Conectar
Fatigue is one of the most common and debilitating symptoms experienced by patients with systemic lupus erythematosus (SLE). Previous studies revealed the association of fatigue with various SLE and non-SLE-related factors. This study aims to explore the prevalence of fatigue and the factors that are associated with fatigue experienced by SLE patients in an outpatient rheumatology clinic setting.
Prospective, observational study using a sample of convenience.
Outpatient rheumatology clinic at a tertiary care centre.
Consecutive subjects with SLE presenting for their outpatient visits enrolled in the ongoing Institutional Review Board-approved ‘Pathogenesis and Natural History of SLE’ protocol.
Disease activity and organ damage accrual were measured by Safety of Estrogens in Lupus Erythematosus: National Assessment Version of the Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) and Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR DI), respectively. Fatigue was measured by the self-reported Fatigue Severity Scale (FSS), and a score of ≥4 was used to define clinically significant fatigue. Correlation analyses were done to determine the association between fatigue and patient demographics, and SLE disease activity and damage indices. Results were considered as statistically significant at p
183 patients completed the study, with a significant proportion (144/183) belonging to ethnic minorities. The overall FSS score was mean (±SD) 4±1.8 and SELENA-SLEDAI score of 3±2.6. The group reporting significant FSS scores ≥4 (N=95) included a higher proportion of White patients, more organ damage (SLICC/ACR DI score mean (±SD) 1.9±1.9) and higher body mass index (BMI) mean (±SD) 29.6±6.7 kg/m2; as compared with the group with FSS scores 2 (p=0.03).
Our study found that organ damage accrual, specifically pulmonary fibrosis and neuropathy as measured by SLICC-ACR DI and high BMI, is associated with clinically significant fatigue in SLE. Furthermore, our results support previous findings that fatigue is independent of SLE disease activity. Findings of our study need to be replicated in independent SLE cohorts measuring fatigue at multiple time points. Mechanistic studies are needed to better understand pathogenesis of fatigue in SLE.
Hand osteoarthritis (OA) is a prevalent and debilitating joint disorder that impairs daily functioning and quality of life. Current treatments are often inadequate in managing the symptoms and progression of the disease. The cytokine interleukin (IL)-17 has been implicated in the inflammatory processes associated with OA, making it a potential target for therapeutic intervention. This trial aims to evaluate the efficacy of vunakizumab, an IL-17A inhibitor, in reducing pain and improving functional outcomes in patients with erosive hand OA.
This multicentre, randomised, placebo-controlled, double-blind trial will enrol 150 participants aged 30–80 years with symptomatic erosive hand OA. Participants will be randomised in a 1:1 ratio to receive either vunakizumab 120 mg or placebo subcutaneously every 4 weeks for 24 weeks, with a loading dose injection period during the first 4 weeks. The primary outcome is the change in hand pain assessed by the Visual Analogue Scale at 28 weeks. Secondary outcomes include changes in physical function measured by the Functional Index for Hand Osteoarthritis, the Quick Disabilities of the Arm, Shoulder and Hand questionnaire and the Health Assessment Questionnaire, as well as changes in grip strength and radiographic and MRI evaluations of the hands.
Written informed consent will be obtained from all participants. The study was approved by the Ethics Committee of Shanghai Sixth People’s Hospital (2024–217) and will adhere to the Declaration of Helsinki. Research results will be published in peer-reviewed journals.
ChiCTR2500101031; https://www.chictr.org.cn/showproj.html?proj=264789.
Previous studies suggest Ireland has the smallest osteoporosis treatment in Europe and very little inappropriate prescribing, in contrast to our experience. In this study, we examine the osteoporosis treatment gap in Ireland by assessing the prevalence of appropriate and inappropriate prescribing in 2 subgroups of the Irish dual-energy X-ray absorptiometry (DXA) Health Informatics Prediction (HIP) Project. Treatment eligibility was defined using established intervention thresholds, including prior fracture, femoral-neck T-score ≤–2.5, glucocorticoid use, or Fracture Risk Assessment Tool (FRAX) major osteoporotic fracture risk ≥20% or hip fracture risk ≥3%.
Secondary cross-sectional analysis of a subgroup of the DXA HIP Project Cohort.
3 hospitals in the West of Ireland. DXA referrals come from primary care providers, hospital consultants and the osteoporosis service.
5564 participants of a previously described convenience cohort including: (i) 3474 subjects referred for a DXA scan, and (ii) 2090 patients who completed a DXA scan.
