The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
Department of Respiratory Medicine, Shenzhen Bao'an Traditional Chinese Medicine Hospital (Group), Shenzhen, Guangdong, China.
PLoS One. 2019 Jan 31;14(1):e0211790. doi: 10.1371/journal.pone.0211790. eCollection 2019.
More and more clinical trials have tried to assess the clinical benefit of anti-interleukin (IL)-13 monoclonal antibodies for uncontrolled asthma. The aim of this study is to evaluate the efficacy and safety of anti-IL-13 monoclonal antibodies for uncontrolled asthma. Major databases were searched for randomized controlled trials comparing the anti-IL-13 treatment and a placebo in uncontrolled asthma. Outcomes, including asthma exacerbation rate, forced expiratory volume in 1 second (FEV1), Asthma Quality of Life Questionnaire (AQLQ) scores, rescue medication use, and adverse events were extracted from included studies for systematic review and meta-analysis. Five studies involving 3476 patients and two anti-IL-13 antibodies (lebrikizumab and tralokinumab) were included in this meta-analysis. Compared to the placebo, anti-IL-13 treatments were associated with significant improvement in asthma exacerbation, FEV1 and AQLQ scores, and reduction in rescue medication use. Adverse events and serious adverse events were similar between two groups. Subgroup analysis showed patients with high periostin level had a lower risk of asthma exacerbation after receiving anti-IL-13 treatment. Our study suggests that anti-IL-13 monoclonal antibodies could improve the management of uncontrolled asthma. Periostin may be a good biomarker to detect the specific subgroup who could get better response to anti-IL-13 treatments. In view of blocking IL-13 alone is possibly not enough to achieve asthma control because of the overlapping pathophysiological roles of IL-13/IL-4 in inflammatory pathways, combined blocking of IL-13 and IL-4 with monoclonal antibodies may be more encouraging.
越来越多的临床试验试图评估抗白细胞介素(IL)-13 单克隆抗体治疗未控制哮喘的临床获益。本研究旨在评估抗 IL-13 单克隆抗体治疗未控制哮喘的疗效和安全性。主要数据库检索了比较抗 IL-13 治疗与安慰剂治疗未控制哮喘的随机对照试验。从纳入的研究中提取哮喘恶化率、1 秒用力呼气量(FEV1)、哮喘生活质量问卷(AQLQ)评分、急救药物使用和不良事件等结局,进行系统评价和荟萃分析。这项荟萃分析纳入了 5 项涉及 3476 例患者和 2 种抗 IL-13 抗体(lebrikizumab 和 tralokinumab)的研究。与安慰剂相比,抗 IL-13 治疗可显著改善哮喘恶化、FEV1 和 AQLQ 评分,并减少急救药物使用。两组间不良反应和严重不良反应相似。亚组分析显示,外周蛋白水平较高的患者接受抗 IL-13 治疗后哮喘恶化的风险较低。本研究表明,抗 IL-13 单克隆抗体可改善未控制哮喘的管理。外周蛋白可能是一种很好的生物标志物,可用于检测对抗 IL-13 治疗有更好反应的特定亚组。鉴于单独阻断 IL-13 可能不足以实现哮喘控制,因为 IL-13/IL-4 在炎症途径中具有重叠的病理生理作用,因此用单克隆抗体联合阻断 IL-13 和 IL-4 可能更有希望。