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BACKGROUND: Early identification, diagnosis and symptom control of psoriatic arthritis (PsA) in patients with psoriasis remain unmet medical needs. OBJECTIVES: To compare the impact of disease and other characteristics between patients with psoriasis who screened positive for PsA using the Psoriasis Epidemiology Screening Tool (PEST) (screen-positive group) and patients who (i) have PsA (PsA group) or (ii) screened negative for PsA (screen-negative group). Also, to determine the proportion of patients at a patient-acceptable symptom state (PASS) in the screen-positive and PsA groups. METHODS: This was a cross-sectional analysis of the CorEvitas Psoriasis Registry. We included a convenience sample of patients with psoriasis from the screen-positive and PsA groups who completed the Psoriatic Arthritis Impact of Disease-12 (PsAID12), and a comparator screen-negative group who did not complete the PsAID12. We report descriptive summaries of demographics, comorbidities, psoriasis characteristics, patient-reported outcome measures and the proportion of patients at PASS (i.e. PsAID12 ≤ 4). RESULTS: The screen-positive, PsA and screen-negative groups included 369, 70 and 4724 patients, respectively. The screen-positive and PsA groups had a similar impact of disease, demographics, comorbidities and psoriasis characteristics (d < 0.337). Mean PsAID12 scores were 3.1 (SD 2.3) and 3.7 (SD 2.6) in the screen-positive and PsA groups, respectively. Compared with patients who screened negative for PsA, patients who screened positive exhibited higher rates of selected known predictors of PsA such as older age, longer psoriasis duration, nail disease and inverse psoriasis. The proportion of patients at PASS was 56% and 67% for the PsA and screen-positive groups, respectively. CONCLUSIONS: The similar profiles between screen-positive and PsA groups, in comparison with the screen-negative group, support observations of possible underdiagnosis of PsA and the increased impact of disease, especially musculoskeletal disease, among patients who screen positive for PsA. The high percentage of patients not at an acceptable symptom state in the PsA and screen-positive groups highlights the need to optimize care in PsA.
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Artrite Psoriásica , Psoríase , Sistema de Registros , Humanos , Artrite Psoriásica/diagnóstico , Artrite Psoriásica/epidemiologia , Estudos Transversais , Masculino , Feminino , Pessoa de Meia-Idade , Adulto , Psoríase/epidemiologia , Medidas de Resultados Relatados pelo Paciente , Idoso , Índice de Gravidade de DoençaRESUMO
BACKGROUND: Psoriasis patients with poor therapeutic response to multiple biologic agents are not well-characterized. OBJECTIVE: To describe the characteristics associated with development of multiple biologic failure (MBF) versus good clinical response (GR) to the first biologic. METHODS: This prospective cohort analysis evaluated patients in the multicenter CorEvitas Psoriasis Registry who initiated their first biologic between 2015 and 2020 and were followed for ≥24 months. Multivariable logistic regression identified sociodemographic, clinical, and patient-reported outcomes that differed between MBF (discontinued ≥2 biologics of different classes, each used for ≥90 days, due to inadequate efficacy) and GR (continued use of first biologic for ≥2 years) patients. RESULTS: One thousand thirty-nine patients were analyzed (490 GR [47.2%], 65 MBF [6.3%]). Female sex, shorter psoriasis duration, earlier year of biologic initiation, prior nonbiologic systemic therapy use, history of hyperlipidemia, and Medicaid insurance were significantly associated with MBF, though the latter 2 variables exhibited wider confidence intervals, indicating a lower level of support. The first-to-second biologic sequence most observed with MBF was Tumor necrosis factor-α inhibitor to IL-17 inhibitor use. LIMITATIONS: Biologic adherence between visits was not evaluated. CONCLUSION: Approximately 6% of psoriasis patients met MBF criteria. The results identify characteristics associated with MBF that may distinguish patients warranting more frequent follow-up.
