RESUMO
OBJECTIVE: To describe 2-year trajectories of the clinical Juvenile Arthritis Disease Activity Score, 10 joints (cJADAS10) and associated baseline characteristics in patients with JIA. METHODS: JIA patients in the Childhood Arthritis and Rheumatology Research Alliance Registry enrolled within 3 months of diagnosis from 15 June 2015 to 6 December 2017 with at least two cJADAS10 scores and 24 months of follow-up were included. Latent growth curve models of cJADAS10 were analysed; a combination of Bayesian information criterion, posterior probabilities and clinical judgement was used to select model of best fit. RESULTS: Five trajectories were identified among the 746 included patients: High, Rapidly Decreasing (HRD) (n = 199, 26.7%); High, Slowly Decreasing (HSD) (n = 154, 20.6%); High, Increasing (HI) (n = 39, 5.2%); Moderate, Persistent (MP) (n = 218, 29.2%); and Moderate, Decreasing (MD) (n = 136, 18.2%). Most patients spent a significant portion of time at moderate to high disease activity levels. At baseline, HSD patients were more likely to be older, have a lower physician global assessment, normal inflammatory markers, longer time to first biologic, and have taken systemic steroids compared with HRD. Those with a HI trajectory were more likely to be ANA negative, have a longer time to first biologic, and less likely to be taking a conventional synthetic DMARD compared with HRD. MP patients were more likely to be older with lower household income, longer time to diagnosis, and markers of higher disease activity than those with a MD trajectory. CONCLUSIONS: Five trajectories of JIA disease activity, and associated baseline variables, were identified.
Assuntos
Antirreumáticos , Artrite Juvenil , Produtos Biológicos , Reumatologia , Humanos , Criança , Artrite Juvenil/diagnóstico , Teorema de Bayes , Antirreumáticos/uso terapêutico , Sistema de Registros , Produtos Biológicos/uso terapêuticoRESUMO
Obesity has reached epidemic proportions and in the US, the age-adjusted obesity prevalence is 32% for men and 36% for women. The osteoarthritis risk is nearly four-fold for obese men and five-fold for obese women. The purpose of this study was to evaluate the US national obesity trends of TKA utilization. The Nationwide Inpatient Sample (NIS), Healthcare Cost and Utilization Project (HCUP), Agency for Healthcare Research and Quality (AHRQ) 2002-2009 datasets were merged to identify 753,268 TKAs. Over this period, obese patients represented 15% of all TKAs. Despite well documented concerns regarding perioperative complications associated with TKA in obese patients, TKA utilization doubled from 2002-2009. Additionally, 30% of obese patients had greater than 3 co-morbidities, compared to 7% in the non-obese group. With greater complication risks, the increasing TKA utilization in obese patients is concerning and warrants increased attention.
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Artroplastia do Joelho/tendências , Obesidade/complicações , Obesidade/epidemiologia , Osteoartrite do Joelho/etiologia , Osteoartrite do Joelho/cirurgia , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Artroplastia do Joelho/estatística & dados numéricos , Criança , Pré-Escolar , Comorbidade , Bases de Dados Factuais , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/epidemiologia , Prevalência , Estudos Retrospectivos , Fatores de Risco , Fatores Sexuais , Estados Unidos/epidemiologia , Adulto JovemRESUMO
OBJECTIVE: Health disparities in childhood-onset systemic lupus erythematosus (SLE) disproportionately impact marginalized populations. Socioeconomically patterned missing data can magnify existing health inequities by supporting inferences that may misrepresent populations of interest. Our objective was to assess missing data and subsequent health equity implications among participants with childhood-onset SLE enrolled in a large pediatric rheumatology registry. METHODS: We evaluated co-missingness of 12 variables representing demographics, socioeconomic position, and clinical factors (e.g., disease-related indices) using Childhood Arthritis and Rheumatology Research Alliance Registry childhood-onset SLE enrollment data (2015-2022; n = 766). We performed logistic regression to calculate odds ratios (ORs) and 95% confidence intervals (95% CIs) for missing disease-related indices at enrollment (Systemic Lupus Erythematosus Disease Activity Index 2000 [SLEDAI-2K] and/or Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index [SDI]) associated with data missingness. We used linear regression to assess the association between socioeconomic factors and SLEDAI-2K at enrollment using 3 analytic methods for missing data: complete case analysis, multiple imputation, and nonprobabilistic bias analyses, with missing values imputed to represent extreme low or high disadvantage. RESULTS: On average, participants were missing 6.2% of data, with over 50% of participants missing at least 1 variable. Missing data correlated most closely with variables within data categories (i.e., demographic). Government-assisted health insurance was associated with missing SLEDAI-2K and/or SDI scores compared to private health insurance (OR 2.04 [95% CI 1.22, 3.41]). The different analytic approaches resulted in varying analytic sample sizes and fundamentally conflicting estimated associations. CONCLUSION: Our results support intentional evaluation of missing data to inform effect estimate interpretation and critical assessment of causal statements that might otherwise misrepresent health inequities.