82.4% were female with a mean age of 66.6 years, 59.6% of whom had a prior fracture. Prescribing data of calcium and vitamin D were available for 3738 (67.2%) subjects, and osteoporosis medication for 4157 (74.7%) subjects. Prescribing information was available for more than 99% of the DXA group, but just over 50% of the referral group. When examined in aggregate, the treatment gap is 6% for calcium and vitamin D and 38% for osteoporosis medication, in line with prior publications. However, among those with prescribing information and at least one indication for treatment, only 58.3% were prescribed calcium and vitamin D and 39.1% an osteoporosis medication. Furthermore, among patients without a clear indication for treatment, 50.6% were prescribed calcium and vitamin D, and 32.5% an osteoporosis medication.
These data suggest the majority of patients with osteoporosis or at high risk of fracture in Ireland today do not receive appropriate osteoporosis treatment, while inappropriate prescribing is substantial. These findings suggest that the true treatment gap in Ireland is substantially larger than aggregate estimates imply.
Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment through targeted disruption of the physiological pathways that maintain tissue tolerance, but which are co-opted by cancers to evade immunosurveillance. Thus, the resultant T-cell activity often causes immune-related adverse events including immune checkpoint inhibitor-induced inflammatory arthritis (ICI-IA). ICI-IA results in functional impairment that frequently persists, even after ICI discontinuation, with substantial quality-of-life impacts for cancer survivors.
A high-quality body of evidence to guide ICI-IA management remains an unmet need. Pharmacological treatment may be prolonged, typically begins with non-specific immunosuppression, including systemic steroids, and is usually only rationalised to more targeted therapy in resistant cases. Moreover, retrospective data suggest the high dose glucocorticoids sometimes used in new-onset ICI-IA may be associated with worse cancer outcomes.
Tumour necrosis factor (TNF) inhibition strategies are well established with excellent efficacy and safety profiles in ‘spontaneous’ inflammatory arthritides including rheumatoid and psoriatic arthritis. Mechanistic evidence from ex vivo and murine studies also supports the utility of anti-TNF therapy for steroid-refractory cases of ICI-IA. Although good clinical responses have been reported in this setting, the REACT trial (REmission induction of Arthritis caused by Cancer ImmunoTherapy) aims to provide randomised and robust clinical evidence for deploying targeted therapy earlier in ICI-IA management. It will test whether up-front anti-TNF therapy can more effectively and quickly control symptoms, reduce glucocorticoid exposure, prevent early ICI discontinuation and increase the frequency of drug-free ICI-IA remission.
REACT is a prospective, multicentre, open-label, superiority, two-arm, randomised controlled clinical trial to guide initial therapy for patients with ICI-IA. The trial will compare the current standard of care (initial prednisolone; Arm A) with the anti-TNF drug, adalimumab without glucocorticoids (Arm B).
The primary outcome is glucocorticoid-free arthritis remission rate at 24 weeks where remission is defined as: (i) No use of systemic or intra-articular glucocorticoids (except when used for adrenal insufficiency) within 4 weeks prior to assessment at 24 weeks; and (ii) absence of synovitis on clinical examination.
The protocol was approved by East Midlands—Leicester South Research Ethics Committee on 31-Oct-2024 (Ref: 24/EM/0202). Participants are required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.
To identify predictors of treatment changes and to evaluate the effectiveness and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) initiating tofacitinib in a real-world setting.
The non-interventional study ESCALATE-RA included 1518 patients with RA from Germany. RA treatment, including all changes in therapy, was documented for 24 months starting from the initial intake of tofacitinib.
All patients started with tofacitinib therapy, either as monotherapy or in combination with methotrexate (MTX).
The impact of several factors of interest on the number and timing of treatment changes was assessed as primary outcome using Cox proportional hazards models. Further outcomes were tofacitinib drug survival and the use of follow-up disease-modifying antirheumatic drugs after first treatment change. We also assessed the effectiveness, concomitant glucocorticoid (GC) use, PROs (such as functional ability, patient satisfaction, pain and quality of life) and safety. Analyses were based on observed data.
‘Lack of efficacy’ (HR 3.30) and ‘intolerance’ (HR 4.43) leading to termination of tofacitinib were key factors favouring therapy changes. Higher patient satisfaction was significantly associated with a reduced likelihood of treatment changes (HR 0.82). Increasing GC doses were associated with a higher probability of step-up/switch changes (HR 1.21). The estimated tofacitinib drug survival was 48% at the end of study. Proportions of patients achieving low disease activity (both Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) 62%) and remission (SDAI 25%, CDAI 28%) increased from baseline under tofacitinib and were comparable between monotherapy and combination therapy with MTX. Mean concomitant GC dose decreased (2 mg/day). PROs indicated reduced pain and fatigue, while functional ability and quality of life improved. 63.9% of the patients experienced a treatment-emergent adverse event (AE), 8.8% a treatment-emergent AE of special interest and deaths occurred in 0.5%.
