Lupus Science & Medicine最新文献

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Outcomes following immunosuppressive therapy withdrawal after complete renal response in proliferative lupus nephritis. 增殖性狼疮性肾炎完全肾反应后停止免疫抑制治疗的结果。
IF 3.7 2区 医学
Lupus Science & Medicine Pub Date : 2025-01-19 DOI: 10.1136/lupus-2024-001375
Paola Vidal-Montal, Javier Narváez, Xavier Fulladosa, Francesca Mitjavila, Olga Capdevila, Joan Torras, Montserrat Gomà, Joan M Nolla
{"title":"Outcomes following immunosuppressive therapy withdrawal after complete renal response in proliferative lupus nephritis.","authors":"Paola Vidal-Montal, Javier Narváez, Xavier Fulladosa, Francesca Mitjavila, Olga Capdevila, Joan Torras, Montserrat Gomà, Joan M Nolla","doi":"10.1136/lupus-2024-001375","DOIUrl":"10.1136/lupus-2024-001375","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the rate and factors influencing renal relapse (RR) in proliferative lupus nephritis (LN) patients who discontinued immunosuppressive therapy (IST), as well as the long-term renal outcomes following RR.</p><p><strong>Methods: </strong>Retrospective, single-centre study of biopsy-confirmed LN patients who had received IST for at least 36 months and maintained complete renal response (CRR) for a minimum of 12 months before therapy discontinuation.</p><p><strong>Results: </strong>Of a total of 106 patients meeting the inclusion criteria, 76 with proliferative classes were selected for analysis. The median duration of IST prior to discontinuation was 83.5 months (IQR 25th-75th: 53.5-120). Relapse occurred in 29 patients (38.2%) at a median of 26.5 months (IQR 25th-75th: 9.25-63.5 months) following IST withdrawal. Relapses were classified as severe in 9 cases (31%) and moderate in 16 cases (55.2%). Renal rebiopsy was performed in 25 of these patients (86.2%), with 80% retaining the same histological class.Discontinuation of IST at ≤34 years of age significantly increased the risk of RR (adjusted HR: 3.5). In contrast, an IST duration exceeding 48 months prior to discontinuation (HR: 0.26), maintaining CRR for at least 48 months (HR: 0.32), achieving complete remission per DORIS (definition of remission in systemic lupus erythematosus) criteria at IST withdrawal (HR: 0.21) and gradual IST tapering (HR: 0.09) were associated with a reduced risk of RR.Following reintroduction of IST, 20 out of 29 patients (68.9%) achieved CRR, 5 (17.2%) achieved a partial response and 4 (13.8%) did not respond; of these, 3 patients (10.3%) progressed to end-stage renal disease.</p><p><strong>Conclusions: </strong>Successful withdrawal of IST is possible in carefully selected patients with proliferative LN. If an RR occurs, most patients are able to remain in remission after resuming IST.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751776/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143008166","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}
引用次数: 0
Elevated serum neurofilament light chain levels in patients with neuropsychiatric systemic lupus erythematosus: a cross-sectional study. 神经精神系统红斑狼疮患者血清神经丝轻链水平升高:一项横断面研究。
IF 3.7 2区 医学
Lupus Science & Medicine Pub Date : 2025-01-19 DOI: 10.1136/lupus-2024-001309
Veronika Balajková, Aneta Prokopcová, Martin Elisak, Hana Mojžišová, Karel Pavelka, Marta Olejárová
{"title":"Elevated serum neurofilament light chain levels in patients with neuropsychiatric systemic lupus erythematosus: a cross-sectional study.","authors":"Veronika Balajková, Aneta Prokopcová, Martin Elisak, Hana Mojžišová, Karel Pavelka, Marta Olejárová","doi":"10.1136/lupus-2024-001309","DOIUrl":"10.1136/lupus-2024-001309","url":null,"abstract":"<p><strong>Background: </strong>The neurofilament light chain (NfL) in cerebrospinal fluid (CSF) and serum as a marker of neuronal damage may be a potential biomarker of neuropsychiatric involvement in SLE (NPSLE).