一项针对中重度哮喘患者接受美泊利珠单抗、奥马珠单抗或度普利尤单抗治疗后的肺功能轨迹研究
2024/07/31
摘要
背景：肺功能是死亡率的独立预测因子。我们评估了一组接受生物制剂治疗的哮喘患者群体的肺功能轨迹。
方法：我们在波士顿大型医疗系统中识别了229名未接受过单克隆抗体治疗的中重度成年哮喘患者，这些患者在2010年至2022年间开始使用奥马珠单抗、美泊利珠单抗或度普利尤单抗。采用广义加性混合模型来估算生物制剂启动后156周内的肺功能轨迹。将FEV1改善或每年下降≤0.5%定义为应答者。使用Kaplan-Meier估计量来评估应答者中FEV1无进一步改善的时间。所有模型均校正了年龄、性别、体重指数、吸烟状况、基线哮喘发作率和基线血液嗜酸粒细胞计数。
结果：88名患者使用美泊利珠单抗，76名患者使用奥马珠单抗，65名患者使用度普利尤单抗。美泊利珠单抗组的基线嗜酸粒细胞计数最高（405个细胞/mcL），奥马珠单抗组最低（250个细胞/mcL）。美泊利珠单抗组的FEV1和FVC均有所改善（FEV1 +20 mL/年；FVC +43 mL/年）。奥马珠单抗组第一年有所改善，随后下降，整体FEV1损失为-44 mL/年，FVC为-32 mL/年。度普利尤单抗组FEV1（+61 mL/年）和FVC（+74 mL/年）均随时间改善。50%的美泊利珠单抗组、58%的奥马珠单抗组和72%的度普利尤单抗组为应答者。应答者中无额外FEV1改善的中位时间，奥马珠单抗为24周、美泊利珠单抗为48周、度普利尤单抗为57周。
结论：在此临床队列中，美泊利珠单抗、奥马珠单抗和度普利尤单抗对FEV1和FVC均有益，且生物制剂启动后的轨迹各不相同。
Lung function trajectories in a cohort of patients with moderate-to-severe asthma on mepolizumab, omalizumab, or dupilumab
Tanawin Nopsopon, Nora A. Barrett, Wanda Phipatanakul, Tanya M. Laidlaw, Scott T. Weiss, Ayobami Akenroye.
Allergy. 2024 May; 79 (5), 1195-1207.
ABSTRACT
BACKGROUND: Lung function is an independent predictor of mortality. We evaluated the lung function trajectories of a cohort of patients with asthma receiving biologic therapy.
METHODS: We identified 229 monoclonal antibody-naïve adult patients with moderate-to-severe asthma who initiated omalizumab, mepolizumab, or dupilumab between 2010 and 2022 in a large healthcare system in Boston, MA. Generalized additive mixed models were used to estimate the lung function trajectories during the 156 weeks following biologic initiation. Response was defined as an improvement in FEV1 or a decrease of ≤0.5% per year. The Kaplan-Meier estimator was used to assess time to no additional improvement in FEV1 in responders. All models were adjusted for age, sex, body mass index, smoking status, baseline exacerbation rate, and baseline blood eosinophil count.
RESULTS: Eighty-eight patients initiated mepolizumab, 76 omalizumab, and 65 dupilumab. Baseline eosinophil count was highest in the mepolizumab group (405 cells/mcL) and lowest for omalizumab (250 cells/mcL). Both FEV1 and FVC improved in the mepolizumab group (FEV1 + 20 mL/year; FVC +43 mL/year). For omalizumab, there was an initial improvement in the first year followed by decline with an overall FEV1 loss of -44 mL/year and FVC -32 mL/year. For dupilumab, both FEV1 (+61 mL/year) and FVC (+74 mL/year) improved over time. Fifty percent of the mepolizumab group, 58% omalizumab, and 72% of dupilumab were responders. The median time to no additional FEV1 improvement in responders was 24 weeks for omalizumab, 48 weeks for mepolizumab, and 57 weeks for dupilumab.
CONCLUSION: In this clinical cohort, mepolizumab, omalizumab, and dupilumab had beneficial effects on FEV1 and FVC with distinct post-initiation trajectories.
