Real-world comparative effectiveness of biologic therapies in severe asthma: EU-ADVANTAGE.

Abstract

Background: In Europe, although multiple biologics have been approved for the treatment of severe asthma (SA), comparative data from real-world settings remain limited. This study compared the real-world effectiveness of dupilumab with that of omalizumab, benralizumab and mepolizumab in European patients with SA.

Methods: In the EU-ADVANTAGE study, physicians from France, Italy, Germany, Spain and the Netherlands were recruited to review medical charts of patients (aged ≥12 years) who had physician-confirmed SA and initiated dupilumab, omalizumab, benralizumab or mepolizumab (index) between May 2019 and February 2022. Patients with ≥12 months of pre- and post-index records were included. Differences in baseline covariates were balanced with inverse probability of treatment weighting (IPTW) between dupilumab and other biologics. Reductions in SA exacerbations and oral corticosteroid (OCS) prescriptions during the 12-month post-index period were estimated using a doubly robust regression.

Results: A total of 2739 patients met all study criteria; 1281, 638, 406 and 414 received dupilumab, omalizumab, benralizumab and mepolizumab, respectively. After IPTW, the majority of baseline covariates were balanced (standardised difference <10%) between dupilumab and other biologics in a pairwise manner. After regression, dupilumab was associated with a lower risk of SA exacerbations during the 12-month post-index period, as follows: 22% versus omalizumab, 35% versus benralizumab and 23% versus mepolizumab. Additionally, dupilumab significantly reduced OCS prescriptions by 25% versus omalizumab, 27% versus benralizumab and 21% versus mepolizumab.

Conclusions: The findings suggest that dupilumab may reduce severe exacerbations and OCS use in patients with SA better than omalizumab, benralizumab and mepolizumab in European real-world settings.