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Objectives: To compare the effectiveness of the infliximab biosimilar (sim-INF) CT-P13 with originator infliximab (orig-INF) over 24 months of follow-up in biological-naïve patients with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA). Methods: Biological-naïve patients from the Rheumatic Diseases Portuguese Register (Reuma.pt), with a clinical diagnosis of RA or axSpA, who were starting either the sim-INF CT-P13 or the orig-INF after 2014 (date of market entry of CT-P13 in Portugal), were included. Patients on biosimilar and originator were compared regarding different response outcomes at 3 and 6 months, adjusting for age, sex and baseline C Reactive Protein (CRP). The main outcome was the change in DAS28-Erythrocyte Sedimentation Rate (ESR) for RA and the ASDAS-CRP for axSpA. Additionally, the effect of sim-INF vs orig-INF on different response outcomes over 24 months of follow-up was tested with longitudinal generalized estimating equations (GEE) models. Results: In total, 140 patients were included, 66 (47%) of which with RA. The distribution of patients starting the sim-INF and the orig-INF was the same between the two diseases (approximately 60% and 40%, respectively). From the 66 patients with RA, 82% were females, mean age was 56 (SD 11) years and mean DAS28-ESR 4.9 (1.3) at baseline. As for the patients with axSpA, 53% were males, mean age was 46 (13.0) years and mean ASDAS-CRP 3.7 (0.9) at baseline. There were no differences in efficacy between RA patients treated with the sim-INF and the orig-INF, either at 3 months (ΔDAS28-ESR: -0.6 (95% CI -1.3; 0.1) vs -1.2 (-2.0; -0.4)), or at 6 months (ΔDAS28- ESR: -0.7 (-1.5; 0.0) vs -1.5 (-2.4; -0.7)). This was also true for patients with axSpA (ΔASDAS at 3 months: -1.6 (-2.0; -1.1) vs -1.4 (-1.8; -0.9) and at 6 months: -1.5 (-2.0; -1.1) vs -1.1 (-1.5; -0.7)). Results were similar with the longitudinal models over 24 months. Conclusion: There are no differences in effectiveness between the sim-INF CT-P13 and the orig-INF in the treatment of biological-naïve patients with active RA and axSpA in clinical practice. [ABSTRACT FROM AUTHOR]

Saraiva F1 ABSTRACT Intra-articular glucocorticoid injection (IAGCI) is frequently used to treat joint pain and inflammation. While its efficacy has been extensively studied, there are not as many detailed descriptions regarding safety. This review aimed to describe the immediate-, short- and long-term complications of IAGCI and their predictors. Most studies mainly report mild and self-limited adverse events with an incidence similar to placebo. However, the reported incidences vary significantly and are mostly inferred from retrospective data. Septic arthritis is the most feared adverse event due to its association with high mortality. Other short-term local complications include injection site pain, post-injection flare, skin hypopigmentation and atrophy, and tendon rupture. Systemic side effects are common, including vasovagal reactions, flushing, increased appetite and mood changes, hyperglycemia in diabetic patients, and bleeding in high-risk patients. Few predictors of complications have been systematically evaluated. However, male gender, advanced age, and pre-existing joint disease have been suggested in retrospective studies to correlate with infection risk. Overall, in most studies, only severe adverse event rates are reported, with no systematic prospective evaluations of safety and no report of predictors of complications. Therefore, since IAGCI is a routinely used treatment, more detailed knowledge of adverse events and complications is warranted. [ABSTRACT FROM AUTHOR]

