Safety and effectiveness of ustekinumab in Crohn's disease: Interim results of post-marketing surveillance in Japan.

ABSTRACT:

Background and aim

Ustekinumab, a human anti-interleukin-12/23 monoclonal antibody, has been approved in Japan for the treatment of Crohn's disease. Here, we report the findings from an 8-week interim analysis of post-marketing surveillance to evaluate the safety and effectiveness of ustekinumab in Japanese patients with Crohn's disease.

Methods

Patients initiating ustekinumab treatment were prospectively evaluated from May 2017 to June 2020 at 91 medical centers in Japan. Adverse drug reactions (ADRs) and serious ADRs (SADRs) were monitored. Effectiveness was evaluated by clinical response, clinical remission, and changes in Crohn's Disease Activity Index (CDAI) and C-reactive protein (CRP) from baseline to week 8. Presence of perianal disease was documented at baseline and

SUBMITTER: Yokoyama S 

PROVIDER: S-EPMC9290907 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature