Biologic therapy in refractory neurobehçet's disease: a multicentre study of 41 patients and literature review.

OBJECTIVES: To assess efficacy and safety of biologic therapy (BT) in neurobehçet's disease (NBD) refractory to glucocorticoids and at least one conventional immunosuppressive drug. METHODS: Open-label, national, multicentre study. NBD diagnosis was based on the International Consensus Recommendation criteria. Outcome variables were efficacy and safety. Main efficacy outcome was clinical remission. Other outcome variables analysed were glucocorticoid-sparing effect and improvement in laboratory parameters. RESULTS: We studied 41 patients [21 women; age 40.6 (10.8) years]. Neurological damage was parenchymal (n = 33, 80.5%) and non-parenchymal (n = 17, 41.5%). First BTs used were infliximab (n = 19), adalimumab (n = 14), golimumab (n = 3), tocilizumab (n = 3) and etanercept (n = 2). After 6 months of BT, neurological remission was complete (n = 23, 56.1%), partial (n = 15, 37.6%) and no response (n = 3, 7.3%). In addition, median (IQR) dose of oral prednisone decreased from 60 (30-60) mg/day at the initial visit to 5 (3.8-10) mg/day after 6 months (P < 0.001). It was also the case for mean erythrocyte sedimentation rate [31.5 (25.6)-15.3 (11.9) mm/1st h, P = 0.011] and median (IQR) C-reactive protein [1.4 (0.2-12.8) to 0.3 (0.1-3) mg/dl, P = 0.001]. After a mean follow-up of 57.5 months, partial or complete neurological remission persisted in 37 patients (90.2%). BT was switched in 22 cases (53.6%) due to inefficacy (n = 16) or adverse events (AEs) (n = 6) and discontinued due to complete prolonged remission (n = 3) or severe AE (n = 1). Serious AEs were observed in two patients under infliximab treatment. CONCLUSIONS: BT appears to be effective and relatively safe in refractory NBD.

Predictive clinical-genetic model of long-term non-response to tumor necrosis factor-alpha inhibitor therapy in spondyloarthritis.

AIM: Tumor necrosis factor inhibitors (TNFi) are effective in controlling disease activity in spondyloarthritis (SpA). However, in a proportion of patients these treatments are ineffective or lead to adverse events. Recently, alternative therapies, such as interleukin (IL)-17 or IL-23 inhibitors, have emerged in the treatment of these pathologies. This study aimed to determine clinical and genetic predictors of non-response to TNFi treatment in 118 spondyloarthritis patients diagnosed according to Assessment in SpondyloArthritis International Society (ASAS) criteria. METHOD: From the literature, 41 single nucleotide polymorphisms (SNPs) were selected that had previously been associated with TNFi treatment response in spondyloarthropathies, rheumatoid arthritis and psoriasis. A clinical non-response was defined as a decrease of <50% of initial Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in axial involvement, or a reduction of less than 1.2 of initial Disease Activity Score of 28 joints-C-reactive protein (DAS28-CRP) in patients with only peripheral involvement. Univariate and multivariate hazard ratios (HR) were determined using Cox proportional hazard models to analyze the potential prognostic factors affecting non-response to TNFi treatment. RESULTS: The clinical factors that significantly increased the non-response rate were: global visual analog scale (VAS), CRP, BASDAI, Bath Ankylosing Spondylitis Functional Index (BASFI), and the number of TNFi used. Only rs11591741 SNP showed an association with non-response. In the multivariate analysis, females had a non-response rate 4.46 times higher than males; each one-point increase in the BASFI index increased the non-response rate by 75%, and being a genotype GG vs GC or CC carrier was associated with an almost 4 times greater non-response rate. CONCLUSION: We developed a clinical-genetic model to identify SpA patients with a long-term non-response to TNFi therapy.

2014 update of the Consensus Statement of the Spanish Society of Rheumatology on the use of biological therapies in rheumatoid arthritis.

OBJECTIVE: To establish recommendations for the management of patients with rheumatoid arthritis (RA) to serve as a reference for all health professionals involved in the care of these patients, and focusing on the role of available synthetic and biologic disease-modifying antirheumatic drugs (DMARDs). METHODS: Consensual recommendations were agreed on by a panel of 14 experts selected by the Spanish Society of Rheumatology (SER). The available scientific evidence was collected by updating three systematic reviews (SR) used for the EULAR 2013 recommendations. A new SR was added to answer an additional question. The literature review of the scientific evidence was made by the SER reviewer's group. The level of evidence and the degree of recommendation was classified according to the Oxford Centre for Evidence-Based Medicine system. A Delphi panel was used to evaluate the level of agreement between panellists (strength of recommendation). RESULTS: Thirteen recommendations for the management of adult RA were emitted. The therapeutic objective should be to treat patients in the early phases of the disease with the aim of achieving clinical remission, with methotrexate playing a central role in the therapeutic strategy of RA as the reference synthetic DMARD. Indications for biologic DMARDs were updated and the concept of the optimization of biologicals was introduced. CONCLUSIONS: We present the fifth update of the SER recommendations for the management of RA with synthetic and biologic DMARDs.

