Safety of Tacrolimus Ointments in Young Children With Atopic Dermatitis

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• The authors evaluated the off-label use of tacrolimus ointment for atopic dermatitis in children aged 1 to 3 years. The rates of infections, growth, serum interleukin levels, and other evaluated parameters were similar between patients treated with tacrolimus and topical steroids over the 3-year follow-up period. No malignancies were reported. Topical tacrolimus in both 0.03% and 0.1% strengths appeared safe and as effective as topical steroids in young children with atopic dermatitis.

• It is reasonable to use topical tacrolimus 0.03% and 0.1% in younger children whose disease is not controlled by topical steroids. Further study on optimal treatment duration and long-term side effects is needed.

–  Caroline K. Crabtree, MD

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BACKGROUND

Topical tacrolimus is used off-label in young children, but data are limited on its use in children under 2 years of age and for long-term treatment.

AIM

To compare safety differences between topical tacrolimus (0.03% and 0.1% ointments) and topical corticosteroids (mild and moderate potency) in young children with atopic dermatitis (AD).

METHODS

We conducted a 36-month follow-up study with 152 young children aged 1-3 years with moderate to severe AD. The children were followed up prospectively, and data were collected on infections, disease severity, growth parameters, vaccination responses and other relevant laboratory tests were gathered.

RESULTS

There were no significant differences between the treatment groups for skin-related infections (SRIs) (P = 0.20), non-SRIs (P = 0.20), growth parameters height (P = 0.60), body weight (P = 0.81), Eczema Area and Severity Index (EASI) (P = 0.19), vaccination responses (P = 0.62), serum cortisone levels (P = 0.23) or serum levels of interleukin (IL)-4, IL-10, IL-12, IL-31 and interferon-γ. EASI decreased significantly in both groups (P < 0.001). In the tacrolimus group, nine patients (11.68%) had detectable tacrolimus blood concentrations at the 1-week visit. There were no malignancies or severe infections during the study, and blood eosinophil counts were similar in both groups.

CONCLUSIONS

Topical tacrolimus (0.03% and 0.1%) and topical corticosteroids (mild and moderate potency) are safe to use in young children with moderate to severe AD, and have comparable efficacy and safety profiles.

Clinical and Experimental Dermatology

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

Clin Exp Dermatol 2021 Nov 19;[EPub Ahead of Print], A Salava, M Perälä, A Pelkonen, M Mäkelä, A Remitz 

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Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

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