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

Published:November 26, 2022DOI:https://doi.org/10.1016/j.rmed.2022.107058

      Highlights

      • Phase-III-trials have shown that dupilumab in severe asthma (SA) is effective and safe. Real-world data on clinical efficacy and safety is limited.
      • This real-world study indicates that dupilumab in SA leads to less asthma exacerbations, decreased oral corticosteroid use, and better asthma control.
      • Most benefits were seen in patients with high eosinophils and FeNO. Dupilumab also proved a safe treatment with infrequent, mild side effects.
      • Therefore, this study implies that the results of the phase-III-trials translate well to daily clinical practice.

      Abstract

      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.

      Keywords

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