Real-World Effectiveness of Dupilumab in Patients with Severe Asthma in Europe: Findings from the EU-ADVANTAGE Study.

BACKGROUND

Dupilumab is approved in Europe for severe asthma (SA) characterized by type 2 inflammation. However, real-world effectiveness data from European countries are limited. EU-ADVANTAGE study aimed to evaluate the real-world effectiveness of dupilumab across five European Union (EU) countries: France, Germany, Italy, the Netherlands, and Spain.

METHODS

This retrospective chart review study leveraged patient medical records captured by physicians within their clinical practice across 5 EU countries. Patients (≥12 years) with physician-confirmed SA who initiated dupilumab (index) between May 2019 and February 2022 and had 12 months of pre- and post-index data were included. SA exacerbations, oral corticosteroid (OCS) prescriptions, and healthcare resource utilization were compared between the 12-month pre- and post-dupilumab initiation. Poisson regression models with robust variance were used to estimate incidence rate ratios (IRRs) for SA exacerbations and OCS prescriptions, after adjusting for COVID-19 and seasonality.

RESULTS

Overall, 1,281 patient records (mean±standard deviation age, 46.0±15.6 years; males, 61.4%) were extracted by 547 physicians. Most patients (91.3%) were biologic naïve before dupilumab initiation. A significant 50% reduction in SA exacerbations (IRR, 0.50; 95%CI, 0.41-0.61) was observed post-dupilumab initiation despite a concurrent 68% reduction in OCS prescriptions (IRR, 0.32; 95%CI, 0.25-0.41) (both P<0.001). Consistent reductions were observed in patients with type 2 inflammatory subgroup. Overall, 9.2% and 3.1% of patients had ≥1 hospitalization during the pre- and post-dupilumab initiation, respectively.

CONCLUSIONS

In this retrospective study, dupilumab was associated with a significant reduction in SA exacerbations and OCS prescriptions, confirming its utility in routine clinical settings.