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1.
Patient ; 13(1): 57-69, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31410723

RESUMO

OBJECTIVES: The aim of this study was to develop and assess the effectiveness of a patient decision aid (PDA) to support treatment decision making in Spanish patients with moderate-to-severe rheumatoid arthritis (RA) who fail to achieve the therapeutic goal with the current disease-modifying antirheumatic treatment strategy. METHODS: The PDA was developed in accordance with the International Patient Decision Aids Standards recommendations. A steering group led the project. Three literature reviews and two focus groups were performed to develop the PDA prototype. To check its comprehensibility, acceptability, and feasibility, alpha-testing was performed using the Decision Support Acceptability Scale (DSAS). Beta-testing was conducted to assess preliminary evidence of PDA efficacy using the Decisional Conflict Scale (DCS) before and after PDA use. Readiness was evaluated using the Preparation for Decision Making Scale (PDMS). RESULTS: The PDA included (1) a brief description of RA, (2) treatment information, and (3) a values clarification section. Alpha-testing revealed that most patients considered that the information was presented in a good or excellent way and it could help clarify their values and facilitate treatment decision making. Most rheumatologists agreed that the PDA was easy to understand, to use, and allowed them to reach a shared decision. Beta-testing showed that PDA significantly reduced overall patients' decisional conflict [33.2 (DE: 21.4) vs 24.6 (23.5); p < 0.001] and prepared the patient for decision making [PDMS: 67.5 (21.0)]. CONCLUSIONS: We developed a PDA for Spanish patients with moderate-to-severe RA that reduces patients' decisional conflict and increases their readiness for decision making. The use of this PDA in routine clinical practice may improve the quality of the decision-making process and the quality of the choices made.

2.
Reumatol Clin ; 16(1): 38-41, 2020.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-29550251

RESUMO

OBJECTIVE: Polymyalgia rheumatica (PR) can be associated with large vessel vasculitis (LVV). We evaluate the diagnostic role of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) and its impact on the treatment of LVV associated with PR. MATERIALS AND METHODS: Retrospective study of patients diagnosed with PR. Data was collected from health records. Blood analysis included acute-phase reactants (APR), C-reactive protein (CRP) and erythrocyte sedimentation rate. An 18F-FDG PET/CT scan was performed in those patients whose symptoms persisted, in those with elevated APR, those who required higher doses of steroids or those who had atypical features of PR (low-grade fever, weight loss, among others). RESULTS: Twenty-three were eligible; 48% (n = 11) of the patients were diagnosed with LVV associated with PR. The site was heterogeneous, but mostly involved the aorta. In 80% of the patients with LVV, a disease-modifying antirheumatic drug was added to their treatment. Elevated CRP values were associated with the likelihood of presenting LVV. CONCLUSIONS: LVV is not uncommon, clinical features and elevated CRP levels should raise suspicion of LVV associated with PR. 18F-FDG PET/CT is useful in identifying LVV associated with PR.

3.
Reumatol Clin ; 2019 Dec 24.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31882343

RESUMO

INTRODUCTION: The current paradigm of the management of rheumatoid arthritis (RA) recommends achieving a state of remission or low disease activity through the treat-to-target strategy. Our study assesses adherence to this strategy. METHOD: Patients with RA (ACR-EULAR 2010 criteria) were included. From each centre, 19 patients were randomly selected. Clinical histories (CH) were assessed by independent auditors, checking compliance with predefined quality criteria. The study was approved by ethics committees. RESULTS: We included 856 patients (mean age 54 years; 71% women). The use of a combined index (CI) was recorded in 61% of cases. Visits were recorded every 4 weeks using a CI in 4% of CH while attempts were made to achieve remission. Monitoring of disease activity every 6-8 months after reaching the target was recorded in 73% of cases. CONCLUSIONS: The implementation of the treat-to-target strategy is barely recorded in patients with RA in routine clinical practice.

4.
Reumatol Clin ; 2019 Nov 10.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31722849

RESUMO

Management of systemic autoimmune diseases is challenging for physicians in their clinical practice. Although not common, they affect thousands of patients in Spain. The family doctor faces patients with symptoms and non-specific cutaneous, mucous, joint, vascular signs or abnormal laboratory findings at the start of the disease process and has to determine when to refer patients to the specialist. To aid in disease detection and better referral, the Spanish Society of Rheumatology and the Spanish Society of Family Medicine has created a group of experts who selected 26 symptoms, key signs and abnormal laboratory findings which were organized by organ and apparatus. Family doctors and rheumatologists with an interest in autoimmune systemic diseases were selected and formed mixed groups of two that then elaborated algorithms for diagnostic guidelines and referral. The algorithms were then reviewed, homogenized and adapted to the algorithm format and application for cell phone (apps) download. The result is the current Referral document of systemic autoimmune diseases for the family doctor in paper format and app (download). It contains easy-to-use algorithms using data from anamnesis, physical examination and laboratory results usually available to primary care, that help diagnose and refer patients to rheumatology or other specialties if needed.