Assuntos
Artrite Juvenil , Equidade em Saúde , Lúpus Eritematoso Sistêmico , Reumatologia , Criança , Humanos , Adolescente , Artrite Juvenil/diagnóstico , Artrite Juvenil/epidemiologia , Artrite Juvenil/complicações , Lúpus Eritematoso Sistêmico/diagnóstico , Lúpus Eritematoso Sistêmico/epidemiologia , Lúpus Eritematoso Sistêmico/terapia , Sistema de Registros , Índice de Gravidade de DoençaRESUMO
OBJECTIVE: To determine the dose-response relationship of tumor necrosis factor (TNF) inhibition in the treatment of juvenile idiopathic arthritis (JIA). METHODS: Participants of the Childhood Arthritis and Rheumatology Research Alliance Registry were eligible for inclusion in the analyses if they started TNF inhibition treatment for JIA. The primary treatment response was determined 3 to 7 months after the start of treatment, based on the JIA American College of Rheumatology Pediatric criteria for improvement, clinical Juvenile Arthritis Disease Activity Score, and persistence of treatment after 6 months. Subsequently, pooled logistic regression models were performed to include long-term follow-up data. The models were adjusted for risk factors associated with poor treatment response. Dosing was expressed by body weight, body surface area, ideal body weight, fat free mass, and lean body mass. RESULTS: Participants treated with adalimumab (n = 328) and etanercept (n = 437) were included in the analyses (median dose 0.82 mg/kg body weight [interquartile range (IQR) 0.66-1.04] and 0.83 mg/kg body weight [IQR 0.75-0.95], respectively). The majority of analyses did not show a relationship between dose and outcome. Where associations were found, results were conflicting. Alternative dosing characteristics based on ideal body weight, fat free mass, and lean body mass did not result in stronger or more consistent associations. CONCLUSION: This study was not able to confirm our hypothesis that increased dosing of TNF inhibitors results in improved treatment outcomes. Although adjustment was performed for risk factors of impaired treatment response, residual confounding by indication likely explains the negative associations found in this study.
