Anca D Askanase, Edward M Vital, Oliver Meier, Armando Turchetta, Huiyan Ashley Mao, Justine Maller, Jorge A Ross Terres, Maria Dall'Era
{"title":"Evaluating the concordance between BICLA and SRI4 in patients with systemic lupus erythematosus from the placebo arms of the EXPLORER and ATHOS trials.","authors":"Anca D Askanase, Edward M Vital, Oliver Meier, Armando Turchetta, Huiyan Ashley Mao, Justine Maller, Jorge A Ross Terres, Maria Dall'Era","doi":"10.1136/lupus-2024-001483","DOIUrl":"10.1136/lupus-2024-001483","url":null,"abstract":"<p><strong>Objective: </strong>The British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) and the Systemic Lupus Erythematosus Responder Index 4 (SRI4) responses are the most common primary endpoints in SLE clinical trials. We examined the concordance and the reasons for discordance in BICLA/SRI4 responses in participants with SLE receiving placebo and standard of care (SOC) in two randomised controlled trials.</p><p><strong>Methods: </strong>This post-hoc analysis included data from the placebo arm (participants treated with SOC) of the EXPLORER (n=87; NCT00137969) and ATHOS (n=80; NCT02908100) trials. Disease activity was measured using BILAG and SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index) in the EXPLORER trial and BILAG-2004 and SLEDAI-2000K in the ATHOS trial. For this analysis, participants were classified as responders or non-responders based on BICLA and SRI4 and the presence of intercurrent events. Concordance and discordance frequencies between BICLA and SRI4 were determined.</p><p><strong>Results: </strong>In EXPLORER, the BICLA response rates were lower than the SRI4 response rates (29.9% vs 41.4% at week 52, respectively), whereas in ATHOS the BICLA and SRI4 response rates were similar (41.2% vs 43.8% at week 48, respectively). The overall BICLA/SRI4 concordance (Cohen's κ score) was moderate (0.46 in EXPLORER and 0.54 in ATHOS at weeks 52 and 48, respectively). At weeks 52 and 48, BICLA+/SRI4- and BICLA-/SRI4+ discordance, respectively, was 6.9% and 18.4% in EXPLORER and 10.0% and 12.5% in ATHOS. In an analysis of ATHOS subgroups based on the presence or absence of rash at baseline, BICLA response was higher at week 48 in participants with arthritis only than in those with arthritis and mucocutaneous comanifestations (63.2% vs 33.9%, respectively). BICLA-/SRI4+ and BICLA+/SRI4- discordance was lower in participants with low compared with normal complement at baseline.</p><p><strong>Conclusions: </strong>BICLA and SRI4 may be discordant in SLE trials. Arthritis and rash were the primary drivers of the discordance, and serology influenced BICLA and SRI4 response, suggesting the need for evaluation of multiple efficacy endpoints rather than a single measure.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12090859/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144102200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Diogo Jesus, Ana Matos, Carla Henriques, Andrea Doria, Luis Sousa Ines
{"title":"SLE-DAS enables an accurate definition of severe lupus disease activity: derivation and validation in a post hoc study of anifrolumab phase II and III studies.","authors":"Diogo Jesus, Ana Matos, Carla Henriques, Andrea Doria, Luis Sousa Ines","doi":"10.1136/lupus-2025-001499","DOIUrl":"10.1136/lupus-2025-001499","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to derive and validate a cut-off for severe disease activity (SDA) using the SLE Disease Activity Score (SLE-DAS) and compare its accuracy and impact on health-related quality of life (HR-QoL) with the British Isles Lupus Assessment Group 2004 (BILAG-2004) and SLE Disease Activity Index 2000 (SLEDAI-2K).</p><p><strong>Methods: </strong>We performed a post hoc analysis of pooled placebo arm data from the MUSE (A Phase II, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus), TULIP-1 and TULIP-2 (Treatment of Uncontrolled Lupus via the Interferon Pathway) trials, including 438 patients with moderate-to-severe SLE. SLE-DAS was scored retrospectively, and a cut-off for SDA was derived using receiver operating characteristic (ROC) curves against the BILAG-2004 numerical score >11 as gold standard. Multiple linear regression analysis and Cohen's d effect size were applied to evaluate the effectiveness of SLE-DAS, BILAG-2004 and SLEDAI-2K SDA classifications in capturing HR-QoL patient-reported outcomes (PROs).