title: Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients.
abstract: OBJECTIVE
  To measure pimecrolimus blood concentrations and to evaluate tolerability and efficacy in children and infants treated topically for atopic dermatitis with pimecrolimus cream 1% for three weeks.
  
  
  METHODS
  Three open label, non-controlled, multiple topical dose studies were conducted in children aged 8-14 years (study A, ten patients), and in infants aged 8-30 months (study B, eight patients) and 4-11 months (study C, eight patients). Pimecrolimus blood concentrations were determined on days 4 and 22 of treatment, and at end of study. Efficacy was assessed using the Eczema Area and Severity Index (EASI).
  
  
  RESULTS
  Pimecrolimus blood concentrations were consistently low, typically (81%) below 1 ng/ml, with more than half of the measurements below the assay limit of quantitation (0.5 ng/ml) in studies A and B. The highest blood concentration measured throughout the three studies was 2.6 ng/ml. The cream was well tolerated, locally and systemically. The most common adverse event suspected to be related to study medication was a transient mild to moderate stinging sensation at the application site in 5/26 patients. There was no indication of any systemic adverse effect. The patients responded well to therapy with a rapid onset of action, usually within four days. Median reductions of EASI from baseline at day 22 were 55% (study A), 63% (study B), and 83% (study C).
  
  
  CONCLUSIONS
  Three weeks treatment of children and infants with extensive atopic dermatitis, using pimecrolimus cream 1% twice daily, is well tolerated and results in minimal systemic exposure, at which no systemic effect is expected.
authors: Department of Dermatology, University Hospital, Nottingham, UK.
authors: B R
authors: BR
authors: Allen
authors: M
authors: M
authors: Lakhanpaul
authors: A
authors: A
authors: Morris
authors: S
authors: S
authors: Lateo
authors: T
authors: T
authors: Davies
authors: G
authors: G
authors: Scott
authors: M
authors: M
authors: Cardno
authors: M-E
authors: ME
authors: Ebelin
authors: P
authors: P
authors: Burtin
authors: T J
authors: TJ
authors: Stephenson
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000097:blood* / Q000188:drug therapy; D003879:Dermatologic Agents / Q000009:adverse effects / Q000097:blood* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000097:blood* / Q000627:therapeutic use; D007223:Infant; D008297:Male; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D007166:Immunosuppressive Agents; C117268:pimecrolimus; D016559:Tacrolimus