RESUMEN
OBJECTIVE: To assess organ damage, with emphasis on the cardiovascular system, over the different stages of the disease in a large SLE cohort. METHODS: Multicentre, longitudinal study of a cohort of 4219 patients with SLE enrolled in the Spanish Society of Rheumatology Lupus Registry. Organ damage was ascertained using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). We longitudinally analysed SDI (globally and for each domain) over time only in the 1274 patients whose dates of damage events had been recorded. RESULTS: During the first year after diagnosis of SLE, 20% of the 1274 patients presented with new damage manifestations. At years 2 and 3, new damage was recorded in 11% and 9% of patients. The annual percentage of patients with new damage after year 5 decreased to 5%. In the first year with the disease, most damage was accumulated in the musculoskeletal, neuropsychiatric and renal systems; in later stages, most damage was in the musculoskeletal, ocular and cardiovascular systems. Considering 'cerebrovascular accident' and 'claudication for 6 months' as cardiovascular items, the cardiovascular system was the second most affected system during the early stages of SLE, with 19% of the patients who presented with damage affected at first year after diagnosis. During the late stages, 20-25% of the patients presenting with new damage did so in this modified cardiovascular domain of the SDI. CONCLUSIONS: New damage occurs mainly during the first year following diagnosis of SLE. Cardiovascular damage is relevant in both the early and the late stages of the disease. Strategies to prevent cardiovascular damage should be implemented early after diagnosis of SLE.
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Sistema Cardiovascular , Lupus Eritematoso Sistémico , Sistema de Registros , Humanos , Lupus Eritematoso Sistémico/complicaciones , Lupus Eritematoso Sistémico/epidemiología , Estudios Longitudinales , Masculino , Femenino , Adulto , España/epidemiología , Persona de Mediana Edad , Sistema Cardiovascular/fisiopatología , Enfermedades Cardiovasculares/epidemiología , Índice de Severidad de la Enfermedad , Progresión de la Enfermedad , ReumatologíaRESUMEN
OBJECTIVE: The persistence of biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs(DMARDs) in monotherapy versus in combination with conventional synthetic (cs) DMARDs is still a controversial topic in rheumatic diseases. To clarify this issue, the retention of the initial treatment strategy of b/tsDMARD in combination with csDMARD versus monotherapy in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients under real-life conditions was evaluated. Factors associated with maintenance of the initial strategy were analysed. METHODS: Nested cohort study within the Spanish BIOBADASER III registry. Bivariate comparisons and multivariate Cox proportional hazards models were used for the analyses. RESULTS: A total of 2521 patients were included in the study. In the multivariate model, the initial strategy of combination therapy was associated with shorter persistence in patients with RA (hazard ratio [HR] 1.58;95% confidence interval [CI] 1.00-2.50; p = .049), PsA (HR 2.48; 95% CI 1.65-3.72) and AS (HR 16.77; 95% CI 7.37-38.16; p < .001), regardless of sex, time of disease progression, baseline disease activity, glucocorticoid use or type of b/tsDMARD. Overall, the combination strategy was associated with an increased incidence of adverse events (incidence rate ratio [IRR] 1.13; 95% CI 1.05-1.21). CONCLUSIONS: In this real-life study, the strategy of combining a b/tsDMARD with a csDMARD is associated with lower persistence and worse safety profile compared to monotherapy in RA and especially in PsA and AS, suggesting that combination therapy should be rethought as first choice in RA patients, but especially in PsA and AS patients.