5.
Rheumatol Int ; 39(11): 1875-1882, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31522232

RESUMO

The objective of this study was to evaluate the impact of digital ulcers (DUs) in daily life of systemic sclerosis (SSc) Spanish patients. We developed a multicenter observational study to compare functional disability in SSc patients with active DUs vs. those without DUs. An additional correlation between perception of patients and physicians on disability due to DUs was performed. A total of 199 patients were enrolled, 70 (35%) with DUs. Patients with DUs were younger (48 vs. 58 years; p < 0.001) and had more frequently the diffuse subtype of SSc (45 vs. 24%; p = 0.004) than patients without DUs. Patients with DUs showed significantly higher scores in the Cochin Hand Function Scale overall (p < 0.002) and for each of its five dimensions. They also showed higher scores in the Systemic Sclerosis Health Assessment Questionnaire items related to hand function such as, dress and self-care (p < 0.013), eat (p < 0.013) and grip (p < 0.03), and higher Visual Analogic Scale scores for pain (p < 0.013), trouble related with Raynaud's Phenomenon (p < 0.001) and sense of severity (p < 0.004). Impact on daily activities was significantly higher in patients with DUs (p = 0.002), with a non-significant trend to experience higher impact on work productivity (p = 0.07). A high correlation was found between DUs patients and physicians opinion on the impact of DUs (daily life: Pearson R = 0.86; work productivity: Pearson R = 0.87). Study findings show an impaired hand function and increased disability for daily life activities and work productivity in SSc patients with DUs compared with patients without DUs in Spanish population.

6.
Med. clín (Ed. impr.) ; 153(6): 225-231, sept. 2019. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-184027

RESUMO

Fundamento y objetivo: Analizar la asociación entre concentraciones de interferón-1alpha (INF1alpha), interleucina 10 (IL-10) y BLyS con la actividad clínica en el lupus eritematoso sistémico (LES). Pacientes y métodos: Estudio observacional transversal de 142 pacientes con LES y 34 controles sanos mediante analítica de sangre y orina y revisión de la historia clínica. La concentración sérica de citocinas se determinó mediante métodos colorimétricos. El análisis bioestadístico se realizó con R (3.3.2). Resultados: El 69% de pacientes mostraron al menos una citocina aumentada. Las tres citocinas están más elevadas en pacientes que en controles (p<0,001, p=0,005 y p=0,043), siendo INF1alpha el más frecuente. Los pacientes fueron categorizados según las concentraciones de las tres citocinas. Encontramos una asociación significativa entre concentraciones elevadas de IL-10/INF1alpha y una mayor actividad clínica según SELENA-SLEDAI (p<0,0001) y, en menor medida, con concentraciones aumentadas de INF1alpha/IL-10/BLyS. Concentraciones elevadas de IL-10/INF1alpha e INF1alpha/IL-10/BLyS se relacionaron con un mayor consumo de C3-C4 (p<0,001 y p=0,001) y títulos elevados de anti-dsDNA (p=0,001 y p=0,002). Concentraciones elevadas de INF1alpha/BLyS se relacionaron con títulos más altos de anti-dsDNA (p=0,004) y positividad ENA (p<0,001). Concentraciones altas de INF1alpha/IL-10/BLyS se relacionaron con la positividad de ANA (p<0,001) y anticuerpos antifosfolípidos (p=0,004). Conclusiones: INF1alpha, IL-10 y BLyS están más elevados en pacientes con LES que en controles sanos. El aumento de IL-10, asociado o no a aumento de BLyS y/o INF1alpha, es la citocina que mejor se ajusta a la actividad clínica del LES medida con métodos clásicos


