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1.
J Rheumatol ; 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31676699

RESUMO

We read with interest the paper by Couderc, et al 1 on the prevalence of renal impairment in patients with spondyloarthritis (SpA) from the ASAS-COMOSPA study (Assessment of Spondyloarthritis international Society-COMOrbidities in SPondyloArthritis). Their results encouraged us to investigate renal impairment prevalence in our cohort.

2.
Artigo em Inglês | MEDLINE | ID: mdl-31628804

RESUMO

OBJECTIVES: To develop a new equation to calculate the Ankylosing Spondylitis Disease Activity Score based on CRP (ASDAS-CRP) using only the BASDAI total score and CRP. METHODS: Axial SpA (axSpA) patients from the Cordoba Spondyloarthritis Registry cohort were recruited as a derivation cohort, while a retrospective sample from the Spanish Rheumatology Society National Registry of Spondyloarthropathies and Ibero American Spondyloarhtritis Registry registers was used as a validation cohort. We built a new equation based only on the BASDAI and CRP, defining a new formula: the BASDAI-based ASDAS (BASDAS). Linear regression analysis was used to determine the coefficients of the equation in the derivation cohort and it was subsequently validated in the validation cohort. RESULTS: A total of 52 axSpA patients in the derivation cohort and 3359 patients in the validation cohort were included. In the derivation cohort, the mean BASDAS [2.24 (s.d. 0.90)] was very similar to the ASDAS-CRP [2.23 (s.d. 0.95)], with a very strong correlation (r = 0.96, P < 0.001). In the validation cohort, the mean BASDAS was 3.31 (s.d. 1.37) and the ASDAS-CRP was 3.19 (s.d. 1.27), which also had a very strong correlation (r = 0.95, P < 0.001). Intraclass correlation coefficients were excellent in both cohorts (0.963 and 0.947, respectively). CONCLUSION: The BASDAS performs similarly to the ASDAS-CRP and can be calculated with only the BASDAI total score and CRP, allowing evaluation of disease activity in retrospective studies where the individual items of the BASDAI are not available.

3.
Rheumatol Int ; 39(12): 2119-2127, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31535169

RESUMO

The objective of our study was to standardize magnetic resonance imaging (MRI) assessment of spine and sacroiliac joints in patients with axial spondyloarthritis (axSpA) and/or inflammatory spinal pain, by creating checklists and templates based on the opinions of rheumatologists and radiologists. A scientific committee developed a series of questionnaires with multiple items regarding MRI in patients with axial inflammatory pain and/or axSpA. Then an expert panel of rheumatologists and radiologists rated all items in a 9-point Likert scale. Finally, the scientific committee and the expert panel met to create the definitive documents. Several definitive checklists and templates were generated for rheumatologist-requested MRI and for radiologist-requested MRI reports of sacroiliac joint and spinal examinations. A technical requirement protocol was also agreed on. Our results could be useful in increasing understanding between rheumatologists and radiologists regarding MRI in axSpA diagnosis and follow-up.

4.
Arthritis Res Ther ; 21(1): 88, 2019 04 05.
Artigo em Inglês | MEDLINE | ID: mdl-30953541

RESUMO

BACKGROUND: Recent data suggest that anti-TNF doses can be reduced in ankylosing spondylitis (AS) patients. Some authors even propose withdrawing treatment in patients in clinical remission; however, at present there is no evidence to support this. OBJECTIVE: To assess how long AS patients with persistent clinical remission remained free of flares after anti-TNF withdrawal and to evaluate the effects of treatment reintroduction. We also analyze the characteristics of patients who did not present clinical relapse. METHODS: Multicenter, prospective, observational study of a cohort of patients with active AS who had received infliximab as a first anti-TNF treatment and who presented persistent remission (more than 6 months). We recorded at baseline and every 6-8 weeks over the 12-month period the age, gender, disease duration, peripheral arthritis or enthesitis, HLA-B27 status, BASDAI, CRP, ESR, BASFI, and three visual analogue scales, spine global pain, spinal night time pain, and patient's global assessment. RESULTS: Thirty-six out of 107 patients (34%) presented persistent remission and were included in our study. After treatment withdrawal, 21 of these 36 patients (58%) presented clinical relapse during follow-up. Infliximab therapy was reintroduced and only 52% achieved clinical remission, as they had before the discontinuation of infliximab; in an additional 10%, reintroduction of infliximab was ineffective, obliging us to change the anti-TNF therapy. No clinical or biological factors were associated with the occurrence of relapse during the follow-up. CONCLUSIONS: Two thirds of patients in clinical remission presented clinical relapse shortly after infliximab withdrawal. Although the reintroduction of infliximab treatment was safe, half of the patients did not present the same clinical response that they had achieved prior to treatment withdrawal.

