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1.
Hypertens Res ; 2024 Apr 08.
Artículo en Inglés | MEDLINE | ID: mdl-38584158

RESUMEN

The Japanese Society of Hypertension updated guidelines for hypertension management (JSH2019), changing the blood pressure (BP) classification. However, evidence is sparse regarding the association of the classification with cardiovascular disease (CVD) events among young to middle-aged workers in Japan. We examined this issue using longitudinal data from Japan Epidemiology Collaboration on Occupational Health Study with a prospective cohort design. Participants were 81,876 workers (aged 20-64 years) without taking antihypertensive medication at baseline. BP in 2011 or 2010 was used as exposure. CVD events that occurred from 2012 to 2021 were retrieved from a within-study registry. Cox regression was used to calculate multivariable-adjusted hazard ratios of CVD events. During 0.5 million person-years of follow-up, 334 cardiovascular events, 75 cardiovascular deaths, and 322 all-cause deaths were documented. Compared with normal BP (systolic BP [SBP] < 120 mmHg and diastolic BP [DBP] < 80 mmHg), multivariable-adjusted hazard ratios (95% confidence intervals) of cardiovascular events were 1.98 (1.49-2.65), 2.10 (1.58-2.77), 3.48 (2.33-5.19), 4.12 (2.22-7.64), and 7.81 (3.99-15.30) for high normal BP (SBP120-129 mmHg and DBP < 80 mmHg), elevated BP (SBP130-139 mmHg and/or DBP80-89 mmHg), stage 1 hypertension (SBP140-159 mmHg and DBP90-99 mmHg), stage 2 hypertension (SBP160-179 mmHg and/or DBP100-109 mmHg), and stage 3 hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg), respectively. The highest population attributable fraction was observed in elevated BP (17.8%), followed by stage 1 hypertension (14.1%). The present data suggest that JSH2019 may help identify Japanese workers at a higher cardiovascular risk.

2.
Respir Investig ; 62(3): 377-383, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38452442

RESUMEN

BACKGROUND: To investigate the outcomes of Pneumocystis jirovecii pneumonia (PCP) between patients with rheumatoid arthritis (RA) treated with and without biologics before PCP onset. PATIENTS AND METHODS: We retrospectively included rheumatoid arthritis (RA) patients with PCP treated with and without biologics before PCP onset. The primary endpoints were 30-day and 180-day survival rates, and the secondary endpoint was severe PCP, including in-hospital death, intensive care unit admission, and requirement of respiratory support during hospitalization. RESULTS: Eighty-two patients were enrolled in this study, including the Biologics group (n = 39) and Non-Biologics group (n = 43). There were no significantly differences in the 30-day and 180-day survival rates and severe PCP rate in the Biologics group and the Non-Biologics group before and after adjusting the patient characteristics. Kaplan-Meier survival curves for death showed no significantly differences between the Biologics and Non-Biologics groups. Cox regression hazard analysis revealed that the average daily prednisolone dose within 90 days before PCP onset was weakly associated with mortality after PCP. CONCLUSIONS: Biologic use before PCP onset did not increase the severity and mortality of PCP compared to non-biologics use in patients with RA.


Asunto(s)
Artritis Reumatoide , Productos Biológicos , Neumonía por Pneumocystis , Humanos , Neumonía por Pneumocystis/complicaciones , Estudios Retrospectivos , Mortalidad Hospitalaria , Artritis Reumatoide/complicaciones , Artritis Reumatoide/tratamiento farmacológico , Factores Biológicos/uso terapéutico , Productos Biológicos/efectos adversos
3.
J Epidemiol ; 34(3): 105-111, 2024 Mar 05.
Artículo en Inglés | MEDLINE | ID: mdl-36908116

RESUMEN

BACKGROUND: Diabetes and prediabetes have been linked with morbidity or mortality from cardiovascular disease, cancer, or other physical disorders among working-age populations, but less is known about outcomes directly related to labor loss (eg, Tlong-term sickness absence [LTSA] or pre-retirement death due to physical disorders).This prospective study aimed to examine the association of diabetes and prediabetes with the risk of a composite outcome of LTSA and pre-retirement death due to physical disorders. The present study also examined the associations of severe outcomes (LTSA or death) due to specific physical disorders or injuries/external causes in relation to diabetes and prediabetes. METHODS: Data were derived from the Japan Epidemiology Collaboration on Occupational Health study. A total of 60,519 workers from 12 companies were followed for 8 years. Diabetes and prediabetes were defined based on the American Diabetes Association criteria. A Cox proportional hazards regression model was used to examine the association between diabetes/prediabetes and severe outcomes due to physical disorders or injuries/external causes. RESULTS: The adjusted hazard ratios of severe outcomes due to all physical disorders were 1.22 (95% confidence interval [CI], 1.02-1.45) and 2.32 (95% CI, 2.04-2.64) for prediabetes and diabetes, respectively. In cause-specific analyses, an increased risk was observed for severe outcomes due to cancers, cardiovascular diseases, diseases of the musculoskeletal system, and injuries/external causes in relation to either or both diabetes and prediabetes. CONCLUSION: Diabetes and prediabetes were associated with an increased risk of severe outcomes due to physical disorders or injuries/external causes among Japanese workers.


