Real-World Effectiveness of Dupilumab 200mg Dose in Oral Corticosteroid Reduction and Exacerbation in patients with severe asthma: findings from the EU-ADVANTAGE study

Abstract

Introduction and Objectives Dupilumab has been approved in Europe for treating severe asthma (SA) characterised by type 2 inflammation. We assessed the association between the use of dupilumab 200mg and the reduction in oral corticosteroid (OCS) use and exacerbations among patients with SA across five EU countries in real-world settings. Methods In the EU-ADVANTAGE study, physicians from France, Germany, Italy, Spain, and the Netherlands retrospectively reviewed medical records of patients (aged >=12 years) who had physician-confirmed SA and initiated dupilumab (index) between May 2019 and February 2022. Patients who received dupilumab 200mg as the maintenance dose were included in this analysis. OCS use (numbers of distinct prescriptions and daily dose) and SA exacerbation defined as either systemic corticosteroid use for >=3 and =150 cells/muL and 95.7% had FeNO >=25 ppb at baseline (both biomarkers elevated: 94.5%). During the post-index period, Poisson regression demonstrated a 71% reduction in SA exacerbation rate (IRR 0.29, 95%CI: 0.23-0.37, p=5mg and >6 months) during the pre-index period. The mean annualised daily mOCS dose per patient- -calculated from the cumulative dose divided by 365 days/ follow-up time-was significantly decreased (p<0.001) from 11.38mg to 0.44mg (median: 4.38mg to 0mg) during the post-index compared to the pre-index period. mOCS users (n=36) further exhibited a reduction in the annualised rate of SA exacerbations per patient, from 2.06 at the pre-index to 0.42 at the post-index, representing an 80% reduction (IRR 0.20, 95%CI: 0.11-0.39, p<0.0001). Conclusions Our analysis revealed a significant reduction in SA exacerbations and mOCS dose among SA patients who received dupilumab 200mg. However, results should be interpreted cautiously owing to the small sample size.