Introduction: Vasculopathy is a crucial feature of systemic sclerosis (SSc). It occurs in almost every patient with SSc, with Raynaud's phenomenon (RP) and digital ulcers (DU) having a great impact on the quality of patients' lives. Intravenous (IV) iloprost, a synthetic analogue of prostacyclin, is broadly used to treat RP and DU secondary to SSc. Currently, there is no standard protocol defined for the iloprost treatment of SSc-associated RP and DU, and, consequently, the management of this treatment is largely based on each centre's experience. Objective: The objective of this study is to evaluate the safety profile of a particular scheme of IV iloprost used in our centre as the standard treatment of SSc-related vascular complications. Methods: We retrospectively evaluated the clinical records of SSc patients, classified according to the 2013 European Alliance of Associations for Rheumatology (EULAR) criteria (31) with SSc-related DU and/or severe RP not responsive to calcium channel blockers (CCB), receiving or who have received IV iloprost infusions from January 1st 2011 to March 31st 2021 Results: Within this time frame, 60 patients (n=44 for DU; n=16 for severe RP) were treated with a monthly 10-hour IV iloprost perfusion with a dosing regimen adapted to individual tolerance. Forty-nine of these 60 patients (81.7%) were on iloprost for more than one year. Within 12 months of therapy, 40 patients have healed the DUs (90.9%), with only 4 patients maintaining active DUs. A significant clinical improvement in RP at 12 months was observed in 87.5% (n=14/16) of SSc patients with severe RP. Eleven AE implying treatment dose/frequency adjustments or suspension were recorded (18.3% of patients): severe headache (n=5), hypotension (n=3), tachycardia (n=1), flushing (n=1) and generalised erythroderma (n=1). In all patients, the perfusion rate was reduced in the following treatment sessions with good tolerance, with the exception of the patient with the generalised erythroderma reaction, who suspended the perfusion and was later switched to bosentan. After a mean follow-up time of 6.9 (+/-) 4.0 years of treatment (range 0.06-22), 24 patients (40%) stopped the therapy, 14 (58.3%) of whom due to clinical improvement. The overall 5-, and 10-year survival rates of IV iloprost were 68.2% and 55.6%, respectively. Conclusion: SSc patients who received this flexible IV iloprost regimen achieved clinical improvement, reflected in the high persistence rate of the drug, with a good tolerability profile. In addition, most side effects were mild and easily managed. [ABSTRACT FROM AUTHOR]

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The Portuguese Rheumatology Society (SPR) embraced quality as a major goal and launched, in early 2015, a program to aim for excellence in global clinical care: Rheuma SPACE - Standard Practice Aiming Clinical Excellence. Evaluating daily reality is the first step in a quality development timeline, ultimately contributing for health gains. Herein we describe the results of the evaluation of the quality indicators defined for this project and the improvement strategies identified. The Rheuma SPACE project included three phases: 1) establishing a set of quality indicators and an excellence quality model; 2) assessment of the current care at Rheumatology departments concerning the defined quality indicators in the scope of the excellence model; and 3) elaboration of global and customized reports for each participating Rheumatology department, resulting in the identification of improvement opportunities. Ten Rheumatology departments, countrywide, including larger and smaller institutions, were asked to participate in Rheuma SPACE. This resulted in an in-dividual report for each department along with global benchmarking practices analysis. Furthermore, a list of improvement initiatives was developed. We concluded that departments lack physicians and need exclusively dedicated nurses. Time dedicated to research and audit activities should be specifically allocated. Internal contracting is well established, and professionals are committed to targets. Processes are still suboptimal, needing standardization of triage criteria, more frequent follow-up, as well as better medical records and multidisciplinary coverage. Regarding outcomes, patients are satisfied with the provided care and professionals with the working environment. However, department facilities for the former, and career related aspects, for the latter should improve. With this innovative study conducted in Portugal we expect to have enlightened tailored opportunities for improvement, ensure patient-focused practices and be able to define the indispensable quality requirements for excellence. [ABSTRACT FROM AUTHOR]

Background: Patients with rheumatoid arthritis (RA) report significant levels of disease impact, which are improved, but not fully abrogated by immunosuppressive therapy, even when remission is achieved. This imposes the need for adjuvant interventions targeting the uncontrolled domains of disease impact. Non-pharmacological interventions are widely used for this purpose, but they have not been the object of professional recommendations or guidelines. Objective: To propose multidisciplinary recommendations to inform clinical care providers regarding the employment of non-pharmacological and non-surgical interventions in the management of patients with RA. Methods: The EULAR standardized operating procedures for the development of recommendations were followed. First, a systematic literature review was performed. Then, a multidisciplinary Technical Expert Panel (TEP) met to develop and discuss the recommendations and research agenda. For each developed recommendation i) the level of evidence and grade of recommendation were determined, and ii) the level of agreement among TEP members was set. A recommendation was adopted if approved by =75% of the TEP members, and the level of agreement was considered high when =8. All relevant national societies were included in this construction process to attain their endorsement. Results: Based on evidence and expert opinion, the TEP developed and agreed on five overarching principles and 12 recommendations for non-pharmacological and non-surgical interventions in patients with RA. The mean level of agreement between the TEP members ranged between 8.5 and 9.9. The recommendations include a broad spectrum of intervention areas, such as exercise, hydrokinesiotherapy, psychological interventions, orthoses, education, general management of comorbidities, among others; and they set the requirements for their application. Conclusions: These recommendations are based on the consensus judgment of clinical experts from a wide range of disciplines and patients' representatives from Portugal. Given the evidence for effectiveness, feasibility and safety, non-pharmacological and non-surgical interventions should be an integral part of standard care for people with RA. It is hoped that these recommendations should be widely implemented in clinical practice. The target audience for these recommendations includes all health professionals involved in the care of patients with RA. The target patient population includes adult Portuguese people with RA. [ABSTRACT FROM AUTHOR]