</p><p><strong>Results: </strong>The optimal SLE-DAS cut-off for SDA was >9.90 (area under the ROC curve=0.847, sensitivity=77.8%, specificity=79.6%). Patients classified as SDA by both SLE-DAS and BILAG-2004 or only by SLE-DAS exhibited similar disease activity, while those classified by BILAG-2004 alone had less severe disease and better HR-QoL. The SLE-DAS cut-off was associated with worse HR-QoL across multiple PROs more consistently than BILAG-2004 or SLEDAI-2K.</p><p><strong>Conclusion: </strong>The SLE-DAS cut-off for SDA provides an accurate definition of SDA in SLE, with good discriminative power and consistent associations with worse HR-QoL. This SLE-DAS definition enhances disease activity classification and offers a practical tool for guiding treatment decisions in clinical practice, as well as selecting patients with SDA for inclusion in clinical trials.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086896/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
María Martínez-Urbistondo, Andrea Higuera-Gómez, Begoña de Cuevillas, Amanda Cuevas-Sierra, Susana Mellor-Pita, Victor Moreno-Torres, Juan-Antonio Vargas, Raquel Castejón, J Alfredo Martínez
{"title":"Visceral fat, cardiovascular risk factors and quality of life in lupus activity categorised via complement C3.","authors":"María Martínez-Urbistondo, Andrea Higuera-Gómez, Begoña de Cuevillas, Amanda Cuevas-Sierra, Susana Mellor-Pita, Victor Moreno-Torres, Juan-Antonio Vargas, Raquel Castejón, J Alfredo Martínez","doi":"10.1136/lupus-2024-001423","DOIUrl":"10.1136/lupus-2024-001423","url":null,"abstract":"<p><strong>Background: </strong>Patients with lupus face increased cardiovascular risk linked to their autoimmune status. This study assesses the relationships between cardiovascular risk factors, lifestyle and health-related quality of life (HRQoL) concerning SLE activity categorised by complement C3.</p><p><strong>Methods: </strong>74 patients with SLE were recruited and stratified as active (C3 <90 mg/dL) or inactive (C3 >90 mg/dL), alongside 74 controls with obesity-related low-grade inflammation, at Hospital Universitario Puerta de Hierro Majadahonda. Anthropometric measurements, clinical and demographic data were recorded, and participants completed validated questionnaires on physical activity, dietary intake and HRQoL. Fasting blood samples were collected for metabolic determinations. Comparative analyses between SLE groups and controls, along with regression models adjusted for variables associated with disease activity, were performed.</p><p><strong>Results: </strong>The inactive SLE group exhibited a less healthy adiposity profile compared with the active group (36.7% vs 33.2% total fat mass; 8.5 AU vs 6.5 AU visceral fat mass) and showed a higher prevalence of cardiovascular risk factors, including markers of obesity, hypertension, dyslipidaemia and increased waist circumference, along with worse HRQoL outcomes. Notably, age, body mass index and insulin resistance were associated with SLE inactivity, while fibrinogen correlated with disease activity as assessed by complement C3 levels. Interestingly, household composition as a sociodemographic variable (alone, couple/children/elderly or other) also showed an independent association with SLE activity.</p><p><strong>Conclusions: </strong>Inactive patients with SLE exhibited more adverse cardiovascular risk markers compared with active patients categorised by complement C3, even when glucocorticoid administration was accounted for. Additionally, this research highlights the potential influence of fibrinogen as well as metabolic and sociodemographic factors on disease activity. These findings emphasise the need for personalised precision management strategies such as measurement of fibrinogen levels and insulin resistance and sociodemographic considerations that address both cardiovascular risk and overall lifestyle plus exposome in patients with SLE and may partly explain SLE activity evolution.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083274/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Erika Hubbard, Prathyusha Bachali, Amrie C Grammer, Peter E Lipsky
