Dupilumab Benefits Patients with Uncontrolled Severe Asthma in Phase 3 Studies
Patients with severe asthma who were treated with dupilumab experienced a reduction in severe exacerbation risk, improved lung function, and reduced dependence on oral corticosteroids.
Dupilumab (Dupixent) significantly reduced the risk of severe asthma attacks, improved lung function, and reduced dependence on oral corticosteroids (OCS) in 2 pivotal phase 3 studies, according to a press release.
The trials, known as QUEST and VENTURE, investigated dupilumab’s use for moderate-to-severe asthma as an add-on maintenance treatment for adults and adolescents with uncontrolled disease. The drug is currently approved for the treatment of adults with controlled moderate-to-severe atopic dermatitis.
According to the data, which was published in the New England Journal of Medicine, the largest benefit was seen in patients with more severe type 2 inflammatory asthma, as evidenced by elevated blood eosinophils or exhaled nitric oxide levels.
In the phase 3 QUEST trial, 1902 participants were enrolled, including 1795 adults and 107 adolescents. The 4 study groups included patients treated with 200 mg every other week (loading dose of 400 mg), 300 mg every other week (loading dose of 600 mg), and 2 separate placebo groups.
Overall, dupilumab reduced severe asthma attacks and improved lung function compared with placebo. According to the study, patients reported improved asthma control and quality of life, as measured by the 5-item Asthma Control Questionnaire (ACQ-5) and Asthma Quality of Life Questionnaire (AQLQ). Patients also experienced lung function improvements 2 weeks after receiving the first dose, which were sustained throughout the 52-week trial.
The phase 3 VENTURE trial included 210 patients with severe asthma who regularly used maintenance OCS in the 6 months prior to enrollment. The 2 study groups were 300 mg dupilumab every other week (loading dose of 600 mg) and placebo.
According to the results, adults and adolescents with severe, steroid-dependent asthma who were treated with dupilumab, when added to standard therapies, could reduce their use of OCS medications while improving asthma control compared with placebo at 24 weeks.
With dupilumab, OCS use decreased by 70% in the overall population and 80% for patients with baseline eosinophil levels 300 cells/microliter or greater. Even with decreased OCS use, patients treated with dupilumab were able to reduce the risk of severe asthma attacks and improve lung function.
Dupilumab is being jointly developed by Sanofi and Regeneron.
The target action date is October 20, 2018, in the United States.
New England Journal of Medicine publishes two positive Phase 3 trials showing Dupixent® (dupilumab) improved moderate-to-severe asthma [news release]. Genzyme’s website. http://news.genzyme.com/press-release/new-england-journal-medicine-publishes-two-positive-phase-3-trials-showing-dupixent-du. Accessed May 22, 2018.