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美国专科医生治疗的重度哮喘成年患者的生物制剂使用情况及治疗结果。

Biologic use and outcomes among adults with severe asthma treated by US subspecialists.

作者信息

Panettieri Reynold A, Ledford Dennis K, Chipps Bradley E, Soong Weily, Lugogo Njira, Carr Warner, Mohan Arjun, Carstens Donna, Genofre Eduardo, Trudo Frank, Ambrose Christopher S

机构信息

Rutgers Institute for Translational Medicine and Science, The State University of New Jersey, New Brunswick, New Jersey.

Division of Allergy and Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, Florida.

出版信息

Ann Allergy Asthma Immunol. 2022 Oct;129(4):467-474.e3. doi: 10.1016/j.anai.2022.06.012. Epub 2022 Jun 19.

Abstract

BACKGROUND

Multiple biologics are now available for severe asthma (SA) treatment and can improve outcomes for patients. However, few available data describe the real-world use and effectiveness of multiple approved biologics, including biologic switching, among subspecialists in the United States.

OBJECTIVE

To evaluate biologic use and associated exacerbation outcomes in a large cohort of subspecialist-treated US adults with SA.

METHODS

CHRONICLE is an ongoing, noninterventional study of subspecialist-treated US adults with SA receiving biologics, maintenance systemic corticosteroids, or those persistently uncontrolled by high-dose inhaled corticosteroids with additional controllers. For enrolled patients, sites report asthma exacerbations and medication use starting 12 months before enrollment. For patients enrolled between February 2018 and February 2021, biologic use and exacerbation outcomes before and after biologic initiation are described.

RESULTS

Among 2793 enrolled patients, 66% (n = 1832) were receiving biologics. The most used biologic (> 1 biologic use per patient allowed) was omalizumab (47%), followed by benralizumab (27%), mepolizumab (26%), dupilumab (18%), and reslizumab (3%). Overall, 16% of patients had biologic switches, 13% had stops, and 89% had ongoing biologic use. Patients starting and switching biologics experienced a 58% (1.80 vs 0.76 per patient-year) and 49% (1.47 vs 0.75 per patient-year) reduction in exacerbations, respectively (both P < .001), with a numerically greater reduction observed among those starting non-anti-immunoglobulin E biologics compared with anti-immunoglobulin E.

CONCLUSION

Real-world starting and switching of biologic therapies for SA were associated with meaningful reductions in exacerbations. With increasing biologic options available, individualized approaches to therapy may improve patient outcomes.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT03373045.

摘要

背景

目前有多种生物制剂可用于治疗重度哮喘(SA),并能改善患者的治疗效果。然而,在美国,很少有可用数据描述多种获批生物制剂在专科医生中的实际使用情况和有效性,包括生物制剂的转换。

目的

评估一大群接受专科医生治疗的美国成年SA患者的生物制剂使用情况及相关的病情加重结局。

方法

CHRONICLE是一项正在进行的非干预性研究,研究对象为接受生物制剂、维持性全身糖皮质激素治疗的美国成年SA专科医生患者,或那些使用高剂量吸入性糖皮质激素及其他控制药物仍持续未得到控制的患者。对于已登记的患者,研究地点报告从登记前12个月开始的哮喘病情加重情况和药物使用情况。对于在2018年2月至2021年2月期间登记的患者,描述了生物制剂开始使用前后的生物制剂使用情况和病情加重结局。

结果

在2793名登记患者中,66%(n = 1832)正在接受生物制剂治疗。使用最多的生物制剂(允许每位患者使用>1种生物制剂)是奥马珠单抗(47%),其次是贝那利珠单抗(27%)、美泊利珠单抗(26%)、度普利尤单抗(18%)和瑞利珠单抗(3%)。总体而言,16%的患者更换了生物制剂,13%的患者停止使用,89%的患者仍在继续使用生物制剂。开始使用和更换生物制剂的患者病情加重情况分别减少了58%(每位患者每年1.80次 vs 0.76次)和49%(每位患者每年1.47次 vs 0.75次)(P均<0.001),与抗免疫球蛋白E生物制剂相比,开始使用非抗免疫球蛋白E生物制剂的患者病情加重减少幅度在数值上更大。

结论

SA生物治疗的实际启动和转换与病情加重的显著减少相关。随着可用生物制剂选择的增加,个体化治疗方法可能会改善患者的治疗效果。

临床试验注册

ClinicalTrials.gov标识符:NCT03373045。

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