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

Arnaud Bourdin; Giorgio Walter Canonica; Johann Christian Virchow; Kinga Borsos; Richard H Stanford; Olivier Ledanois; Jason Kwah; Wenzhen Ge; Lynn Huynh; Mei Sheng Duh; Andra-Ecaterina Boca; Wei-Han Cheng; Aakash Gandhi

doi:10.1186/s12931-026-03515-7

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

Respir Res. 2026 Feb 4;27(1):67. doi: 10.1186/s12931-026-03515-7.

Authors

Affiliations

¹ Department of Respiratory Diseases, CHU Montpellier, University of Montpellier, INSERM, CNRS, PhyMedExp, Montpellier, France.
² Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center, IRCCS, Milan, Italy.
³ Clinic for Pneumology, Allergology, Intensive Care Medicine, Department for Internal Medicine, Universitätemedizin Rostock, Rostock, Germany.
⁴ Sanofi, Cambridge, MA, USA.
⁵ AESARA Inc, Chapel Hill, NC, USA.
⁶ Sanofi, Paris, France.
⁷ Regeneron Pharmaceuticals Inc., Sleepy Hollow, NY, USA.
⁸ Analysis Group Inc., Boston, MA, USA.
⁹ Sanofi, Cambridge, MA, USA. aakash.gandhi@sanofi.com.

Abstract

Background: 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).

Methods: 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.

Results: 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).

Conclusions: Patients with SA initiating dupilumab had a greater lung function improvement than those initiating omalizumab, benralizumab or mepolizumab within EU clinical practice.

Supplementary Information: The online version contains supplementary material available at 10.1186/s12931-026-03515-7.

Keywords: Biologics; Dupilumab; EU-ADVANTAGE; FEV1; Lung function; Real world; Severe asthma.