Comparison of the Effectiveness of Vedolizumab and Ustekinumab in Crohn's Disease Patients Who Failed Anti-tumor Necrosis Factor-α Treatment in Japan: An Observational Study Utilizing Claims Database.

This study aimed to investigate whether the approved sequence of vedolizumab and ustekinumab impacts the results of previous observational studies conducted in the European Union (EU), comparing the effectiveness of these drugs in Crohn's disease (CD) patients who failed anti-tumor necrosis factor-α (TNFα) treatment. We conducted this study in Japan, where the approved sequence of drugs is different from that of the EU. We extracted 256 patients diagnosed with CD, who had a history of anti-TNFα treatment and were prescribed either vedolizumab or ustekinumab, from JMDC claims database. The patients' backgrounds were adjusted by inverse probability of treatment weighting using propensity score. The primary outcome was treatment persistence. Secondary outcomes were a steroid-free period, time to hospitalization, and time to CD-related surgery. The hazard ratios (HR) for survival times were estimated using the Cox proportional hazard model. The treatment persistence (primary endpoint) was significantly longer for ustekinumab than vedolizumab (HR, 0.32; 95% confidence interval (CI), 0.15-0.72). The results of the secondary endpoints were as follows: steroid-free period (HR, 0.38; 95% CI, 0.10-1.48), time to hospitalization (HR, 1.07; 95% CI, 0.60-1.91), or time to CD-related surgery (HR, 0.33; 95% CI, 0.11-0.97). There were no outcomes indicating the superiority of vedolizumab. Our findings suggest that ustekinumab is a more effective treatment option than vedolizumab for CD patients who failed to anti-TNFα treatment, and this finding remains consistent across both Japan and the EU.

Post-marketing surveillance (PMS) of all patients treated with irinotecan in Japan: clinical experience and ADR profile of 13,935 patients.

OBJECTIVE: The actual condition of drug utilization and the adverse drug reactions profile of irinotecan hydrochloride hydrate (irinotecan), an antitumor drug, were examined on the basis of all the case survey results from April 1995 to January 2000. METHODS: Drug utilization and the adverse drug reactions profile of irinotecan were figured out by checking of the patient conditions at the start of therapy and monitoring during on-therapy period in this survey. RESULTS: Among the 13 935 patients investigated, 32% had non-small cell lung cancer, 16% had colorectal cancer, 15% had ovarian cancer and 14% had small cell lung cancer, all principal cancers in which irinotecan was domestically approved for use. Most frequent regimens of each cancer were concomitant use with cisplatin for non-small cell lung cancer and small cell lung cancer (38 and 46%, respectively), concomitant use with cisplatin or mitomycin for ovarian cancer (each 30%) and irinotecan alone for colorectal cancer (51%). The major (grade 3 or more) adverse drug reactions were myelosuppressions such as leukopenia (23.8 and 38.3% for lone and concomitant use, respectively) thrombocytopenia (6.5 and 14.3%) and gastrointestinal tract disorders such as diarrhea (10.2 and 10.0%). CONCLUSIONS: It was reconfirmed that the incidences of serious leukopenia, thrombocytopenia and diarrhea were high among the patients with contraindication or careful administration of its use prescribed in the drug package insert. Therefore, for proper use of irinotecan, it is important to discriminate the patient on the basis of risk status.