Low‐dose cyclosporin A microemulsion in children with severe atopic dermatitis: Clinical and immunological effects

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Abstract
Cyclosporin A (CsA) is an effective and well‐tolerated treatment for severe childhood atopic dermatitis (AD). By starting at a low dose, the therapeutic safety should be further increased. The aim of this study was to evaluate low‐dose CsA in childhood AD with respect to clinical outcome and modulation of T‐cell dysregulation. In an open prospective study, 10 children (age: 22–106 months) with severe AD (mean objective SCORAD score > 40 on two baseline measurements at a minimum interval of 2 weeks) were treated with CsA solution for 8 weeks. All patients received a starting dose of 2.5 mg/kg/day, which was increased stepwise in non‐responders to a maximum of dose of 5 mg/kg/day. Disease activity was monitored using the SCORAD index. The frequency of cytokine‐producing peripheral blood T lymphocytes was analyzed by intracellular cytokine staining, and T‐cell numbers were measured by fluorescence‐activated cell sorter (FACS) analysis. Twenty healthy age‐matched children were included as controls for the immunological data. Nine of the 10 patients had a SCORAD reduction of at least 35%. In seven patients this was achieved with low‐dose CsA at 2.5 mg/kg/day (n = 4) and 3.5 mg kg/day (n = 3). Seven of the nine responders experienced no relapse within the 4‐week follow‐up period. At baseline the percentage of interleukin‐4 (IL‐4), IL‐13, and human leucocyte antigen (HLA)‐DR‐positive CD3+ cells was higher in the patient group than in the controls. After CsA treatment there was a significant reduction in interferon‐γ (IFN‐γ), IL‐2, IL‐4, IL‐13, and HLA‐DR‐positive CD3+ cells. Hence, in severe pediatric AD, CsA microemulsion, when started at a low dose (2.5 mg/kg/day), improves clinical measures of disease, reduces T‐lymphocyte cytokine production, and regulates T‐cell activation.