Young children with moderate‐to‐severe atopic dermatitis can be treated safely and effectively with either topical tacrolimus or mild corticosteroids

Abstract

Aim We collected evidence and safety data for topical tacrolimus in small children with atopic dermatitis (AD) and compared the usage with topical corticosteroid. Methods This was an interim analysis of 75 patients (55% female) at 1 year of an ongoing 3‐year randomised open‐label comparative follow‐up study of topical tacrolimus vs corticosteroid treatment. One‐ to three‐year‐old children with moderate‐to‐severe eczema referred to the Skin and Allergy Hospital in Helsinki, Finland, were enrolled. Results Efficacy parameters, the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), transepidermal water loss (TEWL), eczema area, serum total immunoglobulin E (IgE) and the blood eosinophil count, showed improvement in both groups during the study. However, patients with signs of early sensitisation at baseline (elevated serum total IgE, elevated eosinophil count, positive prick tests or specific IgEs to aero or food allergens) had statistically significantly lower TEWL at the eczema site and a smaller eczema area at 12 months in the tacrolimus group. No severe adverse effects were seen during the treatment. Conclusion Children with AD and signs of early sensitisation appeared to benefit more from early tacrolimus than corticosteroid treatment. Small children may need stronger but nevertheless safe ointment options when treating moderate‐to‐severe AD.

Are Infants and Toddlers with Moderate-to-severe Atopic Dermatitis Undertreated? Experiences of a Finnish Tertiary Care Hospital

“…Interim analysis of a three-year follow-up study ( 4 ) was conducted, comparing 2 treatment modalities; tacrolimus ointment (both 0.03% and 0.1%) and topical corticosteroids (mild and mid-potency), in a cohort of 1 to 3 year old children. This was a randomized non-blinded follow up study with a one week wash-out period.…”

“…A total of 152 children with moderate to severe AD (Rajka and Langeland Eczema Severity Score) ( 4 ) were randomized for topical corticosteroids (hydrocortisone 1% and if needed hydrocortisone-17-butyrate cream) or topical tacrolimus (0.03% and if needed 0.1% ointment). There was a drop out of 15 patients during the first year due to nonadherence.…”

“…For children over 2 years of age 0,03% tacrolimus ointment and 1% pimecrolimus cream have been approved ( 3 ). 0,1% tacrolimus ointment has been used off-label in pediatric AD ( 4 ), but there is still limited data regarding long-term treatment in children under 2 years of age ( 5 ). We analysed the use and safety data of topical tacrolimus in small children with AD and compared the usage with topical corticosteroids.…”

Safety of tacrolimus 0.03% and 0.1% ointments in young children with atopic dermatitis: a 36‐month follow‐up study

“…General patient characteristics are presented in Table 1. In a former publication, we have characterized the baseline patient characteristics in more detail 5 …”

“…Topical tacrolimus (TAC) 0.03% ointment is approved from 2 years of age, but there have been concerns regarding its immunosuppressive potential 4 . TAC 0.1% ointment has been used off‐label in young children, but there is a lack of data regarding its use as long‐term treatment in children aged < 2 years 5 . TAC 0.03% and 0.1% ointments were approved for use in AD in 2002 and to date, no studies have directly linked the topical use of these ointments to systemic immunosuppression or an increased incidence of malignancies 6,7 .…”