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Aim: To assess the golimumab retention rate during up to 8 years of follow up, and any associated factors. Methods: Retrospective analysis of the BIOBADASER (Spanish registry of biological drugs) database, assessing all adults who had ever started golimumab >6 months before the analysis for an approved indication (rheumatoid arthritis [RA], axial spondyloarthritis [SpA] or psoriatic arthritis [PsA]). Results: Among 885 patients (RA 267, axial SpA 370, PsA 248) receiving 944 cycles of golimumab, the retention rate of golimumab was 71.1% (95% confidence interval: 68.0–73.9) at year 1% and 37.7% (95% CI: 33.3–42.1) at year 7 and at year 8. Retention was higher when golimumab was used as the first biological drug (81.7% at year 1, 49.9% at year 7, p < 0.001). In Cox regression analysis, factors associated with golimumab retention included use as first‐line therapy (hazard ratio [HR] for discontinuation 1.52 for second‐ and 1.79 for third/later‐line vs. first‐line), use in axial SpA or PsA rather than RA (HR for axial SpA vs. RA 0.59, for PsA vs. Rheumatoid arthritis 0.67), and treatment with concomitant methotrexate (HR 0.67). Factors associated with golimumab discontinuation were corticosteroid use (HR 1.46) and disease activity above median (HR 1.29) at golimumab initiation. Conclusion: Based on this retrospective analysis of the BIOBADASER registry, nearly two‐fifths (37.7%) of adult rheumatology patients initiating golimumab will remain on treatment for 8 years, with a higher probability of retention in axial SpA or PsA indications and when golimumab is used as first biologic. [ABSTRACT FROM AUTHOR]

Objective: The persistence of biologic (b) and targeted synthetic (ts) disease‐modifying antirheumatic drugs(DMARDs) in monotherapy versus in combination with conventional synthetic (cs) DMARDs is still a controversial topic in rheumatic diseases. To clarify this issue, the retention of the initial treatment strategy of b/tsDMARD in combination with csDMARD versus monotherapy in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients under real‐life conditions was evaluated. Factors associated with maintenance of the initial strategy were analysed. Methods: Nested cohort study within the Spanish BIOBADASER III registry. Bivariate comparisons and multivariate Cox proportional hazards models were used for the analyses. Results: A total of 2521 patients were included in the study. In the multivariate model, the initial strategy of combination therapy was associated with shorter persistence in patients with RA (hazard ratio [HR] 1.58;95% confidence interval [CI] 1.00–2.50; p =.049), PsA (HR 2.48; 95% CI 1.65–3.72) and AS (HR 16.77; 95% CI 7.37–38.16; p <.001), regardless of sex, time of disease progression, baseline disease activity, glucocorticoid use or type of b/tsDMARD. Overall, the combination strategy was associated with an increased incidence of adverse events (incidence rate ratio [IRR] 1.13; 95% CI 1.05–1.21). Conclusions: In this real‐life study, the strategy of combining a b/tsDMARD with a csDMARD is associated with lower persistence and worse safety profile compared to monotherapy in RA and especially in PsA and AS, suggesting that combination therapy should be rethought as first choice in RA patients, but especially in PsA and AS patients. [ABSTRACT FROM AUTHOR]

