Finland: A new study conducted by A. Salava and team noted that the application of tacrolimus 0.03% and 0.1% ointments and topical corticosteroids (low and moderate potency) is safe in young children with moderate-to-severe atopic dermatitis. Also, they both have comparable efficacy and safety profiles. However, evidence on children under long-term therapy seemed to be inadequate.
The findings of this study were published in the journal Clinical and Experimental Dermatology on 19th November 2021.
Topical tacrolimus has been used as off-label medication in young children but data regarding children under 2 years of age and long-term treatment remains limited. To fill this knowledge gap, the researchers aimed to evaluate the safety of tacrolimus 0.03 percent and 0.1 percent ointments compared to corticosteroids in young children with atopic dermatitis.
An elaborate 36-month follow-up study was undertaken with 152 young children aged one to three years old who had moderate-to-severe atopic dermatitis. Children were prospectively monitored, and data on infections, illness severity, growth characteristics, immunization reactions, and other relevant laboratory tests were collected thoroughly.
The results stated that skin-related illnesses, other infections, growth metrics height and weight, EASI scores, vaccine reactions, serum cortisol levels, and serum levels of IL-4, IL-10, IL-12, IL-31, and IFN gamma did not change between treatment groups. In both groups, EASI reduced dramatically.
And in the 1-week of visit, nine patients (11.68 percent) in the tacrolimus group showed significantly detectable tacrolimus blood concentrations. During the trial, no tumours or serious infections were discovered. Additionally, the levels of eosinophils in the blood were comparable in both groups.
Finally, this study data has contributed on extending the knowledge on Tacrolimus use on children under 2 years of age. Also for the long-term treatment and safety limits of the same.
Reference:
Salava, A., Perälä, M., Pelkonen, A., Mäkelä, M. and Remitz, A. (2021), Safety of tacrolimus 0.03% and 0.1% ointments in young children with atopic dermatitis - a 36-month follow-up study. Clinical and Experimental Dermatology. Accepted Author Manuscript. https://doi.org/10.1111/ced.15024