Tacrolimus efficacy in atopic dermatitis in children. A systematic review

Objective: Systematically collect all evidences about the efficacy and security of topical tacrolimus for treatment of atopic dermatitis in children under 12 years of age. Methods: Systematic review of literature with sensitive searches in Medline, Embase, Índice Médico Español, and contact with the first authors of all clinical trials and with the company developing the substance. Results: There are three randomised, blind clinical trials comparing tacrolimus ointment 0,03% with either placebo (two studies) or hydrocortisone aceponate (one study). For efficacy a blanching of over 75% of the lesions was the endpoint of the study. An NNT= 3 (95%CI 3-5) was obtained when compared with placebo, and when compared with hydrocortisone aceponate the NNT was 4 (95%CI 3-5). The most frequent adverse events were pruritus (NNH = 14) and burning skin (NNH = 8 to 9). There is frequently cutaneous absortion of the substance, but the blood levels obtained were very low. Conclusions: Topical tacrolimus is a very efficacious treatment of moderate and severe atopic dermatitis of children 2 to 12 years of age, with a small number of mild adverse events that are well tolerated and limited in time.