Asunto(s)
Diabetes Mellitus , Estado Prediabético , Humanos , Jubilación , Estado Prediabético/epidemiología , Estudios Prospectivos , Japón/epidemiología , Diabetes Mellitus/epidemiología , Ausencia por Enfermedad , Factores de Riesgo
4.
Chest ; 165(1): 58-67, 2024 01.
Artículo en Inglés | MEDLINE | ID: mdl-37574166

RESUMEN

BACKGROUND: Trimethoprim-sulfamethoxazole (TMP-SMX) is an effective treatment for Pneumocystis jirovecii pneumonia (PCP) in immunocompromised patients with and without HIV infection; however, a high incidence of adverse events has been observed. Low-dose TMP-SMX is a potentially effective treatment with fewer adverse events; however, evidence is limited. RESEARCH QUESTION: What is the efficacy and safety of low-dose TMP-SMX for non-HIV PCP compared with conventional-dose TMP-SMX after adjusting for patient background characteristics? STUDY DESIGN AND METHODS: In this multicenter retrospective cohort study, we included patients diagnosed with non-HIV PCP and treated with TMP-SMX between June 2006 and March 2021 at three institutions. The patients were classified into low-dose (TMP < 12.5 mg/kg/d) and conventional-dose (TMP 12.5-20 mg/kg/d) groups. The primary end point was 30-day mortality, and the secondary end points were 180-day mortality, adverse events grade 3 or higher per the Common Terminology Criteria for Adverse Events v5.0, and initial treatment completion rates. Background characteristics were adjusted using the overlap weighting method with propensity scores. RESULTS: Fifty-five patients in the low-dose group and 81 in the conventional-dose group were evaluated. In the overall cohort, the average age was 70.7 years, and the proportion of women was 55.1%. The average dose of TMP-SMX was 8.71 mg/kg/d in the low-dose group and 17.78 mg/kg/d in the conventional-dose group. There was no significant difference in 30-day mortality (6.7% vs 18.4%, respectively; P = .080) or 180-day mortality (14.6% vs 26.1%, respectively; P = .141) after adjusting for patient background characteristics. The incidence of adverse events, especially nausea and hyponatremia, was significantly lower in the low-dose group (29.8% vs 59.0%, respectively; P = .005). The initial treatment completion rates were 43.3% and 29.6% in the low-dose and conventional-dose groups (P = .158), respectively. INTERPRETATION: Survival was similar between the low-dose and conventional-dose TMP-SMX groups, and low-dose TMP-SMX was associated with reduced adverse events in patients with non-HIV PCP.


Asunto(s)
Infecciones por VIH , Neumonía por Pneumocystis , Humanos , Femenino , Anciano , Combinación Trimetoprim y Sulfametoxazol/efectos adversos , Neumonía por Pneumocystis/tratamiento farmacológico , Neumonía por Pneumocystis/complicaciones , Estudios Retrospectivos , Infecciones por VIH/complicaciones , Infecciones por VIH/tratamiento farmacológico , Resultado del Tratamiento
5.
BMC Public Health ; 23(1): 1769, 2023 09 11.
Artículo en Inglés | MEDLINE | ID: mdl-37697320

RESUMEN

BACKGROUND: Living alone has been positively associated with the prevalence of depressive symptoms. We examined how a combination of living alone and pet ownership relates to depressive symptoms. METHODS: As part of the Japan Epidemiology Collaboration on Occupational Health Study, we conducted a survey on health-related lifestyles, including living arrangements and pet ownership, among 12,763 employees of five companies in 2018-2021. Depressive symptoms were assessed using the 11-item Center for Epidemiological Studies-Depression Scale (cutoff score ≥ 9). A Poisson regression model with a robust variance estimator was used to calculate prevalence ratio and 95% confidence interval (CI) while adjusting for covariates. RESULTS: Among the participants, 30.9% were depressed, 17.7% had pets, and 29.1% lived alone. Compared to individuals living with others but not with a pet, those living alone and not with a pet had a 1.17 times higher prevalence ratio of depressive symptoms (95% CI: 1.08-1.26). The corresponding figures were 1.03 (95% CI: 0.95-1.11) for those living with others and pet(s) and 1.42 (95% CI: 1.18-1.69) for those living alone but with pet(s). CONCLUSION: Living alone was significantly associated with a higher prevalence of depressive symptoms. The association was rather stronger among individuals with vs. without pets. Pet ownership may not be associated with decreased depressive symptoms.


