Safety, Efficacy, and Dosage of 1% Pimecrolimus Cream for the Treatment of Atopic Dermatitis in Daily Practice

Jann Lübbe, Sheila F. Friedlander, Bernard Cribier, Marie Anne Morren, Amaro García-Díez, Carlo Gelmetti, Heidelore Hofmann, Ronald H. Houwing, Stephen Kownacki, Richard G B Langley, Marie Virtanen, Klaus Wolff, Steve Wisseh, Claire McGeown, Beatrice Abrams, Dirk Schneider

Research output: Contribution to journalArticle

Abstract

Introduction: Although several controlled clinical trials have demonstrated the efficacy and good tolerability of 1% pimecrolimus cream for the treatment of atopic dermatitis, the results of these trials may not apply to real-life usage. The objective of this study was to evaluate the safety and efficacy of a pimecrolimus-based regimen in daily practice. Methods: This was a 6-month, open-label, multicenter study in 947 patients aged ≥3 months with atopic dermatitis of all severities. The investigators incorporated 1% pimecrolimus cream into patients' standard treatment protocols on the basis of their clinical diagnosis. Use of topical corticosteroids was allowed at the discretion of the physician. Safety and tolerability were evaluated by monitoring adverse events. Efficacy was evaluated by recording changes in the Investigators' Global Assessment scores and pruritus scores at each visit. Results: No clinically unexpected adverse events were reported. The discontinuation rate for adverse events was 2.3%. The disease improvement rate was 53.7% at week 1 and 66.9% at week 24. The pimecrolimus-based regimen was particularly effective for the treatment of lesions involving the face (improvement rate: 61.9% at week 1 and 76.7% at week 24). The greatest therapeutic response was experienced by pediatric patients with mild or moderate disease. Nonetheless, 64% and 65% of infants and children, respectively, with severe/very severe facial disease at baseline were clear/almost clear of signs of atopic dermatitis on their face at week 24. In patients aged

Original languageEnglish
Pages (from-to)121-131
Number of pages11
JournalAmerican Journal of Clinical Dermatology
Volume7
Issue number2
DOIs
Publication statusPublished - 2006

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Atopic Dermatitis
Safety
Research Personnel
Controlled Clinical Trials
Therapeutics
Pruritus
Clinical Protocols
Multicenter Studies
Adrenal Cortex Hormones
Pediatrics
Physicians
pimecrolimus

ASJC Scopus subject areas

  • Dermatology

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Safety, Efficacy, and Dosage of 1% Pimecrolimus Cream for the Treatment of Atopic Dermatitis in Daily Practice. / Lübbe, Jann; Friedlander, Sheila F.; Cribier, Bernard; Morren, Marie Anne; García-Díez, Amaro; Gelmetti, Carlo; Hofmann, Heidelore; Houwing, Ronald H.; Kownacki, Stephen; Langley, Richard G B; Virtanen, Marie; Wolff, Klaus; Wisseh, Steve; McGeown, Claire; Abrams, Beatrice; Schneider, Dirk.

In: American Journal of Clinical Dermatology, Vol. 7, No. 2, 2006, p. 121-131.

Research output: Contribution to journalArticle

Lübbe, J, Friedlander, SF, Cribier, B, Morren, MA, García-Díez, A, Gelmetti, C, Hofmann, H, Houwing, RH, Kownacki, S, Langley, RGB, Virtanen, M, Wolff, K, Wisseh, S, McGeown, C, Abrams, B & Schneider, D 2006, 'Safety, Efficacy, and Dosage of 1% Pimecrolimus Cream for the Treatment of Atopic Dermatitis in Daily Practice', American Journal of Clinical Dermatology, vol. 7, no. 2, pp. 121-131. https://doi.org/10.2165/00128071-200607020-00005
Lübbe, Jann ; Friedlander, Sheila F. ; Cribier, Bernard ; Morren, Marie Anne ; García-Díez, Amaro ; Gelmetti, Carlo ; Hofmann, Heidelore ; Houwing, Ronald H. ; Kownacki, Stephen ; Langley, Richard G B ; Virtanen, Marie ; Wolff, Klaus ; Wisseh, Steve ; McGeown, Claire ; Abrams, Beatrice ; Schneider, Dirk. / Safety, Efficacy, and Dosage of 1% Pimecrolimus Cream for the Treatment of Atopic Dermatitis in Daily Practice. In: American Journal of Clinical Dermatology. 2006 ; Vol. 7, No. 2. pp. 121-131.
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AU - Friedlander, Sheila F.

AU - Cribier, Bernard

AU - Morren, Marie Anne

AU - García-Díez, Amaro

AU - Gelmetti, Carlo

AU - Hofmann, Heidelore

AU - Houwing, Ronald H.

AU - Kownacki, Stephen

AU - Langley, Richard G B

AU - Virtanen, Marie

AU - Wolff, Klaus

AU - Wisseh, Steve

AU - McGeown, Claire

AU - Abrams, Beatrice

AU - Schneider, Dirk

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