奥马珠单抗、美泊利珠单抗和度匹鲁单抗治疗哮喘的疗效比较：一项目标试验模拟。
Comparative effectiveness of omalizumab, mepolizumab, and dupilumab in asthma: A target trial emulation.
机构信息
Division of Allergy and Clinical Immunology, Brigham and Women's Hospital, Boston, Mass; Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, Mass; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md.
Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md; Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Md; Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md.
出版信息
J Allergy Clin Immunol. 2023 May;151(5):1269-1276. doi: 10.1016/j.jaci.2023.01.020. Epub 2023 Feb 3.
BACKGROUND
Multiple mAbs are currently approved for the treatment of asthma. However, there is limited evidence on their comparative effectiveness.
OBJECTIVE
Our aim was to compare the effectiveness of omalizumab, mepolizumab, and dupilumab in individuals with moderate-to-severe asthma.
METHODS
We emulated a hypothetical randomized trial using electronic health records from a large US-based academic health care system. Participants aged 18 years or older with baseline IgE levels between 30 and 700 IU/mL and peripheral eosinophil counts of at least 150 cells/μL were eligible for study inclusion. The study period extended from March 2016 to August 2021. Outcomes included the incidence of asthma-related exacerbations and change in baseline FEV value over 12 months of follow-up.
RESULTS
In all, 68 individuals receiving dupilumab, 68 receiving omalizumab, and 65 receiving mepolizumab met the inclusion criteria. Over 12 months of follow-up, 31 exacerbations occurred over 68 person years (0.46 exacerbations per person year) in the dupilumab group, 63 over 68 person years (0.93 per person year) in the omalizumab group, and 86 over 65 person years (1.32 per person year) in the mepolizumab group (adjusted incidence rate ratios: dupilumab vs mepolizumab, 0.28 [95% CI = 0.09-0.84]; dupilumab vs omalizumab, 0.36 [95% CI = 0.12-1.09]; and omalizumab vs mepolizumab, 0.78 [95% CI = 0.32-1.91]). The differences in the change in FEV comparing patients who received the different biologics were as follows: 0.11 L (95% CI = -0.003 to 0.222 L) for dupilumab versus mepolizumab, 0.082 L (95% CI -0.040 to 0.204 L) for dupilumab versus omalizumab, and 0.026 L (95% CI -0.083 to 0.140 L) for omalizumab versus mepolizumab.
CONCLUSIONS
Among patients with asthma and eosinophil counts of at least 150 cells/μL and IgE levels of 30 to 700 kU/L, dupilumab was associated with greater improvements in exacerbation and FEV value than omalizumab and mepolizumab.
背景
目前有多种单抗获批用于治疗哮喘。然而，关于它们的比较有效性的证据有限。
目的
我们旨在比较奥马珠单抗、美泊利珠单抗和度普利尤单抗在中重度哮喘患者中的疗效。
方法
我们使用来自美国大型学术医疗保健系统的电子健康记录模拟了一项假设的随机试验。纳入研究的参与者年龄在 18 岁或以上，基线 IgE 水平在 30 至 700IU/mL 之间，外周血嗜酸性粒细胞计数至少为 150 个/μL。研究期间为 2016 年 3 月至 2021 年 8 月。主要结局包括哮喘相关加重的发生率和随访 12 个月时的基线 FEV 值变化。
结果
共有 68 名接受度普利尤单抗治疗、68 名接受奥马珠单抗治疗和 65 名接受美泊利珠单抗治疗的患者符合纳入标准。在 12 个月的随访期间，度普利尤单抗组有 31 例（68 人年中 0.46 例/人年）、奥马珠单抗组有 63 例（68 人年中 0.93 例/人年）、美泊利珠单抗组有 86 例（65 人年中 1.32 例/人年）发生哮喘加重（校正发病率比：度普利尤单抗 vs 美泊利珠单抗，0.28 [95%CI 0.09-0.84]；度普利尤单抗 vs 奥马珠单抗，0.36 [95%CI 0.12-1.09]；奥马珠单抗 vs 美泊利珠单抗，0.78 [95%CI = 0.32-1.91]）。不同生物制剂治疗患者的 FEV 值变化差异如下：度普利尤单抗 vs 美泊利珠单抗为 0.11L（95%CI -0.003 至 0.222L）、度普利尤单抗 vs 奥马珠单抗为 0.082L（95%CI -0.040 至 0.204L）、奥马珠单抗 vs 美泊利珠单抗为 0.026L（95%CI -0.083 至 0.140L）。
结论
在嗜酸性粒细胞计数至少为 150 个/μL、IgE 水平为 30 至 700kU/L 的哮喘患者中，与奥马珠单抗和美泊利珠单抗相比，度普利尤单抗治疗可带来更大的哮喘加重和 FEV 值改善。
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