Thorough assessment of the effectiveness of belimumab in a large Spanish multicenter cohort of systemic lupus erythematosus patients.

OBJECTIVES: To provide an overview on the current use of belimumab (BLM) in SLE patients in clinical practice and to examine its efficacy in terms of standardized outcomes, drug survival, as well as patient and safety profiles. METHODS: A longitudinal retrospective multicentre cohort including SLE patients treated with BLM at 18 Spanish centers. Data was collected upon initiation of BLM, at 6 and 12 months after initiation, and at the last recorded visit. Changes in SLEDAI-2K, the proportion of patients who achieved LLDAS and DORIS 2021, and number of flares were compared between visits. Changes in damage, glucocorticoids use and employment status pre-BLM and post-BLM were also assessed. RESULTS: A total of 324 patients were included with a mean follow-up of 3.8 (±2.7) years. LLDAS was attained by 45.8%, 62% and 71% of patients, and DORIS by 24%, 36.2% and 52.5% on successive visits, respectively. Twenty-seven-point two percent of patients were in DORIS ≥ 50% of the visits and a 46% in LLDAS-50. Flares and number of flares were significantly lower one year after treatment with BLM and no changes in damage accrual were observed. Mean (±SD) prednisone dose was significantly reduced over time, with 70 (24%) patients discontinuing GC. CONCLUSION: Our study not only demonstrates belimumab´s efficacy in attaining treat-to-target goals in SLE patients, but also confirms its GC-sparing effect, and its prevention of flares and organ damage accrual.

Prevalence and clinical characteristics of patients with rheumatoid arthritis with interstitial lung disease using unstructured healthcare data and machine learning.

OBJECTIVES: Real-world data regarding rheumatoid arthritis (RA) and its association with interstitial lung disease (ILD) is still scarce. This study aimed to estimate the prevalence of RA and ILD in patients with RA (RAILD) in Spain, and to compare clinical characteristics of patients with RA with and without ILD using natural language processing (NLP) on electronic health records (EHR). METHODS: Observational case-control, retrospective and multicentre study based on the secondary use of unstructured clinical data from patients with adult RA and RAILD from nine hospitals between 2014 and 2019. NLP was used to extract unstructured clinical information from EHR and standardise it into a SNOMED-CT terminology. Prevalence of RA and RAILD were calculated, and a descriptive analysis was performed. Characteristics between patients with RAILD and RA patients without ILD (RAnonILD) were compared. RESULTS: From a source population of 3 176 165 patients and 64 241 683 EHRs, 13 958 patients with RA were identified. Of those, 5.1% patients additionally had ILD (RAILD). The overall age-adjusted prevalence of RA and RAILD were 0.53% and 0.02%, respectively. The most common ILD subtype was usual interstitial pneumonia (29.3%). When comparing RAILD versus RAnonILD patients, RAILD patients were older and had more comorbidities, notably concerning infections (33.6% vs 16.5%, p<0.001), malignancies (15.9% vs 8.5%, p<0.001) and cardiovascular disease (25.8% vs 13.9%, p<0.001) than RAnonILD. RAILD patients also had higher inflammatory burden reflected in more pharmacological prescriptions and higher inflammatory parameters and presented a higher in-hospital mortality with a higher risk of death (HR 2.32; 95% CI 1.59 to 2.81, p<0.001). CONCLUSIONS: We found an estimated age-adjusted prevalence of RA and RAILD by analysing real-world data through NLP. RAILD patients were more vulnerable at the time of inclusion with higher comorbidity and inflammatory burden than RAnonILD, which correlated with higher mortality.

Median nerve compression at elbow level by a proximal cubital artery pseudoaneurysm: a case report

We describe the case of an 82-year-old man who had recently undergone cardiac surgery (quadruple coronary bypass), who consulted due to the appearance of a necrotic eschar on the thumb of the right index finger, together with paraesthesia and hypoaesthesia in the first 3 fingers of the same hand. An ultrasound scan of the right elbow was performed to rule out involvement of the median nerve and an anechoic, thick-walled mass was found, dependent on the wall of the proximal ulnar artery, compatible with a pseudoaneurysm of the same, compressing the nerve. Electromyography showed an acute lesion of the proximal median nerve and angio-CT confirmed the diagnosis of pseudoaneurysm of the proximal ulnar artery. Pseudoaneurysm is a dilatation by rupture of the arterial wall, which does not involve all three layers of the arterial wall and communicates with the vascular lumen. Its development after vascular manipulation is very rare, and it is uncommon for it to act by compressing a nerve structure. In our case, together with vascular surgery, treatment with intralesional thrombin was decided, with good evolution.