Introduction: Tocilizumab (TCZ) treatment is associated with dyslipidaemia, including a rise in triglycerides through a mechanism poorly understood. Three molecules play key roles in the regulation of triglyceride metabolism: apolipoprotein C‐III (ApoC‐III), angiopoietin‐like protein 4(ANGPLT4) and lipoprotein lipase (LPL). The aim of this work was to analyse whether the changes in triglycerides shown by TCZ‐treated RA patients could stem from the dysregulation that can occur in these regulatory molecules. Methods: Twenty‐seven RA patients included in the TOCRIVAR study who received TCZ (8 mg/kg IV/q4w) were evaluated at baseline and at Weeks 12, 24 and 52 of treatment. ANGPTL4, ApoC‐III and LPL, a complete lipid profile and RA disease activity, were analysed at baseline and at each visit. Multivariable linear mixed models were performed to study changes over time in lipids and regulatory molecules. Results: After 24 weeks of TCZ treatment, HDL cholesterol, apolipoprotein A1 and triglycerides increased, whereas lipoprotein (a) decreased significantly from baseline values. However, 1 year after TCZ, no significant differences in lipid pattern were observed with respect to baseline. Serum ANGPTL4 and Apo‐CIII levels decreased gradually over time, both being significantly lower than baseline values at Week 52. LPL concentration did not change significantly during TCZ treatment. Remarkably, the elevation of triglycerides at Week 24 maintained its statistical significance after adjusting for the changes in ApoC‐III, ANGPTL4 and LPL. Conclusion: In TCZ‐treated RA patients basal serum levels of ANGPLT4 and ApoC‐III, but not LPL, decreased significantly. However, the elevation of triglycerides after TCZ was not related to changes in these regulatory molecules. [ABSTRACT FROM AUTHOR]

Cholesterol efflux capacity (CEC), the ability of high-density lipoprotein (HDL) cholesterol to accept cholesterol from macrophages, has been linked to cardiovascular events. Systemic lupus erythematosus (SLE) is characterized by the consumption of complement (C) proteins and has been associated with an increased risk of cardiovascular disease. CEC is reduced in SLE patients compared to controls. In the present work, our objective was to analyze whether the disruption of C influences CEC in patients with SLE. New-generation functional assays of the three pathways of the C system were performed in 207 patients with SLE. Additionally, serum levels of inactive (C1q, C2, C3, C4, and factor D) and activated (C3a) molecules, and regulators (C1-inhibitor and factor H) of C system were measured. CEC, using an in vitro assay, and lipoprotein serum concentrations were assessed. Multivariable linear regression analysis was performed to assess the relationship between C system and CEC. After full multivariable analysis, the alternative C cascade functional test showed a significant and negative relationship with CEC. This was also the case for C2 and C3, in which the associations were found to be positive and statistically significant, after adjustment for covariates. In conclusion, C system and CEC are interconnected in patients with SLE. [ABSTRACT FROM AUTHOR]

Glucocorticoids are associated with serious side effects related to dosing and time of use. Unfortunately, there is no standard method for determining glucocorticoid exposure, especially in patients undergoing long-term treatment. The aim of this work was to create a free and easy-to-use web application to calculate, in a systematic way, the total cumulative dose of corticosteroids. The total cumulative dose is calculated as the sum of all periods of treatment with different doses of corticosteroids, and is expressed as the equivalent dose of prednisone in mg. Glucocorticoid doses during periods in which the available information is missing or incomplete are estimated by systematic assumptions. A simulation exercise using standard patterns of steroid use in polymyalgia rheumatica, and giant cell arteritis showed that even when the period of no information reached 50% of the time, the accuracy of the calculator had a mean absolute percentage error (MAPE) < 7%. This tool simplifies and standardizes the glucocorticoids cumulative dose calculation, thereby minimizing bias in the assessment of glucocorticoid cumulative dose. [ABSTRACT FROM AUTHOR]