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BACKGROUND: The objective was to determine if abdominal fat is related to poor muscle health. METHODS: This cross-sectional study included 428 males and 534 females with appendicular lean mass (ALM, kg) from dual-energy X-ray absorptiometry (DXA), grip strength (kg), and upper extremity muscle "quality" (grip strength/arm lean mass) measured (1996-2001) in the Framingham Offspring Study. Sex-specific linear regressions associated adiposity measures [waist circumference (WC, cm) and visceral adipose tissue (VAT, cm3), and subcutaneous adipose tissue (SAT, cm3)] as Z-scores with each measure of muscle, adjusting for covariates. Models were further stratified by body mass index (BMI, < 30, ≥ 30 kg/m2). RESULTS: Mean (± SD) age was 60 ± 9 years and BMI was 28.9 ± 4.6 kg/m2 (men) and 27.7 ± 5.8 kg/m2, (women). In men, the BMI-stratified analyses showed higher WC was associated with higher ALM (P < 0.0001 each) but with lower muscle quality (P < 0.02) in both BMI groups. Higher SAT was also associated with higher ALM (P = 0.0002) and lower muscle quality (P = 0.0002) in men with BMI < 30, but not in obese men. In women, higher WC, SAT, and VAT were each associated with higher ALM but lower muscle quality, particularly in obese women. Higher SAT (P = 0.05) and VAT (P = 0.04) were associated with higher quadriceps strength in women with BMI < 30 kg/m2 but not in obese women. CONCLUSIONS: Higher abdominal fat may be associated with greater lean mass but poorer muscle quality, particularly in obese women. This suggests that adipose tissue may have endocrine influences on muscle, which should be confirmed in longitudinal studies.
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Adiposidade , Obesidade , Masculino , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Estudos Transversais , Obesidade Abdominal , Índice de Massa Corporal , Estudos Longitudinais , MúsculosRESUMO
BACKGROUND: The characteristics that predict the onset of psoriatic arthritis (PsA) among patients with psoriasis (PsO) may inform diagnosis and treatment. OBJECTIVE: To develop a model to predict the 2-year risk of developing PsA among patients with PsO. METHODS: This was a prospective cohort study of patients in the CorEvitas Psoriasis Registry without PsA at enrollment and with 24-month follow-up. Unregularized and regularized logistic regression models were developed and tested using descriptive variables to predict dermatologist-identified PsA at 24 months. Model performance was compared using the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity. RESULTS: A total of 1489 patients were included. Nine unique predictive models were developed and tested. The optimal model, including Psoriasis Epidemiology Screening Tool (PEST), body mass index (BMI), modified Rheumatic Disease Comorbidity Index, work status, alcohol use, and patient-reported fatigue, predicted the onset of PsA within 24 months (AUC = 68.9%, sensitivity = 82.9%, specificity = 48.8%). A parsimonious model including PEST and BMI had similar performance (AUC = 68.8%; sensitivity = 92.7%, specificity = 36.5%). LIMITATIONS: PsA misclassification bias by dermatologists. CONCLUSION: PEST and BMI were important factors in predicting the development of PsA in patients with PsO over 2 years and thereby foundational for future PsA risk model development.
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Artrite Psoriásica , Psoríase , Humanos , Artrite Psoriásica/diagnóstico , Artrite Psoriásica/epidemiologia , Artrite Psoriásica/terapia , Estudos Prospectivos , Inquéritos e Questionários , Psoríase/diagnóstico , Sistema de RegistrosRESUMO
BACKGROUND: Psoriasis is associated with comorbid systemic metabolic disease. OBJECTIVE: To assess possible associations of comorbid obesity, history of diabetes, hypertension, and hyperlipidemia with response to biologic treatment at 6 months among patients in CorEvitas' Psoriasis Registry. METHODS: Participants included 2924 patients initiating biologic therapy (tumour necrosis factor inhibitors [TNFi], interleukin [IL]-17i, IL-12/23i, or IL-23i) with baseline and 6-month follow-up visits available. Logistic regressions resulted in adjusted odd ratios (OR) and 95% confidence intervals (CI) for achievement of response in select outcomes for those with obesity and history of diabetes, hypertension, and hyperlipidemia relative to those without each. RESULTS: Overall, obesity reduced by 25% to 30% odds of achieving PASI75 (OR, 0.75; 95% CI, 0.64-0.88) and PASI90 (OR, 0.70; 95% CI, 0.59-0.81). History of diabetes reduced odds of achieving PASI75 by 31% (OR, 0.69; 95% CI, 0.56-0.85) and PASI90 by 21% (OR, 0.79; 95% CI, 0.63-0.98). Obesity was associated with lower response to TNFi and IL-17i classes. Independent of obesity, diabetes was associated with poorer outcomes when on IL-17i therapy and hypertension, to a lesser extent, when on the TNFi class. No significant associations were found in the hyperlipidemia group. LIMITATIONS: The study assessed only short-term effectiveness and small sample sizes limited the power to detect differences. CONCLUSION: Assessment of comorbid disease burden is important for improved likelihoods of achieving treatment response with biologics.