{"title":"Validation of eight endotypes of lupus based on whole-blood RNA profiles.","authors":"Erika Hubbard, Prathyusha Bachali, Amrie C Grammer, Peter E Lipsky","doi":"10.1136/lupus-2025-001526","DOIUrl":"10.1136/lupus-2025-001526","url":null,"abstract":"<p><strong>Objective: </strong>We previously described a classification system of persons with SLE based on whole blood RNA profiles and a random forest (RF) algorithm to predict individual patient endotypes. Here, we apply this algorithm prospectively in an independent set of patients to validate its use as a staging biomarker.</p><p><strong>Methods: </strong>Whole blood from 101 patients participating in three clinical trials (NCT03626311, NCT03180021 and NCT05845593) meeting American College of Rheumatology (ACR) or Systemic Lupus Collaborating Clinics (SLICC) criteria for SLE classification was obtained at baseline, and RNA isolated and sequenced. Gene expression values were used as input to gene set variation analysis (GSVA), and the RF algorithm was applied using GSVA enrichment scores of 32 informative gene sets as input. Composite scores summarising gene expression perturbations were assigned to each patient using a ridge logistic regression algorithm.</p><p><strong>Results: </strong>Patients with SLE were subset into eight endotypes identified by the algorithm. Patterns of gene enrichment in the identified endotypes mirrored those found in the previously reported endotypes. Differences in clinical characteristics, including serum complement levels, autoantibody positivity and the presence of nephritis, were observed between patients in various endotypes. Patients with active, concurrent nephritis were disproportionately assigned to the more molecularly perturbed endotypes. Composite scores were significantly, but modestly, inversely correlated with complement but not SLE Disease Activity Index (SLEDAI) or anti-double-stranded DNA antibody (anti-dsDNA) titre.</p><p><strong>Conclusions: </strong>The identification of eight molecular endotypes of lupus based on whole blood gene expression was validated in an independent data set of diverse patients. Endotyping patients with SLE based on transcriptional profiles can provide important status (presence of nephritis) information and provide novel molecular insights in support of personalised management.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xiangning Yuan, Tong Li, Yudong Liu, Min Wang, Xiaoxia Zuo, Ying Jiang, Xuan Zhang
{"title":"Efficacy and safety of belimumab versus rituximab for refractory immune thrombocytopenia in patients with connective tissue disease.","authors":"Xiangning Yuan, Tong Li, Yudong Liu, Min Wang, Xiaoxia Zuo, Ying Jiang, Xuan Zhang","doi":"10.1136/lupus-2025-001501","DOIUrl":"https://doi.org/10.1136/lupus-2025-001501","url":null,"abstract":"<p><strong>Objectives: </strong>Immune thrombocytopenia (ITP) is a haematological manifestation secondary to connective tissue disease (CTD). Many patients with CTD-ITP are refractory to glucocorticoids (GCs) plus immunosuppressant agents (ISAs); rituximab (RTX) is the recommended second-line therapy. Belimumab (BLM) shows efficacy against CTD. We compared the efficacy and safety of RTX and BLM.</p><p><strong>Methods: </strong>Data of patients with CTD-ITP refractory to GCs plus ISAs administered were collected. The data of 11 patients with refractory CTD-ITP who received BLM were compared with those of 15 patients treated with RTX.</p><p><strong>Results: </strong>At week 2, BLM resulted in a better overall response (OR) than RTX (72.7% vs 26.7%, p=0.045). The OR rate was 60.0% (9/15), 66.7% (10/15) and 73.3% (11/15) at week 4, 8 and 12, respectively, in the RTX group. It remained at 72.7% (8/11) during week 4-12 in the BLM group. Excluding the data of three deceased patients, the OR rate dropped at week 24 in both groups (RTX vs BLM, 61.5% (8/13) vs 70.0% (7/10), p=1.000). At week 24, four patients with OR in both groups successfully withdrew GCs to <15 mg prednisone (RTX vs BLM, 40% (4/10) vs 66.7% (4/6), p=0.608). The serum C3 level did not significantly change, whereas the serum immunoglobulin G level significantly decreased at week 4, 8 and 12 in both groups. There were three patients with serious adverse effects who died of severe pneumonia during weeks 12-24.