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Dupilumab effectiveness and safety in patients with chronic rhinosinusitis with nasal polyps: Two-year results from
Anju T Peters1, Andrew A White2, Shigeharu Fujieda3
1Allergy-Immunology Division and the Sinus and Allergy Center, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Background:
Chronic rhinosinusitis with nasal polyps (CRSwNP) has a high symptom burden and severely impairs health-related quality of life. Dupilumab significantly reduced symptoms in phase 3 clinical trials, but evidence from real-world practice is limited.
Objective:
To investigate the long-term effectiveness and safety of dupilumab in patients with CRSwNP in a real-world setting for up to 36 months.
Methods:
The Assessing long-teRm Outcomes in dupiluMAb (AROMA) study (NCT04959448) is a phase 4, prospective, global registry study of adults with CRSwNP who are initiating dupilumab in real-world practice.
Results:
As of May 2024, 691 patients initiated dupilumab, of whom 69.2% had asthma and 74.1% had undergone previous sinonasal surgery. Overall, 40.7% of patients had been prescribed antibiotics for CRSwNP, and 65.8% had been prescribed oral/systemic corticosteroids for CRSwNP in the 2 years before dupilumab initiation. The mean (SD) nasal congestion score (range 0-3) decreased from 1.8 (0.86) at baseline to 0.5 (0.66) at month (M) 24, with improvements observed at M3. Similar improvements were seen with the mean (SD) loss of smell score (range 0-3), decreasing from 2.2 (1.06) at baseline to 0.9 (0.96) at M24, and the 22-item Sino-Nasal Outcome Test (range 0-110), decreasing from 45.9 (21.37) at baseline to 18.4 (14.55) at M24. In the first 6 months, 20.7% of patients reported at least 1 treatment-emergent adverse event.
Conclusion:
In the AROMA global CRSwNP registry, dupilumab rapidly improved symptoms and health-related quality of life, with continued improvements through 24 months of follow-up. These results support dupilumab's long-term effectiveness and safety in CRSwNP in real-world clinical practice.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04959448.