Asunto(s)
Depresión , Pueblos del Este de Asia , Ambiente en el Hogar , Mascotas , Humanos , Depresión/epidemiología , Depresión/psicología , Estilo de Vida Saludable , Propiedad , Mascotas/psicología
6.
BMC Cancer ; 23(1): 555, 2023 Jun 16.
Artículo en Inglés | MEDLINE | ID: mdl-37328825

RESUMEN

BACKGROUND: Metabolic syndrome (MetS) is associated with cancer risk; however, little is known regarding its relationship with the risk of cancer-related premature death and long-term sick leave (LTSL), which can lead to a substantial loss in working years. The present study aimed to quantify the all-site and site-specific associations between MetS and the risk of severe cancer events (a composite outcome of LTSL and mortality due to cancer) in a large working population in Japan. METHODS: We recruited 70,875 workers (59,950 men and 10,925 women), aged 20-59 years, who attended health check-ups in 2011 (10 companies) and 2014 (2 companies). All workers underwent follow up for severe cancer events until March 31, 2020. MetS was defined in accordance with the Joint Interim Statement. Cox regression models were used to quantify the association between baseline MetS and severe cancer events. RESULTS: During 427,379 person-years of follow-up, 523 participants experienced the outcome consisting of 493 LTSLs of which 124 eventually resulted in death, and 30 deaths without taking LTSL. The adjusted hazard ratios (HR) (95% confidence intervals [CI]) for composite severe events due to all-site, obesity-related, and non-obesity-related cancer among those with vs. without MetS were 1.26 (1.03, 1.55), 1.37 (1.04, 1.82), and 1.15 (0.84, 1.56), respectively. In cancer site-specific analyses, MetS was associated with an increased risk of severe events due to pancreatic cancer (HR, 2.06; 95% CI, 0.99-4.26). When mortality was treated solely as the endpoint, the association was significant for all-site (HR, 1.58; 95% CI, 1.10-2.26), and obesity-related (HR, 1.59; 95% CI, 1.00-2.54) cancer. Additionally, a greater number of MetS components was associated with a greater risk of both severe cancer events and cancer-related mortality (P trend < 0.05). CONCLUSION: Among Japanese workers, MetS was associated with an increased risk of severe cancer events, especially those due to obesity-linked cancer.


Asunto(s)
Síndrome Metabólico , Neoplasias Pancreáticas , Femenino , Humanos , Masculino , Pueblos del Este de Asia , Estudios Longitudinales , Síndrome Metabólico/complicaciones , Síndrome Metabólico/epidemiología , Obesidad/complicaciones , Neoplasias Pancreáticas/complicaciones , Factores de Riesgo , Adulto Joven , Adulto , Persona de Mediana Edad
7.
J Ren Nutr ; 33(6): 755-763, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37302717

RESUMEN

OBJECTIVES: Successful renal transplantation reduces mortality rates. However, the decline in the estimated glomerular filtration rate (eGFR) after transplantation is strongly associated with premature mortality in renal transplant recipients (RTRs). Physical activity (PA) is a modifiable lifestyle factor with the potential to maintain or improve eGFR. However, the effects of the type or intensity of PA and sedentary behavior (SB) on eGFR in RTRs remain unclear. The purpose of this study was to clarify the association between accelerometry-measured PA and SB and eGFR in RTRs using isotemporal substitution (IS) analysis. METHODS: A total of 82 renal transplant outpatients participated in this cross-sectional study, of which 65 (average age, 56.9 years; average time post-transplant, 83.0 months) were finally analyzed. All RTRs wore a triaxial accelerometer to measure PA for 7 consecutive days. The measured PA was classified based on intensity into light PA, moderate-to-vigorous PA (MVPA), and SB. The association of each type of PA with eGFR was examined using multi-regression analyses of single-factor, partition, and IS models. The IS model was applied to examine the estimated effects of substituting 30 minutes of SB with an equal amount of time of light PA or MVPA on eGFR. RESULTS: The partition model showed that MVPA was an independent explanatory variable for eGFR (ß = 5.503; P < .05), and the IS model identified that the substitution of time spent in SB with MVPA led to improvements in eGFR (ß = 5.902; P < .05). CONCLUSIONS: The present study suggests that MVPA has an independent and positive association with eGFR, and replacing 30 minutes of SB with MVPA after renal transplantation might lead to the maintenance or improvement of eGFR in RTRs.