</p><p><strong>Conclusions: </strong>BLM may be a safe and effective alternative to RTX for CTD-ITP refractory to GCs plus ISAs.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144027541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Anti-CD20 alone as maintenance immunosuppressive therapy in severe lupus nephritis: a promising experience that needs to be evaluated.","authors":"Sébastien Boutinet, Ludivine Lebourg, Stanislas Faguer, Christophe Richez, Noémie Jourde-Chiche, Eric Daugas","doi":"10.1136/lupus-2025-001509","DOIUrl":"https://doi.org/10.1136/lupus-2025-001509","url":null,"abstract":"","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12067818/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144016026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kathryn Connelly, Rachel Koelmeyer, Darshini Ayton, John May, Kate Gregory, Laura E Eades, Raychel Barallon, Rangi Kandane-Rathnayake, Vera Golder, Afia Anzum, Maisarah Mydin, Munni Akther, Alan Friedman, Anca D Askanase, Cynthia Aranow, Edward Vital, Guillermo Pons-Estel, Hermine Brunner, Kenneth Kalunian, Khadija Dantata, Laurent Arnaud, Laurie Burke, Lee S Simon, Qing Zuraw, Sandra Garces, Victoria P Werth, Ying B Sun, Yoshiya Tanaka, Youmna Lahoud, Alain Cornet, Alessandro Sorrentino, Anisur Rahman, Anna Stevens, Catherine Barbey, Ida Dzifa Dey, Elaine Karis, Eloisa Bonfá, Erika Noss, Eve M D Smith, George Stojan, Jeanette Andersen, Joseph F Merola, Jorge A Ross Terres, Joy Buie, Justine Maller, Marta Mosca, Maja Hojnik, Maria Dall'Era, Richard A Furie, Ronald F van Vollenhoven, Subhashis Banerjee, Eric Morand
{"title":"Domains for inclusion in a novel Treatment Response Measure for Systemic Lupus Erythematosus (TRM-SLE): results of a modified Delphi study.","authors":"Kathryn Connelly, Rachel Koelmeyer, Darshini Ayton, John May, Kate Gregory, Laura E Eades, Raychel Barallon, Rangi Kandane-Rathnayake, Vera Golder, Afia Anzum, Maisarah Mydin, Munni Akther, Alan Friedman, Anca D Askanase, Cynthia Aranow, Edward Vital, Guillermo Pons-Estel, Hermine Brunner, Kenneth Kalunian, Khadija Dantata, Laurent Arnaud, Laurie Burke, Lee S Simon, Qing Zuraw, Sandra Garces, Victoria P Werth, Ying B Sun, Yoshiya Tanaka, Youmna Lahoud, Alain Cornet, Alessandro Sorrentino, Anisur Rahman, Anna Stevens, Catherine Barbey, Ida Dzifa Dey, Elaine Karis, Eloisa Bonfá, Erika Noss, Eve M D Smith, George Stojan, Jeanette Andersen, Joseph F Merola, Jorge A Ross Terres, Joy Buie, Justine Maller, Marta Mosca, Maja Hojnik, Maria Dall'Era, Richard A Furie, Ronald F van Vollenhoven, Subhashis Banerjee, Eric Morand","doi":"10.1136/lupus-2024-001484","DOIUrl":"https://doi.org/10.1136/lupus-2024-001484","url":null,"abstract":"<p><strong>Objectives: </strong>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).</p><p><strong>Methods: </strong>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. In Stage 1, expert lupus clinicians and patient representatives rated domain 'importance' (impact on symptoms, function or survival). In Stage 2, clinicians rated 'important' domains on three characteristics relevant to RCT utility: 'appropriateness' for evaluating change in disease activity, 'representation' in patients with active SLE and 'measurability' in an RCT context. Consensus for domain inclusion was prespecified as all four characteristics achieving a rating ≥7 on a 1-9 scale by ≥70% of participants.</p><p><strong>Results: </strong>Domain nominations from 36/59 (61%) TRM-SLE Taskforce members yielded 34 potential domains which were rated in the modified Delphi study. At least one Delphi round was completed by 87 clinicians and 13 patient representatives. In Stage 1, 14 domains met consensus on 'importance' in both clinician and patient groups, and 11 domains met consensus among patients only. After Stage 2, eight of these domains also reached consensus on 'appropriateness', 'representation' and 'measurability': alopecia, arthritis, haemolytic anaemia, nephritis, mucosal ulcers, rash, serositis and thrombocytopenia.