Pub Date : 2025-09-01Epub Date: 2025-10-11DOI: 10.1080/17520363.2025.2571395
Ramazan Yolaçan, Ramazan Dertli, Feyzullah Uçmak
Aims: Pancreatic cancer has a very poor prognosis and is a leading cause of cancer-related deaths. Our aim is to investigate the presence of novel prognostic markers in pancreatic cancer that are easy to calculate, inexpensive, non-invasive, and do not cause a loss of time.
Methods: A total of 164 patients were included in the study. The demographic and clinical characteristics, laboratory findings, and radiological data of the patients were retrospectively reviewed using hospital records.
Results: Of the patients, 112 (68.3%) were male, and the mean age of all patients was 63.29 ± 12.5 years. The one-,two-,and five-year survival rates of the patients were determined to be 43.9% (n = 72), 29.3% (n = 48), and 21.3% (n = 35), respectively. During the 1-,2, and 5-year follow-ups, the absence of surgery, advanced disease stage, and elevated systemic inflammation response index (SIRI) were identified as independent risk factors for increased mortality in pancreatic cancer. SIRI was found to be a prognostic factor influencing both short- and long-term survival in pancreatic cancer.
Conclusion: We found that SIRI is a stronger prognostic factor than the NLR, PIV, and SII indices in predicting survival in pancreatic cancer. Monitoring SIRI in pancreatic cancer may provide insight into the status of the local immune response and systemic inflammation, and help in estimating patient survival.
{"title":"The systemic inflammatory response index (SIRI) as a prognostic factor for long-term survival in patients with pancreatic cancer.","authors":"Ramazan Yolaçan, Ramazan Dertli, Feyzullah Uçmak","doi":"10.1080/17520363.2025.2571395","DOIUrl":"10.1080/17520363.2025.2571395","url":null,"abstract":"<p><strong>Aims: </strong>Pancreatic cancer has a very poor prognosis and is a leading cause of cancer-related deaths. Our aim is to investigate the presence of novel prognostic markers in pancreatic cancer that are easy to calculate, inexpensive, non-invasive, and do not cause a loss of time.</p><p><strong>Methods: </strong>A total of 164 patients were included in the study. The demographic and clinical characteristics, laboratory findings, and radiological data of the patients were retrospectively reviewed using hospital records.</p><p><strong>Results: </strong>Of the patients, 112 (68.3%) were male, and the mean age of all patients was 63.29 ± 12.5 years. The one-,two-,and five-year survival rates of the patients were determined to be 43.9% (<i>n</i> = 72), 29.3% (<i>n</i> = 48), and 21.3% (<i>n</i> = 35), respectively. During the 1-,2, and 5-year follow-ups, the absence of surgery, advanced disease stage, and elevated systemic inflammation response index (SIRI) were identified as independent risk factors for increased mortality in pancreatic cancer. SIRI was found to be a prognostic factor influencing both short- and long-term survival in pancreatic cancer.</p><p><strong>Conclusion: </strong>We found that SIRI is a stronger prognostic factor than the NLR, PIV, and SII indices in predicting survival in pancreatic cancer. Monitoring SIRI in pancreatic cancer may provide insight into the status of the local immune response and systemic inflammation, and help in estimating patient survival.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"885-893"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12542602/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145273757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-10-10DOI: 10.1080/17520363.2025.2570634
Lanxin Feng, Jianan Li, Xin Zhao, Jianqiao Song, Shuwen Yang, Xiaoyi Wang, Chenyang Liu, Min Zhang, Chenchen Tu, Xiantao Song
Background: Patients with coronary artery disease (CAD) are at an increased risk of cognitive impairment, yet reliable noninvasive biomarkers for identifying high-risk individuals in this population remain scarce. This study aimed to investigate the association between the triglyceride-glucose (TyG) index and cognitive function in patients with CAD.
