Baseline disease characteristics by surgery history among patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the global AROMA registry

Abstract

Purpose

The global Assessing long-teRm Outcomes in dupiluMAb (AROMA) registry study aims to characterize the long-term, real-world use of dupilumab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This paper reports interim analysis of the baseline characteristics for the first 303 patients enrolled in AROMA.

Methods and materials

AROMA is currently ongoing in adult patients with CRSwNP who initiated dupilumab for up to 36 months. This interim analysis describes baseline demographics; systemic/oral corticosteroid (SCS/OCS) and antibiotic use; disease burden; healthcare resource utilization; and medical history. All outcomes are summarized descriptively.

Results

As of February 2023, AROMA had enrolled 303 patients; 61.7 % had ≥1 prior surgery and 38.3 % were surgery naive. Disease burden at baseline was greatest among patients with prior surgery vs the surgery-naive group: 72.2 % vs 62.9 % had used SCS/OCS, mean University of Pennsylvania Smell Identification Test scores were 10.9 vs 19.2, 31.0 % vs 27.6 % of patients reported severe symptoms, and 47.6 %/16.6 % vs 39.7 %/16.4 % of patients were classified as having severe/very severe disease according to global physician assessment scores. Otolaryngologist/ear, nose, throat and allergist/immunologist were the most common specialties seen regularly by CRSwNP patients (52.8 % and 48.2 %, respectively) and surgery-naive patients were more likely to have visited an allergist than those with prior surgery (66.4 % vs 36.9 %).

Conclusions

Patients with CRSwNP in AROMA show considerable disease burden at baseline prior to treatment. Those with prior surgery had worse olfaction and an overall worse burden of disease.

Plain language summary

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a condition characterized by at least 12 weeks of symptoms such as nasal congestion and loss of smell, along with the presence of nasal polyps. Treatment for CRSwNP includes intranasal steroids, but if these cannot control disease, systemic steroids or sinus surgery may be required. Systemic steroids have known side effects and only provide temporary symptom improvement. Following surgery, patients may experience both symptom and polyp recurrence. Dupilumab is a monoclonal antibody that is approved for the treatment of inadequately controlled CRSwNP and can improve disease symptoms such as nasal congestion and loss of smell. This article presents the initial findings from a large global study called AROMA, which observes patients in real-world medical practice for 3 years after initiating dupilumab for CRSwNP. This analysis compares the characteristics of those in the registry who had and had not undergone prior sinonasal surgery for CRSwNP. In this analysis, patients who had previously undergone surgery to remove nasal polyps were more likely to have used steroids for CRSwNP treatment and were in worse health because of their CRSwNP condition despite having similar severity of symptoms at baseline.