5.
Reumatol. clín. (Barc.) ; 15(supl.1): 19-25, abr. 2019. ilus
Artigo em Espanhol | LILACS-Express | ID: ibc-ET1-3357

RESUMO

Las espondiloartritis (EspA) son un grupo de enfermedades crónicas que pueden asociarse, en su progresión, con un daño estructural que, a su vez, produce discapacidad y empeoramiento de la calidad de vida. Están a nuestra disposición distintas técnicas de imagen que pueden ayudarnos a valorar este daño estructural, como la radiografía simple, la tomografía computarizada, la ecografía y la resonancia magnética. Sin embargo, los profesionales clínicos deben tener muy presente una serie de cuestiones a la hora de indicarlas y evaluarlas. Por un lado, existen distintos tipos de lesiones estructurales, que, además, cambian en función del tipo de EspA y pueden ser diferentes dependiendo del tipo de articulación. Por el otro, cada técnica de imagen posee unas características determinadas, por las cuales pueden ser muy sensibles y específicas para un tipo de lesión y no serlo para otros. Además, algunas de ellas actualmente están en fase de validación. Conocer en detalle todos estos aspectos nos permitirá indicar las técnicas de imagen para evaluar y controlar el daño estructural de las EspA de forma más eficiente


Spondyloarthritis (SpA) are a group of chronic diseases that can lead to structural damage during disease progression, which in turn produces disability and impairs quality of life. Several imaging techniques are available that may help to evaluate structural damage, such as plain-film radiography, computed tomography, ultrasound and magnetic resonance. However, clinicians must bear in mind a series of questions when indicating and assessing these procedures. First, there are various types of structural lesions, which also change depending on the type of SpA and may differ depending on the type of joint involved. Second, each imaging technique has particular characteristics making it highly sensitive and specific for one type of lesion but not for others. Third, some of these techniques are currently in the validation phase. Detailed knowledge of all these questions will help to indicate the imaging technique to be used in order to assess and monitor structural damage in SpA more efficiently

6.
Arthritis Res Ther ; 21(1): 11, 2019 01 08.
Artigo em Inglês | MEDLINE | ID: mdl-30621746

RESUMO

OBJECTIVE: The objective was to determine if dose reduction is non-inferior to full-dose TNFi to maintain low disease activity (LDA) in patients already in remission with TNFi, in axial spondyloarthritis. METHODS: Randomized, parallel, non-inferiority, open-label multicentre clinical trial. Patients were eligible if they had axial spondyloarthritis and had been in clinical remission for ≥ 6 months with any available TNFi (adalimumab, etanercept, infliximab, golimumab) at the dose recommended by product labelling. Patients were randomized by automated central allocation to continue the same TNFi dose schedule, or to reduce the dose by roughly half according to the protocol. The main outcome was the proportion of subjects with LDA after 1 year. Serious adverse reactions or infections were recorded. RESULTS: The trial stopped due to end of the funding period, after 126 patients were randomized; 113 patients (84.1% male, mean age (SD) 45.6 (13.0) years) were included in the main per-protocol subset. Non-inferiority was concluded for LDA at 1 year (47/55 (83.8%) patients in the full-dose and 48/58 (81.3%) patients in the reduced-dose arm, adjusted difference (95% CI) - 2.5% (- 16.6% to 11.7%)). Serious adverse reactions or infections were reported in 7/62 patients (11.3%) assigned to full dose and 2/61 patients (3.3%) assigned to reduced dose (p value = 0.164). CONCLUSION: In patients with ankylosing spondylitis in clinical remission for at least 6 months, dose reduction is non-inferior to full TNF inhibitor doses to maintain LDA after 1 year. Serious adverse events may be less frequent with reduced doses. TRIAL REGISTRATION: EU Clinical Trials Registry, EudraCT 2011-005871-18 and ClinicalTrials.gov, NCT01604629 .

