Guy's Severe Asthma Centre, Guy's and Thomas' NHS Trust, London, UK
School of Immunology and Microbial Sciences, King's College London, London, UK.
Eur Respir J. 2024 Jul 11;64(1). doi: 10.1183/13993003.01521-2023. Print 2024 Jul.
Pivotal phase 3 trials and real-world studies have demonstrated benralizumab's overall efficacy and safety in severe eosinophilic asthma (SEA). Additional large-cohort data are needed to confirm its real-world effectiveness in SEA according to previous biologic use and key baseline characteristics important for treatment selection.
XALOC-1 is a large, multinational, retrospective, observational, real-world study programme of benralizumab in adults with SEA. This 48-week integrated analysis assessed annualised exacerbation rate (AER), maintenance oral corticosteroid (mOCS) use, asthma symptom control and lung function during a 12-month baseline period and up to 48 weeks after benralizumab initiation. Subgroup analyses were based on previous biologic use and key baseline clinical characteristics (mOCS use, blood eosinophil count, exacerbation history, age at asthma diagnosis, fractional exhaled nitric oxide level and presence of atopy and chronic rhinosinusitis with nasal polyps).
Out of 1002 patients analysed, 380 were biologic-experienced. At week 48, 71.3% were exacerbation-free ( 17.2% at baseline); relative reduction in AER was 82.7% overall and 72.9% in biologic-experienced patients; rates were maintained across all key clinical characteristic subgroups. Of patients using mOCS at baseline (n=274), 47.4% (130 out of 274) eliminated their use by week 48; the mean reduction from baseline in daily dose was 51.2% and, notably, 34.9% in biologic-experienced patients (n=115). Clinically significant improvements in asthma symptom control and lung function were observed.
In this large, real-world programme, SEA patients treated with benralizumab had substantial improvements in clinical outcomes irrespective of previous biologic use and key clinical characteristics important to therapeutic decision-making in clinical practice.
关键性 3 期试验和真实世界研究已经证明了 benralizumab 在重度嗜酸性粒细胞性哮喘（SEA）中的总体疗效和安全性。需要更多的大型队列数据来根据先前的生物制剂使用和治疗选择重要的关键基线特征，确认其在 SEA 中的真实世界疗效。
XALOC-1 是一项大型的、多国的、回顾性的、观察性的、真实世界的 benralizumab 治疗 SEA 的研究项目。这项为期 48 周的综合分析评估了在 12 个月的基线期和 benralizumab 起始后 48 周内，年化加重率（AER）、维持口服皮质类固醇（mOCS）的使用、哮喘症状控制和肺功能。亚组分析基于先前的生物制剂使用和关键基线临床特征（mOCS 使用、血嗜酸性粒细胞计数、加重史、哮喘诊断年龄、呼气一氧化氮分数和特应性和慢性鼻-鼻窦炎伴鼻息肉的存在）。
在分析的 1002 名患者中，有 380 名是生物制剂治疗经验患者。在第 48 周时，71.3%的患者无加重（基线时为 17.2%）；总体 AER 相对减少了 82.7%，在生物制剂治疗经验患者中减少了 72.9%；在所有关键临床特征亚组中，这些结果都得到了维持。在基线时使用 mOCS 的患者（n=274）中，有 47.4%（130/274）在第 48 周时停用了 mOCS；与基线相比，每日剂量的平均减少量为 51.2%，值得注意的是，在生物制剂治疗经验患者中（n=115）减少了 34.9%。观察到哮喘症状控制和肺功能的临床显著改善。
在这项大型的真实世界项目中，接受 benralizumab 治疗的 SEA 患者在临床结局方面有了显著的改善，无论先前的生物制剂使用情况如何，以及在临床实践中对治疗决策重要的关键临床特征如何。