Assuntos
Antirreumáticos , Artrite Juvenil , Reumatologia , Criança , Humanos , Adalimumab/uso terapêutico , Artrite Juvenil/diagnóstico , Artrite Juvenil/tratamento farmacológico , Etanercepte/efeitos adversos , Antirreumáticos/uso terapêutico , Metotrexato/uso terapêutico , Reumatologia/métodos , Fator de Necrose Tumoral alfa , Resultado do Tratamento , Sistema de RegistrosRESUMO
OBJECTIVE: Etanercept is commonly used to treat juvenile idiopathic arthritis, including juvenile psoriatic arthritis (JPsA); however, information on etanercept's safety and effectiveness in clinical practice is limited. We used data from the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry to evaluate etanercept's safety and effectiveness in JPsA in clinical practice. METHODS: We analysed safety and effectiveness data for paediatric patients enrolled in the CARRA Registry who had a JPsA diagnosis and had used etanercept. Safety was assessed by calculating rates of prespecified adverse events of special interest (AESIs) and serious adverse events (SAEs). Effectiveness was assessed by a variety of disease activity measures. RESULTS: Overall, 226 patients had JPsA and received etanercept; 191 met criteria for safety analysis and 43 met criteria for effectiveness analysis. AESI and SAE incidence rates were low. There were five events: three uveitis, one new-onset neuropathy and one malignancy. Incidence rates were 0.55 (95% CI: 0.18, 1.69), 0.18 (95% CI: 0.03, 1.29) and 0.13 (95% CI: 0.02, 0.09) per 100 patient-years for uveitis, neuropathy and malignancy, respectively. Etanercept showed effectiveness for JPsA treatment; 7 of 15 (46.7%) had an American College of Rheumatology-Pediatric Response 90, 9 of 25 (36.0%) had a clinical Juvenile Arthritis Disease Activity Score 10-joint ≤1.1 and 14 of 27 (51.9%) had clinically inactive disease at the 6-month follow-up. CONCLUSION: Data in the CARRA Registry showed that etanercept treatment was safe in treating children with JPsA, with low AESIs and SAEs. Etanercept was also effective, even when assessed in a small sample size.
Assuntos
Artrite Juvenil , Reumatologia , Humanos , Criança , Estados Unidos , Etanercepte/efeitos adversos , Artrite Juvenil/tratamento farmacológico , Artrite Juvenil/epidemiologia , Artrite Juvenil/diagnóstico , Sistema de RegistrosRESUMO
OBJECTIVE: Children with well-controlled juvenile idiopathic arthritis (JIA) frequently experience flares after medication discontinuation, but the outcomes of these flares have not been well described. The objective of this study was to characterize the rates and predictors of disease recapture among children with JIA who restarted medication to treat disease flare. METHODS: Children with JIA who discontinued conventional synthetic or biologic disease-modifying antirheumatic drugs for well-controlled disease but subsequently experienced a flare and restarted medication were identified from the Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry. The primary outcome was inactive disease (ID) (physician global assessment <1 and active joint count = 0) 6 months after flare. RESULTS: A total of 333 patients had complete data for ID at 6 months after flare. The recapture rate for the cohort was 55%, ranging from 47% (persistent oligoarthritis) to 69% (systemic arthritis) (P = 0.4). Approximately 67% of children achieved ID by 12 months. In the multivariable model, history and reinitiation of biologic drugs were associated with increased odds of successful recapture (odds ratio [OR] 4.79 [95% confidence interval (95% CI) 1.22-18.78] and OR 2.74 [95% CI 1.62-4.63], respectively). Number of joints with limited range of motion was associated with decreased odds (OR 0.83 per 1 joint increase [95% CI 0.72-0.95]). CONCLUSION: Approximately half of JIA flares post-discontinuation were recaptured within 6 months, but rates of recapture varied across JIA categories. These findings inform shared decision-making for patients, families, and clinicians regarding the risks and benefits of medication discontinuation. Better understanding of biologic predictors of successful recapture in JIA are needed.