</p><p><strong>Methods: </strong>80 patients with SLE were included.We obtained paired serum and CSF samples from 48 patients (NPSLE n=32, non-NPSLE n=16) and 31 controls. The serum and CSF levels of NfL were determined using ELISA.</p><p><strong>Results: </strong>Patients with NPSLE demonstrated significantly higher levels of serum NfL compared with the non-NPSLE group (mean 31.68±36.63 pg/mL vs mean 16.75±12.48 pg/mL, respectively, p<0.05) and with controls (mean 10.74±4.36 pg/mL, p<0.01). Notably, CSF NfL concentrations in patients with NPSLE showed an upward trend (mean 1600±2852 pg/mL) in contrast to non-NPSLE patients (mean 393.4±191.9 pg/mL) and controls (mean 509.7±358.5 pg/mL). Furthermore, a positive correlation was observed between serum and CSF NfL levels in patients with NPSLE (R=0.8686, p<0.01). Elevated serum triacylglycerol concentrations, C reactive protein and organ damage were linked to increased serum (p=0.002; p<0.001; p=0.036) and CSF (p=0.008; p=0.007; p<0.001) NfL concentrations. In addition, we established a significant correlation between intrathecal NfL concentrations and interleukin-6 levels in the CSF of patients with NPSLE (R=0.5118, p<0.05).</p><p><strong>Conclusion: </strong>The serum NfL levels may be a readily available marker of neuropsychiatric involvement in SLE.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11752028/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143008081","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}
引用次数: 0
Unravelling the TCRβ repertoire: a key to unlocking the immunopathogenesis and precision medicine in SLE. 解开TCRβ库:解锁SLE免疫发病机制和精准医学的关键。
IF 3.7 2区 医学
Lupus Science & Medicine Pub Date : 2025-01-19 DOI: 10.1136/lupus-2024-001384
Li Zeng, Lijing Yang, Yichen Zhang, Tianzuo Lan, Yang An, Pengming He, Xueping Wen, Shaoping Deng, Zhixin Zhang, Jian Liu, Qiao Zhou
{"title":"Unravelling the TCRβ repertoire: a key to unlocking the immunopathogenesis and precision medicine in SLE.","authors":"Li Zeng, Lijing Yang, Yichen Zhang, Tianzuo Lan, Yang An, Pengming He, Xueping Wen, Shaoping Deng, Zhixin Zhang, Jian Liu, Qiao Zhou","doi":"10.1136/lupus-2024-001384","DOIUrl":"10.1136/lupus-2024-001384","url":null,"abstract":"<p><strong>Objectives: </strong>SLE is a multifaceted autoimmune disorder with a complex pathogenesis involving genetic, environmental and hormonal factors, which converge on immune dysregulation. The T cell receptor (TCR) repertoire's role in SLE has garnered significant interest due to its potential in both diagnostics and therapeutics. Our study aimed to delineate the variances in the TCRβ repertoire between patients with SLE and healthy individuals, correlating these differences with the severity and subtypes of SLE.</p><p><strong>Methods: </strong>We conducted an analysis of blood samples from 50 treatment-naive patients with SLE and 50 healthy donors, employing RNA extraction, high-throughput sequencing and subsequent bioinformatics analysis.</p><p><strong>Results: </strong>Our findings revealed significant alterations in TRBV and TRBJ gene usage frequencies, indicative of a skewed TCR repertoire in patients with SLE. Notably, nine hub TRBV genes were identified as potential biomarkers for SLE with high diagnostic accuracy. Furthermore, we observed a reduction in TCR diversity, characterised by a lower diversity 50 value and increased clonal expansion, which correlated with disease severity.</p><p><strong>Conclusions: </strong>The TCRβ repertoire is significantly altered in SLE, with potential implications for diagnostics and therapeutics. The identified hub genes may serve as novel biomarkers for SLE, and the findings contribute to the understanding of the immunopathogenesis of the disease.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751993/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143008183","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}
引用次数: 0
Impact of quality of life on overall work productivity impairment and activity impairment of patients with systemic lupus erythematosus: the PEONY study. 生活质量对系统性红斑狼疮患者整体工作效率障碍和活动障碍的影响:牡丹研究