7.
Reumatol Clin ; 2018 Sep 04.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-30193774

RESUMO

OBJECTIVE: To develop a consensus to standardize the use of Spanish terms, abbreviations and acronyms in the field of spondyloarthritis (SpA). METHODS: An international task force comprising all native Spanish-speaking Assessment of SpondyloArthritis International Society (ASAS) members, the executive committee of Grupo para el estudio de la Espondiloartritis de la Sociedad Española de Reumatología (GRESSER), two methodologists, two linguists from the Real Academia Nacional de Medicina de España (RANM) and two patients from the Spanish Coordinator of Spondylitis Associations (CEADE) was established. A literature review was performed to identify the conflicting terms/abbreviations/acronyms in SpA. This review examined written sources in Spanish including manuscripts, ICF and ICD, guidelines, recommendations and consensuses. This was followed by a nominal group meeting and a three-round Delphi. The recommendations from the RANM based on the Panhispanic dictionary were followed throughout the process. RESULTS: Consensus was reached for 46 terms, abbreviations or acronyms related to the field of SpA. A Spanish translation was accepted for 6 terms and 6 abbreviations to name or classify the disease, and for 6 terms and 4 abbreviations related to SpA. It was agreed not to translate 15 acronyms into Spanish. However, when mentioning them, it was recommended to follow this structure: type of acronym in Spanish and acronym and expanded form in English. With regard to 7 terms or abbreviations attached to acronyms, it was agreed to translate only the expanded form and a translation was also selected for each of them. CONCLUSIONS: Through this standardization, it is expected to establish a common use of the Spanish nomenclature for SpA. The implementation of this consensus across the community will be of substantial benefit, avoiding misunderstandings and time-consuming processes.

8.
Reumatol. clín. (Barc.) ; 14(3): 155-159, mayo-jun. 2018. ilus
Artigo em Espanhol | IBECS | ID: ibc-174100

RESUMO

Objetivo. Estandarizar la evaluación clínica de pacientes con espondiloartritis (EspA) axial y artritis psoriásica (APs). Métodos. Estudio cualitativo que incluyó: 1) grupo nominal (18 expertos); 2) revisión de la literatura sobre variables empleadas en la evaluación de los pacientes con EspA axial o APs, y 3) grupo focal con reumatólogos y otro con pacientes con EspA axial o APs para analizar la evaluación de las EspA en las consultas de reumatología. Los expertos seleccionaron las variables a incluir en el cuadro de actuación con base en su relevancia, factibilidad en consulta y método/s de medición. Resultados. El cuadro de actuación incluye las variables para valorar antecedentes personales, exploración física, actividad y función, pruebas complementarias y tratamientos. Detalla factores de riesgo de progresión radiográfica, factores predictores de respuesta a terapia biológica, e incluye variables de excelencia. Conclusiones. Este cuadro de actuación para pacientes con EspA axial y APs podrá ayudar a homogeneizar la práctica clínica diaria y a mejorar el manejo y el pronóstico de estos pacientes


Objective. To standardize clinical evaluation of patients with axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) using a checklist. Methods. Qualitative study that included: 1) nominal group (18 experts); 2) literature reviews of measures used in the assessment of patients with axial SpA or PsA; and 3) focus groups, one with rheumatologists and another with patients, organized to become familiar with their opinion on medical assistance. Taking this into account, the experts selected the measures to be included in the checklist based on their relevance, feasibility, and the outcome type. Results. The checklist includes measures for the evaluation of personal history, physical examination, activity and function, laboratory tests, imaging studies and treatments. It also defines risk factors of radiographic progression, predictors of the response to biological therapies, and comprises measures of excellence. Conclusions. This checklist for patients with axial SpA and PsA could help standardize daily clinical practice and improve clinical management and patient prognosis


Assuntos
Humanos , Literatura de Revisão como Assunto , Espondilartrite/diagnóstico , Artrite Psoriásica/diagnóstico , Exame Físico/métodos , Fatores de Risco , Prognóstico , Avaliação de Programas e Projetos de Saúde , Análise Qualitativa , Projetos , Espondilartrite/terapia , Artrite Psoriásica/terapia , Epidemiologia Descritiva , Análise Estatística
9.
Rheumatol Int ; 38(7): 1277-1284, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29786781

