Dupilumab可以改善与健康相关的生活质量：来自3期SINUS研究的结果
2022/07/19
摘要
背景：慢性鼻窦炎伴鼻息肉（CRSwNP）是一种主要由2型炎症介导的疾病，具有较高的症状负担和较低的健康相关生活质量（HRQoL）。本报告旨在全面了解Dupilumab对3期SINUS-24（NCT02912468）和SINUS-52（NCT02898454）试验中重度CRSwNP患者的健康相关生活质量、个体因素和健康状况的影响。
方法：患者被随机分为两组，分别接受Dupilumab（n=438）或安慰剂（n=286）治疗24周（SINUS-24）或52周（SINUS-52）。在SINUS-24意向性治疗 (ITT) 人群（第 24 周)、SINUS-52 ITT（第 52 周）均使用22项鼻窦结局测试（SNOT-22）评估疾病特异性的健康相关生活质量，使用 EuroQoL 视觉模拟量表 (EQ-VAS)评估健康状况，并将患者分为有/无哮喘、非甾体抗炎药加重呼吸道疾病（NSAID-ERD）及鼻窦手术史进行亚组分析。
结果：在基线时，患者的疾病特异性健康相关生活质量和一般健康状况较差，并将“嗅觉/味觉减退”和“鼻塞”确定为最重要的症状。在第24周，与安慰剂相比，Dupilumab显着改善了 SNOT-22 总分、局部评分（鼻、睡眠、功能、情绪和耳朵/面部）和 22-项目评分和 EQ-VAS（所有 p < 0.0001），并且持续改善至 SINUS-52 的第 52 周。无论合并哮喘、NSAID-ERD 或先前的手术如何，都会出现改善。与安慰剂相比，接受Dupilumab 治疗的患者显着超过 SNOT-22 总分和 EQ-VAS 的临床意义阈值（所有亚组 p <0.05，第 24 周未进行手术的患者除外）。
结论：Dupilumab 治疗在严重 CRSwNP 患者的疾病特异性健康相关生活质量的各个方面以及一般健康状况方面都带来了显着的临床意义改善。
Dupilumab improves health related quality of life: Results from the phase 3 SINUS studies
Stella E Lee, Claire Hopkins, Joaquim Mullol,
Abstrast
Background：Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2-mediated inflammatory disease with high symptom burden and reduced health-related quality oflife (HRQoL). This report aimed to comprehensively understand the effects of dupilumab ondomains of HRQoL, their individual elements, and health status in patients with severe CRSwNP from phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) trials.
Methods：Patients were randomized to dupilumab (n = 438) or placebo (n = 286) for 24 weeks(SINUS-24), or 52 weeks (SINUS-52). Disease-specific HRQoL using 22-item sino-nasal outcome test (SNOT-22), and health status using EuroQoL-visual analog scale (EQ-VAS) was evaluated in the pooled intention-to-treat (ITT) population (Week 24), SINUS-52 ITT (Week 52) and in the subgroups with/without asthma; non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD); and prior sinus surgery.
Results：At baseline, patients had poor disease-specific HRQoL and general health status and identified "Decreased sense of smell/taste" and "Nasal blockage" as the most important symptoms. Dupilumab significantly improved SNOT-22 total, domain (Nasal, Sleep, Function, Emotion, and Ear/facial), and 22-item scores, and EQ-VAS, at Week 24 vs placebo (all p < 0.0001), with continued improvements to Week 52 in SINUS-52. Improvements occurred irrespective of comorbid asthma, NSAID-ERD, or prior surgery. A significantly greater proportion of dupilumab-treated patients exceeded clinically meaningful thresholds for SNOT-22 total score and EQ-VAS vs placebo (all subgroups p <0.05 except patients without surgery at Week 24).
Conclusion：Dupilumab treatment led to significant clinically meaningful improvements across all aspects of disease-specific HRQoL, and general health status in patients with severe CRSwNP.
