Devang R Doshi1, Miles M Weinberger. 1. Pediatric Allergy and Pulmonary Division, University of Iowa College of Medicine, Iowa City, Iowa, USA.
Abstract
BACKGROUND: The identification of an autoimmune mechanism for many patients with chronic idiopathic urticaria (CIU) was used as a rational for a controlled clinical trial of cyclosporine for adults with CIU not responsive to usual measures. That randomized placebo controlled clinical trial demonstrated clinical efficacy, acceptable safety, and a suggestion of inducing remission in such patients. OBJECTIVE: To report our experience with cyclosporine in pediatric patients with CIU. METHODS:Fifty-four patients with CIU were referred to us during the period from 2000 through June of 2005. Seven of those, aged 9-16, failed therapy with high dose antihistamines even with the addition of alternate morning prednisone. Neoral brand of cyclosporine, 3 mg/kg/day divided b.i.d., was initiated in these patients. Cyclosporine serum concentrations, blood urea nitrogen (BUN), creatinine, and blood pressure were routinely monitored. RESULTS: All had cessation of hives. This occurred after 1-4 weeks for six of the seven and 8 weeks for one. While some experienced relapses, all were eventually off of all medications and free of hives. None of the seven experienced any adverse effects. CONCLUSIONS: Our experience in children is consistent with a previous controlled clinical trial in adults and supports the efficacy and safety of cyclosporine for CIU. However, we recommend that it be reserved for those whose CIU that is resistant to conventional measures and that patients be carefully monitored with cyclosporine serum concentrations and measures of renal function.
RCT Entities:
BACKGROUND: The identification of an autoimmune mechanism for many patients with chronic idiopathic urticaria (CIU) was used as a rational for a controlled clinical trial of cyclosporine for adults with CIU not responsive to usual measures. That randomized placebo controlled clinical trial demonstrated clinical efficacy, acceptable safety, and a suggestion of inducing remission in such patients. OBJECTIVE: To report our experience with cyclosporine in pediatric patients with CIU. METHODS: Fifty-four patients with CIU were referred to us during the period from 2000 through June of 2005. Seven of those, aged 9-16, failed therapy with high dose antihistamines even with the addition of alternate morning prednisone. Neoral brand of cyclosporine, 3 mg/kg/day divided b.i.d., was initiated in these patients. Cyclosporine serum concentrations, blood ureanitrogen (BUN), creatinine, and blood pressure were routinely monitored. RESULTS: All had cessation of hives. This occurred after 1-4 weeks for six of the seven and 8 weeks for one. While some experienced relapses, all were eventually off of all medications and free of hives. None of the seven experienced any adverse effects. CONCLUSIONS: Our experience in children is consistent with a previous controlled clinical trial in adults and supports the efficacy and safety of cyclosporine for CIU. However, we recommend that it be reserved for those whose CIU that is resistant to conventional measures and that patients be carefully monitored with cyclosporine serum concentrations and measures of renal function.
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