• Allergy · Jan 2020

    Randomized Controlled Trial

    Dupilumab improves health-related quality of life in patients with chronic rhinosinusitis with nasal polyposis.

    • 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 Abbe, Christine Taniou, Chunpeng Fan, Gianluca Pirozzi, GrahamNeil M HNMHRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Puneet Mahajan, Heribert Staudinger, and Asif Khan.
    • Ghent University Hospital, Ghent, Belgium.
    • Allergy. 2020 Jan 1; 75 (1): 148-157.

    BackgroundChronic 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.MethodsFollowing 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.ResultsFollowing 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."ConclusionsIn adults with CRSwNP refractory to treatment with INCS alone, the addition of dupilumab reduced disease severity, significantly improved HRQoL, and improved productivity.© 2019 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.

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