Benralizumab在重度嗜酸性粒细胞性哮喘中根据先前生物制剂使用情况和关键临床亚组的应用：XALOC-1的真实世界
2024/04/24
Benralizumab在重度嗜酸性粒细胞性哮喘中根据先前生物制剂使用情况和关键临床亚组的应用：XALOC-1的真实世界项目
摘要
背景：关键的三期试验和真实世界研究已证明了Benralizumab对重度嗜酸性粒细胞性哮喘（SEA）的总体疗效和安全性。根据既往使用生物制剂的情况以及对治疗选择非常重要的关键基线特征，我们需要更多的大型队列数据来证实Benralizumab对重症嗜酸性粒细胞性哮喘（SEA）的实际疗效。
方法：XALOC-1是一项大型、多国、回顾性、观察性、真实世界研究计划，针对Benralizumab在成人SEA患者中的应用。这项为期 48 周的综合分析评估了 12 个月基线期间和开始使用Benralizumab后 48 周内的年恶化率 (AER)、维持口服皮质类固醇 (mOCS) 使用情况、哮喘症状控制情况和肺功能。亚组分析基于既往生物制剂使用情况和主要基线临床特征（mOCS使用情况、血液嗜酸性粒细胞计数、哮喘加重史、哮喘诊断年龄、呼出气一氧化氮水平以及是否存在过敏症和伴有鼻息肉的慢性鼻炎）。
结果：分析了1002名患者，其中380名曾接受过生物学治疗。第48周时，71.3%的患者无病情加重（基线时为17.2%）；总体AER相对减少率为82.7%，有生物治疗经验的患者为72.9%；所有主要临床特征亚组的AER相对减少率均保持不变。在基线时使用 mOCS 的患者（n=274）中，有 47.4% （130/274）在第 48 周前不再使用；日剂量与基线相比的平均降幅为 51.2%，值得注意的是，生物制剂治疗经验患者（n=115）的降幅为 34.9%。哮喘症状控制和肺功能均有明显改善。
结论：在这一大型真实世界项目中，接受Benralizumab治疗的SEA患者的临床疗效得到了显著改善，与既往使用生物制剂的情况以及临床实践中对治疗决策非常重要的关键临床特征无关。
(中日友好医院呼吸与危重症医学科 沈焜路 摘译 林江涛 审校)
(Eur Respir J. 2024 Apr 4; DOI:10.1183/13993003.01521-2023)
(Eur Respir J. 2024 Apr 4; DOI:10.1183/13993003.01521-2023)
Benralizumab in severe eosinophilic asthma by previous biologic use and key clinical subgroups: real-world XALOC-1 programme
Jackson, D. J., Pelaia, G., Emmanuel, B., Tran, T. N., Cohen, D., Shih, V. H., Shavit, A., Arbetter, D., Katial, R., Rabe, A. P. J., Garcia Gil, E., Pardal, M., Nuevo, J., Watt, M., Boarino, S., Kayaniyil, S., Chaves Loureiro, C., Padilla-Galo, A., & Nair, P.
Abstract
Background: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.
Methods: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).
Results:Of 1002 patients analysed, 380 were biologic-experienced. At Week 48, 71.3% were exacerbation-free (versus 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% (130/274) 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.
Conclusion: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.
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