Adult Patients In Japan Research Articles

Validity of the diagnostic criteria from the Asian Working Group for Cachexia in advanced cancer.

Recently, the Asian Working Group for Cachexia (AWGC) published a consensus statement on diagnostic criteria for cachexia in Asians. We aimed to validate the criteria in adult patients in Japan with advanced cancer. We conducted a single-institution retrospective cohort study between April 2021 and October 2022. The AWGC criteria include chronic comorbidities and either a weight loss of >2% over 3-6months or a body mass index (BMI) of <21kg/m2 . In addition, any of the following items were required: anorexia as a subjective symptom, decreased grip strength as an objective measurement and an elevated C-reactive protein (CRP) level as a biomarker. We used the cut-off value of grip strength of 28/18kg for male/female individuals and CRP level of 5mg/L. Of the 449 consecutive patients, 85 of those who could not be evaluated because of end-of-life or refractory symptoms (n=41) or missing data (n=44) were excluded from the primary analysis. The prevalence of the AWGC-defined cachexia was 76% (n=277), and the median survival time (MST) for all patients was 215 (95% confidence interval [CI] 145-270) days. The prevalence of the following criteria was significantly higher in patients with cachexia than in those without cachexia: a BMI of <21kg/m2 (65% vs. 15%, P<0.001), a weight loss of >2% in 6months (87% vs. 14%, P<0.001), anorexia (75% vs. 47%, P<0.001), a grip strength of <28kg in male individuals (63% vs. 28%, P<0.001) and CRP level of >5mg/L (85% vs. 56%, P<0.001). Overall survival was significantly shorter in patients with cachexia than in those without cachexia (MST 157days, 95% CI 108-226days vs. MST 423days, 95% CI 245days to not available, P=0.0023). The Cox proportional hazards analysis showed that best supportive care (hazard ratio [HR] 2.91, P≤0.001), lung cancer (HR 1.67, P=0.0046), an Eastern Cooperative Oncology Group Performance Status score of ≥3 (HR 1.58, P=0.016), AWGC-defined cachexia (HR 1.56, P=0.015), an age of ≥70years (HR 1.53, P=0.0070), oedema (HR 1.31, P=0.022) and head/neck cancer (HR 0.44, P=0.023) were found to be the significant predictors for mortality. We demonstrated that AWGC-defined cachexia has a significant prognostic value in advanced cancer.

Development of the ward nurses' discharge-oriented dietary support scale for older adult patients in Japan.

This study aimed to develop a ward nurses' dietary support scale, including physical, psychological, and social background factors in preparation for older adult patients' life after discharge. We conducted a cross-sectional study using a self-reported questionnaire. Scale items were created based on a conceptual analysis, and refined by a Delphi survey. In total, 696 nurses across 16 acute care hospitals in Japan were eligible to participate. The questionnaire comprised 51 items that used a five-point Likert-type scale. These items were evaluated using exploratory factor analysis. Reliability was evaluated using Cronbach's alpha and intraclass correlation coefficients (ICC). Pearson's correlation coefficients were calculated to determine concurrent validity, and construct validity was analyzed using confirmatory factor analysis. Altogether, 241 surveys were included in the data analysis; 236 nurses participated in both the test and the retest. The exploratory factor analysis identified 20 items from three factors as follows: "Assessment for healthy eating behavior," "Adjustment of the living environment, including family and caregiver, together with other professions," and "Continual frailty assessment." In the confirmatory factor analysis, the fitness indices supported these results. Cronbach's alpha was 0.932 and ICC was 0.867 for the overall scale. In the concurrent validity, the three factors had a moderate correlation (r = 0.295-0.537, P < .01 and r = 0.254-0.648, P < .01), except for one subscale. We developed a ward nurses' dietary support scale, including physical, psychological, and social background factors in preparation for older adult patients' life after discharge. Its reliability and validity were confirmed.

Serotype Distribution and Antimicrobial Resistance of Streptococcus agalactiae Isolates in Nonpregnant Adults with Streptococcal Toxic Shock Syndrome in Japan in 2014 to 2021.

