HealthDay News — For children younger than 6 years, dupilumab significantly improves signs and symptoms of atopic dermatitis, according to a study published in the Sept. 17 issue of The Lancet.
Amy S. Paller, M.D., from the Feinberg School of Medicine at Northwestern University in Chicago, and colleagues conducted a randomized trial at 31 hospitals, clinics, and academic institutions involving patients aged 6 months to younger than 6 years with moderate-to-severe atopic dermatitis (Investigator’s Global Assessment [IGA] score of 3 to 4] and an inadequate response to topical corticosteroids. Patients were randomly assigned to subcutaneous placebo or dupilumab (83 and 79 patients, respectively) every four weeks plus low-potency topical corticosteroids for 16 weeks.
The researchers found that significantly more patients in the dupilumab versus placebo group had an IGA score of 0 to 1 at week 16 (28 versus 4 percent) and had at least a 75 percent improvement from baseline in the Eczema Area and Severity Index (53 versus 11 percent). The overall prevalence of adverse events was similar (64 and 74 percent in the dupilumab and placebo groups, respectively). The incidence of conjunctivitis was higher in the dupilumab versus placebo group (5 versus 0 percent). There were no serious dupilumab-related adverse events reported.
“By treating more aggressively to calm the immune system activation in these young children with early, severe eczema, we may also reduce the risk of their developing a range of allergic problems, changing their life beyond improving eczema,” Paller said in a statement.
Several authors disclosed financial ties to biopharmaceutical companies, including Regeneron and Sanofi, who jointly developed dupilumab and sponsored the trial.