Se describe el caso de un varón de 82 arios intervenido recientemente de cirugía cardíaca (cuádruple bypass coronario), que consulta por aparición de una escara necrótica en el pulpejo del dedo índice derecho, junto a parestesias e hipoestesias en los tres primeros dedos de dicha mano. Se realiza una ecografía del codo derecho para descartar afectación del nervio mediano y se objetiva una masa anecoica, de paredes engrosadas, dependientes de la pared de la arteria cubital proximal, compatible con pseudoaneurisma de esta, que comprime dicho nervio. En la electromiografía se evidencia una lesión aguda del nervio mediano a nivel proximal y en el angio-TC se confirma el diagnóstico de pseudoaneurisma de la arteria cubital proximal. El pseudoaneurisma es una dilatación por rotura de la pared arterial, que no implica a las tres capas de esta y se comunica con la luz vascular. Su desarrollo tras una manipulación vascular es muy infrecuente y que actúe comprimiendo una estructura nerviosa es poco común. En nuestro caso, conjuntamente con cirugía vascular se decidió tratamiento con trombina intralesional, con buena evolución.

The impact of disease activity on health-related quality of life in patients with systemic lupus erythematosus.

BACKGROUND AND OBJECTIVE: The aim of this research was to investigate the relationship between disease activity and health-related quality of life (HRQoL) in patients with systemic lupus erythematosus (SLE) considering the increased interest in the management of this disease. MATERIALS AND METHODS: HRQoL was measured at clinic visits during a 12-month follow-up period using questionnaires on fatigue (FACIT-FATIGUE); quality of life, EuroQol 5-dimension (EQ-5D-5L) health questionnaire with 5 levels; disability, Health Assessment Questionnaire (HAQ), and a Global Health Status (GHS) scale. Disease activity, organ damage and other clinical factors that could affect HRQoL were recorded. The association between disease activity and HRQoL was assessed using Bayesian linear regression models with monotonic effects. RESULTS: Data from 70 patients at the baseline visit and 42 patients with 1 year of follow-up were analyzed. At baseline, 28.57% of patients presented Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)>6. In the 70 baseline patients, disease activity was associated with HRQoL in all four parameters. In the 42 patients with 12 months of follow-up, the positive association of disease activity with GHS, FACIT-FATIGUE and EQ-5D-5L and the negative association with HAQ was maintained. Patients who are smokers and those receiving immunosuppressant therapy presented low GHS and FACIT-FATIGUE scores. Moreover, older age at inclusion was significantly associated to low GHS, while low leucocyte and 25-OH-vitamin D levels were associated to fatigue perception in SLE patients. CONCLUSION: Our results showed a statistically significant association between disease activity and HRQoL parameters.

Efecto de diferentes esquemas de terapia de deprivación androgénica sobre la densidad mineral ósea de pacientes con cáncer de próstata / Effect of different schemes of androgen deprivation therapy on bone mass density in prostate cancer patients

Objetivos: Evaluar aspectos del metabolismo óseo basal en pacientes con cáncer de próstata y el efecto, en práctica clínica habitual, de diferentes esquemas de tratamiento (intermitente o continuo) con agonistas de la hormona liberadora de hormona luteinizante (LH-RH) y del denosumab en la evolución de la densidad mineral ósea (DMO).MétodosEstudio observacional retrospectivo de una cohorte de pacientes con cáncer de próstata en tratamiento con agonistas LH-RH, valorados en el servicio de reumatología de un hospital de tercer nivel. Se recogieron datos demográficos, índice de FRAX, esquema de tratamiento LH-RH, tratamiento de osteoporosis, datos de laboratorio y de DMO. Se usaron modelos de regresión lineal de efecto mixto analizando la interacción de los esquemas de tratamiento LH-RH, denosumab y la evolución de DMO.ResultadosSe incluyeron 83 pacientes (73±8años). Evaluación basal: el 16% de los pacientes presentaron osteoporosis densitométrica y además un 27% un riesgo elevado de fractura (FRAX). El 80% tenían niveles de vitaminaD <30ng/l. La pauta intermitente de agonistas LH-RH y los niveles elevados de vitaminaD se asociaron a mejor DMO basal. No se detectó asociación entre la evolución de la DMO y las pautas de tratamiento de agonistas LH-RH, pero sí se encontró una correlación positiva con denosumab.ConclusionesUna elevada proporción de pacientes presentaban un alto riesgo de fractura o niveles insuficientes de vitaminaD no detectados previamente. El estudio tanto del metabolismo óseo como del riesgo de fractura son convenientes en estos pacientes. En práctica clínica habitual el efecto sobre la DMO del denosumab se detecta a corto plazo, mientras que el del esquema intermitente con agonistas LH-RH es menos evidente. (AU)