Asunto(s)
Trasplante de Riñón , Humanos , Persona de Mediana Edad , Estudios Transversales , Tasa de Filtración Glomerular , Ejercicio Físico , Conducta Sedentaria , Acelerometría
8.
Mod Rheumatol Case Rep ; 8(1): 145-149, 2023 Dec 29.
Artículo en Inglés | MEDLINE | ID: mdl-37243733

RESUMEN

Eosinophilic granulomatosis with polyangiitis (EGPA) is a small- to medium-vessel necrotising vasculitis and eosinophilic inflammation. Mepolizumab, an anti-interleukin-5 (IL-5) monoclonal antibody has been approved in Japan since 2018 for refractory EGPA treatment. Benralizumab, an anti-IL-5 receptor monoclonal antibody, also has been reported to reduce the glucocorticoid dose in patients with refractory EGPA. On the other hand, several investigators have demonstrated new-onset EGPA under biologics, and it is unclear whether this treatment for severe allergic diseases can prevent the development of EGPA. Herein, we report a case of new-onset EGPA under benralizumab treatment. The patient had fever, weight loss, muscle pain, and paraesthesia, the serum eosinophil count was 0/µL, and the biopsy showed necrotizing vasculitis without eosinophilic infiltration. She was diagnosed as having EGPA and treated with high-dose glucocorticoid and intravenous cyclophosphamide, with a good response. Our case report indicates that anti-IL-5 agents may mask the development of EGPA and clinicians should be aware of the development of EGPA during anti-IL-5 agents.


Asunto(s)
Síndrome de Churg-Strauss , Eosinofilia , Granulomatosis con Poliangitis , Femenino , Humanos , Síndrome de Churg-Strauss/complicaciones , Síndrome de Churg-Strauss/diagnóstico , Síndrome de Churg-Strauss/tratamiento farmacológico , Glucocorticoides/uso terapéutico , Granulomatosis con Poliangitis/complicaciones , Granulomatosis con Poliangitis/diagnóstico , Granulomatosis con Poliangitis/tratamiento farmacológico , Eosinofilia/diagnóstico , Eosinofilia/tratamiento farmacológico , Eosinofilia/etiología
9.
Rheumatol Ther ; 10(4): 917-931, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-37208506

RESUMEN

INTRODUCTION: To evaluate patient-physician communication and patients' understanding of treatment goals in rheumatoid arthritis (RA). METHODS: A cross-sectional online survey of patients with RA and physicians treating RA was conducted between 16 and 30 June 2021. Participants were asked to rate the importance of 17 goals on a 6-point Likert scale, and mean scores were compared between patients and physicians by the Wilcoxon rank sum test. Patients' satisfaction with physician communication and their understanding of treatment goals were also assessed. RESULTS: The responses of 502 patients and 216 physicians were analyzed. The most common patient age group was 50-59 years (28.5%), and the mean disease duration was 10.3 years. Physicians had a mean of 19.2 years of treatment experience and were treating a mean of 44.3 patients. Among the 17 goals assessed, patients placed significantly more importance on drug tapering or discontinuation as short-term goals (3-6 months) and on performing basic activities of daily living, being able to engage in daily tasks, achieving and maintaining remission, maintaining better laboratory values, and drug tapering or discontinuation as long-term goals (5-10 years; all adjusted p < 0.05). Patient treatment satisfaction was significantly associated with disease activity, a feeling of treatment effectiveness, satisfaction with physician communication, and agreement with physician goals. CONCLUSION: Differences exist among patients with RA and physicians treating RA regarding the importance of short- and long-term treatment goals. Good patient-physician communication appears to be important for improving patient satisfaction. TRIAL REGISTRATION: University Hospital Medical Information Network identifier: UMIN000044463.

