Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis - 21/08/11
, Amy S. Paller, MD b, Lawrence Eichenfield, MD c, Richard A. Clark, MD d, Neil Korman, MD, PhD e, Gerald Weinstein, MD f, Ivor Caro, MD g, Eileen Jaracz, PharmD h, M. Joyce Rico, MD hfor the US Tacrolimus Ointment Study Group
Correspondence and reprint requests: Jon M. Hanifin, MD, Oregon Health and Science University, Department of Dermatology, OP06, 3181 SW Sam Jackson Park Rd, Portland, OR 97239.Portland, Oregon; Chicago, Illinois; San Diego and Irvine, California; Stony Brook, New York; Cleveland, Ohio; Boston, Massachusetts; and Deerfield, Illinois
Abstract |
Objective |
This study was designed to evaluate the long-term safety and efficacy of 0.1% tacrolimus ointment in adult and pediatric patients with atopic dermatitis (AD).
Methods |
A total of 408 adult and 391 pediatric patients with AD who had participated in a previous clinical trial of tacrolimus ointment were enrolled in this long-term, open-label, noncomparative trial. Tacrolimus ointment 0.1% was applied twice daily either intermittently or continuously to the affected areas. Efficacy and safety assessments included percent body surface area affected, Eczema Area and Severity Index score, individual signs of AD, and the incidence of adverse events.
Results |
A total of 799 patients were evaluated, of whom 300 (37.5%) were followed for more than 3 years (maximum 49 months). Improvements in efficacy parameters were observed within 1 week of treatment and continued for the duration of the study. Common adverse events included skin burning, pruritus, skin infection, skin erythema, flu-like symptoms, and headache. The incidence of adverse events, including cutaneous infections, did not increase with time on study.
Conclusion |
Tacrolimus ointment therapy is a rapidly effective and safe treatment for the management of AD in pediatric and adult patients for up to 4 years.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AD, %BSA, EASI, HSV, NMSC
Plan
| Supported by a grant from Astellas Pharma US, Inc. Disclosures: Ms Dr Jaracz and Dr Rico are full-time employees of Astellas Pharma US, Inc. All other authors served as principal investigators in this study. Drs Clark and Paller have served as consultants for Astellas Pharma US, Inc. Drs Paller and Korman are on the speakers bureau of Astellas Pharma US, Inc. Portions of this information were presented at the 20th World Congress of Dermatology in Paris, France, July 4, 2002; at the 61st Annual Meeting of the American Academy of Dermatology in San Francisco, Calif, March 21-26, 2003; and at the 60th Anniversary Meeting of the American Academy of Allergy Asthma and Immunology in Denver, Colo, March 7-12, 2003. |
Vol 53 - N° 2S2
P. S186-S194 - août 2005 Retour au numéro
Article précédent
- Tacrolimus ointment 0.03% shows efficacy and safety in pediatric and adult patients with mild to moderate atopic dermatitis
- M. Shane Chapman, Lawrence A. Schachner, Debra Breneman, Mark Boguniewicz, Michael H. Gold, Toni Shull, Gregory J. Linowski, Eileen Jaracz, for the US Tacrolimus Ointment Study Group ∗
- Tacrolimus ointment is safe and effective in the treatment of atopic dermatitis: Results in 8000 patients
- John Y.M. Koo, Alan B. Fleischer, William Abramovits, David M. Pariser, Calvin O. McCall, Thomas D. Horn, Alice B. Gottlieb, Eileen Jaracz, M. Joyce Rico
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