德国哮喘网络（German Asthma Net）：抗IL-5/IL-5(R)治疗应答者的特征分析
2025/04/30
摘要
背景：既往针对重症哮喘患者抗IL-5/IL-5(R)疗法的研究表明，治疗应答主要可通过基线疾病控制良好的指标预测，但长期应答的预测因素尚不明确。
方法：基于德国哮喘网络（GAN）注册系统中真实世界国际队列数据，采用回归分析法评估抗IL-5/IL-5(R)治疗应答者。应答定义为：急性发作或糖皮质激素用量减少≥50%；超级应答需同时完全停用上述两项；临床缓解额外要求哮喘控制（ACT评分≥20）。
结果：347例患者中77%为应答者（女性55%，年龄56.6±12.3岁，随访20.3±13个月），其急性发作率、哮喘控制及激素减量均显著改善。多变量分析显示，吸入糖皮质激素剂量（OR=1.5，p=0.014）、急性发作频率（OR=1.2，p=0.009）和治疗持续时间（OR=1.05，p=0.023）可独立预测应答。单变量分析中，血嗜酸性粒细胞计数预测价值显著（OR=12.4，p=0.004）。超级应答与糖皮质激素依赖及抑郁状态呈负相关，而临床缓解与未使用全身激素、更好哮喘控制及较高FEV1（升）相关。
结论：抗IL-5/IL-5(R)疗法可长期降低急性发作风险和激素负担，尤其对重症高T2炎症负荷患者效果显著。值得注意的是，基线低剂量激素使用和哮喘控制良好标志物可预测临床缓解及超级应答状态。
German Asthma Net: Characterisation of responders to anti-IL-5 and anti-IL-5(R) therapy
Bal, C., Stoshikj, S., Renner, A., Milger, K., Skowasch, D., Schulz, C., Jandl, M., Schmidt, O., Ehmann, R., Zehetmayer, S., Taube, C., Hamelmann, E., Buhl, R., Korn, S., & Idzko, M
Abstract
BACKGROUND:
Previous studies of anti-IL-5/IL-5(R) therapies in severe asthma found that response was mainly predicted by indicators of good baseline disease control. However, long-term response predictors remain unclear.
METHODS:
Responders to anti-IL-5/IL-5(R) therapy in the well-characterised, real-life, international German Asthma Net (GAN) registry were analysed using regression analyses. Response was defined by ≥50% reduction in exacerbations or corticosteroid dose, super-response by a complete stop of both, and remission additionally by controlled asthma (ACT score≥20).
RESULTS:
Seventy-seven percent of 347 patients (55% female, 56.6±12.3 years, follow-up 20.3±13 months) were responders and showed improved exacerbation rates, asthma control, and corticosteroid treatment reduction. Response was independently predicted by inhaled corticosteroid dose (odds ratio [OR] 1.5; p = 0.014), exacerbation rate (OR 1.2; p = 0.009), and treatment duration (OR 1.05, p = 0.023). Univariately, blood eosinophil counts notably predicted response (OR 12.4; p = 0.004). Super-response was inversely associated with corticosteroid dependence and depression. Remission was associated with the absence of systemic corticosteroids, better asthma control, and FEV1 in litre.
CONCLUSION:
These results underscore that long-term anti-IL-5/IL-5(R) therapy reduces exacerbation and corticosteroid burden, especially in patients with severe disease and high type 2 inflammatory burden. Contrastingly, low baseline corticosteroid use and markers of good asthma control predicted remission and super-responder status.
背景：既往针对重症哮喘患者抗IL-5/IL-5(R)疗法的研究表明，治疗应答主要可通过基线疾病控制良好的指标预测，但长期应答的预测因素尚不明确。
方法：基于德国哮喘网络（GAN）注册系统中真实世界国际队列数据，采用回归分析法评估抗IL-5/IL-5(R)治疗应答者。应答定义为：急性发作或糖皮质激素用量减少≥50%；超级应答需同时完全停用上述两项；临床缓解额外要求哮喘控制（ACT评分≥20）。
结果：347例患者中77%为应答者（女性55%，年龄56.6±12.3岁，随访20.3±13个月），其急性发作率、哮喘控制及激素减量均显著改善。多变量分析显示，吸入糖皮质激素剂量（OR=1.5，p=0.014）、急性发作频率（OR=1.2，p=0.009）和治疗持续时间（OR=1.05，p=0.023）可独立预测应答。单变量分析中，血嗜酸性粒细胞计数预测价值显著（OR=12.4，p=0.004）。超级应答与糖皮质激素依赖及抑郁状态呈负相关，而临床缓解与未使用全身激素、更好哮喘控制及较高FEV1（升）相关。
结论：抗IL-5/IL-5(R)疗法可长期降低急性发作风险和激素负担，尤其对重症高T2炎症负荷患者效果显著。值得注意的是，基线低剂量激素使用和哮喘控制良好标志物可预测临床缓解及超级应答状态。
（中日友好医院呼吸与危重症医学科 沈焜路 摘译 林江涛 审校）
（Pulmonology. 2025 Dec 31; DOI: 10.1080/25310429.2025.2460868）
German Asthma Net: Characterisation of responders to anti-IL-5 and anti-IL-5(R) therapy
Bal, C., Stoshikj, S., Renner, A., Milger, K., Skowasch, D., Schulz, C., Jandl, M., Schmidt, O., Ehmann, R., Zehetmayer, S., Taube, C., Hamelmann, E., Buhl, R., Korn, S., & Idzko, M
Abstract
BACKGROUND:
Previous studies of anti-IL-5/IL-5(R) therapies in severe asthma found that response was mainly predicted by indicators of good baseline disease control. However, long-term response predictors remain unclear.
METHODS:
Responders to anti-IL-5/IL-5(R) therapy in the well-characterised, real-life, international German Asthma Net (GAN) registry were analysed using regression analyses. Response was defined by ≥50% reduction in exacerbations or corticosteroid dose, super-response by a complete stop of both, and remission additionally by controlled asthma (ACT score≥20).
RESULTS:
Seventy-seven percent of 347 patients (55% female, 56.6±12.3 years, follow-up 20.3±13 months) were responders and showed improved exacerbation rates, asthma control, and corticosteroid treatment reduction. Response was independently predicted by inhaled corticosteroid dose (odds ratio [OR] 1.5; p = 0.014), exacerbation rate (OR 1.2; p = 0.009), and treatment duration (OR 1.05, p = 0.023). Univariately, blood eosinophil counts notably predicted response (OR 12.4; p = 0.004). Super-response was inversely associated with corticosteroid dependence and depression. Remission was associated with the absence of systemic corticosteroids, better asthma control, and FEV1 in litre.
CONCLUSION:
These results underscore that long-term anti-IL-5/IL-5(R) therapy reduces exacerbation and corticosteroid burden, especially in patients with severe disease and high type 2 inflammatory burden. Contrastingly, low baseline corticosteroid use and markers of good asthma control predicted remission and super-responder status.
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哮喘发作的炎症和临床危险因素（ORACLE2）研究：22项随机试验对照组的患者水平荟萃分析
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