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Antirreumáticos , Artritis Psoriásica , Artritis Reumatoide , Espondilitis Anquilosante , Humanos , Artritis Psoriásica/tratamiento farmacológico , Estudios de Cohortes , Artritis Reumatoide/tratamiento farmacológico , Antirreumáticos/uso terapéutico , Espondilitis Anquilosante/tratamiento farmacológico , Quimioterapia CombinadaRESUMEN
AIM: To assess the golimumab retention rate during up to 8 years of follow up, and any associated factors. METHODS: Retrospective analysis of the BIOBADASER (Spanish registry of biological drugs) database, assessing all adults who had ever started golimumab >6 months before the analysis for an approved indication (rheumatoid arthritis [RA], axial spondyloarthritis [SpA] or psoriatic arthritis [PsA]). RESULTS: Among 885 patients (RA 267, axial SpA 370, PsA 248) receiving 944 cycles of golimumab, the retention rate of golimumab was 71.1% (95% confidence interval: 68.0-73.9) at year 1% and 37.7% (95% CI: 33.3-42.1) at year 7 and at year 8. Retention was higher when golimumab was used as the first biological drug (81.7% at year 1, 49.9% at year 7, p < 0.001). In Cox regression analysis, factors associated with golimumab retention included use as first-line therapy (hazard ratio [HR] for discontinuation 1.52 for second- and 1.79 for third/later-line vs. first-line), use in axial SpA or PsA rather than RA (HR for axial SpA vs. RA 0.59, for PsA vs. Rheumatoid arthritis 0.67), and treatment with concomitant methotrexate (HR 0.67). Factors associated with golimumab discontinuation were corticosteroid use (HR 1.46) and disease activity above median (HR 1.29) at golimumab initiation. CONCLUSION: Based on this retrospective analysis of the BIOBADASER registry, nearly two-fifths (37.7%) of adult rheumatology patients initiating golimumab will remain on treatment for 8 years, with a higher probability of retention in axial SpA or PsA indications and when golimumab is used as first biologic.
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Antirreumáticos , Artritis Psoriásica , Artritis Reumatoide , Espondiloartritis Axial , Espondiloartritis , Adulto , Humanos , Artritis Psoriásica/tratamiento farmacológico , Estudios Retrospectivos , Artritis Reumatoide/tratamiento farmacológico , Antirreumáticos/uso terapéutico , Resultado del TratamientoRESUMEN
OBJECTIVES: To analyse the effect of targeted therapies, either biological (b) disease-modifying antirheumatic drugs (DMARDs), targeted synthetic (ts) DMARDs and other factors (demographics, comorbidities or COVID-19 symptoms) on the risk of COVID-19 related hospitalisation in patients with inflammatory rheumatic diseases. METHODS: The COVIDSER study is an observational cohort including 7782 patients with inflammatory rheumatic diseases. Multivariable logistic regression was used to estimate ORs and 95% CIs of hospitalisation. Antirheumatic medication taken immediately prior to infection, demographic characteristics, rheumatic disease diagnosis, comorbidities and COVID-19 symptoms were analysed. RESULTS: A total of 426 cases of symptomatic COVID-19 from 1 March 2020 to 13 April 2021 were included in the analyses: 106 (24.9%) were hospitalised and 19 (4.4%) died. In multivariate-adjusted models, bDMARDs and tsDMARDs in combination were not associated with hospitalisation compared with conventional synthetic DMARDs (OR 0.55, 95% CI 0.24 to 1.25 of b/tsDMARDs, p=0.15). Tumour necrosis factor inhibitors (TNF-i) were associated with a reduced likelihood of hospitalisation (OR 0.32, 95% CI 0.12 to 0.82, p=0.018), whereas rituximab showed a tendency to an increased risk of hospitalisation (OR 4.85, 95% CI 0.86 to 27.2). Glucocorticoid use was not associated with hospitalisation (OR 1.69, 95% CI 0.81 to 3.55). A mix of sociodemographic factors, comorbidities and COVID-19 symptoms contribute to patients' hospitalisation. CONCLUSIONS: The use of targeted therapies as a group is not associated with COVID-19 severity, except for rituximab, which shows a trend towards an increased risk of hospitalisation, while TNF-i was associated with decreased odds of hospitalisation in patients with rheumatic disease. Other factors like age, male gender, comorbidities and COVID-19 symptoms do play a role.