Methods: This study included 1163 patients with CAD who underwent cognitive function assessment. Multiple regression analyses were conducted to evaluate the relationship between the TyG index and cognitive function. Furthermore, receiver operating characteristic (ROC) curve analysis was conducted to determine the discriminatory ability of the TyG index in identifying patients with mild cognitive impairment (MCI).
Results: The TyG index was negatively correlated with Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) scores (r = -0.16, p < 0.001 and r = -0.33, p < 0.001, respectively). Specifically, when the TyG index was ≥8.72, higher values were associated with increased risk of MCI (OR: 3.69, 95% CI: 2.12, 6.58). ROC analysis revealed that the optimal cutoff value for the TyG index was 8.906 (specificity: 73.8%, sensitivity: 60.2%).
Conclusion: The TyG index is independently associated with cognitive function in patients with CAD, with elevated values associated with an increased risk of MCI.
背景:冠状动脉疾病(CAD)患者发生认知障碍的风险增加,但用于识别这一人群中高危个体的可靠的无创生物标志物仍然很少。本研究旨在探讨冠心病患者甘油三酯-葡萄糖(TyG)指数与认知功能的关系。方法:本研究纳入1163例CAD患者进行认知功能评估。采用多元回归分析评价TyG指数与认知功能的关系。此外,通过受试者工作特征(ROC)曲线分析,确定TyG指数在轻度认知障碍(MCI)患者识别中的区分能力。结果:TyG指数与迷你精神状态检查(MMSE)和蒙特利尔认知评估(MoCA)评分呈负相关(r = -0.16, p r = -0.33, p)结论:TyG指数与CAD患者认知功能独立相关,其升高与MCI风险增加相关。
{"title":"Triglyceride-glucose index as a novel biomarker for mild cognitive impairment in patients with coronary artery disease.","authors":"Lanxin Feng, Jianan Li, Xin Zhao, Jianqiao Song, Shuwen Yang, Xiaoyi Wang, Chenyang Liu, Min Zhang, Chenchen Tu, Xiantao Song","doi":"10.1080/17520363.2025.2570634","DOIUrl":"10.1080/17520363.2025.2570634","url":null,"abstract":"<p><strong>Background: </strong>Patients with coronary artery disease (CAD) are at an increased risk of cognitive impairment, yet reliable noninvasive biomarkers for identifying high-risk individuals in this population remain scarce. This study aimed to investigate the association between the triglyceride-glucose (TyG) index and cognitive function in patients with CAD.</p><p><strong>Methods: </strong>This study included 1163 patients with CAD who underwent cognitive function assessment. Multiple regression analyses were conducted to evaluate the relationship between the TyG index and cognitive function. Furthermore, receiver operating characteristic (ROC) curve analysis was conducted to determine the discriminatory ability of the TyG index in identifying patients with mild cognitive impairment (MCI).</p><p><strong>Results: </strong>The TyG index was negatively correlated with Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) scores (<i>r</i> = -0.16, <i>p</i> < 0.001 and <i>r</i> = -0.33, <i>p</i> < 0.001, respectively). Specifically, when the TyG index was ≥8.72, higher values were associated with increased risk of MCI (OR: 3.69, 95% CI: 2.12, 6.58). ROC analysis revealed that the optimal cutoff value for the TyG index was 8.906 (specificity: 73.8%, sensitivity: 60.2%).</p><p><strong>Conclusion: </strong>The TyG index is independently associated with cognitive function in patients with CAD, with elevated values associated with an increased risk of MCI.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"877-884"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12542614/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145273783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-09-18DOI: 10.1080/17520363.2025.2562556
Tingting Zeng, Lulu Zeng, Qianbin Dai, Yao Zhou, Qing Luo, Lu Zhang
Aim: A retrospective study was designed to compare the expression levels of TNF superfamily member 12 (TNFSF12), which encodes the protein TNF-like weak inducer of apoptosis (TWEAK), and CD163 in peripheral blood monocytes between rheumatoid arthritis (RA) patients and controls, and to correlate their expression with clinical parameters to investigate their potential association with RA.