Key factors for therapy changes in patients with RA treated with tofacitinib were lack of efficacy and intolerance. Higher patient satisfaction was associated with a reduced probability of treatment changes, while increased GC doses led to a higher likelihood of step-ups/switches. Patients demonstrated a marked reduction in disease activity for up to 24 months, along with improvements in functional ability, pain and quality of life. Observed AEs were consistent with the known safety profile of tofacitinib.
Rheumatoid arthritis (RA) and spondyloarthritis (SpA) are chronic inflammatory rheumatic diseases characterised by pain, fatigue, mood disturbances, sleep problems and reduced quality of life. These symptoms are highly variable both between individuals and within individuals across days, reflecting the fluctuating nature of disease activity and daily functioning. Although physical activity is known to alleviate many of these symptoms, individuals with RA and SpA often encounter barriers that limit regular engagement. Capturing the dynamic interplay between symptoms and physical activity therefore requires methods that account for day-to-day and moment-to-moment variability. Ecological momentary assessment (EMA), especially when combined with actigraphy, enables real-time, context-sensitive monitoring of symptoms and physical activity in daily life. However, little is known about the feasibility and acceptability of such protocols in individuals with RA and SpA, for whom participant burden and adherence may represent significant challenges. This pilot study therefore aims to assess the feasibility and acceptability of a 14-day EMA protocol and to explore factors associated with objectively measured physical activity in individuals with RA and SpA.
50 adults diagnosed with RA or SpA will be recruited through rheumatology clinics or via advertisement. Eligible participants must be smartphone users without cognitive or physical impairments affecting participation. After providing consent, participants will complete baseline questionnaires regarding disease activity, quality of life, sleep, pain, fatigue, affective states and will attend a remote session with a member of the research team to learn how to use the mobile app. They will then complete a 14-day EMA protocol, during which data on patient-related outcomes (PROs), including pain, fatigue, sleep quality and affective states (i.e. positive and negative affects) will be assessed four times daily: upon awakening, 11:00, 15:00 and 20:30. Physical activity and sleep will be continuously monitored using both a wrist-worn and a thigh-worn device. Feasibility will be evaluated based on adherence to EMA prompts and actigraphy wear time. Acceptability will be assessed via a study-specific questionnaire and qualitative interviews conducted at the end of the protocol. Exploratory analyses will examine real-time, temporal and lagged relationships between PROs (pain, fatigue affective states), sleep and physical activity levels.
This study was approved by the French national ethics committee [Comité de protection des personnes Nord Ouest I, 2025-A01349-40] on 24/07/2025. The results will be disseminated in peer-reviewed journals and at international conferences.
Psoriatic arthritis (PsA) is a form of inflammatory arthritis linked to psoriasis. Previous research from the UK has found that many people feel unsupported when diagnosed with PsA and lack confidence in managing their condition. This realist review aims to understand what works and does not work for whom and in what circumstances, in relation to healthcare professionals engaging with people to support them in developing self-management skills.
This protocol was developed by defining the scope of the review, using a brief directed literature review to support discussion by an expert group of researchers, healthcare professionals and a patient partner. A theoretical domains framework was generated, consisting of nine initial programme theories. These were further refined with input from Patient and Public Involvement and Engagement groups and used to develop a database search strategy.
A systematic search of MEDLINE, CINAHL, Embase, Emcare and APA PsycINFO will be carried out, supplemented by citation tracking, exploration of grey literature and a mixed methods survey of rheumatology health professionals. Data selection will be performed by a minimum of two reviewers and data from included sources will be extracted using a template. Data will be synthesised narratively with respect to the identified initial programme theories, using these data to refine or refute these theories. This will generate refined programme theories to explain what works for whom and in what circumstances.
Ethical approval for the health professionals survey was granted through the Research Ethics Committee, University of the West of England (Project ID: 10991848). Outputs will be disseminated to the research community through conference presentations and a peer-reviewed journal article. The strategy for sharing outputs with patients and health professionals will be discussed and agreed with knowledge user groups.
Rubella and parvovirus B19 (B19V) infections can present with arthritis-like symptoms in adults instead of typical dermatological symptoms. We quantify associations between rubella and B19V, respectively, with arthritis-like complications using real-world diagnostic testing.
