Dupilumab shows long-term efficacy among asthma patients with, without CRSwNP
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Long-term treatment with dupilumab appeared effective among patients with asthma with or without coexisting chronic rhinosinusitis with nasal polyps, according to a study published in Annals of Allergy, Asthma & Immunology.
Treatment also reduced oral corticosteroid (OCS) doses among patients with severe asthma who depended on OCS usage at baseline, Patrick Berger, MD, PhD, professor of physiology, Cardio-Thoracic Research Center of Bordeaux, University of Bordeaux, and colleagues wrote in the study.
After participating in the QUEST (n = 1,530) or VENTURE (n = 187) studies, patients enrolled in TRAVERSE, where they continued dupilumab (Dupixent; Sanofi, Regeneron; dupilumab/dupilumab group) treatment or switched to dupilumab from placebo (placebo/dupilumab group) through 48 or 96 weeks. Of the included patients, 21% (n = 317) from QUEST and 48% (n = 61) from VENTURE self-reported CRSwNP.
From parent study baselines to week 96, TRAVERSE patients with CRSwNP experienced decreases in annualized exacerbation rates from 2.36 (QUEST) to 0.41 and 2.36 (VENTURE) to 0.45 for the placebo/dupilumab group, with corresponding reductions of 2.39 to 0.32 and 2.32 to 0.35 for the dupilumab/dupilumab group. Results were similar for those patients without CRSwNP, showing a decrease of 2.21 (QUEST) to 0.34 and 2.07 (VENTURE) to 0.21 for placebo/dupilumab and 2 (QUEST) to 0.33 and 1.74 (VENTURE) to 0.41 for dupilumab/dupilumab.
Additionally, patients in VENTURE experienced reductions in mean OCS doses from the parent study baseline that continued through week 96 of TRAVERSE. Among patients in the dupilumab/dupilumab group, 71.4% of those with CRSwNP and 83.3% of those without CRSwNP no longer needed OCS, with corresponding rates of 38.5% and 46.7% in the placebo/dupilumab group
Also, patients in QUEST experienced substantial improvements in FEV1 that were sustained through TRAVERSE. Only those in the dupilumab group experience any changes in FEV1 during VENTURE, which were maintained during TRAVERSE, with placebo/dupilumab patients showing increases from –0.06 to 0.45 L for those with CRSwNP and 0.02 to 0.29 L for those without CRSwNP.
Overall, researchers also observed that improvements in Asthma Control Questionnaire 5 scores and Asthma Quality of Life Questionnaire scores in QUEST and VENTURE continued through week 48 of TRAVERSE.
Treatment-emergent adverse event rates were similar for all groups through TRAVERSE. For those with CRSwNP, this included 80.2% and 83.3% of the placebo/dupilumab groups and 81.6% and 76% for dupilumab only groups from QUEST and VENTURE, respectively. For those without CRSwNP, this included 80% and 72.1% of the placebo/dupilumab groups and 77% and 78.5% of the dupilumab only groups from QUEST and VENTURE, respectively.
With a consistent safety profile, the researchers concluded that dupilumab led to sustained reductions in exacerbations in lung function, asthma control and quality of life as well as OCS dose reduction for patients with severe asthma whether they also had self-reported CRSwNP.
Perspective
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Clifford Bassett, MD, FAAAAI, FACAAI
Dupilumab reduced the annualized asthma exacerbation rate and improved lung function (as measured by pre-bronchodilator FEV1), asthma control and quality of life scores for patients with uncontrolled, moderate to severe or OCS-dependent severe asthma with or without self-reported CRSwNP.
Although dupilumab was associated with similar clinical efficacy among patients with and without self-reported CRSwNP, this study provides efficacy of data over 3 years and demonstrates that dupilumab can decrease OCS and be useful as a steroid-sparing agent for patients with and without CRSwNP.
Also, its authors acknowledge how the study needs statistical power to provide further evidence of relative improvement for those with and without CRSwNP. As patients are self-reporting CRSwNP, diagnosis may not be accurate as well.
Apart from this study, researchers have defined a significant number of individuals with severe asthma (estimated to be at least 3% globally) who have coexisting atopic conditions, including allergic rhinitis, atopic dermatitis and CRSwNPs.
It is important to be aware that CRSwNP is frequently associated with elevated type 2 inflammation. However, even patients with CRS without nasal polyps are also likely to have a similar profile.
I also would like to acknowledge Beth Gordon, MD, for her input in preparing these comments.
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