Publications by authors named "Masayuki Takagishi"
Background: To present the real-world evidence on the safety and effectiveness of ustekinumab (UST) through 52-week treatment for Crohn's disease (CD) under an analysis of post-market surveillance data in Japan.
Methods: This prospective, post-marketing surveillance study was conducted in 341 patients from 91 medical facilities in Japan. Patients received UST 90 mg injected subcutaneously once every 12 weeks (or every 8 weeks if patients show weak effectiveness) after an induction dose given intravenously.
Article Synopsis
- Ustekinumab, an anti-interleukin-12/23 monoclonal antibody, was studied for its safety and effectiveness in treating Crohn's disease in Japan, with data collected from May 2017 to June 2020 across 91 medical centers.
- The study involved 341 patients, showing low rates of adverse drug reactions (5.3%) and serious adverse reactions (2.1%), with worsening of Crohn's disease being the most common issue.
- At 8 weeks, 40% of patients showed clinical response and 48.5% achieved clinical remission, along with significant improvement in disease activity scores; overall, the therapy was deemed effective and safe without new safety concerns.