The incidence of streptococcal toxic shock syndrome (STSS) due to group B Streptococcus (GBS) has been increasing annually in Japan and is becoming a serious challenge. Furthermore, in recent years, penicillin- or clindamycin-resistant strains used in treating streptococcal toxic shock syndrome have been reported. However, no report analyzed >100 isolates of group B Streptococcus causing streptococcal toxic shock syndrome. Therefore, we aimed to perform serotyping and antimicrobial susceptibility testing of 268 isolated group B Streptococcus strains from streptococcal toxic shock syndrome cases involving nonpregnant adult patients in Japan between 2014 and 2021. The most prevalent serotype was Ib, followed by serotypes V, III, and Ia. Seven isolates were resistant to penicillin G, and 17.9% (48 isolates) were resistant to clindamycin. Of the penicillin-resistant group B Streptococcus isolates, 71.4% (5 isolates) were clindamycin resistant. In addition, group B Streptococcus strains resistant to penicillin and clindamycin were isolated from patients with streptococcal toxic shock syndrome. Therefore, before these strains become prevalent, introduction of the group B Streptococcus vaccine is essential for disease prevention. IMPORTANCE Group B Streptococcus (GBS) has been increasingly associated with invasive disease in nonpregnant adults. Such infections are responsible for substantial morbidity and mortality, particularly in individuals with underlying chronic conditions. Streptococcal toxic shock syndrome (STSS) is a severe invasive infection characterized by the sudden onset of shock, multiorgan failure, and high mortality. In this study, we assessed 268 GBS-related STSS cases in nonpregnant adults in Japan between 2014 and 2021. Serotype Ib was the most prevalent, followed by serotypes V, III, and Ia, which were identified in more than 80% of STSS isolates. We found that 48 clindamycin-resistant strains and 7 penicillin G-resistant strains were isolated between 2014 and 2021. We believe that our study makes a significant contribution to the literature because we show that the GBS vaccine, particularly the hexavalent conjugate vaccine, is important to reduce the number of patients with STSS.

Tracheostomy decannulation rates in Japan: a retrospective cohort study using a claims database

Despite the exponential increase in the use of tracheostomy worldwide, rates of tracheostomy decannulation are unknown. We conducted a retrospective cohort study to investigate tracheostomy decannulation rates among adult patients over a two-year period and explored factors associated with prolonged tracheostomy. A health insurance claims database including 3,758,210 people in Japan was used. The primary outcome was time to decannulation. Assessed patient and hospital factors included age, sex, emergency endotracheal intubation, disease, and hospital size. A total of 917 patients underwent tracheostomy, and 752 met the eligibility criteria. Decannulation rates were 40.8% (95% confidence interval 36.8–44.9) at 3 months, 63.9% (58.4–69.0) at 12 months, and 65.0% (59.2–70.3) at 24 months. Hazard ratios of patient and hospital factors for tracheostomy decannulation were 0.44 for age (65–74 years) (95% confidence interval 0.28–0.68), 0.81 (0.63–1.05) for female sex, and 0.59 (0.45–0.76) for emergency endotracheal intubation. Cerebrovascular disease, head injuries, and cardiac arrest had lower hazard ratios compared to other diseases. Decannulation rates among adult patients in Japan increased rapidly up to 3 months after tracheostomy, reaching a plateau after 12 months. Older age, female sex, emergency endotracheal intubation, cerebrovascular disease, head injuries, and cardiac arrest were associated with prolonged tracheostomy.

Prescription trends in anti-seizure medications for adult patients with epilepsy in Japan: A retrospective cohort study using the database of health insurance claims between 2015 and 2019

ObjectiveTo investigate whether newer anti-seizure medications (ASMs) are widely prescribed for a range of adult patients in Japan, including patients with previously and newly diagnosed epilepsy, or with focal and generalized epilepsies. MethodsA retrospective cohort study was conducted using the Japanese insurance claims database including 8.4 million people to identify adults (≥16 years of age) with epilepsy diagnosis code identified between January 2015 and December 2018. Patients were included in the prevalent population if epilepsy was already diagnosed at baseline, and in the incident population if prior baseline data for at least 12 months included no epilepsy diagnosis code or ASM prescription. Patients were followed up from the month when the initial oral ASM was prescribed for up to 4 years until the end of 2019 as long as at least one ASM was prescribed. Proportions of prescribed oral ASMs were analyzed by population with epilepsy (prevalent vs. incident) and classification (focal vs. generalized). Anti-seizure medications were classified into older vs. newer ASMs according to the date of approval before and after 1990, respectively. ResultsA total of 24,691 patients fulfilled the eligibility criteria for the analysis. Of these, 21,046 and 3,645 were included in the prevalent and incident populations, respectively. The proportion of older ASMs significantly decreased, whereas the proportion of newer ASMs significantly increased (p < 0.0001) during the study period. This trend was more apparent in the population with incident epilepsy than in that with prevalent epilepsy, and was also apparent in the subgroup of focal epilepsy, but not in that of generalized epilepsy. Levetiracetam was the most frequently prescribed of the newer ASMs. ConclusionNewer ASMs became more widely prescribed throughout the study period in populations with both prevalent and incident epilepsies, as well as the subpopulation with focal epilepsy. The advantages of newer ASMs such as better safety profiles may have led to the increasing proportions of prescriptions and newer ASMs may increase the treatment options for patients.

Nurses' symptom management and views on death and caring for heart failure and chronic obstructive pulmonary disease.

The number of older adult patients in Japan is increasing and symptom management is needed not only for cancer patients, but also non-cancer patients. This study investigated nurses' symptom management and their views on death and caring for heart failure (HF) and chronic obstructive pulmonary disease (COPD). A cross-sectional survey using a questionnaire was conducted. Survey items were implementation of assessment and non-pharmacological interventions for 14 symptoms at the end-of-life stage, participation in palliative care training courses and attitude toward death and caring, as assessed by the Frommelt attitude toward care of the dying (FATCOD) Scale. A total of 266 (78.5%) nurses responded. More than 90% implemented symptom assessment of dyspnea and cough for both HF and COPD. The mean FATCOD score was 114.7, participation in on-the-job palliative care training courses (p<0.01), and difficulty with near-death issues (p<0.01) were significantly associated with the FATCOD. These results suggest that nurses assessed the major symptoms of HF and COPD. Training courses are important to promote palliative care for non-cancer patients.

Risk of major depressive disorder in adolescent and young adult cancer patients in Japan.

ObjectiveTo estimate the risk of major depressive disorder (MDD) in adolescent and young adult (AYA) patients with cancer in Japan and identify risk factors for MDD among these patients.MethodsThis was a matched cohort study using a large claims database in Japan. Included patients were aged 15–39 years, newly diagnosed with cancer during 2012–2017 and assessable for a follow‐up period of 12 months. Kaplan–Meier estimates and Cox proportional hazards models were used to calculate hazard ratios (HR) and 95% confidence intervals (CI) for MDD in the AYA patients with cancer versus age‐, sex‐ and working status‐matched cancer‐free controls. A subgroups analysis of the AYA patients with cancer was performed to explore MDD risk factors.ResultsA total of 3559 AYA patients with cancer and 35,590 matched controls were included in the analysis. Adolescent and young adult patients with cancer had a three‐fold higher risk for MDD compared with cancer‐free controls (HR, 3.12; 95% CI, 2.64–3.70). Among cancer categories with >100 patients, patients with multiple cancer categories, including those with metastatic cancer (HR, 6.73, 95% CI, 3.65–12.40) and leukemia (HR, 6.30; 95% CI, 3.75–10.58), had the greatest MDD risk versus matched controls. Patients who received inpatient chemotherapy as initial treatment had a higher risk for MDD than patients without chemotherapy (HR, 0.43; 95% CI, 0.30–0.62).ConclusionsAdolescent and young adult patients in Japan with cancer are at high risk for MDD. Particularly, those with multiple cancer categories, leukemia, and those who receive aggressive anticancer treatments should be monitored closely for symptoms of MDD.

Clinical Features and Risk Factors for Mortality in Hospitalized Older Adults with Pneumonia.

Background Pneumonia is a common disease among the aging population in Japan. Hence, it is important to elucidate the risks related to pneumonia mortality. Since Streptococcus pneumoniae is the most commonly observed pathogen, pneumococcal vaccination is recommended to older adults. Therefore, this study aimed to clarify the clinical features of pneumonia, including the status of pneumococcal vaccination, in hospitalized older adult patients in Japan. Methods This single-centered retrospective study was conducted by reviewing the medical records of all patients with acute pneumonia at Fujisawa City Hospital in Japan from April 2018 to March 2019. Patients were divided into two groups based on their history of pneumococcal vaccination. The primary endpoint was in-hospital mortality, while the secondary endpoint was risk factors associated with mortality. Results We included 93 patients with pneumonia in this retrospective study. Although the mortality rate was higher in the vaccinated group (15.8%) than in the unvaccinated group (9.1%), vaccination status was not identified as a significant risk factor for mortality after multivariable logistic regression (odds ratio: 2.71; 95% confidence interval: 0.667–11.02; p=0.16). In addition, the A-DROP score was identified as an independent risk factor (odds ratio: 2.64; 95% confidence interval: 1.22–5.72; p=0.008). Conclusions Our study suggested that the A-DROP score is a risk factor of mortality for pneumonia in older adults. In addition, pneumococcal vaccination history was related to increased mortality; however, the influence of the vaccination remains unclear because of the small sample size.