Cross-sectional and retrospective cohort study.
Reference laboratories across the USA.
Participants with IgM tests for rubella (N=211 917) or B19V (N=644 473) performed at Labcorp from 2014 to 2023. Among these participants, participants with IgM tests for rubella (N=1867) or B19V (N=22 683) and longitudinal laboratory testing through Labcorp were followed for diagnostic tests for rheumatoid arthritis (RA) up to 1.5 years after the viral IgM tests.
Primary outcomes were arthritis-like suspicions by providers and diagnostic testing for RA-associated biomarkers.
Higher proportions of suspicions of arthritis (1.4%, p
Increased awareness of non-typical RA symptoms may facilitate differential diagnosis between rubella, B19V and RA. Recent B19V infections do not occur concurrently with RA; recent B19V infections should be considered in the differential diagnosis for RA when patients present with polyarticular joint symptoms.
High-intensity interval training (HIIT) has been shown to improve cardiovascular health and physical fitness in patients with rheumatoid arthritis (RA). However, patient perspectives on this type of exercise remain insufficiently explored. The aim of this study was to describe experiences of supervised HIIT among patients with RA and to elucidate how patients maintain exercise on their own after completing the supervised intervention.
A qualitative study based on semistructured in-depth individual interviews analysed using qualitative content analysis.
Patients were recruited from a multicentre randomised controlled trial in Western Sweden. Twenty patients (16 women) with RA who had participated in the high-intensity exercise programme for 12 weeks were included in this qualitative interview study.
The supervised HIIT was conducted in a hospital setting.
The results were divided into two domains, corresponding to the two broad open-ended questions. The first domain comprises four categories: (1) challenging and effective with HIIT, (2) belonging to a group facilitates exercise, (3) feeling confident when exercising and (4) stimulating to feel the effect of exercise on the body. The second domain comprises two themes: (1) taking responsibility for one’s health and (2) a feeling of resignation.
HITT was perceived as challenging yet manageable. Follow-up visits with a knowledgeable physiotherapist were requested, since exercise was perceived as a lifelong treatment and just as crucial as pharmacological treatment. Most patients described taking responsibility for their health and maintaining their exercise regime after the supervised intervention; however, some expressed a feeling of resignation and were unready for lifestyle changes. Nevertheless, having RA can be a motivator when exercise is viewed as an important part of medical treatment.
Pain in patients with rheumatoid arthritis (RA) is an unmet clinical need. Targeting joint inflammation with disease-modifying antirheumatic drugs has not resulted in the anticipated reduction in pain for many patients. This can partly be explained by the concept of central sensitisation whereby spinal and supraspinal pathways have a lower threshold of activation, leading to increased perception of pain. Synovial stromal cells, such as fibroblasts, are also thought to play a role through peripheral sensitisation of nerves in the joint. Synovial fibroblasts are known to produce pro-algesic mediators such as interleukin 6 and nerve growth factor at the messenger RNA level. These pro-algesic mediators could activate sensory nerve fibres that send signals from the joint to the spinal cord, thereby driving persistent pain in RA. The purpose of this study is to evaluate which pro-algesic mediators are produced by lining versus sub-lining fibroblasts and whether the level of these mediators correlates with clinical measures of pain in patients with RA.
FiND-Pain RA is a multicentre observational study which will recruit 50 patients with seropositive RA who attend the rheumatology department of Guy’s and St Thomas’ Hospital, London, and the Nuffield Orthopaedic Centre, Oxford. Clinical examination, pain-focused patient-reported outcome measures, ultrasound examination and ultrasound-guided synovial biopsy of the knee will be performed. The levels of known and putative pro-algesic mediators will be measured in fibroblasts from the lining and sub-lining layer of the synovium. The location and spatial morphology of sensory nerve fibres and their proximity to lining and sub-lining fibroblasts will be characterised. The primary outcome will be to determine whether the knee pain scores of participants correlate with the level of leukaemia inhibitory factor, a novel putative pain-mediator expressed in sub-lining fibroblasts. The secondary outcomes will be to determine whether other pro-algesic mediators produced by lining or sub-lining fibroblasts correlate with clinical measures of pain and to assess the location and proximity of sensory nerve fibres to lining versus sub-lining fibroblasts.
The study is a sub-study of the PUMIA (Pain Phenotypes and their Underlying Mechanisms in Inflammatory Arthritis) study, which has been approved by the Bromley Research Ethics Committee (REC: 21/LO/0712). The findings of this study will be disseminated through open-access publications, as well as scientific and clinical conferences.
