Tacrolimus ointment is safe and effective in the treatment of atopic dermatitis: Results in 8000 patients - 21/08/11
Reprint requests to: M. Joyce Rico, MD, Astellas Pharma US, Inc, 3 Parkway N, Deerfield, IL 60015.San Francisco, California; Winston-Salem, North Carolina; Dallas, Texas; Norfolk, Virginia; Atlanta, Georgia; Little Rock, Arkansas; New Brunswick, New Jersey; and Deerfield, Illinois
Abstract |
Objective |
We sought to evaluate the safety and efficacy of tacrolimus ointment in a large cohort of adult and pediatric patients with atopic dermatitis (AD).
Methods |
A cohort of 3964 adult and 3959 pediatric patients with AD were enrolled in this open-label noncomparative study. Patients applied tacrolimus 0.03% or 0.1% ointment twice daily to the affected areas. Efficacy and safety assessments included percentage of body surface area affected and incidence of adverse events, respectively.
Results |
A total of 7923 patients were evaluated; 95.5% had severe or moderate AD at baseline. There was a 52% decrease from baseline in the mean percentage of body surface area affected at month 1 and a 91% decrease at month 18. Two of the most common adverse events, skin burning and pruritus, were generally mild, transient in nature, and decreased in prevalence as AD improved. Severity and frequency of other common adverse events were consistent with expected rates in the general population.
Conclusion |
Tacrolimus ointment monotherapy in almost 8000 pediatric and adult patients led to continuous improvement in AD and revealed no change in the safety profile reported in previous clinical trials.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AD, BSA, %BSA, NMSC
Plan
| Supported by Astellas Pharma US, Inc. Disclosure: Drs Rico and Jaracz are full-time employees of Astellas Pharma US, Inc. Drs Koo and Abramovits have served as consultants for Astellas Pharma US, Inc. Drs Koo, Fleischer, and Abramovits are on the speakers bureau of Astellas Pharma US, Inc. All other authors served as principal investigators in this study. Portions of this information were presented at the 20th World Congress of Dermatology in Paris, France, July 4, 2002, and at the 61st Annual Meeting of the American Academy of Dermatology in San Francisco, Calif, March 21-26, 2003. |
Vol 53 - N° 2S2
P. S195-S205 - août 2005 Retour au numéro
Article précédent
- 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 ∗
- Pneumococcal seroconversion after vaccination for children with atopic dermatitis treated with tacrolimus ointment
- E. Richard Stiehm, Robert L. Roberts, Michael S. Kaplan, Jonathan Corren, Eileen Jaracz, M. Joyce Rico
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