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Background: Chronic spontaneous urticaria (CSU), characterized by the recurrence of pruritic hives and/or angioedema for >6 weeks with no identifiable trigger, has a negative impact on health-related quality of life (HRQoL). Methods: The objective of this web-based cross-sectional study was to evaluate disease control, disease burden, and treatment satisfaction in Japanese adults with CSU using the Urticaria Control Test (UCT), HRQoL outcomes, and the Treatment Satisfaction Questionnaire for Medication–9 items (TSQM-9). Results: In total, 529 adults were included in the analysis (59.9% female), with a mean ± standard deviation (SD) in CSU duration of 13.2 ± 13.0 years. Based on UCT scores, two-thirds of patients had poor (score of 0–7; 23.6%) or insufficient (score of 8–11; 43.3%) symptom control, and one-third had good control (score of 12–16; 33.1%). Overall treatment satisfaction was not high, with mean ± SD TSQM-9 scores of 55.5 ± 17.6% for effectiveness, 68.2 ± 18.8% for convenience, and 59.2 ± 18.4% for global satisfaction. No apparent differences in TSQM-9 scores were observed between patients receiving different medications. HRQoL outcomes were worse among patients with poor/insufficient symptom control. Conclusions: Japanese adults with CSU have a high disease burden, and better treatment options are needed to increase treatment satisfaction. [ABSTRACT FROM AUTHOR]

Introduction: Atopic dermatitis (AD) is a chronic relapsing condition with high disease burden and impact on health-related quality of life (HRQoL). Correlations between clinician- and patient-reported outcomes tend to be poor, and limited data in Asian patients are available. Methods: ADDRESS-J was a prospective, non-interventional, longitudinal study that evaluated the real-world effectiveness and safety of AD treatment in Japanese adults (aged 20–59 years) with moderate-to-severe AD. Three clinician-reported AD severity outcomes (Investigator's Global Assessment, Eczema Area and Severity Index, and body surface area affected), three dermatological patient-reported outcomes (Patient-Oriented Eczema Measure, Dermatology Life Quality Index, and Worst Itch Numerical Rating Scale), and two general HRQoL patient-reported outcomes (5-dimension EuroQoL questionnaire and EuroQol Visual Analog Scale) were collected at baseline and every 3 months throughout the 24-month observation period. Four biomarkers were also analyzed when available (thymus and activation-regulated chemokine [TARC], lactate dehydrogenase [LDH], total immunoglobulin E [IgE], and peripheral blood eosinophil counts [PB EOS]). Spearman's correlation coefficients were calculated using all available pooled data from baseline through 24 months. Results: Correlations between the three clinician-reported outcomes were high/very high (Spearman's correlation coefficients 0.76–0.92); those between the three dermatological patient-reported outcomes were moderate (0.53–0.64), and those between the clinician-reported and dermatological patient-reported outcomes were low/moderate (0.37–0.51). Correlations between the general HRQoL patient-reported outcomes and the clinician-reported and dermatological patient-reported outcomes were negligible–moderate (0.26–0.60). Biomarker correlations with the clinician-reported and dermatological patient-reported outcomes were low/moderate for TARC and LDH (0.44–0.63), but negligible/low for PB EOS and total IgE (0.01–0.41). Conclusions: These results show that clinician- and patient-reported outcomes do not necessarily correlate well in Japanese adults with AD. This highlights the importance of including patient-reported outcomes when assessing disease severity/impact, planning treatment, and assessing response to treatment. Trial Registration: UMIN Clinical Trials Registry (UMIN-CTR) Identifier UMIN000022623. Plain Language Summary: Atopic dermatitis (AD) is a long-term recurring skin disease that needs monitoring over time. Various measures (outcomes) are used to assess the severity of AD and its effect on patients. Some outcomes are based on examinations used by clinicians (doctors). Others are based on questionnaires used by patients themselves to report how severe they feel their AD is, and how it affects their lives. It is not known how well these different measures correlate with one another (how a severity score given by one outcome agrees with that given by another outcome), especially in Asian patients. This analysis used information from ADDRESS-J, a study that followed Japanese adults with moderate-to-severe AD who were treated for AD in the real world for a period of 2 years. It used a statistical method to compare three clinician-reported severity outcomes, three dermatological (skin-related) patient-reported outcomes, and two general health-related quality of life patient-reported outcomes. Agreement between the three clinician-reported outcomes was high or very high. Agreement between the three dermatological patient-reported outcomes was moderate. However, importantly, agreement between the clinician-reported outcomes and the dermatological patient-reported outcomes was low or moderate. Agreement between the general health-related quality of life outcomes and all other dermatological outcomes (whether clinician- or patient-reported) was low or moderate. The study showed that clinician-reported and patient-reported AD outcomes do not necessarily agree well in Japanese adults with AD. This highlights the importance of including patient-reported outcomes when evaluating AD, planning treatment, or judging how well patients are responding to treatment. [ABSTRACT FROM AUTHOR]