Assuntos
Antirreumáticos , Artrite Juvenil , Produtos Biológicos , Reumatologia , Humanos , Criança , Artrite Juvenil/diagnóstico , Artrite Juvenil/tratamento farmacológico , Artrite Juvenil/complicações , Antirreumáticos/efeitos adversos , Produtos Biológicos/efeitos adversos , Sistema de Registros , Resultado do TratamentoRESUMO
OBJECTIVES: Evaluate construct validity of Patient-Reported Outcomes Measurement Information System (PROMIS) Paediatric measures of symptoms and functioning against measures of disease activity among youth with juvenile idiopathic arthritis (JIA) or systemic lupus erythematosus (SLE). DESIGN: Cross-sectional associations among PROMIS measures and clinical metrics of disease activity were estimated. SETTING: Seven clinical sites of the Childhood Arthritis and Rheumatology Alliance (CARRA) in the USA. PARTICIPANTS: Youth aged 8-17 years enrolled in the CARRA Registry. INTERVENTION: PROMIS measures were collected and associations with clinical measures of disease activity estimated, by condition, in bivariate and multivariable analyses with adjustment for sociodemographics, insurance status, medications and disease duration. MAIN OUTCOME MEASURES: PROMIS Paediatric measures of mobility, physical activity, fatigue, pain interference, family relationships, peer relationships, depressive symptoms, psychological stress, anxiety, and meaning and purpose, and clinical metrics of disease. RESULTS: Among 451 youth (average age 13.8 years, 71% female), most (n=393, 87%) had a JIA diagnosis and the remainder (n=58, 13%) had SLE. Among participants with JIA, those with moderate/high compared with low/inactive disease had, on average, worse mobility (multivariable regression coefficient and 95% CIs) (-7.40; -9.30 to -5.50), fatigue (3.22; 1.02 to 5.42), pain interference (4.76; 3.04 to 6.48), peer relationships (-2.58; -4.52 to -1.64), depressive symptoms (3.00; 0.96 to 5.04), anxiety (2.48; 0.40 to 4.56) and psychological stress (2.52; 0.68 to 4.36). For SLE, youth with active versus inactive disease had on average worse mobility (-5.07; -10.15 to 0.01) but PROMIS Paediatric measures did not discriminate participants with active and inactive disease in adjusted analyses. CONCLUSIONS: Seven PROMIS Paediatric measures discriminated between active and inactive disease in youth with JIA. Results advance the usefulness of PROMIS for understanding well-being and improving interventions for youth with JIA, but larger studies are needed to determine utility in SLE cohorts. TRIAL REGISTRATION NUMBER: National Institute of Arthritis and Musculoskeletal and Skin Diseases (U19AR069522).
Assuntos
Artrite Juvenil , Lúpus Eritematoso Sistêmico , Adolescente , Humanos , Criança , Feminino , Masculino , Artrite Juvenil/diagnóstico , Artrite Juvenil/psicologia , Estudos Transversais , Lúpus Eritematoso Sistêmico/diagnóstico , Lúpus Eritematoso Sistêmico/psicologia , Medidas de Resultados Relatados pelo Paciente , Dor/diagnóstico , Fadiga/etiologia , Sistemas de InformaçãoRESUMO
The purpose of this study was to determine if cobalt and chromium ion levels can predict soft tissue damage at total hip revision. This study included 90 metal-on-metal total hip patients with preoperative cobalt and chromium ion levels. Tissue damage noted at revision surgery was graded on a 4-point scale. Sensitivity, specificity, and predictive values were calculated for various threshold values. Receiver operating characteristic analysis was conducted. Using 7 ppb as a threshold, cobalt and chromium ion levels had poor sensitivity and specificity (Co, 65% and 56%; Cr, 29% and 75%). Positive predictive values for cobalt and chromium were only 48% and 26% respectively. The area under the curve was 0.37 for cobalt and 0.44 for chromium. The length of time to revision significantly correlated with tissue damage (P = .001). Ion levels are unreliable predictors of periarticular soft tissue damage and should not be used in isolation as surgical intervention triggers.
Assuntos
Cromo/sangue , Cobalto/sangue , Prótese de Quadril/efeitos adversos , Próteses Articulares Metal-Metal/efeitos adversos , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/cirurgia , Falha de Prótese/efeitos adversos , Humanos , Íons , Complicações Pós-Operatórias/etiologia , Desenho de Prótese , Reoperação , Estudos Retrospectivos , Medição de RiscoRESUMO
OBJECTIVE: To describe high-dose biologic use when treating juvenile idiopathic arthritis (JIA). METHODS: Patients with JIA enrolled in the Childhood Arthritis and Rheumatology Research Alliance Registry and treated with a biologic after enrollment were eligible. We described the frequency of high-dose biologic use and characteristics of patients receiving high-dose biologics. We used regression modeling to compare 6-month outcomes (using disease activity measures) between those who increased their biologic from standard to high dose (high-dose group) to those who initiated and remained on standard dosing (no-change group), and to those who switched biologic agents (biologic-switch group). We also compared serious adverse events (SAEs) between groups. RESULTS: A total of 5,352 patients with JIA were treated with biologics following enrollment; 1,080 (20%) had ever received a high-dose biologic. There were no significant differences in outcomes between the high-dose group and the biologic-switch group; both improved disease activity measures, including the clinical Juvenile Arthritis Disease Activity Score 10 (-3.53 and -3.95, respectively; P = 0.68). Although the SAE rates in the high-dose group and the biologic-switch group were numerically higher than the no-change group, the event rates were similar, and neither rate was significantly higher than in the no-change group (unadjusted incident rate ratio 2.5 [95% confidence interval (95% CI) 0.7-8.5] and 1.8 [95% CI 0.7-4.6], respectively). CONCLUSION: Dosing escalation appears to be a reasonable choice to improve disease control, but large, prospective, randomized studies evaluating specific biologic agents are needed.
