Abstract
Background: There have been no reports demonstrating the efficacy of tapinarof cream (this cream), a therapeutic aryl hydrocarbon receptor modulating topical agent, in maintaining remission among Japanese patients with plaque psoriasis.
Purpose: We investigated the efficacy of this cream in the maintenance of remission in Japanese patients with plaque psoriasis after the patients achieved a score of 0 on the Physician’s Global Assessment (PGA).
Methods: A post-hoc analysis of 116 patients who achieved a score of 0 on the PGA in a phase 3 long-term administration study of Japanese patients with mild-to-severe plaque psoriasis was performed. Items analyzed were “the duration in which a score of 1 or lower on the PGA was maintained,” “patient backgrounds by the duration in which a score of 1 or lower on the PGA was maintained,” and “the duration in which a score of 0 on the PGA was maintained in patients who suspended the application of the drug after achieving a score of 0.”
Results: The median duration in which a score of 1 or lower on the PGA was maintained starting from the time at which the PGA score became 0 was 156.5 days, and the mean duration was 145.9 days. There were no large differences in patient backgrounds when the patients were divided by the median duration in which a score of 1 or lower on the PGA was maintained (156.5 days). The median duration in which a score of 0 on the PGA was maintained in “the patient group who suspended the application of the drug after achieving a score of 0” was 61.0 days, and the mean duration was 83.4 days.
Conclusion: This post-hoc analysis of a trial in Japanese patients with plaque psoriasis demonstrated this cream to be a drug that can be expected to maintain remission of plaque psoriasis.