Department of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine, Shinagawa-ku, Tokyo 142-8666, Japan.
Int J Mol Sci. 2020 Jan 30;21(3):889. doi: 10.3390/ijms21030889.
No head-to-head trials have compared the efficacy and safety between the licensed dosage and administration dosage of dupilumab and benralizumab for inadequately controlled asthma. We conducted an indirect treatment comparison to estimate differences in the efficacy and safety between dupilumab and benralizumab for inadequately controlled asthma using the Bayesian approach. The primary efficacy endpoint was annual exacerbation rate (AER). A subgroup analysis by blood eosinophil count was also performed. The primary safety endpoint was the incidence of any adverse events (AAEs). The results demonstrate that there was no significant difference in the AER between dupilumab and benralizumab in overall patients and the subgroup with the blood eosinophil count of <150. However, the AER was significantly lower in the dupilumab group than in the benralizumab group in the subgroup with a blood eosinophil count of ≥150 but <300, and ≥300 with the rate ratio and 95% credible interval of 0.51 (0.29-0.92) and 0.58 (0.39-0.84), respectively. There was no significant difference in the AAEs between the dupilumab and benralizumab groups. This indirect treatment comparison indicates that dupilumab is superior to benralizumab in patients with inadequately controlled asthma having higher blood eosinophil counts. A direct comparison is required to provide definitive evidence. Systematic Review Registration: UMIN-CTR no. UMIN000036256.
尚无头对头试验比较达必妥和本瑞来珠单抗在控制不佳的哮喘中的许可剂量和给药剂量的疗效和安全性。我们采用贝叶斯方法进行间接治疗比较,以估计达必妥和本瑞来珠单抗治疗控制不佳的哮喘的疗效和安全性差异。主要疗效终点是年加重率(AER)。还进行了基于血嗜酸粒细胞计数的亚组分析。主要安全性终点是任何不良事件(AAE)的发生率。结果表明,在总体患者和血嗜酸粒细胞计数<150 的亚组中,达必妥和本瑞来珠单抗的 AER 没有显著差异。然而,在血嗜酸粒细胞计数≥150 但<300 和≥300 的亚组中,达必妥组的 AER 明显低于本瑞来珠单抗组,其率比和 95%可信区间分别为 0.51(0.29-0.92)和 0.58(0.39-0.84)。达必妥组和本瑞来珠单抗组的 AAE 没有显著差异。这项间接治疗比较表明,在血嗜酸粒细胞计数较高的控制不佳的哮喘患者中,达必妥优于本瑞来珠单抗。需要进行直接比较以提供明确的证据。系统评价注册:UMIN-CTR 编号 UMIN000036256。