TY - JOUR
T1 - Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis
AU - Hanifin, Jon M.
AU - Paller, Amy S.
AU - Eichenfield, Lawrence
AU - Clark, Richard A.
AU - Korman, Neil
AU - Weinstein, Gerald
AU - Caro, Ivor
AU - Jaracz, Eileen
AU - Rico, M. Joyce
N1 - Funding Information:
Supported by a grant from Astellas Pharma US, Inc.
PY - 2005/8
Y1 - 2005/8
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jaad.2005.04.062
DO - 10.1016/j.jaad.2005.04.062
M3 - Article
C2 - 16021174
AN - SCOPUS:22044449340
SN - 0190-9622
VL - 53
SP - S186-S194
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
IS - 2 SUPPL. 2
ER -