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Antirreumáticos , COVID-19 , Enfermedades Reumáticas , Antirreumáticos/efectos adversos , Humanos , Masculino , Enfermedades Reumáticas/tratamiento farmacológico , Enfermedades Reumáticas/epidemiología , SARS-CoV-2 , Factores SociodemográficosRESUMEN
ABSTRACT: This observational, longitudinal retrospective, noncomparative study was designed to assess the persistence and effectiveness of golimumab as a second anti-tumor necrosis factor (TNF) drug in patients with spondyloarthritis requiring discontinuation from a first anti-TNF drug.Data were collected retrospectively for all patients with axial spondyloarthritis or psoriatic arthritis from 20 rheumatology clinics in Spain who started golimumab as a second anti-TNF drug between January 2013 and December 2015. Golimumab persistence was assessed with Kaplan-Meier survival analysis, and associated factors were assessed with Cox regression analysis.210 patients started golimumab as a second anti-TNF drug: 131 with axial spondyloarthritis and 79 with psoriatic arthritis. In axial spondyloarthritis patients, the mean (standard deviation) Bath Ankylosing Spondylitis Disease Activity Index score at baseline was 5.5 (2.1), decreasing to 3.9 (2.0) at month 3 and 3.5 (2.0) at year 1, and remaining stable thereafter. In psoriatic arthritis patients, mean (standard deviation) baseline Disease Activity Score was 4.0 (1.3), reducing to 2.5 (1.2) at month 3 and to 2.2 (1.3) at year 1. Corresponding improvements were recorded from baseline in C-reactive protein levels and erythrocyte sedimentation rates. The probability of persistence of treatment with golimumab was 80% at year 1, 70% at year 2 and 65% at years 3 and year 4, and was similar in those who had stopped the first anti-TNF due to loss of efficacy or other reasons. Cox regression analysis showed that the probability of survival with golimumab was higher in patients with higher erythrocyte sedimentation rate, in patients with axial spondyloarthritis than with psoriatic arthritis, and in those who had discontinued adalimumab as first anti-TNF. Seventy-two patients (34.3%) discontinued golimumab during follow-up, 50 of them due to lack of efficacy.In patients with spondyloarthritis requiring discontinuation from a first anti-TNF drug, treatment with golimumab was effective and showed a high probability of persistence up to 4âyears of treatment.
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Anticuerpos Monoclonales/uso terapéutico , Antirreumáticos/uso terapéutico , Productos Biológicos/uso terapéutico , Espondiloartritis/tratamiento farmacológico , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Adulto , Anciano , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoAsunto(s)
Antirreumáticos/uso terapéutico , Infecciones por Coronavirus/mortalidad , Neumonía Viral/mortalidad , Enfermedades Reumáticas/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/uso terapéutico , Artritis Reumatoide/complicaciones , Artritis Reumatoide/tratamiento farmacológico , Betacoronavirus , COVID-19 , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/fisiopatología , Femenino , Glucocorticoides/uso terapéutico , Hospitalización/estadística & datos numéricos , Humanos , Hidroxicloroquina/uso terapéutico , Unidades de Cuidados Intensivos , Proteína Antagonista del Receptor de Interleucina 1/uso terapéutico , Inhibidores de las Cinasas Janus/uso terapéutico , Masculino , Metotrexato/uso terapéutico , Persona de Mediana Edad , Pandemias , Neumonía Viral/complicaciones , Neumonía Viral/fisiopatología , Enfermedades Reumáticas/complicaciones , Rituximab/uso terapéutico , SARS-CoV-2 , España , Espondiloartropatías/complicaciones , Espondiloartropatías/tratamiento farmacológico , Inhibidores del Factor de Necrosis Tumoral/uso terapéuticoRESUMEN
Objetivo: Describir los objetivos, la metodología y los resultados del primer año de la nueva versión del registro español de acontecimientos adversos de terapias biológicas y fármacos sintéticos con diana identificable en enfermedades reumáticas (BIOBADASER III). Metodología: Registro prospectivo multicéntrico de pacientes con enfermedades inflamatorias reumáticas en tratamiento con terapia biológica o fármacos sintéticos con diana identificable y atendidos en servicios de Reumatología en España. El objetivo principal de BIOBADASER Fase III es la recogida y análisis de acontecimientos adversos al que se ha añadido como objetivo secundario la evaluación de la efectividad mediante la recogida de índices de actividad. Los pacientes que entran en el registro son evaluados al menos una vez cada año y cada vez