Evaluate tofacitinib efficacy, safety and persistence by sex in rheumatoid arthritis (RA).
Post hoc analyses using data from phase III placebo-controlled randomised controlled trials (ORAL Scan, ORAL Sync and ORAL Standard).
ORAL Scan, ORAL Sync and ORAL Standard were global, multicentre trials conducted across 111, 114 and 115 sites, respectively.
The trials enrolled adults with active RA and prior inadequate response to methotrexate (ORAL Scan/ORAL Standard) or ≥1 conventional synthetic or biologic disease-modifying antirheumatic drug (ORAL Sync). Post hoc analyses included 2265 patients (1870 female and 395 male).
Patients received tofacitinib 5 mg or 10 mg two times a day, adalimumab or placebo.
Efficacy outcomes to month 12 included American College of Rheumatology (ACR)20, 50 and 70 responses, Disease Activity Score in 28 joints (DAS28) (erythrocyte sedimentation rate (ESR))-defined low disease activity (LDA) and remission, DAS28 (C reactive protein (CRP)) ≤3.2 and
At baseline, female patients had similar DAS28(CRP and ESR), slightly higher HAQ-DI and lower FACIT-F scores versus male patients (n=395). ORs for active treatments (tofacitinib and adalimumab) versus placebo were generally >1 for ACR20, 50 and 70 responses, DAS28(CRP) ≤3.2 and
In post hoc analyses, tofacitinib was efficacious across both sexes, with higher responses in males observed particularly for more stringent composite endpoints and patient-reported outcomes. Findings are generally consistent with studies of other advanced RA therapies. Safety and persistence were similar across sexes. Interpretation is limited by the small proportion of male patients (
NCT00847613,
Rheumatoid arthritis (RA) is a heterogeneous disease, which current treatment guidelines insufficiently accommodate, as they predominantly emphasise the suppression of disease activity. However, a step towards personalised medicine is preferred to further optimise treatment and requires homogeneous subgroups with similarities in pathophysiological mechanisms and treatment responses. Prior research has already demonstrated notable differences in the pathophysiology of patients with autoantibody-positive and autoantibody-negative RA, as well as differences in treatment responses, which may serve as a strong basis for personalised medicine. Additionally, there is evidence suggesting that an early treatment response is indicative of future courses. Based on these findings, we designed a personalised medicine trial in RA that compares the effectiveness and cost-effectiveness of a tailor-made approach with routine care.
The PeRsonalIsed Medicine in RA (PRIMERA) trial is a multicentre, open-label, randomised controlled trial that includes 300 adult patients with newly diagnosed, DMARD-naïve RA, according to 2010 American College of Rheumatology/EULAR criteria. Patients are randomised into either routine care or a tailor-made approach. Both management approaches use a treat-to-target strategy, aiming for low disease activity (LDA, Disease Activity Score using 44 joints (DAS) ≤2.4). In routine care, initial treatment consists of methotrexate along with a single intramuscular dose of glucocorticoids (GCs) and treatment can be intensified after 3, 7 and 10 months if LDA is not reached. Conversely, initial treatment in the tailor-made approach depends on the presence of autoantibodies, with patients with autoantibody-positive and autoantibody-negative RA starting with hydroxychloroquine or methotrexate together with a single intramuscular dose of GCs, respectively. Medication intensifications will be allowed at months 1, 3, 4, 7 and 10. Intensifications at months 1 and 4 depend on whether patients have an early sufficient response to GCs and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), respectively. The tailor-made approach is superior to routine care if no more biological DMARDs (bDMARDs) or tsDMARDs are used after 10 months of treatment, while the mean DAS over time is lower. Our primary outcome is the proportional difference in bDMARD or tsDMARD usage after 10 months of treatment between routine care and the tailor-made approach. Secondary outcomes are DAS over time, time to achieve LDA, cost-effectiveness and patient-reported outcome measurements over time.
Ethical approval has been granted by Erasmus MC Medical Ethics Review Committee (MEC-2020-0825). The results will be disseminated through peer-review journals and medical congresses.
An abnormal composition of gut bacteria along with alterations in microbial metabolites and reduced gut barrier integrity has been associated with the pathogenesis of chronic autoimmune and inflammatory rheumatic diseases (AIRDs). The aim of the systematic review, for which this protocol is presented, is to evaluate the clinical benefits and potential harms of therapies targeting the intestinal microbiota and/or gut barrier function in AIRDs to inform clinical practice and future research.