Background and objective: to analyse the association between interferon-1alpha (INF1alpha), interleukin-10 (IL-10) and BLyS concentrations and clinical activity in systemic lupus erythematosus (SLE). Patients and methods: A cross-sectional, observational study of 142 SLE patients and 34 healthy controls was performed, through a complete blood and urine test and review of their medical history. Serum concentration of INF1alpha, IL-10 and BLyS was determined by colorimetric methods. A biostatistical analysis was performed with R (3.3.2.). Results: 69% of our SLE patients showed at least one cytokine increased. INF1alpha, IL-10 and BLyS are higher in SLE patients than in healthy controls (P<.001, P=.005 and P=.043, respectively), being INF1alpha the most frequent. Patients were categorised according to low or high concentrations of the three cytokines. We found a significant association between increased IL-10/INF1alpha concentrations and a higher clinical activity measured by SELENA-SLEDAI (P<.0001) and, to a lesser extent, an association with increased INF1alpha/IL-10/BLyS concentrations. Elevated levels of IL-10/INF1alpha and INF1alpha/IL-10/BLyS related to increased C3-C4 consumption (P<.001 and P=.001 respectively) and anti-dsDNA titres (P=.001 and P=.002 respectively). Elevated INF1alpha/BLyS related to higher anti-dsDNA titres (P=.004) and ENA positivity (P<.001). Increased levels of INF1alpha/IL-10/BLyS related to positivity of ANAs (P<.001) and APL (P=.004). Conclusions: INF1alpha, IL-10 and BLyS are higher in SLE patients than in healthy controls. Increased IL-10 levels, regardless of whether or not there were also increased levels of BLyS and/or INF1alpha, was the cytokine that best fit with clinical activity in SLE measured with classic methods


Assuntos
Humanos , Feminino , Criança , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Lúpus Eritematoso Sistêmico/diagnóstico , Lúpus Eritematoso Sistêmico/sangue , Interferon Tipo I/sangue , Interleucina-10/sangue , Linfócitos B/metabolismo , Biomarcadores/sangue , Biomarcadores/urina , Estudos Transversais , Lúpus Eritematoso Sistêmico/urina , Colorimetria/métodos , Bioestatística , Anticorpos Antifosfolipídeos , Inquéritos e Questionários , Ensaio de Imunoadsorção Enzimática , Citocinas/sangue , Citocinas/urina
7.
Radiol Case Rep ; 14(10): 1214-1220, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31417664

RESUMO

We present the case of a 70 years old woman with infectious discitis which was detected using Fluorine fluodeoxiglucose positron emission tomography/computed tomography (18F-FDG PET/CT), after a negative magnetic resonance imaging. A Streptococuss gallolyticus (bovis gender bacteria) grow on culture. In addition 18F-FDG PET also demonstrated infectious endocarditis which was confirmed by transesophageal echocardiography and a colonic neoplasm. Here we have highlighted the potential role of 18F-FDG PET/CT study in patients with a clinical history suggestive of infectious discitis with a negative or indifferent magnetic resonance imaging.

8.
Clin Biomech (Bristol, Avon) ; 68: 169-174, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31220740

RESUMO

BACKGROUND: Evaluate the relationship between structural damage assessed by radiography or ultrasonography in the hands of patients with psoriatic arthritis (PsA) with loss of strength together with functional disability. METHODS: A cross-sectional study was conducted in patients with PsA involving the hands. Erosions and loss of radiographic joint space were measured in the dominant hand using a modified Sharp van der Heijde method and an ultrasound assessment. Hand strength was assessed with a dynamometer and disability was assessed using the Health Assessment Questionnaire (HAQ). The statistical analysis was performed using multiple linear regression models. FINDINGS: 76 patients were included with a mean age of 57 ±â€¯9.9 years, with 56.6% women. A statistically significant relationship was found between presence of erosions and reduction in lateral (p = 0.027) and tip (p = 0.030) pinch strength in the hand. This was also the case for loss of joint space and reduction in lateral (p = 0.012) and tip (p = 0.006) pinch strength. There was an association between total ultrasound (US) alterations and reduction in lateral pinch strength (p = 0.03). An association was also observed between erosions, loss of joint space and total US alterations and disability measured by the HAQ (p < 0.001; <0.001; 0.012, respectively). HAQ scores were associated with a decrease in mean lateral (p < 0.001) and tip (p < 0.001) pinch strength. INTERPRETATION: In patients with PsA involving the hands, structural alterations of the dominant hand assessed by conventional x-ray and ultrasound are associated with loss of strength measured objectively with dynamometry and greater disability also studied subjectively using the HAQ.

