The authors of the first meta-analysis concluded that pimecrolimus 1% was more effective compared with placebo, less effective than potent topical corticosteroids, and had yet to be studied in comparison with low-potency topical corticosteroids. Tacrolimus 0.1% was more effective than placebo, more effective than mild corticosteroids, and as effective as potent topical corticosteroids. It was noted that both these agents caused more burning of the skin than topical corticosteroids—pimecrolimus 1% compared with betamethasone valerate 0.1% (number needed to harm [NNH]=50); tacrolimus 0.1% compared with betamethasone valerate 0.1% and hydrocortisone butyrate 0.1% (NNH=3); and tacrolimus 0.03% compared with the mild corticosteroid hydrocortisone acetate 1% (NNH=10). However, there was no significant difference in the rate of skin infections.
Recommendations from others
In 2003, a work group of dermatologists appointed by the president of the American Academy of Dermatology published a technical report on the guidelines of care for atopic dermatitis.10 This group evaluated the effectiveness of several topical treatments for the treatment of atopic dermatitis. They noted that coal tar and its derivatives may reduce the severity of atopic dermatitis symptoms, but there are significant barriers to compliance. The severity of pruritus associated with atopic dermatitis may be reduced with shortterm use of topical doxepin.
Evidence supports the use of emollients in combination with other topical corticosteroid treatments to reduce the severity of atopic dermatitis. However, emollients need frequent application, which may be associated with poor compliance. The work group also concluded that both tacrolimus and pimecrolimus are effective and safe in reducing the severity of atopic dermatitis symptoms for both children and adults up to 1 year of treatment.
In March 2005, the FDA posted a Public Health Advisory and Alerts for Healthcare Professionals regarding the potential cancer risk from the use tacrolimus and pimecrolimus products when applied to the skin to treat atopic dermatitis. These creams will carry a “black box” warning regarding this potential risk. They recommended use only as a second-line therapy, at minimal amounts necessary, and for short periods of time, not continuously. They also recommended against their use for children aged <2 years and for people with diminished immune systems.