Clinical Efficacy among Patients with Chronic Rhinosinusitis with Nasal Polyps and Clinical Features of Obstructive Lung Disease: Post Hoc Analysis of the Phase III SINUS-24 and SINUS-52 Studies

Authors

Jorge F Maspero
Claus Bachert
Fernando J Martinez
Nicola A Hanania
Benjamin Ortiz
Naimish Patel
Leda P Mannent
Amy Praestgaard
Nami Pandit-Abid
Shahid Siddiqui
Megan Hardin

Publication Date

1-1-2023

Journal

Journal of Asthma and Allergy

DOI

10.2147/JAA.S357393

PMID

37026112

PMCID

PMC10072142

PubMedCentral® Posted Date

3-31-2023

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes

Keywords

obstructive lung disease, chronic obstructive pulmonary disease, dupilumab, type 2 inflammation, interleukin-4, interleukin-13

Abstract

PURPOSE: To provide a descriptive summary of clinical efficacy and health-related quality of life (HRQoL) measures in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and clinical features of obstructive lung disease in the Phase III dupilumab studies SINUS-24 and SINUS-52 (NCT02912468, NCT02898454).

PATIENTS AND METHODS: Patients met a "broad" definition of having clinical features of obstructive lung disease with any of 3 criteria: (i) pre-bronchodilator forced expiratory volume in 1 second (FEV

RESULTS: Across both studies, 131 patients met the "broad" definition, of whom 90 also had asthma, and 115 patients met the "narrow" definition, of whom 74 had asthma. CRSwNP outcomes and HRQoL were improved with dupilumab vs placebo in both the broad and narrow subgroups. Among the 90 patients who met the broad definition and had asthma, dupilumab improved pre-bronchodilator FEV

CONCLUSION: In a population of patients with CRSwNP and clinical features of obstructive lung disease, dupilumab improved CRSwNP and HRQoL outcomes, and, among those with a history of asthma, also improved lung function. These results support further analyses of dupilumab in patients with evidence of type 2 inflammation and obstructive lung disease such as COPD.