BOSTON — Pimecrolimus cream for atopic dermatitis leads to itch-free kids and happier parents, a study has shown.
In a randomized, double-blind trial enrolling 275 children from 3 months to 11 years old with moderate to severe atopic dermatitis, the parents of those children treated with a 1% strength of the topical immunomodulator pimecrolimus (Elidel) reported substantially improved quality of life, compared with parents of children treated with topical corticosteroids, Jennifer Sung, M.D., said at the annual meeting of the American College of Allergy, Asthma, and Immunology.
All of the parents whose children were enrolled in the multicenter vehicle-controlled investigation completed a patient gender-specific version of the Parent's Index of Quality of Life in Atopic Dermatitis (PIQoL-AD) at baseline, week 12, and at the end of the study at week 24.
The questionnaire, which is the only survey specifically designed for parents of children aged 3 months to 12 years, contains 28 true/not true items and has been shown to have good psychometric properties, said Dr. Sung, a clinical investigator at Novartis Pharmaceuticals, East Hanover, N.J., the manufacturer of Elidel.
The questionnaire includes items addressing parents' concerns about their children's appearance, the effort required to prevent itching and provide appropriate care, and the stress of worrying about the condition and the effect of treatments.
Responses are numbered and summed. Scores range from 0 to 28, with higher scores indicating a poorer quality of life. The investigators used an analysis of covariance model to compare changes in scores from baseline to the end of the study, controlling for treatment, center, and baseline score.
At baseline, all mean demographic and clinical characteristics between the 183 children who received the pimecrolimus-based therapy and the 92 who received corticosteroid-based treatment were the same.
In both groups, atopic dermatitis affected at least 5% of each subject's total body surface area.
All of the children in the study received emollients for dry skin and either pimecrolimus cream 1% or corticosteroid twice daily at any sign of active atopic dermatitis.
Corticosteroid subjects who experienced severe flares were given a midpotency topical corticosteroid for evening use until complete resolution, for a maximum of 3 weeks.
The baseline PIQoL-AD score for parents of children in the pimecrolimus and corticosteroid groups, respectively, was 8.4 and 9.3.
At 24 weeks, the respective scores were 4.9 and 6.3, representing an improvement from baseline of 37.6% for the pimecrolimus group and 26.8% for the corticosteroid group, Dr. Sung reported.
“A number of studies have already shown [pimecrolimus] to be a safe, effective, nonsteroidal option for these kids. This study tells us that there's a beneficial effect on their parents' quality of life also,” Dr. Sung said. “Parents are especially relieved not to have to worry about corticosteroid-related side effects.”
