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Comment & Response
September 18, 2018

Safety of Topical Calcineurin Inhibitors for Hailey-Hailey Disease

Author Affiliations
  • 1Department of Dermatology, Suqian First Hospital, Suqian City, Jiangsu Province, China
JAMA. 2018;320(11):1200. doi:10.1001/jama.2018.9554

To the Editor Dr Haley and colleagues1 described a patient with Hailey-Hailey disease (HHD) in a JAMA Clinical Challenge article. The authors stated that long-term topical calcineurin inhibitors (TCIs) such as tacrolimus or pimecrolimus could be applied to control HHD because they lacked the adverse effects of topical corticosteroids. However, the US Food and Drug Administration (FDA) issued a public health advisory in 2005 about a potential cancer risk associated with the use of tacrolimus, based on animal studies and case reports in a small number of patients.2 Although the finding is controversial, the number of patients in whom cancer developed after TCI therapy has been increasing. Development of squamous cell carcinoma has been reported with topical application of 0.1% tacrolimus for 10 months in a patient with HHD, and tacrolimus therapy may have promoted the development of squamous cell carcinoma from the HHD lesion.3 Because of limited and uncertain data on the long-term safety of topical TCIs in HHD treatment, especially as these agents are used off-label, TCIs should be applied as a second-line therapy for short-term or intermittent treatment of HHD, and patients treated with TCIs require careful follow-up.