EULAR recommendations for a core dataset to support clinical care and translational and observational research in systemic lupus erythematosus.

Objectives: To enhance clinical and multicentre research outcomes in systemic lupus erythematosus (SLE), standardised documentation of patient- and disease-related features is important. The aim of this European Alliance of Associations for Rheumatology (EULAR) taskforce was to define a core set of essential items for the comprehensive care of SLE patients in clinical practice, with an extension for vital elements required for translational and observational research.

Methods: A multidisciplinary EULAR task force group engaged in a multistep approach including a 4-round Delphi survey and a face-to-face meeting.

Social determinants of health and disparities across the Patient pathway in Systemic Lupus Erythematosus: a narrative review.

Objective: Systemic Lupus Erythematosus (SLE) is a complex, chronic autoimmune disease with significant heterogeneity in its presentation and progression. Social determinants of health (SDH), including socioeconomic factors, health literacy and access to care, among others, can shape SLE outcomes. This review explores the impact and interaction of these factors across the entire lupus patient pathway - from presentation to therapeutic management and outcomes - and proposes targeted solutions to improve health equity and patient outcomes in SLE.

Pneumococcal and influenza vaccination coverage and impact on COVID-19 infection severity in patients with inflammatory rheumatic diseases: A French National Healthcare Database analysis.

Introduction: It has been suggested that vaccinations could induce a trained immunity able to decrease COVID-19 severity. Our primary aim was to evaluate the COVID-19 severity among patients with inflammatory rheumatic diseases (IRD) vaccinated against pneumococcus and influenza compared to those not vaccinated. A secondary objective was also to determine vaccination coverage within real-life population of IRD patients in France.

The Procoagulant and Fibrinolytic Balance of Extracellular Vesicles Predicts Mortality in Septic Shock Patients.

Septic shock is characterised by abnormal coagulation activation with defective fibrinolysis, leading to a high mortality rate. Cellular activation triggers the release of extracellular vesicles (EVs) conveying both procoagulant and fibrinolytic activities. We investigated whether the balance between these activities, termed EV-coagulolytic balance (EV-CLB), predicts day-90 mortality in 225 septic shock patients included in a multicentre prospective study.

Deucravacitinib, an oral, selective, allosteric, tyrosine kinase 2 inhibitor, in patients with active SLE: efficacy on patient-reported outcomes in a phase II randomised trial.

Objective: In PAISLEY, a 48-week, phase II, randomised controlled trial that assessed deucravacitinib in patients with active SLE, all primary and secondary endpoints were met with the deucravacitinib 3 mg two times per day dose. Changes in patient-reported outcomes, collected as exploratory endpoints, were evaluated in this study.

Methods: Patients with SLE (n=363) were randomised to placebo (n=90) or deucravacitinib 3 mg two times per day (n=91), 6 mg two times per day (n=93) or 12 mg once daily (n=89).

ERN ReCONNET-SLICC-SLEuro expert consensus on the therapeutic management of rare systemic lupus erythematosus manifestations.

Existing guidelines for systemic lupus erythematosus (SLE) predominantly focus on common and major organ involvements. An international taskforce involving experts from three SLE expert groups (ie, the European Reference Network on Rare and Complex Connective Tissue and Musculoskeletal Diseases, the Systemic Lupus Erythematosus International Collaborating Clinics group, and the European Lupus Society) was established. A total of 119 participants contributed to the development of consensus therapeutic strategies for 24 rare SLE manifestations, using a multistep process.

Dual B-cell targeting in systemic lupus erythematosus: The role of combined and sequential therapy with rituximab and belimumab.

Systemic lupus erythematosus (SLE) is a complex autoimmune disease characterized by immune dysregulation and autoantibody production. Despite advances in treatment, achieving sustained disease control remains challenging. Rituximab (RTX) and belimumab (BELI) are two B-cell-targeting biologics with complementary mechanisms of action, leading to increasing interest in their combination as a therapeutic strategy for refractory SLE.

Experiences and unmet needs of persons living with systemic lupus erythematosus in Europe: Lupus Europe's 2024 Swiss knife survey.

Systemic lupus erythematosus (SLE) is a complex autoimmune disease with important variations in disease burden across patients and European countries. In response to previous surveys revealing the burden of SLE on patients, Lupus Europe conducted the 2024 'Swiss Knife' survey to further investigate disease burden, treatment goals, and patient-physician interactions in European patients living with lupus. Between April and May 2024, 4525 patients with self-reported physician-confirmed SLE across 36 European countries participated in an anonymous online study.

European Reference Network (ERN) ReCONNET methodology for the cross-cultural adaptation of instruments for research and care in the context of rare connective tissue diseases (CROSSADAPT).

The traditional process of intercultural adaptation, while suitable for one or a few target languages, is not optimal for developing instruments for rare connective tissue diseases (CTDs) in multiple languages simultaneously. The European Reference Network ReCONNET presents the protocol for a novel methodology for cross-cultural adaptation of instruments for research and care in the context of rare CTDs (ReCONNET-CROSSADAPT). It is initiated by the identification of 'key-terms' that are crucial for maintaining the original meaning of the source document.

Domains for inclusion in a novel Treatment Response Measure for Systemic Lupus Erythematosus (TRM-SLE): results of a modified Delphi study.

Objectives: To achieve consensus on domains of active disease for inclusion in a novel outcome measure for SLE randomised controlled trials (RCTs), the Treatment Response Measure for SLE (TRM-SLE).

Methods: Domains nominated by TRM-SLE Taskforce members were rated in a two-stage modified Delphi study. Each stage comprised two online survey rounds separated by a structured discussion meeting.

Levels of physical activity in a large international cohort of patients with systemic lupus erythematosus.

