title: Long-term efficacy and tolerability of tacrolimus 0.03% ointment in infants:* a two-year open-label study.
abstract: BACKGROUND
  Tacrolimus ointment is effective for treatment of moderate to severe atopic dermatitis (AD) in children aged ≥2 years (Br J Dermatol, 2004; 150: 554). Here, efficacy and tolerability of tacrolimus 0.03% ointment were evaluated in 50 infants aged <2 years at start of treatment.
  
  
  METHODS
  Infants with AD previously enrolled in a tacrolimus ointment pharmacokinetics trial were eligible for a 24-month open-label phase II study. Tacrolimus 0.03% ointment was applied to affected areas until clearance. In cases of exacerbation or clinical worsening, patients restarted treatment.
  
  
  RESULTS
  Mean ± SD Eczema Area and Severity Index (EASI) score improved, from 11.2 ± 10.5 baseline to 2.6 ± 4.1 at endpoint (24 months); mean affected body surface area decreased from 25.2 ± 21.1% to 5.1 ± 9.0%, with improvement on all items of the Physicians' Assessment of Individual Signs. The Physicians' Global Evaluation of Clinical Response showed a result of "cleared"/"excellent" for 63.3% of patients; 85.7% of parents/guardians assessed symptoms as "much better." Treatment was well tolerated, with common, nonserious respiratory infections and gastroenteritis the most frequently reported adverse events. The most common application-site events were infections and pruritus. Over 98% of blood samples showed tacrolimus concentrations <1.0 ng/ml; >40% showed concentrations below the lower limit of quantification (0.0250 ng/ml).
  
  
  CONCLUSIONS
  Over a period of two years, tacrolimus 0.03% ointment was associated with substantial clinical improvement of AD in infants aged <2 years. Treatment tolerability was similar to that seen in older children.
authors.affiliation: Skin and Allergy Hospital, University of Helsinki, Helsinki, Finland.
authors.forename: Johanna M
authors.initials: JM
authors.lastname: Mandelin
authors.forename: Andris
authors.initials: A
authors.lastname: Rubins
authors.forename: Anita
authors.initials: A
authors.lastname: Remitz
authors.forename: Kristine
authors.initials: K
authors.lastname: Cirule
authors.forename: James
authors.initials: J
authors.lastname: Dickinson
authors.forename: Vincent
authors.initials: V
authors.lastname: Ho
authors.forename: Mika J
authors.initials: MJ
authors.lastname: Mäkelä
authors.forename: Silvestrs
authors.initials: S
authors.lastname: Rubins
authors.forename: Sakari
authors.initials: S
authors.lastname: Reitamo
authors.forename: Nasrullah
authors.initials: N
authors.lastname: Undre
mesh_terms: D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004485:Eczema / Q000188:drug therapy; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007223:Infant; D008297:Male; D009824:Ointments; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D009824:Ointments; D016559:Tacrolimus