Tacrolimus ointment 0.03% shows efficacy and safety in pediatric and adult patients with mild to moderate atopic dermatitis - 21/08/11
, Lawrence A. Schachner, MD b, Debra Breneman, MD c, Mark Boguniewicz, MD d, Michael H. Gold, MD e, Toni Shull, RN f, Gregory J. Linowski, BS f, Eileen Jaracz, PharmD ffor the US Tacrolimus Ointment Study Group
Reprint requests: M. Shane Chapman, MD, Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Section of Dermatology, Lebanon, NH 03756.Lebanon, New Hampshire; Miami, Florida; Cincinnati, Ohio; Denver, Colorado; Nashville, Tennessee; and Deerfield, Illinois
Abstract |
Background/Objective |
Tacrolimus ointment is approved for the treatment of moderate to severe atopic dermatitis (AD). We sought to evaluate the efficacy and safety of tacrolimus ointment 0.03% compared with vehicle in the treatment of patients with mild to moderate AD.
Methods |
Two identically designed, independent, randomized, double-blind, 6-week studies—one pediatric and one adult—in patients with mild to moderate AD were conducted. Combined data from 617 patients were used in the analysis. The primary efficacy end point was percentage of patients with treatment success (defined as “clear” or “almost clear” on the Investigator's Global AD Assessment) at end of study.
Results |
As early as day 4, treatment success occurred in 17.7% of patients treated with tacrolimus compared with 9.8% of patients treated with vehicle (P=.003), and by study end had increased to 49.7% for tacrolimus versus 29.0% for vehicle (P < .0001). Tacrolimus was associated with significantly less application site pruritus than vehicle (29.0% vs 37.5%; P=.03). There was no difference between tacrolimus and vehicle in the incidence of application site skin burning and stinging.
Conclusion |
Tacrolimus ointment 0.03% is effective and safe for the management of mild to moderate AD in both adult and pediatric patients, and has a rapid onset of action.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AD, BSA, %BSA, EASI, EOS
Plan
| Supported by Astellas Pharma US, Inc. Disclosures: Ms Shull, Mr Linowski, and Ms Dr Jaracz are full-time employees of Astellas Pharma US, Inc. All other authors served as principal investigators in this study. Drs Chapman, Gold, Schachner, and Boguniewicz have received research support/grants from Astellas Pharma US, Inc. Drs Chapman, Gold, and Boguniewicz are on the speakers bureau of Astellas Pharma US, Inc. Drs Boguniewicz and Gold are on the speakers bureau of Novartis Pharmaceuticals Corp. Drs Chapman and Gold have served as consultants to Astellas Pharma US, Inc. Dr Gold is a consultant and clinical investigator for Novartis Pharmaceuticals Corp. Drs Gold and Boguniewicz have received research support/grants from Novartis Pharmaceuticals Corp. Portions of this information were presented at the 62nd Annual Meeting of the American Academy of Dermatology in Washington, DC, February 6-11, 2004. |
Vol 53 - N° 2S2
P. S177-S185 - août 2005 Retour au numéro
Article précédent
- The role of dendritic cell subtypes in the pathophysiology of atopic dermatitis
- Natalija Novak, Thomas Bieber
- Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis
- Jon M. Hanifin, Amy S. Paller, Lawrence Eichenfield, Richard A. Clark, Neil Korman, Gerald Weinstein, Ivor Caro, Eileen Jaracz, M. Joyce Rico, for the US Tacrolimus Ointment Study Group ∗
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