Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children

Anita Remitz, John Harper, Malcolm Rustin, Wouter F M Goldschmidt, Riitta Palatsi, Pieter G M Van Der Valk, Graham Sharpe, Catherine H. Smith, A. Dobozy, Kristiina Turjanmaa

Research output: Contribution to journalArticle

40 Citations (Scopus)

Abstract

Tacrolimus ointment is a topical calcineurin inhibitor for the treatment of atopic dermatitis. The primary objective of this open-label study was to assess the long-term safety of tacrolimus ointment. The primary end-point was the incidence of adverse events. Secondary end-points included the Eczema Area and Severity Index and a modified version of this index. A total of 466 children with atopic dermatitis, aged 2-15 years, applied 0.03% or 0.1% tacrolimus ointment twice daily for up to 29.5 months. Skin burning and pruritus were the most common application site events; their prevalence decreased over time. There was no increase in viral infections or other adverse events over time. Laboratory profiles were consistent with those reported in atopic populations. Substantial improvement in all efficacy end-points was observed by week 2 and maintained throughout the study. Long-term treatment with tacrolimus ointment is safe and effective in these patients with atopic dermatitis.

Original languageEnglish
Pages (from-to)54-61
Number of pages8
JournalActa Dermato-Venereologica
Volume87
Issue number1
DOIs
Publication statusPublished - 2007

Fingerprint

Tacrolimus
Atopic Dermatitis
Ointments
Safety
Eczema
Virus Diseases
Therapeutics
Pruritus
Skin
Incidence
Population

Keywords

  • Atopic dermatitis
  • Long-term
  • Safety
  • Tacrolimus ointment

ASJC Scopus subject areas

  • Dermatology

Cite this

Remitz, A., Harper, J., Rustin, M., Goldschmidt, W. F. M., Palatsi, R., Van Der Valk, P. G. M., ... Turjanmaa, K. (2007). Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. Acta Dermato-Venereologica, 87(1), 54-61. https://doi.org/10.2340/00015555-0167

Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. / Remitz, Anita; Harper, John; Rustin, Malcolm; Goldschmidt, Wouter F M; Palatsi, Riitta; Van Der Valk, Pieter G M; Sharpe, Graham; Smith, Catherine H.; Dobozy, A.; Turjanmaa, Kristiina.

In: Acta Dermato-Venereologica, Vol. 87, No. 1, 2007, p. 54-61.

Research output: Contribution to journalArticle

Remitz, A, Harper, J, Rustin, M, Goldschmidt, WFM, Palatsi, R, Van Der Valk, PGM, Sharpe, G, Smith, CH, Dobozy, A & Turjanmaa, K 2007, 'Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children', Acta Dermato-Venereologica, vol. 87, no. 1, pp. 54-61. https://doi.org/10.2340/00015555-0167
Remitz, Anita ; Harper, John ; Rustin, Malcolm ; Goldschmidt, Wouter F M ; Palatsi, Riitta ; Van Der Valk, Pieter G M ; Sharpe, Graham ; Smith, Catherine H. ; Dobozy, A. ; Turjanmaa, Kristiina. / Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. In: Acta Dermato-Venereologica. 2007 ; Vol. 87, No. 1. pp. 54-61.
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