Recommendations by the Spanish Society of Rheumatology on risk management of biological treatment and JAK inhibitors in patients with rheumatoid arthritis.

OBJECTIVE: To present recommendations based on the available evidence and the consensus of experts, for risk management of biological treatment and JAK inhibitors in patients with rheumatoid arthritis. METHODS: Clinical research questions relevant to the purpose of the document were identified. These questions were reformulated in PICO format (patient, intervention, comparison, outcome or outcome) by a panel of experts, selected based on their experience in the area. A systematic review of the evidence was carried out, grading according to the GRADE criteria (Grading of Recommendations Assessment, Development, and Evaluation). Specific recommendations were then formulated. RESULTS: 6 PICO questions were proposed by the panel of experts based on their clinical relevance and the existence of recent information regarding the risk of occurrence of serious infections, the risk of reactivation of the hepatitis B virus, the risk of reactivation of the virus varicella-zoster, the risk of appearance of skin (melanoma and non-melanoma) or haematological cancer, the risk of appearance of thromboembolic disease and the risk of progression of the human papilloma virus. A total of 28 recommendations were formulated, structured by question, based on the evidence found and the consensus of the experts. CONCLUSIONS: The SER recommendations on risk management of treatment with biologic therapies and JAK inhibitors in rheumatoid arthritis are presented.

Efficacy and safety of biological therapy compared to synthetic immunomodulatory drugs or placebo in the treatment of Behçet's disease associated uveitis: a systematic review.

The aim of this study is to compare the efficacy and safety of biological therapy with cyclosporin A (CsA), azathioprine (AZA), or placebo in uveitis flares and other ocular outcomes in patients with Behçet disease. A comprehensive and sensitive search in MEDLINE, EMBASE, and the Cochrane Library was performed. We selected articles including: (1) adult patients with Behçet's and uveitis; (2) on biological therapies; (3) placebo or active control with CsA or AZA; (4) analyzing efficacy (number of uveitis flares, macular edema, etc.) and/or safety outcomes. Meta-analyses, systematic reviews, clinical trials, and observational studies with > 10 patients were included. The selection, data collection and quality assessment (Oxford scale) was carried out by 2 reviewers independently. Nine articles of moderate quality were included (6 randomized clinical trials and 3 retrospective studies) involving 378 patients. Most of them, apart from the study drugs received systemic corticosteroids and other immunosuppressant drugs. Infliximab was more effective than CsA in reducing short-term uveitis flares and severe complications of retinal vasculitis in the long term. Rituximab was similar to a combination of cytotoxic drugs in improving inflammatory activity. In patients with active uveitis adalimumab was associated with a lower risk of uveitic flare or visual impairment, and in patients with inactive uveitis to a significantly lowered the risk of flare upon corticosteroid withdrawal. Secukinumab and daclizumab were not superior to placebo in reducing uveitis flares, like interferonα compared to other drugs. Our results highlight the need for better designed comparative studies on Behçet's uveitis.

The effect of smoking on clinical and structural damage in patients with axial spondyloarthritis: A systematic literature review.

OBJECTIVES: To evaluate the association between smoking and clinical parameters and structural damage in axial spondyloarthritis (axSpA). METHODS: We systematically searched MEDLINE, EMBASE and Cochrane Library till November 2015. We selected articles that analysed the smoking impact on disease activity, functional status, structural damage, physical mobility and life quality. Independent extraction of articles by 2 authors using predefined data fields was performed. Studies quality was graded according to the Oxford Level of Evidence scale. RESULTS: A total of 17 articles were selected for inclusion: 2 case-control, 11 cross-sectional and 4 prospective cohort studies, which analysed 4694 patients. Weak evidence suggested a smoking effect on pain, overall assessment of health, disease activity, physical mobility and life quality in ankylosing spondylitis (AS). Moderate-good evidence revealed higher HAQ-AS among smokers (0.025units/y; 95% CI: 0.0071-0.0429; p = 0.007). Every additional unit of ASDAS resulted in an increase of 1.9 vs. 0.4 mSASSS units/2y in AS smokers vs. non-smokers. Good evidence revealed that cigarette smoking and smoking intensity was associated with spinal radiographic progression in axSpA [mSASSS ≥2 units/2y: OR = 2.75, 95% CI: 1.25-6.05, p=0.012; mSASSS progression in heavy smokers (>10 cigarettes/d): OR = 3.57, 95% IC: 1.33-9.60, p = 0.012]. CONCLUSIONS: Published data indicate that smoking has a dose-dependent impact on structural damage progression in axSpA. There is worse HAQ among AS smokers compared to non-smokers. Respect to pain, overall assessment of health, disease activity, physical mobility and life quality, although the evidence level is poor, all evidence points in the same direction: smoking AS patients are worse than non-smoking.