This protocol used the reporting guidelines from the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol. We will search Embase (Ovid), Medline (Ovid) and the Cochrane Library (Central) for reports of randomised controlled trials of patients diagnosed with an AIRD. Eligible interventions are therapies targeting the intestinal microbiota and/or gut barrier function including probiotics, synbiotics, faecal microbiota transplantation, live biotherapeutic products and antibiotics with the intent to modify disease activity in AIRDs. The primary outcome of the evidence synthesis will be based on the primary endpoint of each trial. Secondary efficacy outcomes will be evaluated and selected from the existing core domain sets of the individual diseases and include the following domains: disease control, patient global assessment, physician global assessment, health-related quality of life, fatigue, pain and inflammation. Harms will include the total number of withdrawals, withdrawals due to adverse events, number of patients with serious adverse events, disease flares and deaths. A meta-analysis will be performed for each outcome domain separately. Depending on the type of outcome, the quantitative synthesis will encompass both ORs and standardised mean differences with corresponding 95% CIs.
No ethics approval will be needed for this systematic review. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to disseminate the study results through a peer-reviewed publication.
CRD42025644244.
To evaluate the mental health burden in rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA) using diagnostic and self-reported tools and to examine its associations with current disease activity, patient-reported outcomes and barriers to appropriate care.
Single-centre, cross-sectional, case–control study.
Rheumatology centre of a tertiary care hospital, serving as a referral clinic with outpatient and inpatient care in Czech Republic.
233 patients with rheumatic diseases (113 RA, 120 axSpA) and 170 healthy controls (HC).
Mental disorders (MD) were assessed through a structured psychiatric interview using the International Neuropsychiatric Interview (Mini International Neuropsychiatric Interview) administered by a trained professional and by self-reported questionnaires including the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI). Disease activity was evaluated with the Disease Activity Score-28 with C-reactive protein (DAS28-CRP) for RA and the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) for axSpA, alongside patient-reported outcomes (PROs).
At least one MD was present in 24.8% of RA, 31.7% of axSpA and 7.0% of HC (p
Mental disorders in RA and axSpA are closely associated with higher disease activity and unfavourable PROs, while access to and acceptance of psychiatric care remain markedly insufficient. Systematic integration of mental health assessment and management into rheumatology practice is strongly warranted.
Methotrexate (MTX) effectively controls rheumatoid arthritis (RA) but often leads to side effects (SE) such as gastrointestinal (GI) issues, liver toxicity and bone marrow suppression. To develop clinically interpretable machine learning (ML) models that accurately predict MTX-related SE in patients with RA taking MTX. The aim was to enhance predictive accuracy and to identify patient-specific risk factors using explainable artificial intelligence (XAI), thereby enabling transparent clinical interpretation. We specifically sought to address the unmet need for individualised risk stratification using real-world, multicentre observational data.
Retrospective case-control study.
Across 23 rheumatology clinics in South Korea, based on data from a nationwide multicentre cohort.
A total of 5077 patients with RA were initially enrolled from the Korean Observational Study Network for Arthritis. After excluding those with missing clinical, demographic or prescription data and those not receiving MTX, 2375 patients remained eligible. Among these, 1654 and 1218 patients were included in the overall SE and GI SE analysis groups, respectively, after 1:1 propensity score matching. All patients were aged ≥18 years and met the 1987 American College of Rheumatology classification criteria.
The primary outcome was the presence of SE in patients with RA taking MTX, categorised into overall SE and GI SE, based on standardised patient questionnaires and clinical assessments. The secondary outcome was the identification of key predictors using SHapley Additive exPlanations (SHAP) to enhance the interpretability of ML predictions.
Among six ML classifiers, extreme gradient boosting demonstrated the highest performance in predicting overall SE (area under the curve (AUC) 0.781, F1 score 0.672, area under the precision-recall curve (AUPRC) 0.757) and GI SE (AUC 0.701, F1 score 0.690, AUPRC 0.670). SHAP analysis identified key predictive features including age, physician visual analogue scale score, alanine aminotransferase, Health Assessment Questionnaire score, celecoxib use and drug adherence. Logistic regression confirmed statistical significance for multiple variables (eg, OR 4.63; 95% CI 1.41 to 20.90 for non-adherence >30 days; OR 1.45; 95% CI 1.14 to 1.85 for celecoxib use). DeLong’s test indicated that boosting models significantly outperformed support vector machine (p
Interpretable ML models using real-world clinical data can accurately predict SE in patients with RA taking MTX. These models may facilitate early identification of high-risk individuals and inform personalised treatment strategies. Integration into clinical decision support systems could improve MTX safety monitoring. Further prospective validation in external cohorts is warranted.
