Patients with allergic asthma when provided add-on treatment with the biologic therapy dupilumab (Dupixent), resulted in improved lung function and reduced severe exacerbations, according to findings from post-hoc analysis of phase III data from the Liberty Asthma Quest study.
The findings were also presented at the American College of Allergy, Asthma & Immunology annual scientific meeting by Mario Castro, Washington University in St. Louis.
Dupilumab is a fully human interleukin (IL)-4 receptor-α monoclonal antibody inhibiting IL-4/IL-13 signaling pathways, which are key drivers of Type 2 inflammation.
Originally approved by the FDA in March 2017 as an add-on treatment for atopic dermatitis, the biologic therapy was approved for an asthma indication last month, as an add-on maintenance therapy for patients ages 12 and older with either eosinophilic or oral corticosteroid-dependent asthma.
The analysis compared outcomes in patients with allergic disease versus without, with endpoints of exacerbation rates and the FEV1 measure of lung function. Allergic asthma was defined as total serum immunoglobulin (Ig)E ≥30 kU/L and ≥1 positive perennial aeroallergen-specific IgE (≥0.35 kU/L) at baseline.
A total of 56% of the intent-to-treat population met the criteria for allergic asthma.
- In patients with and without allergic asthma, dupilumab versus placebo significantly reduced annualized severe exacerbation rates during the treatment period.
- In both subgroups, improvements were greater with higher baseline blood eosinophil and fractional exhaled nitric oxide levels.
- Change from baseline FEV1 to week 12 in patients who met criteria for allergic asthma treated with 200 mg dupilumab every 2 weeks versus placebo was least square mean 0.31 ± 0.02 versus 0.18 ± 0.03 (P<0.001).
- Change from baseline FEV1 to week 12 in patients who met allergic asthma criteria treated with 300 mg dupilumab every 2 weeks versus placebo was 0.35 ± 0.02 versus 0.19 ± 0.03 (P<0.001)
- Dupilumab reduced total IgE in patients with and without allergic asthma, and side effects were usually well tolerated.
- The most frequent adverse event in the dupilumab-treated groups versus placebo was injection-site reactions (15%/18% versus 5%/10%, respectively).
“For the post-hoc analysis we compared outcomes in patients with and without evidence of allergic disease and found that the response rate in terms of exacerbations and lung function increases were similar in the two populations,” Castro told MedPage Today.
The researchers concluded that add-on dupilumab reduced severe exacerbations and improved lung function in patients with allergic and non-allergic uncontrolled, moderate-to-severe asthma and was generally well tolerated.
“Clinically, it is important to look at whether this drug works in patients with allergic disease,” Castro told MedPage Today. “We have other treatments for these patients, such as anti-IgE therapies, but the more options we have the better.”
In the phase III Liberty Asthma Quest study, dupilumab administered at 200 and 300 mg every 2 weeks versus matched placebo was shown to reduce annualized severe exacerbation rates and improve pre-bronchodilator lung function, as measured by FEV1, as well as improve quality-of-life measures, and was generally well tolerated in patients with uncontrolled, moderate-to-severe asthma.