title: Treatment of paediatric atopic dermatitis with pimecrolimus (Elidel, SDZ ASM 981): impact on quality of life and health-related quality of life.
abstract: OBJECTIVE
  To report on quality of life (QoL) and health-related quality of life (HRQL) impacts of pimecrolimus (Elidel, Novartis A.G., Basel, Switzerland, SDZ ASM 981) 1% cream in the long-term treatment of paediatric atopic dermatitis.
  
  
  METHODS
  QoL and HRQL data are presented from two 12-month international clinical trials evaluating the efficacy and safety of pimecrolimus 1% cream. Both trials were randomized and double blinded and compared two treatment strategies, one involving the use of emollients, pimecrolimus and topical corticosteroids, the other is 'usual care' (emollients plus topical corticosteroids) with a vehicle cream to maintain study blinding. The first trial (the infant trial) involved patients between ages 3 months and 2 years, whereas the children trial included patients aged 2-17 years. In both trials, QoL of the affected child's parent was evaluated with the parent's index of quality of life in atopic dermatitis (PIQoL-AD). HRQL was assessed in the children trial only with the children's dermatology life quality index (CDLQI). QoL and HRQL assessments were conducted at baseline, 6 weeks, 6 months and 12 months.
  
  
  RESULTS
  Generalized linear modelling of PIQoL-AD scores at each post-baseline visit showed a greater impact on parent's QoL for pimecrolimus compared with control at all time-points in both trials. HRQL scores showed a greater improvement from baseline for children in the pimecrolimus group compared with those in the control group at all time-points.
  
  
  CONCLUSIONS
  The results show a beneficial impact of pimecrolimus on parents' QoL in paediatric atopic dermatitis, confirming findings from earlier shorter term trials. There was also a clear benefit to the HRQL of the children treated.
authors.affiliation: Galen Research, Manchester, UK. smckenna@galen-research.com
authors.forename: S P
authors.initials: SP
authors.lastname: McKenna
authors.forename: D
authors.initials: D
authors.lastname: Whalley
authors.forename: Y
authors.initials: Y
authors.lastname: de Prost
authors.forename: D
authors.initials: D
authors.lastname: Staab
authors.forename: J
authors.initials: J
authors.lastname: Huels
authors.forename: C F
authors.initials: CF
authors.lastname: Paul
authors.forename: D
authors.initials: D
authors.lastname: van Assche
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D065095:Calcineurin Inhibitors; D002648:Child; D002669:Child Welfare; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D019696:Peptidylprolyl Isomerase / Q000037:antagonists & inhibitors; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D065095:Calcineurin Inhibitors; D003879:Dermatologic Agents; C117268:pimecrolimus; D019696:Peptidylprolyl Isomerase; D016559:Tacrolimus