Objective: To assess dietary behaviours and related lifestyles according to the presence or absence of skipping breakfast. Design: We analysed the cross-sectional data from a baseline survey of a large-scale population-based cohort study in Japan conducted in 2011–2016. Participants provided information on dietary behaviours and lifestyles through a self-administered questionnaire. Skipping breakfast was defined as not eating breakfast at least once a week and was classified according to the frequency of skipping breakfast as 1–2, 3–4 or ≥5 times/week. Setting: Sixteen municipalities in seven prefectural areas across Japan under the Japan Public Health Centre-based prospective study for the Next Generation. Participants: 112 785 residents (51 952 males and 60 833 females) aged 40–74 years. Results: After adjustment for age, socio-demographic status, drinking status and smoking status, individuals who skipped breakfast at least once a week, compared with those who ate breakfast every day, were more likely to have adverse dietary behaviours such as frequent eating out (multivariable OR = 2·08, 95 % CI (1·96, 2·21) in males and 2·15, 95 % CI (1·99, 2·33) in females), frequent eating instant foods (1·89, 95 % CI (1·77, 2·01) in males and 1·72, 95 % CI (1·56, 1·89) in females). They had late bedtime (1·85, 95 % CI (1·75, 1·95) in males and 1·98, 95 % CI (1·86, 2·11) in females) and living alone (2·37, 95 % CI (2·17, 2·58) in males and 2·02, 95 % CI (1·83, 2·21) in females), using the logistic regression model. Conclusions: Both adult males and females who skipped breakfast were likely to eat out, to have a dietary habit of eating instant foods and have lifestyles such as late bedtime and living alone than those who ate breakfast. [ABSTRACT FROM AUTHOR]

Growth differentiation factor 15 (GDF-15), which modulates cellular energy balance, is reported to be positively associated with cardiovascular disease. However, there have been no reports about the association between serum GDF-15 concentration and atherosclerosis as evaluated by carotid intima-media thickness (CIMT) among the general population. A cross-sectional study of 536 Japanese individuals aged 60 to 69 years was conducted. To avoid the influence of abnormal cellular energy balance, this study only included participants who had a normal body mass index (BMI) and normal thyroid hormone (free thyroxine and free triiodothyronine) levels. A significant positive association between serum GDF-15 concentration and atherosclerosis was observed. In the sex- and age-adjusted model (Model 1), the odds ratio (OR) (95% confidence interval (CI)) for the logarithmic value of GDF-15 and atherosclerosis was 2.62 (1.67, 5.87). This association remained after adjusting for thyroid function and renal function (Model 2) and further adjusting for known cardiovascular risk factors (Model 3). The corresponding values were 2.61 (1.15, 5.93) for Model 2 and 2.49 (1.08, 5.71) for Model 3, respectively. Serum GDF-15 concentrations could help us to estimate the risk of atherosclerosis by indicating the status of cellular energy balance, which is related to mitochondrial activity among comparative healthy older individuals. [ABSTRACT FROM AUTHOR]

