Real-world, long-term effectiveness of dupilumab treatment in patients with severe asthma: 2 years of the ProVENT study

Background Randomized controlled trials have shown clinical efficacy of dupilumab in patients with severe asthma. However, the long-term effectiveness of dupilumab treatment for asthma in real-life is incompletely understood. Methods ProVENT (NIS-Nr.: 514; study code: OBS16379) is a non-interventional, prospective, 3-year study in patients aged ≥12 years with severe asthma receiving dupilumab per routine clinical care in Austria, Germany, and Switzerland. This interim analysis of ProVENT assessed lung function, asthma control, quality of life, biomarkers, and clinical remission, over the first 2 years in the study. Safety outcomes will be presented in the final analysis. Results 421 patients were screened, and of the 399 patients enrolled in ProVENT, 259 had ≥1 post-baseline assessments and 100 had documented data after 24 months of treatment. At month 24, mean (standard deviation [SD]) improvement from baseline was 0.24 L (0.46) for pre-bronchodilator forced expiratory volume in 1 second (FEV 1 ); 10.10% (15.80) for pre-bronchodilator percent predicted FEV 1 ;-0.96 (1.24) for 5-item Asthma Control Questionnaire score (ACQ-5); 4.4 (5.4) for Asthma Control Test score (ACT); and 0.61 [1.3] for Standardized Asthma Quality of Life Questionnaire overall score (AQLQ[S]). Blood eosinophils, fractional exhaled nitric oxide (FeNO), and total serum immunoglobulin E (IgE) decreased by month 24. Among patients with available data, clinical remission rates were 55.9% at year 1 and 58.0% at year 2. Conclusion In real-world patients with severe asthma, long-term dupilumab treatment is associated with sustained improvements in lung function, asthma control, and quality of life. Nearly 60% of patients achieved clinical asthma remission after 2 years.