Objectives: To evaluate the aspects of the basal bone health status in prostate cancer patients. Furthermore, to evaluate in a real-world setting the effect of different schemes (intermittent or continuous) of androgen deprivation therapy (ADT) and the effect of denosumab in bone mass density (BMD).MethodsObservational, retrospective study of a cohort of prostate cancer patients in treatment with luteinizing hormone-releasing hormone (LH-RH) agonists, evaluated in the rheumatology department of a tertiary center. Demographics, FRAX score, LH-RH treatment scheme, osteoporosis treatment, laboratory data and BMD were collected. Mixed effect regression models to analyze the interaction between LH-RH treatment scheme, denosumab and BMD evolution were used.ResultsEighty-three patients (mean age 71±8years) were included. At the basal evaluation, 16% of patients presented densitometric osteoporosis and 27% of patients presented high fracture risk. Eighty percent of patients had inadequate vitaminD levels. VitaminD >30ng/mL was correlated with higher T-scores. There was no association between LH-RH treatment scheme and BMD evolution, however there was a positive association with denosumab.ConclusionA high proportion of patients presented elevated fracture risk or inadequate vitaminD levels, not previously recognized. Bone health assessment and fracture risk evaluation are convenient in these patients. In a real-world setting, the effect of denosumab in BMD is detected, however the effect of intermittent LH-RH schema treatment is less evident. (AU)

[Effect of different schemes of androgen deprivation therapy on bone mass density in prostate cancer patients]. / Efecto de diferentes esquemas de terapia de deprivación androgénica sobre la densidad mineral ósea de pacientes con cáncer de próstata.

OBJECTIVES: To evaluate the aspects of the basal bone health status in prostate cancer patients. Furthermore, to evaluate in a real-world setting the effect of different schemes (intermittent or continuous) of androgen deprivation therapy (ADT) and the effect of denosumab in bone mass density (BMD). METHODS: Observational, retrospective study of a cohort of prostate cancer patients in treatment with luteinizing hormone-releasing hormone (LH-RH) agonists, evaluated in the rheumatology department of a tertiary center. Demographics, FRAX score, LH-RH treatment scheme, osteoporosis treatment, laboratory data and BMD were collected. Mixed effect regression models to analyze the interaction between LH-RH treatment scheme, denosumab and BMD evolution were used. RESULTS: Eighty-three patients (mean age 71±8years) were included. At the basal evaluation, 16% of patients presented densitometric osteoporosis and 27% of patients presented high fracture risk. Eighty percent of patients had inadequate vitaminD levels. VitaminD >30ng/mL was correlated with higher T-scores. There was no association between LH-RH treatment scheme and BMD evolution, however there was a positive association with denosumab. CONCLUSION: A high proportion of patients presented elevated fracture risk or inadequate vitaminD levels, not previously recognized. Bone health assessment and fracture risk evaluation are convenient in these patients. In a real-world setting, the effect of denosumab in BMD is detected, however the effect of intermittent LH-RH schema treatment is less evident.

Real-world Effectiveness and Safety of JAK Inhibitors in Rheumatoid Arthritis: A Single-centre Study / Efectividad y seguridad en el mundo real de los inhibidores de JAK en la artritis reumatoide: Estudio unicéntrico

Background/objective: To assess the effectiveness and safety of Baricitinib and Tofacitinib in rheumatoid arthritis (RA) patients in “real world” conditions. Methods: A single centre retrospective study was performed including RA patients who had initiated treatment with Baricitinib or Tofacitinib from September-2017 to January-2020. Demographic, clinical, laboratory, efficacy and safety variables were collected from baseline and at months 1, 3, 6, 12, 18 and 24. Effectiveness was evaluated by changes from the baseline in DAS28, SDAI, HAQ and acute phase reactants. Safety analysis included adverse events due to any cause, including infection or intolerance. Infection was considered severe if it implied hospitalization. Statistical analysis consisted in Bayesian mixed ordinal regression models including the monotonic effect of each visit and Kaplan–Meier survival curves. Results: Overall, 98 patients were included. A significant reduction of disease activity scores was noted in both groups. No difference between either treatment was detected in terms of effectiveness even in first line, after bDMARD failure, in monotherapy nor combined therapy. A total of 54 adverse events were recorded of which 18 were considered relevant. The incidence of infection, including Herpes Zoster, was similar in both groups. No patients in either group suffered any tuberculosis, thromboembolic event, malignancy, death or cardiovascular adverse events. Survival analysis did not show any difference between groups. Conclusion: Baricitinib and Tofacitinib are both comparable in terms of effectiveness and safety in real world conditions.(AU)

