医学
杜皮鲁玛
可视模拟标度
安慰剂
鼻息肉
生活质量(医疗保健)
慢性鼻-鼻窦炎
内科学
糠酸莫米松
随机对照试验
鼻窦炎
临床试验
物理疗法
皮质类固醇
外科
病理
哮喘
护理部
替代医学
作者
Claus Bachert,Peter W. Hellings,Joaquim Mullol,Daniel L. Hamilos,Philippe Gevaert,Robert M. Naclerio,Vijay N. Joish,Jingdong Chao,Leda P. Mannent,Nikhil Amin,Adeline Abbé,Christine Taniou,Chunpeng Fan,Gianluca Pirozzi,Neil M.H. Graham,Puneet Mahajan,Heribert Staudinger,Asif Khan
出处
期刊:Allergy
[Wiley]
日期:2019-07-15
卷期号:75 (1): 148-157
被引量:85
摘要
Abstract Background Chronic rhinosinusitis with nasal polyposis (CRSwNP) negatively affects health‐related quality of life (HRQoL). In a previously reported randomized clinical trial (NCT01920893), addition of dupilumab to mometasone furoate in patients with CRSwNP refractory to intranasal corticosteroids (INCS) significantly improved endoscopic, radiographic, and clinical endpoints and patient‐reported outcomes. The objective of this analysis was to examine the impact of dupilumab treatment on HRQoL and productivity using secondary outcome data from this trial. Methods Following a 4‐week mometasone furoate nasal spray run‐in, patients were randomized to commence subcutaneous dupilumab (600 mg loading dose, then 300 mg once weekly for 15 weeks [n = 30], or matched placebo [n = 30]). Outcomes included scores on the CRS disease severity visual analog scale (VAS), 22‐item Sino‐Nasal Outcome Test (SNOT‐22), 5‐dimension EuroQoL (EQ‐5D) general health status VAS, and 36‐item Short‐Form Health Survey (SF‐36) for HRQoL and nasal polyp‐related healthcare resource use questionnaires. Results Following 16 weeks of treatment, the proportion of patients with moderate‐to‐severe CRSwNP (VAS > 3‐10) decreased from 86.2% to 21.4% with dupilumab and 88.0% to 84.2% with placebo. Dupilumab (vs placebo) resulted in significantly greater improvement in HRQoL, based on SNOT‐22, SF‐36, and EQ‐5D VAS scores. The dupilumab group had a significantly lower adjusted annualized mean number of sick leave days (0.09, vs 4.18 with placebo, P = .015) and significantly greater improvement (vs placebo) in the SNOT‐22 item “reduced productivity.” Conclusions In adults with CRSwNP refractory to treatment with INCS alone, the addition of dupilumab reduced disease severity, significantly improved HRQoL, and improved productivity.
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