9.
Reumatol. clín. (Barc.) ; 15(3): 156-164, mayo-jun. 2019. tab
Artigo em Espanhol | IBECS | ID: ibc-184368

RESUMO

Objetivo: El paradigma actual en el tratamiento de la artritis reumatoide (AR) contempla el diagnóstico temprano y el uso precoz de fármacos modificadores de enfermedad (FAME) para alcanzar la remisión o baja actividad inflamatoria, lo cual, se conoce como «treat to target» (T2T). El objetivo del trabajo es desarrollar un indicador compuesto (IC) para evaluar la calidad asistencial en el manejo de los pacientes con AR atendiendo a la estrategia T2T y a otras recomendaciones generales para la atención de estos pacientes. Material y método: La construcción del IC siguió las fases: 1) selección de los criterios de calidad mediante un juicio de expertos; 2) priorización de los criterios, a partir de un Delphi con 20 expertos; 3) diseño de los indicadores de calidad, y 4) cálculo del IC ponderado. La fuente de información para el cálculo del IC son las historias clínicas de los pacientes con AR. Resultados: De los 37 criterios seleccionados, 12 necesitaron una segunda ronda Delphi. Se priorizaron 31 criterios, los cuales presentaron una mediana en relevancia y factibilidad, en las rondas Delphi, mayor o igual a 7,5, con un rango intercuartílico inferior a 3,5, y un grado de acuerdo (puntuación mayor o igual a 8) igual o superior al 80%. Conclusiones: El IC construido, consensuado y ponderado, permite evaluar la calidad asistencial de los pacientes con AR, en las Unidades de Reumatología de hospitales españoles, ofreciendo una medida resumen válida y fácilmente interpretable


Objective: The current guidelines in the treatment of rheumatoid arthritis (RA) include the early diagnosis and early use of disease modifying drugs to achieve remission or low disease activity level, known as "Treat to Target" (T2T). The objective of this study is to develop a composite indicator (CI) to evaluate the quality of care in the management of patients with RA, according to the T2T strategy and other general recommendations concerning the management of these patients. Material and method: The phases of the construction of the CI were: 1) selection of quality criteria through expert judgment; 2) prioritization of the criteria, according to relevance and feasibility, applying the Delphi methodology (two rounds) involving 20 experts; 3) design of quality indicators; and 4) calculation of the weighted CI, using the mean value in relevance and feasibility granted by the experts. The source of information for the calculation of the CI are the medical records of patients with RA. Results: Twelve criteria out of 37 required a second Delphi round. Thirty-one criteria were prioritized. These criteria presented a median in relevance and feasibility greater than or equal to 7.5, with an interquartile range of less than 3.5, and a level of agreement (score greater than or equal to 8) greater than or equal to 80%. Conclusions: The constructed CI allows us to evaluate the quality of care of patients with RA following the T2T strategy in the rheumatology units of Spanish hospitals, offering a valid and easily interpretable summary measure


Assuntos
Humanos , Artrite Reumatoide/epidemiologia , Unidades Hospitalares/organização & administração , Qualidade da Assistência à Saúde/organização & administração , Assistência à Saúde/tendências , Indicadores de Qualidade em Assistência à Saúde
10.
Reumatol Clin ; 2019 May 08.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31078453

RESUMO

INTRODUCTION: Systemic Lupus Erythematosus (SLE) is a multisystemic autoimmune disease that particularly affects young women during their second and third decades. Events attributed to SLE itself and others related to the disease may impact negatively on the quality of life, employment and disability. However, there are not many studies focused on the impact that the disease may have on patients regarding those aspects. In Spain, the evaluation of disability and the assignation of a pension is given by the National Social Security Institute of Spain, INSS ("Instituto Nacional de la Seguridad Social"). OBJECTIVE: To assess the relationship between cumulative damage regarding the affected organ and the percentage of disability recognised by the National Social Security Institute of Spain (INSS) in SLE patients. METHODS: Cross-sectional prospective study of SLE patients according to the SLICC-2012 criteria, from the Rheumatology Service of two Spanish hospitals. We collected clinical and demographic data through personal interview and the SLICC/ACR questionnaire, and classified patients regarding a recognised disability or not. RESULTS: 142 patients were evaluated; 30% had some percentage of official disability. We found a positive correlation between percentage of recognised disability and the SLICC/ACR index score. Musculoskeletal system is the most affected system, without differences between both groups; but we found a higher proportion of damage in nervous system, renal and vasculitis in patients with a recognised disability. CONCLUSION: There is a positive correlation between percentage of recognised disability in Spain and the cumulative damage in SLE.

