This article is part of Pulmonology Advisor’s coverage of the American Thoracic Society Virtual 2020 meeting.
Treatment with 300 mg dupilumab every 2 weeks led to significant improvements in lung function by 16 weeks and up to 24 weeks in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and comorbid asthma plus clinical features of chronic obstructive pulmonary disease (COPD), according to findings presented virtually at the American Thoracic Society (ATS) 2020 Virtual meeting, held August 5 to 10, 2020.
In the phase 3 SINUS-24 (ClinicalTrials.gov Identifier: NCT02912468) and SINUS-52 (ClinicalTrials.gov Identifier: NCT02898454) trials, add-on dupilumab resulted in significant improvements in several outcome measures in patients with severe CRSwNP as well as in patients with CRSwNP and comorbid asthma that was uncontrolled by standard of care.
However, the effect of dupilumab in patients with CRSwNP and asthma plus clinical features of COPD, such as smoking history and airflow obstruction, has yet to be explored. To investigate this question, researchers looked at changes in lung function following the first 24 weeks of treatment in the SINUS-24 and SINUS-52 trials. Patients in both trials were randomly assigned to either placebo or 300 mg dupilumab every 2 weeks for a total of 24 weeks in the SINUS-24 trial or 52 weeks in the SINUS-52 trial.
Patients were considered to have clinical features of COPD if they had a postbronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) of <0.70 and a smoking history; COPD history; asthma and a >10 pack-years history of smoking; or treatment with long-acting β2-agonist/long-acting muscarinic antagonist (with or without inhaled corticosteroids) and a >10 pack-years smoking history.
A total of 258 patients with asthma and 49 patients with clinical features of COPD were randomly assigned to the dupilumab groups, whereas 170 patients with asthma and 40 patients with clinical features of COPD were included in the placebo groups. The investigators observed significant improvements in FEV1 that favored dupilumab over placebo in patients with asthma (P <.0001) and clinical features of COPD (P =.0007) at 16 weeks. These improvements were sustained through 24 weeks.
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Maspero JF, Bachert C, Ortiz B, et al. Lung function in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and comorbid asthma with clinical features of chronic obstructive pulmonary disease (COPD): pooled analysis of the phase 3 SINUS-24 and SINUS-52 studies. Presented at: American Thoracic Society 2020 Virtual; August 5-10, 2020. Abstract #223.