Biologics are recommended in Japan to treat moderate to severe Crohn’s Disease (CD). Although CD is associated with high direct costs in Japan, updated information after ustekinumab’s approval is unavailable. We aimed to evaluate the healthcare resource utilization (HRU) and associated direct costs from the payer’s perspective in Japan. Claims data (2010–2018) were retrospectively analyzed to identify patients with CD. HRU and associated costs were evaluated for 12 months before and after biologic initiation and followed-up till 36 months post-initiation. Outcomes were reported using descriptive statistics. Among the included patients (n = 3,496), 1,783 were on biologics and 1,713 were on non-biologics. Mean (SD) age was 36.4 (13.2) years and patients were predominantly male (76.1%). Patients aged 18–39 years were affected with CD the most (55.3%). Biologic initiation was associated with a reduction in inpatient stay, length of stay, outpatient visits, and associated costs; and an increase in pharmacy costs and total costs after 12 months. Extended follow-up showed a decreasing trend in HRU and costs till 24 months but an increase after 36 months. These findings demonstrated reduction in clinical burden and slight increase in economic burden with biologics. However, indirect costs also need to be evaluated.
Background To present the real-world evidence on the safety and effectiveness of ustekinumab through 52-week treatment for Crohn’s disease 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 ustekinumab 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, were evaluated through 52 weeks. Results The overall rate of clinical remission was 49.2% at week 8 and 56.0% at week 52. The rate of clinical remission in biologic-naïve patients was 75.9% and 66.7% at week 8 and 52 respectively, whereas the rate in biologic-experienced patients was 41.4% and 52.6% at week 8 and 52, respectively. For 52 weeks, the overall incidence of adverse drug reactions and serious adverse drug reactions was 11.7% and 6.7%, respectively. The most frequently reported serious adverse drug reactions was worsening of Crohn’s disease (1.8%). In multivariate analysis, adverse drug reactions incidence was significantly lower in patients with ileal involvement of Crohn’s disease (odds ratio=0.25, 95% confidence interval 0.07 to 0.85, p=0.026,), although disease location has no association with effectiveness of ustekinumab. Conclusions The present study identified no new safety concerns and effectiveness for Crohn’s disease in Japanese patients treated with ustekinumab.
IntroductionUlcerative colitis (UC) is an idiopathic, chronic inflammatory disease of the large intestine. Ustekinumab is a monoclonal antibody against the p40 subunit of interleukin-12 and interleukin-23 and has proven efficacy in inducing and maintaining remission in adult patients with moderate-to-severe UC. In the Symptom Improvement of ulceRative colitis after an Induction dose of Ustekinumab study, we will document the initial treatment response (daily patient-reported outcomes for 8 weeks from first infusion) and treatment patterns of patients wih UC receiving an induction dose of ustekinumab in the real-world setting in Japan. We will also investigate the relationship between the treatment response at week 8 and early indicators of response and determine patient factors that may define the appropriate dosing interval for maintenance therapy.Methods and analysisFor this single-arm, prospective observational study at 24 centres in Japan with a follow-up period of 16/20 weeks, we aim to recruit 140 patients with moderate-to-severe UC between July 2021 and July 2022. All surveys will be conducted in Japanese and patient-reported outcomes relating to rectal bleeding, stool frequency, abdominal pain, nocturnal diarrhoea, tenesmus and perception of UC symptoms will be recorded using a smartphone application, where the patients can enter their initial response to ustekinumab induction therapy on a daily basis. Dosing intervals and the reasons for selecting this interval, and concomitant medications taken during treatment with ustekinumab will be collected by a physician questionnaire at the end of the study. On completion of primary end point (8-week patient-reported outcomes) data collection, results will be reported sequentially.Ethics and disseminationThe study has been approved by the ethics committee of each facility involved and the Institutional Review Board of the non-profit organisation MINS.Trial registration numberUMIN000043753, NCT04963725.
Objective: Golimumab (GLM) is an anti-tumor necrosis factor-alpha antibody therapy for moderately to severely active ulcerative colitis (UC). Endoscopic improvement is considered one of UC treatment's main goals, and earlier prediction of future endosopic improvement has clinical implications. We retrospectively analyzed data from the PURSUIT-J, a phase III randomized controlled trial evaluating the efficacy of GLM in the maintenance phase, to find predictors for endoscopic improvement after 60 weeks of GLM treatment. Methods: Ninety-two patients who had completed the maintenance phase of the PURSUIT-J were divided into two groups: those with Mucosal healing (MHs : Mayo endoscopic subscore of 0 or 1) and those without MH at week 60 (non-MHs). Multivariate logistic regression analysis was conducted using baseline data in the induction phase to determine predictive factors for MHs compared to non-MHs. Results: Twenty-nine patients were classified as MHs and 63 as non-MHs. The multivariate logistic regression analysis showed that the odds ratio for partial Mayo (pMayo) score was highest in MHs (1.87 [95% CI 1.18–2.98]) at baseline in the induction phase. The receiver operating characteristic analysis to determine the timing of predictions of MHs using pMayo showed that an area under the curve reached 0.8 at week 14 after the first GLM administration. Conclusions: pMayo scores at week 14 of GLM treatment are associated with MH at week 60. These results suggest the timing of when a clinical decision to continue GLM based on the patient-reported outcomes and the physician’s general assessment could be considered.
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