title: Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle.
abstract: BACKGROUND
  Intermittent dosing of a topical calcineurin inhibitor for preventing atopic dermatitis (AD) disease relapse in patients with stabilized AD has not been evaluated.
  
  
  OBJECTIVE
  We sought to evaluate the long-term efficacy and safety of 3-times-weekly use of tacrolimus ointment in preventing AD disease relapse.
  
  
  METHODS
  Adult and pediatric patients with moderate to severe AD who were clear of disease after up to 16 weeks of treatment with tacrolimus ointment were randomized in a double-blind fashion to 3-times-weekly treatment with either tacrolimus ointment (0.03% or 0.1%) or vehicle for 40 weeks. The primary end point was the number of flare-free treatment days.
  
  
  RESULTS
  A total of 125 patients were randomized to tacrolimus and 72 patients to vehicle. The mean number of flare-free treatment days was 177 for tacrolimus and 134 for vehicle (P = .003). Median time to first relapse was 169 days for tacrolimus and 43 for vehicle (P = .037).
  
  
  CONCLUSIONS
  Generalizability to all patients seen in clinic may be limited because only patients who responded to tacrolimus ointment in the stabilization phase were randomized into the maintenance phase of the trial.
  
  
  CONCLUSIONS
  Maintenance therapy with tacrolimus ointment was associated with significantly more flare-free days compared with vehicle, and a significantly longer time until first disease relapse.
authors: University of Cincinnati College of Medicine, Cincinnati, Ohio, USA. debra.breneman@uc.edu
authors: Debra
authors: D
authors: Breneman
authors: Alan B
authors: AB
authors: Fleischer
authors: William
authors: W
authors: Abramovits
authors: Joshua
authors: J
authors: Zeichner
authors: Michael H
authors: MH
authors: Gold
authors: Robert S
authors: RS
authors: Kirsner
authors: Toni F
authors: TF
authors: Shull
authors: Andrew W
authors: AW
authors: Crowe
authors: Eileen
authors: E
authors: Jaracz
authors: Jon M
authors: JM
authors: Hanifin
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000517:prevention & control*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D009824:Ointments; D016559:Tacrolimus / Q000008:administration & dosage*; D013997:Time Factors
chemical_list: D007166:Immunosuppressive Agents; D009824:Ointments; D016559:Tacrolimus