Kim Hayeon, Kim Myeong Gyu, Kim Sung-Ryeol, Lee Jae-Hyun, Byun Youngjoo, Park Jiwon, Kim Kyungim
College of Pharmacy, Korea University, Sejong, Republic of Korea.
College of Pharmacy, Ewha Womans University, Seoul, Republic of Korea.
World Allergy Organ J. 2024 Jul 18;17(7):100934. doi: 10.1016/j.waojou.2024.100934. eCollection 2024 Jul.
Few studies have evaluated the comparative efficacy of biologics for asthma. This network meta-analysis aimed to compare the efficacy of biologics.
This study included randomized controlled trials (RCTs) evaluating the efficacy of a biologic compared to a placebo or another biologic in patients with inadequately controlled asthma despite high-intensity treatment, published by January 6, 2022. Two researchers independently searched the PubMed, Embase, Web of Science, and Scopus and assessed the risk of bias using the Cochrane tool. The outcomes of interest were the annual asthma exacerbation rate (AER), forced expiratory volume per second before bronchodilator use (preBD FEV1), the asthma control questionnaire (ACQ), and asthma quality of life questionnaire (AQLQ) results. A frequentist network meta-analysis was conducted, and a random effects model was used to draw pooled incidence rate ratio or standardized mean differences.
Twenty-three RCTs with 8376 participants were retrieved. All biologics included in this study were associated with significantly better effects than placebo in AER, preBD FEV1, and ACQ outcomes. Although there were no significant differences between the biologics in the overall study population, patients with eosinophil levels ≥300 cells/μL or eosinophilic asthma showed that dupilumab and tezepelumab were significantly better than anti-IL-5 biologics in improving preBD FEV1. Additionally, in patients with eosinophil levels ≥300 cells/μL, benralizumab, unlike reslizumab, performed significantly better than placebo in improving ACQ and AQLQ outcomes.
The comparative effects of biologics can be considered with phenotypes and biomarkers to help clinicians select an appropriate treatment for inadequately controlled asthma.
很少有研究评估生物制剂对哮喘的比较疗效。这项网状荟萃分析旨在比较生物制剂的疗效。
本研究纳入了截至2022年1月6日发表的随机对照试验（RCT），这些试验评估了在高强度治疗后哮喘控制不佳的患者中，生物制剂与安慰剂或另一种生物制剂相比的疗效。两名研究人员独立检索了PubMed、Embase、Web of Science和Scopus，并使用Cochrane工具评估偏倚风险。感兴趣的结局指标为年度哮喘加重率（AER）、使用支气管扩张剂前的一秒用力呼气量（预支气管扩张剂使用FEV1）、哮喘控制问卷（ACQ）结果以及哮喘生活质量问卷（AQLQ）结果。进行了频率学派网状荟萃分析，并使用随机效应模型得出合并发病率比或标准化均数差。
共检索到23项RCT，涉及8376名参与者。本研究中纳入的所有生物制剂在AER、预支气管扩张剂使用FEV1和ACQ结局方面均显示出比安慰剂显著更好的效果。尽管在总体研究人群中生物制剂之间没有显著差异，但嗜酸性粒细胞水平≥300个细胞/μL的患者或嗜酸性粒细胞性哮喘患者显示，度普利尤单抗和tezepelumab在改善预支气管扩张剂使用FEV1方面显著优于抗IL-5生物制剂。此外，在嗜酸性粒细胞水平≥300个细胞/μL的患者中，贝那利珠单抗与瑞利珠单抗不同，在改善ACQ和AQLQ结局方面比安慰剂表现显著更好。
生物制剂的比较疗效可结合表型和生物标志物来考虑，以帮助临床医生为哮喘控制不佳的患者选择合适的治疗方法。