IF 3.7 2区 医学
Lupus Science & Medicine Pub Date : 2025-01-19 DOI: 10.1136/lupus-2024-001291
Yoshiya Tanaka, Yusuke Miyazaki, Shintaro Hirata, Katsuhide Kusaka, Shunpei Kosaka, Keisuke Nakatsuka, Kazuyoshi Saito, Shigeru Iwata, Yoshiyuki Yamaguchi, Toshiki Yabe-Wada, Masakazu Fujiwara, Yoshifumi Arita, Mitsuru Hoshino, Naoko Ozaki, Kunihiro Yamaoka, Shingo Nakayamada
{"title":"Impact of quality of life on overall work productivity impairment and activity impairment of patients with systemic lupus erythematosus: the PEONY study.","authors":"Yoshiya Tanaka, Yusuke Miyazaki, Shintaro Hirata, Katsuhide Kusaka, Shunpei Kosaka, Keisuke Nakatsuka, Kazuyoshi Saito, Shigeru Iwata, Yoshiyuki Yamaguchi, Toshiki Yabe-Wada, Masakazu Fujiwara, Yoshifumi Arita, Mitsuru Hoshino, Naoko Ozaki, Kunihiro Yamaoka, Shingo Nakayamada","doi":"10.1136/lupus-2024-001291","DOIUrl":"10.1136/lupus-2024-001291","url":null,"abstract":"<p><strong>Objectives: </strong>Even in a lupus low disease activity state (LLDAS), many patients with SLE continue to face residual symptoms and disease burden. We aimed to evaluate the quality of life, activity impairment and overall work productivity impairment among patients in LLDAS. Residual disease burden was also evaluated for patients in LLDAS.</p><p><strong>Methods: </strong>This prospective, cross-sectional study enrolled Japanese outpatients with SLE. Patients completed patient-reported outcome (PRO) questionnaires, including LupusPRO, Work Productivity and Activity Impairment-Lupus, EQ-5D-5L and Health Assessment Questionnaire-Disability Index. Disease activity and organ damage were investigator-assessed. The primary objective was to assess the residual burden in patients in LLDAS and to investigate the association of LupusPRO domains with activity impairment using multivariate regression analysis. Other objectives were to investigate the relationship between overall work productivity impairment or activity impairment and other PRO or disease activity measures.</p><p><strong>Results: </strong>The analysis set included 205 patients; 93.2% were female, mean (SD) age at index date was 52.5 (14.7) years, mean (SD) duration of morbidity was 167.2 (125.2) months and 164 were in LLDAS. The mean per cent overall work productivity impairment was 22.8% and mean per cent activity impairment was 30.0% for the LLDAS group. Among patients in LLDAS, overall work productivity impairment was significantly associated with the LupusPRO domains Desires-Goals, Body Image and Pain Vitality, and activity impairment was significantly associated with the LupusPRO domains Pain Vitality, Physical Health and Lupus Symptoms.</p><p><strong>Conclusions: </strong>Patients with SLE in LLDAS still experience symptoms associated with activity impairment. Work productivity also showed impairments. Improving their quality of life and achieving social remission will require ongoing monitoring of PROs and tailoring treatments to optimise these outcomes.</p><p><strong>Trial registration number: </strong>jRCT1030210647.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751967/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143008071","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}
引用次数: 0
EXamining the feasibility of exerCisE to manage symptoms of Lupus (EXCEL): a protocol for a randomised controlled pilot study. 检查运动治疗狼疮症状的可行性(EXCEL):一项随机对照试验研究的方案。
IF 3.7 2区 医学
Lupus Science & Medicine Pub Date : 2025-01-16 DOI: 10.1136/lupus-2024-001382
Megan Quickfall, Scott Green, Katie Hesketh, Jet Veldhuijzen Van Zanten, Matthew Cocks, John Reynolds, Alex J Wadley