This study aimed to describe the epidemiology, outcomes and costs of four immune-mediated inflammatory rheumatic diseases (IMIRDs)—systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)—in Brazil’s public and private healthcare systems from 2018 to 2022.
Retrospective observational study.
The study was conducted across hospital and outpatient levels of care in Brazil, based on nationwide data representing the public (Department of Informatics of the Unified Health System—DATASUS) and private (National Supplementary Health Agency—ANS) healthcare sectors.
The study analysed data from four distinct systems: 609 427 patients from the public Outpatient Information System (SIA), 32 119 patients from the public Hospital Information System (SIH), 19 083 deaths from the public Mortality Information System (SIM) and 11 846 hospitalisations from the private healthcare system (ANS).
RA had the highest incidence, ranging from 19.9 to 24.9 per 100 000, while SLE remained stable (6.3–6.7 per 100 000). Prevalence increased for all diseases: RA rose from 95.7 to 136.8, SLE from 23.4 to 38.9, AS from 15.0 to 23.6 and PsA from 10.8 to 17.4 per 100 000. SLE had the highest hospitalisation (7.2%) and lethality rates (8.7%), along with the highest average outpatient cost (US$440.9 per patient). In the private system, RA and SLE accounted for the most hospitalisations (36.3% each). SLE had the highest proportion of emergency hospitalisations (70.5%), while PsA had the highest proportion of elective hospitalisations (61.8%).
RA had the highest prevalence and incidence rates among the studied IMIRDs, while SLE was associated with the highest lethality, outpatient costs and emergency hospitalisations. The rising prevalence of these diseases highlights their growing burden on Brazil’s healthcare systems.
To explore how Australian rheumatologists perceive and recommend running for individuals with rheumatoid arthritis (RA), including their clinical experiences, observations and personal views.
Qualitative exploratory study using semistructured interviews. Interviews were conducted via Microsoft Teams, transcribed verbatim and analysed thematically using NVivo software.
Australia; interviews were conducted remotely via Microsoft Teams with participants joining from either clinical or home environments.
13 practising Australian rheumatologists recruited through purposive and snowball sampling.
Five themes were identified from thematic analysis: (1) perceived benefits of running, (2) risks and clinical cautions, (3) criteria required for discussing running, (4) barriers to running and (5) facilitators to running. Participants acknowledged various benefits of running for individuals with RA, such as improved mental health, lifestyle changes and support for joint health. Concerns included risks of running during active disease phases and overly rapid progression of training loads. Key criteria for recommending running included good disease control, the patient’s running history and personal goals. Barriers included patient concerns around joint harm, lack of guidelines and socioeconomic challenges. Facilitators included stable disease, symptom-guided pacing, gradual load increases, allied health referral and appropriate footwear.
Rheumatologists acknowledged both the potential benefits and risks of running for people with RA. Individualised recommendations based on disease status and patient preferences could enhance the integration of running into care plans. Further research is needed to develop specific guidelines and understand patient outcomes.
Rheumatological diseases represent a widespread heterogeneous group of disorders, united by chronic musculoskeletal inflammatory processes. Despite the increasing effectiveness of new therapies, the lack of adequate treatments for certain conditions and the occurrence of adverse drug reactions have led to the need for alternative strategies, including food supplements. These products are perceived by the patient as a valuable aid without adverse effects. However, adverse reactions to food supplements have been reported, although their incidence cannot be established due to the lack of consumption data. In this context, the IntegraRE project aims at collecting information on the use of food supplements in rheumatology, considering both physicians and patients.
A survey-based cross-sectional study has been designed into two consecutive phases: Phase 1 aims to investigate rheumatologists’ knowledge, attitudes and recommendations to patients regarding food supplements, while Phase 2 focuses on estimating patients’ intake of food supplements, including the specific products used, unit consumed and reasons for their consumption. Questionnaires will be collected from at least 287 rheumatologists and 2000 patients, geographically distributed in proportion to the Italian population. These will gather information on sociodemographic variables, lifestyle factors, knowledge, clinical practices and supplement consumption.
The study protocol has been approved by the Ethics Committee of the Italian National Institute of Health (approval no. AOO 0032395 on 24 July 2024). The results, which will be widely disseminated through conference presentations, peer-reviewed publications and dedicated project webpage, will provide an understanding of the use of food supplements in rheumatology and allow guidelines to be drawn up on their correct use in the clinical practice of rheumatological diseases. Overall, this survey will increase people’s awareness of the effects of food supplements and encourage their safe and conscious use.
