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

Mark Lebwohl, MD; Tara Gower, PhD


October 10, 2006

No Evidence of Systemic Immunosuppression With TCIs

Evidence of the absence of systemic immunosuppression by TCIs was based on several criteria. Studies with tacrolimus ointment showed no effect on cell-mediated immunity or antibody-mediated response to vaccination and no increased rate of cutaneous infection (Figure 4).[47,48,49] Similarly, no evidence of pimecrolimus affecting B-cell-mediated vaccine response or T-cell-mediated delayed-type hypersensitivity and no increase in the rate of systemic infections have been reported in the medical literature ( Table 2 ).[27,50,51] Systemic immunosuppression requires sustained levels of an immunosuppressive agent in the blood, which have not been observed in patients receiving TCIs. Considering that the level of systemic exposure of TCIs is very low and systemic immune function is preserved, it is not surprising that a causal relationship has not been established between use of TCIs and the development of any type of malignancy, including skin malignancy and lymphoma.

Figure 4.

No effect of treatment with tacrolimus 0.03% or hydrocortisone ointment on the immediate response or on T-cell-dependent antibody response after vaccination in children (2-11 years of age) with moderate-to-severe AD. Reprinted with permission from Arch Dis Child.[49] Copyright 2006, British Medical Association.


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