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
2024/07/31
摘要
背景：在真实世界中，哮喘缓解定义的标准尚未达成共识。对生物制剂启动后缓解相关因素仍知之甚少。
目的：量化成人重度哮喘患者在生物制剂治疗启动后实现多领域定义缓解的比例，并确定可用于预测缓解与实现缓解相关的生物制剂治疗前特征。
方法：这是一项纵向队列研究，使用了来自国际重度哮喘登记处（ISAR）的23个国家的数据。在启用生物制剂治疗前后的1年内评估4个哮喘结局领域。先验定义的缓解临界值为：0次急性发作/年、无长期口服皮质类固醇（LTOCS）、部分/良好的哮喘控制、FEV1 pred% ≥ 80%。缓解被定义为：满足2个（急性发作+ LTOCS）、3个（+哮喘控制或+肺功能）和4个（急性发作+ LTOCS+哮喘控制+肺功能）领域。通过多变量分析评估生物制剂治疗前特征与生物制剂治疗后实现缓解之间的关系。
测量及主要结果：50.2%、33.5%、25.8%和20.3%的患者分别达到2个（急性发作+ LTOCS）、3个（+哮喘控制）、3个（+肺功能）和4个（急性发作+ LTOCS+哮喘控制+肺功能）领域缓解标准。哮喘持续时间每增加10年，实现4域缓解的几率会降低15%（OR: 0.85; 95%CI: 0.73, 1.00）。对于那些每年急诊发作次数较少、LTOCS日剂量较低、控制较好和生物制剂启用前肺功能较好的患者，生物制剂治疗后实现缓解的几率增加。
结论：20%的患者在生物制剂启用后1年内达到4域缓解。在生物制剂开始治疗时，损害程度较轻且哮喘持续时间较短的患者在生物治疗后获得缓解的几率更大，这表明如果以缓解为目标，生物制剂治疗不应延迟。
Exploring Definitions and Predictors of Severe Asthma Clinical Remission Post-Biologic in Adults
Am J Respir Crit Care Med. 2024 May 3.
Perez-de-Llano L, Scelo G, Tran TN, Le TT, Faregås M, Cosio BG, Peters M, Pfeffer PE, Al-Ahmad M, Al-Lehebi RO, Altraja A, Bergeron C, Bjermer LH, Bjerrum AS, Bulathsinhala L, Busby J, Cano Rosales DJ, Canonica GW, Carter VA, Charriot J, Christoff GC, Denton EJ, Dorscheid DR, Fernandez Sanchez MJ, Fonseca JA, Gibson PG, Goh CYY, Heaney LG, Heffler E, Hew M, Iwanaga T, Katial R, Koh MS, Kuna P, Larenas-Linnemann DES, Lehtimäki L, Mahboub B, Martin N, Matsumoto H, Menzies-Gow AN, Papadopoulos NG, Popov TA, Porsbjerg CM, Patel P, Rhee CK, Sadatsafavi M, Taillé C, Torres-Duque CA, Tsai MJ, Ulrik CS, Upham JW, von Bülow A, Wang E, Wechsler ME, Price DB.
Abstract
Rationale: There is no consensus on criteria to include in an asthma remission definition in real-life. Factors associated with achieving remission post-biologic-initiation remain poorly understood.
Objectives: To quantify the proportion of adults with severe asthma achieving multi-domaindefined remission post-biologic-initiation and identify pre-biologic characteristics associated with achieving remission which may be used to predict it.
Methods: This was a longitudinal cohort study using data from 23 countries from the International Severe Asthma Registry. Four asthma outcome domains were assessed in the 1-year pre- and post-biologic-initiation. A priori-defined remission cut-offs were: 0 exacerbations/year, no long-term oral corticosteroid (LTOCS), partly/well-controlled asthma, and percent predicted forced expiratory volume in one second ≥80%. Remission was defined using 2 (exacerbations + LTOCS), 3 (+control or +lung function) and 4 of these domains. The association between pre-biologic characteristics and post-biologic remission was assessed by multivariable analysis.
Measurements and main results: 50.2%, 33.5%, 25.8% and 20.3% of patients met criteria for 2, 3 (+control), 3 (+lung function) and 4-domain-remission, respectively. The odds of achieving 4-domain remission decreased by 15% for every additional 10-years asthma duration (odds ratio: 0.85; 95% CI: 0.73, 1.00). The odds of remission increased in those with fewer exacerbations/year, lower LTOCS daily dose, better control and better lung function prebiologic-initiation.
Conclusions: One in 5 patients achieved 4-domain remission within 1-year of biologicinitiation. Patients with less severe impairment and shorter asthma duration at initiation had a greater chance of achieving remission post-biologic, indicating that biologic treatment should not be delayed if remission is the goal.
