title: Long-term management of atopic dermatitis in infants with topical pimecrolimus, a nonsteroid anti-inflammatory drug.
abstract: 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.
authors.affiliation: Department of Dermatology and Allergology, Hannover Medical University, Ricklingerstrasse 5, D-30449 Hannover, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Kapp
authors.forename: Kim
authors.initials: K
authors.lastname: Papp
authors.forename: Ann
authors.initials: A
authors.lastname: Bingham
authors.forename: Regina
authors.initials: R
authors.lastname: Fölster-Holst
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Ortonne
authors.forename: Paul C
authors.initials: PC
authors.lastname: Potter
authors.forename: Wayne
authors.initials: W
authors.lastname: Gulliver
authors.forename: Carle
authors.initials: C
authors.lastname: Paul
authors.forename: Stephen
authors.initials: S
authors.lastname: Molloy
authors.forename: Nathalie
authors.initials: N
authors.lastname: Barbier
authors.forename: Mark
authors.initials: M
authors.lastname: Thurston
authors.forename: Yves
authors.initials: Y
authors.lastname: de Prost
mesh_terms: 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
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003879:Dermatologic Agents; D007166:Immunosuppressive Agents; C117268:pimecrolimus; D016559:Tacrolimus