title: Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children.
abstract: Tacrolimus ointment is a topical calcineurin inhibitor for the treatment of atopic dermatitis. The primary objective of this open-label study was to assess the long-term safety of tacrolimus ointment. The primary end-point was the incidence of adverse events. Secondary end-points included the Eczema Area and Severity Index and a modified version of this index. A total of 466 children with atopic dermatitis, aged 2-15 years, applied 0.03% or 0.1% tacrolimus ointment twice daily for up to 29.5 months. Skin burning and pruritus were the most common application site events; their prevalence decreased over time. There was no increase in viral infections or other adverse events over time. Laboratory profiles were consistent with those reported in atopic populations. Substantial improvement in all efficacy end-points was observed by week 2 and maintained throughout the study. Long-term treatment with tacrolimus ointment is safe and effective in these patients with atopic dermatitis.
authors.affiliation: Department of Dermatology, Helsinki University Central Hospital, Meilahdentie 2, Helsinki, Finland. anita.remitz@hus.fi
authors.forename: Anita
authors.initials: A
authors.lastname: Remitz
authors.forename: John
authors.initials: J
authors.lastname: Harper
authors.forename: Malcolm
authors.initials: M
authors.lastname: Rustin
authors.forename: Wouter F M
authors.initials: WF
authors.lastname: Goldschmidt
authors.forename: Riitta
authors.initials: R
authors.lastname: Palatsi
authors.forename: Pieter G M
authors.initials: PG
authors.lastname: van der Valk
authors.forename: Graham
authors.initials: G
authors.lastname: Sharpe
authors.forename: Catherine H
authors.initials: CH
authors.lastname: Smith
authors.forename: Attila
authors.initials: A
authors.lastname: Dobozy
authors.forename: Kristiina
authors.initials: K
authors.lastname: Turjanmaa
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; 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; D012449:Safety; D016559:Tacrolimus / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D009824:Ointments; D016559:Tacrolimus