Background: Idiopathic inflammatory myopathies (IIM) are a diverse group of autoimmune diseases characterized primarily by muscle weakness and systemic involvement, which can include interstitial lung disease (ILD). ILD is a serious complication in IIM, significantly affecting patient prognosis and quality of life. Early identification of IIM patients at risk for developing ILD is crucial for timely intervention and personalized treatment, yet the factors contributing to this risk remain inadequately defined.
Methods: This retrospective study analyzed medical records of 130 patients with IIM from the First Affiliated Hospital of Xinxiang Medical University, China, between August 2018 and July 2023. Patients were categorized into two groups: IIM with interstitial lung disease (IIM-ILD, n = 75) and IIM without ILD (n = 55). We collected and analyzed demographic, clinical, and laboratory data, including specific autoantibody tests. Multivariate logistic regression identified independent predictors of ILD, and a nomogram was developed to evaluate ILD risk based on significant factors.
Results: This retrospective study analyzed 130 patients with IIM, including 75 with interstitial lung disease and 55 without ILD. The IIM-ILD group was significantly older (58.4 vs. 48.3, p = 0.052) and had higher frequencies of respiratory symptoms including dyspnea (61.3% vs. 14.9%, p < 0.001) and cough (54.7% vs. 10.9%, p < 0.001). Key laboratory differences included elevated ESR (26.5 vs. 10.0 mm/H, p < 0.001), CRP (3.44 vs. 1.64 mmol/L, p = 0.013), and IgG (12.5 vs. 10.9 g/L, p = 0.006), along with lower ALT (29.0 vs. 44.0 U/L, p = 0.001) and AST (32.0 vs. 45.0 U/L, p = 0.021) in the IIM-ILD group. Anti-Jo-1 antibodies were more prevalent in IIM-ILD patients (18.7% vs. 5.5%, p = 0.027). Multivariate analysis identified ESR (OR = 1.063, 95% CI:1.012-1.117, p = 0.015), AST (OR = 0.985, 95% CI:0.970-1.000, p = 0.047), and IgG (OR = 1.191, 95% CI:1.025-1.383, p = 0.022) as independent predictors. These factors, combined with dyspnea and anti-Jo-1 status, were incorporated into a predictive nomogram model. The nomogram demonstrated excellent discrimination (AUC = 0.891, 95% CI:0.836-0.947) with sensitivity of 79.7% and specificity of 82.6%. Calibration curves showed good agreement between predicted and observed outcomes (Hosmer-Lemeshow test, p = 0.779). Decision curve analysis confirmed the model's clinical utility across a wide range of threshold probabilities. This comprehensive model provides clinicians with a practical tool for early identification of IIM patients at high risk for ILD development.
Conclusion: Elevated ESR and CRP levels, in conjunction with lower AST levels, alongside the presence of anti-Jo-1 antibodies and the manifestation of dyspnea are significant biomarkers associated with the risk of developing IIM-ILD. This predictive model enhances early diagnostic cap
背景:特发性炎症性肌病(IIM)是一组以肌肉无力和全身受累为主要特征的自身免疫性疾病,可包括间质性肺疾病(ILD)。ILD是IIM的严重并发症,严重影响患者预后和生活质量。早期识别有发展为ILD风险的IIM患者对于及时干预和个性化治疗至关重要,然而导致这种风险的因素仍然没有得到充分的定义。方法:回顾性分析2018年8月至2023年7月中国新乡医科大学第一附属医院130例IIM患者的病历。患者分为两组:IIM合并间质性肺病(IIM-ILD, n = 75)和IIM无ILD (n = 55)。我们收集并分析了人口统计学、临床和实验室数据,包括特异性自身抗体测试。多元逻辑回归确定了ILD的独立预测因素,并基于显著因素开发了一个nomogram来评估ILD的风险。结果:本回顾性研究分析了130例IIM患者,其中75例合并间质性肺疾病,55例未合并ILD。IIM-ILD组明显更老(58.4比48.3,p = 0.052),呼吸系统症状包括呼吸困难的频率更高(61.3%比14.9%,p)。结论:ESR和CRP水平升高,结合较低的AST水平,以及抗jo1抗体的存在和呼吸困难的表现是与发生IIM-ILD风险相关的重要生物标志物。该预测模型提高了早期诊断能力,促进了风险分层,从而为临床决策提供了信息。然而,需要在更大的多中心队列中进行进一步验证,以证实该模型的预测准确性并优化其临床应用。
