Efficacy and safety of dupilumab as add-on therapy for patients with severe asthma: A real-world Dutch cohort study

Background: Dupilumab as add-on treatment for severe uncontrolled asthma (SA) has shown to be effective and safe by phase-III-trials. Real-world data on clinical efficacy and safety is limited.

Objective: We aim to investigate the efficacy and safety of dupilumab as add-on therapy for SA in a real-world cohort.

Material and methods: The primary endpoint was annually exacerbation-rate (AER). Secondary outcomes were maintenance oral corticosteroid (mOCS) dependency, asthma control (ACQ-5), pulmonary function (FEV₁), quality of life (AQLQ) and frequency of reported adverse events (AEs).

Results: Overall, 148 patients were included. Median AER [IQR] reduced from 4.00 [2.00-5.00] at baseline to 1.00 [0.00-2.00] at 12 months (p < 0.001). mOCS-dependency reduced from 39.9% of the patients at baseline, to 20.3% at 6 months and to 14.9% at 12 months (p < 0.001). Median ACQ improved from 3.00 [2.00-3.80] at baseline to 1.80 [0.60-2.95] after 6 months and to 1.40 [0.20-2.60] after 12 months (p < 0.001). Median FEV₁ (L) improved from 2.21 [1.58-2.85] to 2.50 [2.00-3.06] at 6 months and to 2.51 [1.88-3.04] after 12 months (p < 0.001). The outcomes improved most in subgroups with high eosinophils (≥300/μL) or FeNO (≥50 ppb) at baseline. AEs were reported by 45.3% (67/148), of which headache was most frequent.

Conclusions: This study indicates that dupilumab as add-on therapy for SA is associated with significant improvements in exacerbation-rate, mOCS-dependency, asthma control, pulmonary function, and quality of life. These results are in line with those of previous phase-III-trials.