SAN DIEGO — Serum IgE levels are increased in children aged 3–18 months with atopic dermatitis, suggesting they are at risk of developing asthma and allergies, baseline results from the Study of the Atopic March demonstrated.
The purpose of the Study of the Atopic March (SAM) trial is to determine if treatment with pimecrolimus 1% cream in infancy improves control of atopic dermatitis and reduces the incidence of asthma and allergies at 6 years of age, said Dr. Mark Boguniewicz in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
In a multicenter study funded by Novartis Pharmaceuticals Corp., which developed and markets the pimecrolimus 1% cream Elidel, Dr. Boguniewicz and his associates enrolled 1,091 infants aged 3–18 months who have a family history of atopy and who had clinical evidence of atopic dermatitis for up to 3 months. They conducted an allergy history and total and antigen-specific IgE assessments.
In the treatment component of the trial, children are enrolled in a double-blind phase for 3 years, followed by a 33-month open-label phase for eligible participants. The study presented at the meeting was limited to baseline results.
The mean age of patients at baseline was 8 months, and more than half (62%) were male, reported Dr. Boguniewicz, a pediatric allergist with the National Jewish Medical and Research Center in Denver. The researchers conducted baseline IgE tests on 926 of the children. The median total IgE level was 14 kU/L and was higher for children with moderate atopic dermatitis than for those with mild atopic dermatitis (a median of 18 kU/L vs. 11 kU/L, respectively).
The researchers also observed that children who had more severe atopic dermatitis or who were older at baseline had higher total IgE levels, compared with children who had mild atopic dermatitis or who were younger at baseline.
Baseline tests for antigen-specific IgE showed that almost one-third (29%) were sensitive to egg, whereas 25% were positive to peanut, 22% were positive to milk, and 16% were positive to animal dander.
Dr. Boguniewicz is a scientific advisor to Novartis Pharmaceuticals Corp.