que presenten un acontecimiento adverso o se produzcan modificaciones en el tratamiento. La recogida de datos de la fase iii se inició el 17 de diciembre del 2015. Resultados: Durante el primer año han participado 35 centros. El número de pacientes incluidos en esta nueva fase en diciembre del 2016 era de 2.664. La edad media era de 53,7 años, con una mediana de duración de la enfermedad hasta el inicio de tratamiento de 8,1 años. Un 40,4% de los pacientes estaban diagnosticados de artritis reumatoide. Los acontecimientos adversos más frecuentes eran las infecciones e infestaciones. Conclusiones: La fase iii de BIOBADASER se ha puesto en marcha para responder a un entorno farmacológico cambiante con la aparición de los biosimilares y las pequeñas moléculas en el tratamiento de la patología reumática. Esta nueva etapa se adapta a los cambios normativos en la comunicación de acontecimientos adversos y amplía la información recogida incluyendo los índices de actividad
Objective: Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III). Methodology: Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER Phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase iii began on 17 December 2015. Results: During the first year, 35 centers participated. The number of patients included in this new phase in December 2016 was 2,664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations. Conclusions: BIOBADASER Phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores
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Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Sistemas de Registro de Reacción Adversa a Medicamentos/organización & administración , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Terapia Biológica/efectos adversos , Enfermedades Reumáticas/tratamiento farmacológico , Antirreumáticos/efectos adversos , Anticuerpos Monoclonales Humanizados/efectos adversos , Drogas Sintéticas/efectos adversosRESUMEN
OBJECTIVE: Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III). METHODOLOGY: Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER Phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase iii began on 17 December 2015. RESULTS: During the first year, 35 centers participated. The number of patients included in this new phase in December 2016 was 2,664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations. CONCLUSIONS: BIOBADASER Phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores.
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Antirreumáticos/efectos adversos , Productos Biológicos/efectos adversos , Biosimilares Farmacéuticos/efectos adversos , Vigilancia de Productos Comercializados/métodos , Sistema de Registros , Enfermedades Reumáticas/tratamiento farmacológico , Adulto , Anciano , Antirreumáticos/uso terapéutico , Productos Biológicos/uso terapéutico , Biosimilares Farmacéuticos/uso terapéutico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
The retention rate of a biological drug (percentage of patients remaining on treatment over time) provides an index of a drug's overall effectiveness. The golimumab retention rate as first-line biological therapy was high in clinical trial extensions lasting 5 years. Real-world studies also indicate good retention rates but have been of shorter duration. The probability of retention with golimumab treatment was assessed, as any line of anti-tumor necrosis factor-alpha therapy, for up to 5 years in patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA) or psoriatic arthritis (PsA), associated factors were analyzed. A retrospective database analysis of the Spanish registry of patients with rheumatic disorders receiving biological drugs (BIOBADASER) was performed. Among 353 patients, 29.8% had RA, 41.6% SpA and 28.6% PsA. Golimumab was the first biological drug in 40.1% of patients, second in 30.1% and third/later in 29.8%. The overall probability of retention of golimumab at years 1, 2, 3, 4 and 5 was 85.9% (95% confidence interval 81.4-89.5%), 73.7% (67.1-79.1%), 68.5% (60.5-75.1%), 60.6% (50.2-69.5%) and 57.1% (44.9-67.5%), respectively. Retention was similar across indications (p = 0.070) but was greater when golimumab was used as the first biological agent compared with later therapy lines (p < 0.001). Factors associated with higher retention of golimumab treatment (Cox regression) were use as a first-line biological and concomitant methotrexate treatment; corticosteroid need was associated with lower retention. The long-term probability of golimumab retention was high in this real-world study of patients with rheumatic diseases, especially when used as the first biological drug.
