BackgroundRandomized clinical trials support drug development and uptake of new therapies for systemic lupus erythematosus (SLE). However, challenges to conducting high-quality clinical trials have been noted, including underrepresentation of minoritized populations. Currently, it is not known whether the methodological quality of clinical trials is associated with representativeness of US patients with SLE.MethodsFor this cross-sectional study, we identified industry-sponsored clinical trials of small molecules and biologics for SLE with at least one US enrollment site, with results published in peer-reviewed journals as of January 1, 2026. Trial characteristics were abstracted, and urbanicity of US enrollment sites were classified using the National Center for Health Statistics Urban-Rural Classification System. Trial representativeness by sex, race, and ethnicity were assessed against SLE prevalence in meta-analyzed US lupus registries using participation-to-prevalence ratios (PPRs; ≥0.8 indicating adequate representation). Trial methodological quality was assessed using the Cochrane Risk of Bias 2 tool. Associations between trial risk of bias and representativeness were evaluated.FindingsWe identified 51 trials enrolling 18,466 participants with SLE. Trial representation was adequate for female (median PPR 1 · 03), Hispanic (median PPR 1 · 37), White (median PPR 1 · 03), and Asian participants (median PPR 2 · 40), and Black participants were underrepresented (median PPR 0 · 32). Most US enrollment sites were located in large metropolitan areas. The methodological quality of trials varied (37% at low risk of bias, 35% with some concerns, 27% at high risk of bias) but was not associated with demographic or geographic representativeness.InterpretationWe identified inconsistencies in participant representation and methodological quality across SLE clinical trials. Although trial designs were generally rigorous, limitations of participant inclusion and enrollment site distribution suggest that representation, rather than methodological quality alone, may limit the external validity of SLE clinical trials.

ObjectivesSocial determinants of health (SDOH) and race are associated with disease activity, including lower achievement of the low lupus disease activity state (LLDAS), but it is unknown whether these factors are associated with patient-reported outcomes (PROs). Among a cohort with childhood-onset systemic lupus erythematosus (cSLE) in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry, we investigated associations between race, SDOH, and PROs.MethodsIn this cSLE cohort study, the primary exposure was self-reported race and ethnicity with collected SDOH including insurance status and area deprivation index (ADI). Our primary outcomes were any functional disability by CHAQ (>0) and overall health by PROMIS Global Health-7 across follow-up. Multivariable regression models assessed these associations, adjusting for demographic and disease-related factors.ResultsAmong 540 children with cSLE, most had CHAQ (86%) and PROMIS Global Health-7 (74%) scores collected at Registry enrollment. Functional disability was common (46%), and overall health was below average (median T score 38.8, IQR 34.0-42.1) at enrollment. In unadjusted and adjusted analyses, race, insurance, and ADI were not significantly associated with either outcome. However, PROMIS completion differed significantly by race (p < 0.001).ConclusionsChildren with cSLE in the CARRA Registry commonly report deficits in functional status and overall health. Although race and SDOH were not significantly associated with PROs, differential PROMIS completion by race suggests the potential for bias in these estimates. Interventions to improve completeness and representativeness of PRO data collection are needed to support accurate assessment of health disparities in cSLE across all patient groups.

ObjectiveThis study aimed to identify novel serum biomarkers for lupus nephritis (LN) and evaluate their potential for improving diagnosis, monitoring disease activity, and understanding LN pathogenesis.MethodsA cell adhesion molecules (CAMs) antibody microarray was utilized to identify potential biomarkers of LN using serum samples from LN, chronic kidney disease (CKD), and healthy controls (HC). Differential expression analysis and LASSO regression identified CAM biomarkers in a discovery cohort, followed by ELISA validation in an independent, discovery cohort. Biomarker correlations with clinicopathological parameters were assessed, and receiver operating characteristic (ROC) analyses were performed to examine the potential diagnostic utility.ResultsOf the 17 CAMs analyzed, serum NrCAM and P-Cadherin emerged as the most promising new biomarkers, significantly discriminating LN from HC. Serum NrCAM was found to differentiate between LN and HC (p < 0.0001) as well as active LN (LNA) from inactive LN (LNI) (p < 0.01) in the discovery cohort. Serum P-Cadherin, however, differentiated LN from both HC (p < 0.0001) and CKD (p < 0.001) and distinguished LNA from LNI (p < 0.01). In a larger validation cohort, ROC analyses demonstrated strong diagnostic potential for both biomarkers, with AUC values of 0.92 and 0.82 for serum NrCAM and P-Cadherin, respectively. Significant correlations with SLEDAI, rSLEDAI, and histological indices further underscored their potential relevance to LN severity and activity. Interestingly, serum NrCAM and P-Cadherin are complementary in reflecting renal pathology changes including endocapillary hypercellularity, cellular crescents, glomerulosclerosis, tubular atrophy, and interstitial fibrosis.ConclusionSerum NrCAM and P-Cadherin show promise as non-invasive biomarkers for LN, offering potential utility in diagnosis and disease monitoring. Their ability to distinguish between disease states and correlate with clinical parameters highlights their potential to improve patient stratification and guide personalized treatment approaches in LN.

