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 language | English |
|---|---|
| Pages (from-to) | 121-131 |
| Number of pages | 11 |
| Journal | American Journal of Clinical Dermatology |
| Volume | 7 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 2006 |
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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 journal › Article
}
TY - JOUR
T1 - Safety, Efficacy, and Dosage of 1% Pimecrolimus Cream for the Treatment of Atopic Dermatitis in Daily Practice
AU - Lübbe, Jann
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
PY - 2006
Y1 - 2006
N2 - 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
AB - 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
UR - http://www.scopus.com/inward/record.url?scp=33645867656&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33645867656&partnerID=8YFLogxK
U2 - 10.2165/00128071-200607020-00005
DO - 10.2165/00128071-200607020-00005
M3 - Article
C2 - 16605292
AN - SCOPUS:33645867656
VL - 7
SP - 121
EP - 131
JO - American Journal of Clinical Dermatology
JF - American Journal of Clinical Dermatology
SN - 1175-0561
IS - 2
ER -