Results of Dupilumab in Uncontrolled Asthma Highlighted at ERS

Study results released earlier this month showcased results in children and adults with uncontrolled asthma. The findings were presented at the European Respiratory Society (ERS) 2021 International Congress.

Study results released earlier this month showcased dupilumab (Dupixent) results in children and adults with uncontrolled asthma, as well as for atopic dermatitis. The findings were presented at the European Respiratory Society (ERS) 2021 International Congress.

Dupilumab is a fully human monoclonal antibody that inhibits interleukin (IL)-4 and IL-13, which are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis, and eosinophilic esophagitis.

Results of the phase 3 LIBERTY ASTHMA VOYAGE trial, a randomized double-blind, placebo-controlled study of children aged 6 to 11 years, showed that dupilumab resulted in a reduction of the annualized rate of severe asthma exacerbations, improved lung function, and showed benefits in asthma control, particularly in the subgroup of patients with allergic asthma.

Allergic phenotype was defined as total serum IgE ≥ 30 IU/mL and ≥ 1 perennial aeroallergen-specific IgE ≥ 0.35 kU/L at baseline.

In the subgroup of patients without allergic asthma, dupilumab caused significant reduction in the exacerbation rate compared with placebo. Numerical improvements were found in lung function, but not in asthma control, the investigators said.

In the 52-week study, add-on dupilumab 100/200 mg (for body weight ≤ 30 or > 30 kg) every 2 weeks vs placebo reduced severe asthma exacerbations by 59.3% (P < .0001) and improved percent predicted pre-bronchodilator forced expiratory volume in 1 second (FEV1) at week 12 (least squares [LS] mean difference 5.2; P < .001) in participants with moderate-to-severe type 2 asthma (baseline blood eosinophils ≥ 150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥ 20 parts per billion).

In severe asthma with evidence of allergic asthma, dupilumab significantly reduced the rate of severe asthma attacks with an average reduction of 62% over 1 year compared with placebo (P <.001). For patients without evidence of having allergic asthma, the reduction was 51%.

In lung function, FEV1 improved more than over 12% over the course of the study, compared with 4%-5% in placebo.

As measured by the Asthma Control Questionnaire (ACQ-7-IA), the LS mean difference vs matched placebo was ­–0.52 (95% CI, -0.68 to –0.35; P <.001).

In a similar study looking at results in adolescents and adults with allergic asthma, annualized asthma attack rates were 0.32 vs 0.37 in allergic and 0.27 vs. 0.30 in non-allergic individuals.

Additionally, LS mean improvement in FEV1 from baseline in those with allergic asthma was 0.35L vs. 0.39L in allergic and 0.36L vs. 0.37L in non-allergic individuals.