Antecedentes/objetivo: Evaluar la efectividad y seguridad de baricitinib y tofacitinib en los pacientes con artritis reumatoide (AR) en condiciones del «mundo real». Métodos: Se realizó un estudio retrospectivo unicéntrico que incluyó a los pacientes de AR que habían iniciado tratamiento con baricitinib o tofacitinib de septiembre de 2017 a enero de 2020. Se recopilaron las variables demográficas, clínicas, de laboratorio, de eficacia y seguridad a nivel basal, y transcurridos uno, 3, 6, 12, 18 y 24 meses. La efectividad se evaluó mediante los cambios desde el punto basal en cuanto a DAS28, SDAI, HAQ y los reactantes de fase aguda. El análisis de seguridad incluyó los episodios adversos debido a cualquier causa, incluyendo infección o intolerancia. Se consideró infección grave cuando se produjo hospitalización. El análisis estadístico consistió en modelos mixtos de regresión ordinaria de Bayes incluyendo el efecto monotónico de cada visita y las curvas de supervivencia de Kaplan-Meier. Resultados: En total se incluyeron 98 pacientes. Se observó una reducción significativa de la actividad de la enfermedad en ambos grupos. No se detectó diferencia alguna entre ninguno de los tratamientos en términos de efectividad incluso en primera línea, tras el fallo de bDMARD, en monoterapia ni en terapia combinada. Se registró un total de 54 episodios adversos, de los cuales se consideraron relevantes 18. La incidencia de la infección, incluyendo herpes zoster, fue similar en ambos grupos. Ningún paciente de cualquiera de los grupos padeció episodios adversos tales como tuberculosis, episodio tromboembólico, malignidad, muerte ni episodios adversos de tipo cardiovascular. El análisis de supervivencia no reflejó diferencia alguna entre los grupos. Conclusión: Baricitinib y tofacitinib son comparables en términos de efectividad y seguridad en condiciones del mundo real.(AU)

Cardiovascular risk assessment with carotid ultrasound in rheumatoid arthritis

Background/Objective: To assess the Cardiovascular Risk (CV) in Rheumatoid Arthritis (RA) patients using carotid ultrasound additionally to the traditional CV risk factors.MethodsA cross-sectional case control study was performed including RA patients and matched controls. This study was performed from July-2019 to January-2020. Population over 75 years old, established CV disease and/or chronic kidney disease (from III Stage) were excluded. Statistical analysis included a multivariate variance analysis (Manova) and a negative binomial regression adjusted by confounding factors.ResultsOverall, a total of 200 cases and 111 controls were included in the study. Demographical and clinical variables were comparable between groups. A relationship between age, BMI and high blood pressure was detected in both groups. RA patients showed higher intima-media thickness and higher plaque account compared to controls and it was related to the disease duration and DAS28 score.ConclusionRA leads to a higher intima-media thickness, and this is related to the disease duration and DAS28 score. These findings support that RA acts as an independent cardiovascular risk factor. (AU)

Objetivo: Evaluar el riesgo cardiovascular (RCV) en pacientes con artritis reumatoide (AR) mediante el empleo de la ecografía de carótidas en adición a los factores de riesgo cardiovascular clásicos.MétodosSe realizó un estudio de casos y controles transversal incluyendo pacientes con AR y controles voluntarios sin historia de eventos cardiovasculares. El estudio se llevó a cabo entre julio de 2019 y enero de 2020. Se excluyeron individuos con edad por encima de los 75 años, enfermedad cardiovascular establecida y/o enfermedad renal crónica.ResultadosEn total, se incluyeron 200 pacientes con AR y 111 controles. Las variables demográficas y clínicas fueron comparables entre los grupos de estudio. Se halló correlación entre la edad, el IMC y la presencia de hipertensión arterial en ambos grupos. Los pacientes con AR evidenciaron un mayor grosor íntima-media y una mayor presencia de placas en el estudio de ecografía carotídea respecto a los controles y además demostró guardar relación con una mayor duración de la enfermedad.ConclusionesLa AR conlleva el desarrollo de un mayor grosor íntima-media y ello correlaciona con la duración y la actividad de la enfermedad, lo cual apoya que la AR actúa como un factor de riesgo cardiovascular independiente. (AU)

Real-world Effectiveness and Safety of JAK Inhibitors in Rheumatoid Arthritis: A Single-centre Study.

BACKGROUND/OBJECTIVE: To assess the effectiveness and safety of Baricitinib and Tofacitinib in rheumatoid arthritis (RA) patients in "real world" conditions. METHODS: A single centre retrospective study was performed including RA patients who had initiated treatment with Baricitinib or Tofacitinib from September-2017 to January-2020. Demographic, clinical, laboratory, efficacy and safety variables were collected from baseline and at months 1, 3, 6, 12, 18 and 24. Effectiveness was evaluated by changes from the baseline in DAS28, SDAI, HAQ and acute phase reactants. Safety analysis included adverse events due to any cause, including infection or intolerance. Infection was considered severe if it implied hospitalization. Statistical analysis consisted in Bayesian mixed ordinal regression models including the monotonic effect of each visit and Kaplan-Meier survival curves. RESULTS: Overall, 98 patients were included. A significant reduction of disease activity scores was noted in both groups. No difference between either treatment was detected in terms of effectiveness even in first line, after bDMARD failure, in monotherapy nor combined therapy. A total of 54 adverse events were recorded of which 18 were considered relevant. The incidence of infection, including Herpes Zoster, was similar in both groups. No patients in either group suffered any tuberculosis, thromboembolic event, malignancy, death or cardiovascular adverse events. Survival analysis did not show any difference between groups. CONCLUSION: Baricitinib and Tofacitinib are both comparable in terms of effectiveness and safety in real world conditions.