BackgroundWomen with antiphospholipid antibodies (aPL) and antiphospholipid syndrome (APS) are at increased risk of pregnancy complications. Routinely reported endpoints primarily captures what happens medically but provide limited insight into the experience of the emotional, psychosocial and lived burden of pregnancy planning and pregnancy after loss with aPL/APS. Understanding these aspects is important for patient-centered counselling, supporting adherence and wellbeing and designing future patient-centered care.ObjectivesTo explore how women with aPL/APS experience family planning, pregnancy and pregnancy care including interactions with healthcare professionals and, how living with aPL/APS affects their psychological wellbeing and quality of life.MethodsWe conducted a scoping review of medical and psychology databases to identify qualitative studies and mixed-methods studies with extractable qualitative data. We conducted a thematic analysis to synthesize findings into overarching themes.ResultsWe included six studies (114 women) across four countries. Six overarching themes were identified:1) Regaining control under perceived high risk; 2) reconfiguring family planning in light of APS; 3) living with chronic uncertainty, grief and last-chance pregnancy; 4) social and relational influences on reproductive decision-making; 5) gaps in recognition, information and monitoring and 6) the value of empathic, coordinated, multidisciplinary preconception care. Overall, women's experiences were shaped by reproductive risk, prior pregnancy loss, treatment burden, uncertainty and the quality and continuity of communication with health-care professionals.ConclusionWomen with aPL and APS are at increased risk of adverse pregnancy outcomes. While conventional clinical endpoints typically describe medical outcomes, they may provide limited insights into the emotional, psychosocial and lived burden of pregnancy planning and pregnancy. Understanding these dimensions is important for patient-centered counselling, adherence, wellbeing and the development of future care.

PurposeTargeted biologic therapy has changed the management of systemic lupus erythematosus (SLE), including lupus nephritis (LN), but incomplete response, relapse, glucocorticoid dependence, and refractory organ disease remain common. This article discusses whether bispecific and trispecific antibodies may help move lupus therapy beyond conventional monospecific blockade.Key MessagesMultispecific antibodies are not a single therapeutic class. Their clinical relevance depends on mechanism: dual-pathway blockade, interruption of B-T-cell collaboration, inhibitory non-depleting B-cell silencing, T-cell engager-mediated depletion of B-cell or plasma-cell compartments, and future trispecific immune-reprogramming concepts. Direct lupus evidence remains limited. Obexelimab, which co-engages CD19 and the inhibitory receptor FcγRIIb, provides the most informative randomised SLE dataset, but its phase 2 trial did not meet the primary endpoint and biomarker-defined signals remain hypothesis-generating. Teclistamab, a BCMA × CD3 T-cell engager, offers a provocative single-case proof of concept in refractory SLE with active LN, but also illustrates risks of cytokine release syndrome, infections, and hypogammaglobulinaemia. Rozibafusp alfa, which targets ICOSL and BAFF, illustrates the biological appeal, and clinical difficulty, of rational dual-pathway blockade in SLE.ConclusionsMultispecific antibodies may become useful in lupus if their depth of immune intervention can be matched to disease phenotype, safety risk, and trial design. Their future role will depend on lupus-specific evidence, biomarker-guided selection, and careful positioning between conventional biologics and cellular immune-reprogramming strategies.