Materials & methods: RT-qPCR method was used to determine gene expression of TNFSF12 and CD163 in patients with RA, ankylosing spondylitis (AS) and healthy controls (HC). ROC curve, Pearson correlation analysis, and western blot were used to access the diagnostic performance of TNFSF12/TWEAK and CD163, analyze their correlation with other clinical parameters in RA, and evaluate the protein expression of TWEAK and CD163 in RA.
Results: TNFSF12 and CD163 in RA patients were higher expressed compared with AS and HC; they were helpful to identify RA patients from controls, with area under ROC curve (AUC) being 0.813 and 0.826, respectively, and correlated with ESR and CRP. TWEAK and CD163 in monocytes from RA were significantly upregulated compared with controls.
Conclusion: TNFSF12 and CD163 gene higher expressed in RA patients and related with therapeutic response and inflammation status, can be used as reference index for RA diagnosis and disease monitoring.
目的:通过一项回顾性研究,比较类风湿关节炎(RA)患者和对照组外周血单核细胞中TNF超家族成员12 (TNFSF12)和CD163的表达水平,并将其表达与临床参数相关联,探讨其与RA的潜在关联。TNFSF12编码TNF样细胞凋亡弱诱导剂蛋白(TWEAK)。材料与方法:采用RT-qPCR法检测RA、强直性脊柱炎(AS)和健康对照(HC)患者中TNFSF12和CD163的基因表达。采用ROC曲线、Pearson相关分析、western blot分析TNFSF12/TWEAK和CD163的诊断效能,分析其与RA其他临床参数的相关性,评估TWEAK和CD163在RA中的蛋白表达。结果:RA患者中TNFSF12和CD163的表达高于AS和HC;其ROC曲线下面积(area under ROC curve, AUC)分别为0.813和0.826,与ESR和CRP相关。与对照组相比,RA单核细胞中的TWEAK和CD163显著上调。结论:TNFSF12和CD163基因在RA患者中表达较高,且与治疗反应和炎症状态相关,可作为RA诊断和疾病监测的参考指标。
{"title":"Expression and significance of <i>TNFSF12/</i>TWEAK, <i>CD163</i> in monocytes of patients with newly diagnosed rheumatoid arthritis.","authors":"Tingting Zeng, Lulu Zeng, Qianbin Dai, Yao Zhou, Qing Luo, Lu Zhang","doi":"10.1080/17520363.2025.2562556","DOIUrl":"10.1080/17520363.2025.2562556","url":null,"abstract":"<p><strong>Aim: </strong>A retrospective study was designed to compare the expression levels of TNF superfamily member 12 (TNFSF12), which encodes the protein TNF-like weak inducer of apoptosis (TWEAK), and CD163 in peripheral blood monocytes between rheumatoid arthritis (RA) patients and controls, and to correlate their expression with clinical parameters to investigate their potential association with RA.</p><p><strong>Materials & methods: </strong>RT-qPCR method was used to determine gene expression of TNFSF12 and CD163 in patients with RA, ankylosing spondylitis (AS) and healthy controls (HC). ROC curve, Pearson correlation analysis, and western blot were used to access the diagnostic performance of TNFSF12/TWEAK and CD163, analyze their correlation with other clinical parameters in RA, and evaluate the protein expression of TWEAK and CD163 in RA.</p><p><strong>Results: </strong>TNFSF12 and CD163 in RA patients were higher expressed compared with AS and HC; they were helpful to identify RA patients from controls, with area under ROC curve (AUC) being 0.813 and 0.826, respectively, and correlated with ESR and CRP. TWEAK and CD163 in monocytes from RA were significantly upregulated compared with controls.</p><p><strong>Conclusion: </strong>TNFSF12 and CD163 gene higher expressed in RA patients and related with therapeutic response and inflammation status, can be used as reference index for RA diagnosis and disease monitoring.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"857-865"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145079690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Infective endocarditis (IE) remains a life-threatening condition despite treatment advances. Early identification of high-risk patients is essential. The neutrophil percentage-to-albumin ratio (NPAR) is a novel inflammatory marker linked to poor outcomes in various diseases, but its prognostic value in IE remains unclear. This study aimed to investigate the association between NPAR and in-hospital mortality in patients with IE.