10.
Acta Diabetol ; 60(3): 371-378, 2023 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36527503

RESUMEN

AIMS: We aimed to assess the cross-sectional association of heated tobacco product (HTP) use with prediabetes and diabetes. METHODS: The present analysis included 8950 workers from 5 companies (Study I) and 31,341 workers from another large company (Study II), who participated in the Japan Epidemiology Collaboration on Occupational Health Study. The participants were divided into five groups: never smokers, past smokers, exclusive HTP users, dual users of cigarettes and HTPs, and exclusive cigarette smokers. Diabetes and prediabetes were defined according to the fasting blood glucose and HbA1c levels and self-reported diabetes treatment, using the American Diabetes Association criteria. We analyzed the data of Study I and II separately, and then pooled these estimates using the fixed-effect models, with adjustment for a wide range of covariates. RESULTS: In this study that included 40,291 participants (mean age, 46.6 years; men, 84.3%), about half of the current tobacco-related product users reported using HTPs. Exclusive HTP users had higher odds of prediabetes (pooled odds ratio 1.36; 95% CI 1.25-1.47) and diabetes (1.68; 95% CI 1.45-1.94) than never smokers. Similarly, dual users also had increased odds of prediabetes (pooled odds ratio, 1.26; 95% CI 1.13-1.39) and diabetes (1.93; 95% CI 1.63-2.29). The strength of these associations was comparable to that of cigarette smokers. We observed significantly higher HbA1c and fasting blood glucose levels among both exclusive HTP users and dual users compared to never smokers. CONCLUSION: HTP use was associated with an increased likelihood of prediabetes and diabetes. Prospective studies are warranted to confirm the cross-sectional association.


Asunto(s)
Estado Prediabético , Productos de Tabaco , Humanos , Masculino , Persona de Mediana Edad , Glucemia , Estudios Transversales , Hemoglobina Glucada , Estado Prediabético/epidemiología , Estado Prediabético/etiología , Encuestas y Cuestionarios , Nicotiana , Productos de Tabaco/efectos adversos , Femenino
11.
Mod Rheumatol Case Rep ; 7(1): 172-176, 2023 01 03.
Artículo en Inglés | MEDLINE | ID: mdl-36305628

RESUMEN

The global outbreak of coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus type 2 has prompted the rapid spread and development of vaccines to prevent the spread of the disease. COVID-19 vaccine has demonstrated excellent efficacy in reducing morbidity and severity of the disease, and most adverse reactions are very minor. However, some patients have been reported to develop autoimmune diseases, such as rheumatoid arthritis, myocarditis, Guillain-Barre syndrome, and vasculitis, following COVID-19 vaccination. Herein, we present a case of polyarteritis nodosa with epididymitis, following COVID-19 mRNA vaccination. The patient's initial symptoms were fever and testicular pain, and magnetic resonance imaging showed epididymitis. He was diagnosed as having polyarteritis nodosa with epididymitis and was treated with high-dose prednisolone, with a good clinical outcome.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Epididimitis , Poliarteritis Nudosa , Humanos , Masculino , COVID-19/diagnóstico , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Epididimitis/diagnóstico , Epididimitis/etiología , Poliarteritis Nudosa/diagnóstico , Poliarteritis Nudosa/etiología , Vacunación
12.
Mod Rheumatol Case Rep ; 7(1): 9-13, 2023 01 03.
Artículo en Inglés | MEDLINE | ID: mdl-35285489

RESUMEN

Pyoderma gangrenosum (PG) is a rare chronic skin disease characterised by painful skin ulcers. There are no treatment guidelines for PG, but systemic treatments including biologics are often used. Recently, adalimumab (ADA), a fully human monoclonal antibody against tumour necrosis factor, was approved for refractory PG treatment in Japan. Herein, we report a case of rheumatoid arthritis with refractory PG 2 months after orthopaedic surgery of the foot during treatment with low-dose etanercept and methotrexate. Although adding a moderate dose of glucocorticoid did not improve her PG, the patient showed a remarkable response after switching from etanercept to ADA in a higher dose than that used to treat rheumatoid arthritis. This higher dose of ADA may be effective for the treatment of refractory PG after the failure of other tumour necrosis factor inhibitors.


Asunto(s)
Artritis Reumatoide , Piodermia Gangrenosa , Femenino , Humanos , Adalimumab/uso terapéutico , Etanercept/uso terapéutico , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Infliximab/uso terapéutico , Piodermia Gangrenosa/complicaciones , Piodermia Gangrenosa/diagnóstico , Piodermia Gangrenosa/tratamiento farmacológico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Receptores del Factor de Necrosis Tumoral/uso terapéutico , Inmunoglobulina G/uso terapéutico , Artritis Reumatoide/complicaciones , Artritis Reumatoide/tratamiento farmacológico
13.
J Epidemiol ; 33(6): 311-320, 2023 06 05.
Artículo en Inglés | MEDLINE | ID: mdl-34690243