ObjectiveInfection is a major factor in morbidity and mortality among pediatric systemic lupus erythematosus (SLE) patients, particularly opportunistic infections (OI), which can result in severe clinical outcomes. There is a scarcity of data regarding OI in children with SLE in resource-limited areas. This study aimed to determine the incidence of OI in childhood SLE, describe their characteristics, and identify associated risk factors.MethodsThis study is a retrospective and prospective study from January 2009 to November 2025 at King Chulalongkorn Memorial Hospital, Thailand. Data on demographics, clinical features, laboratory parameters, types of OI, and outcomes were analyzed. Conditional logistic regression analysis was used to identify risk factors for OI in pediatric SLE.ResultsAmong 177 children with SLE, 38 patients developed OI. Person-year incidence of OI was 3.4 per 100 person-year (95% CI: 2.3-4.9). The most common OIs were Candida spp. (27.0%), Aspergillus spp. (13.5%), and Cytomegalovirus (CMV) (13.5%) with respiratory and mucocutaneous sites being the most frequently affected. Pulse intravenous methylprednisolone (IVMP) use during the past 3 months and high disease activity, defined as SLEDAI-2K score ≥ 11, were associated with an increased risk of OI in the multivariate model (adjusted OR, aOR 16.12; 95% CI 3.42-75.85 and aOR 3.46; 95% CI 1.44-8.31, respectively). Other variables, including cumulative prednisolone dose, cumulative cyclophosphamide exposure, complement 3 (C3) and C4 level, absolute lymphocyte count, and serum albumin, were not significantly associated with OI development after adjustment for potential confounders.ConclusionFungal and CMV infections were common OI in pediatric SLE. This finding underscores the importance of clinical vigilance regarding OI and the implementation of preventive strategies in SLE patients with the recent pulse IVMP exposure or high disease activity.

BackgroundAntiphospholipid syndrome (APS) is an autoimmune condition marked by thrombosis and pregnancy complications caused by antiphospholipid antibodies (aPL). This study evaluates immunological, inflammatory, and endothelial biomarkers in primary and secondary APS and SLE to determine their association with clinical outcomes.Material and methodsWe conducted a cross-sectional study including patients with primary (PAPS) (n = 79), secondary (SAPS) (n = 47), SLE (n = 36), and control group (n = 56). Serum and plasma samples were analyzed for aPLs, inflammatory markers (hs-CRP, IL-6), endothelial markers (endoglin), platelet activation (CD41/CD61), tissue factor, and iron metabolism markers (hepcidin, ferritin, UIBC) using ELISA and automated assays. Statistical analyses included group comparisons, correlations, multivariate logistic regression analysis and principal component analysis (PCA).ResultsNon-criteria aPLs, were significantly elevated in all patient groups compared to controls (p < 0.001). Patients with SAPS demonstrated significantly higher levels of aCL IgG, aCL IgA, aβ2GPI IgM, and aPS/PT (IgG and IgM) compared to PAPS. Strong correlations were identified between aPS/PT IgG and the lupus anticoagulant ratio (LAR) (r = 0.670, p < 0.001), as well as between aβ2GPI IgG and LAR (r = 0.625, p < 0.001). Multivariate logistic regression identified that endoglin and ferritin were independently associated with clinical manifestations. For fetal loss, the model was statistically significant (χ[21] = 16.18, p = 0.013); an increase in endoglin raised the probability by 45.1% (OR = 1.451, p = 0.040), while lower ferritin levels were also independently associated (p = 0.004). Ferritin showed the strongest independent association with thrombosis (χ[21] = 19.87, p = 0.011), with each unit increase raising the probability of a thrombotic event by 1.5% (OR = 1.015). PCA identified two main factors explaining 63% of the variance: an "Immunological-related" factor (42.96%) dominated by aCL IgG, aβ2GPI IgG, aPS/PT IgG, and aCL IgA, and a "Prothrombotic and metabolic-related" factor (20.06%) driven by aβ2GPI IgM, tissue factor, aCL IgA, and inversely by UIBC.ConclusionThe study highlights the interplay of immune, inflammatory, and endothelial dysfunction biomarkers in APS and their association with clinical manifestations. Combined assessment of conventional and non-criteria biomarkers may improve understanding of disease mechanisms and support a more comprehensive evaluation of patients with APS.

