Baseline Characteristics of Patients with Asthma Initiating Dupilumab in a Real-World Setting: The REVEAL Registry.

INTRODUCTION

Dupilumab, a fully human monoclonal antibody, blocks the receptors for interleukins 4/13, key and central drivers of type 2 inflammation. Clinical trials demonstrated the safety and efficacy of dupilumab in patients with moderate-to-severe asthma. Here, we aim to describe baseline characteristics of patients initiating dupilumab for asthma, to characterize its safety and effectiveness in real-world clinical practice.

METHODS

REVEAL (pRospEctiVe charactErization of asthma patients treated with dupilumAb in a reaL-world setting; NCT04550962) is a longitudinal, prospective, 3-year observational study of patients aged ≥12 years prescribed dupilumab for asthma in Latin America, the Middle East, Russian Federation, and Singapore per country-specific prescribing information.

RESULTS

Of 376 patients enrolled, 374 were included in the effectiveness analysis set. Most were female (62.6%), white (50.3%), and non-Hispanic or Latino (51.3%). Mean (standard deviation [SD]) age was 47.8 (13.89) years. Tobacco use was rare; 312 (83.4%) patients were never smokers. Most were classified as Global Initiative for Asthma step 4 (17.8%) or 5 (69.5%). Mean (SD) number of prior-year severe exacerbations was 2.0 (4.53) (n = 374). Mean (SD) pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) was 2.2 L (0.83) (n = 306) and 2.3 L (0.86) (n = 212), respectively. Mean (SD) pre-bronchodilator FEV1/forced vital capacity (FVC) ratio was 0.7 (0.13) (n = 301). 242 (64.7%); 231 (61.8%) patients reported allergic rhinitis and chronic rhinosinusitis with nasal polyposis history. Median (Q1-Q3) blood eosinophil counts were 390.0 cells/µL (185.0-700.0) (n = 348) and fractional exhaled nitric oxide levels were 34.0 parts per billion (19.0-60.0) (n = 314).

CONCLUSION

Patients prescribed dupilumab in routine clinical practice were predominantly adult women with severe asthma. Frequent severe exacerbations, high prevalence of coexisting type 2 inflammatory conditions, and elevated type 2 inflammatory biomarkers suggest disease burden is high among patients initiating dupilumab for asthma.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT04550962.