Pediatric atopic dermatitis (AD) can negatively impact the family quality of life (QoL). We report data from the real-world Epidemiology of Children with Atopic Dermatitis Reporting on their Experience (EPI-CARE) study in Japanese pediatric patients, focusing on disease impact on family QoL. Children and adolescents aged 6 months to <18 years completed an online survey between September 2018–December 2019. The impact of disease severity on family QoL and its effect on parents' time were assessed using the dermatitis family impact (DFI) questionnaire. The impact of a family history of allergic conditions, current residency, second-hand smoke exposure, and household pets on AD prevalence and severity was also assessed. Family QoL decreased as AD severity increased, particularly in families with children aged <6 years; but had the greatest impact on sleep and tiredness in families with children aged <12 years. Parents spent at least 4.6 h/week caring for children <6 years, including those with mild symptoms. Most children (>80%) had a family history of allergic conditions; AD prevalence was increased in those exposed to second-hand smoke or household pets. This study demonstrated that pediatric AD in Japanese individuals has negative impacts on family QoL and that family and household environments can influence pediatric AD prevalence. [ABSTRACT FROM AUTHOR]

Angiogenesis inhibition therapy causes hypertension by increasing peripheral vascular resistance. Vasa vasorum angiogenesis plays a crucial role in the development of atherosclerosis. Since vascular endothelial growth factor (VEGF), which contributes to the progress of angiogenesis, is reported to be inversely associated with the minor allele of polymorphism rs3025039, the minor allele of rs3025039 could be inversely associated with atherosclerosis among individuals with hypertension. A cross-sectional study of 1793 older Japanese adults aged 60–89 years with hypertension who participated in general health check-ups was conducted. Atherosclerosis was defined as carotid intima-media thickness (CIMT) ≥ 1.1 mm. The minor allele of polymorphism rs3025020 was positively associated with VEGF. Therefore, in addition to known cardiovascular risk factors, rs3025020 genotype acted as a confounding factor in the present study. Independent of known confounding factors, the minor allele of rs3025039 was inversely associated with atherosclerosis among older Japanese adults with hypertension. The fully adjusted odds ratio (OR) and 95% confidence interval (CI) for atherosclerosis with the minor allele of rs3025039 was 0.78 (0.64, 0.96). The angiogenesis-related polymorphism rs3025039 was associated with the development of atherosclerosis among older Japanese individuals. This study indicates that the development of atherosclerosis among older individuals might partly indicate a capacity for angiogenesis. [ABSTRACT FROM AUTHOR]

Background: Whether fat mass or lean mass affects bone mass in postmenopausal women is controversial. This study aimed to explore the association between body composition measured by bioelectrical impedance analysis (BIA) and bone mass measured by quantitative ultrasound (QUS) in postmenopausal women in Japan. Methods: We conducted a cross-sectional study, The Unzen Study, on 382 community-dwelling postmenopausal Japanese women (mean (standard deviation) age: 68.2 (7.2) years) who participated in periodic health examinations. The stiffness index (SI) was measured using QUS, and body composition (e.g., fat mass and muscle mass) was measured using BIA. Grip strength was measured. Fasting blood samples were collected, and 25-hydroxyvitamin D (25(OH)D), tartrate-resistant acid phosphatase-5b (TRACP-5b), and parathyroid hormone (PTH) levels were measured. Data on current smoking, alcohol consumption, exercise, and any comorbidities (heart disease, lung disease, stroke, or diabetes mellitus) were collected. Results: The SI increased with increasing quartiles of fat mass and muscle mass (both p for trend < 0.001), respectively. There were positive correlations between SI and log (25(OH)D) or grip strength. Fat mass significantly correlated with grip strength. Multiple linear regression analysis showed that higher fat mass was independently and significantly associated with higher SI after adjusting for age, height, comorbidity, current smoking, alcohol consumption, exercise, log (25(OH)D), log (TRACP-5b), log (PTH), and grip strength (p = 0.001). In contrast, no association was observed between muscle mass and SI. Conclusions: Fat mass, but not muscle mass, was a significant determinant of SI in community-dwelling postmenopausal Japanese women. [ABSTRACT FROM AUTHOR]

