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.

The patient was an 80-year-old man who was diagnosed with cStage IIIB non-small cell lung cancer (NSCLC) and early gastric cancer. The advanced lung cancer was treated with chemotherapy while the gastric cancer was monitored. Immune checkpoint inhibitors were effective against the lung cancer for a long period, but new gastric cancer appeared and progressed to an advanced stage, necessitating total gastrectomy 5 years after the diagnosis of NSCLC. The patient is currently being treated with a molecular targeted agent for progression of the lung cancer after gastrectomy. In the future, the number of cases with multiple primary cancers will increase alongside aging of the population and advances in cancer treatment, and a system for tumor-agnostic treatment selection and medical treatment will be necessary.

Background/Aims: Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings. Methods: This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remission, mucosal healing, and Work Productivity and Activity Impairment (WPAI). Results: The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malignancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained > 70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years > 2 to ≤ 3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n = 102) at baseline to 26.9 (n = 84) at 4 weeks. Conclusions Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting.

Objective : The purpose of this clinical research was to create an assessment for patients with muscle disease who wish to continue driving by investigating their motor function and driving experience. Methods : Twenty-four patients with muscle disease who visited our hospital from December 2009 to April 2010 were enrolled in our research. For patients who were still driving, physiatrists evaluated their motor functions, examined simulated driving motions and recorded their driving capabilities and techniques, their ability to get into and out of the vehicle and their ability to store and remove their wheelchairs. Patients no longer driving were asked why they had given up driving. Results : Fifteen patients who continued driving had enough upper limb strength and could simulate driving motions, though the location and degree of their muscle weakness were variable. Five of fifteen drove with the aid of a hand-operated brake and accelerator. Seven needed personal assistance: three to get into and out of the vehicles, six to store and remove wheelchairs. The nine patients who had stopped driving reported that the primary reason for discontinuing driving was that they recognized their muscles were insufficient to control the vehicle. Conclusions : We propose to evaluate muscle strength and to test simulated driving motions when assessing patients with muscle disease. A hand-operated brake and accelerator is efficient for patients with lower limb muscle weakness. However, since no efficient automobile modifications are available for those patients who cannot get into and get out of their vehicles or store and remove their wheelchairs by themselves, we suggest arranging personal assistance for such patients.