Volume 58, Issue 6 , Pages 990-999, June 2008
Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: A randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle
Background
Intermittent dosing of a topical calcineurin inhibitor for preventing atopic dermatitis (AD) disease relapse in patients with stabilized AD has not been evaluated.
Objective
We sought to evaluate the long-term efficacy and safety of 3-times-weekly use of tacrolimus ointment in preventing AD disease relapse.
Methods
Adult and pediatric patients with moderate to severe AD who were clear of disease after up to 16 weeks of treatment with tacrolimus ointment were randomized in a double-blind fashion to 3-times-weekly treatment with either tacrolimus ointment (0.03% or 0.1%) or vehicle for 40 weeks. The primary end point was the number of flare-free treatment days.
Results
A total of 125 patients were randomized to tacrolimus and 72 patients to vehicle. The mean number of flare-free treatment days was 177 for tacrolimus and 134 for vehicle (P = .003). Median time to first relapse was 169 days for tacrolimus and 43 for vehicle (P = .037).
Limitations
Generalizability to all patients seen in clinic may be limited because only patients who responded to tacrolimus ointment in the stabilization phase were randomized into the maintenance phase of the trial.
Conclusions
Maintenance therapy with tacrolimus ointment was associated with significantly more flare-free days compared with vehicle, and a significantly longer time until first disease relapse.
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Supported by Astellas Pharma US, Inc.
Disclosures: Dr Jaracz, Ms Shull, and Mr Crowe are full-time employees of Astellas Pharma US Inc. All other authors have served as principal investigators in this study. Drs Breneman, Fleischer, Abramovits, and Hanifin have also served as clinical investigators for Novartis. Drs Fleischer, Abramovits, and Zeichner have served in one or more roles (advisory board, clinical investigator, consultancy, speakers bureau) in one or more of the following companies: 3M, Abbott, Allergan, Amgen, Astellas Pharma US Inc, Astralis, Biogen Idec, Bradley, Centocor, Cephalon, Chestervalley, Collagenex, Combe, CombinatoRx, Connetics, Coria, Dermik, Doak, Dow, Dr Reddy's Laboratories, Ferndale, Galderma, Genentech, Gerson Lehrman, GlaxoSmithKline, Graceway Pharmaceuticals, Healthpoint, Intendis, Kikaku America International, Leo Pharma, Medicis, Merrimack, Merz, Novartis, Ortho-Neutrogena, Pfizer, Photocure, Pierre Favre, QLT USA, Quinnova, Roche, Serono, Sinclair Pharma, Steifel Laboratories, Synta Pharma, Thermosurgery, Valeant, Vertex, Warner Chilcott, WaveRX, and Zars. Drs Gold and Kirsner have no conflicts of interest to declare.
Portions of the information included in this article were presented at the American Academy of Dermatology Annual Meeting, San Francisco, Calif, March 3-7, 2006; the American College of Allergy, Asthma, and Immunology Annual Meeting, Philadelphia, Pa, November 9-15, 2006; and the American Academy of Dermatology Summer Academy Meeting, New York, NY, August 1-5, 2007.
PII: S0190-9622(08)00239-9
doi:10.1016/j.jaad.2008.02.008
© 2008 American Academy of Dermatology, Inc. Published by Elsevier Inc All rights reserved.
Volume 58, Issue 6 , Pages 990-999, June 2008