RESUMEN

BACKGROUND: Metabolic syndrome (MetS) has been associated with various chronic diseases that may lead to long-term sickness absence (LTSA), but there is lacking information on the direct association between MetS and LTSA. The present study aimed to investigate the all-cause and cause-specific associations between MetS and the risk of medically certified LTSA among Japanese workers. METHODS: We recruited 67,403 workers (57,276 men and 10,127 women), aged 20-59 years from 13 companies in Japan during their health check-ups in 2011 (11 companies) and 2014 (2 companies), and we followed them for LTSA events (≥30 consecutive days) until March 31, 2020. MetS was defined according to the Joint Interim Statement. A Cox proportional hazards regression model was used to estimate hazard ratios (HRs) and its 95% confidence intervals (CIs) for LTSA associated with MetS and its components. RESULTS: During 408,324 person-years of follow-up, 2,915 workers experienced LTSA. The adjusted HR for all-cause LTSA was 1.54 (95% CI, 1.41-1.68) among those with MetS compared to those without MetS. In cause-specific analysis, HRs associated with MetS significantly increased for LTSA due to overall physical disorders (1.76); cardiovascular diseases (3.16); diseases of the musculoskeletal system and connective tissue (2.01); cancers (1.24); obesity-related cancers (1.35); mental, behavioral, and neurodevelopmental disorders (1.28); reaction to severe stress and adjustment disorders (1.46); and external causes (1.46). The number of MetS components were also significantly associated with increased LTSA risk. CONCLUSION: MetS was associated with an increase in the risk of LTSA due to various diseases among Japanese workers.


Asunto(s)
Síndrome Metabólico , Femenino , Humanos , Masculino , Pueblos del Este de Asia , Japón/epidemiología , Síndrome Metabólico/epidemiología , Obesidad , Ausencia por Enfermedad , Adulto Joven , Adulto , Persona de Mediana Edad
14.
Lancet Rheumatol ; 5(4): e215-e224, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38251524

RESUMEN

BACKGROUND: Efficacy of combination therapy with methotrexate and biological disease-modifying antirheumatic drugs is well established in the management of patients with rheumatoid arthritis; however, the optimal dose of methotrexate to administer with a tumour necrosis factor inhibitor remains unclear. We aimed to clarify the efficacy and safety of adalimumab combined with reduced methotrexate dose compared with the maximum tolerated methotrexate dose in patients with rheumatoid arthritis and an inadequate response to methotrexate monotherapy. METHODS: In this open-label, randomised controlled trial, we recruited methotrexate-naive patients with rheumatoid arthritis and a disease duration of less than 2 years across 24 secondary or tertiary care hospitals across Japan, South Korea, and Taiwan. At initiation, methotrexate was given orally and increased to the maximum tolerated dose by week 12. Patients who did not achieve remission on the basis of the Simplified Disease Activity Index (SDAI) at week 24 were randomly assigned (1:1) to receive adalimumab (40 mg biweekly) combined with a continued maximum tolerated dose of methotrexate or adalimumab combined with a reduced dose of methotrexate. The primary endpoint was non-inferiority of adalimumab plus reduced-dose methotrexate to adalimumab plus maximal-dose methotrexate based on SDAI remission at week 48, assessed in the modified full-analysis set with a pre-specified non-inferiority margin of -15%, based on a two-sided 90% CI. Adverse events were assessed in the safety analysis set. This trial is registered with ClinicalTrials.gov, NCT03505008 and has been completed. FINDINGS: From April 18, 2018, to June 2, 2020, from 323 patients screened, 300 were enrolled, and 291 patients were included in the full analysis set. The mean age was 57·7 years (SD 15·2), 217 (75%) were female, 74 (25%) were male, and all patients were of Asian ethnicity. The mean SDAI at study enrolment was 26·5 (SD 12·4). 52 patients discontinued the study before week 24 or at week 24 before randomisation. At week 24, 105 (36%) of 291 patients achieved remission and continued methotrexate monotherapy through week 48. 134 (46%) did not achieve remission at week 24 and were randomly assigned to receive adalimumab plus the maximum tolerated dose of methotrexate (n=68) or adalimumab plus reduced-dose methotrexate (n=66). Remission at week 48 was achieved in 25 (38%) of 66 and 27 (44%) of 61 patients, respectively, with an adjusted risk difference of 6·4% (90% CI -7·0 to 19·8), which met the non-inferiority margin of -15%. Adverse events after week 24 tended to be more frequent in the maximum tolerated dose group than in the reduced-dose group (24 [35%] vs 13 [20%], p=0·054). Between week 24 and 48, there were 14 serious adverse events (6 in the methotrexate monotherapy group, 5 in the adalimumab plus maximal-dose methotrexate, and 3 in the adalimumab plus reduced-dose methotrexate group), and no deaths. INTERPRETATION: The MIRACLE study showed that the efficacy of adalimumab combined with reduced methotrexate dose was not inferior to that with the maximum tolerated methotrexate dose, with a tendency to a better safety profile. FUNDING: Eisai.