Efectividad de belimumab en el tratamiento de la nefritis lúpica: análisis de 8 casos / Efectiveness of belimumab in the treatment of lupus nephritis: analysis of 8 cases

Introducción y objetivo: Belimumab es un anticuerpo monoclonal aprobado para pacientes con lupus eritematoso sistémico (LES), con indicación reciente para nefritis lúpica (NL).El objetivo es analizar la eficacia de belimumab en pacientes con NL.MétodosEstudio transversal, retrospectivo, que incluye pacientes diagnosticados de LES (criterios SLICC/ACR 2012), con nefritis demostrada mediante biopsia, tratados con belimumab. Se recogieron datos serológicos, función renal (creatinina y filtrado glomerular) y sedimento urinario.ResultadosSe incluyen 8 pacientes con edad media de 37,56 (7,03) años, con 15,13 (8,71) años de evolución de la enfermedad y 4,61 (2,64) años desde el inicio de belimumab.La proteinuria se redujo hasta alcanzar valores normales en 6 pacientes, manteniéndose la función renal estable desde el inicio del tratamiento en todos los casos. Se registró una reducción del nivel de anti-DNA y una normalización del complemento en los casos en que estaba reducido. En uno de los pacientes se registró un aumento del título de anti-DNA, manteniéndose el complemento normal. (AU)

Introduction and objective: Belimumab is a monoclonal antibody targeting BLyS approved for Systemic Lupus Erythematosus (SLE), with recent indication for lupus nephritis (LN).To analyze effectiveness of Belimumab in LN patients.MethodsRetrospective and cross-sectional study including SLE patients (SLICC/ACR 2012 criteria) with LN demonstrated by kidney biopsy, treated with Belimumab. A clinical history review was made and serological data, kidney function and urine sediment were collected.ResultsEight patients with LN demonstrated by kidney biopsy were included. Median age was 37.56 (7.03) years, with 15.13 (8.71) years since SLE diagnosis was made and 4.61 (2.64) years since onset of belimumab.Proteinuria was reduced to normal values in 6 patients, and renal function was stable from the beginning of treatment in all cases. There was a reduction in the anti-DNA level and normalization of complement in those cases in which it was reduced. One patient presented an increase in anti-DNA titer, with normal complement.ConclusionsIn clinical practice, belimumab can improve LN in terms of serological activity, kidney function and urine sediment. (AU)

Utility of cytokines CXCL4, CXCL8 and GDF15 as biomarkers in systemic sclerosis

Background and objectives: Systemic sclerosis (SSc) is an autoinmune disease that can affect several organs and its mortality is fundamentally related to its pulmonary involvement. There are some cytokines with high serum levels of patients with SSc. Our goal is to determine the role of CXCL4, CXCL8 and GDF15 in the physiopathology of SSc and whether they can be considered organic damage biomarkers.Patients and methodsObservational case–control study of SSc patients (ACR/EULAR 2013 criteria). Demographic, clinical, analytical, activity, severity, health perception, and disability variables were collected. Moreover, Videocapillaroscopy, Echocardiography and Respiratory Function Test were made. Serum levels of CXCL4, CXCL8 and GDF15 were measured both in SSc patients and in healthy controls.ResultsA total of 42 patients were included (95.4% women), with an average age of 59.2 years and a median of 4 years from diagnosis. We also included 42 healthy controls. We found significantly higher levels of GDF15 in SSc patients than in controls (p<0.001), but no higher CXCL4 or CXCL8 levels. GDF15 was associated with Diffuse SSc, pulmonary arterial hypertension, interstitial lung disease, less forced vital capacity, high titles of antiScl70, disease activity, and dilated loops in capillaroscopy. CXCL4 levels were associated to a higher Rodnan punctuation, while CXCL8 was associated to C4 fraction consumption and tortuosities in capillaroscopy. (AU)

Antecedentes y objetivos: La esclerosis sistémica (ES) es una enfermedad autoinmunitaria que afecta a diferentes órganos y cuya mortalidad se relaciona fundamentalmente con su afectación pulmonar. Los pacientes con ES presentan niveles séricos elevados de algunas citocinas. Nuestro objetivo es determinar el papel de CXCL4, CXCL8 y GDF15 en la fisiopatología de la ES, y si pueden considerarse biomarcadores de daño orgánico.Pacientes y métodosEstudio observacional de casos-controles, con pacientes afectados de ES (criterios ACR/EULAR 2013) y controles sanos. Se determinaron los niveles séricos de CXCL4, CXCL8 y GDF15 en ambos grupos, y se registraron variables demográficas, clínicas, analíticas, de actividad, gravedad, percepción de salud y discapacidad de pacientes con ES, a quienes, además, se les realizó videocapilaroscopia, ecocardiograma y espirometría.ResultadosSe incluyeron 42 pacientes (95,4% mujeres), con una edad media de 59,2 años y una mediana de 4 años desde el diagnóstico, con 42 controles sanos. Se hallaron niveles significativamente mayores de GDF15 en pacientes con ES que en controles (p<0,001), pero no de CXCL4 ni CXCL8. GDF15 se asoció a ES difusa, hipertensión pulmonar, enfermedad pulmonar intersticial, menor capacidad vital forzada, títulos altos de anti-Scl70, actividad de ES y dilataciones capilares. Asimismo, los niveles de CXCL4 se asociaron a mayor afectación cutánea (Rodnan), mientras que CXCL8 se asoció a consumo de la fracción C4 del complemento y tortuosidades en la capilaroscopia. (AU)

Efectiveness of belimumab in the treatment of lupus nephritis: analysis of 8 cases. / Efectividad de belimumab en el tratamiento de la nefritis lúpica: análisis de 8 casos.

