Five biologicals have been approved for severe eosinophilic asthma, a well‐recognized phenotype. Systematic reviews (SR) evaluated the efficacy and safety of benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab (alphabetical order) compared to standard of care for severe eosinophilic asthma. PubMed, Embase and Cochrane Library were searched to identify RCTs and health economic evaluations, published in English. Critical and important asthma‐related outcomes were evaluated for each of the biologicals. The risk of bias and the certainty of the evidence were assessed using GRADE. 19 RCTs (three RCTs for benralizumab, three RCTs for dupilumab, three RCTs for mepolizumab, five RCTs for omalizumab and five RCTs for reslizumab), including subjects 12 to 75 years old (except for omalizumab including also subjects 6‐11 years old), ranging from 12 to 56 weeks were evaluated. All biologicals reduce exacerbation rates with high certainty of evidence: benralizumab incidence rate ratio (IRR) 0.53 (95% CI 0.39 to 0.72), dupilumab (IRR) 0.43 (95% CI 0.32 to 0.59), mepolizumab IRR 0.49 (95% CI 0.38 to 0.66), omalizumab (IRR) 0.56 (95% CI 0.40 to 0.77) and reslizumab (IRR) 0.46 (95% CI 0.37 to 0.58). Benralizumab, dupilumab and mepolizumab reduce the daily dose of oral corticosteroids (OCS) with high certainty of evidence. All evaluated biologicals probably improve asthma control, QoL and FEV1, without reaching the minimal important difference (moderate certainty). Benralizumab, mepolizumab and reslizumab slightly increase drug‐related adverse events (AE) and drug‐related serious AE (low to very low certainty of evidence). The incremental cost‐effectiveness ratio per quality‐adjusted life year value is above the willingness to pay threshold for all biologicals (moderate certainty). Potential savings are driven by decrease in hospitalizations, emergency and primary care visits. There is high certainty that all approved biologicals reduce the rate of severe asthma exacerbations and for benralizumab, dupilumab and mepolizumab for reducing OCS. There is moderate certainty for improving asthma control, QoL, FEV1. More data on long‐term safety are needed together with more efficacy data in the paediatric population.

中文翻译：

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生物制品（benralizumab、dupilumab、mepolizumab、omalizumab和reslizumab）治疗重度嗜酸性粒细胞性哮喘的疗效和安全性

五种生物制剂已被批准用于治疗重度嗜酸性粒细胞哮喘，这是一种公认​​的表型。系统评价 (SR) 评估了 benralizumab、dupilumab、mepolizumab、omalizumab 和 reslizumab（按字母顺序）与严重嗜酸性粒细胞性哮喘的护理标准相比的疗效和安全性。检索了 PubMed、Embase 和 Cochrane 图书馆，以确定以英文发表的 RCT 和卫生经济学评估。评估了每种生物制剂的关键和重要的哮喘相关结果。使用 GRADE 评估偏倚风险和证据的确定性。19 项 RCT（贝那利珠单抗 3 项 RCT、杜匹单抗 3 项 RCT、美泊利单抗 3 项 RCT、奥马珠单抗 5 项 RCT 和 reslizumab 5 项 RCT），包括 12 至 75 岁受试者（奥马珠单抗除外，还包括 6-11 岁受试者），评估范围为 12 至 56 周。所有生物制剂均以高确定性证据降低急性加重率：贝那利珠单抗发生率比 (IRR) 0.53（95% CI 0.39 至 0.72），dupilumab (IRR) 0.43（95% CI 0.32 至 0.59），美泊利珠单抗 IRR 0.49（935% CI） 0.66)、奥马珠单抗 (IRR) 0.56（95% CI 0.40 至 0.77）和 reslizumab (IRR) 0.46（95% CI 0.37 至 0.58）。Benralizumab、dupilumab 和 mepolizumab 降低了口服皮质类固醇 (OCS) 的日剂量，并且具有高度确定性的证据。所有评估的生物制品都可能改善哮喘控制、QoL 和 FEV1，但没有达到最小的重要差异（中等确定性）。Benralizumab、mepolizumab 和 reslizumab 轻微增加药物相关不良事件 (AE) 和药物相关严重 AE（低至极低的证据质量）。每个质量调整生命年值的增量成本效益比高于所有生物制品的支付意愿阈值（中等确定性）。住院、急诊和初级保健就诊次数的减少推动了潜在的节省。高度肯定的是，所有获批的生物制品都可以降低严重哮喘发作的发生率，而贝那利珠单抗、杜匹单抗和美泊利珠单抗可以降低 OCS。改善哮喘控制、QoL、FEV1 有中等确定性。需要更多关于长期安全性的数据以及更多儿科人群的疗效数据。高度肯定的是，所有获批的生物制品都可以降低严重哮喘发作的发生率，而贝那利珠单抗、杜匹单抗和美泊利珠单抗可以降低 OCS。改善哮喘控制、QoL、FEV1 有中等确定性。需要更多关于长期安全性的数据以及更多儿科人群的疗效数据。高度肯定的是，所有获批的生物制品都可以降低严重哮喘发作的发生率，而贝那利珠单抗、杜匹单抗和美泊利珠单抗可以降低 OCS。改善哮喘控制、QoL、FEV1 有中等确定性。需要更多关于长期安全性的数据以及更多儿科人群的疗效数据。