Background/Aims: The objectives of this real-world study were to determine 1-year persistence with vedolizumab in patients with ulcerative colitis and to evaluate factors contributing to loss of response. Methods: In this multicenter, retrospective, observational chart review, patients with moderately to severely active ulcerative colitis who received ≥ 1 dose of vedolizumab in clinical practice at 16 tertiary hospitals in Japan (from December 2018 through February 2020) were enrolled. Results: Persistence with vedolizumab was 64.5% (n = 370); the median follow-up time was 53.2 weeks. Discontinuation due to loss of response among initial clinical remitters was reported in 12.5% (35/281) of patients. Multivariate analysis showed that concomitant use of tacrolimus (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.00–7.62; P= 0.050) and shorter disease duration (OR for median duration ≥ 7.8 years vs. < 7.8 years, 0.33; 95% CI, 0.13–0.82; P= 0.017) were associated with discontinuation due to loss of response. Loss of response was not associated with prior use of anti-tumor necrosis factor alpha therapy, age at the time of treatment, disease severity, or concomitant corticosteroids or immunomodulators. Of the 25 patients with disease duration < 1 year, 32.0% discontinued due to loss of response. Conclusions Persistence with vedolizumab was consistent with previous reports. Use of tacrolimus and shorter disease duration were the main predictors of decreased persistence.

PMDA, the Japanese regulatory agency, has worked for reinforcing and enhancing its post-marketing safety measures as stated in the second mid-term (FY 2009-2013) plan. MIHARI Project-Medical Information for Risk Assessment Initiative was started in FY 2009 to develop a new safety assessment system for post-marketing drugs using Japanese electronic healthcare data in PMDA. In the second mid-term, we examined characteristics of some electronic healthcare data available in Japan including, claims data, hospital information system data and Diagnosis Procedure Combination (DPC) data in order to make efficient use of those databases for the purpose of drug safety assessment. In addition, some pilot pharmacoepidemiological studies for risk assessment and drug utilization were conducted by use of these electronic healthcare data. Based on the accumulated findings, knowledge, and experiences from the pilot studies, we established the framework by FY 2013 to implement pharmacoepidemiology-based safety assessment in PMDA. In the third mid-term (FY 2014-2018), one of the important mission is to apply this framework into the current risk management process of drug safety. For that purpose, cooperation with other divisions of PMDA such as Office of Safety and Office of New Drug is a key. Simultaneously, we will work to establish an access to another database and novel pharmacoepidemiological methods using electronic healthcare data. A large-scale electronic health record database (MID-NET) as well as national claims database are expected to be an important database in the future activities of MIHARI Project. Furthermore, in April 2015, PMDA established new office focusing on Medical Informatics and Epidemiology for further promotion of electronic healthcare data utilization in Japan. In this article, we describe history and past activities of MIHARI Project followed by future challenges.

Struma ovarii is a rare tumor that is defined as an ovarian teratoma with a thyroid tissue component exceeding 50%. Most of these tumors are benign, with malignant struma ovarii occurring in <1% of patients. Here, we describe the case of a 49-year-old female patient with malignant struma ovarii who developed thoracic spine metastasis. She had undergone an oophorectomy and was diagnosed with struma ovarii 10 years previously. She had remained recurrence-free thereafter. At 49 years of age, she developed low back pain and was admitted to our hospital for evaluation of a spinal tumor at the Th7 level. An emergency bone biopsy led to a diagnosis of metastasis from malignant struma ovarii. External beam radiotherapy inhibited further tumor growth and there was no resulting muscle weakness. This is the first report of spinal metastasis occurring 10 years after resection of struma ovarii, indicating the need for long-term follow-up.
Biopsy ; Diagnosis ; Emergencies ; Female ; Humans ; Low Back Pain ; Middle Aged ; Muscle Weakness ; Neoplasm Metastasis* ; Ovariectomy ; Radiotherapy ; Recurrence ; Spinal Neoplasms ; Spine ; Struma Ovarii* ; Teratoma ; Thyroid Gland

Purpose and Method: It is known that people have insufficient recognition about hospital-based palliative care units (PCUs). Patients with cancer and their families are probably not well informed about PCUs on its admission. To understand the situation of patients and their families before and after PCU admission, a questionnaire survey was performed and evaluated by PCU nurses. Result: As a result, two points regarding PCU admission have become clear. First, about 55％ of the nurses reported that prior to PCU admission, patients and family members lacked proper information about PCUs; about 62% of the nurses felt that PCUs had not been appropriately explained to the patients; and about 37% of the nurses felt that family members had not received an appropriate explanation of PCUs at the time of PCU admission. Second, before PCU admission, the main concern of patients and their families was proper utilization of PCUs. After admission, their main concerns were the extent of treatment provided in the PCU and the progress of the disease. Conclution: These results suggest that appropriate information on PCUs, including the scope of treatment provided to patients and the requirements for PCU admission, is necessary for general ward staff as well as for the patients and their families prior to PCU admission.