Bone health, vitamin D and lupus.

The prevalence of vitamin D deficiency and insufficiency among patients with systemic lupus erythematosus is high. This is likely due to photoprotection measures in addition to intrinsic factors of the disease. Low levels of vitamin D increase the risk of low bone mineral density and fracture. Vitamin D deficiency could also have undesirable effects on patients' immune response, enhancing mechanisms of loss of tolerance and autoimmunity. Vitamin D levels should be periodically monitored and patients should be treated with the objective of reaching vitamin D levels higher than 30-40 ng/ml.

Consenso SER sobre la gestión de riesgo del tratamiento con terapias biológicas en pacientes con enfermedades reumáticas / Consensus statement of the spanish society of rheumatology on risk management of biologic therapy in rheumatic patients

Objetivo: Dado el creciente uso de las terapias biológicas en distintas enfermedades reumatológicas, y la importancia de la gestión de riesgo de las mismas, desde la Sociedad Española de Reumatología (SER) se ha impulsado el desarrollo de recomendaciones basadas en la mejor evidencia posible. Estas deben de servir de referencia para reumatólogos e implicados en el tratamiento de pacientes en tratamiento o en los que se quiere indicar la terapia biológica independientemente de su enfermedad de base. Métodos: Las recomendaciones se emitieron siguiendo la metodología de grupos nominales. El nivel de evidencia y el grado de recomendación se clasificaron según el modelo del Center for Evidence Based Medicine de Oxford y el grado de acuerdo se extrajo por técnica Delphi. Se utilizó toda la información de consensos y guías de práctica clínica previas. Resultados: Se realizan recomendaciones sobre la gestión del riesgo del uso de las terapias biológicas en pacientes con enfermedades reumática. Incluyen la gestión del riesgo de la indicación, gestión del riesgo antes de iniciar el tratamiento, gestión del riesgo durante el seguimiento, actitud ante acontecimientos adversos, y actitud en situaciones especiales. Conclusiones: Se presentan las recomendaciones SER sobre la gestión del riesgo del tratamiento con terapias biológicas (AU)

Objective: Due to the increasing use of biologic therapy in rheumatic diseases and the importance of its risk management, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and those involved in the treatment of patients who are using, or about to use biologic therapy irrespectively of the rheumatic disease. Methods: Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and degree of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through a Delphi technique. Evidence from previous consensus and clinical guidelines was used. Results: We have produced recommendations on risk management of biologic therapy in rheumatic patients. These recommendations include indication risk management, risk management before the use of biologic therapy, risk management during follow-up, attitude to adverse events, and attitude to special situations. Conclusions: We present the SER recommendations related to biologic therapy risk management (AU)

[Consensus statement of the Spanish Society of Rheumatology on risk management of biologic therapy in rheumatic patients]. / Consenso SER sobre la gestión de riesgo del tratamiento con terapias biológicas en pacientes con enfermedades reumáticas.

OBJECTIVE: Due to the increasing use of biologic therapy in rheumatic diseases and the importance of its risk management, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and those involved in the treatment of patients who are using, or about to use biologic therapy irrespectively of the rheumatic disease. METHODS: Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and degree of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through a Delphi technique. Evidence from previous consensus and clinical guidelines was used. RESULTS: We have produced recommendations on risk management of biologic therapy in rheumatic patients. These recommendations include indication risk management, risk management before the use of biologic therapy, risk management during follow-up, attitude to adverse events, and attitude to special situations. CONCLUSIONS: We present the SER recommendations related to biologic therapy risk management.

Tratamiento de fondo del síndrome seco. ¿Qué puede aportar el reumatólogo? / Etiologic treatment of sicca syndrome. What can the rheumatologist offer?