{"title":"Integration of clinical and serological biomarkers in a nomogram for predicting interstitial lung disease in idiopathic inflammatory myopathies.","authors":"Zhixia Wang, Jingyun Zhang, Jin Li, Xiaona Mao, Yangyang Li, Dekun Wang, Wenpeng Ge, Jingzhan Li, Changhua Liang, Zhiqiang Zhang","doi":"10.1186/s41927-025-00534-7","DOIUrl":"10.1186/s41927-025-00534-7","url":null,"abstract":"<p><strong>Background: </strong>Idiopathic inflammatory myopathies (IIM) are a diverse group of autoimmune diseases characterized primarily by muscle weakness and systemic involvement, which can include interstitial lung disease (ILD). ILD is a serious complication in IIM, significantly affecting patient prognosis and quality of life. Early identification of IIM patients at risk for developing ILD is crucial for timely intervention and personalized treatment, yet the factors contributing to this risk remain inadequately defined.</p><p><strong>Methods: </strong>This retrospective study analyzed medical records of 130 patients with IIM from the First Affiliated Hospital of Xinxiang Medical University, China, between August 2018 and July 2023. Patients were categorized into two groups: IIM with interstitial lung disease (IIM-ILD, n = 75) and IIM without ILD (n = 55). We collected and analyzed demographic, clinical, and laboratory data, including specific autoantibody tests. Multivariate logistic regression identified independent predictors of ILD, and a nomogram was developed to evaluate ILD risk based on significant factors.</p><p><strong>Results: </strong>This retrospective study analyzed 130 patients with IIM, including 75 with interstitial lung disease and 55 without ILD. The IIM-ILD group was significantly older (58.4 vs. 48.3, p = 0.052) and had higher frequencies of respiratory symptoms including dyspnea (61.3% vs. 14.9%, p < 0.001) and cough (54.7% vs. 10.9%, p < 0.001). Key laboratory differences included elevated ESR (26.5 vs. 10.0 mm/H, p < 0.001), CRP (3.44 vs. 1.64 mmol/L, p = 0.013), and IgG (12.5 vs. 10.9 g/L, p = 0.006), along with lower ALT (29.0 vs. 44.0 U/L, p = 0.001) and AST (32.0 vs. 45.0 U/L, p = 0.021) in the IIM-ILD group. Anti-Jo-1 antibodies were more prevalent in IIM-ILD patients (18.7% vs. 5.5%, p = 0.027). Multivariate analysis identified ESR (OR = 1.063, 95% CI:1.012-1.117, p = 0.015), AST (OR = 0.985, 95% CI:0.970-1.000, p = 0.047), and IgG (OR = 1.191, 95% CI:1.025-1.383, p = 0.022) as independent predictors. These factors, combined with dyspnea and anti-Jo-1 status, were incorporated into a predictive nomogram model. The nomogram demonstrated excellent discrimination (AUC = 0.891, 95% CI:0.836-0.947) with sensitivity of 79.7% and specificity of 82.6%. Calibration curves showed good agreement between predicted and observed outcomes (Hosmer-Lemeshow test, p = 0.779). Decision curve analysis confirmed the model's clinical utility across a wide range of threshold probabilities. This comprehensive model provides clinicians with a practical tool for early identification of IIM patients at high risk for ILD development.</p><p><strong>Conclusion: </strong>Elevated ESR and CRP levels, in conjunction with lower AST levels, alongside the presence of anti-Jo-1 antibodies and the manifestation of dyspnea are significant biomarkers associated with the risk of developing IIM-ILD. This predictive model enhances early diagnostic cap","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"9 1","pages":"73"},"PeriodicalIF":2.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12219061/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144538802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-01DOI: 10.1186/s41927-025-00501-2
Jack Ainsworth, Marita Bolic, Ibrahim Ismail, Zinat Mohammadpour, John Wood
Background: Rheumatoid arthritis is an autoimmune disease that can cause joint destruction, pain, loss of function, and reduced quality of life. Recent advancements in treatment have made it possible to control the impacts of this once-debilitating disease through early intervention. While numerous studies have examined barriers to rheumatoid arthritis care, no review has synthesized sociodemographic and economic factors across high-, upper middle-, and lower middle-income countries. This gap in the literature highlights the need for a comprehensive review that informs global health interventions. This review explores sociodemographic and economic barriers to initial specialist care for patients with rheumatoid arthritis.
