D1.148 - Real-world effectiveness of dupilumab administered every 4 weeks in patients with moderate to severe asthma

Dupilumab, an anti-interleukin-4 receptor α monoclonal antibody, is a potential add-on therapy for patients with uncontrolled severe asthma, with a recommended dosing interval of every 2 weeks. However, real-world evidence regarding the clinical outcomes of an extended 4-week dosing interval remains limited.

From January 2019 to December 2025, the medical records of adult patients with moderate to severe asthma treated with dupilumab for more than six months were reviewed retrospectively. Clinical responses were evaluated at 3, 6, and 12 months after treatment initiation. Longitudinal changes in lung function and Asthma Control Test (ACT) were analyzed using linear mixed-effects models with time as a fixed effect and subject as a random intercept. Annualized severe exacerbation rates and systemic corticosteroid (OCS) requirements during the 12 months before and after dupilumab initiation were compared using paired nonparametric tests.

A total of 26 patients were included. Dupilumab administered every 4 weeks was associated with significant improvements in lung function, with a median increase in FEV₁ of 6.5% (IQR 1.75-12; p =0.002) and 130 mL (IQR 0-280 mL; p=0.008), as well as a clinically meaningful median increase in ACT score of 7.5 points at 12 months (overall time effect, p<0.001). The annualized rate of severe exacerbations significantly decreased after treatment compared with the preceding year (Z = -3.345, p < 0.001). Annualized OCS use was also significantly reduced following dupilumab initiation (Z = -3.462, p < 0.001), indicating a marked steroid-sparing effect.

In this real-world cohort, dupilumab administered at a 4-week interval was associated with sustained improvements in lung function and asthma control, along with reductions in exacerbations and OCS use. These findings suggest that extended dosing intervals may be a feasible treatment option for selected patients with moderate to severe asthma, although further comparative studies are warranted.