Safety and effectiveness of eculizumab in Japanese patients with generalized myasthenia gravis: interim analysis of post-marketing surveillance.

Background:Eculizumab, a humanized monoclonal antibody targeted to terminal complement protein C5, is approved in Japan for treatment of patients with anti-acetylcholine receptor antibody-positive (AChR+) generalized myasthenia gravis (gMG) whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIg) therapy or plasmapheresis.Methods:This interim analysis of mandatory post-marketing surveillance in Japan assessed the safety and effectiveness of eculizumab at 26 weeks after treatment initiation in patients with AChR+ gMG.Results:Data were available for 40 adult patients in Japan [62.5% (25/40) female; mean age at eculizumab initiation, 51.0 years]. Fifteen patients had a history of thymoma. Six patients were excluded from the effectiveness analysis set due to participation in the open-label extension part of the phase III, randomized, double-blind, placebo-controlled REGAIN study [ClinicalTrials.gov identifier: NCT02301624]. After 26 weeks’ follow up, 32 patients (80%) were continuing eculizumab treatment. Adverse drug reactions were reported by seven patients [most frequently headache (n = 3)]. One death was reported during eculizumab treatment (relationship unclear as determined by the treating physician) and there was one death 45 days after the last dose (considered unrelated). No meningococcal infections were reported. Mean (standard deviation) changes from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores were −3.7 (2.61) (n = 27) and −5.6 (3.50) (n = 26), respectively, at 12 weeks, and −4.3 (2.72) (n = 26) and −5.6 (4.02) (n = 24), respectively, at 26 weeks. Improvements in MG-ADL and QMG scores were generally similar in patients with/without a history of thymoma. Frequency of IVIg use decreased following eculizumab initiation.Conclusion:In a real-world setting, eculizumab was effective and well tolerated for the treatment of AChR+ gMG in adult Japanese patients whose disease was refractory to IVIg or plasmapheresis. These findings are consistent with the efficacy and safety results from the global phase III REGAIN study of eculizumab.

Patients’ preferences and factors influencing initial advance care planning discussions’ timing: A cross-cultural mixed-methods study

Background: Although advance care planning discussions are increasingly accepted worldwide, their ideal timing is uncertain and cultural factors may pertain. Aim: To evaluate timing and factors affecting initiation of advance care planning discussions for adult patients in Japan and Taiwan. Design: Mixed-methods questionnaire survey to quantitatively determine percentages of patients willing to initiate advance care planning discussions at four stages of illness trajectory ranging from healthy to undeniably ill, and to identify qualitative perceptions underlying preferred timing. Setting/participants: Patients aged 40–75 years visiting outpatient departments at four Japanese and two Taiwanese hospitals were randomly recruited. Results: Overall (of 700 respondents), 72% (of 365) in Japan and 84% (of 335) in Taiwan (p < 0.001) accepted discussion before illness. In Japan, factors associated with willingness before illness were younger age and rejection of life-sustaining treatments; in Taiwan, older age, stronger social support, and rejection of life-sustaining treatments. Four main categories of attitudes were extracted: the most common welcomed discussion as a wise precaution, responses in this first category outnumbered preference for postponement of discussion until imminent end of life, acceptance of the universal inevitability of death, and preference for discussion at healthcare providers’ initiative. Conclusion: The majority of patients are willing to begin discussion before their health is severely compromised; about one out of five patients are unwilling to begin until clearly facing death. To promote advance care planning, healthcare providers must be mindful of patients’ preferences and factors associated with acceptance and reluctance to initiate advance care planning.

Treatment strategies for recurrent ovarian cancer in older adult patients in Japan: a study based on real-world data.