Methods: The review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. A search of CINAHL, MEDLINE, Scopus and Emcare was completed in May 2024.
Results: Of the 5165 studies identified through the literature search, 121 full-text articles were reviewed, and 25 studies examining sociodemographic and economic barriers to specialist care were selected for analysis. A total of 17 high-income, one upper middle-income and seven lower middle-income countries were represented. Low socioeconomic status, low income and rurality were consistently reported as barriers to initial rheumatologist appointments across all countries in this review.
Conclusion: These findings underscore the importance of addressing common barriers such as low socioeconomic status and rurality in global health interventions. Future large prospective studies are essential to better understand the relationship between sociodemographic factors and timely access to care.
{"title":"Sociodemographic and economic barriers to initial specialist care for patients with rheumatoid arthritis: a scoping review.","authors":"Jack Ainsworth, Marita Bolic, Ibrahim Ismail, Zinat Mohammadpour, John Wood","doi":"10.1186/s41927-025-00501-2","DOIUrl":"10.1186/s41927-025-00501-2","url":null,"abstract":"<p><strong>Background: </strong>Rheumatoid arthritis is an autoimmune disease that can cause joint destruction, pain, loss of function, and reduced quality of life. Recent advancements in treatment have made it possible to control the impacts of this once-debilitating disease through early intervention. While numerous studies have examined barriers to rheumatoid arthritis care, no review has synthesized sociodemographic and economic factors across high-, upper middle-, and lower middle-income countries. This gap in the literature highlights the need for a comprehensive review that informs global health interventions. This review explores sociodemographic and economic barriers to initial specialist care for patients with rheumatoid arthritis.</p><p><strong>Methods: </strong>The review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. A search of CINAHL, MEDLINE, Scopus and Emcare was completed in May 2024.</p><p><strong>Results: </strong>Of the 5165 studies identified through the literature search, 121 full-text articles were reviewed, and 25 studies examining sociodemographic and economic barriers to specialist care were selected for analysis. A total of 17 high-income, one upper middle-income and seven lower middle-income countries were represented. Low socioeconomic status, low income and rurality were consistently reported as barriers to initial rheumatologist appointments across all countries in this review.</p><p><strong>Conclusion: </strong>These findings underscore the importance of addressing common barriers such as low socioeconomic status and rurality in global health interventions. Future large prospective studies are essential to better understand the relationship between sociodemographic factors and timely access to care.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"9 1","pages":"76"},"PeriodicalIF":2.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12220584/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144538805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-01DOI: 10.1186/s41927-025-00527-6
Stylianos Georgiadis, Daniela Di Giuseppe, Almut Scherer, Merete Lund Hetland, Gareth T Jones, Bente Glintborg, Anne Gitte Loft, Johan K Wallman, Brigitte Michelsen, Eirik Klami Kristianslund, Ayten Yazici, Merih Birlik, Jakub Závada, Michael J Nissen, Adrian Ciurea, Bjorn Gudbjornsson, Olafur Palsson, Ziga Rotar, Matija Tomšič, Heikki Relas, Johanna Huhtakangas, Ana Maria Rodrigues, Maria José Santos, Isabel Castrejon, Federico Díaz-González, Marleen van de Sande, Pasoon Hellamand, Lykke Midtbøll Ørnbjerg
Background: To investigate a patient-level single imputation approach for patient reported outcomes (PROs) that express similar contents or associated PROs, where a PRO whose value is missing at a particular timepoint is substituted by another PRO whose value is available at the same timepoint.
