Dupixent significantly reduced severe asthma attacks in children
In a broad type 2 inflammatory asthma patient population, defined as having elevated eosinophils (EOS) or elevated fractional exhaled nitric oxide (FeNO), Dupixent added to standard of care significantly reduced asthma attacks (exacerbations) and improved lung function, as early as two weeks after the first dose, compared to standard of care alone. More than 90% of children in the trial had at least one concurrent type 2 inflammatory condition including atopic dermatitis and eosinophilic esophagitis. Safety results from the clinical trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with moderate-to-severe asthma. Despite standard-of-care therapy such as inhaled corticosteroids (ICS), children with uncontrolled moderate-to-severe asthma continue to experience symptoms such as coughing, wheezing, and difficulty breathing, and are at risk of severe asthma attacks. For these children, this often leads to frequent hospitalizations and emergency room visits requiring use of systemic corticosteroids which can carry significant risks when used long-term. Uncontrolled asthma can cause children to miss school, and can interfere with physical activity and routine tasks including walking up stairs and playing sports. In the U.S., there are approximately 75,000 children 6-11 years old with uncontrolled moderate-to-severe asthma, and many more of these children worldwide. Efficacy : The primary endpoint assessed the annualized rate of severe asthma attacks in two primary pre-specified populations: patients with baseline blood EOS greater than 300 cells/?l and patients with markers of type 2 inflammation (FeNO ?20 ppb or EOS greater than 150 cells/?l). 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: 1. Reduced rate of severe asthma attacks, with a 65% (p<0.0001) and 59% (p><0.0001) 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). 2.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 (least squares mean difference for dupixent vs. placebo of 5.3 and 5.2 percentage points, p="0.0036" and p="0.0009)," respectively, as measured by percent predicted fev1 (fev1pp). fev1pp is a common endpoint in pediatric asthma trials to evaluate a patient’s change in lung function compared to their predicted lung function based on a number of factors including age, height and sex, to account for children’s growing lung capacity at different stages of development. this clinically meaningful improvement in lung function was observed as early as two weeks and was sustained for up to 52 weeks. safety : 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% for dupixent and 80% for placebo. adverse events that were most commonly observed with dupixent versus placebo included injection site reactions (18% for dupixent and 13% for placebo), viral upper respiratory tract infections (12% for dupixent and 10% for placebo), and eosinophilia (6% for dupixent and 1% for placebo).></0.0001)></0.0001)>