特泽鲁单抗和度普利尤单抗治疗哮喘的疗效比较：一项跨国回顾性队列研究
2025/12/30
摘要
背景：尽管度普利尤单抗和特泽鲁单抗均被批准用于治疗重度哮喘，但比较二者疗效的真实世界证据仍然有限。
目的：比较特泽鲁单抗与度普利尤单抗在减少哮喘患者病情急性加重方面的疗效。
方法：数据来源于TriNetX全球协作网络。研究纳入了2021年12月17日至2024年9月1日期间开始使用度普利尤单抗或特泽鲁单抗的18岁及以上成年人。主要结局指标为首次哮喘急性加重的时间，次要结局指标为全身性皮质类固醇的使用情况。两项结局指标均进行为期一年的评估。根据血液嗜酸性粒细胞计数、是否存在慢性阻塞性肺疾病（COPD）、既往生物制剂使用情况和肥胖情况进行亚组分析。采用倾向得分匹配法平衡组间协变量。使用 Kaplan - Meier 曲线和 Cox 回归模型评估比较疗效。
结果：经过1:1匹配后，每组各纳入688例匹配患者。在匹配队列中，度普利尤单抗和特泽鲁单抗治疗组的哮喘急性加重风险无差异（风险比[HR]为0.96；95%置信区间[CI]为0.83 - 1.10）。这一结果在敏感性分析中保持一致。在所有血液嗜酸性粒细胞水平下，无论是否存在COPD、既往是否使用过生物制剂或是否肥胖，两种生物制剂均显示出相似的益处。两种生物制剂治疗组全身性皮质类固醇的使用风险也相似（HR为0.97；95% CI为0.85 - 1.10）。
结论：度普利尤单抗和特泽鲁单抗在哮喘急性加重风险方面无显著差异。由于可能存在残余混杂因素，有必要进一步研究，以指导临床实践中生物疗法的选择。
Comparative Effectiveness of Tezepelumab and Dupilumab in Asthma: A Multinational Retrospective Cohort Study
Chun-Tse Hung, Yu-Chien Hung, Chen-Yen An, Chi-Won Suk
Abstract
Background: Although both dupilumab and tezepelumab are approved for severe asthma, real-world evidence comparing their effectiveness remains limited.
Objective: To compare the effectiveness of tezepelumab versus dupilumab in reducing asthma exacerbations among patients with asthma.
Methods: Data were obtained from the Global Collaborative Network of TriNetX. Adults aged ≥18 years who initiated dupilumab or tezepelumab between December 17, 2021, and September 1, 2024, were included. The primary outcome was time to first asthma exacerbation, and the secondary outcome was systemic corticosteroid use. Both outcomes were assessed over one year. Subgroup analyses were conducted by blood eosinophil counts, presence of chronic obstructive pulmonary disease (COPD), prior biologics use, and obesity. Propensity score matching was used to balance covariates between groups. Kaplan-Meier curves and Cox regression models were used to estimate comparative effectiveness.
Results: After 1:1 matching, 688 matched patients were included in each group. In the matched cohorts, the risk of asthma exacerbation did not differ between dupilumab and tezepelumab (HR, 0.96; 95% CI, 0.83-1.10). This finding was consistent across sensitivity analyses. Both biologics showed similar benefits across all blood eosinophil levels and regardless of COPD, prior biologics use, or obesity. The risk of systemic corticosteroids use was also similar between both biologics (HR, 0.97; 95% CI, 0.85-1.10).
Conclusion: No significant difference in exacerbation risk was found between dupilumab and tezepelumab. Since residual confounding may exist, further investigation is warranted to guide the selection of biological therapies in clinical practice.
背景：尽管度普利尤单抗和特泽鲁单抗均被批准用于治疗重度哮喘，但比较二者疗效的真实世界证据仍然有限。
目的：比较特泽鲁单抗与度普利尤单抗在减少哮喘患者病情急性加重方面的疗效。
方法：数据来源于TriNetX全球协作网络。研究纳入了2021年12月17日至2024年9月1日期间开始使用度普利尤单抗或特泽鲁单抗的18岁及以上成年人。主要结局指标为首次哮喘急性加重的时间，次要结局指标为全身性皮质类固醇的使用情况。两项结局指标均进行为期一年的评估。根据血液嗜酸性粒细胞计数、是否存在慢性阻塞性肺疾病（COPD）、既往生物制剂使用情况和肥胖情况进行亚组分析。采用倾向得分匹配法平衡组间协变量。使用 Kaplan - Meier 曲线和 Cox 回归模型评估比较疗效。
结果：经过1:1匹配后，每组各纳入688例匹配患者。在匹配队列中，度普利尤单抗和特泽鲁单抗治疗组的哮喘急性加重风险无差异（风险比[HR]为0.96；95%置信区间[CI]为0.83 - 1.10）。这一结果在敏感性分析中保持一致。在所有血液嗜酸性粒细胞水平下，无论是否存在COPD、既往是否使用过生物制剂或是否肥胖，两种生物制剂均显示出相似的益处。两种生物制剂治疗组全身性皮质类固醇的使用风险也相似（HR为0.97；95% CI为0.85 - 1.10）。
结论：度普利尤单抗和特泽鲁单抗在哮喘急性加重风险方面无显著差异。由于可能存在残余混杂因素，有必要进一步研究，以指导临床实践中生物疗法的选择。
（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 Pract. 2025 Nov 27:S2213-2198(25)01129-8. doi: 10.1016/j.jaip.2025.11.024. ）
（J Allergy Clin Immunol Pract. 2025 Nov 27:S2213-2198(25)01129-8. doi: 10.1016/j.jaip.2025.11.024. ）
Comparative Effectiveness of Tezepelumab and Dupilumab in Asthma: A Multinational Retrospective Cohort Study
Chun-Tse Hung, Yu-Chien Hung, Chen-Yen An, Chi-Won Suk
Abstract
Background: Although both dupilumab and tezepelumab are approved for severe asthma, real-world evidence comparing their effectiveness remains limited.
Objective: To compare the effectiveness of tezepelumab versus dupilumab in reducing asthma exacerbations among patients with asthma.
Methods: Data were obtained from the Global Collaborative Network of TriNetX. Adults aged ≥18 years who initiated dupilumab or tezepelumab between December 17, 2021, and September 1, 2024, were included. The primary outcome was time to first asthma exacerbation, and the secondary outcome was systemic corticosteroid use. Both outcomes were assessed over one year. Subgroup analyses were conducted by blood eosinophil counts, presence of chronic obstructive pulmonary disease (COPD), prior biologics use, and obesity. Propensity score matching was used to balance covariates between groups. Kaplan-Meier curves and Cox regression models were used to estimate comparative effectiveness.
Results: After 1:1 matching, 688 matched patients were included in each group. In the matched cohorts, the risk of asthma exacerbation did not differ between dupilumab and tezepelumab (HR, 0.96; 95% CI, 0.83-1.10). This finding was consistent across sensitivity analyses. Both biologics showed similar benefits across all blood eosinophil levels and regardless of COPD, prior biologics use, or obesity. The risk of systemic corticosteroids use was also similar between both biologics (HR, 0.97; 95% CI, 0.85-1.10).
Conclusion: No significant difference in exacerbation risk was found between dupilumab and tezepelumab. Since residual confounding may exist, further investigation is warranted to guide the selection of biological therapies in clinical practice.
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