Future topical therapy based on a real-world medical information database study (DEFENDER) on treatment of psoriasis vulgaris in Japan

Objective: New options for treating psoriasis vulgaris have become increasingly available. Given this context, the present study (DEFENDER) aimed to study future options for topical therapy by investigating how psoriasis vulgaris is treated in real clinical practice in Japan. Methods: We obtained data on patients diagnosed with psoriasis vulgaris who had been treated with topical therapy, systemic therapy, and phototherapy from a real-world medical information database that mainly targets general practitioners throughout Japan. Treatment details were examined by practice specialty (all clinical departments, dermatology, and non-dermatology) by reviewing the data from June 1, 2021, and from December 1, 2023. We also evaluated changes over the course of the two-and-a-half-year period. Results: The study included 10,687 cases from June 1, 2021, and 25,140 cases from December 1, 2023. Approximately 10% of these cases involved treatment of psoriasis vulgaris in non-dermatology practices. The results showed that psoriasis vulgaris was mainly treated by topical therapy, with steroids being the most commonly prescribed. In addition to steroid monotherapy and multiple steroid therapy, it was revealed that, as of December 2023, a combination with active vitamin D₃ was widely prescribed. Prescriptions of topical fixed-dose combination drugs, the second most commonly prescribed treatments, increased over the two-and-a-half-year period. Regarding dosage form, ointments were a popular choice; however, a new topical foam formulation developed for topical fixed-dose combination drugs was also increasingly prescribed. Compared with non-dermatology practices, dermatology practices used a higher proportion of combination therapy comprising topical fixed-dose combination drugs in addition to conventionally co-administered steroids and active vitamin D₃. Conclusion: The results of the present study revealed that in the topical treatment of psoriasis vulgaris in real clinical practice in Japan, it was considered problematic that steroids and active vitamin D₃ are still commonly prescribed as monotherapy or combination therapy. A problem with steroids is the risk of adverse drug reactions, and active vitamin D₃ has problems such as insufficient efficacy due to lower treatment adherence. On the other hand, topical fixed-dose combination drugs, which are recommended as first-line topical therapy, may overcome these problems, and new dosage forms have become available. Consequently, dermatology practices can now select the dosage form according to each patient's lesion and lifestyle. Therefore, based on a recent treatment trend, in future topical therapy, it is considered desirable to choose the more optimal medication and dosage form, focusing on topical fixed-dose combination drugs such as Cal/BDP, in which three different dosage forms are available, aiming to maintain good treatment adherence for each patient.