ArticleJournal of gastroenterology and hepatology2021
Safety and effectiveness of ustekinumab in Crohn's disease: Interim results of post-marketing surveillance in Japan.
Article in Journal of gastroenterology and hepatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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12 citing papers in PubMed, 14 citations in OpenAlex.
- Drug-associated inflammatory bowel disease: a real-world pharmacovigilance study using the FAERS and JADER databases.Frontiers in immunology · 2026Article
- Long-Term Effectiveness and Safety of Ustekinumab in Crohn's Disease: Results from a Large Real-Life Cohort Study.Journal of clinical medicine · 2024Article
- Ustekinumab in the Treatment of Inflammatory Bowel Diseases: Evolving Paradigms.Journal of clinical medicine · 2024Review
- Research progress of Ustekinumab in the treatment of inflammatory bowel disease.Frontiers in immunology · 2024Review
- Predictive factors of the clinical efficacy of ustekinumab in patients with refractory Crohn's disease: tertiary centers experience in Japan.International journal of colorectal disease · 2023Article
- Systematic Review and Meta-Analysis of Observational Studies on the Effectiveness and Safety of Ustekinumab among Patients with Inflammatory Bowel Disease in Eastern and Western Countries.Journal of clinical medicine · 2023Review
- Safety and Effectiveness of Ustekinumab for Crohn's Disease in Japanese Post-marketing Surveillance in Biologic-Naive and -Experienced Conriemed.Crohn's & colitis 360 · 2023Article
- Real-world effectiveness and safety of ustekinumab induction therapy for Korean patients with Crohn's disease: a KASID prospective multicenter study.Intestinal research · 2023Article
- Article
- Real-World Evidence of the Effectiveness and Safety of Ustekinumab for the Treatment of Crohn's Disease: Systematic Review and Meta-Analysis of Observational Studies.Journal of clinical medicine · 2022Review
- Safety and effectiveness of ustekinumab in Crohn's disease: Interim results of post-marketing surveillance in Japan.Journal of gastroenterology and hepatology · 2021Article
- The Efficacy of Combination Therapy with Ustekinumab and Budesonide for Crohn's Disease: A Randomized Controlled Trial.Inflammatory intestinal diseasesArticle
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
Abstract
BACKGROUND AND
aimUstekinumab, 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.
methodsPatients 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 week 8.
resultsIn total, 341 patients were enrolled in the study, of which 339 were included in the safety analysis while 334 were included in the effectiveness analysis. The overall incidences of ADRs and SADRs were 5.3% and 2.1%, respectively. Worsening of Crohn's disease was the most common event. The clinical response and clinical remission rate at week 8 were 40.0% and 48.5%, respectively. Significant improvements in CDAI and serum CRP (P < 0.001) were observed at week 8. CDAI decreased significantly (mean difference: -31.4; 95% confidence interval: -61.1, -1.7; P = 0.038) in biologics-naïve patients versus patients who had received two or more biologics.
conclusionsThis 8-week interim analysis of the real-world study confirmed the effectiveness of ustekinumab-based therapy in Japanese patients with Crohn's disease. No new safety concerns were found during 8-week induction period in the Japanese clinical settings.
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