Efficacy and tolerability of three different doses of oral pimecrolimus in the treatment of moderate to severe atopic dermatitis: A randomized controlled trial

K. Wolff, C. Fleming, Jon Hanifin, K. Papp, S. Reitamo, M. Rustinn, N. Shear, W. Silny, N. Korman, I. Marks, R. Cherill, S. Emady-Azar, Carle Paul

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Background: Adult atopic dermatitis (AD) can seriously affect quality of life of patients and their families, and patients' disease is frequently not satisfactorily controlled with topical therapy. There is a need for alternatives to topical treatment in patients with moderate to severe AD. Objectives: To investigate the efficacy and safety of oral pimecrolimus, and to determine the response to three different doses in the treatment of AD. Methods: In a double-blind, placebo-controlled, parallel-group, dose-finding study, patients with moderate to severe AD were randomized to receive either placebo, or oral pimecrolimus 10, 20 or 30 mg twice daily. The study consisted of a pre-treatment phase, a 12-week double-blind treatment phase, and a 12-week post-treatment phase. Results: In total, 103 patients were randomized. A clear, dose-dependent therapeutic effect of pimecrolimus treatment was observed, with a statistically significant onset of efficacy at week 2 and the greatest reduction from baseline of the Eczema Area and Severity Index of 66-6% at week 7 in the 30 mg twice daily dose group. Oral pimecrolimus was well tolerated and there were no signs of nephrotoxicity or the induction of hypertension. Conclusions: These data demonstrate the clinically relevant efficacy and short-term safety of oral pimecrolimus in adults with moderate to severe AD. Longer-term studies in larger cohorts are now required.

Original languageEnglish (US)
Pages (from-to)1296-1303
Number of pages8
JournalBritish Journal of Dermatology
Volume152
Issue number6
DOIs
StatePublished - Jun 2005

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Atopic Dermatitis
Randomized Controlled Trials
Therapeutics
Placebos
Safety
Eczema
Therapeutic Uses
pimecrolimus
Quality of Life
Hypertension

Keywords

  • Adults
  • Atopic dermatitis
  • Pimecrolimus
  • Randomized controlled trial

ASJC Scopus subject areas

  • Dermatology

Cite this

Efficacy and tolerability of three different doses of oral pimecrolimus in the treatment of moderate to severe atopic dermatitis : A randomized controlled trial. / Wolff, K.; Fleming, C.; Hanifin, Jon; Papp, K.; Reitamo, S.; Rustinn, M.; Shear, N.; Silny, W.; Korman, N.; Marks, I.; Cherill, R.; Emady-Azar, S.; Paul, Carle.

In: British Journal of Dermatology, Vol. 152, No. 6, 06.2005, p. 1296-1303.

Research output: Contribution to journalArticle

Wolff, K, Fleming, C, Hanifin, J, Papp, K, Reitamo, S, Rustinn, M, Shear, N, Silny, W, Korman, N, Marks, I, Cherill, R, Emady-Azar, S & Paul, C 2005, 'Efficacy and tolerability of three different doses of oral pimecrolimus in the treatment of moderate to severe atopic dermatitis: A randomized controlled trial', British Journal of Dermatology, vol. 152, no. 6, pp. 1296-1303. https://doi.org/10.1111/j.1365-2133.2005.06674.x
Wolff, K. ; Fleming, C. ; Hanifin, Jon ; Papp, K. ; Reitamo, S. ; Rustinn, M. ; Shear, N. ; Silny, W. ; Korman, N. ; Marks, I. ; Cherill, R. ; Emady-Azar, S. ; Paul, Carle. / Efficacy and tolerability of three different doses of oral pimecrolimus in the treatment of moderate to severe atopic dermatitis : A randomized controlled trial. In: British Journal of Dermatology. 2005 ; Vol. 152, No. 6. pp. 1296-1303.
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AU - Papp, K.

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AU - Silny, W.

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