Methods: We retrospectively analyzed 263 patients diagnosed with IE between January 2009 and January 2024 at a tertiary care center. Clinical, laboratory, and echocardiographic data were collected. NPAR was calculated as (Neutrophil %/Albumin [g/dL]). Predictors of mortality were identified using LASSO-based logistic regression, and a nomogram was constructed to illustrate predictive performance.
Results: In-hospital mortality occurred in 59 patients (22.4%). NPAR was significantly higher among non-survivors (median: 0.335 vs. 0.228, p < 0.001). High NPAR ( >0.274) was independently associated with in-hospital mortality (OR: 6.70, 95% CI: 3.07-15.61, p < 0.001), along with large vegetation and diabetes mellitus. High NPAR showed good discriminative power (AUC = 0.72, 95% CI: 0.66-0.79, p < 0.001).
Conclusion: High NPAR was an independent predictor of in-hospital mortality in IE and may serve as a simple, cost-effective biomarker for early risk stratification.
背景:尽管治疗进展,感染性心内膜炎(IE)仍然是一种危及生命的疾病。早期识别高危患者至关重要。中性粒细胞百分比与白蛋白比率(NPAR)是一种新的炎症标志物,与各种疾病的不良预后有关,但其在IE中的预后价值尚不清楚。本研究旨在探讨NPAR与IE患者住院死亡率之间的关系。方法:我们回顾性分析了2009年1月至2024年1月在三级保健中心诊断为IE的263例患者。收集临床、实验室和超声心动图资料。NPAR计算为(中性粒细胞%/白蛋白[g/dL])。使用基于lasso的逻辑回归确定死亡率的预测因子,并构建了一个nomogram来说明预测性能。结果:住院死亡59例(22.4%)。非幸存者的NPAR显著更高(中位数:0.335 vs. 0.228, p 0.274)与住院死亡率独立相关(OR: 6.70, 95% CI: 3.07-15.61, p p)结论:高NPAR是IE住院死亡率的独立预测因子,可作为早期风险分层的简单、经济有效的生物标志物。
{"title":"Neutrophil percentage-to-albumin ratio as a predictor of In-hospital mortality in infective endocarditis.","authors":"Muhammet Mucahit Tiryaki, Cemalettin Yilmaz, Huseyin Sefa Ince, Banu Karaca, Fatma Kayaalti Esin, Tuncay Kiris","doi":"10.1080/17520363.2025.2562554","DOIUrl":"10.1080/17520363.2025.2562554","url":null,"abstract":"<p><strong>Background: </strong>Infective endocarditis (IE) remains a life-threatening condition despite treatment advances. Early identification of high-risk patients is essential. The neutrophil percentage-to-albumin ratio (NPAR) is a novel inflammatory marker linked to poor outcomes in various diseases, but its prognostic value in IE remains unclear. This study aimed to investigate the association between NPAR and in-hospital mortality in patients with IE.</p><p><strong>Methods: </strong>We retrospectively analyzed 263 patients diagnosed with IE between January 2009 and January 2024 at a tertiary care center. Clinical, laboratory, and echocardiographic data were collected. NPAR was calculated as (Neutrophil %/Albumin [g/dL]). Predictors of mortality were identified using LASSO-based logistic regression, and a nomogram was constructed to illustrate predictive performance.</p><p><strong>Results: </strong>In-hospital mortality occurred in 59 patients (22.4%). NPAR was significantly higher among non-survivors (median: 0.335 vs. 0.228, <i>p</i> < 0.001). High NPAR ( >0.274) was independently associated with in-hospital mortality (OR: 6.70, 95% CI: 3.07-15.61, <i>p</i> < 0.001), along with large vegetation and diabetes mellitus. High NPAR showed good discriminative power (AUC = 0.72, 95% CI: 0.66-0.79, <i>p</i> < 0.001).</p><p><strong>Conclusion: </strong>High NPAR was an independent predictor of in-hospital mortality in IE and may serve as a simple, cost-effective biomarker for early risk stratification.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"867-874"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477859/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: There are meta-analyses about the correlation between non-coding RNA and the prognosis of gastric cancer, which are focus on a single or a particular type of non-coding RNA. This study aims to verify the correlation between various non-coding RNAs and the prognosis of gastric cancer through meta-analysis.
