Report of the Topical Calcineurin Inhibitor Task Force of the American College of Allergy, Asthma and Immunology and the American Academy of Allergy, Asthma and Immunology

Atopic Dermatitis: an Update and Review of the Literature

“…During acute flares, steroids should be used in combination with emollient skin care to avoid steroid overuse and steroid-related side effects (10). It is important in ADS treatment with pimecrolimus and tacrolimus according guidelines and recommendation to include optimal skin care, identification of triggers, treatment of infections and avoidance of allergens (35). FDA raised concerns about potential malignancy risk that can be observed with increased concerns for risk for Both agents proved to be effective, with a good safety profile for a treatment period of up to 2 years with pimecrolimus and up to 4 years with tacrolimus (10,37).…”

“…FDA raised concerns about potential malignancy risk that can be observed with increased concerns for risk for Both agents proved to be effective, with a good safety profile for a treatment period of up to 2 years with pimecrolimus and up to 4 years with tacrolimus (10,37). Current FDA guidelines recommend that topical pimecrolimus nad tacrolimus are indicated for the shortterm or intermittent-long-term treatment of AD in patients 2 years of age or older who are unresponsive to or intolerant of other conventional therapies or in whom there therapies are inadvisable because of potential cancer risk (35).…”

Safety and Efficacy of Pimecrolimus in Atopic Dermatitis: A 5-Year Randomized Trial

“…The lack of systemic immunosuppression is likely due to the minimal systemic drug exposure in both infants and children. 38 40 The results of the Petite Study show for the first time that as-needed first-line treatment with PIM or TCSs has no safety concerns and no impact on the maturation of the developing immune system. The data suggest that PIM had similar efficacy to TCS and PIM was associated with a substantial corticosteroid-sparing effect.…”

Topical Calcineurin Inhibitors and Malignancy Risk

“…This also implies increase of TCS use, along with all its adverse effects, especially when used in young infants or in areas such as the face, eyelids, neck, genitals or intertriginous areas due to higher systemic exsposure (4,14). Many opinion leaders and medical associations, including the American academy of allergy, asthma and immunology (AAAAI), American college of allergy, asthma and immunology (ACAAI), American academy of dermatology, canadian dermatology association (CDA), and Canadian society of allergy and clinical immunology (CSACI) released position statements, expressing disagreement about box warning, promoting the safety of the TCIs and demanding reconsideration of the alert (15)(16)(17)(18). In September 2010, the FDA released a comprehensive review of TCI safety summarizing data from six studies including more than 6 million patients (19)(20)(21)(22)(23)(24)(25)(26).…”