Methods: We performed a simulation study on registry-based spondyloarthritis data to explore the potential interchangeability between the patient pain (PPA) and fatigue (PFA) assessment scores and relevant Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) individual questions, and between PPA, PFA and patient global assessment (PGA). Performance was assessed per imputation method in terms of relative bias and coverage. Sample size, level of missingness and missing data pattern were included as parameters in the simulations.
Results: All applied scenarios to interchange PPA with BASDAI question 2 (axial pain), BASDAI question 3 (peripheral joint pain/swelling) or their average failed. Interchangeability between PFA and BASDAI question 1 (fatigue/tiredness) was acceptable for partially (up to 50%) missing data. When interchanging patient assessment scores (PPA, PFA and PGA), we observed inconsistent results in terms of performance. The performance of the applied methods depended on the sample size and the level of missingness, but not heavily on the underlying missing data pattern.
Conclusions: Interchanging PFA and the BASDAI fatigue question was justified for partially missing data, while interchangeability between PPA, PFA and PGA, and between PPA and the BASDAI pain questions was not advised. Our findings suggest that registering patient assessment scores and BASDAI questions is recommended.
{"title":"Interchangeability of patient pain, fatigue and global scores in patients with spondyloarthritis - a registry-based simulation study.","authors":"Stylianos Georgiadis, Daniela Di Giuseppe, Almut Scherer, Merete Lund Hetland, Gareth T Jones, Bente Glintborg, Anne Gitte Loft, Johan K Wallman, Brigitte Michelsen, Eirik Klami Kristianslund, Ayten Yazici, Merih Birlik, Jakub Závada, Michael J Nissen, Adrian Ciurea, Bjorn Gudbjornsson, Olafur Palsson, Ziga Rotar, Matija Tomšič, Heikki Relas, Johanna Huhtakangas, Ana Maria Rodrigues, Maria José Santos, Isabel Castrejon, Federico Díaz-González, Marleen van de Sande, Pasoon Hellamand, Lykke Midtbøll Ørnbjerg","doi":"10.1186/s41927-025-00527-6","DOIUrl":"10.1186/s41927-025-00527-6","url":null,"abstract":"<p><strong>Background: </strong>To investigate a patient-level single imputation approach for patient reported outcomes (PROs) that express similar contents or associated PROs, where a PRO whose value is missing at a particular timepoint is substituted by another PRO whose value is available at the same timepoint.</p><p><strong>Methods: </strong>We performed a simulation study on registry-based spondyloarthritis data to explore the potential interchangeability between the patient pain (PPA) and fatigue (PFA) assessment scores and relevant Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) individual questions, and between PPA, PFA and patient global assessment (PGA). Performance was assessed per imputation method in terms of relative bias and coverage. Sample size, level of missingness and missing data pattern were included as parameters in the simulations.</p><p><strong>Results: </strong>All applied scenarios to interchange PPA with BASDAI question 2 (axial pain), BASDAI question 3 (peripheral joint pain/swelling) or their average failed. Interchangeability between PFA and BASDAI question 1 (fatigue/tiredness) was acceptable for partially (up to 50%) missing data. When interchanging patient assessment scores (PPA, PFA and PGA), we observed inconsistent results in terms of performance. The performance of the applied methods depended on the sample size and the level of missingness, but not heavily on the underlying missing data pattern.</p><p><strong>Conclusions: </strong>Interchanging PFA and the BASDAI fatigue question was justified for partially missing data, while interchangeability between PPA, PFA and PGA, and between PPA and the BASDAI pain questions was not advised. Our findings suggest that registering patient assessment scores and BASDAI questions is recommended.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"9 1","pages":"75"},"PeriodicalIF":2.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12217374/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144538803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-01DOI: 10.1186/s41927-025-00538-3
Jun Yan, Hua Guo, Lin-Xin Zhang, Pei Chen, Yong-Ku Du, Juan Li, Ya-Ya Gao, Nan Ye
Background: Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by joint destruction and systemic inflammation, both of which significantly impair patients' quality of life. Mild cognitive impairment (MCI), a reversible precursor to dementia, is increasingly prevalent among elderly RA patients. Early identification of MCI in this population allows for timely interventions to slow cognitive decline.