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Anticuerpos Monoclonales/uso terapéutico , Artritis Psoriásica/tratamiento farmacológico , Artritis Reumatoide/tratamiento farmacológico , Cumplimiento de la Medicación/estadística & datos numéricos , Espondiloartropatías/tratamiento farmacológico , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Corticoesteroides/uso terapéutico , Adulto , Antirreumáticos/uso terapéutico , Quimioterapia Combinada , Femenino , Humanos , Masculino , Metotrexato/uso terapéutico , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Sistema de Registros , Estudios Retrospectivos , EspañaRESUMEN
BACKGROUND: Raspberry and strawberry are high value-added food products that can contribute to human health due to the abundance of polyphenols that they contain. Polyphenols are secondary metabolites and therefore devoted to improve plant adaptation, these polyphenol profile can be induced applying different stimuli, such as certain bacteria. The aim of this study was twofold: (i) to evaluate the ability of two bacterial strains to modulate secondary metabolisms in strawberry and raspberry, and (ii) to explore the ability of plant extracts to modify enzyme activities related to metabolic syndrome. RESULTS: Total phenolic and anthocyanin content was higher in strawberries than in raspberries, despite similar antioxidant capacities. Strawberry extracts performed better on the tested enzymes, except on α-glucosidase inhibition capacity. Bacillus amyloliquefaciens stabilized the effects of extracts at different points in time, and Pseudomonas fluorescens modified plant metabolism after more inoculations (spring) in both species, improving the effects of raspberry extracts on α-glucosidase, COX1, and COX2, and of strawberry on α-amylase and COX1. CONCLUSION: It is good to include these two fruits in the diet because they improve the activity of metabolic syndrome-related enzymes. Applying either strain during plant growth modifies the bioactive profile of the plants, improving the effects of the fruit extracts on human health. © 2018 Society of Chemical Industry.
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Fragaria/metabolismo , Frutas/microbiología , Síndrome Metabólico/enzimología , Extractos Vegetales/química , Rubus/metabolismo , Antocianinas/química , Antocianinas/metabolismo , Bacillus amyloliquefaciens/metabolismo , Ciclooxigenasa 1/química , Ciclooxigenasa 1/metabolismo , Ciclooxigenasa 2/química , Ciclooxigenasa 2/metabolismo , Inhibidores Enzimáticos/química , Inhibidores Enzimáticos/metabolismo , Fragaria/microbiología , Frutas/química , Frutas/metabolismo , Humanos , Síndrome Metabólico/dietoterapia , Fenoles/química , Fenoles/metabolismo , Extractos Vegetales/metabolismo , Pseudomonas fluorescens/metabolismo , Rubus/química , Rubus/microbiología , alfa-Amilasas/genética , alfa-Amilasas/metabolismo , alfa-Glucosidasas/química , alfa-Glucosidasas/metabolismoRESUMEN
PURPOSE: To assess efficacy, safety, and cost-effectiveness of adalimumab (ADA) therapy optimization in a large series of patients with uveitis due to Behçet disease (BD) who achieved remission after the use of this biologic agent. DESIGN: Open-label multicenter study of ADA-treated patients with BD uveitis refractory to conventional immunosuppressants. SUBJECTS: Sixty-five of 74 patients with uveitis due to BD, who achieved remission after a median ADA duration of 6 (range, 3-12) months. ADA was optimized in 23 (35.4%) of them. This biologic agent was maintained at a dose of 40 mg/subcutaneously/2 weeks in the remaining 42 patients. METHODS: After remission, based on a shared decision between the patient and the treating physician, ADA was optimized. When agreement between patient and physician was reached, optimization was performed by prolonging the ADA dosing interval progressively. Comparison between optimized and nonoptimized patients was performed. MAIN OUTCOME MEASURES: Efficacy, safety, and cost-effectiveness in optimized and nonoptimized groups. To determine efficacy, intraocular inflammation (anterior chamber cells, vitritis, and retinal vasculitis), macular thickness, visual acuity, and the sparing effect of glucocorticoids were assessed. RESULTS: No demographic or ocular differences were found at the time of ADA onset between the optimized and the nonoptimized groups. Most ocular outcomes were similar after a mean ± standard deviation follow-up of 34.7±13.3 and 26±21.3 months in the optimized and nonoptimized groups, respectively. However, relevant adverse effects were only seen in the nonoptimized group (lymphoma, pneumonia, severe local reaction at the injection site, and bacteremia by Escherichia coli, 1 each). Moreover, the mean ADA treatment costs were lower in the optimized group than in the nonoptimized group (6101.25 euros/patient/year vs. 12 339.48; P < 0.01). CONCLUSION: ADA optimization in BD uveitis refractory to conventional therapy is effective, safe, and cost-effective.
