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Use of pimecrolimus cream 1% (Elidel) in the treatment of atopic dermatitis in infants and children: the effects of ethnic origin and baseline disease severity on treatment outcome.
Int J Dermatol. 2005 Jan; 44(1):70-5.IJ

Abstract

BACKGROUND

Pimecrolimus cream 1%, a cell-selective inhibitor of inflammatory cytokines, has been shown to be effective in treating atopic dermatitis (AD). This report examines the effect of ethnic origin and baseline disease severity on treatment outcomes in pediatric patients with AD treated with pimecrolimus cream 1%.

METHODS

The analysis included 589 patients aged 3 months to 17 years from three 6-week, randomized, multicenter studies of similar design. Patients were treated with pimecrolimus cream 1% or vehicle twice daily. Efficacy, safety and tolerability in Caucasian and non-Caucasian groups were compared. In addition, the effect of baseline disease severity on treatment outcome was investigated.

RESULTS

A total of 321 Caucasian and 268 non-Caucasian patients [Blacks, Asians and others (including Hispanics)] with mild, moderate or severe disease at baseline were included. Baseline characteristics were comparable between the pimecrolimus and vehicle control groups and between Caucasian and non-Caucasian groups. Significantly higher efficacy [measured by Investigators' Global Assessment and Eczema Area and Severity Index (EASI) scores] was achieved in the pimecrolimus-treated group, compared with the vehicle group, irrespective of ethnic origin. Baseline disease severity had no effect on treatment outcome: patients with both mild and moderate AD responded well to pimecrolimus (absolute change from baseline in EASI score -2.60 and -5.48, respectively; both P < 0.001). Pimecrolimus cream 1% was safe and well tolerated in all ethnic groups and at all levels of disease severity.

CONCLUSIONS

Ethnic origin and baseline disease severity had no effect on treatment outcome with pimecrolimus cream 1% in patients with AD.

Authors+Show Affiliations

Children's Hospital, San Diego, CA, USA. leichenfield@UCSD.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15663667

Citation

Eichenfield, Lawrence F., et al. "Use of Pimecrolimus Cream 1% (Elidel) in the Treatment of Atopic Dermatitis in Infants and Children: the Effects of Ethnic Origin and Baseline Disease Severity On Treatment Outcome." International Journal of Dermatology, vol. 44, no. 1, 2005, pp. 70-5.
Eichenfield LF, Lucky AW, Langley RG, et al. Use of pimecrolimus cream 1% (Elidel) in the treatment of atopic dermatitis in infants and children: the effects of ethnic origin and baseline disease severity on treatment outcome. Int J Dermatol. 2005;44(1):70-5.
Eichenfield, L. F., Lucky, A. W., Langley, R. G., Lynde, C., Kaufmann, R., Todd, G., Lindsley, L., Barbier, N., & Felser, J. M. (2005). Use of pimecrolimus cream 1% (Elidel) in the treatment of atopic dermatitis in infants and children: the effects of ethnic origin and baseline disease severity on treatment outcome. International Journal of Dermatology, 44(1), 70-5.
Eichenfield LF, et al. Use of Pimecrolimus Cream 1% (Elidel) in the Treatment of Atopic Dermatitis in Infants and Children: the Effects of Ethnic Origin and Baseline Disease Severity On Treatment Outcome. Int J Dermatol. 2005;44(1):70-5. PubMed PMID: 15663667.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Use of pimecrolimus cream 1% (Elidel) in the treatment of atopic dermatitis in infants and children: the effects of ethnic origin and baseline disease severity on treatment outcome. AU - Eichenfield,Lawrence F, AU - Lucky,Anne W, AU - Langley,Richard G B, AU - Lynde,Charles, AU - Kaufmann,Roland, AU - Todd,Gail, AU - Lindsley,Linda, AU - Barbier,Nathalie, AU - Felser,James M, PY - 2005/1/25/pubmed PY - 2005/4/30/medline PY - 2005/1/25/entrez SP - 70 EP - 5 JF - International journal of dermatology JO - Int J Dermatol VL - 44 IS - 1 N2 - BACKGROUND: Pimecrolimus cream 1%, a cell-selective inhibitor of inflammatory cytokines, has been shown to be effective in treating atopic dermatitis (AD). This report examines the effect of ethnic origin and baseline disease severity on treatment outcomes in pediatric patients with AD treated with pimecrolimus cream 1%. METHODS: The analysis included 589 patients aged 3 months to 17 years from three 6-week, randomized, multicenter studies of similar design. Patients were treated with pimecrolimus cream 1% or vehicle twice daily. Efficacy, safety and tolerability in Caucasian and non-Caucasian groups were compared. In addition, the effect of baseline disease severity on treatment outcome was investigated. RESULTS: A total of 321 Caucasian and 268 non-Caucasian patients [Blacks, Asians and others (including Hispanics)] with mild, moderate or severe disease at baseline were included. Baseline characteristics were comparable between the pimecrolimus and vehicle control groups and between Caucasian and non-Caucasian groups. Significantly higher efficacy [measured by Investigators' Global Assessment and Eczema Area and Severity Index (EASI) scores] was achieved in the pimecrolimus-treated group, compared with the vehicle group, irrespective of ethnic origin. Baseline disease severity had no effect on treatment outcome: patients with both mild and moderate AD responded well to pimecrolimus (absolute change from baseline in EASI score -2.60 and -5.48, respectively; both P < 0.001). Pimecrolimus cream 1% was safe and well tolerated in all ethnic groups and at all levels of disease severity. CONCLUSIONS: Ethnic origin and baseline disease severity had no effect on treatment outcome with pimecrolimus cream 1% in patients with AD. SN - 0011-9059 UR - https://www.unboundmedicine.com/medline/citation/15663667/Use_of_pimecrolimus_cream_1__Elidel__in_the_treatment_of_atopic_dermatitis_in_infants_and_children:_the_effects_of_ethnic_origin_and_baseline_disease_severity_on_treatment_outcome_ L2 - https://doi.org/10.1111/j.1365-4632.2004.02234.x DB - PRIME DP - Unbound Medicine ER -