11.
Clin Rheumatol ; 38(9): 2411-2421, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31028551

RESUMO

OBJECTIVE: To assess the long-term safety, tolerability, and effectiveness of tocilizumab (TCZ) as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in clinical practice in patients with moderate to severe rheumatoid arthritis (RA). METHODS: Patients in the 24-week, open-label ACT-SURE study who had at least a moderate EULAR response by week 24 and were from a participating country were eligible for this long-term extension (LTE); the patients continued to receive TCZ 8 mg/kg intravenously every 4 weeks as monotherapy or in combination with ≥ 1 csDMARD for up to an additional 108 weeks. The primary endpoint was the incidence of adverse events (AEs) and serious AEs (SAEs). Effectiveness endpoints included Disease Activity Score in 28 joints (DAS28) responses, American College of Rheumatology (ACR) responses, and patient-reported outcomes (PROs). RESULTS: Of the 1102 patients who completed the core 24-week study, 934 participated in the LTE; the median exposure to TCZ was 64.3 weeks. From baseline to the end of the LTE, AEs and SAEs occurred in 90% and 9% of patients, respectively. The overall event rates (95% CI) of AEs and SAEs were 406.5 per 100 patient-years (PY) (395.5, 417.8) and 8.8 per 100 PY (7.3, 10.6), respectively. Mean (SD) improvement in DAS28 was 4.12 (1.18), P < 0.0001. The DAS28 remission rates, ACR response rates, and PRO scores were maintained during the LTE study. CONCLUSION: In clinical practice, TCZ as monotherapy or in combination with csDMARDs was safe, well tolerated, and efficacious in patients with moderate to severe RA.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Glucocorticoides/uso terapêutico , /uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Humanizados/efeitos adversos , Antirreumáticos/efeitos adversos , Artrite Reumatoide/diagnóstico , Quimioterapia Combinada , Feminino , Glucocorticoides/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Resultado do Tratamento , Adulto Jovem
12.
Med Clin (Barc) ; 153(6): 225-231, 2019 09 27.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-30795903

RESUMO

BACKGROUND AND OBJECTIVE: to analyse the association between interferon-1α (INF1α), interleukin-10 (IL-10) and BLyS concentrations and clinical activity in systemic lupus erythematosus (SLE). PATIENTS AND METHODS: A cross-sectional, observational study of 142 SLE patients and 34 healthy controls was performed, through a complete blood and urine test and review of their medical history. Serum concentration of INF1α, IL-10 and BLyS was determined by colorimetric methods. A biostatistical analysis was performed with R (3.3.2.). RESULTS: 69% of our SLE patients showed at least one cytokine increased. INF1α, IL-10 and BLyS are higher in SLE patients than in healthy controls (P<.001, P=.005 and P=.043, respectively), being INF1α the most frequent. Patients were categorised according to low or high concentrations of the three cytokines. We found a significant association between increased IL-10/INF1α concentrations and a higher clinical activity measured by SELENA-SLEDAI (P<.0001) and, to a lesser extent, an association with increased INF1α/IL-10/BLyS concentrations. Elevated levels of IL-10/INF1α and INF1α/IL-10/BLyS related to increased C3-C4 consumption (P<.001 and P=.001 respectively) and anti-dsDNA titres (P=.001 and P=.002 respectively). Elevated INF1α/BLyS related to higher anti-dsDNA titres (P=.004) and ENA positivity (P<.001). Increased levels of INF1α/IL-10/BLyS related to positivity of ANAs (P<.001) and APL (P=.004). CONCLUSIONS: INF1α, IL-10 and BLyS are higher in SLE patients than in healthy controls. Increased IL-10 levels, regardless of whether or not there were also increased levels of BLyS and/or INF1α, was the cytokine that best fit with clinical activity in SLE measured with classic methods.

