Results showed Dupixent demonstrated a significant improvement in multiple asthma endpoints in two Phase 3 clinical trials in a broad population of patients with uncontrolled asthma, irrespective of minimum baseline eosinophil levels or other biomarkers of Type 2 inflammation
Greater benefit observed in patients with higher levels of markers of Type 2 inflammation, as evidenced by eosinophils or exhaled nitric oxide levels
In steroid-sparing VENTURE trial, Dupixent-treated patients substantially reduced use of oral corticosteroids, yet had fewer exacerbations and improved lung function compared to placebo.
In both trials, Dupixent treated patients showed significant lung function improvement two weeks after first dose that was sustained over 52 weeks
The New England Journal of Medicine (NEJM) today published detailed results from two Phase 3 trials for the investigational use of Dupixent® (dupilumab) 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. These data were simultaneously presented at the American Thoracic Society 2018 International Conference.
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. 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.
The investigational use of Dupixent as an add-on maintenance treatment of adults and adolescents with uncontrolled moderate-to-severe asthma is currently under regulatory review in several countries, including the U.S., Japan and in the European Union (EU), and the safety and efficacy for this use have not been evaluated by any regulatory authority. In the U.S., the target action date is October 20, 2018. Dupixent is currently approved in a number of countries for the treatment of adults with uncontrolled moderate-to-severe atopic dermatitis.