Long-term management of atopic dermatitis in infants with topical pimecrolimus, a nonsteroid anti-inflammatory drug.
BACKGROUND
Pimecrolimus cream 1% (Elidel, SDZ ASM 981), a nonsteroid selective inhibitor of inflammatory cytokines, is effective in the treatment of atopic dermatitis (AD). In this study we compared early intervention with pimecrolimus cream with treatment with a vehicle control.


OBJECTIVE
The purpose of this investigation was to assess whether early treatment in infants of AD signs/symptoms with pimecrolimus could influence long-term outcome by preventing disease flares.


METHODS
In this 1-year, double-blind controlled study, 251 infants aged 3 to 23 months with AD were randomized 4:1 to a pimecrolimus-based regimen (n = 204) or a conventional treatment regimen (n = 47). Both groups used emollients for dry skin. Early AD signs and symptoms were treated either with pimecrolimus cream to prevent flares or, in the control group, with vehicle. Vehicle was used to maintain blinding conditions. In the event of flares, moderately potent corticosteroid was permitted in both groups. The primary efficacy end point was the incidence of flares at 6 months.


RESULTS
Pimecrolimus significantly reduced the incidence of flares compared with control treatment (P <.001), with 67.6% versus 30.4% of patients completing 6 months with no flare and 56.9% versus 28.3% completing 12 months with no flare. Overall corticosteroid use was substantially lower in the pimecrolimus group: 63.7% versus 34.8% of patients did not use corticosteroids at all during the study. Pimecrolimus was also more effective than control treatment in the long-term control of pruritus and the signs of AD. There were no clinically significant differences in incidence of adverse events between the 2 treatment groups.


CONCLUSIONS
Treatment with pimecrolimus of early signs and symptoms significantly modified the disease course in infants by reducing the incidence of flares and improving overall control of AD. Pimecrolimus was safe and well tolerated.
Kapp
Alexander
A
Department of Dermatology and Allergology, Hannover Medical University, Ricklingerstrasse 5, D-30449 Hannover, Germany.
Papp
Kim
K
Bingham
Ann
A
Fölster-Holst
Regina
R
Ortonne
Jean-Paul
JP
Potter
Paul C
PC
Gulliver
Wayne
W
Paul
Carle
C
Molloy
Stephen
S
Barbier
Nathalie
N
Thurston
Mark
M
de Prost
Yves
Y
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D003257:Consumer Product Safety; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000503:physiopathology; D003879:Dermatologic Agents / Q000627:therapeutic use*; D019468:Disease Management; D004311:Double-Blind Method; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007223:Infant; D016559:Tacrolimus / Q000031:analogs & derivatives / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003879:Dermatologic Agents; D007166:Immunosuppressive Agents; C117268:pimecrolimus; D016559:Tacrolimus