{"title":"EXamining the feasibility of exerCisE to manage symptoms of Lupus (EXCEL): a protocol for a randomised controlled pilot study.","authors":"Megan Quickfall, Scott Green, Katie Hesketh, Jet Veldhuijzen Van Zanten, Matthew Cocks, John Reynolds, Alex J Wadley","doi":"10.1136/lupus-2024-001382","DOIUrl":"10.1136/lupus-2024-001382","url":null,"abstract":"<p><strong>Introduction: </strong>SLE is a chronic autoimmune disease that results in sustained hyperactivation of innate and adaptive immune cells and widespread inflammatory damage. Regular exercise reduces SLE symptoms including fatigue and joint pain and improves patient quality of life. However, most individuals with SLE are not sufficiently active to achieve these benefits, and guidance on the optimal approach to exercise is limited. EXCEL will examine the feasibility of conducting a large-scale randomised controlled trial comparing the effects of a remotely monitored, home-based, exercise programme with standard of care for individuals with SLE.</p><p><strong>Methods and analysis: </strong>30 females with SLE will be recruited, and those randomised into Exercise (SLE-Ex) will codesign a progressive training plan with support from the research team. The aim of each 12-week plan will be to complete 150 min of moderate (60-70% heart rate max, HR<sub>max</sub>) or 90 min of vigorous exercise (>70% HR<sub>max</sub>) per week. SLE-Ex will be encouraged to exercise independently (without support) from weeks 13-18. Participants with SLE that are randomised into Control (SLE-Con) will maintain habitual activity without support for 18 weeks. Measures of feasibility and acceptability will be reported, and peripheral blood will be collected at weeks 0, 12 and 18 to explore whether the frequency, phenotype and metabolic profile of lymphocyte subsets has changed. Biomarkers of SLE activity, and self-reported measures of fatigue, sleep quality and health-related quality of life will also be monitored at these timepoints. Blood and self-reported measures will be compared with a healthy control (HC) group (n=15, age and body mass index matched) at baseline only.</p><p><strong>Ethics and dissemination: </strong>A favourable ethical opinion was given by South East Scotland Research Ethics Committee (22/SS/0082). Findings will be disseminated at conferences and published in peer-reviewed journals.</p><p><strong>Trial registration number: </strong>ISRCTN72757645.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751982/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143008086","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}
引用次数: 0
Effect of Benson relaxation response technique on the quality of life among patients with systemic lupus erythematous: quasi-experimental study. 本森放松反应技术对系统性红斑狼疮患者生活质量的影响:准实验研究。
IF 3.7 2区 医学
Lupus Science & Medicine Pub Date : 2025-01-14 DOI: 10.1136/lupus-2024-001301
Arwa Masadeh, Basema Mohammad Nofal, Rami Masa'deh
{"title":"Effect of Benson relaxation response technique on the quality of life among patients with systemic lupus erythematous: quasi-experimental study.","authors":"Arwa Masadeh, Basema Mohammad Nofal, Rami Masa'deh","doi":"10.1136/lupus-2024-001301","DOIUrl":"10.1136/lupus-2024-001301","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate the effect of Benson relaxation response technique (BRRT) on the quality of life (QOL) among patients with systemic lupus erythematous (SLE).</p><p><strong>Methodology: </strong>A quasi-experimental design was used to conveniently recruit 170 patients with SLE. Participants were divided into two groups, the control and the intervention group for which the BRRT intervention was administered. Utilising an online questionnaire, the QOL was assessed among the two groups, before and 2 months after the intervention, using the Arabic version of the short form 36-item health survey.</p><p><strong>Results: </strong>After 2 months of the intervention, the intervention group exhibited significantly higher levels in both components of QOL; physical (<i>t</i>(143.31)=15.35, p<0.001); and mental component (<i>t</i>(143.58)=12.35, p<0.001). Additionally, for the intervention group, the results revealed a statistically significant increase in the levels of both components from baseline measurement; physical (<i>t</i>(84)=-16.24, p<0.001) and mental component (<i>t</i>(84)=-12.93, p<0.001).</p><p><strong>Conclusion: </strong>The findings demonstrate a notable positive impact of BRRT on QOL among patients with SLE. Healthcare professionals can potentially improve the overall well-being of patients with SLE and complement traditional treatment by implementing BRRT into their care.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11752001/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142984026","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}
