This randomized Phase 3 trial evaluated brodalumab for palmoplantar pustulosis in Japanese adults who had a diagnosis for at least 24 weeks and showed inadequate response to prior therapy. The study included 35 patients receiving brodalumab and 43 patients receiving placebo who later switched to brodalumab. Participants received the medication every two weeks for up to 68 weeks.
The primary outcome measured improvement in the PPPASI total score. Results showed a score of 23.83 in the brodalumab group versus 22.37 in the placebo group. Secondary outcomes included responses at 50, 75, and 90 percent improvement, as well as quality of life measures.
Safety data revealed frequent infection-related events, with otitis externa occurring in 44.0 per 100 person-years. These events were Grade 1 or 2 only and considered controllable. Twenty-eight patients in the brodalumab group and 20 in the placebo group discontinued the study, primarily due to patient withdrawal. No serious adverse events were reported.
Readers should note that long-term data were unavailable prior to this study. The findings suggest brodalumab may be used in appropriate patients, balancing safety risks and efficacy benefits. This trial adds to the understanding of treatment options for this specific skin condition.