Elbow clinical, ultrasonographic and radiographic study in patients with inflammatory joint diseases.

The main objective of this cross-sectional observational study was to investigate the relationship between clinical, ultrasonographic (US) and radiographic elbow features in patients with inflammatory joint diseases (IJD). The secondary objective was to evaluate the association between regional clinical elbow diagnoses and imaging findings. Consecutive patients with IJD attending follow-up visits were assessed for elbow pain and standardized elbow examination. Seven regional clinical diagnoses were defined. Digital elbow radiographs were read for 9 abnormalities. A standardized elbow grayscale (GS) and power Doppler (PD) scan recorded 13 defined abnormalities. Analysis encompassed 361 clinical, 361 US and 340 radiographic elbow assessments from 181 patients. US and clinical assessments showed an overall higher agreement than radiographic and clinical assessments (68.8 vs 59.1%, p = 0.001). When structural US abnormalities were compared with radiographic findings, agreement was slightly higher than when comparing all US abnormalities with radiographic findings (77.3%, k 0.533 and 73.5%, k 0.492). Enthesophytes, the most common abnormalities, were not associated with clinical findings. Subclinical US-synovitis and US-enthesopathy were found, respectively, in 17.3 and 14.1% of the clinically normal elbows. Clinical elbow arthritis prevalence and bias-adjusted kappa (PABAK) agreement was good for radiographic fat pad sign, PD-synovitis and GS-synovitis. Clinical elbow enthesopathy PABAK agreement was moderate for GS-enthesopathy and radiographic calcifications. US showed acceptable agreement with clinical and radiographic assessments for detecting elbow inflammatory and structural abnormalities in patients with IJD. Because US detected more abnormalities than radiography and has the capability to detect more subclinical abnormalities, US may be potentially used as a first-line elbow diagnostic tool in this clinical setting.

¿El control precoz de la artritis reumatoide augura un mejor pronóstico a largo plazo? / Does early treatment of Rheumatoid Arthritis lead to a better long-term prognosis?

El tiempo es una dimensión de importancia capital en la mayoría de las enfermedades crónicas y, especialmente, en las enfermedades reumáticas inflamatorias, donde influye en muchos aspectos. El tratamiento precoz de la artritis reumatoide es esencial, debido a que el proceso destructivo articular comienza muy pronto, en las primeras semanas o meses, y la actividad inflamatoria mantenida en el tiempo es responsable de todas las consecuencias de la enfermedad. La introducción de fármacos nuevos con una acción más rápida y eficaz, como los fármacos biológicos anti-TNF, ha supuesto un cambio radical en la estrategia de tratamiento de la artritis reumatoide, permitiendo, incluso, que la inducción de la remisión y la detención del proceso destructivo articular sean unos objetivos posibles (AU)

Time is a crucial dimension in most chronic diseases, especially in inflammatory rheumatic disease, which it affects in many ways. Early treatment in rheumatoid arthritis (RA) is an essential issue, as joint damage occurs within the first weeks or months of the disease process and inflammatory activity maintained over time is responsible for all of the consequences of the disease. The introduction of new drugs with faster and more effective action, such as tumor necrosis factor (TNF) inhibitors, has represented a major shift in the strategy of RA treatment, allowing the clinician to aim for remission and prevention of structural damage as realizable goals (AU)

[Does early treatment of Rheumatoid Arthritis lead to a better long-term prognosis?]. / ¿El control precoz de la artritis reumatoide augura un mejor pronóstico a largo plazo?