Assuntos
Antirreumáticos , Artrite Juvenil , Produtos Biológicos , Reumatologia , Criança , Humanos , Artrite Juvenil/diagnóstico , Artrite Juvenil/tratamento farmacológico , Antirreumáticos/efeitos adversos , Estudos Prospectivos , Sistema de Registros , Produtos Biológicos/efeitos adversos , Fatores Biológicos/uso terapêutico , Resultado do TratamentoRESUMO
BACKGROUND: The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed consensus treatment plans (CTPs) to compare treatment initiation strategies for systemic juvenile idiopathic arthritis (sJIA). First-line options for sJIA treatment (FROST) was a prospective observational study to assess CTP outcomes using the CARRA Registry. METHODS: Patients with new-onset sJIA were enrolled if they received initial treatment according to the biologic CTPs (IL-1 or IL-6 inhibitor) or non-biologic CTPs (glucocorticoid (GC) monotherapy or methotrexate). CTPs could be used with or without systemic GC. Primary outcome was achievement of clinical inactive disease (CID) at 9 months without current use of GC. Due to the small numbers of patients in the non-biologic CTPs, no statistical comparisons were made between the CTPs. RESULTS: Seventy-three patients were enrolled: 63 (86%) in the biologic CTPs and 10 (14%) in the non-biologic CTPs. CTP choice appeared to be strongly influenced by physician preference. During the first month of follow-up, oral GC use was observed in 54% of biologic CTP patients and 90% of non-biologic CTPs patients. Five (50%) non-biologic CTP patients subsequently received biologics within 4 months of follow-up. Overall, 30/53 (57%) of patients achieved CID at 9 months without current GC use. CONCLUSION: Nearly all patients received treatment with biologics during the study period, and 46% of biologic CTP patients did not receive oral GC within the first month of treatment. The majority of patients had favorable short-term clinical outcomes. Increased use of biologics and decreased use of GC may lead to improved outcomes in sJIA.
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Artrite Juvenil , Humanos , Artrite Juvenil/tratamento farmacológico , Projetos de PesquisaRESUMO
BACKGROUND: Irrigation and débridement is an attractive low morbidity solution for acute periprosthetic knee infection. However, the failure rate in the literature is high, averaging 68% (range, 61%-82%). Patients who fail subsequently undergo two-stage reimplantation after a prolonged period of illness. This leads to higher surgical risk and further delays in rehabilitation and may contribute to failure of subsequent revision surgery. QUESTIONS/PURPOSES: We determined the rerevision rate due to infection after two-stage reimplantation performed for failed irrigation and débridement of infected TKA. METHODS: We performed a multicenter retrospective review of periprosthetic knee infections treated with a two-stage procedure from 1994 to 2008. Selection criteria for the study included initial treatment with irrigation and débridement and subsequent two-stage revision surgery. Failure of two-stage revision was defined as the need for any additional surgery due to infection. RESULTS: Of the 83 knees that had undergone previous irrigation and débridement, 28 (34%) failed subsequent two-stage revision and required reoperation for persistent infection. CONCLUSIONS: The failure rate in this series of two-stage revisions for periprosthetic knee infection in patients treated with previous irrigation and débridement is considerably higher than previously reported failure rates of two-stage revision. Factors affecting the failure rate may include host quality, thoroughness of débridement, and organism virulence. Patients and surgeons must understand that irrigation and débridement, while initially attractive, may lead to high failure rates of subsequent two-stage reimplantation. LEVEL OF EVIDENCE: Level III, therapeutic study. See the guidelines online for a complete description of level of evidence.