Objective: This study aims to identify independent risk factors for MCI in elderly patients with RA and to develop a predictive nomogram.
Methods: We enrolled 378 elderly RA patients, aged 60 to 80 years, from Xi'an Fifth Hospital between December 2023 and December 2024. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA), with scores ranging from 20 to 26 indicating MCI. We analyzed demographic, clinical, and laboratory data to identify risk factors through logistic regression and constructed a nomogram. The model's performance was evaluated using receiver operating characteristic (ROC) curves, calibration plots, and decision curve analysis (DCA).
Results: Among the 378 patients, 94 (24.87%) were classified in the RA-MCI group. Multivariate analysis identified the course of disease (COD) (OR = 1.07, 95% CI: 1.03-1.10), elevated Disease Activity Score-28 (DAS28) (OR = 1.31, 95% CI: 1.13-1.53), high C-reactive protein (CRP) levels (OR = 1.01, 95% CI: 1.01-1.02), and osteoporosis (OP) (OR = 1.88, 95% CI: 1.14-3.13) as independent risk factors. The nomogram demonstrated moderate discrimination (AUC = 0.750, 95% CI: 0.696-0.805) and clinical utility.
Conclusion: The COD, OP, DAS28, and CRP levels are key predictors of MCI in elderly RA patients. The proposed nomogram provides a practical tool for early risk stratification, facilitating targeted interventions to delay cognitive decline.
Trial registration: This study conformed to the principles outlined in the Declaration of Helsinki and received approval from the Medical Ethics Committee of Xi'an Fifth Hospital (Approval No.: [2023] Ethics Review 55). Additionally, the trial was registered with the Chinese Clinical Trial Registry (Registration No.: ChiCTR2300077337, Registration Date: 2023-11-01). Written informed consent was obtained from all individual participants included in the study.
{"title":"Risk factors and predictive model for mild cognitive impairment in elderly patients with rheumatoid arthritis.","authors":"Jun Yan, Hua Guo, Lin-Xin Zhang, Pei Chen, Yong-Ku Du, Juan Li, Ya-Ya Gao, Nan Ye","doi":"10.1186/s41927-025-00538-3","DOIUrl":"10.1186/s41927-025-00538-3","url":null,"abstract":"<p><strong>Background: </strong>Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by joint destruction and systemic inflammation, both of which significantly impair patients' quality of life. Mild cognitive impairment (MCI), a reversible precursor to dementia, is increasingly prevalent among elderly RA patients. Early identification of MCI in this population allows for timely interventions to slow cognitive decline.</p><p><strong>Objective: </strong>This study aims to identify independent risk factors for MCI in elderly patients with RA and to develop a predictive nomogram.</p><p><strong>Methods: </strong>We enrolled 378 elderly RA patients, aged 60 to 80 years, from Xi'an Fifth Hospital between December 2023 and December 2024. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA), with scores ranging from 20 to 26 indicating MCI. We analyzed demographic, clinical, and laboratory data to identify risk factors through logistic regression and constructed a nomogram. The model's performance was evaluated using receiver operating characteristic (ROC) curves, calibration plots, and decision curve analysis (DCA).</p><p><strong>Results: </strong>Among the 378 patients, 94 (24.87%) were classified in the RA-MCI group. Multivariate analysis identified the course of disease (COD) (OR = 1.07, 95% CI: 1.03-1.10), elevated Disease Activity Score-28 (DAS28) (OR = 1.31, 95% CI: 1.13-1.53), high C-reactive protein (CRP) levels (OR = 1.01, 95% CI: 1.01-1.02), and osteoporosis (OP) (OR = 1.88, 95% CI: 1.14-3.13) as independent risk factors. The nomogram demonstrated moderate discrimination (AUC = 0.750, 95% CI: 0.696-0.805) and clinical utility.</p><p><strong>Conclusion: </strong>The COD, OP, DAS28, and CRP levels are key predictors of MCI in elderly RA patients. The proposed nomogram provides a practical tool for early risk stratification, facilitating targeted interventions to delay cognitive decline.