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

Abstract

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-c. 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.

Factors associated with severity of atopic dermatitis – a Finnish cross‐sectional study

“…In conclusion, there seem to be valuable factors which relate to severe AD 51 . A sub‐typing of patients in relation to confirmed severity determinants may be useful for course prediction, prognosis and targeted management 52‐54 …”

“…51 A sub-typing of patients in relation to confirmed severity determinants may be useful for course prediction, prognosis and targeted management. [52][53][54] visits were carried out in the Skin and Allergy Hospital, Helsinki University Hospital, Finland. The study was approved by the Ethics Committee of Medicine of the Hospital District of Helsinki and Uusimaa (HUS), Finland.…”

“… 51 A sub‐typing of patients in relation to confirmed severity determinants may be useful for course prediction, prognosis and targeted management. 52 , 53 , 54 …”

The long‐term safety of topical corticosteroids in atopic dermatitis: A systematic review

“…One case-control study 26 had previously been published partially elsewhere, 28 however we obtained further complete data from the author. We found conflicting results (three studies found no increased risk 21,22,26 and one study suggested increased risk 27 ). No cases of new cases of lymphoma were identified in either of the RCTs (n = 2418 and n = 152) which were collectively assessed as "moderate" certainty evidence (Table 2).…”

Atopic dermatitisReview of comorbidities and therapeutics

“…29 Tacrolimus 0.03% and 0.1% ointments are approved for adults and 0.03% for children aged 2 to 15 years with moderate-to-severe AD. 34 Pimecrolimus 1% cream is indicated for non-immunocompromised adults and children aged more than or equal to 2 years with mild-to-moderate AD. 35 TCIs are recommended as steroid-sparing agents for use on affected areas, but may cause skin burning and pruritus in some patients, especially when applied to actively inflamed skin.…”