A pesar de la evidencia, existen dudas sobre el posicionamiento de apremilast en el algoritmo de tratamiento de la artritis psoriásica (APs). El objetivo del presente proyecto fue recoger la evidencia científica y la experiencia de un grupo de reumatólogos expertos en el manejo de la APs sobre el uso de apremilast en la práctica clínica en España. Un comité científico formado por 6 expertos propuso 5 escenarios clínicos donde la evidencia sobre el uso de apremilast en APs era controvertida: 1) eficacia en APs periférica; 2) eficacia en entesitis y dactilitis; 3) eficacia en APs con afectación cutánea; 4) comorbilidades, y 5) seguridad de apremilast. Tras esto, un panel de 17 reumatólogos expertos en el tratamiento de la APs discutió estos escenarios y generó un cuestionario con 50 preguntas y 156 ítems según metodología Delphi, el cual fue respondido de forma anónima por los panelistas. Tras 2 rondas de votación, el panel de expertos alcanzó el consenso en 93 de los 156 ítems planteados (59,6%) (67 apropiados y 26 inapropiados). El grado de consenso fue del 53,3% en el área de «Eficacia en APs periférica»; del 60,0% en «Eficacia en entesitis y dactilitis»; del 50,0% en «Eficacia en APs con afectación cutánea»; del 57,1% en «Manejo de las comorbilidades en pacientes con APs», y del 67,3% en «Implicaciones de la seguridad en el uso de apremilast». La opinión estructurada de los expertos complementa la evidencia disponible y contribuye al establecimiento de pautas consensuadas para el uso de apremilast en APs. Despite the evidence, there are doubts about the positioning of apremilast in the psoriatic arthritis (PsA) treatment algorithm. The objective of this project was to collect the scientific evidence and the experience of a group of rheumatologists who are experts in the management of PsA with apremilast in clinical practice in Spain. A scientific committee made up of 6 experts proposed 5 clinical scenarios where the evidence on the use of apremilast in PsA was controversial: 1) efficacy in peripheral PsA; 2) efficacy in enthesitis and dactylitis; 3) efficacy in PsA with skin involvement; 4) comorbidities, and 5) apremilast safety. After this, a panel of 17 rheumatologists with expertise in PsA management discussed these scenarios and generated a questionnaire with 50 questions and 156 items following the Delphi methodology. This questionnaire was anonymously answered by the panel. After 2 voting rounds, the panel of experts reached consensus in 93 of the 156 items raised (59.6%) (67 appropiate and 26 inappropiate). The degree of consensus was 53.3% in the area of "Efficacy in peripheral PsA"; 60.0% in "Efficacy in enthesitis and dactylitis"; 50.0% in "Efficacy in PsA with skin involvement"; 57.1% in "Management of comorbidities in patients with PsA", and 67.3% in "Implications of safety in the use of apremilast". The structured opinion of the experts complements the available evidence and contributes to the establishment of consensual guidelines for the use of apremilast in PsA. [ABSTRACT FROM AUTHOR]

To determine the number of rheumatologists per 100,000 inhabitants working in public or private centres in Spain as a whole, and by Autonomous Community and their distribution by age and sex. Cross-sectional study based on the information contained in the database of the Spanish Society of Rheumatology. Quality control was performed by contact (e-mail and telephone call) with the heads of the clinical services of each of the hospitals (public and private). The information analysed was the age, sex and place of work of active rheumatologists in February 2020. The rates of rheumatologists per 100,000 inhabitants were calculated from population data from the National Institute of Statistics. The rate of rheumatology specialists per 100,000 inhabitants in Spain was estimated at 2.17. The percentage of women was 59.7%, with a higher female/male ratio at younger ages. The lowest proportion of specialists per 100,000 inhabitants was in the community of Valencia (1.6), and the highest in Cantabria (3.2). Variations were found in the rate of rheumatologists per 100,000 inhabitants among the Autonomous Communities. The distribution by age and sex showed a tendency towards female rheumatologists, especially in the younger age strata. [ABSTRACT FROM AUTHOR]

