Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis

Jon Hanifin, Amy S. Paller, Lawrence Eichenfield, Richard A. Clark, Neil Korman, Gerald Weinstein, Ivor Caro, Eileen Jaracz, M. Joyce Rico

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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.

Original languageEnglish (US)
JournalJournal of the American Academy of Dermatology
Volume53
Issue number2 SUPPL. 2
DOIs
StatePublished - Aug 2005

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Tacrolimus
Atopic Dermatitis
Ointments
Safety
Skin
Pediatrics
Body Surface Area
Eczema
Incidence
Therapeutics
Erythema
Pruritus
Infection
Headache
Clinical Trials

ASJC Scopus subject areas

  • Dermatology

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Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis. / Hanifin, Jon; Paller, Amy S.; Eichenfield, Lawrence; Clark, Richard A.; Korman, Neil; Weinstein, Gerald; Caro, Ivor; Jaracz, Eileen; Rico, M. Joyce.

In: Journal of the American Academy of Dermatology, Vol. 53, No. 2 SUPPL. 2, 08.2005.

Research output: Contribution to journalArticle

Hanifin, Jon ; Paller, Amy S. ; Eichenfield, Lawrence ; Clark, Richard A. ; Korman, Neil ; Weinstein, Gerald ; Caro, Ivor ; Jaracz, Eileen ; Rico, M. Joyce. / Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis. In: Journal of the American Academy of Dermatology. 2005 ; Vol. 53, No. 2 SUPPL. 2.
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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.",
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