奥马珠单抗、美泊利珠单抗和度普利尤单抗治疗哮喘有效性比较：靶向试验模拟
2023/02/20
摘要
背景：多种单克隆抗体目前已被批准用于治疗哮喘。然而，关于其相对有效性的证据有限。
目的：比较奥马珠单抗、美泊利珠单抗和度普利尤单抗对中度至重度哮喘患者的有效性。
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。年龄≥18岁且基线免疫球蛋白E水平在30至700 IU / ml之间且外周嗜酸性粒细胞计数为≥150个细胞/μL的参与者有资格纳入研究。研究时间为2016年3月至2021年8月。结局包括哮喘相关急性发作的发生率和12个月随访期间基线一秒用力呼气量（FEV1）的变化。
结果：68例使用度普利尤单抗，68例使用奥马珠单抗，65例接受美泊利珠单抗治疗符合纳入标准。在12个月的随访中，度普利尤单抗组在68人年内发生31例加重（每人年0.46例加重），奥马珠单抗组在68人年（0.93例/人年）内发生63例加重，美泊利珠单抗组在65人年（1.32例/人年）内发生86例[调整后发病率比：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）。接受度普利尤单抗的患者与接受美泊利珠单抗的患者相比，FEV1变化的差异为0.11（95%CI-0.003至0.222）L，度普利尤单抗与奥玛珠单抗的差异为0.082（95%CI-0.040至0.204）L，而奥玛珠珠单抗与美泊利单抗的差异则为0.026（95%CI-0.083至0.140）L。。
结论：在哮喘和嗜酸性粒细胞计数为≥150 个细胞/μL且IgE 水平为30-700 kU/L的患者中，度普利尤单抗与奥马珠单抗和美泊利珠单抗相比，急性加重和FEV1的改善更大。
COMPARATIVE EFFECTIVENESS OF OMALIZUMAB, MEPOLIZUMAB, AND DUPILUMAB IN ASTHMA: A TARGET TRIAL EMULATION
Ayobami T Akenroye, Jodi B Segal, Guohai Zhou, Dinah Foer, Lily Li, G Caleb Alexander, Corinne A Keet, John W Jackson
Abstract
Background: Multiple monoclonal antibodies are currently approved for the treatment of asthma. However, there is limited evidence on their comparative effectiveness.
Objective: 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 with baseline immunoglobulin E levels between 30 and 700 IU/ml and peripheral eosinophil counts of ≥ 150 cells/microliter were eligible for study inclusion. The study period was March 2016 to August 2021. Outcomes included the incidence of asthma-related exacerbations and change in baseline forced expiratory volume in one second (FEV1) over 12 months of follow up.
Results: Sixty-eight individuals on dupilumab, 68 on omalizumab, and 65 on mepolizumab met 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% confidence interval [CI] 0.09 - 0.84; dupilumab vs. omalizumab (0.36, CI 0.12-1.09); omalizumab vs. mepolizumab (0.78, CI 0.32-1.91). The difference in FEV1 change comparing patients receiving dupilumab to those receiving mepolizumab was 0.11 (CI -0.003 to 0.222) L, 0.082 (CI -0.040 to 0.204) L for dupilumab vs. omalizumab, and 0.026 (CI -0.083 to 0.140) L omalizumab vs. mepolizumab.
Conclusions: Among patients with asthma and eosinophil counts of ≥150 cells/microliter and IgE levels of 30-700 kU/L, dupilumab was associated with greater improvements in exacerbation and FEV1 than omalizumab and mepolizumab.
背景：多种单克隆抗体目前已被批准用于治疗哮喘。然而，关于其相对有效性的证据有限。
目的：比较奥马珠单抗、美泊利珠单抗和度普利尤单抗对中度至重度哮喘患者的有效性。
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。年龄≥18岁且基线免疫球蛋白E水平在30至700 IU / ml之间且外周嗜酸性粒细胞计数为≥150个细胞/μL的参与者有资格纳入研究。研究时间为2016年3月至2021年8月。结局包括哮喘相关急性发作的发生率和12个月随访期间基线一秒用力呼气量（FEV1）的变化。
结果：68例使用度普利尤单抗，68例使用奥马珠单抗，65例接受美泊利珠单抗治疗符合纳入标准。在12个月的随访中，度普利尤单抗组在68人年内发生31例加重（每人年0.46例加重），奥马珠单抗组在68人年（0.93例/人年）内发生63例加重，美泊利珠单抗组在65人年（1.32例/人年）内发生86例[调整后发病率比：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）。接受度普利尤单抗的患者与接受美泊利珠单抗的患者相比，FEV1变化的差异为0.11（95%CI-0.003至0.222）L，度普利尤单抗与奥玛珠单抗的差异为0.082（95%CI-0.040至0.204）L，而奥玛珠珠单抗与美泊利单抗的差异则为0.026（95%CI-0.083至0.140）L。。
结论：在哮喘和嗜酸性粒细胞计数为≥150 个细胞/μL且IgE 水平为30-700 kU/L的患者中，度普利尤单抗与奥马珠单抗和美泊利珠单抗相比，急性加重和FEV1的改善更大。
(中日友好医院呼吸与危重症医学科 李红雯 摘译 林江涛 审校)
(J Allergy Clin Immunol. 2023 Feb 3;S0091-6749(23)00144-6. doi: 10.1016/j.jaci.2023.01.020.)
(J Allergy Clin Immunol. 2023 Feb 3;S0091-6749(23)00144-6. doi: 10.1016/j.jaci.2023.01.020.)
COMPARATIVE EFFECTIVENESS OF OMALIZUMAB, MEPOLIZUMAB, AND DUPILUMAB IN ASTHMA: A TARGET TRIAL EMULATION
Ayobami T Akenroye, Jodi B Segal, Guohai Zhou, Dinah Foer, Lily Li, G Caleb Alexander, Corinne A Keet, John W Jackson
Abstract
Background: Multiple monoclonal antibodies are currently approved for the treatment of asthma. However, there is limited evidence on their comparative effectiveness.
Objective: 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 with baseline immunoglobulin E levels between 30 and 700 IU/ml and peripheral eosinophil counts of ≥ 150 cells/microliter were eligible for study inclusion. The study period was March 2016 to August 2021. Outcomes included the incidence of asthma-related exacerbations and change in baseline forced expiratory volume in one second (FEV1) over 12 months of follow up.
Results: Sixty-eight individuals on dupilumab, 68 on omalizumab, and 65 on mepolizumab met 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% confidence interval [CI] 0.09 - 0.84; dupilumab vs. omalizumab (0.36, CI 0.12-1.09); omalizumab vs. mepolizumab (0.78, CI 0.32-1.91). The difference in FEV1 change comparing patients receiving dupilumab to those receiving mepolizumab was 0.11 (CI -0.003 to 0.222) L, 0.082 (CI -0.040 to 0.204) L for dupilumab vs. omalizumab, and 0.026 (CI -0.083 to 0.140) L omalizumab vs. mepolizumab.
Conclusions: Among patients with asthma and eosinophil counts of ≥150 cells/microliter and IgE levels of 30-700 kU/L, dupilumab was associated with greater improvements in exacerbation and FEV1 than omalizumab and mepolizumab.
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痰液2型标志物可预测抗白细胞介素-5治疗的重症哮喘的缓解
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在严重未控制的嗜酸性粒细胞性哮喘患者中，使用贝那利珠单抗后嗜酸性粒细胞耗竭与甘露醇诱导的气道高反应性减弱相关
