Steroid-sparing effect of pimecrolimus cream 1% in children with severe atopic dermatitis.
OBJECTIVE
To investigate if pimecrolimus cream 1% reduces the need for steroids in the long-term management of severe pediatric atopic dermatitis (AD).


METHODS
A total of 184 pediatric patients (aged 2-17 years) with a history of severe AD according to Rajka and Langeland were enrolled. Patients were randomized to treatment with pimecrolimus cream or vehicle cream for a 24-week period. Prednicarbate 0.25% was applied as rescue medication.


RESULTS
Patients on pimecrolimus required steroids on a mean of 29% of study days, compared with 35% of patients on vehicle (p = 0.1841). On the head and neck only, the respective figures were 10 versus 19% (p = 0.0009). In patients enrolled with acute severe disease (Investigator's Global Assessment > or = 4), steroids were used on 28% of the days in the pimecrolimus group compared to 45% in the control group (p = 0.0024). On the head and neck, steroids were used on 10% of study days with pimecrolimus versus 30% with vehicle (p < 0.0001).


CONCLUSIONS
The results indicate that the need for topical steroids on the head and neck is reduced with pimecrolimus cream 1% in the management of severe pediatric AD according to the definition of Rajka and Langeland.
Zuberbier
Torsten
T
Department of Dermatology and Allergy, Allergy Centre Charité, Berlin, Germany. torsten.zuberbier@charite.de
Heinzerling
Lucie
L
Bieber
Thomas
T
Schauer
Uwe
U
Klebs
Sven
S
Bräutigam
Matthias
M
D000287:Administration, Topical; D000293:Adolescent; D065095:Calcineurin Inhibitors; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000473:pathology; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D009824:Ointments; D011239:Prednisolone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D065095:Calcineurin Inhibitors; D003879:Dermatologic Agents; D005938:Glucocorticoids; D009824:Ointments; C117268:pimecrolimus; D011239:Prednisolone; C035287:prednicarbate; D016559:Tacrolimus