Treatment of infants with atopic eczema with pimecrolimus cream 1% improves parents' quality of life:: A multicenter, randomized trial

Atopic eczema begins primarily in infancy or early childhood, and sleep loss due to night-time pruritus can have a considerable impact on patients' and parents' quality of life (QoL). In this study, infants (n = 196) with mild to severe atopic eczema were randomized 2:1, double-blind, to receive either pimecrolimus cream 1% (Elidel (R), Novartis Pharma, Nurnberg, Germany) or the corresponding vehicle bid for 4 wk, followed by a 12 wk, open-label phase and a 4 wk, treatment-free, follow-up period. The parents' QoL was measured at baseline and at the end of the double-blind phase, using the questionnaire 'QoL in Parents of Children with Atopic Dermatitis' (PQoL-AD), thus data presented here refer to the initial 4-wk treatment phase only. After 4 wk of double-blind treatment, an increase in the mean percentage change from baseline in eczema area and severity index of 71.5% was observed with pimecrolimus, compared with 19.4% with vehicle. The increase in efficacy was paralleled by the following mean percentage changes from baseline in the five domains of the questionnaire in pimecrolimus and vehicle, respectively: psychosomatic well-being: 14.6% vs. 6.2%; effects on social life: 6.7% vs. 2.3%; confidence in medical treatment: 10.0% vs. 3.7%; emotional coping: 16.1% vs. 6.5%; acceptance of disease: 19.6% vs. 7.0%. Analysis (ancova) of the dependent variable difference from baseline and the covariate baseline value revealed values of p < 0.05 for all five domains, despite the very short duration of the study. It is concluded that improvements in atopic eczema in infants achieved by treatment with pimecrolimus have a significant beneficial effect on the QoL of parents.