ObjectiveTo characterize the burden and MRI subtypes of cerebral small vessel disease (cSVD) in antiphospholipid syndrome (APS) and to identify clinical factors associated with cSVD.MethodsWe retrospectively analyzed 132 patients with APS and age- and sex-matched healthy controls. MRI markers for cSVD, including lacunes, enlarged perivascular spaces (EPVS), microbleeds, and white matter hyperintensities (WMH), were rated using validated scales. Total cSVD scores (0-4) were calculated. Logistic regression analyses adjusted for age, sex, and disease duration were used to identify risk factors.ResultsMore than half of patients with APS (51.5%) exhibited cSVD, whereas only 24.2% had a history of stroke. Lacunes were the predominant subtype (46.2%), followed by WMH (16.7%), EPVS (14.4%), and microbleeds (12.1%). Subclinical cSVD was present in 34.8% of patients with APS without neurological symptoms. Hypertension (OR 3.69, 95%CI 1.17-11.65, p = 0.026), prior thrombosis (OR 22.15, 95%CI 2.11-232.27, p = 0.010), and prior stroke (OR 10.71, 95%CI 2.47-46.36, p = 0.002) were independently associated with cSVD, while individual aPL profiles were not.ConclusioncSVD is a common feature in patients with APS and often occurs in the absence of neurological manifestations. The predominance of lacunes suggests a pattern of recurrent microvascular injury. Hypertension and thrombotic history are major contributors, underscoring the need for comprehensive vascular risk assessment. These findings highlight the potential value of MRI screening in selected patients with APS and call for longitudinal studies to clarify its prognostic significance.

ObjectivesGalectin-9 and IP-10 are downstream effectors of the type I interferon (IFN) pathway and have been proposed as surrogate biomarkers of IFN signature in systemic lupus erythematosus (SLE). This study aimed to investigate the association of serum Galectin-9 and IP-10 levels with disease activity in lupus nephritis (LN) and to compare them with those in disease controls, including antiphospholipid syndrome (APS) and primary Sjögren's disease (pSD), and healthy controls.MethodsFifty-nine patients with biopsy-proven LN (31 active, 28 inactive), 36 patients with APS, 17 patients with pSD, and 61 healthy volunteers were enrolled. All SLE patients fulfilled both the SLICC and the 2019 EULAR/ACR classification criteria. Serum Galectin-9 and IP-10 levels were measured by enzyme-linked immunosorbent assay (ELISA) in samples obtained at the same visit as the disease activity assessment. In patients with active LN, kidney biopsy was performed as part of the same clinical evaluation, whereas patients with inactive LN had a previously established biopsy-proven diagnosis of LN.ResultsAmong 59 LN patients (74.6% female; mean age 37.9 ± 12 years), serum levels of both biomarkers were significantly higher in the active LN group compared with inactive LN, APS, pSD, and healthy controls (p ≤ 0.05). Biomarker levels did not differ significantly among the inactive LN, APS, and pSD groups (p > 0.05); however, all three groups showed significantly higher levels compared to healthy controls (p ≤ 0.05). Both biomarkers showed weak but statistically significant correlations with SLEDAI scores (Galectin-9: r = 0.36, p = 0.004; IP-10: r = 0.33, p = 0.009). ROC analysis demonstrated moderate discriminatory ability for distinguishing active from inactive LN (AUC: 0.695 for Galectin-9; 0.658 for IP-10).ConclusionSerum Galectin-9 and IP-10 are elevated in active LN and show weak but statistically significant correlations with SLEDAI scores. However, elevated levels are not specific to LN, as similar values are observed in inactive LN, APS, and pSD, suggesting these markers reflect a shared IFN-driven inflammatory state rather than LN-specific pathology.