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Adalimumab/administración & dosificación , Síndrome de Behçet/complicaciones , Uveítis/tratamiento farmacológico , Agudeza Visual , Adulto , Antiinflamatorios/administración & dosificación , Síndrome de Behçet/tratamiento farmacológico , Relación Dosis-Respuesta a Droga , Femenino , Angiografía con Fluoresceína , Fondo de Ojo , Humanos , Inmunosupresores/uso terapéutico , Masculino , Estudios Retrospectivos , Tomografía de Coherencia Óptica , Resultado del Tratamiento , Uveítis/diagnóstico , Uveítis/etiologíaRESUMEN
OBJECTIVE: To estimate the unit costs of administering intravenous (IV) biological agents in day hospitals (DHs) in the Spanish National Health System. PATIENTS AND METHODS: Data were obtained from 188 patients with rheumatoid arthritis, collected from nine DHs, receiving one of the following IV therapies: infliximab (n=48), rituximab (n=38), abatacept (n=41), or tocilizumab (n=61). The fieldwork was carried out between March 2013 and March 2014. The following three groups of costs were considered: 1) structural costs, 2) material costs, and 3) staff costs. Staff costs were considered a fixed cost and were estimated according to the DH theoretical level of activity, which includes, as well as personal care of each patient, the DH general activities (complete imputation method, CIM). In addition, an alternative calculation was performed, in which the staff costs were considered a variable cost imputed according to the time spent on direct care (partial imputation method, PIM). All costs were expressed in euros for the reference year 2014. RESULTS: The average total cost was 146.12 per infusion (standard deviation [SD] ±87.11; CIM) and 29.70 per infusion (SD ±11.42; PIM). The structure-related costs per infusion varied between 2.23 and 62.35 per patient and DH; the cost of consumables oscillated between 3.48 and 20.34 per patient and DH. In terms of the care process, the average difference between the shortest and the longest time taken by different hospitals to administer an IV biological therapy was 113 minutes. CONCLUSION: The average total cost of infusion was less than that normally used in models of economic evaluation coming from secondary sources. This cost is even less when the staff costs are imputed according to the PIM. A high degree of variability was observed between different DHs in the cost of the consumables, in the structure-related costs, and in those of the care process.
RESUMEN
The aim of the study was to profile those patients included in the RELESSER registry with histologically proven renal involvement in order to better understand the current state of lupus nephritis (LN) in Spain. RELESSER-TRANS is a multicenter cross-sectional registry with an analytical component. Information was collected from the medical records of patients with systemic lupus erythematosus who were followed at participating rheumatology units. A total of 359 variables including demographic data, clinical manifestations, disease activity, severity, comorbidities, LN outcome, treatments, and mortality were recorded. Only patients with a histological confirmation of LN were included. We performed a descriptive analysis, chi-square or Student's t tests according to the type of variable and its relationship with LN. Odds ratio and confidence intervals were calculated by using simple logistic regression. LN was histologically confirmed in 1092/3575 patients (30.5%). Most patients were female (85.7%), Caucasian (90.2%), and the mean age at LN diagnosis was 28.4â±â12.7 years. The risk for LN development was higher in men (M/F:47.85/30.91%, Pâ<â0.001), in younger individuals (Pâ<â0.001), and in Hispanics (Pâ=â0.03). Complete response to treatment was achieved in 68.3% of patients; 10.35% developed ESRD, which required a kidney transplant in 45% of such cases. The older the patient, the greater was the likelihood of complete response (Pâ<â0.001). Recurrences were associated with persistent lupus activity at the time of the last visit (Pâ<â0.001) and with ESRD (Pâ<â0.001). Thrombotic microangiopathy was a risk factor for ESRD (Pâ=â0.04), as for the necessity of dialysis (Pâ=â0.01) or renal transplantation (Pâ=â0.03). LN itself was a poor prognostic risk factor of mortality (OR 2.4 [1.81-3.22], Pâ<â0.001). Patients receiving antimalarials had a significantly lower risk of developing LN (Pâ<â0.001) and ESRD (Pâ<â0.001), and responded better to specific treatments for LN (Pâ=â0.014). More than two-thirds of the patients with LN from a wide European cohort achieved a complete response to treatment. The presence of positive anti-Sm antibodies was associated with a higher frequency of LN and a decreased rate of complete response to treatment. The use of antimalarials reduced both the risk of developing renal disease and its severity, and contributed to attaining a complete renal response.
