To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Long-Term Intermittent Tacrolimus Thwarts Flares in Paediatric Atopic Dermatitis: Presented at EADV URL: http://www.pslgroup.com/dg/22CBFE.htm Doctor's Guide September 18, 2008
By Jill Stein PARIS -- September 18, 2008 -- Long-term, intermittent, once-daily therapy with tacrolimus ointment is a viable and effective disease management option for paediatric patients with stabilised atopic dermatitis (AD), according to data from 2 large, phase 4 trials presented here at the 17th European Academy of Dermatology and Venereology (EADV) Congress. Diamant Thaci, MD, J. W. Goethe University, Frankfurt, Germany, and colleagues assessed the efficacy and safety of long-term intermittent treatment with tacrolimus ointment compared with a standard acute-treatment approach for preventing flares in patients 2 to 15 years old. The standard acute-treatment approach involved vehicle with tacrolimus rescue. "The management of AD involves the short-term control of flares in conjunction with long-term maintenance therapy that aims to reduce the incidence and severity of flares, extend remission, improve quality of life, and minimise the disease impact over time," Dr. Thaci said in a presentation on September 18. "Drug therapy has usually been based on topical corticosteroids. However, the topical calcineurin inhibitors tacrolimus ointment and pimecrolimus cream have been increasingly used in recent years," he added. "Short-term, intermittent, topical treatment with the potent corticosteroid fluticasone propionate has been shown to decrease the risk of AD relapse. However, continuous application of topical corticosteroids for the long-term management of AD has been associated with long local and systemic side effects and is not recommended." The current analysis examined data from 2 studies. A US study enrolled paediatric patients with moderate to severe AD who were randomised to 4 days of twice-daily, double-blind therapy with either alclometasone ointment 0.05% or tacrolimus 0.03%, followed by a stabilisation phase of up to 16 weeks with open-label tacrolimus 0.03% twice daily. Patients whose disease stabilised underwent new randomisation to double-blind tacrolimus 0.03% or vehicle applied once-a-day, 3 times weekly, for up to 40 weeks as part of a maintenance phase. The primary endpoint was number of flare-free treatment days. The second, European study, enrolled paediatric patients with mild to severe AD who achieved an Investigator Global Assessment score of <=2 following a stabilisation phase of up to 6 weeks with open-label tacrolimus 0.03% twice daily who were randomised to tacrolimus 0.03% or vehicle applied once daily, twice weekly, for 12 months. The primary endpoint was the number of flares requiring substantial therapeutic intervention. During the maintenance phase of both studies, flares were treated with tacrolimus 0.03% twice daily until cleared. The use of corticosteroids was not allowed. Overall, 104 patients in the US study who completed the stabilisation phase were then randomised into the maintenance phase. Tacrolimus maintenance treatment increased the mean number of flare-free days compared with conventional treatment (174 vs 107; P = .0008) and the median time to first flare (116 vs 31 days; P = .043), while the mean number of exacerbation days was reduced (47 vs 76 days; P = .041). In the European study, 250 patients were randomised into the maintenance phase. Tacrolimus maintenance treatment decreased the number of flares that required a substantial therapeutic intervention compared with conventional treatment (50.4% vs 29.6%). The safety profiles for the 2 treatments were similar. Tacrolimus ointment was well tolerated, according to the researchers. Overall, the finding of the 2 studies suggest that use of tacrolimus ointment 0.03% in children may successfully treat active lesions and subsequently prevent, delay, and/or decrease the occurrence of AD flares, Dr. Thaci concluded. Funding for the study was provided by Astellas Pharma. [Presentation title: Long-Term Intermittent Use of Tacrolimus Ointment as Maintenance Treatment for Flare Prevention in Pediatric Patients With Stabilized Atopic Dermatitis. Abstract FP0108] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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