Objective: To investigate the relationship between body mass index (BMI) and disease activity in patients with Juvenile Idiopathic Arthritis (JIA). Methods: Patients with JIA, aged =18 years, registered at the Rheumatic Diseases Portuguese Register (Reuma.pt) in Portugal and Brazil were included. Ageand sex-specific BMI percentiles were calculated based on WHO growth standard charts and categorized into underweight (P<3), normal weight (3=P=85), overweight (8597). Disease activity was assessed by Juvenile Arthritis Disease Activity Score (JADAS-27). Uni- and multivariable analyses were performed. Results: A total of 275 patients were included. The prevalence of underweight, normal weight, overweight and obesity was 6.9%, 67.3%, 15.3% and 10.5%, respectively. Underweight patients had significantly higher number of active joints (p<0.001), patient's/parent's global assessment of disease activity (PGA) (p=0.020), physician's global assessment of disease activity (PhGA) (p<0.001), erythrocyte sedimentation rate (ESR) (p=0.032) and overall higher JADAS-27 (p<0.001), compared to patients with normal weight, overweight and obesity. In the multivariable regression, normal weight (B=-9.43, p<0.01), overweight (B=-9.30, p=0.01) and obesity (B=-9.12, p=0.01) were significantly associated with lower disease activity compared to underweight, when adjusted for age, gender, country, ethnicity, JIA category and therapies used. The diagnosis of RF- (B=3.65, p=0.006) or RF+ polyarticular JIA (B=5.29, p=0.024), the absence of DMARD therapy (B=5.54, p<0.001) and the use of oral GC (B=4.98, p=0.002) were also associated with higher JADAS-27. Conclusion: We found an independent association between underweight and higher disease activity in patients with JIA. Further studies are needed to understand the underlying mechanisms of this association. [ABSTRACT FROM AUTHOR]

Patients with inflammatory rheumatic diseases refractory to conventional disease modifying antirheumatic drugs (DMARDs)have been treated with biologics for the last two decades. It is also known that patients under biologics present a higher risk of developing Tuberculosis (TB). Portugal has now a TB incidence classified as low. National recommendations advise on latent TB screening before starting biologic treatment. This screening consists in the detection of risk factors and/or signs and symptoms of latent TB through clinical history, physical examination, chest X-ray, tuberculin skin test and Interferon Gamma Release Assay (IGRA) test. We describe five clinical cases of patients who underwent biologic treatment at our Hospital and developed TB. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate belimumab effectiveness and safety in real-life Portuguese patients with Systemic Lupus Erythematosus (SLE). Materials and Methods: Multicenter cohort study including all SLE patients treated with belimumab in se - ven Portuguese rheumatology centers. Demographic, clinical and serological data were collected at baseline, 6, 12 and 24 months of treatment with belimumab. To evaluate effectiveness we used SLE Responder Index (SRI) rates and changes in SELENA-SLEDAI. Safety was evaluated by the number of adverse events. Results: Thirty-eight patients were included: 37 (97.4%) female, with a mean age of 46.2±13.9 years. Mean SELENA-SLEDAI was 8.2±3.9, 78.8% had elevated anti-double-stranded DNA (anti-dsDNA) antibodies and 72.7% had complement consumption at baseline. Multiorgan involvement was the leading cause for the use of belimumab. SRI response was achieved in 51.9%, 60% and 91.7% at 6, 12 and 24 months of belimumab treatment, respectively. LUNDEX adjusted SRI response rates were 45.4%, 45.0% and 45.8% at 6, 12 and 24 months of belimumab, respectively. Mean SELENA-SLEDAI, anti-dsDNA antibodies and daily prednisolone dosage decreased significantly from baseline to 6, 12 and 24 months and C3 levels increased significantly at 12 months of belimumab treatment. Five patients presented adverse events (infections in three cases) and eleven patients discontinued belimumab (four due to inefficacy, three due to adverse events and four were lost to follow-up). Conclusions: Our study confirmed, in real-life Portuguese patients with active SLE, the effectiveness of belimumab in reduction of disease activity, immunological response and steroid-sparing, with a good safety profile. [ABSTRACT FROM AUTHOR]