背景：肺功能是死亡率的独立预测因子。我们评估了一组接受生物制剂治疗的哮喘患者群体的肺功能轨迹。
方法：我们在波士顿大型医疗系统中识别了229名未接受过单克隆抗体治疗的中重度成年哮喘患者，这些患者在2010年至2022年间开始使用奥马珠单抗、美泊利珠单抗或度普利尤单抗。采用广义加性混合模型来估算生物制剂启动后156周内的肺功能轨迹。将FEV1改善或每年下降≤0.5%定义为应答者。使用Kaplan-Meier估计量来评估应答者中FEV1无进一步改善的时间。所有模型均校正了年龄、性别、体重指数、吸烟状况、基线哮喘发作率和基线血液嗜酸粒细胞计数。
结果：88名患者使用美泊利珠单抗，76名患者使用奥马珠单抗，65名患者使用度普利尤单抗。美泊利珠单抗组的基线嗜酸粒细胞计数最高（405个细胞/mcL），奥马珠单抗组最低（250个细胞/mcL）。美泊利珠单抗组的FEV1和FVC均有所改善（FEV1 +20 mL/年；FVC +43 mL/年）。奥马珠单抗组第一年有所改善，随后下降，整体FEV1损失为-44 mL/年，FVC为-32 mL/年。度普利尤单抗组FEV1（+61 mL/年）和FVC（+74 mL/年）均随时间改善。50%的美泊利珠单抗组、58%的奥马珠单抗组和72%的度普利尤单抗组为应答者。应答者中无额外FEV1改善的中位时间，奥马珠单抗为24周、美泊利珠单抗为48周、度普利尤单抗为57周。
结论：在此临床队列中，美泊利珠单抗、奥马珠单抗和度普利尤单抗对FEV1和FVC均有益，且生物制剂启动后的轨迹各不相同。
(四川大学华西医院呼吸与危重症医学科 邓稞1 王霁1 王刚1 译)
(Allergy. 2024 May; 79 (5), 1195-1207.)
(Allergy. 2024 May; 79 (5), 1195-1207.)
Lung function trajectories in a cohort of patients with moderate-to-severe asthma on mepolizumab, omalizumab, or dupilumab
Tanawin Nopsopon, Nora A. Barrett, Wanda Phipatanakul, Tanya M. Laidlaw, Scott T. Weiss, Ayobami Akenroye.
Allergy. 2024 May; 79 (5), 1195-1207.
ABSTRACT
BACKGROUND: Lung function is an independent predictor of mortality. We evaluated the lung function trajectories of a cohort of patients with asthma receiving biologic therapy.
METHODS: We identified 229 monoclonal antibody-naïve adult patients with moderate-to-severe asthma who initiated omalizumab, mepolizumab, or dupilumab between 2010 and 2022 in a large healthcare system in Boston, MA. Generalized additive mixed models were used to estimate the lung function trajectories during the 156 weeks following biologic initiation. Response was defined as an improvement in FEV1 or a decrease of ≤0.5% per year. The Kaplan-Meier estimator was used to assess time to no additional improvement in FEV1 in responders. All models were adjusted for age, sex, body mass index, smoking status, baseline exacerbation rate, and baseline blood eosinophil count.
RESULTS: Eighty-eight patients initiated mepolizumab, 76 omalizumab, and 65 dupilumab. Baseline eosinophil count was highest in the mepolizumab group (405 cells/mcL) and lowest for omalizumab (250 cells/mcL). Both FEV1 and FVC improved in the mepolizumab group (FEV1 + 20 mL/year; FVC +43 mL/year). For omalizumab, there was an initial improvement in the first year followed by decline with an overall FEV1 loss of -44 mL/year and FVC -32 mL/year. For dupilumab, both FEV1 (+61 mL/year) and FVC (+74 mL/year) improved over time. Fifty percent of the mepolizumab group, 58% omalizumab, and 72% of dupilumab were responders. The median time to no additional FEV1 improvement in responders was 24 weeks for omalizumab, 48 weeks for mepolizumab, and 57 weeks for dupilumab.
CONCLUSION: In this clinical cohort, mepolizumab, omalizumab, and dupilumab had beneficial effects on FEV1 and FVC with distinct post-initiation trajectories.
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在严重哮喘中滴定抗IL5生物制剂（OPTIMAL）：一项开放标签随机对照试验
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探讨成人重度哮喘生物制剂治疗后临床缓解的定义和预测因素
