ABSTRACT
Introduction: Real-world evidence on patients with moderate-to-severe asthma treated with dupilumab is limited. Patients included in clinical trials may differ from the ones seen on a clinical office setting. The objective of our study was to characterize real-world effectiveness of dupilumab in US, as an add-on treatment in patients with moderate to severe asthma. Method(s): We retrospectively included patients (>=12 years of age) diagnosed with asthma, initiating dupilumab (index) between November 2018 to September 2020, with 12 months pre- and post-index information. The study employed a pre-post self-control design (TriNetX Dataworks, USA). Asthma exacerbation rates before vs. after dupilumab initiation were analyzed using Generalized Estimating Equations models with Poisson probabilistic link to estimate incidence rate ratios (IRRs). Sensitivity analyses on asthma exacerbations adjusted for COVID-19 confounding effects were performed using natural cubic splines to allow for time-varying effect estimates during pre- and post-pandemic time periods. Result(s): A total of 2400 patients initiating dupilumab met all study criteria and 75.3% were biologic naive. Dupilumab reduced risk of asthma exacerbations by 38% (IRR: 0.62 [95% confidence interval: 0.58-0.65], P=<.0001). Significant reductions in asthma exacerbations were observed in patients with at least 1 or 2, pre-index, asthma exacerbations, by eosinophil count categories, and when adjusted for impact of COVID-19 (Table-1) Conclusion(s): The US ADVANTAGE study demonstrated real-world effectiveness of dupilumab in reducing asthma exacerbation among patients 12 years and older in US clinical practice. These findings are generally consistent with data from previous pivotal clinical trials with dupilumab. Copyright © 2022