13.
Semin Arthritis Rheum ; 49(1): 126-135, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30655091

RESUMO

OBJECTIVE: Tocilizumab (TCZ) has shown efficacy in clinical trials on giant cell arteritis (GCA). Real-world data are scarce. Our objective was to assess efficacy and safety of TCZ in unselected patients with GCA in clinical practice Methods: Observational, open-label multicenter study from 40 national referral centers of GCA patients treated with TCZ due to inefficacy or adverse events of previous therapy. Outcomes variables were improvement of clinical features, acute phase reactants, glucocorticoid-sparing effect, prolonged remission and relapses. A comparative study was performed: (a) TCZ route (SC vs. IV); (b) GCA duration (≤6 vs. >6 months); (c) serious infections (with or without); (d) ≤15 vs. >15 mg/day at TCZ onset. RESULTS: 134 patients; mean age, 73.0 ± 8.8 years. TCZ was started after a median [IQR] time from GCA diagnosis of 13.5 [5.0-33.5] months. Ninety-eight (73.1%) patients had received immunosuppressive agents. After 1 month of TCZ 93.9% experienced clinical improvement. Reduction of CRP from 1.7 [0.4-3.2] to 0.11 [0.05-0.5] mg/dL (p < 0.0001), ESR from 33 [14.5-61] to 6 [2-12] mm/1st hour (p < 0.0001) and decrease in patients with anemia from 16.4% to 3.8% (p < 0.0001) were observed. Regardless of administration route or disease duration, clinical improvement leading to remission at 6, 12, 18, 24 months was observed in 55.5%, 70.4%, 69.2% and 90% of patients. Most relevant adverse side-effect was serious infections (10.6/100 patients-year), associated with higher doses of prednisone during the first three months of therapy. CONCLUSION: In clinical practice, TCZ yields a rapid and maintained improvement of refractory GCA. Serious infections appear to be higher than in clinical trials.

14.
Reumatol Clin ; 15(6): 338-342, 2019.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-29273497

RESUMO

OBJECTIVE: The AR Excellence project evaluates clinical monitoring in patients with rheumatoid arthritis (RA) in Spain. The aim of the study was to analyze the use of methotrexate (MTX) in the AR Excellence cohort and to compare it with current recommendations. PATIENTS AND METHODS: We collected data from RA patients who initiated treatment with MTX. They included demographics, dose and routes of administration, switching among them, highest dose in each route, combinations with other disease-modifying antirheumatic drugs (DMARDs), time to combination with another DMARD (either conventional or biological) and adverse events. RESULTS: Six hundred twenty-five patients with RA (mean age 55 years; 70.6% women) were included, with an average disease duration of 21 months. Ninety percent of the patients initiated treatment with MTX. Therapy was begun with a mean dose of 11mg per week; this initial dose was increased in 58% of the individuals. The average time to reach the full dose of MTX (20mg a week) was 6,67 months. Time to combination of MTX with another DMARD, either synthetic or biological, was 3 months. In all, 67.4% of the patients received oral MTX and the route was subcutaneous in 18.6%. In 12% of the cases, there was a change in the route of administration after a period of 6 months. In 544 patients, folate supplements were added to MTX; MTX-related adverse events were detected in 17.3% of the patients. CONCLUSION: MTX is currently the pivotal treatment in RA. The subanalysis of the AR Excellence project demonstrates that MTX escalation to its full doses is not done with adequate speed. The subcutaneous route is used in a small proportion of patients.

15.
Anal Bioanal Chem ; 411(19): 4709-4720, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30317445

RESUMO

The mechanism of self-recognition of the autoantigen TROVE2, a common biomarker in autoimmune diseases, has been studied with a quartz crystal microbalance with dissipation monitoring (QCM-D) and dual polarization interferometry (DPI). The complementarity and remarkable analytical features of both techniques has allowed new insights into the onset of systemic lupus erythematosus (SLE) to be achieved at the molecular level. The in vitro study for SLE patients and healthy subjects suggests that anti-TROVE2 autoantibodies may undergo an antibody bipolar bridging. An epitope-paratope-specific binding initially occurs to activate a hidden Fc receptor in the TROVE2 tertiary structure. This bipolar mechanism may contribute to the pathogenic accumulation of anti-TROVE2 autoantibody immune complex in autoimmune disease. Furthermore, the specific calcium-dependent protein-protein bridges point out at how the TRIM21/TROVE2 association might occur, suggesting that the TROVE2 protein could stimulate the intracellular immune signaling via the TRIM21 PRY-SPRY domain. These findings may help to better understand the origins of the specificity and affinity of TROVE2 interactions, which might play a key role in the SLE pathogenesis. This manuscript gives one of the first practical applications of two novel functions (-df/dD and Δh/molec) for the analysis of the data provided by QCM-D and DPI. In addition, it is the first time that QCM-D has been used for mapping hidden Fc receptors as well as linear epitopes in a protein tertiary structure. Graphical abstract ᅟ.