Introduction: Physical activity (PA) holds a pivotal role in the improvement of mental health or depressive symptoms, as well as in the prevention of cardiovascular diseases (CVDs). Patients with SLE are exposed to an increased risk of CVDs and suffer from deteriorated quality of life compared with the general population. The aim of this study was to assess PA level and characteristics in a large international cohort of patients with SLE.

Scoping literature review to identify candidate domains for the OMERACT Systemic Lupus Erythematosus core outcome set.

Objective: To identify candidate Systemic Lupus Erythematosus (SLE) domains from the literature for consideration towards the development of the SLE Core Outcome Set.

Methods: This was a comprehensive scoping literature review of SLE clinical trials and systematic reviews published since 2010. Studies were identified from 5 databases and were screened for eligibility.

Real-world oral glucocorticoid use in SLE: a nation-wide population-based study using the French medico-administrative (SNDS) claim database.

Background: Oral glucocorticoids (OCS) remain one of the most important treatments for SLE but are associated with damage. Evidence regarding the real-world use of OCS in nationwide SLE populations is currently lacking. The aim of this study was to analyse OCS use and SLE treatments in French patients with SLE at the national level.

Framework for implementing treat-to-target in systemic lupus erythematosus routine clinical care: consensus statements from an international task force.

Implementation of Treat-to-Target (T2T) in routine clinical practice remains low in systemic lupus erythematosus (SLE). Real-world data reveal excessive use of glucocorticoids (GCs) and frequently inadequate disease control. Here, an international task force convened to develop a consensus framework for implementing T2T in routine clinical care of adult patients with SLE.

Caspase-1 activation, IL-1/IL-6 signature and IFNγ-induced chemokines in lungs of COVID-19 patients.

Rationale: COVID-19-associated acute-respiratory distress syndrome (C-ARDS) results from a direct viral injury associated with host excessive innate immune response mainly affecting the lungs. However, cytokine profile in the lung compartment of C-ARDS patients has not been widely studied, nor compared to non-COVID related ARDS (NC-ARDS).

Objectives: To evaluate caspase-1 activation, IL-1 signature, and other inflammatory cytokine pathways associated with tissue damage using post-mortem lung tissues, bronchoalveolar lavage fluids (BALF), and serum across the spectrum of COVID-19 severity.

Real-world treatment patterns and clinical characteristics in patients with moderate-to-severe systemic lupus erythematosus: an analysis of the SLE Prospective Observational Cohort Study (SPOCS).

Objectives: Systemic lupus erythematosus (SLE) is a disease with heterogeneous treatment patterns largely based on organ involvement and disease severity. The SLE Prospective Observational Cohort Study (SPOCS) collected data worldwide over 3 years from patients with moderate-to-severe SLE. We report real-world patterns of medication use in patients enrolled in SPOCS.

Interferon-α biological activity is associated with disease activity and risk of flare in cutaneous lupus erythematosus: A monocentric study of 184 patients.

Background: Cutaneous lupus erythematosus (CLE) is associated with unpredictable flares and may induce permanent damage. There is currently no biomarker routinely available in CLE.

Objective: To evaluate the performance of interferon-α (IFN-α) biological activity as biomarker of CLE activity and risk of flare.

Identifying meaningful aspects of health and concepts of interest for assessment in systemic lupus erythematosus: implications for digital clinical measure development.

Objectives: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with heterogeneous clinical manifestations which significantly impacts the daily lives of patients. Herein, we aimed to (i) investigate patients' perspectives on and experience with SLE; (ii) identify meaningful aspects of health (MAHs) and concepts of interest (COIs) in SLE that could be evaluated using digital clinical measures (DCMs); and (iii) identify target DCMs for their assessment.

Methods: A mixed-methods, multistep approach was deployed for (i) exploring patients' experience with SLE through a social media listening study and focused group discussions with patients; (ii) mapping patients' experiences to define MAHs and identify COIs measurable using DCMs; (iii) selecting DCMs for the target COIs; and (iv) identifying types of wearable sensors for measuring COIs in the patients.

Economic burden of systemic lupus erythematosus and lupus nephritis in France: a nationwide population-based study using the French medico-administrative (SNDS) claims database.

Objectives: Data on the economic consequences of systemic lupus erythematosus (SLE) and lupus nephritis (LN) are scarce in Europe. We aimed to estimate the total direct costs attributable to SLE and LN in France, at the nationwide level.

Methods: Patients with SLE and LN were identified in the French nationwide health insurance database (SNDS).

Factors associated with severity and mortality of COVID-19 in patients with connective tissue diseases and rheumatoid arthritis: A nation-wide, population-based analysis of the French national medico-administrative SNDS database.

Objectives: To investigate the risk and predictors of severity and mortality of COVID-19 infection in patients with Connective Tissue Diseases (CTDs).

Methods: Using the French nationwide claims and hospitalization database, we assembled a nation-wide exhaustive cohort of adult CTD patients with rheumatoid arthritis, systemic lupus, Sjögren's disease, inflammatory myopathies, systemic sclerosis. We analyzed the rates of hospitalization, severe inpatient stays (intensive care unit [ICU] admissions or in-hospital mortality), and in-hospital mortality with COVID-19 from January 1st to December 31st, 2020.

Systemic capillary leak syndrome.

The vascular endothelial barrier maintains intravascular volume and metabolic homeostasis. Although plasma fluids and proteins extravasate continuously from tissue microvasculature (capillaries, post-capillary venules), systemic vascular leakage increases in critical illness associated with sepsis, burns and trauma, among others, or in association with certain drugs or toxin exposures. Systemically dysregulated fluid homeostasis, which can lead to hypovolaemia, hypotensive shock and widespread tissue oedema, has been termed systemic capillary leak syndrome (SCLS) when overt secondary causes (for example, heart or liver failure) are excluded.