RESUMO

To develop and evaluate a web application based on multimedia animations, combined with a training program, to improve the prescription of exercises in spondyloarthritis (SpA). After a review of exercises included in the main clinical trials and recommendations of international societies, a multidisciplinary team-rehabilitators, rheumatologists, physiotherapists, computer scientists and graphic designers-developed a web application for the prescription of exercises (EJES-3D). Once completed, this was presented to 12 pairs of rehabilitators-rheumatologists from the same hospital in a workshop. Knowledge about exercise was tested in rheumatologists before and 6 months after the workshop, when they also evaluated the application. The EJES-3D application includes 38 multimedia videos and allows prescribing predesigned programs or customizing them. A patient can consult the prescribed exercises at any time from a device with internet connection (mobile, tablet, or computer). The vast majority of the evaluators (89%) were satisfied or very satisfied and considered that their expectations regarding the usefulness of the web application had been met. They highlighted the ability to tailor exercises adapted to the different stages of the disease and the quality and variety of the videos. They also indicated some limitations of the application and operational problems. The EJES-3D tool was positively evaluated by experts in SpA, potentially the most demanding group of users with the most critical capacity. This allows a preliminary validation of the contents, usefulness, and ease of use. Analyzing and correcting the errors and limitations detected is allowing us to improve the EJES-3D tool.

10.
Clin Exp Rheumatol ; 2018 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-29745878

RESUMO

OBJECTIVES: To study whether disease status at treatment initiation has changed after the issue of the ASAS classification criteria. METHODS: REGISPONSERBIO registers patients with axial spondyloarthritis (axSpA) on biological treatment since 2013. It includes patients starting biological treatment (incident) or already on biological therapies (prevalent). Patients in both groups were compared in terms of: age at disease onset and at treatment start, disease duration, gender, HLA-B27, body mass index (BMI), BASDAI, BASFI, C-reactive protein, ESR, metrological data, ASQoL, WAPAI, extra-articular manifestations, comorbidities, radiological study, type of biological treatment and concomitant treatments. RESULTS: 256 patients were included, of whom 174 (65%) were already on biologic therapy. Compared to incident patients, prevalent patients started treatment with longer disease duration (15 vs. 8.6 years; p<0.001), a higher proportion of them were men (83% vs. 67%; p=0.01), a smaller proportion of them showed non-radiographic axial spondylarthritis (nr-axSpA)(17% vs. 32%; p<0.01), and a higher proportion had HLAB27 (85% vs. 73%; p=0.02). There were no statistically significant differences in terms of disease activity, degree of disability, quality of life, or prevalence of extra-articular manifestations. CONCLUSIONS: Data suggest that, after the issue of the new classification criteria for SpA, biological therapy is being administered earlier than previously in SpA patients and in a higher proportion of patients with nr-axSpA. However, this change in prescribing profile, apparently, has not caused an over-treatment, as patients do not seem to have a lower disease burden than prior to the issue of the criteria.

11.
Reumatol Clin ; 14(3): 155-159, 2018 May - Jun.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-28284772

RESUMO

OBJECTIVE: To standardize clinical evaluation of patients with axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) using a checklist. METHODS: Qualitative study that included: 1) nominal group (18 experts); 2) literature reviews of measures used in the assessment of patients with axial SpA or PsA; and 3) focus groups, one with rheumatologists and another with patients, organized to become familiar with their opinion on medical assistance. Taking this into account, the experts selected the measures to be included in the checklist based on their relevance, feasibility, and the outcome type. RESULTS: The checklist includes measures for the evaluation of personal history, physical examination, activity and function, laboratory tests, imaging studies and treatments. It also defines risk factors of radiographic progression, predictors of the response to biological therapies, and comprises measures of excellence. CONCLUSIONS: This checklist for patients with axial SpA and PsA could help standardize daily clinical practice and improve clinical management and patient prognosis.