Methods: The studies documenting the association between non-coding RNAs and the prognosis of gastric cancer up until September 2023 were extracted. The outcomes of the univariate and multivariate analyses were combined for each noncoding RNA. Sources of heterogeneity were determined by meta-regression analysis, and publication bias was assessed using the Egger test.
Results: Fifty-five studies were included in meta-analysis, of which 40 reported miRNAs and 14 reported lncRNAs. The up-regulation of miR-17-5p, miR-21, miR-214, miR-20a, lnc-CECR7, lnc-SNHG15, lnc-Sox2ot, lnc-ANRIL, lnc-DSCR8, lnc-ZEB1-AS1 and lnc-NEAT1 were associated with an unfavorable OS in gastric cancer. Elevated level of lnc-PVT1 correlated with an adverse DFS in gastric cancer. A diminished expression of miR-133a, miR-141, miR-206, and miR-1236-3p predicted a poor OS of gastric cancer.
Conclusions: Various non-coding RNAs are associated with the prognosis of gastric cancer based on new evidence-based medical evidence, which provides a potential value for clinical diagnosis and treatment.
{"title":"Evidence-based medical evidence: non-coding RNAs serve as prognostic biomarkers for gastric cancer.","authors":"Zhiren Zhou, Hongkun Ma, Yanan Liu, Xueqing Zhang, Xiaojing Huang, Zheng Li, Huanyu Ren, Huiru Niu, Hao Liao, Xiaojing Zhang, Hongzhi Pan, Lina Zou, Shengzhong Rong","doi":"10.1080/17520363.2025.2570639","DOIUrl":"10.1080/17520363.2025.2570639","url":null,"abstract":"<p><strong>Objective: </strong>There are meta-analyses about the correlation between non-coding RNA and the prognosis of gastric cancer, which are focus on a single or a particular type of non-coding RNA. This study aims to verify the correlation between various non-coding RNAs and the prognosis of gastric cancer through meta-analysis.</p><p><strong>Methods: </strong>The studies documenting the association between non-coding RNAs and the prognosis of gastric cancer up until September 2023 were extracted. The outcomes of the univariate and multivariate analyses were combined for each noncoding RNA. Sources of heterogeneity were determined by meta-regression analysis, and publication bias was assessed using the Egger test.</p><p><strong>Results: </strong>Fifty-five studies were included in meta-analysis, of which 40 reported miRNAs and 14 reported lncRNAs. The up-regulation of miR-17-5p, miR-21, miR-214, miR-20a, lnc-CECR7, lnc-SNHG15, lnc-Sox2ot, lnc-ANRIL, lnc-DSCR8, lnc-ZEB1-AS1 and lnc-NEAT1 were associated with an unfavorable OS in gastric cancer. Elevated level of lnc-PVT1 correlated with an adverse DFS in gastric cancer. A diminished expression of miR-133a, miR-141, miR-206, and miR-1236-3p predicted a poor OS of gastric cancer.</p><p><strong>Conclusions: </strong>Various non-coding RNAs are associated with the prognosis of gastric cancer based on new evidence-based medical evidence, which provides a potential value for clinical diagnosis and treatment.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"921-932"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12542616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145249887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-09-16DOI: 10.1080/17520363.2025.2562546
Sydney Stern, Kristin Jamenis, Sreedharan Sabarinath, Shawna L Weis, Robert Schuck, Michael Pacanowski
Introduction: The use of biomarkers as surrogate endpoints, supported by strong mechanistic, epidemiologic, and/or clinical data, provides drug development programs with endpoints that predict clinical benefit and may be more sensitive to drug effects than clinical endpoints. Neurofilament light chain (NfL) is a marker of neuroaxonal injury that has emerged as a promising biomarker for neurodegenerative diseases.