</p><p><strong>Conclusions: </strong>Considering patient and clinician perspectives, we reached consensus to include eight disease activity domains for future development into the novel TRM-SLE clinical trial outcome measure, aiming to improve trial interpretability and success.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12067843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rashmi Dhital, Rebecca J Baer, Kenneth Kalunian, Christina Chambers
{"title":"Adverse pregnancy outcomes across SLE subgroups: significance of cardiovascular events.","authors":"Rashmi Dhital, Rebecca J Baer, Kenneth Kalunian, Christina Chambers","doi":"10.1136/lupus-2025-001507","DOIUrl":"https://doi.org/10.1136/lupus-2025-001507","url":null,"abstract":"<p><strong>Objective: </strong>SLE is associated with increased risks of maternal cardiovascular events (CVEs) as well as adverse pregnancy outcomes. The influence of maternal CVEs on pregnancy complications in lupus is not clearly known. Our primary aim was to assess the risks of adverse pregnancy outcomes in individuals with SLE, specifically examining the influence of CVEs.</p><p><strong>Methods: </strong>Using a California population-based birth cohort from 2005 to 2020, pregnant individuals with SLE were identified via International Classification of Diseases codes on maternal discharge records and further subdivided based on whether they had lupus nephritis (LN) or antiphospholipid syndrome (APS). We analysed adjusted relative risks (aRRs) of adverse pregnancy outcomes in SLE subgroups, comparing those with and without CVEs, to the reference group of pregnant individuals without autoimmune rheumatic diseases or APS and CVEs. CVEs were broadly defined to encompass thromboembolic and cardiovascular conditions associated with SLE.</p><p><strong>Results: </strong>CVEs complicated 17 130/7004 334 (0.2%) of pregnancies in individuals without autoimmune rheumatic diseases or APS, and 176/8422 (2.1%) with SLE, including 52/903 (5.8%) with LN and 40/513 (7.8%) with APS. Compared with the reference group, the aRRs for maternal complications were higher in SLE subgroups: non-cardiac severe maternal morbidity (3.2-fold to 31.5-fold), intensive care admission (2.0-fold to 12.2-fold), 1 year re-admission (2.4-fold to 6.0-fold) and death (7.0-fold to 7.9-fold). Similarly, adverse infant outcomes were higher: preterm birth (2.3-fold to 6.8-fold), small-for-gestational-age infant (1.8-fold to 3.4-fold), neonatal intensive care admission (2.1-fold to 7.9-fold) and infant death (1.6-fold to 3.7-fold), with highest risk estimates for SLE with LN or APS, particularly when complicated by CVEs.</p><p><strong>Conclusions: </strong>LN and APS in SLE contributed to incremental risks for adverse outcomes, with the combination of LN or APS with CVEs yielding the highest point estimates. This underscores the importance of disease severity but also the impact of CVEs, helping to individualise the risks of pregnancy complications for various SLE subpopulations.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12049864/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144000718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Antonio Silaide Araujo, Emilia Inoue Sato, Alexandre Wagner Silva de Souza, Fábio Jennings, Gianna Mastroianni Kirsztajn, Ricardo Sesso, Edgard Torres Dos Reis-Neto