Elderly patients with cancer are often at risk for undertreatment because of frailty, an aging-specific problem. However, current real-world conditions of recurrent ovarian cancer treatment in elderly patients remain unclear. This study aimed to clarify treatment patterns in elderly patients with recurrent ovarian cancer. We used an ovarian cancer database containing the diagnosis and initial therapy of all patients at the National Cancer Center Hospital in Japan from 2007 to 2014. Patients were stratified into the platinum-sensitive group and the platinum-resistant group. We retrospectively assessed chemotherapy use in patients aged ≤ 64, 65-69, 70-74, 75-79, and ≥ 80years. Among 253 patients (sensitive group: 135; resistant group: 118), by age group 91%, 95%, 100%, 100%, and 100% received chemotherapy in the sensitive group, and 79%, 67%, 50%, 29%, 0% received chemotherapy in the resistant group, respectively. In the resistant group, the percentage of patients aged 70-74 or 75-79years who received chemotherapy was significantly lower than the percentage among patients aged ≤ 64years, respectively (p = 0.01, p = 0.01). In multivariate analysis, age ≥ 70years (odds ratio [OR], 4.412; 95% confidence interval (CI), 1.628-11.959; p = 0.004) and platinum-free interval < 3months (OR, 3.434; 95% CI, 1.401-8.399; p = 0.007) were inversely associated with chemotherapy use. Doctors and patients did not consider chemotherapy in patients aged ≥ 70years with platinum-resistant disease. Older age was independently and inversely associated with chemotherapy use in platinum-resistant ovarian cancer. Our results highlight the importance of demographic information in clinical decision-making for elderly patients.

Real-world treatment patterns and patient-reported outcomes in episodic and chronic migraine in Japan: analysis of data from the Adelphi migraine disease specific programme

BackgroundIn Japan, detailed information on the characteristics, disease burden, and treatment patterns of people living with migraine is limited. The aim of this study was to compare clinical characteristics, disease burden, and treatment patterns in people with episodic migraine (EM) or chronic migraine (CM) using real-world data from clinical practice in Japan.MethodsThis was an analysis of data collected in 2014 by the Adelphi Migraine Disease Specific Programme, a cross-sectional survey of physicians and their consulting adult patients in Japan, using physician and patient questionnaires. We report patient demographics, prescribed treatment, work productivity, and quality-of-life data for people with CM (≥15 headache days/month) or EM (not fulfilling CM criteria). In descriptive analyses, continuous and categorical measures were assessed using t-tests and Chi-squared tests, respectively.ResultsPhysicians provided data for 977 patients (mean age 44.5 years; 77.2% female; 94.5% with EM, 5.5% with CM). A total of 634/977 (64.9%) invited patients (600 with EM; 34 with CM) also provided data. Acute therapy was currently being prescribed in 93.7% and 100% of patients with EM and CM, respectively (p = 0.069); corresponding percentages for current preventive therapy prescriptions were 40.5% and 68.5% (p < 0.001). According to physicians who provided data, preventive therapy was used at least once by significantly fewer patients with EM than with CM (42.3% vs. 68.5%, respectively; p < 0.001). Among patients who provided physicians with information on issues with their current therapy (acute therapy: n = 668 with EM, n = 38 with CM; preventive therapy: n = 295 with EM, n = 21 with CM), lack of efficacy was the most frequently identified problem (acute therapy: EM 35.3%, CM 39.5% [p = 0.833]; preventive therapy: EM 35.3%, CM 52.4% [p = 0.131]). Moderate-to-severe headache-related disability (Migraine Disability Assessment total score ≥ 11) was reported by significantly fewer patients with EM than with CM (21.0% vs. 60.0%, respectively; p < 0.001) among patients who provided data.ConclusionsPreventive treatment patterns in people with EM versus CM differ in Japan, with both types of migraine posing notable disease burdens. Our findings demonstrate that more effective migraine therapies are required to reduce the burden of the disease.

Impact of Outpatient Rehabilitation Service in Preventing the Deterioration of the Care-Needs Level Among Japanese Older Adults Availing Long-Term Care Insurance: A Propensity Score Matched Retrospective Study.

Outpatient rehabilitation (OR) and outpatient day long-term care (ODLC) services are frequently used by older adult patients in Japan. However, there is a need to clarify that OR service, which has more rehabilitation professionals than ODLC, has the role of providing rehabilitation. This retrospective study examined the impact of OR services by comparing the two services based on City A data from the care-needs certification survey conducted between 2015 to 2017. We performed a propensity score matched analysis to compare the changes in the care level and function of OR and ODLC users after two years. The results showed that OR users showed a lower deterioration in care levels and less decline in the activities of daily living (ADL) in dementia and adaptation to social life. In the analysis of older adults requiring support, OR users had a lower deterioration in care levels and less decline in the ADL in dementia and behavioral and psychological symptoms than ODLC users did. There was no difference between the two services with respect to older adults requiring long-term care. The OR service has had an increasingly preventive effect on the deterioration of care levels compared to the ODLC service, which was particularly evident in older adults requiring support.

