title: Proactive disease management with 0.03% tacrolimus ointment for children with atopic dermatitis: results of a randomized, multicentre, comparative study.
abstract: BACKGROUND
  Long-term treatment for atopic dermatitis (AD) using low-dose, intermittent, topical anti-inflammatory agents may control acute disease and prevent exacerbations.
  
  
  OBJECTIVE
  This 12-month, European, multicentre, randomized study investigated if proactive, twice-weekly application of 0.03% tacrolimus ointment can keep AD in remission and reduce the incidence of disease exacerbation (DE) in children.
  
  
  METHODS
  During the initial open-label period, 267 children with AD applied 0.03% tacrolimus ointment twice daily for up to 6 weeks to all affected areas. When an Investigator Global Assessment (IGA) score of <or=2 was achieved, the patient entered the disease control period (DCP) and was randomized to receive tacrolimus (n=125) or vehicle ointment (n=125) twice weekly for 12 months. Exacerbations were treated with 0.03% tacrolimus ointment twice daily until an IGA<or=2 was regained, then randomized treatment was restarted.
  
  
  RESULTS
  The outcome measure was the number of DEs during the DCP that required substantial therapeutic intervention. Proactive application of 0.03% tacrolimus ointment significantly reduced the number of DEs during the DCP that required substantial therapeutic intervention (median difference: 1.0; P<0.001; Wilcoxon rank-sum test), the percentage of DE treatment days (median difference: 6.2; P<0.001; Wilcoxon rank-sum test), and increased the time to first DE requiring intervention (median: 173 vs. 38 days; P<0.001; stratified log-rank test). Differences in quality of life scores were not significant between groups. The adverse event profile was similar for both treatment approaches.
  
  
  CONCLUSIONS
  Twice-weekly proactive application of 0.03% tacrolimus ointment over 12 months was effective for most paediatric study patients in preventing, delaying and reducing the occurrence of AD exacerbations.
authors.affiliation: Department of Dermatology and Venerology, J.W. Goethe University, Theodor-Stern-Kai 7, Frankfurt, D-60596 Germany. thaci@em.uni-frankfurt.de
authors.forename: D
authors.initials: D
authors.lastname: Thaçi
authors.forename: S
authors.initials: S
authors.lastname: Reitamo
authors.forename: M A
authors.initials: MA
authors.lastname: Gonzalez Ensenat
authors.forename: C
authors.initials: C
authors.lastname: Moss
authors.forename: V
authors.initials: V
authors.lastname: Boccaletti
authors.forename: T
authors.initials: T
authors.lastname: Cainelli
authors.forename: P
authors.initials: P
authors.lastname: van der Valk
authors.forename: H
authors.initials: H
authors.lastname: Buckova
authors.forename: M
authors.initials: M
authors.lastname: Sebastian
authors.forename: M L
authors.initials: ML
authors.lastname: Schuttelaar
authors.forename: T
authors.initials: T
authors.lastname: Ruzicka
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004643:Emollients / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D004643:Emollients; D007166:Immunosuppressive Agents; D016559:Tacrolimus