意大利重症哮喘登记库回顾性纵向队列研究：生物制剂治疗肥胖与非肥胖重症哮喘患者的临床结局及病情缓解变化趋势
2026/06/01
摘要
背景：肥胖在重症哮喘人群中高发，且与哮喘控制不佳、肺功能下降及合并症多发相关。登记数据提示肥胖可能削弱生物制剂疗效，但相关研究结论尚未统一。
目的：本研究旨在分析肥胖对重症哮喘患者远期临床结局的影响。
方法：回顾性分析2017年至2024年纳入意大利重症哮喘网络登记库的2098例成年重症哮喘患者。按用药状态将患者分为三类：未使用过生物制剂、观察期内启动生物制剂治疗、入组时已接受生物制剂治疗。体质量指数≥30kg/m2判定为肥胖。观察结局指标包含哮喘急性发作次数、哮喘控制测试评分、哮喘生活质量问卷评分、第1秒用力呼气容积；病情缓解定义为连续12个月满足既定标准：无急性发作、未口服糖皮质激素、哮喘控制测试评分≥20分、第1秒用力呼气容积占预计值百分比≥80%。采用零膨胀负二项模型与线性混合效应模型分析指标纵向变化，运用Kaplan-Meier法及Cox回归模型评估病情缓解情况。
结果：2098例患者中，1118例既往未使用生物制剂，980例入组时已接受生物制剂治疗；肥胖患者共405例，占比19.3%。基线数据显示，肥胖患者哮喘控制水平更差、生活质量评分更低、合并症更多，但鼻息肉患病率更低，2型炎症水平也相对更低。随访期间，肥胖与非肥胖患者的哮喘发作频次、哮喘控制水平、生活质量及肺功能均得到相近程度改善，不同用药分组间差异无统计学意义。随访24个月时，患者累计病情缓解率为22%～25%。肥胖不会影响病情缓解概率，未用药组风险比0.88，95%置信区间0.57~1.37；持续用药组风险比0.91，95%置信区间0.44~1.89。
结论：生物制剂对肥胖型重症哮喘患者仍具备显著疗效。无论体质量指数高低，患者各项临床指标的改善趋势基本一致，凸显长期随访监测的临床价值。
Clinical outcomes and remission trajectories in obese and non-obese patients with severe asthma treated with biologics: a retrospective longitudinal cohort study from the Severe Asthma Network Italy (SANI) registry.
Di Bona D, Di Gioia G, Heffler E, Parente R, Serviddio G, Blasi F, Paggiaro P, Canonica GW; SANI network.
Abstract
BACKGROUND:Obesity is common in severe asthma and associated with poorer control, reduced lung function, and comorbidities. Registry data suggest that obesity may lessen biologic effectiveness, but findings are inconsistent.
OBJECTIVE:We assessed the impact of obesity on long-term outcomes.
METHODS:We retrospectively analysed 2098 adults with severe asthma enrolled in the Italian Severe Asthma Network registry between 2017 and 2024. Patients were classified as biologic-naïve, initiating treatment during observation, or on-treatment at registry entry. Obesity was defined as body mass index (BMI) ≥30 kg/m2. Outcomes included exacerbations, Asthma Control Test (ACT), Asthma Quality of Life Questionnaire (AQLQ), Forced Expiratory Volume in 1 second (FEV1), and remission, defined as ≥12 consecutive months meeting prespecified criteria (no exacerbations or oral corticosteroids, ACT ≥ 20, FEV1 ≥ 80% predicted). Longitudinal changes were assessed using zero-inflated negative binomial and linear mixed-effects models; remission by Kaplan-Meier and Cox models.
RESULTS:Of 2098 patients (1118 biologic-naïve; 980 on biologics at inclusion), 405 (19.3%) were obese. At baseline, obese patients showed poorer control, lower AQLQ, more comorbidities, but fewer nasal polyps and lower type-2 inflammation. During follow-up, exacerbations, ACT, AQLQ, and FEV1 improved similarly in obese and non-obese, without significant differences across naïve or on-treatment cohorts. At 24 months, cumulative remission probability was 22-25%. Obesity did not influence remission likelihood (HR for BMI ≥ 30: 0.88 [95% CI 0.57-1.37] in naïve; 0.91 [0.44-1.89] in on-treatment).
CONCLUSION: Biologics remain efficacious in obese patients with severe asthma. Treatment achieved comparable improvement trajectories across all outcomes regardless of BMI, highlighting the importance of long-term follow-up.
