TY - JOUR
T1 - Dupilumab improves health-related quality of life in patients with chronic rhinosinusitis with nasal polyposis
AU - Bachert, Claus
AU - Hellings, Peter W.
AU - Mullol, Joaquim
AU - Hamilos, Daniel L.
AU - Gevaert, Philippe
AU - Naclerio, Robert M.
AU - Joish, Vijay N.
AU - Chao, Jingdong
AU - Mannent, Leda P.
AU - Amin, Nikhil
AU - Abbe, Adeline
AU - Taniou, Christine
AU - Fan, Chunpeng
AU - Pirozzi, Gianluca
AU - Graham, Neil M.H.
AU - Mahajan, Puneet
AU - Staudinger, Heribert
AU - Khan, Asif
N1 - Publisher Copyright:
© 2019 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.
PY - 2020/1/1
Y1 - 2020/1/1
N2 - 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.
AB - 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.
KW - ENT (rhinitis
KW - biologics
KW - nasal polyps…)
KW - quality of life
KW - sinusitis
UR - http://www.scopus.com/inward/record.url?scp=85074362072&partnerID=8YFLogxK
U2 - 10.1111/all.13984
DO - 10.1111/all.13984
M3 - Article
C2 - 31306495
AN - SCOPUS:85074362072
SN - 0105-4538
VL - 75
SP - 148
EP - 157
JO - Allergy: European Journal of Allergy and Clinical Immunology
JF - Allergy: European Journal of Allergy and Clinical Immunology
IS - 1
ER -