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.
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.
Eichenfield
Lawrence F
LF
Children's Hospital, San Diego, CA, USA. leichenfield@UCSD.edu
Lucky
Anne W
AW
Langley
Richard G B
RG
Lynde
Charles
C
Kaufmann
Roland
R
Todd
Gail
G
Lindsley
Linda
L
Barbier
Nathalie
N
Felser
James M
JM
D000293:Adolescent; D001213:Asian; D044383:Black People; D065095:Calcineurin Inhibitors; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000145:classification / Q000188:drug therapy* / Q000208:ethnology; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005006:Ethnicity; D006630:Hispanic or Latino; D006801:Humans; D007223:Infant; D019696:Peptidylprolyl Isomerase / Q000037:antagonists & inhibitors*; D014677:Pharmaceutical Vehicles; D012449:Safety; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome; D044465:White People
D065095:Calcineurin Inhibitors; D003879:Dermatologic Agents; D014677:Pharmaceutical Vehicles; C117268:pimecrolimus; D019696:Peptidylprolyl Isomerase; D016559:Tacrolimus