Real-World Characteristics of Patients with Severe Asthma prior to Starting Dupilumab: The ProVENT Study

Respiration. 2024;103(1):10-21. doi: 10.1159/000535390. Epub 2023 Dec 12.

Abstract

Introduction: Dupilumab is approved for the treatment of severe type 2 (T2) asthma; however, the characteristics of patients receiving dupilumab in routine clinical practice are incompletely understood. This study describes the characteristics of patients with severe asthma before dupilumab treatment in a real-world setting.

Methods: This interim analysis of an ongoing real-life study of dupilumab assessed baseline characteristics of the first patient cohort enrolled in the ProVENT study.

Results: A total of 99 patients (59% females) were analyzed (17% received another biologic before dupilumab treatment and 15% were on maintenance oral corticosteroid treatment). Adult-onset asthma (>18 years) and an allergic phenotype were documented in 58% and 48% of patients, respectively. Median (interquartile range) age was 54 (40-61) years; the median number of exacerbations in the last 24 months was 1 (0-3); median fractional exhaled nitric oxide (FeNO) value was 38 (23-64) ppb; and median blood eosinophils (bEOS) count was 184 (8-505) cells/µL. According to the United Kingdom Severe Asthma Registry classification, 53% of patients had T2 intermediate asthma (bEOS ≥150 cells/µL or FeNO ≥25 ppb), 17% had T2 high asthma (bEOS ≥150 cells/µL and FeNO ≥25 ppb), and 4% had T2 low asthma (bEOS <150 cells/µL and FeNO <25 ppb). At least one GINA criterion for T2 airway inflammation was documented in 70% of patients. T2 comorbidities were observed in 64% of patients.

Conclusions: This analysis suggests that patients eligible for dupilumab treatment display various clinical and biochemical characteristics rather than one clear-cut phenotype.

Keywords: Blood eosinophils; Dupilumab; Fractional exhaled nitric oxide; ProVENT; Type 2 asthma.

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Asthma* / drug therapy
  • Eosinophils
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nitric Oxide* / analysis

Substances

  • dupilumab
  • Nitric Oxide
  • Antibodies, Monoclonal, Humanized

Grants and funding

The ProVENT study is sponsored by Sanofi and Regeneron Pharmaceuticals, Inc.