12.
Acta Reumatol Port ; 42(2): 176-182, 2017 Apr-Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28693033

RESUMO

The definition of axial involvement in psoriatic arthritis (PsA) is still under debate. Currently, the axial spondyloarthritis (SpA) criteria defined by Assessment of Spondyloarthritis International Society (ASAS) may be the most adequate.(1) The aims of present study were to assess axial involvement according to ASAS criteria in an observational PsA cohort and define the clinical characteristics more associated with this kind of involvement. Our study included consecutive patients who had a visit in a tertiary Rheumatology centre. All patients included fulfill ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria for PsA and all of them had a recent radiographic assessment of sacroiliitis. Clinical and laboratorial data were taken into account to classify patients as fulfilling or not ASAS criteria for axial SpA. Clinical and demographic data were analyzed about their association with presence of ASAS criteria of axial SpA in an univariable logistic regression analysis. Variables with a p-value <0.05 were re-tested in a multivariable logistic regression. Those variables that maintained statistical significance were tested alone in another multivariable model. Analyses were performed with IBM SPSS Statistics (version 20.0). Regarding the 233 patients included, only 42 patients (19.4%) fulfilled ASAS criteria for axial SpA. However, 22 patients had asymptomatic radiographic sacroiliitis according to modified New York criteria. The prevalence of asymptomatic sacroiliitis was 15.7% between patients without axial symptoms. In multivariable analysis, inflammatory back pain (IBP) [OR=25.111; 95% confidence interval (CI) = 8.770, 71.900, p-value <0.001], presence of HLA-B27 [OR=9.072; 95% CI=2.756, 29.860; p-value <0.001] and male gender [OR=3.767; 95% CI=1.264, 11.232; p-value = 0.017] were associated to axial involvement according to ASAS criteria. Axial SpA ASAS criteria are useful to identify axial involvement in PsA patients. This type of involvement is more common in males, in the presence of HLA-B27 and IBP. Axial disease should be systematically assessed in clinical practice, mainly in patients presenting with this clinical features.


Assuntos
Artrite Psoriásica/complicações , Artrite Psoriásica/diagnóstico , Espondilartrite/diagnóstico , Espondilartrite/etiologia , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
13.
Medicine (Baltimore) ; 96(24): e7099, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28614228

RESUMO

Whether a repeat renal biopsy is helpful during lupus nephritis (LN) flares remains debatable. In order to analyze the clinical utility of repeat renal biopsy in this complex situation, we retrospectively reviewed our series of 54 LN patients who had one or more repeat biopsies performed only on clinical indications. Additionally, we reviewed 686 well-documented similar cases previously reported (PubMed 1990-2015).The analysis of all patients reviewed showed that histological transformations are common during a LN flare, ranging from 40% to 76% of cases. However, the prevalence of transformations and the clinical value of repeat biopsy vary when they are analyzed according to proliferative or nonproliferative lesions.The great majority of patients with class II (78% in our series and 77.5% in the literature review) progressed to a higher grade of nephritis (classes III, IV, or V), resulting in worse renal prognosis. The frequency of pathological conversion in class V is lower (33% and 43%, respectively) but equally clinically relevant, since almost all cases switched to a proliferative class. Therefore, repeat biopsy is highly advisable in patients with nonproliferative LN at baseline biopsy, because these patients have a reasonable likelihood of switch to a proliferative LN that may require more aggressive immunosuppression.In contrast, the majority of patients (82% and 73%) with proliferative classes in the reference biopsy (III, IV or mixed III/IV + V), remained into proliferative classes on repeat biopsy. Although rebiopsy in this group does not seem as necessary, it is still advisable since it will allow us to identify the 18% to 20% of patients that switch to a nonproliferative class. In addition, consistent with the reported clinical experience, repeat biopsy might also be helpful to identify selected cases with clear progression of proliferative lesions despite the initial treatment, for whom it is advisable to intensify inmunosuppression. Thus, our experience and the literature data support that repeat biopsy also brings more advantges than threats in this group.The results of the repeat biopsy led to a change in the immunosuppresive treatment in more than half of the patients on average, intensifying it in the majority of the cases, but also reducing it in 5% to 30%.


Assuntos
Rim/patologia , Nefrite Lúpica/patologia , Biópsia , Progressão da Doença , Feminino , Humanos , Imunossupressores/uso terapêutico , Rim/efeitos dos fármacos , Nefrite Lúpica/tratamento farmacológico , Nefrite Lúpica/metabolismo , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Índice de Gravidade de Doença
14.
Ophthalmology ; 123(8): 1632-1636, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-27084561