En el síndrome de Sjögren primario (SSP) no se ha descrito hasta el momento una terapia eficaz para las manifestaciones glandulares a pesar del desarrollo de múltiples agentes orales y biológicos en los últimos años. Varios fármacos empleados como tratamiento de fondo en otras enfermedades se han probado empíricamente y, reconocida la hiperactividad de la célula B en el SSP, también los moduladores de estas se han ensayado en esta enfermedad. En este artículo se revisan los datos existentes sobre el uso de tratamientos modificadores de la enfermedad exclusivamente en el síndrome seco, encontrando que los ensayos publicados con fármacos antirreumáticos orales han mostrado resultados contradictorios y desalentadores, mientras que algunos tratamientos biológicos han resultado esperanzadores. Los problemas encontrados se centran sobre todo en la falta de una correcta y homogénea metodología en los diseños de los ensayos (AU)

No effective treatment has been documented for the glandular primary Sjögren syndrome (PSS) despite the development of oral and biologic agents that have significant activity against other autoimmune disorders. Some disease-modifying agents have been empirically evaluated for the treatment of PSS. Targeting B cells also seems very promising in SSP because of the B-cell hyperactivity recognized in this desease. This article reviews existing data on the use of disease-modifying therapy for glandular of SSP. To date, published studies and trials of oral DMARDs for the treatment of SSP have shown disappointing results. B-cell modulation is clearly a promising therapy for PSS. Many challenges in trial design and execution are evident from the studies reviewed (AU)

Actualización del Documento de Consenso de la Sociedad Española de Reumatología sobre el uso de terapias biológicas en la artritis reumatoide / Update of the Consensus Statement of the Spanish Society of Rheumatology on the management of biologic therapies in rheumatoid arthritis

Objetivo Servir de referencia para reumatólogos e implicados en el tratamiento de la artritis reumatoide que vayan a utilizar o consideren la utilización de terapias biológicas en su manejo. Métodos Las recomendaciones se emitieron siguiendo la metodología de grupos nominales y basadas en revisiones sistemáticas. El nivel de evidencia y el grado de recomendación se clasificaron según el modelo del Center for Evidence Based Medicine de Oxford y el grado de acuerdo se extrajo por técnica Delphi. Resultados Se realizan recomendaciones sobre el uso de los siete agentes biológicos disponibles para la artritis reumatoide en la actualidad en nuestro país. El objetivo del tratamiento es lograr la remisión de la enfermedad lo más precozmente posible. Se revisan las indicaciones y matizaciones del uso de terapias biológicas y cuál debe ser la evaluación previa y la vigilancia del paciente con estos fármacos. Conclusiones Se presentan las actualizaciones a las recomendaciones SER para el uso de terapias biológicas en pacientes con artritis reumatoide(AU)

Objective To provide a reference to rheumatologists and to those involved in the treatment of RA who are using, or about to use biologic therapy. Methods Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and grade of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through Delphi technique. Results We have produced recommendations on the use of the seven biologic agents available for RA in our country. The objective of treatment is to achieve the remission of the disease as quickly as possible. Indications and nuances regarding the use of biologic therapy were reviewed as well as the evaluation that should be performed prior to administration and the follow up of patients undergoing this therapy. Conclusions We present an update on the SER recommendations for the use of biologic therapy in patients with RA(AU)

Tratamiento de situaciones clinicas dificiles en pacientes con artritis reumatoide: cancer / Management of difficult situations in patients with RA: Cancer

Los pacientes con artritis reumatoide (AR) tienen un mayor riesgo del desarrollo de ciertos tipos de cáncer, como linfomas o cáncer de pulmón. La gravedad de la enfermedad se asocia a un mayor riesgo de desarrollo de linfoma. Los agentes anti-TNF-α (tumor necrosis factor alpha ‘factor de necrosis tumoral alfa’) no aumentan la incidencia de cáncer pero pueden desencadenar la aparición de un linfoma en un subgrupo de pacientes con AR. Se ha relacionado el uso de agentes anti-TNF-α con una mayor frecuencia de diagnósticos de cáncer de piel no melanomas. Aunque el metotrexato (MTX) no aumenta la incidencia global de linfoma o de tumores sólidos, su uso se asocia esporádicamente al desarrollo de linfoma. Estos linfomas inducidos por el MTX en ocasiones desaparecen tras suspender el fármaco (AU)

Rheumatoid arthritis (RA) patients have a higher risk of developing some types of cancer, such as lymphoma or lung cancer. The severity of the disease is associated with a higher risk of developing lymphoma. Anti-TNF-α agents do not increase the incidence of neoplasm, but could trigger the onset of lymphoma in a subgroup of RA patients. Anti-TNF-α agents have been associated with a higher frequency of non-melanoma skin cancer. Although methotrexate does not increase the overall incidence of lymphoma or solid neoplasm, its use is sporadically associated with the development of lymphoma. These methotrexate-induced lymphomas occasionally disappear after withdrawal of the drug (AU)

Tratamiento del síndrome del túnel carpiano / Treatment of carpal tunnel syndrome

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