Comparative effectiveness of biologics in lung function improvement among patients with severe asthma: a real-world study

Biologics have demonstrated lung function improvement in clinical trials. However, real-world comparative effectiveness data from European countries are limited. This real-world study compared lung function improvements with dupilumab and other biologics across five European Union (EU) countries in patients with severe asthma (SA). The EU-ADVANTAGE was a retrospective chart review study conducted in patients (aged ≥ 12 years) with SA who initiated a biologic (dupilumab, omalizumab, benralizumab or mepolizumab) between May 2019 and February 2022 (index date). Patients with at least one record of pre-bronchodilator (BD) or post-BD forced expiratory volume in 1s (FEV1) available within 12-month pre- and post-index periods were analysed. Inverse probability of treatment weighting (IPTW) was applied to balance baseline characteristics between treatments. Improvements in percent predicted FEV1 (ppFEV1) within 12 months after biologic initiation were assessed in those with either pre- or post-BD FEV1, using doubly robust linear regression. A total of 845 patients had pre-BD ppFEV1 and 557 had post-BD ppFEV1 data in both pre- and post-index periods, respectively. After IPTW, several baseline characteristics were balanced (standardised mean difference < 10%), and residual confounding was accounted for using doubly robust linear regression. Based on regression analysis, dupilumab-treated patients achieved a greater improvement in pre-BD ppFEV1 than those treated with omalizumab (Δ5.25%; 95% confidence interval [CI], 3.02–7.49; p < 0.0001), benralizumab (Δ3.23%; 95% CI, 0.03–6.43; p = 0.048), or mepolizumab (Δ3.29%; 95% CI, 0.33–6.24; p = 0.029) within 12 months. Similar differences were observed in post-BD ppFEV1 (p < 0.05). Patients with SA initiating dupilumab had a greater lung function improvement than those initiating omalizumab, benralizumab or mepolizumab within EU clinical practice.