Patients with fragility fractures are two times as likely to suffer future fractures as their peers who have not suffered a fracture. In addition, 40% of those who suffer fragility fractures do not recover their level of functioning in terms of activities of daily living after 1 year. The present study aims to verify the hypothesis that a semipersonalised home-based exercise intervention may improve patients’ independence and reduce the number of hospital admissions compared with usual care for a population that suffers fragility fractures.
This parallel-arm single-blinded randomised-controlled trial will take place at the University of Cordoba (Spain) between September 2022 and September 2024. Patients aged >50 years old who have undergone surgery for a fragility hip fracture and who were prefracture independent (Barthel index (BI)>60) will be invited to participate. Patients will be excluded if they present a different type of fracture, mild or greater cognitive impairment or contraindication to exercise training. Patients will then be randomised into exercise or usual care group. The former will receive a daily walking appointment (number of steps to be completed inside home, interspersed with sit-to-stand movements) with the total volume increasing weekly. The latter will receive the usual care. The outcomes, collected at baseline, at the end of training (3 months) and at follow-up (6 months) by blinded operators will include the BI and number of readmissions (primary outcomes) and quality of life, exercise capacity, strength, cognitive status, bone mineral density and laboratory biomarkers (secondary outcomes). Variables related to quality of life, cognitive status, laboratory markers and densitometry will also be analysed.
The research ethics committee of the province of Cordoba approved the project (number 326; date 28 July 2021). Patients who meet the eligibility criteria will receive a patient information document and the consent form and will be encouraged to ask any questions. The proposed research respects the fundamental principles of the Declaration of Helsinki, the Council of Europe Declaration on Human Rights and Biomedicine, the UNESCO Universal Declaration on the Human Genome and Human Rights, and the Oviedo Council on Human Rights and Biomedicine. The data obtained in this study will be confidential. They will be treated by the Organic Law 3/2018, of 5 December, on the Protection of Personal Data and Guarantee of Digital Rights, keeping it strictly confidential and not accessible to unauthorised third parties, and the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on Data Protection (RGPD). Written informed consent will be obtained from all the participants. The study’s results will be published in peer-reviewed journals and presented at scientific congresses worldwide. The results will also be disseminated through patient advocacy group newsletters and social media platforms. Patient partners will help select the appropriate channels and develop plain-language summaries tailored to their communities’ needs.
ClinicalTrials.gov ID: NCT04934358 (registration date: 14 June 2021).
Giant cell arteritis (GCA) is a vision-threatening systemic vasculitis for which no universally accessible diagnostic tool exists. Optic nerve sheath diameter (ONSD), measurable via ultrasound, has emerged as a promising, non-invasive biomarker of cranial GCA. The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis (SONIC-GCA) aims to validate ONSD ultrasound as a diagnostic and monitoring tool in GCA.
SONIC-GCA is a prospective, multicentre study enrolling patients referred for the evaluation of suspected GCA. A total of 285 participants will undergo optic nerve sheath ultrasound and digital retinal funduscopy, followed by a standardised GCA assessment. All participants will be followed for a minimum of 6 months, at which time an external adjudication committee will confirm the diagnosis of GCA. Those diagnosed with GCA will be followed for 2 years, with repeated optic nerve sheath ultrasound and digital retinal funduscopy at months 3, 6, 12, 18, 24 and at relapse, if applicable.
The primary outcome is the diagnostic accuracy of ONSD to detect GCA, which will be evaluated using receiver operating characteristic curve analysis, with adjudicated GCA status serving as the reference standard. Secondary outcomes will address several complementary domains: its value for relapse monitoring will be assessed through time-dependent Cox proportional hazards models, examining whether baseline or longitudinal ONSD predicts relapse risk; intraobserver and interobserver reliability will be determined using intraclass correlation coefficients, providing quantitative estimates of measurement reproducibility; and its association with retinal findings will be evaluated by correlating ONSD measurements with ocular imaging and clinical retinal outcomes. Together, these analyses will comprehensively determine the diagnostic, prognostic and operational utility of ONSD in GCA.
The study has been peer-reviewed by the scientific committee and approved by the CIUSSS du Nord-de-l’Île-de-Montréal Research Ethics Board. Each participating site will obtain local ethics approval prior to enrolment. All participants will provide informed consent. Results will be disseminated through peer-reviewed publications, conference presentations and webinars.
FreshRSS 