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Produtos Biológicos , Diabetes Mellitus , Hipertensão , Psoríase , Produtos Biológicos/uso terapêutico , Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/epidemiologia , Humanos , Hipertensão/complicações , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Obesidade/complicações , Obesidade/epidemiologia , Psoríase/complicações , Psoríase/tratamento farmacológico , Psoríase/epidemiologia , Sistema de Registros , Resultado do Tratamento , Inibidores do Fator de Necrose TumoralRESUMO
To compare drug survival of ixekizumab to other IL-17 inhibitors (IL-17i) and TNF inhibitors (TNFi) among patients with psoriasis (PsO) in a real-world setting. Participants included adult PsO patients enrolled in the Corrona Psoriasis Registry who initiated ixekizumab, TNFi, or other IL-17i between 16 March 2016 to 10 August 2019 and completed ≥1 follow-up visit. Multivariable adjusted hazard ratios (HR) were calculated to estimate the risk for drug discontinuation in the ixekizumab group relative to the other drugs. Among the 1604 drug initiations, 552 initiated ixekizumab, 450 initiated TNFi, and 602 initiated other IL-17i. Mean age was 51 years, 49% were women, and 52% were obese (BMI > 30). Ixekizumab patients had a higher proportion of patients with PASI >12 at drug initiation (24%) than TNFi (15%) and other IL-17i (19%). Over a median of 11 months of follow-up, 723/1604 (45%) drug discontinuations occurred. Persistence of ixekizumab, TNFi, and other IL-17i at 24-months were 68%, 33%, and 46%, among biologic-naïve patients (n = 543), and 46%, 23%, and 36%, for biologic-experienced patients (n = 1061), respectively. Ixekizumab patients had a 64% lower risk of discontinuation vs TNFi (HR = 0.36; 95% CI 0.27-0.47) and a 31% lower risk vs other IL-17i (HR = 0.69, 95% CI 0.55-0.87) after adjustment for biologic experience and other covariates. HRs were similar when limited to patients with moderate-to-severe PsO (BSA > 3, PASI > 3, and IGA > 1, n = 1076) at initiation. In our study of real-world patients with PsO, initiators of ixekizumab had more prolonged drug survival than both initiators of TNFi and other IL-17i up to 2 years of follow-up.
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Anticorpos Monoclonais Humanizados , Interleucina-17/antagonistas & inibidores , Psoríase , Inibidores do Fator de Necrose Tumoral , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Sistema de RegistrosRESUMO
OBJECTIVE: To investigate a proposed cognitively-mediated pathway whereby pain contributes to gait impairments by acting as a distractor in community-living older adults. DESIGN: A cross-sectional study of a population-based cohort of older adults. SETTING: Urban and suburban communities in a large metropolitan area. PARTICIPANTS: Community-living participants (N=302) 70 years and older recruited from a previous population-based cohort. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Gait parameters including gait speed, stride length, double support and swing characteristics, and variability were assessed under single- and dual-task conditions involving cognitive challenges (eg, counting backward). A joint pain questionnaire assessed pain distribution in the back and major joints. We examined pain-gait relationships using multivariable linear regression and bootstrapping mediation procedures. RESULTS: Forty-three percent of participants had pain in 2 or more musculoskeletal sites. Pain distribution was related to slower gait speed and other gait characteristics for all gait conditions. Associations persisted after adjustment for age, sex, education, body mass index, medication, and vision. Decrements in gait measures related to pain were comparable with decrements in gait related to dual-task conditions. There were no differences in dual-task cost among the pain distribution groups. Adjusted for confounders, pain-gait relationships appear mediated by selective attention. CONCLUSIONS: These findings suggest that chronic pain contributes to decrements in gait, including slower gait speed, and that it operates through a cognitively-mediated pathway. Further research is needed to understand the mechanisms via pain alters mobility and to develop interventions to improve mobility among older adults with chronic pain.