背景：慢性鼻窦炎伴鼻息肉（CRSwNP）是一种主要由2型炎症介导的疾病，具有较高的症状负担和较低的健康相关生活质量（HRQoL）。本报告旨在全面了解Dupilumab对3期SINUS-24（NCT02912468）和SINUS-52（NCT02898454）试验中重度CRSwNP患者的健康相关生活质量、个体因素和健康状况的影响。
方法：患者被随机分为两组，分别接受Dupilumab（n=438）或安慰剂（n=286）治疗24周（SINUS-24）或52周（SINUS-52）。在SINUS-24意向性治疗 (ITT) 人群（第 24 周)、SINUS-52 ITT（第 52 周）均使用22项鼻窦结局测试（SNOT-22）评估疾病特异性的健康相关生活质量，使用 EuroQoL 视觉模拟量表 (EQ-VAS)评估健康状况，并将患者分为有/无哮喘、非甾体抗炎药加重呼吸道疾病（NSAID-ERD）及鼻窦手术史进行亚组分析。
结果：在基线时，患者的疾病特异性健康相关生活质量和一般健康状况较差，并将“嗅觉/味觉减退”和“鼻塞”确定为最重要的症状。在第24周，与安慰剂相比，Dupilumab显着改善了 SNOT-22 总分、局部评分（鼻、睡眠、功能、情绪和耳朵/面部）和 22-项目评分和 EQ-VAS（所有 p < 0.0001），并且持续改善至 SINUS-52 的第 52 周。无论合并哮喘、NSAID-ERD 或先前的手术如何，都会出现改善。与安慰剂相比，接受Dupilumab 治疗的患者显着超过 SNOT-22 总分和 EQ-VAS 的临床意义阈值（所有亚组 p <0.05，第 24 周未进行手术的患者除外）。
结论：Dupilumab 治疗在严重 CRSwNP 患者的疾病特异性健康相关生活质量的各个方面以及一般健康状况方面都带来了显着的临床意义改善。
(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)
(Allergy 2022 Jul;77(7):2211-2221 doi:10.1111/all.15222)
(Allergy 2022 Jul;77(7):2211-2221 doi:10.1111/all.15222)
Dupilumab improves health related quality of life: Results from the phase 3 SINUS studies
Stella E Lee, Claire Hopkins, Joaquim Mullol,
Abstrast
Background：Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2-mediated inflammatory disease with high symptom burden and reduced health-related quality oflife (HRQoL). This report aimed to comprehensively understand the effects of dupilumab ondomains of HRQoL, their individual elements, and health status in patients with severe CRSwNP from phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) trials.
Methods：Patients were randomized to dupilumab (n = 438) or placebo (n = 286) for 24 weeks(SINUS-24), or 52 weeks (SINUS-52). Disease-specific HRQoL using 22-item sino-nasal outcome test (SNOT-22), and health status using EuroQoL-visual analog scale (EQ-VAS) was evaluated in the pooled intention-to-treat (ITT) population (Week 24), SINUS-52 ITT (Week 52) and in the subgroups with/without asthma; non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD); and prior sinus surgery.
Results：At baseline, patients had poor disease-specific HRQoL and general health status and identified "Decreased sense of smell/taste" and "Nasal blockage" as the most important symptoms. Dupilumab significantly improved SNOT-22 total, domain (Nasal, Sleep, Function, Emotion, and Ear/facial), and 22-item scores, and EQ-VAS, at Week 24 vs placebo (all p < 0.0001), with continued improvements to Week 52 in SINUS-52. Improvements occurred irrespective of comorbid asthma, NSAID-ERD, or prior surgery. A significantly greater proportion of dupilumab-treated patients exceeded clinically meaningful thresholds for SNOT-22 total score and EQ-VAS vs placebo (all subgroups p <0.05 except patients without surgery at Week 24).
Conclusion：Dupilumab treatment led to significant clinically meaningful improvements across all aspects of disease-specific HRQoL, and general health status in patients with severe CRSwNP.
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