{"title":"Validation cohort of a tool to predict proliferative histological class in lupus nephritis based on clinical and laboratory data: LUCAS Study (Lupus Nephritis Class Assessment System).","authors":"Antonio Silaide Araujo, Emilia Inoue Sato, Alexandre Wagner Silva de Souza, Fábio Jennings, Gianna Mastroianni Kirsztajn, Ricardo Sesso, Edgard Torres Dos Reis-Neto","doi":"10.1136/lupus-2025-001538","DOIUrl":"https://doi.org/10.1136/lupus-2025-001538","url":null,"abstract":"<p><strong>Objectives: </strong>Primary: To validate a previously developed lupus nephritis (LN) histologic class predictor tool (III or IV±(V) vs V). In this instrument, urinary sediment, anti-dsDNA antibody and serum creatinine were predictor variables. Secondary: To evaluate its accuracy in different cut levels of urinary red cell count and LN patient's profile that may be useful to guide diagnosis and treatment, especially when kidney biopsy is not available.</p><p><strong>Methods: </strong>A retrospective, cross-sectional study of 196 patients with SLE who underwent kidney biopsy, analysing sensitivity, specificity, positive and negative predictive values, accuracy, and positive and negative likelihood ratios.</p><p><strong>Results: </strong>81.6% of the patients were female, 60.2% were non-Caucasian and the mean age at the time of the biopsy was 31.2±10.4 years. 30 patients presented class III, 104 class IV, 36 class V and 26 mixed classes (7 class III+V and 19 class IV+V). In the validation cohort, sensitivity was 90.6%, specifically was 66.7%, positive predictive value was 92.4% and accuracy was 86.2%, in predicting proliferative classes (class III or IV(±V) vs class V). There was no difference when analysing urinary red cell counts >5 x 10<sup>3</sup>/mL, >10 x 10<sup>3</sup>/mL or >20 x 10<sup>3</sup>/mL, as well as when the tool was applied in the first or recurrent LN and in proliferative LN without class V.</p><p><strong>Conclusions: </strong>The validation of a tool to predict proliferative histologic class showed good performance, like that found in the development cohort, without difference in accuracy with different cut-off points for urinary red cell count or number of flares of LN. It is easily applied and can be accessed via the internet (https://nefritelupica.medicalcore.com.br).</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12039031/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143989136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Rural-urban disparities in hospitalisation for myocardial infarction in systemic lupus erythematosus in the USA.","authors":"Jasvinder A Singh, Sumanth Chandrupatla","doi":"10.1136/lupus-2025-001516","DOIUrl":"https://doi.org/10.1136/lupus-2025-001516","url":null,"abstract":"<p><strong>Objective: </strong>To assess whether rural-urban disparities exist in people with SLE for hospitalisation with myocardial infarction (MI).</p><p><strong>Methods: </strong>We used the 2016-2019 US National Inpatient Sample data that contain all hospitalisation data. In people with a diagnosis of SLE, we assessed the multivariable adjusted ORs (aORs) to examine the association of rural patient residence with MI hospitalisation, while adjusting for demographics, payer, income, hospital characteristics and the Deyo-Charlson Comorbidity Index.</p><p><strong>Results: </strong>We found that the crude rates of patients hospitalised with MI per 100 000 area specific SLE hospitalisations were higher in rural versus urban residents with SLE, 2265 versus 1435 (p value<0.001). In the multivariable-adjusted model that accounted for demographics, insurance payer, household income, comorbidities and hospital characteristics including geographical location, we found that rural residence was associated with an aOR of 1.98 (95% CI, 1.71 to 2.29; reference category, urban residence) of MI hospitalisations in people with SLE. Other factors significantly associated with the risk of MI were male sex, Medicaid or private insurance, urban not teaching or urban teaching hospital, Midwest region and a private hospital control, either for profit or not for profit.</p><p><strong>Conclusion: </strong>Rural residence doubled the risk of MI hospitalisation in people with SLE independent of demographics, payer status, social determinants of health and hospital characteristics. Our study highlights the disproportionate effect of rurality on health outcomes in people with SLE within the USA and a clear rural-urban gap disparity. Interventions to reduce this disparity are needed.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12039025/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144027540","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}