Assuntos
Autoantígenos/fisiologia , Interferometria/métodos , Lúpus Eritematoso Sistêmico/imunologia , Técnicas de Microbalança de Cristal de Quartzo , RNA Citoplasmático Pequeno/fisiologia , Ribonucleoproteínas/fisiologia , Autoanticorpos/imunologia , Autoantígenos/química , Autoantígenos/imunologia , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Conformação Proteica , RNA Citoplasmático Pequeno/química , RNA Citoplasmático Pequeno/imunologia , Ribonucleoproteínas/química , Ribonucleoproteínas/imunologia
16.
Clin Exp Rheumatol ; 37(3): 437-444, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30299241

RESUMO

OBJECTIVES: The aim of the JUST-ACT study was to assess whether the add-on effect of tocilizumab (TCZ) to background methotrexate (MTX) observed in MTX-inadequate responders with active rheumatoid arthritis (RA), would be sustained when MTX is withdrawn. METHODS: A double-blind, parallel-group, phase 3 study in biologic-naïve RA patients with a disease activity score 28 (DAS28)>3.2 despite MTX which were treated with TCZ+MTX for an initial 16-week period. Patients who at week 16 achieved low disease activity (LDA) (DAS28≤3.2) were randomised to continue with TCZ+MTX or switch to TCZ + placebo (PBO) for an additional 12 weeks. The primary endpoint was the change in DAS28-ESR from the randomisation at week 16 to week 28. Non-inferiority was confirmed if the upper limit of the two-sided 95%CI for the treatment difference between TCZ+MTX and TCZ monotherapy groups was lower than the selected non-inferiority margin of 0.6. RESULTS: 261 patients completed the first 16 weeks of TCZ+MTX treatment and 165 were randomised (83 to TCZ+MTX and 82 to TCZ+PBO). For the primary endpoint, the adjusted treatment difference (95% CI) in mean change of DAS28-ESR was -0.06 (-0.40 to 0.27), and therefore the non-inferiority of switching to TCZ monotherapy versus continuing with TCZ+MTX was demonstrated. In both treatment groups, the percentage of patients in clinical remission from 16 to 28 weeks was similar as were the improvements in disease activity, functional disability and quality of life. CONCLUSIONS: In MTX non-responder patients achieving LDA with TCZ+MTX, switching to TCZ monotherapy is non-inferior to continuing the combination.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos , Artrite Reumatoide , Metotrexato/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Resultado do Tratamento
17.
Reumatol Clin ; 15(3): 156-164, 2019.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-28789978

RESUMO

OBJECTIVE: The current guidelines in the treatment of rheumatoid arthritis (RA) include the early diagnosis and early use of disease modifying drugs to achieve remission or low disease activity level, known as "Treat to Target" (T2T). The objective of this study is to develop a composite indicator (CI) to evaluate the quality of care in the management of patients with RA, according to the T2T strategy and other general recommendations concerning the management of these patients. MATERIAL AND METHOD: The phases of the construction of the CI were: 1) selection of quality criteria through expert judgment; 2) prioritization of the criteria, according to relevance and feasibility, applying the Delphi methodology (two rounds) involving 20 experts; 3) design of quality indicators; and 4) calculation of the weighted CI, using the mean value in relevance and feasibility granted by the experts. The source of information for the calculation of the CI are the medical records of patients with RA. RESULTS: Twelve criteria out of 37 required a second Delphi round. Thirty-one criteria were prioritized. These criteria presented a median in relevance and feasibility greater than or equal to 7.5, with an interquartile range of less than 3.5, and a level of agreement (score greater than or equal to 8) greater than or equal to 80%. CONCLUSIONS: The constructed CI allows us to evaluate the quality of care of patients with RA following the T2T strategy in the rheumatology units of Spanish hospitals, offering a valid and easily interpretable summary measure.


Assuntos
Artrite Reumatoide/terapia , Ambulatório Hospitalar , Indicadores de Qualidade em Assistência à Saúde , Qualidade da Assistência à Saúde , Antirreumáticos/uso terapêutico , Técnica Delfos , Prova Pericial , Humanos , Registros Médicos , Espanha
18.
Reumatol Clin ; 2018 Aug 08.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-30098882