Purpose: Regarding epidemiological studies, the role of vitamin D in musculoskeletal functionality (muscle weakness and physical performance) among elderly people is still controversial. The purpose of the present study was to investigate the associations between 25-hydroxyvitamin D [25(OH)D] and physical performance among community-dwelling middle-aged and old Japanese men and women. Methods: The subjects were community-dwelling 297 men and 415 women aged 50 years and over. Data on height (m) and weight (kg) were collected. Serum 25(OH)D, parathyroid hormone, calcium, and albumin levels were measured. Serum 25(OH)D was classified into deficiency group: < 20 ng/mL, insufficiency group: 20–30 ng/mL, and sufficiency group: ≧ 30 ng/mL. Physical performance was assessed by grip strength, chair stand time, and functional reach. Information on current smoking, alcohol drinking, regular exercise, any comorbidities (hypertension, heart disease, diabetes mellitus, lung disease, and stroke), and pain (lumbar and knee) was collected. Results: Vitamin D deficiency and insufficiency based on serum 25(OH)D levels were observed in 15.2% and 56.9% of men and 52.0% and 43.6% of women, respectively. In men, higher serum 25(OH)D levels were associated with better grip strength (p for trend = 0.003), chair stand time (p for trend = 0.042), and functional reach (p for trend <0.001). On the other hand, these parameters were not associated with serum 25(OH)D levels in women. Conclusion: A higher level of serum 25(OH)D was associated with better physical performance in men but not in women. [ABSTRACT FROM AUTHOR]

Background: Several studies have reported that height is inversely associated with risk of cardiovascular disease but positively associated with cancer risk. On the other hand, evidence has been accumulating that anemia reflects poor health and increased vulnerability to poor outcomes in older persons. Moreover, alcohol consumption has also been reported to be associated with mortality. However, no studies have reported on a possible association between height and risk of anemia in relation to drinking status. Methods: We conducted a cross-sectional study of 1287 men aged 40-89 years undergoing general health check-ups. Results: Independent from classic cardiovascular risk factors, we found a significant inverse association between height and anemia for non-drinkers and a J-shaped association for drinkers. The multivariable odds ratio (ORs) of an increment of 1 SD (standard deviation) in height (6.68 cm) for anemia for non-drinkers was 0.59 (0.45-0.77). For drinkers, with the second quartile of height (Q2) as the reference group, the multivariable OR of anemia was 2.68(0.90-7.96) ( p = 0.075) for the lowest height quartile (Q1), 2.73(0.92-8.08) for the third quartile (Q3) and 4.82(1.65-14.10) for the highest quartile (Q4) ( p = 0.004). Conclusion: Height was found to be associated with anemia for rural Japanese men and drinking status is likely to affect those associations. [ABSTRACT FROM AUTHOR]