INTRODUCTION AND OBJECTIVE: Belimumab is a monoclonal antibody targeting BLyS approved for Systemic Lupus Erythematosus (SLE), with recent indication for lupus nephritis (LN). To analyze effectiveness of Belimumab in LN patients. METHODS: Retrospective and cross-sectional study including SLE patients (SLICC/ACR 2012 criteria) with LN demonstrated by kidney biopsy, treated with Belimumab. A clinical history review was made and serological data, kidney function and urine sediment were collected. RESULTS: Eight patients with LN demonstrated by kidney biopsy were included. Median age was 37.56 (7.03) years, with 15.13 (8.71) years since SLE diagnosis was made and 4.61 (2.64) years since onset of belimumab. Proteinuria was reduced to normal values in 6 patients, and renal function was stable from the beginning of treatment in all cases. There was a reduction in the anti-DNA level and normalization of complement in those cases in which it was reduced. One patient presented an increase in anti-DNA titer, with normal complement. CONCLUSIONS: In clinical practice, belimumab can improve LN in terms of serological activity, kidney function and urine sediment.

Real-world evidence of tofacitinib in rheumatoid arthritis patients in Spain.

The purpose of this narrative review is to provide an overview of the real-world data on the use of tofacitinib in patients with active rheumatoid arthritis (RA) in Spain. Sixteen retrospective studies carried out in Spain between 2019 and 2021 have been analyzed, considering patients' characteristics, and treatment patterns, effectiveness, and safety. In those studies, approximately 511 patients received tofacitinib during the study period. They were predominantly women (mean age: 48-61 years). The percentage of patients receiving tofacitinib as monotherapy ranged between 20.0% and 67.9%. Only five studies reported the combined use of corticosteroids (42.0-84.5% of patients), with a mean dose varying from 1.8 to 7.2 mg. A wide range of patients (36.0-85.7%) had failed a previous biological disease-modifying anti-rheumatic drug. The most frequent reason for treatment discontinuation was the lack of efficacy, and the most common adverse event described was herpes zoster infection. Real-world studies complement clinical trials by adding efficacy and safety data in real-world settings to the benefit/risk profile of the drug. The profile of RA patients receiving tofacitinib in Spain has similarities with other real-world studies conducted in other countries.

Cardiovascular risk assessment with carotid ultrasound in rheumatoid arthritis.

BACKGROUND/OBJECTIVE: To assess the Cardiovascular Risk (CV) in Rheumatoid Arthritis (RA) patients using carotid ultrasound additionally to the traditional CV risk factors. METHODS: A cross-sectional case control study was performed including RA patients and matched controls. This study was performed from July-2019 to January-2020. Population over 75 years old, established CV disease and/or chronic kidney disease (from III Stage) were excluded. Statistical analysis included a multivariate variance analysis (Manova) and a negative binomial regression adjusted by confounding factors. RESULTS: Overall, a total of 200 cases and 111 controls were included in the study. Demographical and clinical variables were comparable between groups. A relationship between age, BMI and high blood pressure was detected in both groups. RA patients showed higher intima-media thickness and higher plaque account compared to controls and it was related to the disease duration and DAS28 score. CONCLUSION: RA leads to a higher intima-media thickness, and this is related to the disease duration and DAS28 score. These findings support that RA acts as an independent cardiovascular risk factor.

CT-Guided Needle Biopsy in Vertebral Osteomyelitis: Study of Factors That Could Influence in Culture Yield.

OBJECTIVE: The aim of this study was to analyze which are the main factors that could influence the result of a CT guided biopsy in vertebral osteomyelitis (VO) patients. METHODS: A single center retrospective observational study was performed including adult patients who had been diagnosed with VO and undergone CT guided needle biopsy from January 2010 to January 2020. Demographical features, concurrent diseases, laboratory findings, microbiological diagnosis, radiological data, medical complications, antibiotic exposure were compiled. Multivariate analysis was performed with a logistic regression comparing the patients depending on the culture result. RESULTS: Seventy-seven patients were included in the study. Baseline characteristics were comparable between groups. Sample culture was positive in 43 cases (56%). Microorganism isolated were gram+(72%), gram-(14%), mycobacteria (7%) and fungi (7%). Delay in the procedure, antibiotic exposure and blood culture positivity were also similar among both groups. The biopsy results were not influenced by the CRP value, the presence of fever nor antibiotic exposure. The longer duration of back pain was associated to a lower probability of a positive culture. CONCLUSIONS: In conclusion, our study displays an acceptable reliability of CT guided needle biopsy in VO patients, even in cases under antibiotic treatment. The presence of fever or CRP values did not predict a positive culture. Delay in diagnosis could impact negatively on culture yield.

