Treatment with dupilumab (Dupixent, Regeneron and Sanofi) demonstrated positive results in patients from 6 to 11 years of age with severe atopic dermatitis, according to data from a phase 3 trial.
 
Dupilumab is currently approved for patients older than 12 years with moderate-to-severe atopic dermatitis, as well as for moderate-to-severe asthma and adults with chronic rhinosinusitis with nasal polyposis.
 
According to Regeneron, the results from the trial are the first to assess a biologic medicine in children under the age of 12 with atopic dermatitis.
 
The study evaluated the efficacy and safety of dupilumab with standard-of-care topical corticosteroids (TCS) in 367 children aged 6 to 11 years with severe atopic dermatitis whose disease could not be adequately controlled with topical medications. Patients in the trial received TCS and were randomized into 3 treatment groups for a 16-week period: dupilumab 100 mg or 200 mg every 2 weeks (based on weight), with an initial dose of 200 mg or 400 mg, respectively, and placebo every 2 or 4 weeks.
 
For the primary endpoints, the researchers assessed the proportion of patients achieving an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index (EASI-75) at 16 weeks.
 
Overall, treatment with dupilumab in addition to TCS significantly improved measures of overall disease severity, skin clearing, itching, and health-related quality of life compared with TCS alone.
 
The results at 16 weeks showed:
  • Seventy percent of patients who received dupilumab every 4 weeks (300 mg flat dose) and 67% of patients who received dupilumab every 2 weeks (100 mg or 200 mg, based on weight) achieved 75% or greater skin improvement, compared with 27% for placebo (p<0.0001 for both).
  • Thirty-three percent of patients who received dupilumab every 4 weeks and 30% of patients who received dupilumab every 2 weeks achieved clear or almost clear skin, compared with 11% for placebo (p<0.0001 and p=0.0004, respectively).
  • The average EASI score improvement from baseline was 82% in the dupilumab every 4 weeks group and 78% in the dupilumab every 2 weeks group, compared with 49% for placebo (p<0.0001 for both).
Additionally, overall rates of adverse events were 65% for dupilumab every 4 weeks, 67% for dupilumab every 2 weeks, and 73% for placebo.
 
“In this trial, children with severe atopic dermatitis had uncontrolled disease covering, on average, nearly 60% of their skin. The unrelenting symptoms of this disease, which impact not just the child but the whole family, including widespread rashes, intense and persistent itching, and skin lesions,” John Reed, MD, PhD, global head of research and development at Sanofi, said in a statement. “Symptoms of severe atopic dermatitis can take a toll on children both physically and emotionally. We are encouraged by these results, which demonstrate that Dupixent improved skin lesions, reduced itching, cleared the skin and importantly, improved health-related quality of life measures for these young patients.”
 
Regeneron expects to submit data from the trial to the FDA in Q4 2019, according to the press release. 
 
Reference
 
Dupixent (dupilumab) showed positive topline results in phase 3 trial of children aged 6 to 11 years with severe atopic dermatitis [news release]. Regeneron. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-showed-positive-topline-results-phase-3. Accessed August 6, 2019.