1453. Ninety-One Day Quality of Life Post-Pneumonia Diagnosis in Adult Patients in Japan

BackgroundPneumonia is a serious illness with potentially long-lasting but poorly-characterized impact on quality of life. The Japanese Goto Epidemiology Study is a prospective, active, population-based surveillance study of adults with community-onset pneumonia (COP), that includes assessment of Quality Adjusted Life Years (QALYs).MethodsPatients with X-ray/CT scan confirmed COP enrolled in the Goto study and consented to participate in QALY assessment responded to Japanese versions of EuroQol-5D-5L (EQ-5D-5L) health state classification (primary), EQ-5D visual analog scale, and SF-6D (secondary) instruments. This interim analysis reports 91-day QALYs based on Day 1 (diagnosis), 8, 16, 31, and 91 EQ-5D-5L responses of patients enrolled between June 1, 2017 and February 7, 2008. For comparison, we developed hypothetical QALYs had the patients not developed pneumonia (control) using the EQ-5D-5L scores from Day -30 (via recall) carried forward and adjusted by the natural decline in scores and death with age. QALYs were calculated as the area (trapezoidal method) under the survival weighted pneumonia and control EQ-5D-5L QALY score curves.ResultsThe 234 patients were 55% male, 88% aged ≥64 years, 45% nursing home residents, and 65% initially hospitalized (35% initially outpatient) for COP. Compliance for interviews among survivors was 100%. EQ-5D-5L scores were 0.732 at Day −30, decreased to 0.590 at diagnosis, and rose to 0.675 by Day 91. The average scores at all time points remained below Day −30 (all P values <0.01). Compared with hypothetical controls, development of pneumonia on average resulted in a loss of 0.0292 QALYs (P < 0.001) during the first 91 days of follow-up.ConclusionAmong residents of Goto Island, Japan, significant QALY losses were observed in association with a diagnosis of pneumonia and had not returned to baseline by 3 months after diagnosis. Scores and cumulative QALY losses during the first 3 months after pneumonia diagnosis were comparable to those experienced by US adults with chronic heart failure during a 3-month period.Disclosures H. Glick,K. Hirano, Pfizer Inc.: Consultant, Research support. T. Miyazaki, Pfizer Inc.: Collaborator, Research support and Speaker honorarium. . J. Suaya, E. Gonzalez, B. D. Gessner, A. G. Arguedas, Pfizer Inc.: Employee and Shareholder, Salary. R. E. Isturiz, Pfizer, Inc: Employee and Shareholder, Salary and Stock & Stock Options. . S. Kohno, Pfizer Inc.: Consultant, Research support and Speaker honorarium.

PIN46 - COST-EFFECTIVENESS COMPARISON OF BALOXAVIR MARBOXIL AND LANINAMIVIR FOR THE TREATMENT OF INFLUENZA IN JAPAN

Antiviral drugs are recommended and widely used for the treatment of influenza in Japan. The aim of this study was to investigate cost-effectiveness of baloxavir marboxil (baloxavir) versus laninamivir, the most widely used antiviral for influenza in Japan, in otherwise healthy adult patients conditional on result of rapid influenza diagnostic test. A decision tree was used to describe the course of influenza and predict associated costs and quality-adjusted life-years (QALYs) over one year, by antiviral. Costs were valued from the public healthcare payer’s perspective, including influenza test, antiviral acquisition, other medications, physician visits, any other outpatients costs associated with influenza or adverse events, and hospitalisations. Resource utilisation and unit costs were obtained from an analysis of the JammNet claims database and adjusted to year 2018. Health state utilities were driven by influenza symptoms, drug-related adverse events (DRAEs), and complications caused by influenza. They were obtained from the clinical trial of baloxavir using EQ-5D-5L and a previous UK model commissioned by NICE. Deterministic and probabilistic sensitivity analyses (DSA/PSA) were performed. A willingness-to–pay threshold of ¥5,000,000/QALY was considered. The estimated total costs per patient were ¥9,393 and ¥9,130 for baloxavir and laninamivir respectively. The additional acquisition cost of baloxavir was partly offset by adverse event costs avoided. The incremental cost/QALY gained for baloxavir versus laninamivir was ¥2,336,603, which is below the considered willingness-to-pay threshold. The main influential factors of the model results were probability of DRAEs and duration of influenza symptoms for laninamivir based on the results of DSA. The PSA showed a probability of 65% that baloxavir is cost-effective versus laninamivir. This model suggests that treating influenza with baloxavir would be cost-effective compared to laninamivir in otherwise healthy adult patients in Japan. Further evaluations are needed in different settings such as high-risk population.

