Affiliation:
1. Janssen Pharmaceutical K.K., Medical affairs division , Tokyo , Japan
2. Janssen Pharmaceutical K.K., Research & Development division , Tokyo , Japan
3. Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University , Iwate , Japan
Abstract
AbstractBackgroundTo 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.MethodsThis 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. Clinical response (100-point decrease in Crohn’s Disease Activity Index [CDAI] score), clinical remission (CDAI score of <150), steroid-free clinical remission, C-reactive protein, endoscopy, physician global assessment, and adverse drug reactions (ADRs) were evaluated through 52 weeks.ResultsThe overall rate of clinical remission was 49.2% at week 8 and 56.0% at week 52. The rate of clinical remission in biologic-naive patients was 75.9% and 66.7% at weeks 8 and 52, respectively, whereas the rate in biologic-experienced patients was 41.4% and 52.6% at weeks 8 and 52, respectively. For 52 weeks, the overall incidence of ADRs and serious adverse drug reactions (SADRs) was 11.7% and 6.7%, respectively. The most frequently reported SADRs was worsening of CD (1.8%). In multivariate analysis, ADRs incidence was significantly lower in patients with ileal involvement of CD (odds ratio = 0.25, 95% CI 0.07–0.85, P = .026), although disease location has no association with effectiveness of UST.ConclusionsThe present study identified no new safety concerns and effectiveness for CD in Japanese patients treated with UST.
Funder
Janssen Pharmaceutical K.K., Tokyo, Japan
Publisher
Oxford University Press (OUP)
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献