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度普利尤单抗对口服皮质类固醇依赖性重度哮喘的呼吸困难、睡眠和活动的长期影响

2023/03/21

   摘要
   背景:严重哮喘影响生活质量(QoL),包括呼吸困难、睡眠和活动受限。度普利尤单抗是一种完全的人单克隆抗体,可以阻断白介素-4和-13的共享受体成分,这两种受体是2型炎症的关键和核心驱动因素。第三期LIBERTY ASTHMA VENTURE (NCT02528214)和LIBERTY ASTHMA TRAVERSE开放标签扩展(NCT02134028)评估了口服皮质类固醇(OCS)依赖性重症哮喘患者的度普利尤单抗300mg vs安慰剂,每2周持续24周(VENTURE), 仅度普利尤单抗再延长48至96周(TRAVERSE)。
   目的:评估度普利尤单抗对哮喘生活质量问卷(AQLQ)中与呼吸症状、睡眠和活动限制以及OCS减少有关的影响。
   方法:在VENTURE和TRAVERSE研究中,呼吸症状、睡眠和活动相关项目AQLQ得分为6或7的患者比例,以及VENTURE中OCS剂量的减少的比例。
   结果:在VENTURE研究中,与安慰剂相比,度普利尤单抗治疗组患者在第24周时在呼吸症状相关(42.7%-60.2% vs 22.4%-39.3%)、睡眠相关(45.6%-65.0% vs 27.1%-47.7%)和活动相关(44.7%-51.5% vs 22.4%-34.6%) AQLQ项目中得分为6或7的比例明显更高。度普利尤单抗/度普利尤单抗组通过TRAVERSE维持了改善,安慰剂/度普利尤单抗组增加到度普利尤单抗治疗水平。在VENTURE研究中观察到OCS剂量显著减少;在呼吸症状、睡眠症状和活动相关项目AQLQ评分为6或7的患者中,度普利尤单抗治疗组高达90%和60%,安慰剂治疗组为65%和41%。
   结论:在重度OCS依赖性哮喘患者中,度普利尤单抗改善了与呼吸症状、睡眠和活动受限相关的生活质量,并减少了OCS的使用。

 
 (中日友好医院呼吸与危重症医学科 万静萱 摘译 林江涛 审校)
(Ann Allergy Asthma Immunol. 2023 Mar;130(3):298-304. doi: 10.1016/j.anai.2022.12.002,IF:4.969)


 
 
The long-term effect of dupilumab on dyspnea, sleep, and activity in oral corticosteroid-dependent severe asthma.
 
Lawrence D Sher , Giovanni Passalacqua , Camille Taillé
 
Abstrast
Background: Severe asthma impacts quality of life (QoL), including dyspnea, sleep, and activity limitation. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukins-4 and -13, which are key and central drivers of type 2 inflammation. Phase 3 LIBERTY ASTHMA VENTURE (NCT02528214) and LIBERTY ASTHMA TRAVERSE open-label extension (NCT02134028) evaluated dupilumab 300 mg vs placebo every 2 weeks for 24 weeks (VENTURE) and dupilumab only for an additional 48 to 96 weeks (TRAVERSE) in patients with oral corticosteroid (OCS)-dependent severe asthma.
Objectives: To assess dupilumab's impact on Asthma QoL Questionnaire (AQLQ) items related to breathing symptoms, sleep, and activity limitation, and on OCS reduction.
Methods: The proportion of patients with AQLQ scores of 6 or 7 for breathing symptoms-, sleeping-, and activity-related items in VENTURE and TRAVERSE, together with OCS dose reductions in VENTURE.
Results: In VENTURE, significantly greater proportions of dupilumab- vs placebo-treated patients achieved scores of 6 or 7 by week 24 in breathing symptoms-related (42.7%-60.2% vs 22.4%-39.3%), sleeping-related (45.6%-65.0% vs 27.1%-47.7%), and activity-related (44.7%-51.5% vs 22.4%-34.6%) AQLQ items. Improvements were maintained through TRAVERSE in the dupilumab/dupilumab group and increased to dupilumab treatment levels in the placebo/dupilumab group. Significant OCS dose reductions were observed in VENTURE; up to 90% and 60% of dupilumab-treated vs 65% and 41% of placebo-treated patients with AQLQ scores of 6 or 7 in breathing symptoms-, sleeping-, and activity-related items achieved greater than or equal to 50% dose reduction and eliminated OCS at week 24, respectively.
Conclusions: In patients with severe OCS-dependent asthma, dupilumab improved QoL related to breathing symptoms, sleep, and activity limitation, and reduced OCS use.
 
 


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