Two Phase III trials for Dupixent in asthma published in NEJM.- Sanofi + Regeneron.
The New England Journal of Medicine has published detailed results from two Phase III trials for the investigational use of Dupixent (dupilumab), from Sanofi and Regeneron, in moderate-to-severe asthma. The results showed that Dupixent significantly reduced the risk of severe asthma attacks (exacerbations), improved lung function and reduced dependence on oral corticosteroids (OCS). The trials, known as QUEST and VENTURE, are part of the pivotal clinical trial program that evaluated Dupixent in uncontrolled asthma patients. Dupixent demonstrated significant improvements in the key primary and secondary endpoints across the overall populations in both QUEST and VENTURE, with the largest benefit experienced in patients with more severe Type 2 inflammatory asthma, as evidenced by elevated blood eosinophils or exhaled nitric oxide levels.
The QUEST trial showed that a broad population of adults and adolescents with moderate-to-severe asthma (no minimum blood eosinophil level requirement or other biomarker requirement at baseline) benefited when Dupixent was added to their standard therapies. Dupixent reduced severe asthma attacks and improved lung function compared to placebo. VENTURE trial also did not require minimum biomarker levels for enrollment. The study showed that adults and adolescents with severe, steroid-dependent asthma who were treated with Dupixent, when added to standard therapies, could reduce their use of OCS medications while improving asthma control compared to placebo at 24 weeks. With Dupixent, OCS use decreased by 70 percent in the overall population (vs. 42 percent for placebo), and 80 percent for patients with baseline eosinophil levels 300 cells/microliter or greater (vs. 43 percent for placebo).
Type 2 asthma can also be characterized by other parameters, including elevated Immunoglobulin E (IgE). Dupixent blocks the IL-4/IL-13 pathway, which is emerging as a central driver of Type 2 allergic inflammation in asthma, as well as in a range of other allergic or atopic diseases. These data were simultaneously presented at the American Thoracic Society 2018 International Conference.
See: Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma
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