RESUMO

PURPOSE: To describe and analyze the prevalence of spondyloarthritis (SpA) in patients with anterior uveitis (AU). DESIGN: Multicentric, observational, prospective study. PARTICIPANTS: Consecutive patients with AU who were human leukocyte antigen (HLA)-B27 positive or HLA-B27 negative with more than 1 episode of AU separated by at least 3 months were selected. Patients with a previous diagnosis of SpA were excluded. METHODS: Included patients were evaluated by an ophthalmologist and a rheumatologist following a predefined visit schedule. MAIN OUTCOME MEASURES: Sociodemographic and clinical variables including the diagnosis of SpA according to Assessment of SpondyloArthritis International Society (ASAS) criteria and an exhaustive ophthalmological examination (best-corrected visual acuity, intraocular pressure, biomicroscopic examination of the anterior and posterior segment of the eye, cataract evaluation, optical coherence tomography evaluating both the 1-mm central retina thickness and the optic nerve head and retinal nerve fiber layer, and visual field in a dark room with 1 eye patched) were collected. Baseline descriptive, bivariate, and concordance analyses were performed. RESULTS: We included 798 patients, mostly men (59%) with a mean age of 45 years; 60% were AU HLA-B27 positive, and 40% had recurrent negative AU HLA-B27. A total of 50.2% and 17.5% of patients presented axial and peripheral SpA according to ASAS criteria, respectively. Patients with AU who were HLA-B27 positive were more frequently diagnosed with axial (69.8% vs. 27.3%, P < 0.0001) and peripheral SpA (21.9% vs. 11.1%, P < 0.0001) than patients with recurrent negative AU HLA-B27. In general, we did not detect important differences between groups in the ophthalmologic variables. CONCLUSIONS: A large percentage of patients with clinically significant AU have an undiagnosed SpA. This percentage is even higher if the HLA-B27 haplotype is positive.


Assuntos
Espondilartrite/epidemiologia , Uveíte Anterior/epidemiologia , Adulto , Feminino , Antígeno HLA-B27/imunologia , Humanos , Estudos Interdisciplinares , Pressão Intraocular/fisiologia , Masculino , Pessoa de Meia-Idade , Fibras Nervosas/patologia , Prevalência , Estudos Prospectivos , Retina/patologia , Células Ganglionares da Retina/patologia , Espanha/epidemiologia , Espondilartrite/diagnóstico , Espondilartrite/imunologia , Tomografia de Coerência Óptica , Uveíte Anterior/diagnóstico , Uveíte Anterior/imunologia , Acuidade Visual/fisiologia , Campos Visuais/fisiologia
16.
Trials ; 16: 370, 2015 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-26289076

RESUMO

BACKGROUND: Dose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice. METHODS/DESIGN: To address this issue the Spanish Society of Rheumatology (SER) and Spanish Society of Clinical Pharmacology (SEFC) designed a 3-year multicenter, randomized, open-label, controlled clinical trial (2 years for inclusion and 1 year of follow-up). The study is expected to include 190 patients with axial spondyloarthritis on stable maintenance treatment (≥4 months) with any anti-TNF agent at doses recommended in the summary of product characteristics. Patients will be randomized to either a dose reduction arm or maintenance of the dosing regimen as per the official labelling recommendations. Randomization will be stratified according to the anti-TNF agent received before study inclusion. Patient follow-up, visit schedule, and examinations will be maintained as per normal clinical practice recommendations according to SER guidelines. The study aims to test the hypothesis of noninferiority of the dose reduction strategy compared with standard treatment. The first patients were recruited in July 2012, and study completion is scheduled for the end of April 2015. DISCUSSION: The REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical decision now made empirically. The study results may help inform clinical decisions relevant to both patients and healthcare decision makers. TRIAL REGISTRATION: EudraCT 2011-005871-18 (21 December 2011).


Assuntos
Anti-Inflamatórios/administração & dosagem , Produtos Biológicos/administração & dosagem , Coluna Vertebral/efeitos dos fármacos , Espondilartrite/tratamento farmacológico , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Anti-Inflamatórios/efeitos adversos , Produtos Biológicos/efeitos adversos , Fenômenos Biomecânicos , Protocolos Clínicos , Técnicas de Apoio para a Decisão , Esquema de Medicação , Humanos , Estudos Prospectivos , Recuperação de Função Fisiológica , Indução de Remissão , Projetos de Pesquisa , Espanha , Coluna Vertebral/imunologia , Coluna Vertebral/fisiopatologia , Espondilartrite/diagnóstico , Espondilartrite/imunologia , Espondilartrite/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Fator de Necrose Tumoral alfa/imunologia
17.
Clin Infect Dis ; 60(3): 349-56, 2015 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-25313252

