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Efficacy and Safety of Dupilumab Versus Omalizumab in Patients
With Severe CRSwNP and Coexisting Asthma (EVEREST):
Results From a First, Prospective, Head-to-Head Phase 4 Trial

De Corso E, et al. EAACI. 2025. Oral presentation.

Study design

Safety

Safety profiles of dupilumab and omalizumab were comparable and consistent with known profiles (study-related TEAEs, 19.6% and 21.4%; serious TEAEs, 1.7% and 4.0%; discontinuations due to TEAEs, 2.8% and 1.2%, respectively; with no deaths occurring during the study).

aPatients from 17 countries in North America and Europe participated in this study. bAccording to the GINA 2020 guidelines. BL, baseline; EAACI, European Academy of Allergy and Clinical Immunology; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroids, LS, least-squares; LSMD, least-squares mean difference; MFNS, mometasone furoate; NP, nasal polyp; NPS, nasal polyp score; NSAID-ERD, nonsteroidal anti-inflammatory drug–exacerbated respiratory disease; q2w, every 2 weeks; q4w, every 4 weeks; R, randomization; SC, subcutaneous; SCS, systemic corticosteroids; TEAE, treatment-emergent adverse event; UPSIT, University of Pennsylvania Smell Identification Test. De Corso E, et al. EAACI. 2025. Oral presentation.

Secondary end points

Asthma-related end points

Summary

In EVEREST, dupilumab demonstrated superiority over omalizumab for all outcomes prespecified in the testing hierarchy in patients with severe CRSwNP and coexisting asthma. Safety profiles were comparable.

aThe following secondary end points were included in the multiplicity adjustment scheme and tested in the following order: Change from BL to Week 24 in (1) LoS, (2) NCS, (3) TSS. bDupilumab vs omalizumab LSMD at Week 24. cEnd points not included in multiplicity adjustment hierarchy; P-values are nominal. ACQ-7, 7-item asthma control questionnaire; BD, bronchodilator; BL, baseline; EAACI, European Academy of Allergy and Clinical Immunology; FEV1, forced expiratory volume in 1 second; LoS, loss of smell; LS, least-squares; LSMD, least-squares mean difference; NCS, nasal congestion score; PNIF, peak nasal inspiratory flow; r-VAS; rhinosinusitis visual analog scale; SNOT-22, 22-item Sinonasal Outcomes Test; TSS, total symptom score. De Corso E, et al. EAACI. 2025. Oral presentation.

MAT-BH-2600330 – 1.0 – 06/2026