The quality of life benefits of pimecrolimus cream 1% in the long-term management of mild to severe pediatric atopic dermatitis

Abstract

Background: Atopic dermatitis (AD), an inflammatory skin disease primarily affecting children, has been shown to impact quality of life (QoL). Pimecrolimus cream 1% (PIM) is a steroid-free cream with demonstrated efficacy in the acute treatment and long-term management of pediatric and adult AD. A 6-month, double-blind, vehicle controlled study was conducted with a secondary aim to evaluate the quality of life impact of using a PIM-based or corticosteroid (CS)-based treatment regimen among parents of children with mild to severe AD.Methods: 275 children aged 3 months to 11 years with mild to severe AD were randomized 2:1 to receive treatment with PIM or vehicle cream. Subjects applied emollients for dry skin and PIM or vehicle twice daily at the first signs of AD. For severe flares, a mid-potency topical CS indicated for once daily use in AD replaced the evening study drug application for a maximum of 3 weeks or until all AD resolved. Parents completed the parent’s index of quality of life-atopic dermatitis (PIQoL-AD), a 28-item validated questionnaire, which measures parent’s needs-based QoL, at baseline, week 12, and study completion. Change scores from baseline to week 24 for the PIQoL-AD were compared between treatment groups. Negative change scores indicate improvement.Results: Although parents in both groups reported improvement in their PIQoL-AD scores at week 24, the improvement was greater for the PIM group. The mean change score from baseline to week 24 for the PIQoL-AD was −3.3 in the PIM group (37.6% improvement from baseline) vs. −2.6 in the CS-based treatment group (26.8% improvement from baseline). ANCOVA results for change from baseline with treatment and center as main effects and baseline score as a covariate indicated a between-group difference of −1.2, which approached statistical significance [p = 0.056; 95% CI = (−2.5, 0.0)].Conclusion: The results demonstrated that a pimecrolimus cream 1% based long-term treatment regimen had a beneficial effect on parent’s quality of life. This QoL benefit is consistent with the efficacy results do ZÁnted in the study. Background: Atopic dermatitis (AD), an inflammatory skin disease primarily affecting children, has been shown to impact quality of life (QoL). Pimecrolimus cream 1% (PIM) is a steroid-free cream with demonstrated efficacy in the acute treatment and long-term management of pediatric and adult AD. A 6-month, double-blind, vehicle controlled study was conducted with a secondary aim to evaluate the quality of life impact of using a PIM-based or corticosteroid (CS)-based treatment regimen among parents of children with mild to severe AD. Methods: 275 children aged 3 months to 11 years with mild to severe AD were randomized 2:1 to receive treatment with PIM or vehicle cream. Subjects applied emollients for dry skin and PIM or vehicle twice daily at the first signs of AD. For severe flares, a mid-potency topical CS indicated for once daily use in AD replaced the evening study drug application for a maximum of 3 weeks or until all AD resolved. Parents completed the parent’s index of quality of life-atopic dermatitis (PIQoL-AD), a 28-item validated questionnaire, which measures parent’s needs-based QoL, at baseline, week 12, and study completion. Change scores from baseline to week 24 for the PIQoL-AD were compared between treatment groups. Negative change scores indicate improvement. Results: Although parents in both groups reported improvement in their PIQoL-AD scores at week 24, the improvement was greater for the PIM group. The mean change score from baseline to week 24 for the PIQoL-AD was −3.3 in the PIM group (37.6% improvement from baseline) vs. −2.6 in the CS-based treatment group (26.8% improvement from baseline). ANCOVA results for change from baseline with treatment and center as main effects and baseline score as a covariate indicated a between-group difference of −1.2, which approached statistical significance [p = 0.056; 95% CI = (−2.5, 0.0)]. Conclusion: The results demonstrated that a pimecrolimus cream 1% based long-term treatment regimen had a beneficial effect on parent’s quality of life. This QoL benefit is consistent with the efficacy results do ZÁnted in the study.