引用次数: 0
Neutrophil gelatinase-associated lipocalin (NGAL) in lupus nephritis and beyond. 中性粒细胞明胶酶相关脂钙蛋白(NGAL)在狼疮肾炎及其他疾病中的作用。
IF 3.7 2区 医学
Lupus Science & Medicine Pub Date : 2025-01-14 DOI: 10.1136/lupus-2024-001418
Marina Barguil Macedo, Ting Wang, Andreas Jönsen, Anders A Bengtsson, Iva Gunnarsson, Elisabet Svenungsson, Christian Lood
{"title":"Neutrophil gelatinase-associated lipocalin (NGAL) in lupus nephritis and beyond.","authors":"Marina Barguil Macedo, Ting Wang, Andreas Jönsen, Anders A Bengtsson, Iva Gunnarsson, Elisabet Svenungsson, Christian Lood","doi":"10.1136/lupus-2024-001418","DOIUrl":"10.1136/lupus-2024-001418","url":null,"abstract":"<p><strong>Objectives: </strong>To study neutrophil gelatinase-associated lipocalin (NGAL) levels in peripheral blood in SLE, and to propose a mechanism by which neutrophils secrete NGAL on stimulation with immune complexes (IC).</p><p><strong>Methods: </strong>NGAL was measured by ELISA in two independent Swedish SLE cohorts acting as exploratory and validation cohort (n=124 and n=308, respectively), disease controls (n=38) and healthy controls (n=77). NGAL levels were measured in supernatant from IC-stimulated neutrophils in the presence or absence of a toll-like receptor 8 inhibitor (TLR8i).</p><p><strong>Results: </strong>In the exploratory cohort, serum levels of NGAL were increased in patients with SLE as compared with healthy controls (p=0.021), and associated with histological-proven membranoproliferative lupus nephritis (LN) (p=0.018). In the validation cohort, plasma levels of NGAL were elevated in patients with a history of LN (p=0.0048), as well as in patients with SLE with secondary antiphospholipid syndrome (APS) compared with those without (p=0.0022). In both cohorts, NGAL was able to discriminate patients with a creatinine clearance <60 mL/min (chronic kidney disease stage 3 or more) with high accuracy, with an area under the curve of 0.92 (p<0.0001) and 0.94 (p=0.0088), respectively. Neutrophils stimulated with IC secrete more NGAL, when compared with baseline, and this process was blocked by adding a TLR8i.</p><p><strong>Conclusion: </strong>Blood levels of NGAL are increased in patients with SLE with decreased kidney function, and in those with secondary APS. The mechanism behind NGAL increase in SLE may be related to TLR8 pathway activation by circulating RNA-containing IC.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751952/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142984031","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}
引用次数: 0
Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis. 贝利单抗上市后安全性评价:药物警戒分析。
IF 3.7 2区 医学
Lupus Science & Medicine Pub Date : 2025-01-09 DOI: 10.1136/lupus-2024-001400
Huqun Li, Wenlong Xie, Chongshu Wang, Cuilian Guo
{"title":"Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis.","authors":"Huqun Li, Wenlong Xie, Chongshu Wang, Cuilian Guo","doi":"10.1136/lupus-2024-001400","DOIUrl":"10.1136/lupus-2024-001400","url":null,"abstract":"<p><strong>Objective: </strong>The present study aimed to provide a comprehensive evaluation of the postmarketing safety of belimumab based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>Adverse event (AE) reports in the FAERS database from January 2021 to December 2023 were extracted to perform the disproportionality analysis by calculating the reporting OR. The clinical characteristics and onset times of AEs were investigated. The differences across ages and regions in belimumab-related AEs were also explored.