Dupixent^® (dupilumab) significantly reduces severe asthma attacks in children, finds study

Regeneron Pharmaceuticals Inc. and Sanofi have revealed that Dupixent^® (dupilumab) significantly reduced asthma attacks and improved lung function compared to standard of care (SOC) in 408 children aged six to 11 years old with uncontrolled moderate-to-severe asthma.

The Phase III trial was evaluating the efficacy and safety of Dupixent in addition to SOC maintenance therapy of medium-dose inhaled corticosteroid (ICS) with a second controller medication or high-dose ICS with or without a second controller medication.

Children with uncontrolled moderate-to-severe asthma continue to experience symptoms such as coughing, wheezing and difficulty breathing, despite SOC therapies such as ICS. They are also at risk of severe asthma attacks requiring hospitalisation. In the US, there are approximately 75,000 children (aged six to 11) with uncontrolled moderate-to-severe asthma and many more can be found worldwide.

“Children with moderate-to-severe asthma live with a heavy and unpredictable disease burden. Even while taking maximum treatments including inhaled corticosteroids, they suffer from multiple asthma attacks each year that may require hospitalisation,” said Dr George Yancopoulos, President and Chief Scientific Officer of Regeneron. “These impressive Phase III data in children with asthma show Dupixent significantly reduced annual severe asthma attacks and also improved lung function consistently across patients with markers of type 2 inflammation.”

Dr John Reed, Global Head of Research and Development at Sanofi, added: “Children with uncontrolled moderate-to-severe asthma often struggle to breathe, largely because of their impaired lung function and this can have a serious impact on a child’s quality of life… Dupixent is the only biologic shown in a controlled Phase III trial to improve lung function in children, which is generally consistent with results seen in the adolescent and adult trials. These positive data are especially encouraging for younger children who are struggling to manage their uncontrolled asthma.”

The type 2 inflammatory asthma patient population, including the children enrolled in this study, are defined as having elevated eosinophils (EOS) or elevated fractional exhaled nitric oxide (FeNO). The primary endpoint assessed the annualised rate of severe asthma attacks in two primary pre-specified populations: patients with baseline blood EOS ≥300 cells/μl and patients with markers of type 2 inflammation (FeNO ≥20 ppb or EOS ≥150 cells/μl). Across these two patient groups respectively, those who added Dupixent (100 mg or 200 mg every two weeks, based on weight) to standard of care experienced:

• Reduced rate of severe asthma attacks, with a 65 percent and 59 percent average reduction over one year compared to placebo (0.24 and 0.31 events per year for Dupixent vs. 0.67 and 0.75 for placebo, respectively).
• Improved lung function at 12 weeks compared to baseline by 10.15 and 10.53 percentage points for Dupixent vs. 4.83 and 5.32 percentage points for placebo, as measured by percent predicted FEV₁ (FEV₁pp). This clinically meaningful improvement in lung function was observed as early as two weeks and was sustained for up to 52 weeks.

The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with moderate-to-severe asthma. Over one year, overall rates of adverse events were 83 percent for Dupixent and 80 percent for placebo. Adverse events that were most commonly observed included injection site reactions (18 percent Dupixent, 13 percent placebo), viral upper respiratory tract infections (12 percent Dupixent, 10 percent placebo) and eosinophilia (six percent Dupixent, one percent placebo).

About Dupixent

Dupixent is a fully-human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signalling. Data from clinical trials indicates that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis and eosinophilic esophagitis.

Within the US, Dupixent is approved for the treatment of patients aged six plus with moderate-to-severe atopic dermatitis that is not well controlled with topical prescription therapies, or who cannot use topical therapies; for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged >12 whose asthma is not controlled with their current asthma medicines; and for use with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled.

Outside of the US, Dupixent is approved in the EU and Japan for specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma. Dupixent is also approved in the EU and Japan to treat certain adults with severe CRSwNP.