(409) Dupilumab effectiveness through 24 months in patients from the United States with CRSwNP enrolled in the global AROMA registry

Wednesday, October 29, 2025

Presenter(s)

Louis Hudspeth

Director, Medical Value & Outcome, North America Medical Affairs.
Cambridge, Massachusetts, United States

Primary Author(s)

Davis J. C, n/a

Otolaryngologist
MD
Birmingham, Alabama, United States

Co-Author(s)

Miguel Lanz, MD

Allergy & Asthma Specialist
AAADRS Clinical Research Center
Coral Gables, Florida, United States
Njira Lugogo, MD

Clinical Associate Professor
Michigan Medicine, University of Michigan
Ann Arbor, Michigan, United States
Laurie McWilliams, n/a

Immunology specialist
Physician
Raleigh, North Carolina, United States
Changming Xia, Dr.

Associate Director, Statistics
Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
Tarrytown, New York, United States
Mark Corbett, n/a

Senior Medical Affairs Director Lead Rhinology and Allergy
Senior Medical Affairs Director Lead Rhinology and Allergy
Morristown, New Jersey, United States
Scott Nash, MD

Director, Medical Affairs Immunology
Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
Tarrytown, New York, United States

Background: : AROMA (NCT04959448), a phase 4 global registry study, recruited patients initiating dupilumab for chronic rhinosinusitis with nasal polyps (CRSwNP) in real-world clinical practice. Here, we provide a summary of the baseline characteristics and effectiveness of dupilumab treatment in patients from the United States (US) in the AROMA study through 24 months.

Objective: : To report the long-term effectiveness of dupilumab in patients from the US with CRSwNP enrolled in the global AROMA registry (NCT04959448).

Methods: : AROMA enrolled adults with CRSwNP initiating dupilumab in real-world clinical practice, monitoring them for up to 36 months (M).

Results: : AROMA enrolled a total of 691 patients, with 370 patients enrolled within the US. Mean (SD) age was 48.6 (14.00) years, 46.5% were male, and 70.5% were white. Nasal congestion scores (range 0–3) decreased from mean 1.6 (SD 0.87; n=325) at baseline, to 0.9 (0.79; n=280) at M3, 0.8 (0.78; n=172) at M12, 0.8 (0.74; n=96) at M18, and 0.7 (0.74; n=44) at M24. Loss of smell scores (range 0–3) decreased from mean (SD) 1.9 (1.17; n=325) at baseline, to 1.0 (1.05; n=280) at M3, 0.9 (1.06; n=172) at M12, 0.9 (1.06; n=96) at M18, and 1.1 (0.98; n=44) at M24. 22-item sino-nasal outcome test scores (range 0–110) changed from mean (SD) 41.8 (21.15; n=288) at baseline, to 21.1 (15.53; n=218) at M3, 17.0 (15.68; n=107) at M12, 17.4 (16.29; n=40) at M18, and 22.2 (15.72; n=19) at M24. Patients reporting “no symptoms” on the global patient assessment were 4.6% (n=13) at baseline, 29.1% (n=66) at M6, 33.1% (n=45) at M12, 33.3% (n=18) at M18, and 30.4% (n=7) at M24.

Conclusions: : For patients from the US in the global AROMA registry, dupilumab initiation rapidly improved disease severity, assessed by patient-reported outcomes and maintained up to 24M-’ follow-up. Patients in the US in AROMA had less severe CRSwNP disease at baseline compared with patients in pivotal SINUS-24/52 phase 3 trials.

Sponsorship:: Research sponsored by Regeneron Pharmaceuticals Inc. and Sanofi. Medical writing assistance provided by Sean Booth, MRes, of Adelphi Group, Macclesfield, UK, funded by Regeneron Pharmaceuticals Inc. and Sanofi according to the Good Publication Practice guidelines. Editorial assistance was provided by Ann Joy, M Pharm of Sanofi.