Real-World Insurance Claims Analysis of Venous Thromboembolism in Japanese Patients with Inflammatory Bowel Disease.

BACKGROUND: Inflammatory bowel disease (IBD), which encompasses both ulcerative colitis (UC) and Crohn's disease (CD), is a risk factor for venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). AIM: To investigate the incidence of, and risk factors for, VTE in patients with IBD in Japan. METHODS: This was a retrospective, non-interventional study in patients with IBD from the Japan Medical Data Center claims database. Incidence rates (IRs; unique patients with events per 100 patient-years) were calculated for VTE, DVT, and PE among the IBD, UC, and CD cohorts. Odds ratios of potential risk factors were calculated by univariate and multivariate analyses in a nested case-control design. RESULTS: Overall, 16 273 patients with IBD were included: 13 585 with UC and 3443 with CD. VTE events occurred in 1.3%, 1.2%, and 1.9% of patients with IBD, UC, and CD, respectively. In patients with IBD, UC, and CD, IRs of VTE were 0.45, 0.40, and 0.64, respectively, IRs of DVT were 0.42, 0.38, and 0.61, respectively, and IRs of PE were 0.07, 0.07, and 0.11, respectively. In patients with IBD, treatment history (immunomodulators), cardiovascular risk (hypertension, high-density lipoprotein or diabetes mellitus, and history of coronary artery disease or heart failure), malignancy, and undergoing major surgery were identified as potential risk factors for VTE in the multivariate analysis, with similar risk factors reported for patients with UC and CD. CONCLUSIONS: This large study provides insight into the incidence and risk factors for VTE in patients with IBD from Japan.

Validation of a claims-based algorithm to identify cases of ulcerative colitis in Japan.

BACKGROUND AND AIM: The prevalence of ulcerative colitis (UC) is increasing in Japan. Validated claims-based definitions are required to investigate the epidemiology of UC and its treatment and disease course in clinical practice. This study aimed to develop a claims-based algorithm for UC in Japan. METHODS: A committee of epidemiologists, gastroenterologists, and internal medicine physicians developed a claims-based definition for UC, based on diagnostic codes and claims for UC treatments, procedures (cytapheresis), or surgery (postoperative claims). Claims data and medical records for a random sample of 200 cases per site at two large tertiary care academic centers in Japan were used to calculate the positive predictive value (PPV) of the algorithm for three gold standards of diagnosis, defined as physician diagnosis in the medical records, adjudicated cases, or registration in the Japanese Intractable Disease Registry (IDR). RESULTS: Overall, 1139 claims-defined UC cases were identified. Among 393 randomly sampled cases (mean age 44; 48% female), 94% had received ≥ 1 systemic treatment (immunosuppressants, tumor necrosis factor inhibitors, corticosteroids, or antidiarrheals), 7% had cytapheresis, and 7% had postoperative claims. When physician diagnosis was used as a gold standard, PPV was 90.6% (95% confidence interval [CI]: 87.7-93.5). PPV with expert adjudication was also 90.6% (95% CI: 87.7-93.5). PPVs with enrollment in the IDR as gold standard were lower at 41.5% (95% CI: 36.6-46.3) due to incomplete case registration. CONCLUSIONS: The claims-based algorithm developed for use in Japan is likely to identify UC cases with high PPV for clinical studies using administrative claims databases.

Burden of illness, medication adherence, and unmet medical needs in Japanese patients with atopic dermatitis: A retrospective analysis of a cross-sectional questionnaire survey.

Atopic dermatitis (AD) negatively affects patients' daily lives. Poor medication adherence is a major barrier to treatment success. However, factors causing patients' poor adherence are unclear. This study aimed to identify factors associated with improvement of medication adherence in Japanese patients with AD and to evaluate illness burden and unmet medical needs for AD. We retrospectively analyzed Web-based questionnaire surveys conducted in 2018 in patients with AD aged 15 years and above who had been in- or outpatients within the past year from the survey. Quality of life using the EuroQol 5-Dimension (EQ-5D), and work productivity and activity impairment using Work Productivity and Activity Impairment Questionnaire (WPAI) were compared between patients and matched controls who had not visited a hospital for any disease within the past year. Subpopulation analysis was performed to explore factors affecting medication adherence. Unmet medical needs in AD treatment were identified by the percentage of patients who rated issues on the questionnaire as important but who were unsatisfied with them. In this study, we identified 1739 patients with AD. The scores of EQ-5D and WPAI showed that patients had statistically lower quality of life and higher impairment of work and activities than controls. High medication adherence scores were seen in patients with high health literacy levels and those who were well satisfied with communication with health-care providers, information received from them, or explanations of AD. Current unmet medical needs for AD were medical treatment costs, ease of hospital visits and explanations about disease prognosis. Patients tended to put a higher priority on communication with physicians than on that with nurses and pharmacists. In conclusion, we have identified patients' higher health literacy levels and satisfaction with the communication with their health-care provider as potential factors to improve medication adherence.