Methods: We identified Investigational New Drug programs submitted to the U.S. Food and Drug Administration between 2005-2024 that proposed to use NfL as a pharmacodynamic biomarker, biomarker for patient selection or stratification, and/or surrogate endpoint for accelerated approval.
Results: A total of 50 programs were identified with most from the last five years. Of the 50 programs, 94% (n = 47) proposed NfL as a pharmacodynamic biomarker, 8% (n = 4) for patient selection, 52% (n = 26) for patient stratification, and 20% (n = 10) as a surrogate endpoint. Of the programs evaluating NfL as a pharmacodynamic biomarker with available data on NfL levels (n = 21), approximately 50% reported NfL changes that correlated with drug exposure.
Conclusion: This analysis highlights the important role that NfL plays in clinical trials and identifies future areas of research and study design considerations to strengthen the support of NfL as a biomarker.
{"title":"Trends in clinical studies evaluating neurofilament light chain as a biomarker.","authors":"Sydney Stern, Kristin Jamenis, Sreedharan Sabarinath, Shawna L Weis, Robert Schuck, Michael Pacanowski","doi":"10.1080/17520363.2025.2562546","DOIUrl":"10.1080/17520363.2025.2562546","url":null,"abstract":"<p><strong>Introduction: </strong>The use of biomarkers as surrogate endpoints, supported by strong mechanistic, epidemiologic, and/or clinical data, provides drug development programs with endpoints that predict clinical benefit and may be more sensitive to drug effects than clinical endpoints. Neurofilament light chain (NfL) is a marker of neuroaxonal injury that has emerged as a promising biomarker for neurodegenerative diseases.</p><p><strong>Methods: </strong>We identified Investigational New Drug programs submitted to the U.S. Food and Drug Administration between 2005-2024 that proposed to use NfL as a pharmacodynamic biomarker, biomarker for patient selection or stratification, and/or surrogate endpoint for accelerated approval.</p><p><strong>Results: </strong>A total of 50 programs were identified with most from the last five years. Of the 50 programs, 94% (<i>n</i> = 47) proposed NfL as a pharmacodynamic biomarker, 8% (<i>n</i> = 4) for patient selection, 52% (<i>n</i> = 26) for patient stratification, and 20% (<i>n</i> = 10) as a surrogate endpoint. Of the programs evaluating NfL as a pharmacodynamic biomarker with available data on NfL levels (<i>n</i> = 21), approximately 50% reported NfL changes that correlated with drug exposure.</p><p><strong>Conclusion: </strong>This analysis highlights the important role that NfL plays in clinical trials and identifies future areas of research and study design considerations to strengthen the support of NfL as a biomarker.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"813-823"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12453014/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-09-22DOI: 10.1080/17520363.2025.2562551
Manuel Sánchez-de-la-Torre, Clémentine Puech, David de Gonzalo-Calvo
{"title":"From molecules to meaning: non-coding RNAs as biomarkers in obstructive sleep apnea.","authors":"Manuel Sánchez-de-la-Torre, Clémentine Puech, David de Gonzalo-Calvo","doi":"10.1080/17520363.2025.2562551","DOIUrl":"10.1080/17520363.2025.2562551","url":null,"abstract":"","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"807-809"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477864/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145111647","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-08-15DOI: 10.1080/17520363.2025.2548759
Berhan Keskin, Aykun Hakgor, Fatih Erkam Olgun, Ahmet Berk Duman, Beytullah Cakal, Seda Tanyeri, Barkın Kultursay, Canan Elif Yildiz, Emir Dervis, Ibrahim Oguz Karaca, Bilal Boztosun
Background: The Naples Prognostic Score (NPS) is a composite index of inflammation and nutritional status. This study aimed to evaluate the prognostic value of NPS for long-term all-cause mortality in non-ST-elevation myocardial infarction (NSTEMI).
