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®, Novartis Pharma, Nürnberg, 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.