背景：肥胖在重症哮喘人群中高发，且与哮喘控制不佳、肺功能下降及合并症多发相关。登记数据提示肥胖可能削弱生物制剂疗效，但相关研究结论尚未统一。
目的：本研究旨在分析肥胖对重症哮喘患者远期临床结局的影响。
方法：回顾性分析2017年至2024年纳入意大利重症哮喘网络登记库的2098例成年重症哮喘患者。按用药状态将患者分为三类：未使用过生物制剂、观察期内启动生物制剂治疗、入组时已接受生物制剂治疗。体质量指数≥30kg/m2判定为肥胖。观察结局指标包含哮喘急性发作次数、哮喘控制测试评分、哮喘生活质量问卷评分、第1秒用力呼气容积；病情缓解定义为连续12个月满足既定标准：无急性发作、未口服糖皮质激素、哮喘控制测试评分≥20分、第1秒用力呼气容积占预计值百分比≥80%。采用零膨胀负二项模型与线性混合效应模型分析指标纵向变化，运用Kaplan-Meier法及Cox回归模型评估病情缓解情况。
结果：2098例患者中，1118例既往未使用生物制剂，980例入组时已接受生物制剂治疗；肥胖患者共405例，占比19.3%。基线数据显示，肥胖患者哮喘控制水平更差、生活质量评分更低、合并症更多，但鼻息肉患病率更低，2型炎症水平也相对更低。随访期间，肥胖与非肥胖患者的哮喘发作频次、哮喘控制水平、生活质量及肺功能均得到相近程度改善，不同用药分组间差异无统计学意义。随访24个月时，患者累计病情缓解率为22%～25%。肥胖不会影响病情缓解概率，未用药组风险比0.88，95%置信区间0.57~1.37；持续用药组风险比0.91，95%置信区间0.44~1.89。
结论：生物制剂对肥胖型重症哮喘患者仍具备显著疗效。无论体质量指数高低，患者各项临床指标的改善趋势基本一致，凸显长期随访监测的临床价值。
（中日友好医院呼吸与危重症医学科 张婧媛 摘译 林江涛 审校）
（Lancet Reg Health Eur. 2026 May 7;66:101695. doi: 10.1016/j.lanepe.2026.101695.）
（Lancet Reg Health Eur. 2026 May 7;66:101695. doi: 10.1016/j.lanepe.2026.101695.）
Clinical outcomes and remission trajectories in obese and non-obese patients with severe asthma treated with biologics: a retrospective longitudinal cohort study from the Severe Asthma Network Italy (SANI) registry.
Di Bona D, Di Gioia G, Heffler E, Parente R, Serviddio G, Blasi F, Paggiaro P, Canonica GW; SANI network.
Abstract
BACKGROUND:Obesity is common in severe asthma and associated with poorer control, reduced lung function, and comorbidities. Registry data suggest that obesity may lessen biologic effectiveness, but findings are inconsistent.
OBJECTIVE:We assessed the impact of obesity on long-term outcomes.
METHODS:We retrospectively analysed 2098 adults with severe asthma enrolled in the Italian Severe Asthma Network registry between 2017 and 2024. Patients were classified as biologic-naïve, initiating treatment during observation, or on-treatment at registry entry. Obesity was defined as body mass index (BMI) ≥30 kg/m2. Outcomes included exacerbations, Asthma Control Test (ACT), Asthma Quality of Life Questionnaire (AQLQ), Forced Expiratory Volume in 1 second (FEV1), and remission, defined as ≥12 consecutive months meeting prespecified criteria (no exacerbations or oral corticosteroids, ACT ≥ 20, FEV1 ≥ 80% predicted). Longitudinal changes were assessed using zero-inflated negative binomial and linear mixed-effects models; remission by Kaplan-Meier and Cox models.
RESULTS:Of 2098 patients (1118 biologic-naïve; 980 on biologics at inclusion), 405 (19.3%) were obese. At baseline, obese patients showed poorer control, lower AQLQ, more comorbidities, but fewer nasal polyps and lower type-2 inflammation. During follow-up, exacerbations, ACT, AQLQ, and FEV1 improved similarly in obese and non-obese, without significant differences across naïve or on-treatment cohorts. At 24 months, cumulative remission probability was 22-25%. Obesity did not influence remission likelihood (HR for BMI ≥ 30: 0.88 [95% CI 0.57-1.37] in naïve; 0.91 [0.44-1.89] in on-treatment).
CONCLUSION: Biologics remain efficacious in obese patients with severe asthma. Treatment achieved comparable improvement trajectories across all outcomes regardless of BMI, highlighting the importance of long-term follow-up.
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