RESUMO

OBJECTIVE: To draft recommendations on interleukin 6 (IL-6) blockade in rheumatoid arthritis (RA), based on best evidence and experience. METHODS: A group of 10 experts on IL-6 blockade in RA was selected. The 2 coordinators formulated 23 questions about IL-6 blockade (indications, efficacy, safety, etc.). A systematic review was conducted to answer the questions. Using this information, inclusion and exclusion criteria were established, as were the search strategies (Medline, EMBASE and the Cochrane Library were searched). Two different reviewers selected the articles. Evidence tables were created. At the same time, European League Against Rheumatism and American College of Rheumatology abstracts were evaluated. Based on this evidence, the coordinators proposed preliminary recommendations that the experts discussed and voted on in a nominal group meeting. The level of evidence and grade of recommendation were established using the Oxford Centre for Evidence Based Medicine and the level of agreement with the Delphi technique (2 rounds). Agreement was established if at least 80% of the experts voted yes (yes/no). RESULTS: The 8 preliminary recommendations were accepted after the Delphi process. They covered aspects such as the use of these therapies in monotherapy, in combination, in patients with refractory disease or intolerant patients, response evaluation, optimization and risk management. CONCLUSIONS: The manuscript aims to solve frequently asked questions and aid in decision making strategies when treating RA patients with IL-6 blockade.

20.
Reumatol. clín. (Barc.) ; 14(3): 142-149, mayo-jun. 2018. tab
Artigo em Espanhol | IBECS | ID: ibc-174098

RESUMO

Objetivos. Desarrollar recomendaciones sobre el uso de metrotexato (MTX) parenteral en pacientes con enfermedades reumáticas, fundamentalmente en la artritis reumatoide, basadas en la mejor evidencia y experiencia. Métodos. Se seleccionó un grupo de 21 expertos reumatólogos en el manejo de MTX. El coordinador generó 13 preguntas sobre el uso de MTX parenteral (perfiles de indicación, eficacia, seguridad, costo-eficacia y biodisponibilidad) para ser contestadas mediante una revisión sistemática de la literatura. Con base en las preguntas se definieron los criterios de inclusión y exclusión, y las estrategias de búsqueda (en Medline, EMBASE y la Cochrane Library). Tres revisores seleccionaron los artículos resultantes de la búsqueda. Se generaron tablas de evidencia. Paralelamente se evaluaron abstracts de congresos de la European League Against Rheumatism (EULAR) y del American College of Rheumatology (ACR). Con toda esta evidencia el coordinador generó 13 recomendaciones preliminares que se evaluaron, discutieron y votaron en una reunión del grupo nominal con los expertos. Para cada recomendación se estableció el nivel de evidencia y grado de recomendación, y el grado de acuerdo mediante un Delphi. Se definió acuerdo si al menos el 80% de los participantes contestaron sí a la recomendación (sí o no). Resultados. La mayoría de la evidencia proviene de la artritis reumatoide. De las 13 recomendaciones preliminares se aceptaron 11 recomendaciones sobre el uso de MTX parenteral en reumatología. Dos no se llegaron a votar y se decidió no incluirlas, pero se comentan en el texto final. Conclusiones. Este documento pretende resolver algunos interrogantes clínicos habituales y facilitar la toma de decisiones con el uso de MTX parenteral


Objective. To develop recommendations for the use of parenteral methotrexate (MTX) in rheumatic diseases, mainly rheumatoid arthritis, based on best evidence and experience. Methods. A group of 21 experts on parenteral MTX use was selected. The coordinator formulated 13 questions about parenteral MTX (indications, efficacy, safety and cost-effectiveness). A systematic review was conducted to answer the questions. Using this information, inclusion and exclusion criteria were established, as were the search strategies (involving Medline, EMBASE and the Cochrane Library). Three different reviewers selected the articles. Evidence tables were created. Abstracts from the European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) were evaluated. Based on this evidence, the coordinator proposed preliminary recommendations that the experts discussed and voted in a nominal group meeting. The level of evidence and grade of recommendation were established using the Oxford Center for Evidence-Based Medicine and the level of agreement with the Delphi technique (2 rounds). Agreement was established if at least 80% of the experts voted yes (yes/no). Results. Most of the evidence involved rheumatoid arthritis. A total of 13 preliminary recommendations on the use of parenteral MTX were proposed; 11 of them were accepted. Two of the 13 were not voted and are commented on in the main text. Conclusions. The manuscript aims to solve frequent questions and help in decision-making strategies when treating patients with parenteral MTX


Assuntos
Humanos , Doenças Reumáticas/tratamento farmacológico , Artrite Reumatoide/tratamento farmacológico , Metotrexato/uso terapêutico , Resultado do Tratamento , Consenso , Conferências de Consenso como Assunto , Infusões Parenterais , Técnica Delfos , Adesão à Medicação , Automedicação/normas
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