title: Long-term safety and tolerability of pimecrolimus cream 1% and topical corticosteroids in adults with moderate to severe atopic dermatitis.
abstract: OBJECTIVE
  This randomized, double-blind, multi-centre study compared the long-term safety and tolerability of pimecrolimus cream 1% and topical corticosteroids (TCS) in 658 adults with moderate-severe atopic dermatitis (AD).
  
  
  METHODS
  Patients applied either pimecrolimus or TCS (i.e. 0.1% triamcinolone acetonide cream and/or 1% hydrocortisone acetate cream) twice daily to all affected areas until complete clearance or for up to 1 year. The study was approved by the institutional review board or ethics committee at each centre.
  
  
  RESULTS
  A majority of patients treated with either pimecrolimus or TCS used the drug on a continuous basis over 1 year. In patients who had >30% of the body surface involved by AD, the incidence rate of all skin infections was significantly lower in the pimecrolimus group than in the TCS group (95% CI of the treatment difference: -25.3% to -3.4%). The most frequent application site reaction was burning (25.9% of patients on pimecrolimus and 10.9% on TCS), which was transient and mild-moderate in most cases. Three TCS-treated patients reported skin striae. There were no treatment-related serious or clinically significant systemic adverse events. Efficacy was better in patients on continuous TCS therapy, although patients completing the study were similarly well-controlled in both groups. About 42% of the pimecrolimus-treated patients were maintained for 1 year without TCS.
  
  
  CONCLUSIONS
  Pimecrolimus demonstrated a favourable safety profile when used to treat adult patients with moderate-severe AD for up to 1 year. A significant proportion of patients could be maintained without TCS for a year.
authors.affiliation: Universitätsklinikum Münster, Hautklinik, Muenster Germany. luger@uni-muenster.de
authors.forename: T A
authors.initials: TA
authors.lastname: Luger
authors.forename: M
authors.initials: M
authors.lastname: Lahfa
authors.forename: R
authors.initials: R
authors.lastname: Fölster-Holst
authors.forename: W P
authors.initials: WP
authors.lastname: Gulliver
authors.forename: R
authors.initials: R
authors.lastname: Allen
authors.forename: S
authors.initials: S
authors.lastname: Molloy
authors.forename: N
authors.initials: N
authors.lastname: Barbier
authors.forename: C
authors.initials: C
authors.lastname: Paul
authors.forename: J D
authors.initials: JD
authors.lastname: Bos
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D002170:Canada; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage*; D016896:Treatment Outcome; D014481:United States
chemical_list: D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D016559:Tacrolimus