Descriptive epidemiology and outcomes of bone sarcomas in adolescent and young adult patients in Japan

BackgroundThere have been fewer improvements in the clinical outcomes of adolescent and young adult (AYA) patients with cancer than for children and older adults, possibly because fewer studies focus on patients in this age group. The aims of this study were (1) to determine survival rates of bone sarcoma among AYAs in Japan (for comparison with other age groups), and (2) to establish whether belonging to the AYA age group at diagnosis was correlated with poor cancer survival in Japan.MethodsA total of 3457 patients diagnosed with bone sarcoma (1930 male and 1527 female) were identified from 63,931 records in the Bone and Soft Tissue Tumor (BSTT) registry, a nationwide Japanese database, from 2006 to 2013. The histologic subtypes of bone sarcoma were osteosarcoma, chondrosarcoma, and Ewing sarcoma. The primary endpoints for prognosis were the occurrence of tumor-related death. We compared the epidemiological features of AYAs with other age groups. The cancer survival rates were calculated using the Kaplan-Meier method. Cox proportional hazards models were used to analyze the prognostic factors for cancer survival.ResultsThe majority of AYA had osteosarcoma 631 (56.2%), while 198 (17.6%) had chondrosarcoma. The frequency of bone sarcoma occurrence was highest among AYA patients, who accounted for a marked proportion of patients with each type of sarcoma. With the exception of sarcoma type, AYA patients did not significantly differ from patients in other age groups for any of the investigated clinicopathological parameters. Cancer survival of AYA patients was significantly higher than in the elderly. Univariate and multivariate analyses revealed that AYA status was not a predictor of poor cancer survival. However, older age (≥65 years) was a predictor of poor cancer survival in patients with overall bone sarcoma, osteosarcoma, chondrosarcoma.ConclusionThis epidemiological study is the first to investigate AYA patients with bone sarcoma using the nationwide BSTT Registry. We found that cancer survival of AYA patients was significantly higher than that of the elderly. AYA status was not a predictor of poor cancer survival in Japan.

Shorter survival in adolescent and young adult patients, compared to adult patients, with stage IV colorectal cancer in Japan

BackgroundThe incidence of colorectal cancer in adolescent and young adult patients is increasing. However, survival and clinical features of young patients, especially those with stage IV disease, relative to adult patients remain unclear.MethodsThis retrospective single-institution cohort study was conducted at a tertiary care cancer center. Subjects were 861 consecutive patients who were diagnosed with stage IV colorectal cancer at the age of 15 to 74 years and who were referred to the division of surgery or gastrointestinal oncology at the National Cancer Center Hospital from 1999 to 2013. Overall survival (OS) was investigated and clinicopathological variables were analyzed for prognostic significance.ResultsOf these, 66 (8%) were adolescent and young adult patients and 795 (92%) were adult patients. Median survival time was 13.6 months in adolescent and young adult patients and 22.4 months in adult patients, and 5-year OS rates were 17.3% and 20.3%, respectively, indicating significant worse prognosis of adolescent and young adult patients (p = 0.042). However, age itself was not an independent factor associated with prognosis by multivariate analysis. When compared with adult patients, adolescent and young adult patients consisted of higher proportion of the patients who did not undergo resection of primary tumor, which was an independent factor associated with poor prognosis in multivariate analysis. In patients who did not undergo resection (n = 349), OS of adolescent and young adult patients were significantly worse (p = 0.033).ConclusionsPrognoses were worse in adolescent and young adult patients with stage IV colorectal cancer compared to adult patients in Japan, due to a higher proportion of patients who did not undergo resection with more advanced and severe disease, but not due to age itself.

