Real-World Findings From the Provent Study of Dupilumab Therapy for Severe Asthma: 2-Year Analysis
Author(s)
Marek Lommatzsch, Prof. Dr.1, Stephanie Korn2, Olaf Schmidt, Dr.3, Hartmut Timmermann, Dr.4, Monika Gappa, Dr.5, Henrik Watz, Dr.6, Jason Kwah, MD PhD7, Olivier LEDANOIS, Dr.8, Nicole Nischan, Dr.9, Matthias Hahn, Dr.10, Andreas Heimann, Dr.10.
1University of Rostock, Rostock, Germany, 2IKF Pneumologie Mainz, Germany, 3Pneumologie Mittelrhein, Bendorf, Germany, 4Pneumologicum, Hamburg, Germany, 5Children’s Hospital, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany, 6Velocity Clinical Research, Ahrensburg, Germany, 7Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA, 8Sanofi, Paris, France, 9Sanofi, Berlin, Germany, 10Sanofi, Frankfurt, Germany.
1University of Rostock, Rostock, Germany, 2IKF Pneumologie Mainz, Germany, 3Pneumologie Mittelrhein, Bendorf, Germany, 4Pneumologicum, Hamburg, Germany, 5Children’s Hospital, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany, 6Velocity Clinical Research, Ahrensburg, Germany, 7Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA, 8Sanofi, Paris, France, 9Sanofi, Berlin, Germany, 10Sanofi, Frankfurt, Germany.
OBJECTIVES: To report the impact of dupilumab on asthma control, quality of life (QoL), exacerbations, and remission in patients with severe uncontrolled asthma.
METHODS: ProVENT is a prospective, non-interventional study of real-world dupilumab therapy for patients aged ≥12 years with severe uncontrolled asthma in Germany, Austria, and Switzerland. ProVENT enrolled 399 patients; here, we report outcomes in 100 patients who completed 2 years in the study.
RESULTS: At baseline, the median age was 56 years, 53% were female patients, and all patients had experienced exacerbations in the 2 years prior to enrollment. Asthma control was measured using the 5-item Asthma Control Questionnaire (ACQ-5) and Asthma Control Test (ACT). Asthma control improved steadily during the 2 years. Median ACQ-5 and ACT values at baseline, Year 1, and Year 2 timepoints were 2.6, 1.1, and 0.9, and 14, 21, and 22, respectively. QoL was measured using the Asthma Quality of Life Questionnaire (AQLQ). Median QoL increased from 5.3 at baseline to 6.3 at both Year 1 and Year 2. After 2 years of dupilumab treatment, most patients with severe asthma no longer experienced any exacerbations (89% at both Year 1 and Year 2 timepoints, respectively). Asthma remission was defined as no oral corticosteroid use, no exacerbations, ACT ≥20 or ACQ ≤1.5, and improved or stable lung function (pre-bronchodilator ppFEV1 ≥80% or decrease in FEV1 ≤ 5% compared with baseline). During this 2-year analysis, over half of the patients in the study achieved remission (56% at Year 1 and 58% at Year 2 timepoints). Safety findings were aligned with previous studies.
CONCLUSIONS: In this real-world study, patients initiating dupilumab and followed for 2 years showed improved asthma control, better quality of life, and reduced asthma exacerbations. These findings may contribute to lower healthcare utilization in patients with severe asthma.
METHODS: ProVENT is a prospective, non-interventional study of real-world dupilumab therapy for patients aged ≥12 years with severe uncontrolled asthma in Germany, Austria, and Switzerland. ProVENT enrolled 399 patients; here, we report outcomes in 100 patients who completed 2 years in the study.
RESULTS: At baseline, the median age was 56 years, 53% were female patients, and all patients had experienced exacerbations in the 2 years prior to enrollment. Asthma control was measured using the 5-item Asthma Control Questionnaire (ACQ-5) and Asthma Control Test (ACT). Asthma control improved steadily during the 2 years. Median ACQ-5 and ACT values at baseline, Year 1, and Year 2 timepoints were 2.6, 1.1, and 0.9, and 14, 21, and 22, respectively. QoL was measured using the Asthma Quality of Life Questionnaire (AQLQ). Median QoL increased from 5.3 at baseline to 6.3 at both Year 1 and Year 2. After 2 years of dupilumab treatment, most patients with severe asthma no longer experienced any exacerbations (89% at both Year 1 and Year 2 timepoints, respectively). Asthma remission was defined as no oral corticosteroid use, no exacerbations, ACT ≥20 or ACQ ≤1.5, and improved or stable lung function (pre-bronchodilator ppFEV1 ≥80% or decrease in FEV1 ≤ 5% compared with baseline). During this 2-year analysis, over half of the patients in the study achieved remission (56% at Year 1 and 58% at Year 2 timepoints). Safety findings were aligned with previous studies.
CONCLUSIONS: In this real-world study, patients initiating dupilumab and followed for 2 years showed improved asthma control, better quality of life, and reduced asthma exacerbations. These findings may contribute to lower healthcare utilization in patients with severe asthma.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
SA82
Topic
Study Approaches
Topic Subcategory
Registries
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)