ObjectiveTo characterize the burden of herpes zoster (HZ) in systemic lupus erythematosus (SLE) and to examine clinical correlates of HZ and patients' attitudes toward the recombinant zoster vaccine (RZV).MethodsWe conducted a single-center retrospective cohort study combined with a cross-sectional survey among consecutive adult outpatients with SLE between December 2024 and June 2025. HZ episodes after SLE diagnosis were ascertained via structured interviews. Incidence rates were calculated as the number of HZ episodes per 1000 person-years from SLE diagnosis to enrollment. Participants were classified into three groups according to the number of HZ episodes: HZ[0], HZ[1], and HZ[≥2] groups. Factors associated with HZ development were assessed using multivariable logistic regression. Patients were asked about willingness to receive RZV ("yes", "no", or "not sure") and reasons for the response.ResultsAmong 170 patients with SLE, 73 (43%) reported at least one HZ episode after SLE diagnosis, and 29 (40% of those with HZ) reported recurrent HZ. During 3138 person-years of follow-up, at least 102 HZ episodes were reported, yielding a minimum incidence of 32.5 per 1000 person-years. In multivariable analysis, ever use of azathioprine (OR 2.74, 95% CI 1.03-7.29) and renal dysfunction (OR 2.59, 95% CI 1.04-6.48) were associated with HZ development. Attitude data were available for 159 patients: 31 (20%) were willing to receive RZV, 47 (30%) were unwilling, and 81 (50%) were unsure.ConclusionsHZ was common and frequently recurrent in this Japanese SLE cohort. Ever use of azathioprine and renal dysfunction were associated with HZ development, while willingness to receive RZV was low. Risk-stratified clinician counselling and shared decision-making may improve acceptance of HZ prevention strategies in high-risk patients with SLE.

BackgroundThe prognostic relevance of lupus nephritis (LN) occurring at systemic lupus erythematosus (SLE) onset versus later remains uncertain, particularly in Hispanic populations.MethodsWe conducted a retrospective cohort study of adults (≥18 years) with biopsy-proven LN from tertiary centers in Colombia (2011-2024). The exposure was LN at SLE onset (LNSO), defined as LN diagnosed concurrently with SLE or with kidney biopsy within 30 days of SLE onset, versus LN occurring later (non-LNSO). The primary outcome was end-stage kidney disease (ESKD), defined as sustained eGFR <15 mL/min/1.73 m[2] for ≥3 months, chronic dialysis, or kidney transplantation. Secondary outcomes were all-cause mortality and a composite of ESKD, death, or doubling of creatinine. Associations were estimated using cause-specific Cox and Fine-Gray models. A 180-day landmark analysis assessed the impact of no remission at 6 months.ResultsAmong 428 patients, 281 (65.7%) had LNSO and 147 (34.3%) non-LNSO. Median follow-up was 5.3 years. ESKD occurred in 72 patients (16.8%) and did not differ by LNSO status (log-rank p = 0.278). LNSO was not associated with ESKD (adjusted HR 0.87; 95% CI 0.48-1.60) or in competing-risk models (sHR 0.85; 95% CI 0.19-3.84). Lower baseline eGFR, higher NIH chronicity index, and higher non-renal damage were associated with ESKD. The composite outcome occurred in 156 patients and was not associated with LNSO. No remission at 6 months strongly predicted adverse outcomes.ConclusionsLNSO was not independently associated with kidney or survival outcomes. Baseline function, chronicity, non-renal damage, and early response were the main prognostic factors.

BackgroundSystemic lupus erythematosus (SLE) is characterized by chronic systemic inflammation, frequent corticosteroid exposure, and heightened cardiometabolic vulnerability. Metabolic syndrome (MetS) has become a clinically significant comorbidity among individuals with SLE. We performed an updated systematic review and meta-analysis to better understand the prevalence and identify the factors associated with the occurrence of MetS in SLE.MethodsPubMed, Scopus, and Web of Science were systematically searched through January 4, 2026 to identify observational studies reporting the prevalence of MetS among individuals with SLE. Random-effects meta-analytic models were applied to calculate pooled prevalence estimates and evaluate the associations with potential risk factors.ResultsThe overall pooled prevalence of MetS in patients with SLE was estimated at 0.27 (95% CI: 0.24-0.30). Sex-stratified analyses showed a prevalence of 0.36 (95% CI: 0.25-0.47) in male patients and 0.27 (95% CI: 0.23-0.30) in female patients. Across continents, the highest prevalence was observed in Africa (0.36, 95% CI: 0.30-0.41), followed by South America (0.32, 95% CI: 0.24-0.40), Asia (0.27, 95% CI: 0.22-0.32), Europe (0.23, 95% CI: 0.18-0.28), and North America (0.21, 95% CI: 0.14-0.30). Regarding medication use, hydroxychloroquine was associated with a significantly reduced risk of MetS (OR = 0.66, 95% CI: 0.52-0.83; P < 0.01), whereas cyclophosphamide (OR = 1.39, 95% CI: 1.06-1.81; P = 0.02), azathioprine (OR = 1.25, 95% CI: 1.00-1.55; P = 0.04), and mycophenolate mofetil (OR = 1.13, 95% CI: 1.03-1.23; P = 0.01) were each associated with a significant increased risk of MetS. No significant associations were found for steroids (OR = 1.34, 95% CI: 0.97-1.83; P = 0.07), methotrexate (OR = 1.07, 95% CI: 0.78-1.47; P = 0.84), or cyclosporine use (OR = 1.19, 95% CI: 0.64-2.21; P = 0.33). The analysis also identified several risk factors for MetS in SLE patients. Patients with MetS were older (Hedges' g = 0.47; P < 0.01), had higher BMI (Hedges' g = 0.88; P < 0.01), and higher total cholesterol (Hedges' g = 0.39; P < 0.01) and LDL levels (Hedges' g = 0.41; P < 0.01) than those without MetS.ConclusionMetS is prevalent among individuals with SLE and is influenced by demographic, clinical, and treatment-related factors. These findings highlight the need for targeted monitoring and management strategies to reduce the cardiometabolic risk in this population.

