Patients with asthma who were with or without a diagnosis of nasal polyps were found to have results with long-term dupilumab.
There are approximately 262 million people in the world who are living with asthma, which is characterized by episodic airflow limitation and respiratory symptoms. Chronic rhinosinusitis and/or nasal polyps (CRS/NP) have been found in approximately 50% of people with severe asthma. Dupilumab had been found to improve lung function and maintain low exacerbation rates in the TRAVERSE study. This current study aimed to report long-term efficacy in patients who were enrolled in the QUEST and VENTURE studies who did and did not self-report coexisting CRS/NP by performing a post hoc analysis of the TRAVERSE study.
This study used the participants of TRAVERSE, all of whom had completed a phase 2 or 3 study of dupilumab for asthma. Patients who were on a medium- or high-dose inhaled corticosteroid and at least 1 other controller medication at baseline were eligible. Patients from QUEST and VENTURE were rolled over from the parent study. All enrolled patients were given dupilumab for 48 or 96 weeks, depending on their date of enrollment.
Patients who were enrolled in TRAVERSE from QUEST and VENTURE were evaluated separately and divided into subgroups depending on the presence of self-reported CRS/NP at baseline. The current study primarily aimed to evaluate the annual rate of severe asthma exacerbations.
There were 317 patients who reported CRS/NP and 1213 who did not have self-reported CRS/NP who were enrolled in QUEST. There were 61 patients with CRS/NP and 126 without who enrolled in VENTURE. All were included in this study. Patients enrolled in QUEST with CRS/NP were older than those without CRS/NP, had experienced more severe exacerbations in the previous year, and had higher baseline levels of blood eosinophils and FeNO. In patients enrolled in VENTURE, those with CRS-NP had a higher baseline optimized oral corticosteroids (OCS) dose and higher forced expiratory volume.
Patients in the dupilumab group had larger decreases in the unadjusted annualized exacerbation rate compared with the placebo group in patients both with and without CRS/NP during the QUEST trial. The annualized exacerbation rate among patients with CRS/NP in this trial decreased from 2.36 to 1.48 in the placebo group in and decreased from 2.39 to 0.49 in the dupilumab group. Patients without CRS/NP in the QUEST trial saw a decreased exacerbation rate from 2.21 to 0.91 in the placebo group and 2.00 to 0.51 in the dupilumab group. The trend of decrease continued throughout the treatment period in TRAVERSE.
The decreases in exacerbation rate found in the VENTURE trial also continued in TRAVERSE, as exacerbation rates had decreased to 0.45 and 0.35 in the placebo/dupilumab and dupilumab/dupilumab groups by the end of TRAVERSE. Decreases were found in patients without CRS/NP by the end of the study as well.
Mean OCS dose was reduced in patients who were enrolled in VENTURE and TRAVERSE in patients both with and without CRS/NP. Among patients with self-reported CRS/NP, the percentage mean (SD) reduction from baseline was 37.9% (52.3) at week 0, 54.4% (49.4) at week 48, and 68.5% (32.5) at week 96 in the placebo/dupilumab group and 70.7% (40.4), 76.9% (31.3), and 85.7% (24.4), respectively, in the dupilumab/dupilumab group.
Patients without CRS/NP had 50.5% (46.8), 55.8% (39.6), and 73.9% (27.3) mean reductions in weeks 0, 48, and 96 in the placebo/dupilumab group and 75.5% (39.8), 81.3% (30.5), and 89.6% (29.1) in the dupilumab/dupilumab group at the same time points.
There were some limitations to this study. The self-reported nature of the diagnosis of CRS/NP, the lack of a severity assessment of CRS/NP, no specific end points for CRS/NP, and the small population of OCS-dependent patients were all limitations to the results of this study. This study was not able to compare patients from different parent studies.
The researchers concluded that this analysis of patients with moderate to severe or OCS-dependent asthma with or without CRS/NP would benefit from dupilumab to reduce their exacerbations of asthma.
Berger P, Menzies-Gow A, Peters AT, et al. Long-term efficacy of dupilumab in asthma with and without chronic rhinosinusitis and/or nasal polyps. Ann Allergy Asthma Immunol. Published online November 6, 2022. doi:10.1016/j.anai.2022.11.006