Assuntos
Artroplastia do Joelho/efeitos adversos , Desbridamento , Articulação do Joelho/cirurgia , Prótese do Joelho/efeitos adversos , Infecções Relacionadas à Prótese/cirurgia , Irrigação Terapêutica , Adulto , Idoso , Idoso de 80 Anos ou mais , Artroplastia do Joelho/instrumentação , Distinções e Prêmios , Distribuição de Qui-Quadrado , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infecções Relacionadas à Prótese/microbiologia , Reoperação , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Falha de Tratamento , Estados UnidosRESUMO
The ASR (articular surface replacement) XL (DePuy, Warsaw, Ind) metal-on-metal hip arthroplasty offers the advantage of stability and increased motion. However, an alarming number of early failures prompted the evaluation of patients treated with this system. A prospective study of patients who underwent arthroplasty with the ASR XL system was performed. Patients with 2-year follow-up or any revision were included. Failure rates, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, and radiographs were evaluated. Ninety-five patients (105 hips) were included. There were 16 revisions. Thirteen (12%) were aseptic acetabular failures. Eight were revised for aseptic loosening; 4, for metallosis; 1, for malposition; 2, for infection; and 1, for periprosthetic fracture. Mean time to revision was 1.6 years (0.18-3.4 years). The ASR XL with a revision rate of 12% is the second reported 1 piece metal-on-metal system with a significant failure rate at early follow-up. This particular class of implants has inherent design flaws that lead to early failure.
Assuntos
Artroplastia de Quadril/instrumentação , Articulação do Quadril/cirurgia , Prótese de Quadril , Osteoartrite do Quadril/cirurgia , Falha de Prótese , Adolescente , Adulto , Idoso , Artroplastia de Quadril/métodos , Mau Alinhamento Ósseo/epidemiologia , Feminino , Seguimentos , Articulação do Quadril/diagnóstico por imagem , Humanos , Incidência , Masculino , Metais , Pessoa de Meia-Idade , Infecções Relacionadas à Prótese/epidemiologia , Radiografia , Reoperação , Estudos Retrospectivos , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: Biologic medications have significantly improved disease control and outcomes of patients with juvenile idiopathic arthritis (JIA). Current treatment recommendations suggest escalating therapy, including changing biologics if needed, when inactive or low disease activity is not attained. The patterns and reasons for switching biologics in clinical practice in North America are not well described. METHODS: We used the Childhood Arthritis and Rheumatology Research Alliance Registry and included individuals with JIA if they newly started a biologic after January 1, 2008, and had at least 12 months of subsequent observable time. Subjects with systemic JIA were excluded. We compared characteristics of switchers and nonswitchers using chi-square for categorical variables and Wilcoxon rank-sum test for continuous variables, and used linear regression for time analysis. RESULTS: Of the eligible children, 1361 with JIA in the registry started a biologic (94% tumor necrosis factor inhibitors [TNFi]). Median followup time was 30 months and 349 (26%) switched biologics. Among biologic switchers, ineffectiveness/disease flare was the most common reason for switch (202, 58%). The most common documented switch was from etanercept to another TNFi (221, 63%). The median time to switch to a second biologic decreased substantially from 55.2 months in 2008 to 7.2 months in 2016. CONCLUSION: In a multicenter cohort of patients with JIA starting a biologic, one-quarter switched to a second biologic, and the time to switching decreased in recent years. Additional studies should evaluate the outcomes and optimal timing of switching and preferred sequence of biologic use.
