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

Mark Lebwohl, MD; Tara Gower, PhD


October 10, 2006


AD is a common inflammatory disease that substantially affects patients' lives. To control AD, treatment is frequently multimodal, incorporating several nonpharmacologic and pharmacologic approaches. Although topical corticosteroids have been the mainstay of treatment for AD, TCIs are an additional and valuable treatment option for long-term management. Clinical trials and in-practice experience have demonstrated that TCIs effectively treat AD symptoms and reduce the number of major AD flares. Despite recent concerns about the safety of TCIs, which were raised by the FDA, reports of malignancy in clinical trials and in postmarketing surveillance, along with pharmacokinetic and toxicology studies, have indicated that TCIs have not been causally associated with malignancy or systemic immunosuppression. However, ongoing analysis of TCIs in long-term safety studies, postmarketing surveillance, and patient registries will further establish their safety profile and evaluate any malignancy risk. As a class, TCIs will continue to be an integral part of the treatment armamentarium for patients with AD.


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