Kyriakopoulos Christos, Gogali Athena, Markozannes Georgios, Kostikas Konstantinos
Respiratory Medicine Department, University of Ioannina Faculty of Medicine, Ioannina, Greece.
Department of Hygiene and Epidemiology, University of Ioannina Faculty of Medicine, Ioannina, Greece.
Eur Respir Rev. 2024 Apr 24;33(172). doi: 10.1183/16000617.0238-2023. Print 2024 Apr 30.
Six biologic agents are now approved for patients with severe asthma. This meta-analysis aimed to assess the efficacy and safety of licensed biologic agents in patients with severe asthma, including the recently approved tezepelumab.
We searched MEDLINE, Embase and CENTRAL to identify randomised controlled trials involving licensed biologics until 31 January 2023. We used random-effects meta-analysis models for efficacy, including subgroup analyses by individual agents and markers of T2-high inflammation (blood eosinophils and fractional exhaled nitric oxide), and assessed safety.
48 studies with 16 350 patients were included in the meta-analysis. Biologics were associated with a 44% reduction in the annualised rate of asthma exacerbations (rate ratio 0.56, 95% CI 0.51-0.62) and 60% reduction of hospitalisations (rate ratio 0.40, 95% CI 0.27-0.60), a mean increase in the forced expiratory volume in 1 s of 0.11 L (95% CI 0.09-0.14), a reduction in asthma control questionnaire by 0.34 points (95% CI -0.46--0.23) and an increase in asthma quality of life questionnaire by 0.38 points (95% CI 0.26-0.49). There was heterogeneity between different classes of biologics in certain outcomes, with overall greater efficacy in patients with T2 inflammation. Overall, biologics exhibited a favourable safety profile.
This comprehensive meta-analysis demonstrated that licensed asthma biologics reduce exacerbations and hospitalisations, improve lung function, asthma control and quality of life, and limit the use of systemic corticosteroids, with a favourable safety profile. These effects are more prominent in patients with evidence of T2 inflammation.
目前有六种生物制剂被批准用于重度哮喘患者。本荟萃分析旨在评估已获许可的生物制剂在重度哮喘患者中的疗效和安全性，包括最近获批的tezepelumab。
我们检索了MEDLINE、Embase和CENTRAL，以识别截至2023年1月31日涉及已获许可生物制剂的随机对照试验。我们使用随机效应荟萃分析模型评估疗效，包括按个体药物和T2高炎症标志物（血液嗜酸性粒细胞和呼出一氧化氮分数）进行亚组分析，并评估安全性。
荟萃分析纳入了48项研究，共16350例患者。生物制剂使哮喘急性发作年化率降低44%（率比0.56，95%CI 0.51 - 0.62），住院率降低60%（率比0.40，95%CI 0.27 - 0.60），1秒用力呼气容积平均增加0.11L（95%CI 0.09 - 0.14），哮喘控制问卷评分降低0.34分（95%CI -0.46 - -0.23），哮喘生活质量问卷评分增加0.38分（95%CI 0.26 - 0.49）。不同类别的生物制剂在某些结局方面存在异质性，T2炎症患者总体疗效更佳。总体而言，生物制剂表现出良好的安全性。
这项全面的荟萃分析表明，已获许可的哮喘生物制剂可减少急性发作和住院次数，改善肺功能、哮喘控制和生活质量，并限制全身用糖皮质激素的使用，且安全性良好。这些效果在有T2炎症证据的患者中更为显著。
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