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BackgroundThere is no large real-world data regarding efficacy and safety of immunotherapy in gastric cancer (GC). Although some tumors can grow rapidly after immunotherapy, the patient proportions and survival outcomes are unclear in GC.MethodsA multicenter, prospective observational study was performed to evaluate clinical outcomes including survival time, safety, and tumor behavior of nivolumab treatment for patients with advanced GC. Primary endpoint was overall survival (OS), and secondary endpoints included response rate (RR), disease control rate (DCR), progression-free survival (PFS), tumor growth rate (TGR) at first evaluation, and safety.ResultsOf 501 enrolled patients, 487 were evaluable (median age 70 years, 71% male, performance status 0/1/2 [42%/44%/14%], 21% HER2-pos, 42% patients with ascites). Median OS was 5.82 months (95% CI 5.29–7.00) with a 1-year survival rate of 30% and median PFS of 1.84 months (95% CI 1.71–1.97). The DCR was 39.4% and the RR was 14.2% (95% CI 10.3–18.8) in 282 patients with measurable lesions. In 219 patients evaluable for TGR, 20.5% were identified as hyperprogressive disease (HPD). OS from the first evaluation of patients with HPD was shorter compared with non-HPD (HR 1.77, 95% CI 1.25–2.51, P = 0.001), but it was not worse than that of patients with progression and non-HPD (HR 1.05, 95% CI 0.72–1.53, P = 0.8). A multivariate analysis revealed the presence of peritoneal metastasis was a prognostic factor for OS and PFS.ConclusionsOur real-world data demonstrated the comparable survival time to a previous clinical trial and revealed the frequency and prognosis of patients with HPD in advanced GC treated with nivolumab.

Evidence is accumulating that early consumption is more beneficial than is delayed introduction as a strategy for primary prevention of food allergy. However, allergic reactions caused by early introduction of such solid foods have been a problematic issue. We investigated whether or not early stepwise introduction of eggs to infants with eczema combined with optimal eczema treatment would prevent egg allergy at 1 year of age. In this randomised, double-blind, placebo-controlled trial, we enrolled infants 4–5 months of age with eczema from two centres in Japan. Exclusion criteria were being born before 37 weeks of gestational age, experience of ingestion of hen's eggs or egg products, history of immediate allergic reaction to hen's eggs, history of non-immediate allergic reaction to a particular type of food, and complications of any severe disease. Infants were randomly assigned (block size of four; stratified by institution and sex) to early introduction of egg or placebo (1:1). Participants in the egg group consumed orally 50 mg of heated egg powder per day from 6 months to 9 months of age and 250 mg per day thereafter until 12 months of age. We aggressively treated participants' eczema at entry and maintained control without exacerbations throughout the intervention period. Participants and physicians were masked to assignment, and allocation was concealed. The primary outcome was the proportion of participants with hen's egg allergy confirmed by open oral food challenges at 12 months of age, assessed blindly by standardised methods, in all randomly allocated participants who received the intervention. This trial is registered with the University Hospital Medical Information Network Clinical Trials Registry, number UMIN000008673. Between Sept 18, 2012, and Feb 13, 2015, we randomly allocated 147 participants (73 [50%] to the egg group and 74 [50%] to the placebo group). This trial was terminated on the basis of the results of the scheduled interim analysis of 100 participants, which showed a significant difference between the two groups (four [9%] of 47 participants had an egg allergy in the egg group vs 18 [38%] of 47 in the placebo group; risk ratio 0·222 [95% CI 0·081–0·607]; p=0·0012). In the primary analysis population, five (8%) of 60 participants had an egg allergy in the egg group compared with 23 (38%) of 61 in the placebo group (risk ratio 0·221 [0·090–0·543]; p=0·0001). The only difference in adverse events between groups was admissions to hospital (six [10%] of 60 in the egg group vs none in the placebo group; p=0·022). 19 acute events occurred in nine (15%) participants in the egg group versus 14 events in 11 (18%) participants in the placebo group after intake of the trial powder. Introduction of heated egg in a stepwise manner along with aggressive eczema treatment is a safe and efficacious way to prevent hen's egg allergy in high-risk infants. In this study, we developed a practical approach to overcome the second wave of the allergic epidemic caused by food allergy. Ministry of Health, Labour and Welfare, and National Centre for Child Health and Development, Japan.

