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The ProVENT data highlight dupilumab’s efficacy in treating severe asthma, with improvements in control, quality of life, and exacerbations being observed.
Dupilumab therapy for patients living with severe asthma leads to long-lasting improvements in lung function, asthma control, quality of life, and exacerbation reductions, new findings suggest, with remission being observed in over half of those treated within 1 to 2 years.1
This data were presented at the American Thoracic Society (ATS) International Conference in the poster titled ‘Severe Asthma After 2 Years of Dupilumab Therapy: Real-world Data From the ProVENT Study.’ The research was presented by Henrik Watz, MD, PhD, the medical director at Velocity Clinical Research Grosshansdorf in Grosshansdorf, Germany.
Watz and coauthors continue to be involved in the ongoing ProVENT study, with the analysis having a multi-center, prospective, non-interventional observational design. The investigators looked at the real-world implementation of dupilumab as a treatment for individuals with severe asthma across Austria, Germany, and Switzerland.
Since the ProVENT study’s initiation in February 2020, there have been 412 study subjects with severe asthma involved in the analysis who are also receiving dupilumab as medication. To date, 399 participants’ data have been evaluated by Watz et al from the point of baseline, 185 following a single year of the treatment’s use, and 100 following 2 years.
The investigators highlighted that 3% of the trial participants were aged 18 years or younger and that women made up 53% of the cohort. Additionally, the median patient age was 56 years, and 65% were non-smokers. 60% of these individuals had at least a single comorbidity associated with type 2 inflammation, and 84% were shown not to have received biologic therapies in the preceding 2-year timespan.
Biomarker evaluations by the investigative team demonstrated that Fractional Exhaled Nitric Oxide (FeNO) and blood eosinophil levels were recorded in 80% and 63% of trial participants, respectively, prior to their beginning treatment with dupilumab. Over the course of their treatment, the subjects’ measurements were less frequent, taken in only 34% (FeNO) and 10% (eosinophils).1
Normalization of participants’ FeNO levels to below 25 ppb was observed in the ProVENT study after the initial follow-up interaction. Levels were consistently shown to be low through 2 years of treatment with dupilumab.
Over the course of the 2-year timeframe, those included as participants were shown by Watz and coauthors to have notable and sustained asthma control improvements. They highlighted a decrease in median score on the 5-item Asthma Control Questionnaire (ACQ-5) from 2.6 to 0.9, along with a rise in Asthma Control Test (ACT) scores from a median of 15 to 22.
Additionally, patients’ lung function, assessed via median forced expiratory volume in one second (FEV₁), showed improvement from 2.25 liters to 2.52 liters following 3 months of therapy. Function remained stable, with a median of 2.51 liters following 2 years.
Watz and colleagues found that participants’ Asthma Quality of Life Questionnaire (AQLQ) scores rose from a median of 5.25 to 6.25, suggesting life quality upticks. Before dupilumab use, all participants had experienced at least a single asthma exacerbation in the prior 2 years, with a median of 2 such events. After treatment, 89% of ProVENT participants remained exacerbation-free at both the 1- and 2-year marks.
Asthma remission—which the investigative team defined as an ACT score of ≥20 or an ACQ score of ≤1.5, the absence of exacerbations or systemic corticosteroid utilization, and either FEV₁ ≥80% of predicted or an FEV₁ decline ≤5% of predicted—was attained by 56% of trial subjects after 1 year and 58% after 2 years.
The team further highlighted the consistency of safety outcomes with those reported in the clinical registration trials of dupilumab.
For additional information on data presented at ATS 2025, view our latest conference coverage.
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