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Background: Quality of care is a key component of the right to health, and the route to equity and dignity. The aim of the project Rheuma SPACE - Standard Practice Aiming Clinical Excellence was to develop a set of quality indicators focused in rheumatoid arthritis care and apply them to rheumatology departments of the Portuguese National Health Service in order to benchmark the care for these patients. This article details the methodology that was applied. Methodology: This was a single country, three-phase project, each phase comprising multiple steps. The first step defined quality indicators and the excellence quality model to be used. It involved a literature search for international benchmarking of quality of care initiatives and indicators, followed by a pre-selection of an initial set of indicators. The set of indicators was latter on narrowed after an online Delphi round with all Portuguese rheumatologists and two consensus meetings involving the study task force. A set of 26 quality indicators was defined, within the three classic Donabe dian dimensions of healthcare quality: Structure (9), Pro cesses (11), and Outcomes (6). These indicators cover eleven domains of quality of care: personnel and organizational structure, training and research, facilities, equipment and information technology, budgeting and financial resources, access to care, clinical records, patient communication, multidisciplinary management, clinical outcomes, and patient and personnel satisfaction. Decision on quality and excellence thresholds for each of the 26 quality indicators was agreed upon a consensus meeting gathering principal investigators of the eight Rheumatology Departments that decided to participate, task force core set members and invited representatives of all Portuguese Departments/Units. Rheumatoid arthritis was the chosen disease model of the project based on the reliability of the outcomes to be measured in the context of this condition. The se - cond step was the assessment of the participating Rheumatology Departments. During eighteen months, research teams applied the 26 quality indicators to their own Departments. The third step comprised data ana - lysis and the elaboration of individual Rheumatology Department reports and of a global public report. Results: Eight Departments, comprising 80 specialists, 20 residents and 30 nurses, covering 5.904.080 inhabitants, underwent quality evaluation. More than one thousand patients (1.325) and 113 health professionals' surveys were analysed, as well as data from 570 clinical records and 3.927 medical appointments on rheumatoid arthritis patients. Discussion: 26 quality indicators were used for the first evaluation of Portuguese Rheumatology Departments, turning Rheuma SPACE into a pioneer project. Data analysis and benchmarking will be the subject of a further publication. [ABSTRACT FROM AUTHOR]

Objectives: To assess the discontinuation of first-line biological treatment and to evaluate the reasons and predictors thereof in patients with rheumatoid arthritis (RA) from daily clinical practice. Methods: RA patients registered in the Rheumatic Di - seases Portuguese Register (Reuma.pt) starting treatment with biologic DMARDs (bDMARDs) were inclu - ded in this prospective observational study. The main outcome was the time to discontinuation (in years) due to any cause. Discontinuation was defined as a 90-day discontinuation of treatment or the occurrence of any switch to another bDMARD during follow-up. Baseline and time-varying sociodemographic and clinical cha - racteristics were tested as possible predictors of discontinuation using multivariable Cox models. Results: Of the 1,851 RA patients included in the study, 871 (47%) discontinued their first bDMARD. The median overall persistence of the first bDMARD was 5.5 years and the leading cause of discontinuation was inefficacy [N=476 (55%)], followed by adverse events [N=262 (30%)], other causes [N=69, (8%)] and unknown causes [N=64 (7%)]. Patients with a higher HAQ score (more disability) at baseline were more likely to discontinue their first bDMARD [hazard ratio (HR):1.39 (95% CI: 1.17-1.64)], as were patients with a higher number of comorbidities [HR: 1.17 (1.05--1.29)] and patients starting treatment from 2007 onwards [HR:1.89 (1.5-2.38)]. On the contrary, recei ving TNFi bDMARD [HR:0.74 (0.57-0.94)] as opposed to non-TNFi was associated with less discontinuation. Expectedly, the higher the DAS28 during follow-up the higher the likelihood to discontinue bDMARD [HR:1.08 (1.06-1.1)]. No other time-varying predictor was found. Conclusion: In the Portuguese RA population, mainte - nance of first-line bDMARD was shown to be relati ve - ly high. Inefficacy was the leading cause of discontinua - tion. Features found to predict drug discontinuation (e.g. baseline disability) may contribute to inform cli - nician's decisions in clinical practice. [ABSTRACT FROM AUTHOR]