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Dor Crônica/fisiopatologia , Marcha , Idoso , Idoso de 80 Anos ou mais , Boston , Estudos Transversais , Feminino , Humanos , Estudos Longitudinais , Masculino , Medição da Dor , Inquéritos e QuestionáriosRESUMO
Cognitive functions are important correlates of health outcomes across the life-course. Individual differences in cognitive functions are partly heritable. Epigenetic modifications, such as DNA methylation, are susceptible to both genetic and environmental factors and may provide insights into individual differences in cognitive functions. Epigenome-wide meta-analyses for blood-based DNA methylation levels at ~420,000 CpG sites were performed for seven measures of cognitive functioning using data from 11 cohorts. CpGs that passed a Bonferroni correction, adjusting for the number of CpGs and cognitive tests, were assessed for: longitudinal change; being under genetic control (methylation QTLs); and associations with brain health (structural MRI), brain methylation and Alzheimer's disease pathology. Across the seven measures of cognitive functioning (meta-analysis n range: 2557-6809), there were epigenome-wide significant (P < 1.7 × 10-8) associations for global cognitive function (cg21450381, P = 1.6 × 10-8), and phonemic verbal fluency (cg12507869, P = 2.5 × 10-9). The CpGs are located in an intergenic region on chromosome 12 and the INPP5A gene on chromosome 10, respectively. Both probes have moderate correlations (~0.4) with brain methylation in Brodmann area 20 (ventral temporal cortex). Neither probe showed evidence of longitudinal change in late-life or associations with white matter brain MRI measures in one cohort with these data. A methylation QTL analysis suggested that rs113565688 was a cis methylation QTL for cg12507869 (P = 5 × 10-5 and 4 × 10-13 in two lookup cohorts). We demonstrate a link between blood-based DNA methylation and measures of phonemic verbal fluency and global cognitive ability. Further research is warranted to understand the mechanisms linking genomic regulatory changes with cognitive function to health and disease.
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Cognição/fisiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Ilhas de CpG , Metilação de DNA , Epigênese Genética , Feminino , Estudo de Associação Genômica Ampla/métodos , Genômica , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
Although muscle mass influences strength in older adults, it is unclear whether low lean mass measured by dual-energy X-ray absorptiometry (DXA) is an independent risk factor for hip fracture. Our objective was to determine the association between DXA lean mass and incident hip fracture risk among 1978 women aged 50 years and older participating in the Framingham Study Original and Offspring cohorts. Leg and total body lean mass (kg) were assessed from whole-body DXA scans collected in 1992-2001. Hip fracture follow-up extended from DXA assessment to the occurrence of fracture, death, drop-out, or end of follow-up in 2007. Cox proportional hazards regression was used to calculate hazard ratios (HR) and 95% confidence intervals (CI) estimating the relative risk of hip fracture associated with a 1-kg increase in baseline lean mass. Mean age was 66 years (range 50-93). Over a median of 8 years of follow-up, 99 hip fractures occurred. In models adjusted for age, height, study cohort, and percent total body fat, neither leg (HR 1.11; 95% CI 0.94, 1.31) nor total body (HR 1.06; 95% CI 0.99, 1.13) lean mass were associated with hip fracture. After further adjustment for femoral neck bone mineral density, leg lean mass results were similar (HR 1.10; 95% CI 0.93, 1.30). In contrast, 1 kg greater total body lean mass was associated with 9% higher hip fracture risk (HR 1.09; 95% CI 1.02, 1.18). Our findings suggest that in women, lower lean mass measured by DXA is not associated with increased risk of hip fracture.