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Nefritis Lúpica/epidemiología , Sistema de Registros , Adolescente , Adulto , Femenino , Humanos , Nefritis Lúpica/terapia , Masculino , Recurrencia , Estudios Retrospectivos , Reumatología , España/epidemiología , Adulto JovenRESUMEN
Blackberry (Rubus sp.) fruit has a high content of anthocyanins, but its health benefits have not been sufficiently explored in healthy individuals. Thus, the aim of the study was to determine the effects of blackberry extract on lipid and glucose variables in female and male rats. Sprague Dawley rats were given a standard pellet (SD) or cafeteria (CD) diet supplemented (SD+R and CD+R) or not with Rubus extract for 80 days. Female rats given SD+R had lower body and liver weights than SD females; both sexes given SD+R showed lower plasma glucose and insulin, higher plasma NEFA, glycerol and 3-hydroxybutyrate, and higher liver concentration of triacylglycerols than SD rats. The homeostasis model of insulin resistance (HOMA) was lower in SD+R rats than in SD rats, but higher in CD rats. No effects of Rubus extract were observed in CD rats. In conclusion, Rubus extract, in rats given SD, decreased glycemia and increased insulin sensitivity. It also increased lipid breakdown in adipose tissue. The effects were greater in females than in males. No effect was seen in rats given CD, probably as a result of their high insulin resistance.
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Suplementos Dietéticos , Resistencia a la Insulina , Extractos Vegetales/administración & dosificación , Rubus/química , Animales , Glucemia/metabolismo , Colesterol/sangre , Dieta/veterinaria , Femenino , Insulina/sangre , Masculino , Ratas , Ratas Sprague-Dawley , Triglicéridos/sangreRESUMEN
OBJECTIVE: The aim of this study was to assess the efficacy of anti-TNF-α therapy in refractory uveitis due to Behçet's disease (BD). METHODS: We performed a multicentre study of 124 patients with BD uveitis refractory to conventional treatment including high-dose corticosteroids and at least one standard immunosuppressive agent. Patients were treated for at least 12 months with infliximab (IFX) (3-5 mg/kg at 0, 2 and 6 weeks and then every 4-8 weeks) or adalimumab (ADA) (usually 40 mg every 2 weeks). The main outcome measures were degree of anterior and posterior chamber inflammation, visual acuity, macular thickness and immunosuppression load. RESULTS: Sixty-eight men and 56 women (221 affected eyes) were studied. The mean age was 38.6 years (s.d. 10.4). HLA-B51 was positive in 66.1% of patients and uveitis was bilateral in 78.2%. IFX was the first biologic agent in 77 cases (62%) and ADA was first in 47 (38%). In most cases anti-TNF-α drugs were used in combination with conventional immunosuppressive drugs. At the onset of anti-TNF-α therapy, anterior chamber and vitreous inflammation was observed in 57% and 64.4% of patients, respectively. In both conditions the damage decreased significantly after 1 year. At baseline, 50 patients (80 eyes) had macular thickening [optical coherence tomography (OCT) >250 µm] and 35 (49 eyes) had cystoid macular oedema (OCT>300 µm) that improved from 420 µm (s.d. 119.5) at baseline to 271 µm (s.d. 45.6) at month 12 (P < 0.01). The best-corrected visual acuity and the suppression load also showed significant improvement. After 1 year of follow-up, 67.7% of patients were inactive. Biologic therapy was well tolerated in most cases. CONCLUSION: Anti-TNF-α therapy is effective and relatively safe in refractory BD uveitis.
Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales/uso terapéutico , Síndrome de Behçet/tratamiento farmacológico , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Uveítis/tratamiento farmacológico , Adalimumab , Adolescente , Adulto , Anciano , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales Humanizados/efectos adversos , Síndrome de Behçet/complicaciones , Productos Biológicos/efectos adversos , Productos Biológicos/uso terapéutico , Niño , Esquema de Medicación , Resistencia a Medicamentos , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Glucocorticoides/administración & dosificación , Glucocorticoides/uso terapéutico , Humanos , Inmunosupresores/uso terapéutico , Infliximab , Masculino , Persona de Mediana Edad , Prednisona/administración & dosificación , Prednisona/uso terapéutico , Resultado del Tratamiento , Uveítis/etiología , Adulto JovenRESUMEN
The present study reports a screening for PGPR in a highly selective environment, the rhizosphere of rice plants, in southwestern of Spain. Among the 900 isolates, only 38% were positive for at least one of the biochemical activities to detect putative PGPR. The best 80 isolates were selected and identified by 16S rRNA partial sequencing. Among these, 13 strains were selected for growth promotion assays. Only one strain (BaC1-38) was able to significantly increase height, while nine strains significantly inhibited it. Five strains significantly increased dry weight, and only BaC1-21 significantly decreased it. Based on significant modifications in growth, three bacteria (BaC1-13, BaC1-21 and BaC1-38) were tested for systemic induction of resistance against stress challenge (salt and Xanthomonas campestris infection). Protection against salt stress and pathogen infection was similar; BaC1-38 protected by 80%, BaC1-13 by 50% and BaC1-21 only by 20%. Toxicity of salt stress to the plants was evaluated by photosynthetic efficiency of seedlings. Fv/Fm only decreased significantly in plants inoculated with BaC1-13. ΦPSII also decreased significantly in plants inoculated with BaC1-21, but increased significantly with BaC1-38. NPQ decreased significantly in plants inoculated with BaC1-21. The two strains able to induce systemic resistance against Xanthomonas campestris seem to work by different pathways. BaC1-13 primed enzymes related with the detoxification of reactive oxygen species (ROS). However, BaC1-38 primed pathogenesis-related proteins (PRs), and this pathway was more effective, both improved chlorophyll index confirming the priming state of the plant.
Asunto(s)
Oryza/metabolismo , Oryza/fisiología , Plantones/metabolismo , Plantones/fisiología , Oryza/efectos de los fármacos , Proteínas de Plantas/metabolismo , Especies Reactivas de Oxígeno/metabolismo , Rizosfera , Plantones/efectos de los fármacos , Cloruro de Sodio/farmacologíaRESUMEN
Berries are a rich source of antioxidants compounds, among which is the catechin group. Determination of the monomers (catechin and epicatechin) in fruits is a first step in the way to establish a relationship between polyphenols and their effects on human health. The purpose of this work is to develop a method to determine free catechins in blackberry by MEKC and to characterize levels of catechins in fresh fruits of Rubus fruticosus var. Lochness throughout the annual production period. A methanolic extract was prepared from fresh fruit. Then, it was evaporated and the residue was extracted with diethyl ether. MEKC conditions: phosphoric acid, 30 mmol/L; SDS, 40 mmol/L and triethylamine, 0.1% v/v at pH 2.3; -15 kV of voltage; 10-s hydrodynamic injection; 25°C temperature; and detection at 200 nm. Instrumental and interday precision were lower than 4.7 and 10% RSD, respectively. Only (-)-epicatechin was quantified in blackberries and ranged from 120 to 620 mg/kg fresh weight, which were the lowest values in December and the highest in June. A solid-liquid extraction and an MEKC method were successfully applied to determine (-)-epicatechins in blackberry for the first time. A strong dependence of (-)-epicatechin on the annual average temperature was observed.