Asunto(s)
Antirreumáticos , Artritis Reumatoide , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adalimumab/efectos adversos , Antirreumáticos/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Metotrexato/efectos adversos , Inhibidores del Factor de Necrosis Tumoral
15.
Sci Rep ; 12(1): 17385, 2022 10 17.
Artículo en Inglés | MEDLINE | ID: mdl-36253392

RESUMEN

We aimed to assess the association between heated tobacco product (HTP) use and high-density lipoprotein cholesterol (HDL-C) concentration. Our study included 12,268 workers from five companies (Study I) and 36,503 workers from another large company (Study II). Participants were categorized into five groups: never smokers, past smokers, exclusive HTP users, dual users of cigarettes and HTPs, and exclusive cigarette smokers. We analyzed the data of Studies I and II separately and then pooled these estimates using a fixed-effect model. Of the 48,771 participants, 9.3% were exclusive HTP users, and 6.0% were dual users. Exclusive HTP users had modestly but significantly lower concentrations of HDL-C than never smokers, with the pooled mean difference being - 1.1 (95% CI - 1.5 to - 0.6) mg/dL. Dual users showed a further reduction (mean difference - 3.7 (- 4.2 to - 3.2) mg/dL), which was comparable to that of exclusive cigarette smokers versus never smokers (mean difference - 4.3 (- 4.7 to - 3.9) mg/dL). The pooled odds ratios (95% CIs) of having low HDL-C (< 40 mg/dL for men and 50 mg/dL for women) were 1, 0.99 (0.90-1.11), 1.25 (1.09-1.43), 2.02 (1.76-2.32), and 2.09 (1.88-2.32) for never smokers, past smokers, exclusive HTP users, dual users, and exclusive cigarette smokers, respectively. In conclusion, exclusive HTP users had lower HDL-C concentrations than never smokers, although higher than exclusive cigarette smokers. Moreover, dual users had HDL-C concentrations similar to those in exclusive cigarette smokers.


Asunto(s)
Sistemas Electrónicos de Liberación de Nicotina , Productos de Tabaco , HDL-Colesterol , Femenino , Humanos , Masculino , Fumadores , Nicotiana
16.
Case Rep Rheumatol ; 2022: 3124887, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36052104

RESUMEN

The coronavirus disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 has led to rapid progress in vaccine development to prevent the spread of the disease. Although COVID-19 vaccines have excellent effectiveness in reducing morbidity and disease severity with minor adverse reactions, some patients develop late hypersensitivity events as autoimmune reactions such as rheumatoid arthritis, lupus nephritis, and vasculitis following COVID-19 vaccination. Herein, we describe a case of pneumonitis following COVID-19 mRNA vaccination in a patient with rheumatoid arthritis, which resolved spontaneously.

17.
Intern Med ; 61(22): 3449-3452, 2022 Nov 15.
Artículo en Inglés | MEDLINE | ID: mdl-36070943

RESUMEN

Coronavirus disease 2019 (COVID-19) has spread worldwide since 2019, and mRNA vaccines for the disease have been rapidly delivered to limit the severity of infection. However, while these vaccines are effective in reducing the morbidity and severity of the disease, some patients develop severe adverse drug reactions and new-onset autoimmune phenomena, such as myocarditis, thrombosis with thrombocytopenia, and vasculitis. In addition, some patients develop arthritis following vaccination, including rheumatoid arthritis (RA). We herein report a case of new-onset seropositive RA following COVID-19 mRNA vaccination. Although tests for rheumatoid factor and anti-cyclic citrullinated peptide antibody had been negative three years before vaccination, the patient developed seropositive RA following COVID-19 mRNA vaccination.


Asunto(s)
Artritis Reumatoide , Vacunas contra la COVID-19 , COVID-19 , Humanos , Artritis Reumatoide/complicaciones , Artritis Reumatoide/tratamiento farmacológico , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Factor Reumatoide , ARN Mensajero , Vacunación/efectos adversos
18.
Intern Med ; 61(22): 3453-3457, 2022 Nov 15.
Artículo en Inglés | MEDLINE | ID: mdl-36070946