To evaluate medical costs and resource use in patients with rheumatoid arthritis (RA) with and without diabetes mellitus (DM). Data were obtained from the Japan Medical Data Center (JMDC) claims database. The baseline period comprised 6 months before the index date (first prescription date post-RA diagnosis) while the 12-month duration post-index date was the follow-up period. Patients with RA and DM prescribed an antidiabetic drug in the baseline period constituted the DM group, while patients with RA without DM or an antidiabetic prescription in the baseline and follow-up periods belonged to the non-DM group. Patients were matched by sex, age, Charlson Comorbidity Index (CCI), months from the first RA codes, and medications. The primary endpoint was total medical costs per patient in the follow-up period. The secondary endpoints were costs for drugs, treatments, and materials, their sub-categories, and proportions of patients using the sub-categories. One hundred and sixty-one DM group patients and 2,974 non-DM group patients were eligible for inclusion, and 109 patients were matched from each group. The median values of age and CCI were 59 years and 2.0 in both groups. After excluding DM-specific costs, both total medical costs and drug costs were significantly higher in the DM group compared with the non-DM group (total medical costs: DM/ non-DM: 5,163 USD/ 3,782 USD, P < 0.05; drug costs: DM/ non-DM: 2,242 USD/ 1,066 USD, P < 0.05) because of a higher proportion of biological disease-modifying antirheumatic drug (DMARD) users in the DM group (DM/ non-DM: 14.7%/ 5.5%). Treatment costs and material costs did not differ between the two groups. Medical costs for RA were higher in the DM group than in the non-DM group because of a higher proportion of biological DMARD users.

To evaluate medical costs and resource use in patients with rheumatoid arthritis (RA) treated with and without oral or injectable glucocorticoids (GCs) as part of their initial treatment with disease-modifying antirheumatic drugs (DMARDs). Patients included in the Japan Medical Data Center health insurance claims database and diagnosed with RA were considered. The date of the first prescription of a DMARD (index date) after an observable 6-month period (baseline) was used to define follow-up (12 months post-index date) periods. Patients with at least one GC prescription in the follow-up period were included in the GC group, and patients without a GC prescription in the follow-up period were classified as the non-GC group. The primary endpoints were costs for drugs, treatments, and materials per patient in the follow-up period. Drugs were divided into medications for RA or for adverse events (AEs). The secondary endpoints were proportions of patients using the subcategories of each resource. The incidence of hospitalization during the follow-up period was evaluated. A total of 1,670 and 1,487 patients with median ages of 51.0 and 50.0 years were evaluated in the GC and non-GC groups, respectively. The costs for drugs, treatments, and materials were significantly higher in the GC group compared with the non-GC group (GC/ non-GC; drug costs for RA and AEs, 2,818 USD/ 1,882 USD; drug costs for RA only, 2,697 USD/ 1,805 USD; treatment costs, 2,365 USD/ 1,860 USD; material costs, 112 USD/ 77 USD; P < 0.05). The resource use in almost all drug and treatment subcategories was higher in the GC group. The incidence of hospitalization was also higher in the GC group. Patients with RA treated with GCs in the first year after starting DMARDs tended to use more resources and have higher medical costs than patients not treated with GCs.

