Abstract Number: 101

Update on safety of topical calcineurin inhibitors in atopic dermatitis: Recommendations and current evidence

L. Anderson1, J. Su2, G. Varigos1

Meeting: 2018 Dermcoll

Session Information

Date: -

Session Title: Poster Presentations

Session Time: -

Topical corticosteroids (TCS) have long been the mainstay of pharmacologic treatment for atopic dermatitis, but their long-term use has been associated with concerns of skin atrophy, barrier disruption and the potential for percutaneous absorption.
The introduction of topical calcineurin inhibitors (TCI), tacrolimus and pimecrolimus, has provided a valuable treatment alternative. In 2006, however, the U.S Food and Drug Administration (FDA) issued a boxed warning for both TCI’s. This was based on the theoretical risk of skin malignancy and lymphoma, stemming from animal studies and data from systemic administration for solid organ transplants. In Australia, pimecrolimus is approved for short-term use in patients aged 3 months or older, but in the USA and Europe the use of TCI’s are restricted to children >2 years of age, thus often withheld from children with the greatest disease burden.
Since the introduction of the black box warning, there has been growing discordance between recommendations and current evidence. Data from systematic reviews and meta analyses, post monitoring reports, and epidemiological studies, have revealed no evidence to substantiate a causal relationship between TCI use and malignancy. In fact, TCI related malignancies have been found to occur at a similar to or lower rate compared to the general population, and there is no increased risk among patients treated using TCI’s versus TCS.
We present an update of the literature, evaluating the justification for current restrictions. We also discuss the place for long term safety studies, particularly in Australian children, and suggest potential revisions to treatment recommendations.