• La goutte est la forme d'arthrite inflammatoire la plus courante dans les pays développés et certaines études témoignent d'une augmentation très nette, tant de sa prévalence que de son incidence, au cours des dernières décennies. • La goutte génère des coûts directs et indirects substantiels, c'est pourquoi il est essentiel d'établir une estimation précise de sa prévalence afin d'optimiser la planification des soins de santé. • Il s'agit de la première étude nationale menée en Espagne visant à estimer la prévalence de la goutte. Estimer la prévalence de la goutte en Espagne. Étude transversale de population portant sur des sujets âgés de 20 ans et plus. Les individus sélectionnés de manière aléatoire ont tout d'abord été contactés par téléphone et invités à répondre à des questionnaires spécifiques au dépistage des maladies rhumatismales. Lorsque le premier dépistage obtenait un résultat positif, les dossiers médicaux étaient ensuite analysés et/ou un entretien téléphonique était organisé par un rhumatologue, suivi d'une consultation médicale en cas de besoin. Les cas nouvellement diagnostiqués devaient remplir les critères de l'ACR/EULAR 2015. Pour calculer la prévalence et son IC à 95 %, le plan d'échantillonnage a été pris en compte et la pondération calculée selon l'âge, le sexe et l'origine géographique. Au total, 4916 individus ont été inclus, 1361 avaient un résultat positif au dépistage de la goutte (dont 59 qui rapportaient un diagnostic antérieur). Parmi eux, 51 ont été classés comme manquants et 95 comme des cas de goutte. Un cas supplémentaire a été identifié à l'occasion d'un dépistage positif pour la fibromyalgie et le syndrome de Sjögren et ce, malgré un diagnostic antérieur de goutte confirmé par l'analyse du dossier médical. Parmi les 96 cas de goutte, 31 (32 %) étaient des diagnostics de novo. La prévalence estimée pondérée de la goutte était de 2,4 % (IC 95 % 1,95–2,95), elle était plus élevée chez les hommes (4,55 % [IC 95 % 3,65–5,65]) que chez les femmes (0,38 % [IC 95 % 0,19–0,76]). EPISER2016 est la première étude de population visant à estimer la prévalence de la goutte en Espagne. Les patients non diagnostiqués représentaient une large proportion des cas de goutte, soulignant l'intérêt des approches fondées sur la population pour estimer la prévalence des maladies sous-diagnostiquées. Le recours à des initiatives nationales validées est essentiel pour garantir la fiabilité des données de santé et ainsi améliorer la planification des soins et la prise de décision. [ABSTRACT FROM AUTHOR]

Objective: Axial osteoarthritis (OA) is a common cause of back and neck pain, however, few studies have examined its prevalence. The aim was to estimate the prevalence and the characteristics of symptomatic axial OA in Spain. Methods: EPISER2016 is a cross-sectional multicenter population-based study of people aged 40 years or older. Subjects were randomly selected using multistage stratified cluster sampling. Participants were contacted by telephone to complete rheumatic disease screening questionnaires. Two phenotypes were analyzed, patients with Non-exclusive axial OA (NEA-OA) and Exclusive axial OA (EA-OA). To calculate the prevalence and its 95% confidence interval (CI), the sample design was considered and weighting was calculated according to age, sex and geographic origin. Results: Prevalence of NEA-OA by clinical or clinical-radiographic criteria was 19.17% (95% CI: 17.82–20.59). The frequency of NEA-OA increased with age (being 3.6 times more likely in patients aged 80 s or more than in those between 40 and 49 years) and body mass index. It was significantly more frequent in women, as well as in the center of Spain. It was less frequent in those with a higher level of education. Lumbar OA was more frequent than cervical OA. This difference grew with increasing age and was not associated with gender. It was also greater in overweight and obese subjects. Conclusions: This is the first study on the prevalence of axial OA phenotypes in Europe describing the associated socio-demographic, anthropometric, and lifestyle variables. [ABSTRACT FROM AUTHOR]