Utility of cytokines CXCL4, CXCL8 and GDF15 as biomarkers in systemic sclerosis.

BACKGROUND AND OBJECTIVES: Systemic sclerosis (SSc) is an autoinmune disease that can affect several organs and its mortality is fundamentally related to its pulmonary involvement. There are some cytokines with high serum levels of patients with SSc. Our goal is to determine the role of CXCL4, CXCL8 and GDF15 in the physiopathology of SSc and whether they can be considered organic damage biomarkers. PATIENTS AND METHODS: Observational case-control study of SSc patients (ACR/EULAR 2013 criteria). Demographic, clinical, analytical, activity, severity, health perception, and disability variables were collected. Moreover, Videocapillaroscopy, Echocardiography and Respiratory Function Test were made. Serum levels of CXCL4, CXCL8 and GDF15 were measured both in SSc patients and in healthy controls. RESULTS: A total of 42 patients were included (95.4% women), with an average age of 59.2 years and a median of 4 years from diagnosis. We also included 42 healthy controls. We found significantly higher levels of GDF15 in SSc patients than in controls (p<0.001), but no higher CXCL4 or CXCL8 levels. GDF15 was associated with Diffuse SSc, pulmonary arterial hypertension, interstitial lung disease, less forced vital capacity, high titles of antiScl70, disease activity, and dilated loops in capillaroscopy. CXCL4 levels were associated to a higher Rodnan punctuation, while CXCL8 was associated to C4 fraction consumption and tortuosities in capillaroscopy. CONCLUSIONS: GDF15 high levels were associated with diffuse SSc, lung impairment, disease activity and changes in capillaroscopy. Moreover, CXCL4 was only associated with skin impairment, while CXCL8 was not related to organic damage.

CT-Guided Needle Biopsy in Vertebral Osteomyelitis: Study of Factors That Could Influence in Culture Yield / Punción asistida por TC en pacientes con osteomielitis vertebral: análisis de los factores que condicionan su rentabilidad

Objective: The aim of this study was to analyze which are the main factors that could influence the result of a CT guided biopsy in vertebral osteomyelitis (VO) patients. Methods: A single center retrospective observational study was performed including adult patients who had been diagnosed with VO and undergone CT guided needle biopsy from January 2010 to January 2020. Demographical features, concurrent diseases, laboratory findings, microbiological diagnosis, radiological data, medical complications, antibiotic exposure were compiled. Multivariate analysis was performed with a logistic regression comparing the patients depending on the culture result. Results: Seventy-seven patients were included in the study. Baseline characteristics were comparable between groups. Sample culture was positive in 43 cases (56%). Microorganism isolated were gram+(72%), gram−(14%), mycobacteria (7%) and fungi (7%). Delay in the procedure, antibiotic exposure and blood culture positivity were also similar among both groups. The biopsy results were not influenced by the CRP value, the presence of fever nor antibiotic exposure. The longer duration of back pain was associated to a lower probability of a positive culture. Conclusions: In conclusion, our study displays an acceptable reliability of CT guided needle biopsy in VO patients, even in cases under antibiotic treatment. The presence of fever or CRP values did not predict a positive culture. Delay in diagnosis could impact negatively on culture yield.(AU)

Objetivo: El propósito del presente estudio es analizar qué factores pueden influir en el resultado del cultivo de las muestras obtenidas por punción guiada por TC en pacientes con osteomielitis vertebral. Métodos: Se realizó un estudio en un único centro, retrospectivo y observacional en pacientes diagnosticados de osteomielitis vertebral, que fueron subsidiarios de punción-biopsia entre enero de 2010 y enero de 2020. Se recogieron para su análisis, variables demográficas, comorbilidades, resultados de laboratorio, radiología, el tratamiento previo con antibióticos y la demora previa a la realización de la técnica. Se realizó un análisis multivariante mediante regresión logística. Resultados: Se incluyó a un total de 77 pacientes que fueron sometidos a la técnica. Sus características basales fueron similares. El cultivo fue positivo en 43 casos (56%). Los microorganismos aislados fueron gram + (72%), gram – (14%), micobacterias (7%) y hongos (7%). El retraso en la ejecución de la técnica y el tratamiento previo con antibióticos fue similar en ambos grupos. Ni el valor de PCR, la presencia de fiebre ni la antibioterapia tuvieron influencia en el resultado del cultivo. Se observó que una mayor duración del dolor lumbar se relacionó con una menor probabilidad de obtener un resultado positivo en el cultivo. Conclusiones: Incluso bajo exposición antibiótica, la punción asistida por TC mostró una rentabilidad aceptable. La presencia de fiebre o valores elevados de PCR no fueron predictivos de positividad del cultivo. El retraso diagnóstico sí podría impactar negativamente en la rentabilidad diagnóstica del cultivo procedente de la biopsia.(AU)

Influence of the EULAR recommendations for the use of imaging in large vessel vasculitis in the diagnosis of giant cell arteritis: results of the ARTESER register.

