Objective To assess the efficacy and safety of tacrolimus ointment in a large population of patients with atopic dermatitis (AD) by pooling data from individual Asian studies, and to compare the results of this study with those in the United States, Europe, and Japan.
Materials and methods We analyzed the pooled data from individual studies conducted in the eight Asian areas. The efficacy assessments included success rate based on Physician’s Global Evaluation of Clinical Response, Eczema Area Severity Index (EASI), Percent Body Surface Area (%BSA) affected, Patient’s Assessment of Itch (Itch), Dermatology Life Quality Index (DLQI) and children’s DLQI (CDLQI). The results that were published in the United States, Europe, and Japan were cited.
Results A total of 860 patients were included in this study. The success rates were more than 80% in both adult and pediatric patients. Similar success rates were shown in the United States, European, and Japanese studies. There were no differences in the improvements in %BSA affected, EASI, and Itch between this study and the United States study. In both Asia and the United States, tacrolimus therapy improved total quality of life and all subscales in DLQI and CDLQI. Skin burning and pruritus were common adverse events among the Asian, United States and European studies.
Conclusions Tacrolimus ointment is an effective and well-tolerated treatment option in patients with AD in Asia. In this study, the efficacy and safety of tacrolimus are similar to those in the United States, European, and Japan studies.