Abstract：
OBJECTIVE: Several monoclonal antibodies (MoAbs) targeting specific type 2 immune reactions have been developed as innovative therapeutic approaches for chronic inflammatory airway diseases, such as chronic sinusitis with nasal polyps (CRSwNP) and asthma. However, the clinical safety of these MoAbs and how to choose them are not clear. Therefore, we aimed to assess the systemic drug- and dose-based safety of MoAbs in chronic airway inflammation using network meta-analysis (NMA).
METHODS: Electronic databases were systematically searched for relevant studies published in English between January 2009 and December 2022. Eligible studies must have clearly reported adverse events (AEs) among the MoAbs\' safety data.
RESULTS: 1). Regarding serious AEs, mepolizumab was significantly safer than placebo; in terms of permanent treatment discontinuation, reslizumab and dupilumab were significantly safer than benralizumab. 2). Regarding asthma worsening, dupilumab was associated with the best safety profile; was safer than dupilumab/300 mg/q2-4w. 3). In terms of injection-site reactions, dupilumab posed a higher risk than placebo; dupilumab/300 mg/qw posed a higher risk than dupilumab/300 mg/q2w and dupilumab/300 mg/q2-4w; lebrikizumab/250 mg/q4w posed a higher risk than lebrikizumab/37.5 mg/q4w; mepolizumab/100 mg/q4w posed a higher risk than mepolizumab/75 mg/q4w; benralizumab/30 mg/q4-8w posed a higher risk than benralizumab/20 mg/q4-8w. 4) In CRSwNP patients combined with asthma, the risks of experiencing AEs were not increased.
CONCLUSIONS: Overall, biologics are safe and well tolerated in chronic inflammatory airway disease. This drug- and dose-based NMA provides further evidence on the different safety profiles of different emerging MoAbs. This information may help guide rational drug use and provide clinical recommendations for choosing MoAbs.
BACKGROUND: SYSTEMATIC REVIEW REGISTRATION (PROSPERO #CRD42023387610).
METHODS: Electronic databases were systematically searched for relevant studies published in English between January 2009 and December 2022. Eligible studies must have clearly reported adverse events (AEs) among the MoAbs\' safety data.
RESULTS: 1). Regarding serious AEs, mepolizumab was significantly safer than placebo; in terms of permanent treatment discontinuation, reslizumab and dupilumab were significantly safer than benralizumab. 2). Regarding asthma worsening, dupilumab was associated with the best safety profile; was safer than dupilumab/300 mg/q2-4w. 3). In terms of injection-site reactions, dupilumab posed a higher risk than placebo; dupilumab/300 mg/qw posed a higher risk than dupilumab/300 mg/q2w and dupilumab/300 mg/q2-4w; lebrikizumab/250 mg/q4w posed a higher risk than lebrikizumab/37.5 mg/q4w; mepolizumab/100 mg/q4w posed a higher risk than mepolizumab/75 mg/q4w; benralizumab/30 mg/q4-8w posed a higher risk than benralizumab/20 mg/q4-8w. 4) In CRSwNP patients combined with asthma, the risks of experiencing AEs were not increased.
CONCLUSIONS: Overall, biologics are safe and well tolerated in chronic inflammatory airway disease. This drug- and dose-based NMA provides further evidence on the different safety profiles of different emerging MoAbs. This information may help guide rational drug use and provide clinical recommendations for choosing MoAbs.
BACKGROUND: SYSTEMATIC REVIEW REGISTRATION (PROSPERO #CRD42023387610).
摘要：
目的：已经开发了几种靶向特异性2型免疫反应的单克隆抗体（MoAbs）作为慢性炎症性气道疾病的创新治疗方法，如慢性鼻窦炎伴鼻息肉（CRSwNP）和哮喘。然而,这些MoAbs的临床安全性以及如何选择它们尚不清楚。因此,我们旨在使用网络meta分析(NMA)评估MoAbs在慢性气道炎症中的全身药物和剂量安全性.
方法：对2009年1月至2022年12月期间以英文发表的相关研究进行了系统的电子数据库检索。符合条件的研究必须在MoAbs的安全性数据中明确报告不良事件(AE)。
结果：1）。关于严重的AE，美泊利单抗比安慰剂显著更安全；就永久停药而言，瑞利珠单抗和dupilumab比贝那利珠单抗更安全.2).关于哮喘恶化，dupilumab与最佳安全性相关;比dupilumab/300mg/q2-4w更安全。3).就注射部位反应而言，dupilumab的风险高于安慰剂;dupilumab/300mg/q2w的风险高于dupilumab/300mg/q2w和dupilumab/300mg/q2-4w的风险;lebrikizumab/250mg/q4w的风险高于lebrikizumab/37.5mg/q4w的风险高于8qalmg4)在CRSwNP合并哮喘患者中，出现AE的风险并未增加.
结论：总体而言，生物制剂在慢性炎症性气道疾病中安全且耐受性良好.这种基于药物和剂量的NMA为不同新兴MoAbs的不同安全性提供了进一步的证据。这些信息可能有助于指导合理用药，并为选择MoAbs提供临床建议。
背景：系统审查注册（PROSPERO#CRD42023387610）。
方法：对2009年1月至2022年12月期间以英文发表的相关研究进行了系统的电子数据库检索。符合条件的研究必须在MoAbs的安全性数据中明确报告不良事件(AE)。
结果：1）。关于严重的AE，美泊利单抗比安慰剂显著更安全；就永久停药而言，瑞利珠单抗和dupilumab比贝那利珠单抗更安全.2).关于哮喘恶化，dupilumab与最佳安全性相关;比dupilumab/300mg/q2-4w更安全。3).就注射部位反应而言，dupilumab的风险高于安慰剂;dupilumab/300mg/q2w的风险高于dupilumab/300mg/q2w和dupilumab/300mg/q2-4w的风险;lebrikizumab/250mg/q4w的风险高于lebrikizumab/37.5mg/q4w的风险高于8qalmg4)在CRSwNP合并哮喘患者中，出现AE的风险并未增加.
结论：总体而言，生物制剂在慢性炎症性气道疾病中安全且耐受性良好.这种基于药物和剂量的NMA为不同新兴MoAbs的不同安全性提供了进一步的证据。这些信息可能有助于指导合理用药，并为选择MoAbs提供临床建议。
背景：系统审查注册（PROSPERO#CRD42023387610）。