Time is a crucial dimension in most chronic diseases, especially in inflammatory rheumatic disease, which it affects in many ways. Early treatment in rheumatoid arthritis (RA) is an essential issue, as joint damage occurs within the first weeks or months of the disease process and inflammatory activity maintained over time is responsible for all of the consequences of the disease. The introduction of new drugs with faster and more effective action, such as tumor necrosis factor (TNF) inhibitors, has represented a major shift in the strategy of RA treatment, allowing the clinician to aim for remission and prevention of structural damage as realizable goals.

¿Cómo son los pacientes con artritis reumatoide de reciente comienzo en España? Descripción de la cohorte PROAR / What are patients with early rheumatoid arthritis like in Spain? Description of the PROAR cohort

Fundamento y objetivo Identificación de factores presentes en la artritis de reciente comienzo que puedan ayudar a predecir el desarrollo o no de artritis reumatoide (AR). Descripción de las características clínicas de una cohorte de AR de inicio. Pacientes y método Cohorte de inicio prospectiva de 5 años de duración en 34 servicios de reumatología españoles formada por pacientes con oligoartritis y poliartritis de menos de 1 año de evolución no tratados previamente. A todos los pacientes se les realizó al inicio una valoración de la actividad inflamatoria, capacidad funcional y factores de riesgo de AR. Además se realizaron radiografías de manos y pies y determinaciones de factor reumatoide (FR) y de anticuerpos anti-CCP. Tras 3 años, se evaluó el diagnóstico definitivo y las variables que determinaron la evolución hacia AR. Resultados Se incluyó a 171 pacientes, de los que 161 (94,2%) acabaron cumpliendo criterios diagnósticos de AR, la mayoría (157; 97,5%) en la visita inicial. Los factores relacionados con el diagnóstico de AR fueron: el FR positivo (odds ratio [OR]=8,5; intervalo de confianza [IC] del 95%, 1–69,8), los anti-CCP (OR=8,5; IC del 95%, 0,96–75,7) y el DAS28 (OR=1,9; IC del 95%, 1,1–3,3). El 65% de los pacientes presentaban erosiones en la visita basal. Conclusiones Tanto la extensión de la afección articular como tener un FR positivo y anticuerpos anti-CCP permiten predecir la evolución a AR. El daño radiológico, en muchos pacientes, ya está al inicio, por lo que es más importante un tratamiento contundente precoz que esperar a tener un diagnóstico de AR (AU)

Objective To identify factors present in recent onset arthritis that may help to predict rheumatoid arthritis (RA), and to describe a cohort of recent onset RA. Patients and method A 5 year prospective cohort of patients with early oligo and polyarthritis (< 1 year of evolution) from 34 rheumatology units, was studied. Sociodemographic, clinical features and RA risk factors were recorded. Rheumatoid factor (RF), anti-CCP determinations and radiographs of hands and feet were analyzed too. After three years, a diagnosis of certainty and the variables that determined the evolution to RA, were evaluated. Results One hundred and seventy one patients were included; 161 (94.2%) fulfilled RA diagnostic criteria; most of them (157; 97.5%) in the first visit. Factors associated with RA diagnosis were: positive RF, anti-CCP and DAS-28; 65% of the patients had radiological erosions in the first visit. Conclusions Positive RF, anti-CCP and the disease activity are predictive factors of RA. Radiological damage exists very early in most of patients, that's why it is more important to treat the disease aggressively instead than achieving an RA diagnosis of certainty (AU)

[What are patients with early rheumatoid arthritis like in Spain? Description of the PROAR cohort]. / ¿Cómo son los pacientes con artritis reumatoide de reciente comienzo en España? Descripción de la cohorte PROAR.