ObjectivesTo explore pregnancy-related concerns among women with systemic lupus erythematosus (SLE) and impact of the disease on desired family size.MethodCross-sectional, single-center study, including women with SLE diagnosed before menopause. Data were collected via questionnaires and medical records. Participants were classified into three groups: (i) those who never conceived (Group 1); (ii) those who had conceived before SLE diagnosis (Group 2), and (iii) those who had conceived at least once after disease diagnosis (Group 3). Continuous variables were analyzed using Kruskal-Wallis with Mann-Whitney U post-hoc tests; categorical variables using Chi-square or Fisher's exact tests.Results152 patients were included and 75% had received information from their treating physician on reproductive health. Most common pregnancy-related concerns were the need to receive medication during pregnancy (56.6%), followed by concerns about pregnancy complications (53.9%). Women in Group 1 were younger and mainly attributed not having children to personal choice and not to SLE (56.4%). In contrast, women in Groups 2 and 3 frequently reported having fewer children than desired (35.3% and 44.6%, respectively), mostly due to SLE-related concerns (83.3% and 86.2%, respectively). In Group 3, deviation from desired family size was smaller among women who conceived in more recent periods (2015-2024, 32%), although attribution of deviations to SLE remained high.ConclusionsSLE affects women's reproductive decisions, underscoring the importance of tailored counseling.

ObjectiveWhile triple antiphospholipid antibody (aPL) positivity is associated with a higher risk of thrombosis, the clinical significance of single aPL positivity remains unclear. This study aimed to assess the prevalence, clinical characteristics, and cardiovascular disease (CVD) risk profile of persistently single aPL-positive primary antiphospholipid syndrome (PAPS) patients.MethodsWe conducted a retrospective analysis for APS patients from the APS ACTION registry with confirmed persistent single aPL positivity (after testing for lupus anticoagulant [LA], anticardiolipin [aCL] IgG/IgM, or anti-β2-glycoprotein I [aβ2GPI] IgG/IgM), defined by the Revised Sapporo APS Classification Criteria. Triple aPL-tested single aPL-positive patients with no APS classification were used as a control group. Demographics, clinical characteristics, aPL profiles, and adjusted Global APS Score (aGAPSS) were compared between two groups.ResultsAmong 233 PAPS patients tested, 84 (36%) had single aPL positivity: 67 (79%) LA positive, eight (10%) aCL IgG or IgM positive, and 9 (11%) aβ2GPI IgG or IgM positive. Among 97 aPL-positive patients with no APS classification, 22 (22.7%) had single aPL-positivity: nine LA positive, eight aCL IgG or IgM positive, and 5 aβ2GPI IgG or IgM positive. Single LA positivity was significantly more common in PAPS patients, whereas aCL IgM or aβ2GPI IgM positivity were significantly more common in those without APS classification. Historical thrombosis recurrence was observed in 26% of single aPL-positive PAPS patients, predominantly among those with LA positivity (86%).ConclusionsIn this international cohort of persistently aPL-positive individuals, 36% had single aPL positivity, mostly positive LA test. Although "single" aPL-positivity is traditionally considered as a lower-risk profile, findings highlight the importance of differentiating between single LA-positivity and single aCL/aβ2GPI positivity, and the need for individualized risk stratification.