Methods: In this study, 396 consecutive NSTEMI patients who underwent coronary angiography/percutaneous coronary intervention between 1 August 2023, and 31 July 2024, were included. Patients were stratified into low (NPS: 0-1), intermediate (NPS: 2), and high (NPS: 3-4) risk groups. Median follow-up was 433 days. Univariate logistic regression identified predictors of longterm mortality. These were then entered into LASSOpenalized logistic regression for variable selection. Multivariate Cox proportional hazards models assessed the independent predictors of long-term mortality, adjusting for SYNTAX score, hemoglobin, sodium, age, and left ventricular ejection fraction (LVEF).
Results: High-risk NPS patients (n = 91) had higher long-term mortality (17.6%) compared with intermediate-risk (3.7%) and low-risk (3.5%) groups (p < 0.001). In the adjusted Cox model, high-risk NPS independently predicted long-term mortality (HR:3.79; 95% CI 1.55-9.27; p = 0.003), whereas neutrophil-to-lymphocyte ratio (NLR) and C-reactive protein (CRP) were not significant when substituted for NPS.
Conclusion: In NSTEMI patients, NPS independently predicts long-term all-cause mortality beyond traditional risk markers and outperforms isolated inflammatory indices such as NLR and CRP.
{"title":"Prognostic impact of Naples prognostic score on long-term mortality in non-ST-elevation myocardial infarction.","authors":"Berhan Keskin, Aykun Hakgor, Fatih Erkam Olgun, Ahmet Berk Duman, Beytullah Cakal, Seda Tanyeri, Barkın Kultursay, Canan Elif Yildiz, Emir Dervis, Ibrahim Oguz Karaca, Bilal Boztosun","doi":"10.1080/17520363.2025.2548759","DOIUrl":"10.1080/17520363.2025.2548759","url":null,"abstract":"<p><strong>Background: </strong>The Naples Prognostic Score (NPS) is a composite index of inflammation and nutritional status. This study aimed to evaluate the prognostic value of NPS for long-term all-cause mortality in non-ST-elevation myocardial infarction (NSTEMI).</p><p><strong>Methods: </strong>In this study, 396 consecutive NSTEMI patients who underwent coronary angiography/percutaneous coronary intervention between 1 August 2023, and 31 July 2024, were included. Patients were stratified into low (NPS: 0-1), intermediate (NPS: 2), and high (NPS: 3-4) risk groups. Median follow-up was 433 days. Univariate logistic regression identified predictors of longterm mortality. These were then entered into LASSOpenalized logistic regression for variable selection. Multivariate Cox proportional hazards models assessed the independent predictors of long-term mortality, adjusting for SYNTAX score, hemoglobin, sodium, age, and left ventricular ejection fraction (LVEF).</p><p><strong>Results: </strong>High-risk NPS patients (<i>n</i> = 91) had higher long-term mortality (17.6%) compared with intermediate-risk (3.7%) and low-risk (3.5%) groups (<i>p</i> < 0.001). In the adjusted Cox model, high-risk NPS independently predicted long-term mortality (HR:3.79; 95% CI 1.55-9.27; <i>p</i> = 0.003), whereas neutrophil-to-lymphocyte ratio (NLR) and C-reactive protein (CRP) were not significant when substituted for NPS.</p><p><strong>Conclusion: </strong>In NSTEMI patients, NPS independently predicts long-term all-cause mortality beyond traditional risk markers and outperforms isolated inflammatory indices such as NLR and CRP.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"825-835"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12481722/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144858911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-09-15DOI: 10.1080/17520363.2025.2561397
Javier Arredondo Montero
{"title":"<i>Letter to the Editor</i>: Association is not prediction - choosing the right tools for diagnostic evidence synthesis.","authors":"Javier Arredondo Montero","doi":"10.1080/17520363.2025.2561397","DOIUrl":"10.1080/17520363.2025.2561397","url":null,"abstract":"","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"811-812"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12481721/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145063396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-08-22DOI: 10.1080/17520363.2025.2538429
Lin Li, Xiaoying Wang, Dan Li, Zhenfang Liu
Objective: To investigate the relationship between Group B Streptococcus (GBS) infection in pregnant women and adverse pregnancy events (APEs), as well as serum inflammatory factors (IFs) and coagulation parameters.