OBJECTIVE: To identify factors present in recent onset arthritis that may help to predict rheumatoid arthritis (RA), and to describe a cohort of recent onset RA. PATIENTS AND METHOD: A 5 year prospective cohort of patients with early oligo and polyarthritis (< 1 year of evolution) from 34 rheumatology units, was studied. Sociodemographic, clinical features and RA risk factors were recorded. Rheumatoid factor (RF), anti-CCP determinations and radiographs of hands and feet were analyzed too. After three years, a diagnosis of certainty and the variables that determined the evolution to RA, were evaluated. RESULTS: One hundred and seventy one patients were included; 161 (94.2%) fulfilled RA diagnostic criteria; most of them (157; 97.5%) in the first visit. Factors associated with RA diagnosis were: positive RF, anti-CCP and DAS-28; 65% of the patients had radiological erosions in the first visit. CONCLUSIONS: Positive RF, anti-CCP and the disease activity are predictive factors of RA. Radiological damage exists very early in most of patients, that's why it is more important to treat the disease aggressively instead than achieving an RA diagnosis of certainty.

[Variations in the drug treatment of rheumatoid arthritis in Spain]. / Variabilidad en el tratamiento farmacológico de la artritis reumatoide en España.

BACKGROUND: Variations in the use of healthcare resources can result in differences in the outcome of rheumatoid arthritis (RA). The emAR study was developed to determine variations in the management of socio-sanitary resources, including drugs use, in patients with this disorder. PATIENTS AND METHOD: The clinical records of 1,379 patients, randomly selected among all RA patients attended in Spanish hospitals, were reviewed. Information about prescription of disease modifying anti-rheumatic drugs (DMARD), non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, analgesics, gastric protectors and drugs for osteoporosis was collected. In addition, socio-demographic- and disease-related information, as well as data from hospitals, medical units and responsible physicians were also obtained in each patient. RESULTS: There was a high level of DMARD and NSAID prescription that was associated with patient or disease characteristics. Treatment with corticosteroids, as well as with the remaining drugs, showed a substantial regional variability, which may be related to physician-associated variables as well as to patient- and disease-associated characteristics. CONCLUSIONS: Variability in the management of therapeutic resources in RA patients mainly depends on the characteristics of the patient or the disease. There is also a variation that is influenced by physician's characteristics; in some cases, the available scientific evidence may not support this variability.

Variabilidad en el tratamiento farmacológico de la artritis reumatoide en España / Variations in the treatment of rheumatoid arthritis in Spain

FUNDAMENTO: La variabilidad en el uso de recursos sanitarios puede tener consecuencias en el desenlace de la artritis reumatoide (AR). El estudio en AR se desarrolló para conocer la variabilidad en el empleo de diferentes recursos sociosanitarios, entre ellos el de fármacos, en pacientes con esta enfermedad. PACIENTES Y MÉTODO: Se revisaron las historias clínicas de 1.379 pacientes seleccionados de forma aleatoria entre los atendidos en hospitales de todo el Estado español. Se recogió la prescripción de fármacos modificadores de la enfermedad (FME), antiinflamatorios no esteroideos (AINE), glucocorticoides, analgésicos, infiltraciones, protectores gástricos y fármacos para la osteoporosis durante los dos últimos años. Además se recabaron datos sociodemográficos y de la enfermedad en cada paciente, así como datos del hospital, servicio y médico responsable. RESULTADOS: El uso de FME y AINE está muy extendido en España y se relaciona con variables dependientes del paciente o la enfermedad. El uso de glucocorticoides presenta, al igual que el resto de tratamientos, una notable variabilidad regional, probablemente relacionada con variables dependientes del médico responsable, además de con las del paciente o la enfermedad. CONCLUSIONES: La variabilidad en el uso de recursos terapéuticos en pacientes con AR depende mayoritariamente de las características del paciente o la enfermedad. Pero existe una variabilidad dependiente del médico que, en algunos casos, podría ir en contra de la evidencia científica disponible. (AU)

Factores pronósticos de la artritis reumatoide / Prognostic factors in rheumatoid arthritish

No disponible

Presencia de anticuerpos anticardiolipina en el curso de un proceso de poliartritis por Parvovirus B19 / Anticardiolipin antibodies in a patient with polyarthritis due to Parvovirus B19 infection

No disponible