RESUMEN

Coronavirus disease 2019 (COVID-19) vaccines have been delivered worldwide to prevent the spread of the disease, and almost all Japanese have received the mRNA vaccines "BNT162b2" (Pfizer-BioNTech) or "mRNA-1273" (Moderna). These vaccines have shown efficacy and safety with only minor adverse drug reactions. However, some patients develop severe adverse drug reactions, including autoimmune reactions. In addition, systemic vasculitis, mainly small-vessel vasculitis, following COVID-19 vaccination, has been reported. However, only a few investigators have reported medium-vessel vasculitis following vaccination. We herein report a case of medium-vessel vasculitis presenting with myalgia as the initial clinical manifestation following COVID-19 Moderna vaccination.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Vacunas , Vasculitis , Humanos , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Mialgia/etiología , Vacunación , Vasculitis/etiología
19.
Curr Oncol Rep ; 24(11): 1645-1659, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-35947284

RESUMEN

PURPOSE OF REVIEW: Breast cancer (BC) recurrence dramatically decreases 5-year survival, which causes a fear of BC recurrence among a majority of BC survivors. Evidence is currently inconsistent on whether post-diagnosis recreational physical activity (rPA) can prevent BC recurrence due to the small number of included studies, as well as methodological heterogeneity among the studies. This systematic review aimed to clarify the association between post-diagnosis rPA and the risk of BC recurrence, by conducting a meta-analysis while controlling for the categories of rPA across the existing studies. RECENT FINDINGS: Prospective cohort studies were searched, and five studies were eligible for the meta-analysis. Of 10,094 patients with BC, 1561 had recurrence during the follow-up period ranging from 12 to 156 months. The meta-analysis revealed that patients whose post-diagnosis rPA was ≥ 7.5 metabolic equivalents (MET-h/week) had a lower BC risk than patients whose rPA was 0-3 MET-h/week (hazard ratio [HR], 0.65; 95% CI, 0.58-0.73, p < 0.00001, I2 = 0%). The review indicated that a post-diagnosis rPA of ≥ 7.5 MET-h/week could reduce the risk of BC recurrence by 35%. Although it is necessary to investigate randomized controlled studies in the future, this result will strengthen strategies for the care and/or treatment of patients after BC and can motivate BC survivors to participate in rPA programs after BC diagnosis.


Asunto(s)
Neoplasias de la Mama , Supervivientes de Cáncer , Humanos , Femenino , Neoplasias de la Mama/etiología , Estudios Prospectivos , Recurrencia Local de Neoplasia/prevención & control , Recurrencia Local de Neoplasia/diagnóstico , Ejercicio Físico
20.
Int J Rheum Dis ; 25(8): 897-909, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35678075

RESUMEN

OBJECTIVE: To investigate the impact of dysphagia on long-term survival and swallowing function outcomes in patients with idiopathic inflammatory myopathy other than inclusion body myositis. METHODS: We retrospectively evaluated consecutive patients with idiopathic inflammatory myopathy other than inclusion body myositis to investigate the impact of dysphagia and its severity assessed using the Food Intake LEVEL Scale on survival and swallowing function outcomes. Time-to-event analyses were used, including Kaplan-Meier curves with log-rank (trend) test, cumulative incidence with Gray's test, and Cox proportional hazards models. RESULTS: Of the 254 patients, 26 were dysphagic, including eight severe (Food Intake LEVEL Scale [FILS] score 2, 3) and six most severe (FILS score 1) cases; 210 were non-dysphagic, and 18 were indeterminate cases. During the 5 years after myositis diagnosis, 15 (57.7%) dysphagic and 31 (14.8%) non-dysphagic patients died, and dysphagic patients had significantly shorter survival. However, multivariate analysis showed that shorter survival was significantly associated with baseline age-adjusted Charlson Comorbidity Index (hazard ratio [HR] 1.57, 95% confidence interval [CI] 1.36-1.82]), but not with dysphagia (HR 1.46, 95% CI 0.69-3.10). Dysphagia severity was significantly associated with delayed recovery of dysphagia. In 20 non-severe or severe dysphagic cases, 19 restored swallowing function within 1 year. The most severe cases had a significantly higher cumulative probability of death before recovery from dysphagia than severe cases. CONCLUSION: The poor survival of dysphagic myositis patients was largely confounded by advanced age and comorbid malignancies. However, patients with the most severe dysphagia had a significantly worse swallowing function and survival prognosis than those with milder dysphagia.


Asunto(s)
Trastornos de Deglución , Miositis por Cuerpos de Inclusión , Miositis , Deglución , Trastornos de Deglución/diagnóstico , Trastornos de Deglución/etiología , Humanos , Miositis/complicaciones , Miositis/diagnóstico , Miositis por Cuerpos de Inclusión/complicaciones , Miositis por Cuerpos de Inclusión/diagnóstico , Miositis por Cuerpos de Inclusión/terapia , Estudios Retrospectivos
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