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Fraturas do Quadril , Músculo Esquelético , Osteoporose Pós-Menopausa , Fraturas por Osteoporose , Absorciometria de Fóton , Idoso , Idoso de 80 Anos ou mais , Composição Corporal/fisiologia , Feminino , Fraturas do Quadril/etiologia , Humanos , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/complicações , Fraturas por Osteoporose/etiologia , Fatores de RiscoRESUMO
BACKGROUND: Heart failure (HF) with preserved ejection fraction (HFpEF) comprises nearly half of prevalent HF, yet is challenging to curate in a large database of electronic medical records (EMR) since it requires both accurate HF diagnosis and left ventricular ejection fraction (EF) values to be consistently ≥50%. METHODS: We used the national Veterans Affairs EMR to curate a cohort of HFpEF patients from 2002 to 2014. EF values were extracted from clinical documents utilizing natural language processing and an iterative approach was used to refine the algorithm for verification of clinical HFpEF. The final algorithm utilized the following inclusion criteria: any International Classification of Diseases-9 (ICD-9) code of HF (428.xx); all recorded EF ≥50%; and either B-type natriuretic peptide (BNP) or aminoterminal pro-BNP (NT-proBNP) values recorded OR diuretic use within one month of diagnosis of HF. Validation of the algorithm was performed by 3 independent reviewers doing manual chart review of 100 HFpEF cases and 100 controls. RESULTS: We established a HFpEF cohort of 80,248 patients (out of a total 1,155,376 patients with the ICD-9 diagnosis of HF). Mean age was 72 years; 96% were males and 12% were African-Americans. Validation analysis of the HFpEF algorithm had a sensitivity of 88%, specificity of 96%, positive predictive value of 96%, and a negative predictive value of 87% to identify HFpEF cases. CONCLUSION: We developed a sensitive, highly specific algorithm for detecting HFpEF in a large national database. This approach may be applicable to other large EMR databases to identify HFpEF patients.
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Mineração de Dados/métodos , Registros Eletrônicos de Saúde , Insuficiência Cardíaca/diagnóstico , Volume Sistólico , Função Ventricular Esquerda , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Bases de Dados Factuais , Diuréticos/uso terapêutico , Ecocardiografia , Feminino , Insuficiência Cardíaca/classificação , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/fisiopatologia , Humanos , Classificação Internacional de Doenças , Masculino , Pessoa de Meia-Idade , Peptídeo Natriurético Encefálico/sangue , Processamento de Linguagem Natural , Fragmentos de Peptídeos/sangue , Reprodutibilidade dos Testes , Estados Unidos/epidemiologia , United States Department of Veterans AffairsAssuntos
Psoríase/diagnóstico , Qualidade de Vida , Superfície Corporal , Fármacos Dermatológicos/uso terapêutico , Seguimentos , Humanos , Psoríase/tratamento farmacológico , Psoríase/psicologia , Sistema de Registros/estatística & dados numéricos , Índice de Gravidade de Doença , Resultado do TratamentoAssuntos
Antidepressivos/uso terapêutico , Depressão/epidemiologia , Prurido/tratamento farmacológico , Psoríase/tratamento farmacológico , Adulto , Idoso , Estudos de Casos e Controles , Depressão/diagnóstico , Depressão/tratamento farmacológico , Depressão/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Prurido/diagnóstico , Prurido/etiologia , Prurido/psicologia , Psoríase/complicações , Psoríase/diagnóstico , Psoríase/psicologia , Sistema de Registros/estatística & dados numéricos , Autorrelato , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
BACKGROUND: The impact of dietary protein intake on lower extremity lean mass and strength in community-dwelling adult Americans is not fully understood. OBJECTIVES: The objective was to determine the associations between total protein (TP), animal protein (AP), and plant protein (PP) intakes and lean mass of the legs and quadriceps muscle strength. We further examined whether the associations with quadriceps strength may be explained by lean mass of the legs. METHODS: This cross-sectional study included men (n = 1166) and women (n = 1509) from the Framingham Offspring Cohort in Massachusetts. Protein intake in grams per day was measured in either 1995-1998 or 1998-2001. Leg lean mass and isometric quadriceps strength, both in kilograms, were measured in 1996-2001. Multilinear regression models estimated adjusted least squares means of each of the muscle measures by quartile categories of protein intake, adjusting for relevant confounders and covariates. RESULTS: Mean age was 59 ± 9 y (range: 29-86 y) and TP intake was 80 ± 27 g/d in men and 76 ± 26 g/d in women. In men and women, leg lean mass was higher in participants in the highest quartiles of TP and AP intake compared with those in the lowest quartiles of intake [least squares means (kg): TP-17.6 vs. 17.1 in men, P-trend: 0.005, and 11.7 vs. 11.4 in women, P-trend: 0.006; AP-17.6 vs. 17.1 in men, P-trend: 0.002, and 11.7 vs. 11.4 in women, P-trend: 0.003]. PP intake was not associated with lean mass in either sex. In men and women, quadriceps strength was higher in participants in the highest quartile of PP intake compared with those in the lowest quartile [least squares means (kg): 22.9 vs. 21.7 in men, P-trend: 0.01, and 19.0 vs. 18.2 in women, P-trend: 0.01]; this association was no longer significant after adjustment for fruit and vegetable intake (P-trend: 0.06 in men and 0.10 in women). Although no significant association was observed for AP intake in either sex, nonsignificant protective trends were observed for TP intake (P-trend: 0.08 in men and 0.10 in women). CONCLUSIONS: Our findings suggest that maintaining adequate protein intake with age may help preserve muscle mass and strength in adult men and women. Dietary protein types may differentially affect muscle mass and strength. Whether PP is a marker of dietary quality or has a direct effect on muscle strength (independent of lean mass) needs to be further clarified.
