A Safety Assessment of Topical Calcineurin Inhibitors in the Treatment of Atopic Dermatitis

Mark Lebwohl, MD; Tara Gower, PhD

Disclosures

October 10, 2006

Safety Profile of TCIs

TCIs have a favorable safety profile. The most common adverse events are mild-to-moderate application-site reactions, including skin burning, stinging, pruritus, and erythema ( Table 1 ).[20,26,27,32] Generally, the overall adverse-event profiles of both TCIs and their vehicle are similar. Compared with topical corticosteroids, TCIs have not been found to induce skin atrophy or HPA axis suppression.[12,13,21,33,34] A single study showed a slight increase in total viral skin infections with pimecrolimus vs the control group; however, this did not reach statistical significance.[27] TCIs can be applied to all skin surfaces, including the neck and face (areas frequently affected in children with AD) and intertriginous areas, compared with midpotency to high-potency topical corticosteroids, which may have a higher level of absorption in these sensitive skin areas.

The TCI label changes (revised indication and the addition of a boxed warning and patient medication guide) arose from the FDA's concern about a theoretical cancer risk. This concern is based on adverse-effect data from high-dose and prolonged use of oral calcineurin inhibitors for posttransplant immunosuppression, high-dose toxicology studies in animal models, and rare cases of lymphoma and skin malignancy reported in postmarketing surveillance. The FDA-approved boxed warning states that a causal relationship has not been established between the rare cases of malignancy reported and the use of TCIs. However, the label does reiterate that TCIs should not be used for continuous long-term treatment in any age group and that they are not indicated for use in children aged < 2 years. To date, no evidence suggests a causal link between TCI use and malignancy on the basis of extensive safety, pharmacokinetic and toxicology data, and clinical experience with millions of patients.[35,36]

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