Introduction This study aimed to evaluate fracture incidence in patients with rheumatoid arthritis (RA) over 13 years in the Institute of Rheumatology Rheumatoid Arthritis (IORRA) cohort study. Materials and methods The IORRA is a prospective observational cohort study of Japanese patients with RA. Between 2011 and 2023, 10,257 patients with RA were enrolled. Clinical parameters and data on fractures were collected biannually using self-reported questionnaires. The fracture incidence, standardized by sex, age, and Japanese Health Assessment Questionnaire score, was calculated for each two-year period. Results From 2011 to 2023, the proportions of patients achieving Disease Activity Score in 28 joints remission, using biologic disease-modifying antirheumatic drugs, and taking osteoporosis medications increased (38.0% to 64.7%, 14.2% to 42.2%, and 31.6% to 38.3%, respectively), while the proportion of glucocorticoid use decreased (38.3% to 22.2%). The incidence of all and non-vertebral fractures increased from 47.2 and 36.7/1000 person-years in 2011 to 52.8 and 43.0/1000 person-years in 2023, respectively. Using 2023 as the reference, the standardized incidence ratios for all and non-vertebral fractures were: 2011–2012, 0.90 [95% confidence interval (CI) 0.82–0.98] and 0.86 (95% CI 0.78–0.95); 2013–2014, 0.88 (95% CI 0.81–0.96) and 0.84 (95% CI 0.76–0.93); 2015–2016, 0.94 (95% CI 0.86–1.02) and 0.89 (95% CI 0.80–0.98); 2017–2018, 0.97 (95% CI 0.88–1.07) and 0.94 (95% CI 0.84–1.05); 2019–2020, 0.95 (95% CI 0.84–1.07) and 0.93 (95% CI 0.81–1.06); 2021–2022, 1.00 (95% CI 0.89–1.13) and 0.99 (95% CI 0.86–1.13). Conclusion Despite advancements in RA management over 13 years, fracture incidence may have increased in patients with RA.

The anti-CCR4 antibody mogamulizumab led to significant improvement in neurologic function among patients with HTLV-1–associated tropical spastic paraparesis. Mild rash was the most common side effect.

This study investigated the effect of a home-based computerized cognitive training program that utilizes a digital application for training abacus-based mental calculations, “SoroTouch,” on the cognitive functions of healthy middle-aged and older people using a randomized controlled trial. The participants were 20 adults (aged 42–79 years) who were involved in community-based activities for dementia prevention held by a certain organization. The participants were assigned randomly to the intervention (SoroTouch) group or control group. The SoroTouch group received home-based cognitive training with SoroTouch, being asked to use the software every day for 6 months, while the control group did not receive any intervention. To investigate the effect of SoroTouch, CogEvo, a cognitive functions test battery utilizing a tablet device, was administered to all participants once per month during the 6-month intervention period. In addition, before and after the intervention, all participants were asked to take the CogEvo and the Japanese version of the Montreal Cognitive Assessment (MoCA-J). The analyses showed that the SoroTouch group did not improve total scores of the CogEvo and MoCA-J, but large group differences were observed in the two tasks of the CogEvo as follows: ‘Follow the order’ (modified Trail Making Test) at 2 months after the beginning of the intervention (group differences; 39.4, 95% confidence interval; 7.6–71.2) and ‘Route 99’ at 6 months (group differences; 39.6, 95% confidence interval; 4.9–74.4). These results provide evidence that a home-based computerized cognitive training program SoroTouch has the potential to improve working memory, attention and planning in healthy middle-aged and older adults.

Abstract Background This prospective observational study evaluated the real-world effectiveness of nivolumab monotherapy in previously treated advanced gastric cancer (GC). A preplanned 2-year final analysis was performed to confirm survival and tumor behavior with nivolumab monotherapy. Patients and Methods The primary endpoint was overall survival (OS). The data regarding tumor size were prospectively collected and evaluated using the RECIST criteria. Exploratory analyses were performed for survival according to the tumor response and depth of response (DpR) in patients with measurable lesions who were receiving nivolumab monotherapy as third- or later-line therapy. Results In 487 patients, the median OS and progression-free survival (PFS) were 5.8 (95% CI 5.3-6.9) months and 1.8 (95% CI 1.7-2.0) months, respectively. The response rate (RR) was 14.5% in 282 patients with measurable lesions. In 234 patients treated with third- or later-line, the DpR was found to be associated with PFS and OS in the Spearman analysis (r = 0.55 and 0.44, respectively) as well as using a discrete variable. When the DpR was divided into 5 groups (−20%≥DpR; −20%

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