</p><p><strong>Results: </strong>A total of 4 974 201 AE reports were retrieved from the FAERS database, among which 9782 reports were related to belimumab. 485 positive safety signals related to belimumab were identified. In addition to the labelled AEs, such as depression and infections, new unexpected AEs, including product dose omission issue and inappropriate schedule of product administration, were identified. The median onset time of belimumab-related AEs was 75 days. Moreover, our analysis revealed frequently reported AEs in paediatric patients, such as systemic lupus erythematosus, and in adult patients, such as injection site pain. Additionally, AEs such as drug ineffective were commonly reported in patients of North America, Asia and Europe, while AEs, including an inappropriate schedule of product administration, had a high incidence in patients of South America.</p><p><strong>Conclusion: </strong>The current study provides a valuable evaluation of the postmarketing safety of belimumab. Further studies are required to validate and confirm these findings. Clinicians should be vigilant regarding these potential AEs and pay more attention to the proper dosage regimen of belimumab in clinical practice.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751785/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142965516","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}
引用次数: 0
Interplay of NF-κB and PPAR-γ transcription factors in patients with juvenile systemic lupus erythematosus. NF-κB和PPAR-γ转录因子在幼年系统性红斑狼疮患者中的相互作用。
IF 3.7 2区 医学
Lupus Science & Medicine Pub Date : 2025-01-08 DOI: 10.1136/lupus-2024-001263
Sinem Durmus, Sezgin Sahin, Amra Adrovic, Kenan Barut, Remise Gelisgen, Hafize Uzun, Ozgur Kasapcopur
{"title":"Interplay of NF-κB and PPAR-γ transcription factors in patients with juvenile systemic lupus erythematosus.","authors":"Sinem Durmus, Sezgin Sahin, Amra Adrovic, Kenan Barut, Remise Gelisgen, Hafize Uzun, Ozgur Kasapcopur","doi":"10.1136/lupus-2024-001263","DOIUrl":"10.1136/lupus-2024-001263","url":null,"abstract":"<p><strong>Objective: </strong>Juvenile SLE (jSLE) is an autoimmune disease characterised by the presence of high levels of autoantibodies, predominantly targeting nuclear antigens, resulting in a breakdown of self-tolerance. However, its pathogenesis is multifactorial and poorly understood. The aim of this study was to evaluate the potential of nuclear factor-kappa B (NF-κB) and peroxisome proliferator-activated receptor-gamma (PPAR-γ) as biomarkers for jSLE.</p><p><strong>Methods: </strong>In this study, serum NF-κB and PPAR-γ levels were determined by immunoassay in 42 patients with jSLE. In addition, 19 juvenile systemic sclerosis (jSSc) and 25 age-matched healthy children were selected as patient control and healthy control, respectively.</p><p><strong>Results: </strong>Serum NF-κB levels in patients with jSLE demonstrated a positive trend towards elevation compared with the controls with no significant difference (p=0.030). In addition, serum NF-κB levels in patients with jSSc were significantly higher than that of the healthy controls (p=0.005). Serum PPAR-γ levels were tend to be lower in both patients with jSLE and jSSc compared with the controls, with no significant difference. Specifically, NF-κB levels were significantly higher in patients with jSLE with cumulative damage (PedSDI≥1) compared with those without, at p=0.044. Logistic regression showed that PPAR-γ levels lower than 2.42 ng/mL were associated with the development of jSLE (OR 7.59) and lower than 2.16 ng/mL for jSSc (OR 10.90). The combined high levels of NF-κB with low PPAR-γ increased the risk of developing jSSc by 21.33-fold.