</p><p><strong>Trial registration: </strong>This study conformed to the principles outlined in the Declaration of Helsinki and received approval from the Medical Ethics Committee of Xi'an Fifth Hospital (Approval No.: [2023] Ethics Review 55). Additionally, the trial was registered with the Chinese Clinical Trial Registry (Registration No.: ChiCTR2300077337, Registration Date: 2023-11-01). Written informed consent was obtained from all individual participants included in the study.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"9 1","pages":"69"},"PeriodicalIF":2.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12219160/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144538804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-09DOI: 10.1186/s41927-025-00525-8
Grace Kim, Leanna M Ross, Alyssa M Sudnick, Johanna L Johnson, Carl F Pieper, Margery A Connelly, Olga Ilkayeva, Michael J Muehlbauer, Connie W Bales, Kathryn N Porter Starr, William E Kraus, Brian J Andonian, Kim M Huffman
<p><strong>Background: </strong>Rheumatoid arthritis (RA) is associated with increased cardiometabolic risk due to inflammation and traditional risk factors, both of which can be mitigated by lifestyle modifications. This study examines metabolic pathways influenced by lifestyle changes and related to improved cardiometabolic risk.</p><p><strong>Methods: </strong>This is a secondary exploratory analysis of the Supervised Weight loss and Exercise Training (SWET) study, in which twenty older adults with RA and overweight/obesity were randomized to 16 weeks of SWET or a counseling program. Baseline and post-intervention measures included mass spectrometry (MS) and nuclear magnetic resonance (NMR) metabolites and lipoproteins; cardiometabolic risk parameters; and RA clinical outcomes. Principal components analysis (PCA) reduced MS change scores into change factors. Between-group differences were assessed with t-tests and linear regression. Within-group differences were assessed with Wilcoxon-signed rank tests. Spearman's rank correlated MS change factors and NMR change scores with clinical outcomes.</p><p><strong>Results: </strong>Group differences were minimal. In all participants, improvements in metabolic syndrome score were associated with increases in PCA Factor 1 (short- and medium-chain acylcarnitines) and ketone bodies (ρ=-0.57, unadjusted p = 0.009, adjusted p = 0.04; ρ=-0.45, unadjusted p = 0.049, adjusted p = 1.00) and decreases in large low-density lipoprotein particles (LDLp) and large high-density lipoprotein particles (HDLp) (ρ = 0.48, unadjusted p = 0.03, adjusted p = 1.00; ρ = 0.48, unadjusted p = 0.03, adjusted p = 1.00). Improvements in RA disease activity (DAS-28<sub>ESR</sub>) were associated with reductions in very large triglyceride-rich lipoprotein particles (TRLp) (ρ = 0.60, unadjusted p = 0.01, adjusted p = 0.48). Improvements in patient-reported physical health were associated with reductions in HDL-c, ApoA1 concentrations, and medium HDLp (ρ=-0.50, unadjusted p = 0.03, adjusted p = 1.00; ρ=-0.47, unadjusted p = 0.04, adjusted p = 1.00; ρ=-0.45, unadjusted p = 0.047, adjusted p = 1.00). Improvements in patient-reported mental health were associated with decreases in high-density lipoprotein 6 (H6) particles (ρ=-0.60, unadjusted p = 0.03, adjusted p = 1.00), medium HDLp (ρ=-0.54, unadjusted p = 0.01, adjusted p = 0.48), and LDL size (ρ=-0.52, unadjusted p = 0.02, adjusted p = 0.96).</p><p><strong>Conclusion: </strong>In older adults with RA and overweight/obesity, both intensive supervised weight loss and exercise and lifestyle-based counseling influenced metabolic pathways, enhancing lipid metabolism (e.g., reductions in large LDLp) and metabolic flexibility (e.g., increases in fasting ketones and short- and medium-chain acylcarnitines). However, reductions in HDL-related measures should be interpreted cautiously as they may not reflect improved cardiometabolic risk.</p><p><strong>Trial registration: </strong>ClinicalTrials