La Sociedad Española de Reumatología elaboró en el año 2000 el estudio EPISER2000 para conocer la prevalencia de la artrosis y otras enfermedades reumáticas en España. Los cambios sociodemográficos y en los hábitos de vida ocurridos en los últimos años en España justifican actualizar los datos de las enfermedades reumáticas (EPISER2016). Estimar la prevalencia de artrosis sintomática de columna cervical, columna lumbar, cadera, rodilla y mano, en población adulta en España. Estudio transversal de base poblacional. Se realizó un muestreo aleatorizado polietápico estratificado y por conglomerados. Los participantes fueron contactados por teléfono para cumplimentar un cuestionario de cribado de artrosis. El reumatólogo confirmaba o descartaba el diagnóstico. Se utilizaron los criterios-clínicos-ACR para diagnosticar artrosis de manos y los criterios clínico-radiológicos-ACR para diagnosticar la artrosis de rodilla y cadera. La prevalencia de artrosis en España en una o más de las localizaciones estudiadas fue de 29,35%. La prevalencia de artrosis-cervical fue del 10,10% y de artrosis-lumbar del 15,52%. Ambas son más frecuentes en mujeres y a mayor edad, así como en personas con niveles de estudios bajos y obesidad. La prevalencia de artrosis de cadera fue del 5,13% y la de artrosis de rodilla del 13,83%; estas se asocian con el sexo femenino, sobrepeso y obesidad, menor frecuencia en nivel de estudios alto y con la edad. La prevalencia de la artrosis de mano fue del 7,73%. Es más frecuente en mujeres, obesas, con bajo nivel de estudios y mayor edad. El estudio EPISER2016 es el primero que analiza la prevalencia de artrosis sintomática en 5 localizaciones (columna cervical, lumbar, rodilla, cadera y manos) en España. La artrosis de la columna lumbar es la más prevalente. The Spanish Society of Rheumatology carried out the EPISER2000 study in 2000 to determine the prevalence of osteoarthritis and other rheumatic diseases in the Spanish population. Recent sociodemographic changes and lifestyle habits in Spain justified updating the epidemiological data on osteoarthritis and other rheumatic diseases (EPISER2016-study). To estimate the prevalence of symptomatic osteoarthritis of the cervical spine, lumbar spine, hip, knee and hand in the adult population in Spain. Cross-sectional population-based study. A multistage and stratified random cluster sampling was carried out. The participants were contacted by telephone to complete an osteoarthritis screening questionnaire. A rheumatologist confirmed or discarded the diagnosis. The ACR-clinical-criteria were used to diagnose hand-osteoarthritis and the ACR-clinical-radiological criteria to diagnose knee- and hip-osteoarthritis. To estimate the prevalence and its 95% confidence interval, weights were calculated according to the probability of selection in each of the sampling stages. The prevalence of osteoarthritis in Spain in one or more of the locations studied was 29.35%. The prevalence of cervical-osteoarthritis was 10.10% and of lumbar-osteoarthritis 15.52%. Both are more frequent in women and at older ages, as well as in people with low levels of education and obesity. The prevalence of hip-osteoarthritis was 5.13%, that of knee-osteoarthritis 13.83%, these are associated with female sex, overweight and obesity. The prevalence of hand osteoarthritis was 7.73%. It is more frequent in women, who are obese, with a low educational level and who are older. The EPISER2016 study is the first to analyse the prevalence of symptomatic osteoarthritis in 5 locations (cervical, lumbar, knee, hip and hands) in Spain. Lumbar spine osteoarthritis is the most prevalent. [ABSTRACT FROM AUTHOR]

Background: Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction. Retention of golimumab was high in clinical trial extensions and real-world studies up to 5 years in patients with immune-mediated rheumatic diseases. Objective: To assess the probability of real-world long-term retention of treatment with golimumab up to 7 years after treatment initiation. Methods: This retrospective noninterventional study involved analysis of the Spanish biological drugs registry, BIOBADASER. Adults who had ever received golimumab for rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA), and had initiated it > 6 months before the analysis date, were included. Results: Among 685 patients (28.5% RA, 42.9% SpA, 28.6% PsA), the overall probability of retention of golimumab treatment since initiation was 71.7% (95% confidence interval 68.1–74.9) at year 1, 60.5% (56.5–64.2%) at year 2, 55.6% (51.5–59.5%) at year 3, 50.6% (46.2–54.8%) at year 4, 45.1% (40.1–50.0%) at year 5, 44.2% (39.0–49.3) at year 6, and 39.5% (32.8–46.2) at year 7. Retention was greater in patients with axial SpA or PsA versus RA (p < 0.001) and when golimumab was used as first-line treatment versus third or later lines (p < 0.001). Factors associated with greater golimumab retention in Cox regression included use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy. Steroids were associated with lower retention. Conclusion: In this real-world study of RA, axial SpA, and PsA patients, the retention rate of golimumab was 39.5% at year 7. Key Points • Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction. • This real-world study of 685 patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA) showed that golimumab treatment had a retention rate up to 39.5% at year 7. • Greater golimumab retention was associated with use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy [ABSTRACT FROM AUTHOR]