RESUMO

BACKGROUND: The extent to which anti-tumor necrosis factor (TNF)-associated tuberculosis can be prevented is unclear, and there is no established guidance on the optimal screening strategy for latent tuberculosis (LTBI) in patients about to start anti-TNF therapy. We aimed to determine the effectiveness of a comprehensive program for the prevention of anti-TNF-associated tuberculosis, and to evaluate 3 LTBI screening strategies and the need for retesting patients with negative results at baseline. METHODS: In total, 726 patients were screened prior to anti-TNF therapy using 1 of 3 diagnostic strategies over 3 consecutive periods: first, a 2-step tuberculin skin test (TST); second, a 2-step TST plus QuantiFERON-TB Gold In-Tube test (QFT-GIT) (2-step TST/QFT); and third, a single-step TST plus QFT-GIT (TST/QFT). Infected patients were offered preventive therapy. We assessed differences in the incidence of tuberculosis between anti-TNF exposed and nonexposed patients, and between the 3 study periods. RESULTS: Tuberculosis developed during the first year in 2.85 per 1000 exposed patient-years (3/1052 patient-years) and 1.77 per 1000 nonexposed patient-years (1/566 patient-years). No cases occurred beyond the first year of treatment. LTBI diagnoses decreased with the single-step TST/QFT (26.5%) compared with the 2-step TST (42.5%; P < .001) and 2-step TST/QFT (38.5%; P = .02); the incidence of tuberculosis among exposed patients did not change significantly across the 3 periods (2.63/1000, 3.91/1000, and 2.4/1000 patient-years, respectively). CONCLUSIONS: Although anti-TNF-associated tuberculosis can be reduced, some risk remains during the first year of therapy. Neither the 2-step TST nor systematic retesting after negative baseline testing is justified.


Assuntos
Tuberculose Latente/prevenção & controle , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Estudos de Coortes , Feminino , Humanos , Tuberculose Latente/etiologia , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Medição de Risco , Teste Tuberculínico
18.
J Rheumatol ; 41(12): 2409-12, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25362657

RESUMO

OBJECTIVE: To evaluate clinical factors associated with the absence of radiographic progression in patients with spondylitis. METHODS: The cross-sectional study included 672 patients. All patients presented a disease evolution of more than 15 years. Patients were classified as with radiographic spinal involvement versus without radiographic spinal involvement. We included clinical variables potentially related to null radiological progression. RESULTS: Seventy-five patients had no radiographic involvement. These patients were predominantly female, had a lower erythrocyte sedimentation rate (ESR), and a lower C-reactive protein level. Multivariate analysis showed an association with the female sex and low ESR. CONCLUSION: Clinical factors associated with this lack of progression were female sex and low ESR.


Assuntos
Vértebra Cervical Áxis/fisiopatologia , Progressão da Doença , Espondilite Anquilosante/sangue , Espondilite Anquilosante/fisiopatologia , Adolescente , Adulto , Biomarcadores/sangue , Sedimentação Sanguínea , Proteína C-Reativa/metabolismo , Estudos Transversais , Feminino , Humanos , Masculino , Análise Multivariada , Radiografia , Sistema de Registros , Fatores Sexuais , Espanha , Espondilite Anquilosante/diagnóstico por imagem , Adulto Jovem
19.
Reumatol. clín. (Barc.) ; 10(4): 204-209, jul.-ago. 2014. tab, ilus
Artigo em Inglês | IBECS | ID: ibc-124007

RESUMO

Objective: To investigate which of the 2 ankylosing spondylitis (AS) disease activity instruments identifies better those patients with characteristics that have been associated with positive response to anti-TNF therapy. Methods: Data from patients with AS in the REGISPONSER registry were analyzed. Patients were categorized by disease activity using 3 different selection criteria: elevated Bath Ankylosing Spondylitis Disease Activity Index criteria (BASDAI≥4), high Ankylosing Spondylitis Disease Activity Score (ASDAS≥2.1), or very high ASDAS (ASDAS≥3.5). To determine which criterion selects for patients most likely to respond to anti-TNF therapy, the groups of patients selected with each criterion were compared on five disease characteristics that are associated with good response to anti-TNF therapy: lower age, lower function score, less enthesitis, higher C-reactive protein (CRP), and HLA-B27-positive status. Results: 50.9%, 66.3%, and 24.9% of 1156 patients had elevated BASDAI, high ASDAS, or very high ASDAS, respectively. Compared to patients selected with elevated BASDAI, more patients selected with high ASDAS had characteristics associated with good response to anti-TNF therapy. Patients with very high ASDAS had higher CRP and were younger, but more frequently had enthesitis and had higher function scores when compared to those with elevated BASDAI. Conclusions: Selection of AS patients with the ASDAS instrument results in patient sub-populations with different characteristics than those selected with the BASDAI instrument. Since some of these characteristics have been associated with response to anti-TNF therapy, further study should establish if the choice of selection instrument improves the outcome of therapy in the selected populations