We investigated the efficacy and safety of dupilumab in Japanese patients aged ≥6 months to <18 years old with moderate-to-severe atopic dermatitis not adequately controlled with existing therapies. In this randomized, double-blind, phase 3 study, patients received dupilumab (n = 30) or placebo (n = 32) with concomitant topical corticosteroids for 16 weeks, then all patients received dupilumab from 16 to 52 weeks. The primary endpoint was the proportion of patients with ≥75% improvement in Eczema Area and Severity Index (EASI) score from baseline (EASI-75) to Week 16. Key secondary endpoints included changes in EASI score, proportion of patients with investigator global assessment (IGA) scores of 0/1, and changes in worst daily itch numerical rating scale (NRS) scores (evaluated in patients aged ≥6 to <12 years [n = 35]). At Week 16, more patients achieved EASI-75 with dupilumab than placebo (43.3% vs 18.8%; P = 0.0304), and the least squares mean (LSM) difference in percent change in EASI scores at Week 16 of dupilumab vs placebo was –39.4% (P = 0.0003). However, no significant difference in the proportion of patients achieving IGA scores of 0/1 at Week 16 with dupilumab versus placebo were seen (10.0% vs 9.4%; P = 0.8476). The percent change in worst daily itch NRS scores at Week 16 was higher with dupilumab (LSM difference: –33.3%; nominal P = 0.0117). Dupilumab was well tolerated; no new safety signals were identified. Dupilumab showed consistent efficacy and was well tolerated in Japanese patients aged ≥6 months to <18 years with moderate-to-severe atopic dermatitis previously insufficiently controlled with existing therapies. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Osteoporosis and related fractures, a worldwide public health issue of growing concern, is characterized by compromised bone strength and an increased risk of fracture. Here we show an association between self-reported walking speed and bone mass among community-dwelling postmenopausal Japanese women aged 50 years and older. DESIGN; CROSS-SECTIONAL STUDY: Setting and Participants; The survey population included 1008 postmenopausal women 50-92 years of age residing in rural communities.Methods: Self-reported walking speed was ascertained by asking the participants: "Is your walking speed faster than others of the same age and sex?" to which participants responded "yes (faster)" or "no (moderate/slower)." Calcaneal stiffness index was measured.Results: Women with a faster self-reported walking speed were younger and had a lower BMI, higher stiffness index, and higher grip strength than women with a slower walking speed. Multiple linear regression analysis adjusted for age, BMI, grip strength, comorbidity, current smoking, and alcohol drinking status showed a significant association between faster self-reported walking speed and higher calcaneal stiffness index (p <  0.001).Conclusions: Our findings suggest that questionnaires of walking speed may be useful for predicting bone mass and that a fast self-reported walking may benefit bone health in postmenopausal women. [ABSTRACT FROM AUTHOR]

Abstract: Objective: The influence of hyperuricemia on atherosclerosis is controversial. Subclinical carotid atherosclerosis can be defined in two ways in terms of mean and maximum carotid intima-media thickness (CIMT): one with mean CIMT ≥ 1.1 mm and the other with maximum CIMT ≥ 1.1 mm. However, no studies have been reported of the association between hyperuricemia and subclinical carotid atherosclerosis while taking the two different ways of classification into account. Methods: We conducted a cross-sectional study of 4133 subjects (1492 men and 2641 women) aged 30–89 years undergoing general health check-ups. For analysis of various associations, we calculated the multivariable odds ratios (ORs) for the two ways classifications of subclinical carotid atherosclerosis in relation to hyperuricemia. Results: Hyperuricemia-related renal impairment constitutes a significant marker for subclinical carotid atherosclerosis with mean CIMT ≥ 1.1 mm for both men and women, while hyperuricemia per se was found to be beneficially associated with risk of subclinical carotid atherosclerosis with maximum CIMT ≥ 1.1 mm for men. The classical cardiovascular risk factors without adjustment for glomerular filtration rate (GFR) of ORs for subclinical carotid atherosclerosis (mean CIMT ≥ 1.1 mm) and subclinical carotid atherosclerosis (maximum CIMT ≥ 1.1 mm) were 2.20(1.10–4.22) and 0.84(0.63–1.13) for men and 2.12(1.02–4.38) and 0.92(0.66–1.27) for women. After further adjustment for GFR, the corresponding values were 1.54(0.74–3.20) and 0.67(0.49–0.92) for men and 1.32(0.61–2.88) and 0.80(0.57–1.12) for women. Conclusion: Hyperuricemia-related renal impairment is a significant marker for subclinical carotid atherosclerosis for both men and women, while hyperuricemia per se may be inversely associated with subclinical carotid atherosclerosis for men as seen in a rural community-dwelling Japanese population. [Copyright &y& Elsevier]