EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients
Summary
Primary Objective -To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell Secondary Objectives * To evaluate the efficacy of dupilumab in improving chronic rhinosinusitis with nasal polyps (CRSwNP) symptoms at Week 24 compared to omalizumab * To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab * To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab * To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab * To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab * To evaluate the safety of dupilumab and omalizumab
Timeline
- Start
- 2021-09-27
- Primary completion
- 2024-10-16
- Completion
- 2024-12-27
Outcome
Met primary endpoint
paper Improvements were significantly greater with dupilumab than omalizumab for all primary and secondary efficacy endpoints at week 24. PMID 41033334 ↗
paper Least squares mean differences in change from baseline dupilumab over omalizumab were: nasal polyp score -1·60 (95% CI -1·96 to -1·25; p<0·0001) PMID 41033334 ↗
paper and UPSIT 8·0 (6·3 to 9·7; p<0·0001). PMID 41033334 ↗
Publications
- De Corso E, Canonica GW, Heffler E, Springer M, Grzegorzek T, Viana M, Horvath Z, Mullol J, Gevaert P, Michel J, Peters AT, Wagenmann M, Zaghloul S, Zhang M, Corbett M, Nash S, Angello JT, Radwan A, Deniz Y, Martin A, Hellings PW. Dupilumab versus omalizumab in patients with chronic rhinosinusitis with nasal polyps and coexisting asthma (EVEREST): a multicentre, randomised, double-blind, head-to-head phase 4 trial. Lancet Respir Med. 2025 Dec;13(12):1067-1077. doi: 10.1016/S2213-2600(25)00287-5. Epub 2025 Sep 28.
- De Prado Gomez PharmD MSc L, Khan Mbbs Mph AH, Peters Md AT, Bachert Md PhD C, Wagenmann Md M, Heffler Md PhD E, Hopkins BMBCh C, Hellings Md PhD PW, Zhang PhD M, Xing PhD J, Rowe Md P, Jacob-Nara Md Mph DHSc JA. Efficacy and Safety of Dupilumab Versus Omalizumab in Chronic Rhinosinusitis With Nasal Polyps and Asthma: EVEREST Trial Design. Am J Rhinol Allergy. 2022 Nov;36(6):788-795. doi: 10.1177/19458924221112211. Epub 2022 Jul 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | Omalizumab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Omalizumab | Monoclonal antibody | 600 mg | Subcutaneous |