Long-term control of atopic dermatitis with pimecrolimus cream 1% in infants and young children: a two-year study.
OBJECTIVE
The safety and efficacy of treatment with pimecrolimus cream 1% was evaluated for up to 2 years in infants and young children with atopic dermatitis. Ninety-one patients participated in a 1-year, open-label extension to a 1-year double-blind study. Of these, 76 received pimecrolimus for 2 years. Pimecrolimus was applied twice daily at the first signs or symptoms of the disease until clearance. Outcome measures included the incidence of adverse events and the Eczema Area and Severity Index (EASI).


RESULTS
No patient discontinued because of adverse events. The incidence of systemic and skin infections did not increase over time. Over the 2-year period, 2 patients experienced an episode of clinically diagnosed eczema herpeticum. In patients receiving pimecrolimus for 2 years, the mean decrease in EASI score from baseline was 68.7% at 3 months and 70.8% at 24 months.


CONCLUSIONS
Treatment with pimecrolimus cream 1% for up to 2 years was well tolerated and resulted in a marked and sustained improvement of atopic dermatitis.
Papp
Kim A
KA
Probity Medical Research, Hannover Medical University, Waterloo, Ontario, Canada. kapapp@probitymedical.com
Werfel
Thomas
T
Fölster-Holst
Regina
R
Ortonne
Jean-Paul
JP
Potter
Paul C
PC
de Prost
Yves
Y
Davidson
Miles J
MJ
Barbier
Nathalie
N
Goertz
Hans-Peter
HP
Paul
Carle
C
D000279:Administration, Cutaneous; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007223:Infant; D008297:Male; D009824:Ointments; D012074:Remission Induction; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D009824:Ointments; C117268:pimecrolimus; D016559:Tacrolimus