Objetivo: Investigar cual de 2 instrumentos actividad de la enfermedad para espondilitis anquilosante (EA) identifica mejor a los pacientes con las características que se han asociado con una respuesta positiva a la terapia anti-TNF. Métodos: Se analizaron los datos de los pacientes con EA del registro REGISPONSER. Los pacientes fueron clasificados de acuerdo a la actividad de la enfermedad utilizando 3 criterios diferentes de selección: criterios de espondilitis anquilosante, Índice de Actividad de la Enfermedad elevado (BASDAI ≥ 4), puntuación alta de Actividad de la Enfermedad (ASDAS ≥ 2,1) o ASDAS muy elevado (ASDAS ≥ 3,5). Para determinar qué criterio seleccionaba a pacientes con más probabilidades de responder a terapia anti-TNF, se compararon cinco características de la enfermedad que se asocian con una buena respuesta a la terapia anti-TNF en los grupos de pacientes seleccionados con cada criterio: edad menor, calificación de la función, menorentesitis, mayor nivel de proteína C-reactiva (PCR), y la presencia de HLA-B27 positivo. Resultados: 50,9%, 66,3% y 24,9% de los 1.156 pacientes tenían BASDAI elevado, ASDAS alto, o muy altos, respectivamente. En comparación con los pacientes con BASDAI elevado seleccionados, más pacientes seleccionados con ASDAS altos tenían características asociadas con una buena respuesta a la terapia anti-TNF. Los pacientes con ASDAS altos tenía PCR más elevada y eran más jóvenes, pero con mayor frecuencia tenían entesitis y calificaciones de función más altos en comparación con aquellos con niveles elevados de BASDAI. Conclusiones: La selección de los pacientes mediante los resultados del instrumento ASDASresulta en sub-poblaciones de pacientes con características diferentes a las seleccionadas con el instrumento BASDAI. Dado que algunas de estas características se han asociado con la respuesta a la terapia anti-TNF, se requiere de mayor estudio para establecer si la elección del instrumento de selección mejora el resultado del tratamiento en las poblaciones seleccionadas (AU)


Assuntos
Humanos , Espondilite Anquilosante/fisiopatologia , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Espondilite Anquilosante/classificação , Estudos Transversais , Seleção de Pacientes
20.
Reumatol Clin ; 10(4): 204-9, 2014 Jul-Aug.
Artigo em Inglês | MEDLINE | ID: mdl-24598027

RESUMO

OBJECTIVE: To investigate which of the 2 ankylosing spondylitis (AS) disease activity instruments identifies better those patients with characteristics that have been associated with positive response to anti-TNF therapy. METHODS: Data from patients with AS in the REGISPONSER registry were analyzed. Patients were categorized by disease activity using 3 different selection criteria: elevated Bath Ankylosing Spondylitis Disease Activity Index criteria (BASDAI≥4), high Ankylosing Spondylitis Disease Activity Score (ASDAS≥2.1), or very high ASDAS (ASDAS≥3.5). To determine which criterion selects for patients most likely to respond to anti-TNF therapy, the groups of patients selected with each criterion were compared on five disease characteristics that are associated with good response to anti-TNF therapy: lower age, lower function score, less enthesitis, higher C-reactive protein (CRP), and HLA-B27-positive status. RESULTS: 50.9%, 66.3%, and 24.9% of 1156 patients had elevated BASDAI, high ASDAS, or very high ASDAS, respectively. Compared to patients selected with elevated BASDAI, more patients selected with high ASDAS had characteristics associated with good response to anti-TNF therapy. Patients with very high ASDAS had higher CRP and were younger, but more frequently had enthesitis and had higher function scores when compared to those with elevated BASDAI. CONCLUSIONS: Selection of AS patients with the ASDAS instrument results in patient sub-populations with different characteristics than those selected with the BASDAI instrument. Since some of these characteristics have been associated with response to anti-TNF therapy, further study should establish if the choice of selection instrument improves the outcome of therapy in the selected populations.


Assuntos
Algoritmos , Seleção de Pacientes , Espondilite Anquilosante/diagnóstico , Espondilite Anquilosante/tratamento farmacológico , Inquéritos e Questionários , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
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