DUPILUMAB VERSUS OMALIZUMAB IMPROVES CLINICAL OUTCOMES IN PATIENTS WITH SEVERE CHRONIC RHINOSINUSITIS WITH NASAL POLYPS, COEXISTING ASTHMA, AND ANOSMIA IN THE PHASE 4 EVEREST STUDY
Author(s)
Anju T Peters, MD1, HEFFLER ENRICO MARCO, MD, PhD2, CANONICA GIORGIO WALTER, MD2, Brian J. Lipworth, MD, PhD3, Martin Wagenmann, MD, PhD4, Gaelle Bego Le Bagousse, MSc5, Arman Altincatal, MS6, Mark Corbett, MD7, Scott Nash, MD8, Rebecca Gall, MD8, Andrew Moraco, MD6, John Oppenheimer, MD9.
1Northwestern University Feinberg School of Medicine, Chicago, IL, USA, 2Humitas University, Pieve Emanuele, Italy, 3Scottish Centre for Respiratory Research, University of Dundee, Dundee, United Kingdom, 4Düsseldorf University Hospital (UKD), Düsseldorf, Germany, 5Sanofi, Gentilly, France, 6Sanofi, Cambridge, MA, USA, 7Sanofi, Morristown, NJ, USA, 8Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA, 9UMDNJ Rutgers University School of Medicine, Newark, NJ, USA.
1Northwestern University Feinberg School of Medicine, Chicago, IL, USA, 2Humitas University, Pieve Emanuele, Italy, 3Scottish Centre for Respiratory Research, University of Dundee, Dundee, United Kingdom, 4Düsseldorf University Hospital (UKD), Düsseldorf, Germany, 5Sanofi, Gentilly, France, 6Sanofi, Cambridge, MA, USA, 7Sanofi, Morristown, NJ, USA, 8Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA, 9UMDNJ Rutgers University School of Medicine, Newark, NJ, USA.
OBJECTIVES: Loss of smell, or anosmia, is a hallmark of chronic rhinosinusitis with nasal polyps (CRSwNP) that is commonly associated with comorbid asthma. Anosmia affects up to 80-90% of patients with uncontrolled CRSwNP and significantly impairs quality of life but remains underrecognized in patients with coexisting asthma. Dupilumab and omalizumab are both approved for the treatment of CRSwNP and moderate-to-severe asthma. This post hoc analysis evaluated the efficacy of dupilumab vs omalizumab on clinical and functional outcomes in patients who were anosmic at baseline in the phase 4 EVEREST study (NCT04998604).
METHODS: Patients aged ≥18 years with severe CRSwNP and uncontrolled asthma (defined as 5-item Asthma Control Questionnaire [ACQ-5] score ≥1.5) received background intranasal and inhaled corticosteroids and a second asthma controller ( long-acting β2-agonist/leukotriene receptor antagonist) and were randomized 1:1 to receive dupilumab 300 mg q2w (n=181) or omalizumab 75-600 mg q2w/q4w (n=179). The anosmia subgroup included patients with baseline University of Pennsylvania Smell Identification Test scores ≤18 (range 0-40). At Week 24, estimated mean changes from baseline in nasal polyp score (NPS; range 0-8), loss of smell (LoS) score (range 0-3), pre-bronchodilator forced expiratory volume in 1 second (FEV1), and ACQ-5 score (range 0-6) were evaluated.
RESULTS: Of 360 patients evaluated for anosmia, 324 (90%) were anosmic at baseline. Of these, 166 received dupilumab, and 158 received omalizumab. At Week 24, dupilumab vs omalizumab reduced NPS (least squares mean difference [95% CI]: -1.75 [-2.12, -1.39]) and LoS score (-0.87 [-1.08, -0.66]), increased pre-bronchodilator FEV₁ (0.18 L [0.07, 0.29]), and reduced ACQ-5 score (-0.54 [-0.75, -0.33]).
CONCLUSIONS: In patients with severe CRSwNP and uncontrolled, coexisting asthma who were anosmic at baseline, dupilumab treatment resulted in greater improvements than omalizumab in nasal polyp burden, LoS severity, lung function, and asthma control over 24 weeks.
METHODS: Patients aged ≥18 years with severe CRSwNP and uncontrolled asthma (defined as 5-item Asthma Control Questionnaire [ACQ-5] score ≥1.5) received background intranasal and inhaled corticosteroids and a second asthma controller ( long-acting β2-agonist/leukotriene receptor antagonist) and were randomized 1:1 to receive dupilumab 300 mg q2w (n=181) or omalizumab 75-600 mg q2w/q4w (n=179). The anosmia subgroup included patients with baseline University of Pennsylvania Smell Identification Test scores ≤18 (range 0-40). At Week 24, estimated mean changes from baseline in nasal polyp score (NPS; range 0-8), loss of smell (LoS) score (range 0-3), pre-bronchodilator forced expiratory volume in 1 second (FEV1), and ACQ-5 score (range 0-6) were evaluated.
RESULTS: Of 360 patients evaluated for anosmia, 324 (90%) were anosmic at baseline. Of these, 166 received dupilumab, and 158 received omalizumab. At Week 24, dupilumab vs omalizumab reduced NPS (least squares mean difference [95% CI]: -1.75 [-2.12, -1.39]) and LoS score (-0.87 [-1.08, -0.66]), increased pre-bronchodilator FEV₁ (0.18 L [0.07, 0.29]), and reduced ACQ-5 score (-0.54 [-0.75, -0.33]).
CONCLUSIONS: In patients with severe CRSwNP and uncontrolled, coexisting asthma who were anosmic at baseline, dupilumab treatment resulted in greater improvements than omalizumab in nasal polyp burden, LoS severity, lung function, and asthma control over 24 weeks.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO38
Topic
Clinical Outcomes, Patient-Centered Research
Topic Subcategory
Clinical Outcomes Assessment, Clinician Reported Outcomes, Comparative Effectiveness or Efficacy
Disease
Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)