Abstract
Objective: To compare the efficacy and safety of tacrolimus ointment 0.1% and pimecrolimus cream 1% in adult patients with moderate to very severe atopic dermatitis (AD). Methods: A total of 281 patients (141 treated with tacrolimus and 140 treated with pimecrolimus) were randomized to a multicenter, investigator‐blinded, 6‐week study. Results: Tacrolimus‐treated patients had significantly greater improvements in the Eczema Area Severity Index score compared with pimecrolimus‐treated patients (mean percent reduction from baseline to study end: 57% vs 39%, respectively; p = 0.0002). Treatment success was also significantly greater among the tacrolimus‐treated patients compared with pimecrolimus‐treated patients (40% vs 22% at study end; p = 0.001), as was the improvement in percentage of total body surface area affected (a reduction of 49% vs 34% at study end; p = 0.01). Both treatment groups had similar improvements in patient assessment of itch. There were no significant differences in the incidences of adverse events, including application‐site burning and application‐site pruritus, the two most commonly reported adverse events. Significantly more pimecrolimus‐treated patients than tacrolimus‐treated patients withdrew from the study due to lack of efficacy (10 vs 1, p = 0.005). Conclusion: Tacrolimus ointment is more effective than pimecrolimus cream in adults with moderate to very severe AD. Both agents have a similar safety profile.