A randomized, double-blind, parallel-group, phase III study of shortening the dosing interval of subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis and an inadequate response to subcutaneous tocilizumab every other week: Results of the 12-week double-blind period

Objective: To determine the efficacy and safety of subcutaneous tocilizumab (TCZ-SC) monotherapy every week (qw) versus every other week (q2w) in patients with rheumatoid arthritis who had an inadequate response to TCZ-SC q2w.Methods: Adult patients in Japan with inadequate response to TCZ-SC q2w were randomized to either TCZ-SC 162 mg qw monotherapy or TCZ-SC 162 mg q2w monotherapy for 12 weeks (double-blind). The primary endpoint was the change from baseline in adjusted Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) at week 12. Efficacy, safety and pharmacokinetics were assessed.Results: TCZ-SC qw was superior to TCZ-SC q2w for adjusted mean change in DAS28-ESR from baseline to week 12. The difference in the change in DAS28-ESR between TCZ-SC qw and q2w was −1.21 (95%CI: −2.13, −0.30, p = .0108). A higher proportion of patients receiving TCZ-SC qw achieved DAS28-ESR remission/low disease activity than TCZ-SC q2w. Adverse events were 71.4% and 66.7% for TCZ-SC qw and q2w, respectively; infection was the most common event with one fatal case with TCZ-SC qw.Conclusions: In patients with inadequate response to TCZ-SC q2w, shortening the dosing interval to qw improved efficacy with acceptable tolerability. Occurrence of infection for both TCZ q2w and qw is important and needs careful attention.

Effect of pre-hospital advanced airway management for out-of-hospital cardiac arrest caused by respiratory disease: a propensity score-matched study.

Optimal pre-hospital care for out-of-hospital cardiac arrest (OHCA) caused by respiratory disease may differ from that for OHCA associated with other aetiologies, especially with respect to respiratory management. We aimed to investigate whether pre-hospital advanced airway management (AAM) was associated with favourable outcomes after OHCA caused by intrinsic respiratory disease. This nationwide, population-based, propensity score-matched study of adult patients in Japan with OHCA due to respiratory disease from 1 January 2005 to 31 December 2012 compared patients with and without pre-hospital AAM. The primary outcome was neurologically favourable survival at one month after the OHCA. Of 49,534 eligible patients, 20,458 received pre-hospital AAM and 29,076 did not. In a propensity score-matched cohort (18,483 versus 18,483 patients), the odds of neurologically favourable survival were significantly lower for patients receiving pre-hospital AAM (0.6% versus 1.5%; odds ratio [OR] 0.42 [95% confidence interval {CI} 0.34 to 0.52]). The results from multivariable logistic regression analysis also showed that pre-hospital AAM was significantly associated with a decreased chance of neurologically favourable survival (adjusted OR 0.43 [95% CI 0.35 to 0.52]). Similar findings were observed for one-month survival and pre-hospital return of spontaneous circulation. In subgroup analyses, pre-hospital AAM was associated with poor neurological outcomes, regardless of the type of airway device used (laryngeal mask airway, adjusted OR 0.35 [95% CI 0.19 to 0.57]; oesophageal obturator airway, adjusted OR 0.44 [95% CI 0.35 to 0.55]; and endotracheal tube, adjusted OR 0.47 [95% CI 0.30 to 0.69]). In conclusion, pre-hospital AAM was associated with poor neurological outcome among patients with OHCA caused by intrinsic respiratory disease.

Socioeconomic status and type 2 diabetes complications among young adult patients in Japan

ObjectiveTo assess the relationship between socioeconomic status (SES) and complications of type 2 diabetes among young adults in Japan.DesignA cross-sectional study.SettingOutpatient wards of 96 member hospitals and clinics of the Japan Federation of Democratic Medical Institutions.ParticipantsA total of 782 outpatients with type 2 diabetes (525 males, 257 females), aged 20–40 years as of March 31, 2012. After excluding 110 participants whose retinopathy diagnosis was in question, 672 participants were analyzed.MeasurementsWe examined the relations between SES (educational level, income, type of public healthcare insurance, and employment status) and diabetes complications (retinopathy and nephropathy) using a multivariate logistic regression analysis.ResultsThe prevalence of type 2 diabetic retinopathy was 23.2%, while that of nephropathy was 8.9%. The odds of having retinopathy were higher among junior high school graduates (OR 1.91, 95% CI 1.09–3.34), patients receiving public assistance (OR 2.19, 95% CI 1.20–3.95), and patients with irregular (OR 1.72, 95% CI 1.03–2.86) or no employment (OR 2.23, 95% CI 1.36–3.68), compared to those with a higher SES, even after covariate adjustment (e.g., age, gender, body mass index). Similarly, the odds of having nephropathy were higher among patients with middle (OR 3.61, 95% CI 1.69–8.27) or low income levels (OR 2.53, 95% CI 1.11–6.07), even after covariate adjustment.ConclusionsLow SES was associated with a greater likelihood of type 2 diabetes complications in young adults. These findings suggest the necessity of health policies that mitigate socioeconomic disparity and thereby reduce the prevalence of diabetic complications.