OBJECTIVE: The main study objective was to determine how giant cell arteritis (GCA) is diagnosed in our clinical practice and whether the EULAR recommendations have influenced the diagnostic procedures used. METHODS: ARTEritis of the Rheumatology Spanish Society -Sociedad Española de Reumatología (ARTESER) is a multicentre observational retrospective study conducted in 26 hospitals with support from the Spanish Society of Rheumatology. All patients diagnosed with GCA between 1 June 2013 and 29 March 2019 were included. The gold standard for the diagnosis of GCA was the judgement of the physician in charge, according to clinical criteria, supported by data available from laboratory tests, imaging studies (ultrasound, positron emission tomography (PET) and MRI/CT angiography) and temporal artery biopsy (TAB) when available. RESULTS: We included 1675 patients with GCA (mean age±SD (76.9±8.1) years, 1178 women (70.3%)). Of these, 776 patients had a positive TAB (46.3%), 503 (30.0%) positive ultrasound, 245 positive PET (14.6%) and 64 positive MRI/CT angiography (3.8%). These percentages changed substantially over the study. From 2013 to 2019, the use of ultrasound in diagnosis grew from 25.8% to 52.9% and PET from 12.3% to 19.6%, while use of TAB decreased from 50.3% to 33.3%. CONCLUSIONS: Biopsy was the most widely used diagnostic test for confirming GCA, but use of imaging as a diagnostic tool has grown in recent years. Following publication of the 2018 EULAR recommendations, ultrasound has displaced biopsy as the first-line diagnostic test; TAB was performed in a third and PET in a fifth of cases.

Decreased DNA hydroxymethylation and increased DNA demethylation are associated with high antioxidant response in systemic lupus erythematosus patients / Asociación entre la disminución de hidroximetilación y el incremento de la desmetilación del ADN y la respuesta antioxidante en los pacientes de lupus eritematoso sistémico

Objectives: DNA hydroxymethylation may be induced by oxidative stress in lupus patients, so we investigated the association between DNA hydroxymethylation and demethylation with the antioxidant response.MethodsA case–control study was performed including lupus patients and matched healthy controls. Serum concentration of glutathione (GSH), glutathione disulphide (GSSG), superoxide dismutase (SOD) and total antioxidant capacity (TAC), 5-mC and 5-hmC were determined.ResultsOne hundred and forty-two patients and 34 controls were included. 5-hmC levels were lower in SLE patients than in controls. GSH and GSSG values were lower in patients, while SOD levels were higher in patients. TAC did not show significant differences, but higher demethylation and lower hydroxydemethylation were associated to increased TAC values. Lower demethylation was associated with cytopenia and lower hydroxymethylation with longer course of the disease. Lower levels of GSH and GSSG and higher SOD values were associated with accumulated damage assessed by SLICC-ACR.ConclusionsLower hydroxymethylation in patients than in controls was observed. Moreover, higher demethylation and lower hydroxymethylation leads to high TAC levels. DNA hydroxymethylation seems to be related to longer course of the disease. (AU)

Objetivos: La hidroximetilación del ADN puede estar inducida por el estrés oxidativo en pacientes de lupus, por lo que estudiamos la asociación entre hidroximetilación del ADN y desmetilación sin respuesta antioxidante.MétodosSe realizó un control de casos que incluyó a pacientes de lupus pareados con controles sanos. Se calcularon la concentración sérica de glutatión (GSH), glutatión disulfuro (GSSG), superóxido dismutasa (SOD), capacidad antioxidante total (CAT), 5-mC y 5-hmC.ResultadosSe incluyeron 142 pacientes y 34 controles. Los niveles de 5-hmC fueron menores en el grupo de pacientes de LES que en el de controles. Los valores de GSH y GSSG fueron menores en el grupo de pacientes, mientras que los valores de SOD fueron superiores en el grupo de pacientes. La CAT no reflejó diferencias significativas, pero el incremento de desmetilación y la disminución de hidroximetilación estuvieron asociados al incremento de los valores de la CAT. La disminución de la desmetilación estuvo asociada a citopenia, y la disminución de la hidroximetilación a un curso más corto de la enfermedad. Los niveles menores de GSH y GSSG, y los valores superiores de SOD estuvieron asociados a una acumulación del daño, según lo evaluado mediante SLICC-ACR.ConclusionesSe observó menor hidroximetilación en los pacientes que en los controles. Además, el incremento de la desmetilación y la disminución de la hidroximetilación conllevan unos altos niveles de CAT. La hidroximetilación del ADN parece estar relacionada con un curso más largo de la enfermedad. (AU)