Dupixent improves atopic dermatitis in young children

Pediatric patients with atopic dermatitis who were treated with Dupixent plus topical corticosteroids had significant reductions in itch and improved quality of life in a phase 3 trial, according to a press release.

Dupixent (dupilumab; Regeneron, Sanofi), a fully monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, was compared to placebo in children aged 6 months to 5 years in the LIBERTY AD PRESCHOOL trial.

Subjects in the double-blind, placebo-controlled trial received 200 mg or 300 mg of Dupixent, based on body weight, every 4 weeks for the duration of the 16-week trial, as well as topical corticosteroids, or placebo.

Clear or almost clear skin was achieved in 28% of Dupixent patients, compared with 4% of those taking placebo (P < 0.0001). In addition, 53% of the study population had greater overall disease improvement from baseline, compared with 11% of those on placebo, according to the release.

Overall disease severity, as measured by the Eczema Area and Severity Index, was improved by an average of 70% in the Dupixent group, compared with 20% in the placebo group, while itch improved in 49% of the study group, compared with 2% of the placebo group.

“These data show that Dupixent dramatically reduced the impact of atopic dermatitis on the lives of these young children and their families, with rapidly cleared skin, improved itch and improved observed patient outcomes, including sleep and skin pain,” George D. Yancopoulous, MD, PhD, president and chief scientific officer at Regeneron, said in the release.

Adverse events were reported in 64% of the Dupixent group and 74% of the placebo group. These included nasopharyngitis (8% Dupixent, 9% placebo), upper respiratory tract infection (6% Dupixent, 8% placebo), conjunctivitis (5% Dupixent, 0% placebo), herpes viral infections (6% Dupixent, 5% placebo) and injection site reactions (2% Dupixent, 3% placebo).

“Knowing that safety is of the utmost importance for physicians and parents when considering treatment options for children and infants, we are encouraged by the results of this trial showing Dupixent addressed the signs and symptoms of atopic dermatitis without broadly suppressing the immune system, demonstrating the potential it could have for these very young patients,” John Reed, MD, PhD, global head of research and development at Sanofi, said in the release.

Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

Full results of this study will be announced at an upcoming scientific meeting, the release said.