Baseline disease characteristics among patients with chronic rhinosinusitis with nasal polyps in AROMA: A global registry study.

Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammatory disease of the nasal and paranasal sinuses. In phase III clinical trials, dupilumab significantly improved objective and patient-reported measures of CRSwNP versus placebo. However, a real-world evidence gap exists between efficacy and effectiveness data for dupilumab in CRSwNP, particularly in the United States. Objective: Assessing Long-teRm Outcomes of dupiluMAb Treatment in Adult Patients With CRSwNP (AROMA) aims to characterize patients who receive dupilumab for CRSwNP in a real-world setting and evaluate long-term effectiveness. Methods: AROMA is a prospective global registry study that is recruiting adult patients with uncontrolled CRSwNP who were initiating dupilumab and following them for up to 36 months. Baseline demographics and disease characteristics were assessed for all patients entering the registry. Results: As of February 2023, the study had recruited 303 patients of a target enrollment of 700, with a mean age of 50.8 years, and 57.1% were recruited in the United States. A history of asthma was reported in 70.6% of the patients and a history of allergic rhinitis in 70.6% of the patients. In the 24 months before enrollment, 61.7% of the patients had at least one sinonasal surgery and 68.6% used systemic corticosteroids. At baseline, 35.0% of the patients were receiving intranasal corticosteroids and 33.3% were receiving leukotriene receptor antagonists. In the Global Patient Assessment, 31.7% and 29.7% of the patients reported moderate and severe CRSwNP symptoms, respectively, during the past week. Conclusion: Patients in AROMA had a high disease burden in terms of symptoms, comorbidities, and treatment burden. Nearly two-thirds of patients with CRSwNP had at least one sinonasal surgery before initiating dupilumab.Clinical trial NCT04959448 (AROMA), www.clinicaltrials.gov.