Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part II, Safety

In two randomized, double-bind, multicenter studies, a total of 631 adult p atients with moderate to severe atopic dermatitis applied tacrolimus ointme nt (0.03% or 0.1%) or vehicle twice daily for up to 12 mreeks. The mean per cent body surface area (%BSA) affected at baseline was 45%, and 56% of pati ents had severe atopic dermatitis. As previously reported, these studies sh owed that tacrolimus ointment was superior to vehicle for all efficacy para meters measured. This report focuses on the safety of tacrolimus ointment i n these studies. The most common adverse events were the sensation of skin burning, pruritus, flu-like symptoms, skin erythema, and headache. Skin bur ning and pruritus were more common among patients with severe or extensive disease; these events were usually brief and were resolved during the first few days of treatment. Common adverse events with a significantly higher i ncidence in one or both of the tacrolimus ointment groups than in the vehic le group included skin burning, flu-like symptoms, and headache. More patie nts in the vehicle group discontinued the study because of an adverse event than in either of the tacrolimus ointment groups. There were no notable or consistent changes in any laboratory variables. Tacrolimus was not detecte d in 80% of blood samples collected. Measurable concentrations of tacrolimu s were transitory and were not associated with adverse events. Tacrolimus o intment is a safe therapy for the treatment of adult patients with atopic d ermatitis on the face, neck, or other body regions.