Assuntos
Antirreumáticos , Artrite Juvenil , Produtos Biológicos , Reumatologia , Antirreumáticos/uso terapêutico , Artrite Juvenil/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Criança , Estudos de Coortes , Humanos , Sistema de Registros , Resultado do TratamentoRESUMO
OBJECTIVE: The optimal time to start biologics in polyarticular juvenile idiopathic arthritis (JIA) remains uncertain. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed 3 consensus treatment plans (CTPs) for untreated polyarticular JIA to compare strategies for starting biologics. METHODS: Start Time Optimization of Biologics in Polyarticular JIA (STOP-JIA) was a prospective, observational, CARRA Registry study comparing the effectiveness of 3 CTPs: 1) the step-up plan (initial nonbiologic disease-modifying antirheumatic drug [DMARD] monotherapy, adding a biologic if needed, 2) the early combination plan (DMARD and biologic started together), and 3) the biologic first plan (biologic monotherapy). The primary outcome measure was clinically inactive disease according to the provisional American College of Rheumatology (ACR) criteria, without glucocorticoids, at 12 months. Secondary outcome measures included Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and mobility scores, inactive disease as defined by the clinical Juvenile Arthritis Disease Activity Score in 10 joints (JADAS-10), and the ACR Pediatric 70 criteria (Pedi 70). RESULTS: Of 400 patients enrolled, 257 (64%) began the step-up plan, 100 (25%) the early combination plan, and 43 (11%) the biologic first plan. After propensity score weighting and multiple imputation, clinically inactive disease according to the ACR criteria was achieved in 37% of those on the early combination plan, 32% on the step-up plan, and 24% on the biologic first plan (P = 0.17). Inactive disease according to the clinical JADAS-10 (score ≤2.5) was also achieved in more patients on the early combination plan than the step-up plan (59% versus 43%; P = 0.03), as was ACR Pedi 70 (81% versus 62%; P = 0.008), but generalizability was limited by missing data. PROMIS measures improved in all groups, but without significant differences. Twenty serious adverse events were reported (mostly infections). CONCLUSION: Achievement of clinically inactive disease without glucocorticoids did not significantly differ between groups at 12 months. While there was a significantly higher likelihood of early combination therapy achieving inactive disease according to the clinical JADAS-10 and ACR Pedi 70, these results require further exploration.
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Antirreumáticos/uso terapêutico , Artrite Juvenil/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Adolescente , Antirreumáticos/administração & dosagem , Produtos Biológicos/administração & dosagem , Criança , Consenso , Esquema de Medicação , Humanos , Fatores de Tempo , Tempo para o Tratamento , Resultado do TratamentoRESUMO
OBJECTIVE: To document the need for additional Food and Drug Administration (FDA)-approved medications for the treatment of juvenile idiopathic arthritis (JIA). METHODS: The electronic medical records of JIA patients treated at Cincinnati Children's Hospital Medical Center (CCHMC) and data from JIA patients enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry were included in this study. Unmet medication need was defined in 2 ways: (a) the presence of chronically uncontrolled JIA, defined as a physician global assessment of JIA activity ≥3 (on a 0-10 scale, where 0 = inactive) OR ≥3 joints with active arthritis OR a patient global assessment of well-being ≥3 (on a 0-10 scale, where 0 = very well), despite sequential use of ≥2 biologic disease-modifying antirheumatic drugs (bDMARDs); and (b) the use of ≥1 bDMARD not approved for any JIA category. RESULTS: At CCHMC, 829 of 1,599 JIA patients (52%) were treated with ≥1 bDMARD, and 304 (19%) had been exposed to ≥1 unapproved bDMARD. In the CARRA Registry, 4,766 of 7,379 children (65%) had received ≥1 bDMARD, and 1,122 (15%) had been prescribed ≥1 unapproved bDMARD. Of those children treated with ≥2 bDMARDs for whom complete data were available, 52% (255 of 487) at CCHMC and 45% (527 of 1,159) in the CARRA Registry had chronically uncontrolled JIA despite the use of ≥2 bDMARDs. CONCLUSION: Despite the availability of bDMARDs currently approved for JIA, there is persistent need for additional therapies to control JIA signs and symptoms. Since FDA approval is critical to ensure access to bDMARDs, the study and licensing of new medications is critical to address the unmet medication need and to further improve JIA outcomes.
