title: Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis.
abstract: OBJECTIVE
  This study was designed to evaluate the long-term safety and efficacy of 0.1% tacrolimus ointment in adult and pediatric patients with atopic dermatitis (AD).
  
  
  METHODS
  A total of 408 adult and 391 pediatric patients with AD who had participated in a previous clinical trial of tacrolimus ointment were enrolled in this long-term, open-label, noncomparative trial. Tacrolimus ointment 0.1% was applied twice daily either intermittently or continuously to the affected areas. Efficacy and safety assessments included percent body surface area affected, Eczema Area and Severity Index score, individual signs of AD, and the incidence of adverse events.
  
  
  RESULTS
  A total of 799 patients were evaluated, of whom 300 (37.5%) were followed for more than 3 years (maximum 49 months). Improvements in efficacy parameters were observed within 1 week of treatment and continued for the duration of the study. Common adverse events included skin burning, pruritus, skin infection, skin erythema, flu-like symptoms, and headache. The incidence of adverse events, including cutaneous infections, did not increase with time on study.
  
  
  CONCLUSIONS
  Tacrolimus ointment therapy is a rapidly effective and safe treatment for the management of AD in pediatric and adult patients for up to 4 years.
authors: Oregon Health Sciences University, Portland, Oregon 97239, USA. hanifinj@ohsu.edu
authors: Jon M
authors: JM
authors: Hanifin
authors: Amy S
authors: AS
authors: Paller
authors: Lawrence
authors: L
authors: Eichenfield
authors: Richard A
authors: RA
authors: Clark
authors: Neil
authors: N
authors: Korman
authors: Gerald
authors: G
authors: Weinstein
authors: Ivor
authors: I
authors: Caro
authors: Eileen
authors: E
authors: Jaracz
authors: M Joyce
authors: MJ
authors: Rico
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D009824:Ointments; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D007166:Immunosuppressive Agents; D009824:Ointments; D016559:Tacrolimus