Effects of pimecrolimus cream 1% in the treatment of patients with atopic dermatitis who demonstrate a clinical insensitivity to topical corticosteroids: a randomized, multicentre vehicle-controlled trial.
BACKGROUND
Colonization with Staphylococcus aureus in atopic dermatitis (AD) is often associated with worsening of clinical symptoms. Staphylococcus aureus produces superantigens that contribute to cutaneous inflammation and corticosteroid (CS) resistance.


OBJECTIVE
To investigate the relationship between CS insensitivity, S. aureus colonization and superantigen production in AD, and to explore the efficacy of pimecrolimus cream in CS-insensitive AD.


METHODS
This was a randomized, double-blind, vehicle-controlled, multicentre, parallel-group study. Seventy-three patients with AD, aged 2-49 years, who had a documented clinical insensitivity to topical CS, were recruited. The primary efficacy parameters combined laboratory (including S. aureus colonization, superantigens) and clinical assessments [including Eczema Area and Severity Index (EASI), whole body Investigator's Global Assessment (IGA), pruritus assessment score, patient's assessment score of disease control].


RESULTS
An increase in S. aureus counts correlated with worsening of clinical score (week 6 vs. baseline) when assessed by IGA, pruritus severity and patient assessment. The presence of superantigens correlated with this worsening. During the 6-week double-blind phase, disease improvement in the pimecrolimus cream group was demonstrated by decreasing EASI scores compared with vehicle. Mean EASI scores for the head and neck showed greater improvement in the pimecrolimus cream group than in the vehicle group at all observed time points.


CONCLUSIONS
In a cohort of patients with clinical insensitivity to CS there was a significant positive correlation between S. aureus and disease severity. Results suggest that for some of these patients, treatment with pimecrolimus cream 1% is useful, especially in the head/neck area.
Leung
D Y M
DY
Department of Pediatrics, University of Colorado Denver, and Division of Pediatric Allergy/Immunology, National Jewish Health, Denver, CO 80206, USA. leungd@njhealth.org
Hanifin
J M
JM
Pariser
D M
DM
Barber
K A
KA
Langley
R G
RG
Schlievert
P M
PM
Abrams
B
B
Hultsch
T
T
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000382:microbiology; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D014677:Pharmaceutical Vehicles / Q000008:administration & dosage; D013207:Staphylococcal Skin Infections / Q000188:drug therapy* / Q000276:immunology; D013211:Staphylococcus aureus / Q000187:drug effects / Q000276:immunology; D018089:Superantigens / Q000276:immunology; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D055815:Young Adult
D003879:Dermatologic Agents; D007166:Immunosuppressive Agents; D014677:Pharmaceutical Vehicles; D018089:Superantigens; C117268:pimecrolimus; D016559:Tacrolimus