Accounting for 2.2-4.7% of all tuberculosis cases in Europe and USA and around 10-15% of extra-pulmonary tuberculosis cases, osteoarticular tuberculosis tends to be chronic, slowly progressive and destructive. We report the case of an 81-year-old male with 3 weeks of progressively worsening pain, swelling and limited range of motion of the left knee. A knee arthroscopy was performed for synovial biopsy at our department, revealing diffuse synovitis with scarce villi formation. The positive polymerase chain reaction assay for Mycobacterium tuberculosis in the synovial tissue allowed the establishment of the diagnosis and synovium histology showed caseating granulomas. A lengthy delay between first symptoms of osteoarticular tuberculosis and the beginning of treatment has been reported. A high index of suspicion, synovial membrane biopsy and appropriate microbiologic tes - ting are fundamental to avoid a delay in diagnosis. [ABSTRACT FROM AUTHOR]

Introduction: An excess in cardiovascular (CV) morbidity and mortality has been recognized in Rheumatoid Arthritis (RA) patients when compared to the ge - neral population. Given the paucity of prospective data, our aim was to estimate the incidence of CV events and the contribution of traditional CVD risk factors and RA- -related parameters to future events. Methods: Incident fatal and non-fatal CV events (hospitalizations due to unstable angina, myocardial infarction, coronary artery revascularization procedures, stroke, or CV death) were assessed in a prospective cohort of RA women followed since 2007 and without CV events at cohort entry. The presence of traditional CV risk factors, disease characteristics, medication, carotid ultrasound, and biomarkers of inflammation and endothelial activation were evaluated at baseline. Univariate Cox proportional hazard models were used to identify risk factors for CV events. Results: Among 106 women followed over 565 patient-years we identified 4 CV events (1 fatal stroke, 2 myocardial infarction and 1 unstable angina), which contributed to an incidence rate of 7 per 1000 person- -years (95%CI 2.0- 13.9). Patients who developed CV events were older, but the distribution of other traditional CV risk factors was otherwise similar in both groups. Also, corticosteroid dosage and proportion of patients with carotid atherosclerotic plaques was hi - gher in those with CV events. Erythrocyte sedimentaartigo tion rate (ESR) (HR 1.036; 95%CI 1.005-1.067) and soluble intercellular adhesion molecule-1 (sICAM-1) serum levels (HR 1.002; 95%CI 1.000-1.003) significantly contributed to CV events. These results remained signi ficant after adjusting for patients' age. Conclusion: We found an incidence of cardiovascular events in women with RA of 7 per 1000 patent-years. This value is similar to that found in other Portuguese cohort of RA patients1 and much higher than the incidence reported for the general Portuguese population. Markers of inflammation and endothelial activation contributed significantly to CV events, but the limited number of events prevents further analysis. [ABSTRACT FROM AUTHOR]

Objective: To provide evidence-based guidance for the rational and safe prescription of biological therapies in children and adolescents with juvenile idiopathic arthritis (JIAs), considering the latest available evidence and the new licensed biologics. Methods: Rheumatologists and Pediatricians with expertise in Pediatric Rheumatology updated the recommendations endorsed by the Portuguese Society of Rheumatology and the Portuguese Society of Pediatrics based on published evidence and expert opinion. The level of agreement with final propositions was voted using an online survey. Results: In total, 20 recommendations to guide the use of biological therapy in children and adolescents with JIAs are issued, comprising 4 general principles and 16 specific recommendations. A consensus was achieved regarding the eligibility and response criteria, maintenance of biological therapy, and procedures in case of non-res - ponse, for each JIA category. Specific recommendations concerning safety procedures were also updated. Conclusions: These recommendations take into account the specificities of each JIA category and are intended to continuously improve the management of JIA patients. [ABSTRACT FROM AUTHOR]

The article discusses the history and administration of Portuguese royal education in America in the 18th century, in relation to the history of education in Brazil. Topics mentioned include the role of education in Brazil in establishing institutional and social relations in Brazilian society, the political-administrative and judicial structures of the Portuguese administration in Brazil, and educational structures established under Portuguese rule.

An introduction is presented on the history of written culture, education, and teaching under the Portuguese government of the 18th and 19th centuries.

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The optimization of the properties of a lead compound is the first goal of most pre-clinical research projects. Optimiza-tion strategies may be applied to the syn-thesis of analogous compounds in order to minimize cost and time. One strategy of synthesis is the change of the substitu-ents in the molecule. The manual method of Topliss was introduced for the prediction of the substituted compounds that will have the most potent activity in a series of aromatic substituted ana-logues. A modified Topliss method is pro-posed that consist of the quantitative cor-relation by a single regression equation of the activity of a series of 4 or 5 substi-tuted aromatic compounds with the de-scriptor parameters: hydrophobic, electronic. [ABSTRACT FROM AUTHOR]

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