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Índice de Massa Corporal , Proteínas Alimentares/administração & dosagem , Força Muscular , Músculo Quadríceps/fisiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Composição Corporal , Estudos Transversais , Feminino , Humanos , Masculino , Massachusetts , Pessoa de Meia-IdadeRESUMO
Osteoporosis is characterized by systemic impairment of bone mass, strength, and microarchitecture, resulting in increased risk for fragility fracture, disability, loss of independence, and even death. Adequate nutrition is important in achieving and maintaining optimal bone mass, as well as preventing this debilitating disease. It is widely accepted that adequate calcium and vitamin D intake are necessary for good bone health; however, nutritional benefits to bone go beyond these two nutrients. This review article will provide updated information on all nutrients and foods now understood to alter bone health. Specifically, this paper will focus on related research from the Framingham Osteoporosis Study, an ancillary study of the Framingham Heart Study, with data on more than 5000 adult men and women.
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Dieta , Fenômenos Fisiológicos da Nutrição , Osteoporose/prevenção & controle , Densidade Óssea/fisiologia , Osso e Ossos/metabolismo , Feminino , Fraturas Ósseas/prevenção & controle , Humanos , MasculinoAssuntos
Produtos Biológicos/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Uso de Medicamentos/estatística & dados numéricos , Psoríase/tratamento farmacológico , Academias e Institutos/normas , Adulto , Idade de Início , Idoso , Dermatologia/normas , Dermatologia/estatística & dados numéricos , Dermatologia/tendências , Uso de Medicamentos/normas , Uso de Medicamentos/tendências , Feminino , Geografia , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Guias de Prática Clínica como Assunto , Estudos Prospectivos , Psoríase/diagnóstico , Psoríase/epidemiologia , Psoríase/imunologia , Sistema de Registros/estatística & dados numéricos , Fatores de Risco , Índice de Gravidade de Doença , Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: To examine (i) the association of percentage of total energy intake from protein (protein intake %) with bone mineral density (BMD, g/cm2) and bone loss at the femoral neck, trochanter and lumbar spine (L2-L4) and (ii) Ca as an effect modifier. SETTING: The Framingham Offspring Study. SUBJECTS: Men (n 1280) and women (n 1639) completed an FFQ in 1992-1995 or 1995-1998 and underwent baseline BMD measurement by dual-energy X-ray absorptiometry in 1996-2000. Men (n 495) and women (n 680) had follow-up BMD measured in 2002-2005. DESIGN: Cohort study using multivariable regression to examine the association of protein intake % with each BMD, adjusting for covariates. Statistical interaction between protein intake % and Ca (total, dietary, supplemental) intake was examined. RESULTS: The mean age at baseline was 61 (sd 9) years. In the cross-sectional analyses, protein intake % was positively associated with all BMD sites (P range: 0·02-0·04) in women but not in men. Significant interactions were observed with total Ca intake (<800 mg/d v. ≥800 mg/d) in women at all bone sites (P range: 0·002-0·02). Upon stratification, protein intake % was positively associated with all BMD sites (P range: 0·04-0·10) in women with low Ca intakes but not in those with high Ca intakes. In the longitudinal analyses, in men, higher protein intake % was associated with more bone loss at the trochanter (P = 0·01) while no associations were seen in women, regardless of Ca intake. CONCLUSIONS: This suggests that greater protein intake benefits women especially those with lower Ca intakes. However, protein effects are not significant for short-term changes in bone density. Contrastingly, in men, higher protein intakes lead to greater bone loss at the trochanter. Longer follow-up is required to examine the impact of protein on bone loss.