Methods: A retrospective analysis was conducted on 2,200 late-pregnancy women who delivered at Maternal and Child Health Hospital from March 2020 to January 2023. Data on GBS infection, serotyping, immunofluorescence, coagulation parameters, and APEs were collected. APE incidence was compared between groups, and logistic regression was performed to analyze inflammatory factors and coagulation parameters in GBS-positive women with and without APEs.
Results: Among the participants, 593 (26.95%) were GBS-positive, and 1,607 (73.05%) were GBS-negative. The GBS-positive group had significantly higher rates of preterm birth, intrauterine infection, premature rupture of membranes, placental abruption, postpartum hemorrhage, and meconium-stained amniotic fluid compared to the GBS-negative group (p < 0.05). Logistic regression identified white blood cell count, high-sensitivity C-reactive protein, tumor necrosis factor-α, interleukin-6 (IL-6), interleukin-1β, procalcitonin, and fibrinogen as independent risk factors for APEs (p < 0.05).
Conclusion: GBS infection increases the risk of adverse pregnancy events and is closely associated with alterations in inflammatory and coagulation markers.
{"title":"Serum inflammatory and coagulation markers in GBS infection and adverse pregnancy outcomes.","authors":"Lin Li, Xiaoying Wang, Dan Li, Zhenfang Liu","doi":"10.1080/17520363.2025.2538429","DOIUrl":"https://doi.org/10.1080/17520363.2025.2538429","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the relationship between Group B Streptococcus (GBS) infection in pregnant women and adverse pregnancy events (APEs), as well as serum inflammatory factors (IFs) and coagulation parameters.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on 2,200 late-pregnancy women who delivered at Maternal and Child Health Hospital from March 2020 to January 2023. Data on GBS infection, serotyping, immunofluorescence, coagulation parameters, and APEs were collected. APE incidence was compared between groups, and logistic regression was performed to analyze inflammatory factors and coagulation parameters in GBS-positive women with and without APEs.</p><p><strong>Results: </strong>Among the participants, 593 (26.95%) were GBS-positive, and 1,607 (73.05%) were GBS-negative. The GBS-positive group had significantly higher rates of preterm birth, intrauterine infection, premature rupture of membranes, placental abruption, postpartum hemorrhage, and meconium-stained amniotic fluid compared to the GBS-negative group (<i>p</i> < 0.05). Logistic regression identified white blood cell count, high-sensitivity C-reactive protein, tumor necrosis factor-α, interleukin-6 (IL-6), interleukin-1β, procalcitonin, and fibrinogen as independent risk factors for APEs (<i>p</i> < 0.05).</p><p><strong>Conclusion: </strong>GBS infection increases the risk of adverse pregnancy events and is closely associated with alterations in inflammatory and coagulation markers.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"1-9"},"PeriodicalIF":2.1,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144943265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}