A Phase 3 study evaluating dupilumab (Dupixent; Sanofi and Regeneron) in adults and adolescents with severe, steroid-dependent asthma showed that the biologic agent reduced steroid use, asthma attacks, and improved lung function in this patient population.
The LIBERTY ASTHMA VENTURE study included 210 patients (dupilumab arm: 103; placebo arm: 107) with severe asthma and regular use of maintenance oral corticosteroids (OCS) in the six months prior to enrollment. Patients were randomized to receive either dupilumab 300mg every other week with a loading dose of 600mg or placebo. The median baseline eosinophil count was 260 eosinophils/microliter.
At 24 weeks, dupilumab added to standard therapies significantly reduced the use of maintenance OCS by 70% on average (median reduction of 100%) compared to 42% with placebo (median reduction of 50%) (P<0.0001). In patients with baseline eosinophil counts ≥300 cells/microliter, adding dupilumab significantly reduced OCS use by 80% on average (median reduction of 100%) compared to 43% for placebo (median reduction of 50%)(nominal P=0.0001).
In addition, patients treated with dupilumab had 59% and 71% fewer exacerbations in the overall population and in patients with eosinophil counts ≥300 cells/microliter, respectively. Compared to placebo, dupilumab improved lung function (as assessed by forced expiratory volume over one second [FEV1]) by 220mL (15%) in the overall population and by 320mL (25%) in patients with eosinophil counts ≥300 cells/microliter.
In the overall population, 80% of patients in the dupilumab arm reduced their OCS dose by at least half while maintaining overall asthma control compared to 50% of patients in the placebo arm. In patients with eosinophil counts ≥300 cells/microliter, 88% of patients in the dupilumab group reduced their OCS dose by at least half compared to 52% for placebo.
“Severe, uncontrolled asthma can lead to a dependence on oral corticosteroids, with systemic steroid exposure potentially leading to serious short- and long-term adverse effects, including weight gain, diabetes, osteoporosis, glaucoma, anxiety, depression, cardiovascular disease and immunosuppression,” said Professor Mario Castro, MD, MPH, FCCP, Washington University School of Medicine in St. Louis. “There is an urgent need for new therapies that can decrease or eliminate chronic oral corticosteroid use, as well as reduce severe asthma attacks and improve lung function in this difficult-to-treat patient population.”
Dupilumab is a fully human monoclonal antibody that is designed to simultaneously inhibit overactive signaling of IL-4 and IL-13 cytokines. In March 2017, the Food and Drug Administration (FDA) approved Dupixent in the U.S. for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies.
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