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Densidade Óssea , Proteínas Alimentares/administração & dosagem , Osteoporose/fisiopatologia , Absorciometria de Fóton , Adulto , Idoso , Idoso de 80 Anos ou mais , Índice de Massa Corporal , Cálcio da Dieta/administração & dosagem , Estudos de Coortes , Estudos Transversais , Suplementos Nutricionais , Ingestão de Energia , Feminino , Colo do Fêmur/fisiologia , Seguimentos , Humanos , Modelos Lineares , Vértebras Lombares/fisiologia , Masculino , Massachusetts , Pessoa de Meia-Idade , Análise Multivariada , Avaliação Nutricional , Inquéritos e Questionários , Vitamina D/administração & dosagemRESUMO
INTRODUCTION: Data assessing longer-term real-world effectiveness and treatment patterns with upadacitinib (UPA), a Janus kinase inhibitor, in rheumatoid arthritis (RA) are lacking. We assessed improvement in clinical and patient-reported outcomes and treatment patterns for up to 12 months among adult patients with RA initiating UPA. METHODS: Data were collected from the CorEvitas® RA Registry (08/2019-04/2022). Eligible patients had moderate to severe RA (Clinical Disease Activity Index [CDAI] > 10) and follow-up visits at 6 or 12 months after UPA initiation. Outcomes were mean change from baseline, percentage achieving minimal clinically important differences (MCID) in clinical and patient-reported outcomes, and disease activity at follow-up. We evaluated clinical outcomes and therapy changes among patients with tumor necrosis factor inhibitor (TNFi) experience and among those receiving UPA as first-line therapy, as well as those receiving UPA as monotherapy versus as part of combination therapy. We further evaluated whether outcomes were similar among those that remained on therapy. RESULTS: Patients treated with UPA (6-month cohort, N = 469; 12-month cohort, N = 263) had statistically significant improvements (p < 0.001) in mean CDAI, tender/swollen joint counts, pain, and fatigue at follow-up. At 12 months, 46.0% achieved MCID in CDAI and 40.0% achieved low disease activity/remission. Overall, 43.0% discontinued UPA at 12 months; of those receiving combination treatment (N = 90) with conventional therapies and UPA, 42.2% (N = 38) discontinued conventional therapy. Findings were similar in the 6-month cohort and among subgroups. Changes from baseline and proportions of patients achieving MCID or clinical outcomes tended to be numerically lower among patients with TNFi experience and numerically higher among those receiving UPA as first-line therapy. CONCLUSIONS: UPA initiation was associated with improvements in clinical and patient-reported outcomes, with meaningful clinical improvements regardless of prior TNFi experience, line of therapy, or concomitant use of conventional therapies. Further research is needed to better understand sustained response of UPA over longer treatment periods.
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OBJECTIVE: To describe and identify associated factors for patient-clinician discordance of disease assessment at biologic or Janus kinase inhibitor (JAKi) initiation and over 12 months following initiation in patients with rheumatoid arthritis (RA) from a US RA registry. METHODS: Analyses included CorEvitas RA Registry patients who initiated their first biologic or JAKi on or after February 1, 2015, and had 6- and 12-month follow-up visits. Positive discordance was defined as patient global assessment (visual analog scale [VAS-100]) minus physician's global assessment (VAS-100) equal to 30 points or more. Persistent discordance was defined as positive discordance at all three visits. Mixed-effects logistic regression was used to determine risk factors for positive discordance at initiation and for persistent discordance. RESULTS: Among 2227 first-time biologic/JAKi-initiating patients, 613 had both follow-up visits available and were included in initiation visit analyses, and of these, 163 had positive discordance at initiation and were included in persistent discordance analyses. About 30% of all patients had positive discordance at any visit, and one third of these (10% total) were persistent at all three visits. Multivariable analyses revealed that worse scores on the Clinical Disease Activity Index, greater patient-reported pain and fatigue, and greater functional impairment were associated with positive discordance at the time of therapy initiation. Being disabled versus working full-time and being female were associated with higher odds and having Medicare versus no insurance was associated with lower odds of having persistent positive discordance. CONCLUSION: Results suggest positive discordance is common among real-world patients with RA initiating their first biologic or JAKi. The identified risk factors associated with patient-clinician discordance will help clinicians foster a more patient-centric discussion in treatment decisions.