Real-world safety and effectiveness of adalimumab in patients with pyoderma gangrenosum: Interim analysis of a post-marketing observational study in Japan.

ABSTRACT: Pyoderma gangrenosum (PG) is a rapidly progressive disease characterized by deep ulcers, predominantly in the lower extremities. Adalimumab, a monoclonal antibody against tumor necrosis factor alpha, is the first drug approved for PG treatment in Japan, ahead of other countries. We conducted a multicenter, open-label, post-marketing observational study to evaluate the safety and effectiveness of adalimumab in Japanese patients with PG. Of 67 patients enrolled, 37 in the safety analysis set and 32 in the effectiveness analysis set were included in this interim analysis. (Nineteen patients whose case report forms were not collected and 11 whose data were not fixed by the data cut-off date were excluded from the study). In the safety analysis set, the mean age was 62.9 years and 86.5% of pati

SUBMITTER: Yamamoto T 

PROVIDER: S-EPMC11807368 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature