rapid and sustained reductions in blood eosinophil counts. This twice-yearly regimen markedly reduces injection frequency and may lessen treatment burden. In the replicate phase 3 SWIFT-1 and SWIFT-2 trials, depemokimab reduced the pooled annualized rate of clinically significant exacerbations by 54% and exacerbations requiring hospitalization or emergency department care by 72% compared with placebo in patients aged 12 years or older with severe eosinophilic asthma. In chronic rhinosinusitis with nasal polyps (CRSwNP), depemokimab was evaluated in the replicate phase 3 ANCHOR-1 and ANCHOR-2 trials. Both coprimary endpoints were met, and these studies provide evidence that twice-yearly depemokimab reduces the endoscopic nasal polyp score and improves nasal obstruction over 52 weeks in inadequately controlled CRSwNP. Depemokimab is approved for both severe asthma with type 2 inflammation and severe CRSwNP, making it a therapeutic option when both conditions coexist. Based on currently available evidence, depemokimab represents an additional option for patients with severe eosinophilic asthma in whom prevention of exacerbation is a major therapeutic goal. The twice-yearly dosing schedule may also be relevant when reducing treatment burden is a patient priority, although the effect of this reduction on adherence and persistence remains to be proved.