Assuntos
Antirreumáticos/uso terapêutico , Artrite Juvenil/tratamento farmacológico , Necessidades e Demandas de Serviços de Saúde , Criança , Humanos , Sistema de RegistrosRESUMO
African Americans, other minorities and underserved populations are consistently under- represented in clinical trials. Such underrepresentation results in a gap in the evidence base, and health disparities. The ABC Cardiovascular Implementation Study (CVIS) is a comprehensive prospective cohort registry that integrates social determinants of health. ABC CVIS uses real world clinical practice data to address critical gaps in care by facilitating robust participation of African Americans and other minorities in clinical trials. ABC CVIS will include diverse patients from collaborating ABC member private practices, as well as patients from academic health centers and Federally Qualified Health Centers (FQHCs). This paper describes the rationale and design of the ABC CVIS Registry. The registry will: (1) prospectively collect socio-demographic, clinical and biospecimen data from enrolled adults, adolescents and children with prioritized cardiovascular diseases; (2) Evaluate the safety and clinical outcomes of new therapeutic agents, including post marketing surveillance and pharmacovigilance; (3) Support National Institutes of Health (NIH) and industry sponsored research; (4) Support Quality Measures standards from the Center for Medicare and Medicaid Services (CMS) and Commercial Health Plans. The registry will utilize novel data and technology tools to facilitate mobile health technology application programming interface (API) to health system or practice electronic health records (EHR). Long term, CVIS will become the most comprehensive patient registry for underserved diverse patients with cardiovascular disease (CVD) and co morbid conditions, providing real world data to address health disparities. At least 10,000 patients will be enrolled from 50 sites across the United States.
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Negro ou Afro-Americano/estatística & dados numéricos , Determinantes Sociais da Saúde/estatística & dados numéricos , Populações Vulneráveis/estatística & dados numéricos , Georgia , Humanos , Estudos Prospectivos , Sistema de RegistrosRESUMO
The best bearing to use in the young active population remains unknown because there are currently no evidence-based data to rely on. This article compares the prevalence of periacetabular osteolysis using computerized tomography in patients with metal-on-metal, ceramic-on-ceramic, and metal-on-cross-linked bearings at a minimum 5-year follow-up.
Assuntos
Articulação do Quadril/cirurgia , Prótese de Quadril , Osteólise/epidemiologia , Desenho de Prótese , Idoso , Cerâmica , Feminino , Articulação do Quadril/diagnóstico por imagem , Humanos , Masculino , Metais , Pessoa de Meia-Idade , Estudos Retrospectivos , Tomografia Computadorizada por Raios XRESUMO
With the demand for total joint arthroplasty and overall life expectancy increasing, there will be an increase in the need for revision arthroplasty surgeries. Given that revision joint surgeries are more demanding for both surgeon and patient with longer operative times, increased blood loss, and multiple patient comorbidities, the current mindset is that older patients who undergo a total hip revision or total knee revision have higher mortality rates than younger patients. We identified 1737 revision total joint patients who were at least 2 years postoperative for inclusion in the study. The overall perioperative mortality rate (defined as deaths occurring between 0 and 3 months following revision joint surgery) was calculated and then stratified by revision knee surgery, revision hip surgery, and age. In addition, mortality rates were compared for patients younger than 70 years, between 70 and 80 years and older than 80 years. The overall perioperative mortality rate after revision total hip or knee surgery was 0.7%. After stratifying by age, the perioperative mortality rate was 0.2% in patients younger than 70 years, 0.8% in patients 70 to 79 years, and 2.63% in patients older than 80 years. Of the 1737 patients, 541 died >1 year following their revision surgery at an average time to death of 6.9 years. The observed perioperative mortality rates following revision total joint surgery at a single center were extremely low among all age groups. Therefore, the age of patients undergoing revision surgery should not be the sole determinant of perioperative survival. Additionally, it appears that the mean postoperative survival noted here seems to justify the additional resources used in revision surgery regardless of age. As limited resources exert pressure on an already overburdened healthcare system, rationing of care for certain procedures may ensue using age as a specific criteria. This study should add clarity to this issue.