</p><p><strong>Conclusions: </strong>The observed trend of elevated NF-κB levels and decreased PPAR-γ levels in our study suggests their potential as biomarkers associated with increased proinflammatory signalling in jSLE and jSSc. However, our findings must be regarded as hypothesis-generating and confirmed in larger datasets. Moreover, their roles in monitoring the course of a disease and guiding therapeutic strategies in juvenile systemic autoimmune diseases need to be clearly investigated. Further extension of these findings may lead to better management and improvement in the outcomes of such patients.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751921/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142950798","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}
引用次数: 0
Belimumab versus telitacicept in sequential treatment after rituximab for refractory lupus nephritis: a real-world multicentre study. 利妥昔单抗治疗难治性狼疮性肾炎后,贝利单抗与替利他塞普序贯治疗:一项真实世界的多中心研究。
IF 3.7 2区 医学
Lupus Science & Medicine Pub Date : 2025-01-06 DOI: 10.1136/lupus-2024-001296
Yiting Chen, Xin Lei, Jianhang Xu, Xiaochan Chen, Hong Pan, Qiankun Zhang, Junni Wang, Pingping Ren, Lan Lan, Nan Shi, Liangliang Chen, Yaomin Wang, Jianghua Chen, Lie Jin, Yi Yang, Jing Xue, Fei Han
{"title":"Belimumab versus telitacicept in sequential treatment after rituximab for refractory lupus nephritis: a real-world multicentre study.","authors":"Yiting Chen, Xin Lei, Jianhang Xu, Xiaochan Chen, Hong Pan, Qiankun Zhang, Junni Wang, Pingping Ren, Lan Lan, Nan Shi, Liangliang Chen, Yaomin Wang, Jianghua Chen, Lie Jin, Yi Yang, Jing Xue, Fei Han","doi":"10.1136/lupus-2024-001296","DOIUrl":"10.1136/lupus-2024-001296","url":null,"abstract":"<p><strong>Objective: </strong>Both belimumab and telitacicept are recognised blockers for B lymphocyte activation, both of which have been approved as add-on therapies for SLE in China. The aim of this study is to compare the efficacy of rituximab (RTX) followed by belimumab or telitacicept in a real-world cohort.</p><p><strong>Methods: </strong>A total of 49 refractory lupus nephritis patients were enrolled from four independent centres, subsequently categorised into two treatment groups: belimumab group (n=35) and telitacicept group (n=14) based on their treatment following RTX. The outcomes of renal response rates were evaluated.</p><p><strong>Results: </strong>In this study cohort, 63.3% presented with anti-dsDNA antibody positivity and 79.6% exhibited hypocomplementemia, with a mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score of 13±6, estimated glomerular filtration rate (eGFR) of 76.2 (30.2, 113.7) mL/min and urinary protein creatinine ratio (uPCR) of 2.45 (0.77, 5.19) g/g. There was no significant differences between groups. After a follow-up duration of 26±12 months, renal objective remission rate was 80.0% (28 patients) in belimumab group and 85.7% (12 patients) in telitacicept group (difference, 5.7 percentage points, 95% CI, -25.8 to 26.8, p=1.000). Renal complete response was 54.3% (19 patients) in belimumab group and 78.6% (11 patients) in telitacicept group (difference, 24.3 percentage points, 95% CI, 9.7 to 47.8, p=0.194). The anti-dsDNA antibody, complement, eGFR, uPCR and SLEDAI-2K Score were improved in both groups with a significant reduction in prednisone dose. Major adverse effects included immunoglobulin deficiency, respiratory tract infection and urinary tract infection. No death occurred.</p><p><strong>Conclusions: </strong>The sequential treatment of belimumab or telitacicept following RTX may represent a promising therapeutic approach in the management of refractory lupus nephritis. Further investigation is necessary to establish optimal protocols and long-term benefits.</p>","PeriodicalId":18126,"journal":{"name":"Lupus Science & Medicine","volume":"12 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751942/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024096","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}
引用次数: 0
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