长期疗效显著但持续缓解罕见：重度哮喘抗IL5/Rα生物疗法应答的个体水平五年稳定性分析
2025/12/29
摘要
背景：抗白细胞介素5/受体α（IL5/Rα）疗法用于治疗重度哮喘已有十年，其在降低急性加重率和维持性口服糖皮质激素（mOCS）负担方面效果显著。然而，关于其长期、真实世界的持续缓解情况知之甚少。我们旨在评估抗IL5/Rα疗法应答在五年内的稳定性。
方法：研究纳入了2016年1月至2020年7月期间在丹麦开始接受抗IL5/Rα治疗的所有成年重度哮喘患者。每年评估一次五维度缓解（无急性加重、无mOCS使用、FEV1 > 80%、ACQ < 1.5 且未换用非抗IL5/Rα生物制剂），持续五年。
结果：共纳入482名患者（中位年龄56岁，48%为女性）。基线时，13.9%的患者符合无急性加重标准，66.0%符合无mOCS使用标准，29.7%符合FEV1 > 80%标准，26.5%符合ACQ < 1.5标准。至第五年时，18.7%的患者换用了非抗IL5/Rα生物制剂。五年间，总体缓解率在17.6%至23.1%之间。然而，缓解状态呈现动态变化；每年约有15.2%的缓解患者在下一年未能达到缓解标准。共有37.4%的患者至少实现过一年的缓解，其中部分患者首次达到缓解是在第二年或第三年。仅有7.7%的患者实现了持续五年的缓解。未能达到缓解的主要原因是永久性肺功能受损（FEV1）和持续的症状控制不佳。33.6%的患者在五年内持续无急性加重且未使用mOCS。
结论：重度哮喘患者对抗IL5/Rα疗法应答良好，五年内所有评估维度均有显著改善。但缓解是一种动态状态，存在间歇性复发，根据现行标准，实现长期持续缓解较为罕见。
Long-term efficacy but rare sustained remission: Individual-level five-year stability in anti-IL5/Rα biologic therapy response for severe asthma
Håkansson KEJ, Hansen S, Soendergaard MB, et al.
Abstract
BACKGROUND:For a decade, anti-Interleukin 5/Receptor alpha (IL5/Rα) has been available for severe asthma, with marked reductions in exacerbation rates and maintenance oral corticosteroid (mOCS) burden. However, little is known about the long-term, real-world sustained remission. We aimed to assess the stability of response to anti-IL5/Rα over five years.
METHODS:All Danish adults initiating anti-IL5/Rα for severe asthma during JAN2016-JUL2020 were included. Five-domain remission (no exacerbations, no mOCS, FEV1>80%, ACQ<1.5 nor switch to non-anti-IL5/Rα) was assessed annually for five years.
RESULTS: In total, 482 patients were included (median age 56, 48% female). At baseline, 13.9% fulfilled the criteria of no exacerbations, 66.0% of no mOCS, 29.7% of FEV1>80%, and 26.5% of ACQ<1.5. At year five, 18.7% had switched to a non-anti-IL5/Rα biologic.The overall remission rate was 17.6%—23.1% over five years. However, remission was found to be dynamic; approximately 15.2% of patients in remission per annum did not fulfil the remission criteria the subsequent year. At least one year of remission was achieved by 37.4% of patients, with some patients first achieving remission during year two or three.Only 7.7% achieved sustained five-year remission. Failure to achieve remission was driven by permanently impaired FEV1 and persistent uncontrolled symptoms. Five-year sustained freedom from exacerbations and mOCS use was seen in 33.6% of patients.
CONCLUSION:Patients with severe asthma respond well to anti-IL5/Rα with substantial improvements across all domains over five years. Remission is a dynamic state with intermittent relapses, and sustained long-term remission is rare using current domains.
背景：抗白细胞介素5/受体α（IL5/Rα）疗法用于治疗重度哮喘已有十年，其在降低急性加重率和维持性口服糖皮质激素（mOCS）负担方面效果显著。然而，关于其长期、真实世界的持续缓解情况知之甚少。我们旨在评估抗IL5/Rα疗法应答在五年内的稳定性。
方法：研究纳入了2016年1月至2020年7月期间在丹麦开始接受抗IL5/Rα治疗的所有成年重度哮喘患者。每年评估一次五维度缓解（无急性加重、无mOCS使用、FEV1 > 80%、ACQ < 1.5 且未换用非抗IL5/Rα生物制剂），持续五年。
结果：共纳入482名患者（中位年龄56岁，48%为女性）。基线时，13.9%的患者符合无急性加重标准，66.0%符合无mOCS使用标准，29.7%符合FEV1 > 80%标准，26.5%符合ACQ < 1.5标准。至第五年时，18.7%的患者换用了非抗IL5/Rα生物制剂。五年间，总体缓解率在17.6%至23.1%之间。然而，缓解状态呈现动态变化；每年约有15.2%的缓解患者在下一年未能达到缓解标准。共有37.4%的患者至少实现过一年的缓解，其中部分患者首次达到缓解是在第二年或第三年。仅有7.7%的患者实现了持续五年的缓解。未能达到缓解的主要原因是永久性肺功能受损（FEV1）和持续的症状控制不佳。33.6%的患者在五年内持续无急性加重且未使用mOCS。
结论：重度哮喘患者对抗IL5/Rα疗法应答良好，五年内所有评估维度均有显著改善。但缓解是一种动态状态，存在间歇性复发，根据现行标准，实现长期持续缓解较为罕见。
（中日友好医院呼吸与危重症医学科 李春晓 摘译 林江涛 审校）
（Eur Respir J. 2025 Nov 27:2500926.DOI: 10.1183/13993003.00926-2025.）
Long-term efficacy but rare sustained remission: Individual-level five-year stability in anti-IL5/Rα biologic therapy response for severe asthma
Håkansson KEJ, Hansen S, Soendergaard MB, et al.
Abstract
BACKGROUND:For a decade, anti-Interleukin 5/Receptor alpha (IL5/Rα) has been available for severe asthma, with marked reductions in exacerbation rates and maintenance oral corticosteroid (mOCS) burden. However, little is known about the long-term, real-world sustained remission. We aimed to assess the stability of response to anti-IL5/Rα over five years.
METHODS:All Danish adults initiating anti-IL5/Rα for severe asthma during JAN2016-JUL2020 were included. Five-domain remission (no exacerbations, no mOCS, FEV1>80%, ACQ<1.5 nor switch to non-anti-IL5/Rα) was assessed annually for five years.
RESULTS: In total, 482 patients were included (median age 56, 48% female). At baseline, 13.9% fulfilled the criteria of no exacerbations, 66.0% of no mOCS, 29.7% of FEV1>80%, and 26.5% of ACQ<1.5. At year five, 18.7% had switched to a non-anti-IL5/Rα biologic.The overall remission rate was 17.6%—23.1% over five years. However, remission was found to be dynamic; approximately 15.2% of patients in remission per annum did not fulfil the remission criteria the subsequent year. At least one year of remission was achieved by 37.4% of patients, with some patients first achieving remission during year two or three.Only 7.7% achieved sustained five-year remission. Failure to achieve remission was driven by permanently impaired FEV1 and persistent uncontrolled symptoms. Five-year sustained freedom from exacerbations and mOCS use was seen in 33.6% of patients.
CONCLUSION:Patients with severe asthma respond well to anti-IL5/Rα with substantial improvements across all domains over five years. Remission is a dynamic state with intermittent relapses, and sustained long-term remission is rare using current domains.
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