生物治疗对重度哮喘患者的临床缓解：英国重度哮喘登记研究的分析
2023/11/23
摘要
背景：新型生物疗法彻底改变了重症哮喘的管理，具有更雄心勃勃的治疗目标。在这里，我们分析了临床缓解的定义，将其作为建议的治疗目标，并考虑了大型现实世界重症哮喘队列中与临床缓解相关的特征。
方法：对英国严重哮喘登记研究（UKSAR）登记的符合严格的国家生物制剂准入标准的患者进行回顾性分析。患者接受了生物制剂前的基线评估和年度审查。临床缓解的主要定义包括哮喘控制问卷<1.5，没有口服皮质类固醇用于疾病控制，FEV1≥正常下限（LLN）或≤-100毫升（与基线相比）。
结果：18.3%的患者达到了缓解的主要定义。生物治疗的高T2生物标志物患者的调整后缓解比率为7.44倍（95%CI 1.73，31.95）。女性（OR 0.61，95%CI 0.45，0.93）、肥胖（OR 0.49，95%CI 0.24，0.65）或生物治疗前ACQ≥1.5（OR 0.19，95%CI 0.12，0.31）患者的调整后缓解比率较低。疾病持续时间每增加10年，缓解的可能性降低14%（95%CI 0.76，0.97）。根据所应用定义，队列中有12%至21%的患者达到临床缓解；大多数未达到缓解的患者未能达到多项标准。
结论：18.3%的患者达到了临床缓解的主要定义。T2生物标志物水平高、病程短和合并症少的患者更有可能缓解。需要进一步研究在重度哮喘中开始生物制剂的最佳时间。
Clinical remission in severe asthma with Biologic Therapy: an analysis from the UK Severe Asthma Registry
P Jane McDowell, Ron McDowell, John Busby, M Chad Eastwood, Pujan H Patel, David J Jackson, Adel Mansur, Mitesh Patel, Hassan Burhan, Simon Doe, Rekha Chaudhuri, Robin Gore, James W Dodd, Deepak Subramanian, Thomas Brown, Liam G Heaney; UK Severe Asthma Registry
Abstract
BACKGROUND:Novel biologic therapies have revolutionised the management of severe asthma with more ambitious treatment aims. Here we analyse the definition of clinical remission as a suggested treatment goal and consider the characteristics associated with clinical remission in a large, real-world severe asthma cohort.
Methods: Retrospective analysis of severe asthma patients registered in the UK Severe Asthma Registry (UKSAR) who met strict national access criteria for biologics. Patients had a pre-biologics baseline assessment and annual review. Primary definition of clinical remission applied included Asthma Control Questionnaire <1.5 and no oral corticosteroids for disease control and FEV1 ≥lower limit of normal (LLN) or ≤-100 mLs change from baseline.
Results: 18.3% of patients achieved the primary definition of remission. The adjusted odds of remission on biologic therapy were 7.44-fold higher in patients with high T2-biomarkers (95%CI 1.73,31.95). The adjusted odds of remission were lower in patients who were female (OR 0.61, 95%CI 0.45,0.93), obese (OR 0.49, 95%CI 0.24,0.65) or have an ACQ≥1.5 (OR 0.19, 95%CI 0.12,0.31) pre-biologic therapy. The likelihood of remission reduced by 14% for every 10-year increase in disease duration (95%CI 0.76,0.97).12 to 21% of the cohort attained clinical remission depending on the definition applied; most of those who did not achieve remission failed to meet multiple criteria.
Conclusion: 18.3% of patients achieved the primary definition of clinical remission. Remission was more likely in T2 biomarker high patients with shorter duration of disease and less comorbidity. Further research on the optimum time to commence biologics in severe asthma is required.
背景：新型生物疗法彻底改变了重症哮喘的管理，具有更雄心勃勃的治疗目标。在这里，我们分析了临床缓解的定义，将其作为建议的治疗目标，并考虑了大型现实世界重症哮喘队列中与临床缓解相关的特征。
方法：对英国严重哮喘登记研究（UKSAR）登记的符合严格的国家生物制剂准入标准的患者进行回顾性分析。患者接受了生物制剂前的基线评估和年度审查。临床缓解的主要定义包括哮喘控制问卷<1.5，没有口服皮质类固醇用于疾病控制，FEV1≥正常下限（LLN）或≤-100毫升（与基线相比）。
结果：18.3%的患者达到了缓解的主要定义。生物治疗的高T2生物标志物患者的调整后缓解比率为7.44倍（95%CI 1.73，31.95）。女性（OR 0.61，95%CI 0.45，0.93）、肥胖（OR 0.49，95%CI 0.24，0.65）或生物治疗前ACQ≥1.5（OR 0.19，95%CI 0.12，0.31）患者的调整后缓解比率较低。疾病持续时间每增加10年，缓解的可能性降低14%（95%CI 0.76，0.97）。根据所应用定义，队列中有12%至21%的患者达到临床缓解；大多数未达到缓解的患者未能达到多项标准。
结论：18.3%的患者达到了临床缓解的主要定义。T2生物标志物水平高、病程短和合并症少的患者更有可能缓解。需要进一步研究在重度哮喘中开始生物制剂的最佳时间。
(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)
(Eur Respir J. 2023 Oct 19:2300819. doi: 10.1183/13993003.00819-2023.)
(Eur Respir J. 2023 Oct 19:2300819. doi: 10.1183/13993003.00819-2023.)
Clinical remission in severe asthma with Biologic Therapy: an analysis from the UK Severe Asthma Registry
P Jane McDowell, Ron McDowell, John Busby, M Chad Eastwood, Pujan H Patel, David J Jackson, Adel Mansur, Mitesh Patel, Hassan Burhan, Simon Doe, Rekha Chaudhuri, Robin Gore, James W Dodd, Deepak Subramanian, Thomas Brown, Liam G Heaney; UK Severe Asthma Registry
Abstract
BACKGROUND:Novel biologic therapies have revolutionised the management of severe asthma with more ambitious treatment aims. Here we analyse the definition of clinical remission as a suggested treatment goal and consider the characteristics associated with clinical remission in a large, real-world severe asthma cohort.
Methods: Retrospective analysis of severe asthma patients registered in the UK Severe Asthma Registry (UKSAR) who met strict national access criteria for biologics. Patients had a pre-biologics baseline assessment and annual review. Primary definition of clinical remission applied included Asthma Control Questionnaire <1.5 and no oral corticosteroids for disease control and FEV1 ≥lower limit of normal (LLN) or ≤-100 mLs change from baseline.
Results: 18.3% of patients achieved the primary definition of remission. The adjusted odds of remission on biologic therapy were 7.44-fold higher in patients with high T2-biomarkers (95%CI 1.73,31.95). The adjusted odds of remission were lower in patients who were female (OR 0.61, 95%CI 0.45,0.93), obese (OR 0.49, 95%CI 0.24,0.65) or have an ACQ≥1.5 (OR 0.19, 95%CI 0.12,0.31) pre-biologic therapy. The likelihood of remission reduced by 14% for every 10-year increase in disease duration (95%CI 0.76,0.97).12 to 21% of the cohort attained clinical remission depending on the definition applied; most of those who did not achieve remission failed to meet multiple criteria.
Conclusion: 18.3% of patients achieved the primary definition of clinical remission. Remission was more likely in T2 biomarker high patients with shorter duration of disease and less comorbidity. Further research on the optimum time to commence biologics in severe asthma is required.
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