WITH HIGH-DOSE INHALED CORTICOSTEROID IN PATIENTS WITH COEXISTING CHRONIC RHINOSINUSITIS WITH NASAL POLYPS AND UNCONTROLLED ASTHMA IN EVEREST
Author(s)
Arnaud Bourdin, MD1, Michael Wechsler, MD2, Martin Wagenmann, MD3, Caresse Campbell, PhD, MPH4, Arman Altincatal, MS4, Scott Nash, MD5, Mark Corbett, MD6, Rebecca Gall, MD5, Andrew Moraco, MD4, Rohit K. Katial, MD2;
1PhyMedExp, University of Montpellier, Montpellier, France, 2National Jewish Health, Denver, CO, USA, 3Düsseldorf University Hospital (UKD), Düsseldorf, Germany, 4Sanofi, Cambridge, MA, USA, 5Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA, 6Sanofi, Morristown, NJ, USA
1PhyMedExp, University of Montpellier, Montpellier, France, 2National Jewish Health, Denver, CO, USA, 3Düsseldorf University Hospital (UKD), Düsseldorf, Germany, 4Sanofi, Cambridge, MA, USA, 5Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA, 6Sanofi, Morristown, NJ, USA
OBJECTIVES: Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) often have coexisting asthma. Patients with asthma uncontrolled by medium-dose inhaled corticosteroids (ICS) may have their dose increased despite limited evidence of additional benefits and increased risk of side effects. In EVEREST, dupilumab vs omalizumab significantly improved CRSwNP- and asthma-related outcomes. Here, we report the efficacy of dupilumab + medium-dose ICS (DPL+mICS) vs omalizumab + high-dose ICS (OMA+hICS) in EVEREST.
METHODS: In EVEREST (NCT04998604), patients aged ≥18 years with severe CRSwNP and coexisting uncontrolled asthma (defined as 5-item Asthma Control Questionnaire [ACQ] score ≥1.5) received background intranasal corticosteroids, ICS, and a second asthma controller (i.e. long-acting β2-agonist/leukotriene receptor antagonist) and were randomized 1:1 to dupilumab 300 mg q2w or omalizumab 75-600 mg q2w/q4w for 24 weeks. In the DPL+mICS/OMA+hICS subgroups, estimated mean changes from baseline to Week 24 in University of Pennsylvania Smell Identification Test (UPSIT) score (range 0-40, higher scores indicating increased ability to differentiate odorants), pre-bronchodilator forced expiratory volume in 1 second (FEV1), 7-item ACQ score (ACQ-7; range 0-6), and loss of smell (LoS) score (range 0-3, higher scores indicating increased symptom severity) were evaluated.
RESULTS: In the DPL+mICS (n=52)/OMA+hICS (n=29) groups, baseline mean (SD) UPSIT score was 10.8 (4.4)/10.7 (6.8), pre-bronchodilator FEV1 was 2.8 L (1.0)/2.4 L (0.9), ACQ-7 score was 2.8 (0.7)/3.1 (1.0), and LoS score was 2.9 (0.4)/2.8 (0.4). At Week 24, estimated mean change from baseline for DPL+mICS/OMA+hICS was as follows: UPSIT score, 12.0 (95% CI: 9.3, 14.7)/2.4 (−1.2, 6.0); pre-bronchodilator FEV1, 0.3 L (0.2, 0.5)/0.1 L (−0.1, 0.4); ACQ-7 score, −2.0 (−2.3, −1.8)/−1.5 (−2.0, −1.0); LoS score, −1.5 (−1.8, −1.2)/−0.7 (−1.1, −0.3).
CONCLUSIONS: In patients with coexisting CRSwNP and uncontrolled asthma, DPL+mICS provided greater improvements in smell differentiation, lung function, asthma control, and ability to smell than OMA+hICS.
METHODS: In EVEREST (NCT04998604), patients aged ≥18 years with severe CRSwNP and coexisting uncontrolled asthma (defined as 5-item Asthma Control Questionnaire [ACQ] score ≥1.5) received background intranasal corticosteroids, ICS, and a second asthma controller (i.e. long-acting β2-agonist/leukotriene receptor antagonist) and were randomized 1:1 to dupilumab 300 mg q2w or omalizumab 75-600 mg q2w/q4w for 24 weeks. In the DPL+mICS/OMA+hICS subgroups, estimated mean changes from baseline to Week 24 in University of Pennsylvania Smell Identification Test (UPSIT) score (range 0-40, higher scores indicating increased ability to differentiate odorants), pre-bronchodilator forced expiratory volume in 1 second (FEV1), 7-item ACQ score (ACQ-7; range 0-6), and loss of smell (LoS) score (range 0-3, higher scores indicating increased symptom severity) were evaluated.
RESULTS: In the DPL+mICS (n=52)/OMA+hICS (n=29) groups, baseline mean (SD) UPSIT score was 10.8 (4.4)/10.7 (6.8), pre-bronchodilator FEV1 was 2.8 L (1.0)/2.4 L (0.9), ACQ-7 score was 2.8 (0.7)/3.1 (1.0), and LoS score was 2.9 (0.4)/2.8 (0.4). At Week 24, estimated mean change from baseline for DPL+mICS/OMA+hICS was as follows: UPSIT score, 12.0 (95% CI: 9.3, 14.7)/2.4 (−1.2, 6.0); pre-bronchodilator FEV1, 0.3 L (0.2, 0.5)/0.1 L (−0.1, 0.4); ACQ-7 score, −2.0 (−2.3, −1.8)/−1.5 (−2.0, −1.0); LoS score, −1.5 (−1.8, −1.2)/−0.7 (−1.1, −0.3).
CONCLUSIONS: In patients with coexisting CRSwNP and uncontrolled asthma, DPL+mICS provided greater improvements in smell differentiation, lung function, asthma control, and ability to smell than OMA+hICS.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO190
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy
Disease
SDC: Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory), STA: Biologics & Biosimilars