The better understanding of the safety of biologic DMARDs (bDMARDs), as well as the emergence of new bDMARDs against different therapeutic targets and biosimilars have likely influenced the use patterns of these compounds over time. The aim of this study is to assess changes in demographic characteristics, disease activity and treatment patterns in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) who started a first- or second-line biologic between 2007 and mid-2020. Patients diagnosed with RA, PsA or AS included in the BIOBADASER registry from January 2007 to July 2020 were included. According to the start date of a first- or second-line biologic therapy, patients were stratified into four time periods: 2007–2009; 2010–2013; 2014–2017; 2018–2020 and analyzed cross-sectionally in each period. Demographic and clinical variables, as well as the type of biologic used, were assessed. Generalized linear models were applied to study the evolution of the variables of interest over time periods, the diagnosis, and the interactions between them. A total of 4543 patients initiated a first biologic during the entire time frame of the study. Over the four time periods, disease evolution at the time of biologic initiation (p < 0.001), disease activity (p < 0.001), retention rate (p < 0.001) and the use of tumor necrosis factor inhibitors as a first-line treatment (p < 0.001) showed a significant tendency to decrease. Conversely, comorbidities, as assessed by the Charlson index (p < 0.001), and the percentage of patients using bDMARDs in monotherapy (p < 0.001), and corticosteroids (p < 0.001) tended to increase over time. Over the entire period of the study's analysis, 3289 patients started a second biologic. The following trends were observed: decreased DAS28 at switching (p < 0.001), lower retention rates (p = 0.004), and incremental changes to the therapeutic target between the first and second biologic (p < 0.001). From 2007 until now rheumatic patients who started a biologic were older, exhibited less clinical activity, presented more comorbidities, and switched to a different biologic more frequently and earlier. [ABSTRACT FROM AUTHOR]

Objective: To estimate the prevalence of gout in Spain.Methods: Cross-sectional, population-based study of people aged 20 years or older. First, randomly selected individuals were contacted by telephone and rheumatic disease screening questionnaires were conducted. If the first screening was positive, medical records were then reviewed and/or a phone questionnaire was conducted by a rheumatologist, followed by an appointment if necessary. Newly diagnosed cases had to fulfil the ACR/EULAR 2015 criteria. To calculate the prevalence and its 95% CI, the sample design was taken into account and weighing was calculated according to age, sex and geographic origin.Results: In all, 4916 individuals were included, 1361 had a positive screening result for gout (59 of them reported a prior diagnosis). Of these, 51 were classified as missing and 95 were classified as gout cases. An additional case was detected through a positive screening for fibromyalgia and Sjögren's syndrome, although a previous gout diagnosis was confirmed by a review of the medical records. Of the 96 gout cases, 31 (32%) were de novo diagnoses. The estimated weighted prevalence of gout was 2.4% (95% CI 1.95-2.95), with a higher prevalence in men (4.55% [95%CI 3.65-5.65]) than women (0.38% [95%CI 0.19-0.76]).Conclusion: EPISER2016 is the first population-based study to estimate the prevalence of gout in Spain. Undiagnosed patients accounted for a substantial proportion of cases, highlighting the need for population-approaches when estimating the prevalence of infra-diagnosed diseases. Reliable national approaches are key to obtaining accurate estimates of diseases to better aid healthcare and workforce planning. [ABSTRACT FROM AUTHOR]