背景：在真实世界中，哮喘缓解定义的标准尚未达成共识。对生物制剂启动后缓解相关因素仍知之甚少。
目的：量化成人重度哮喘患者在生物制剂治疗启动后实现多领域定义缓解的比例，并确定可用于预测缓解与实现缓解相关的生物制剂治疗前特征。
方法：这是一项纵向队列研究，使用了来自国际重度哮喘登记处（ISAR）的23个国家的数据。在启用生物制剂治疗前后的1年内评估4个哮喘结局领域。先验定义的缓解临界值为：0次急性发作/年、无长期口服皮质类固醇（LTOCS）、部分/良好的哮喘控制、FEV1 pred% ≥ 80%。缓解被定义为：满足2个（急性发作+ LTOCS）、3个（+哮喘控制或+肺功能）和4个（急性发作+ LTOCS+哮喘控制+肺功能）领域。通过多变量分析评估生物制剂治疗前特征与生物制剂治疗后实现缓解之间的关系。
测量及主要结果：50.2%、33.5%、25.8%和20.3%的患者分别达到2个（急性发作+ LTOCS）、3个（+哮喘控制）、3个（+肺功能）和4个（急性发作+ LTOCS+哮喘控制+肺功能）领域缓解标准。哮喘持续时间每增加10年，实现4域缓解的几率会降低15%（OR: 0.85; 95%CI: 0.73, 1.00）。对于那些每年急诊发作次数较少、LTOCS日剂量较低、控制较好和生物制剂启用前肺功能较好的患者，生物制剂治疗后实现缓解的几率增加。
结论：20%的患者在生物制剂启用后1年内达到4域缓解。在生物制剂开始治疗时，损害程度较轻且哮喘持续时间较短的患者在生物治疗后获得缓解的几率更大，这表明如果以缓解为目标，生物制剂治疗不应延迟。
(四川大学华西医院呼吸与危重症医学科 吴雯雯1 王霁1 王刚1 译)
(Am J Respir Crit Care Med. 2024 May 3.)
(Am J Respir Crit Care Med. 2024 May 3.)
Exploring Definitions and Predictors of Severe Asthma Clinical Remission Post-Biologic in Adults
Am J Respir Crit Care Med. 2024 May 3.
Perez-de-Llano L, Scelo G, Tran TN, Le TT, Faregås M, Cosio BG, Peters M, Pfeffer PE, Al-Ahmad M, Al-Lehebi RO, Altraja A, Bergeron C, Bjermer LH, Bjerrum AS, Bulathsinhala L, Busby J, Cano Rosales DJ, Canonica GW, Carter VA, Charriot J, Christoff GC, Denton EJ, Dorscheid DR, Fernandez Sanchez MJ, Fonseca JA, Gibson PG, Goh CYY, Heaney LG, Heffler E, Hew M, Iwanaga T, Katial R, Koh MS, Kuna P, Larenas-Linnemann DES, Lehtimäki L, Mahboub B, Martin N, Matsumoto H, Menzies-Gow AN, Papadopoulos NG, Popov TA, Porsbjerg CM, Patel P, Rhee CK, Sadatsafavi M, Taillé C, Torres-Duque CA, Tsai MJ, Ulrik CS, Upham JW, von Bülow A, Wang E, Wechsler ME, Price DB.
Abstract
Rationale: There is no consensus on criteria to include in an asthma remission definition in real-life. Factors associated with achieving remission post-biologic-initiation remain poorly understood.
Objectives: To quantify the proportion of adults with severe asthma achieving multi-domaindefined remission post-biologic-initiation and identify pre-biologic characteristics associated with achieving remission which may be used to predict it.
Methods: This was a longitudinal cohort study using data from 23 countries from the International Severe Asthma Registry. Four asthma outcome domains were assessed in the 1-year pre- and post-biologic-initiation. A priori-defined remission cut-offs were: 0 exacerbations/year, no long-term oral corticosteroid (LTOCS), partly/well-controlled asthma, and percent predicted forced expiratory volume in one second ≥80%. Remission was defined using 2 (exacerbations + LTOCS), 3 (+control or +lung function) and 4 of these domains. The association between pre-biologic characteristics and post-biologic remission was assessed by multivariable analysis.
Measurements and main results: 50.2%, 33.5%, 25.8% and 20.3% of patients met criteria for 2, 3 (+control), 3 (+lung function) and 4-domain-remission, respectively. The odds of achieving 4-domain remission decreased by 15% for every additional 10-years asthma duration (odds ratio: 0.85; 95% CI: 0.73, 1.00). The odds of remission increased in those with fewer exacerbations/year, lower LTOCS daily dose, better control and better lung function prebiologic-initiation.
Conclusions: One in 5 patients achieved 4-domain remission within 1-year of biologicinitiation. Patients with less severe impairment and shorter asthma duration at initiation had a greater chance of achieving remission post-biologic, indicating that biologic treatment should not be delayed if remission is the goal.
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