{"title":"The impact of lifestyle modification on metabolic pathways in older adults with overweight/obesity and rheumatoid arthritis: a secondary exploratory analysis of the SWET-RA study.","authors":"Grace Kim, Leanna M Ross, Alyssa M Sudnick, Johanna L Johnson, Carl F Pieper, Margery A Connelly, Olga Ilkayeva, Michael J Muehlbauer, Connie W Bales, Kathryn N Porter Starr, William E Kraus, Brian J Andonian, Kim M Huffman","doi":"10.1186/s41927-025-00525-8","DOIUrl":"10.1186/s41927-025-00525-8","url":null,"abstract":"<p><strong>Background: </strong>Rheumatoid arthritis (RA) is associated with increased cardiometabolic risk due to inflammation and traditional risk factors, both of which can be mitigated by lifestyle modifications. This study examines metabolic pathways influenced by lifestyle changes and related to improved cardiometabolic risk.</p><p><strong>Methods: </strong>This is a secondary exploratory analysis of the Supervised Weight loss and Exercise Training (SWET) study, in which twenty older adults with RA and overweight/obesity were randomized to 16 weeks of SWET or a counseling program. Baseline and post-intervention measures included mass spectrometry (MS) and nuclear magnetic resonance (NMR) metabolites and lipoproteins; cardiometabolic risk parameters; and RA clinical outcomes. Principal components analysis (PCA) reduced MS change scores into change factors. Between-group differences were assessed with t-tests and linear regression. Within-group differences were assessed with Wilcoxon-signed rank tests. Spearman's rank correlated MS change factors and NMR change scores with clinical outcomes.</p><p><strong>Results: </strong>Group differences were minimal. In all participants, improvements in metabolic syndrome score were associated with increases in PCA Factor 1 (short- and medium-chain acylcarnitines) and ketone bodies (ρ=-0.57, unadjusted p = 0.009, adjusted p = 0.04; ρ=-0.45, unadjusted p = 0.049, adjusted p = 1.00) and decreases in large low-density lipoprotein particles (LDLp) and large high-density lipoprotein particles (HDLp) (ρ = 0.48, unadjusted p = 0.03, adjusted p = 1.00; ρ = 0.48, unadjusted p = 0.03, adjusted p = 1.00). Improvements in RA disease activity (DAS-28<sub>ESR</sub>) were associated with reductions in very large triglyceride-rich lipoprotein particles (TRLp) (ρ = 0.60, unadjusted p = 0.01, adjusted p = 0.48). Improvements in patient-reported physical health were associated with reductions in HDL-c, ApoA1 concentrations, and medium HDLp (ρ=-0.50, unadjusted p = 0.03, adjusted p = 1.00; ρ=-0.47, unadjusted p = 0.04, adjusted p = 1.00; ρ=-0.45, unadjusted p = 0.047, adjusted p = 1.00). Improvements in patient-reported mental health were associated with decreases in high-density lipoprotein 6 (H6) particles (ρ=-0.60, unadjusted p = 0.03, adjusted p = 1.00), medium HDLp (ρ=-0.54, unadjusted p = 0.01, adjusted p = 0.48), and LDL size (ρ=-0.52, unadjusted p = 0.02, adjusted p = 0.96).</p><p><strong>Conclusion: </strong>In older adults with RA and overweight/obesity, both intensive supervised weight loss and exercise and lifestyle-based counseling influenced metabolic pathways, enhancing lipid metabolism (e.g., reductions in large LDLp) and metabolic flexibility (e.g., increases in fasting ketones and short- and medium-chain acylcarnitines). However, reductions in HDL-related measures should be interpreted cautiously as they may not reflect improved cardiometabolic risk.</p><p><strong>Trial registration: </strong>ClinicalTrials","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"9 1","pages":"68"},"PeriodicalIF":2.1,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12147280/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257364","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-09DOI: 10.1186/s41927-025-00517-8
Mohadeseh Soltanian, Mohammad Hassan Kalantar Neyestanaki, Aida Mehdipour, Maryam Masoumi, Mohammad Aghaali, Ali Saleh, Mojtaba Hossein Nattaj
Background: Oxidative stress plays a critical role in the pathogenesis of autoimmune diseases, including rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Assessing total antioxidant capacity (TAC) and total oxidant status (TOS) in saliva offers a non-invasive method to evaluate oxidative stress and its relationship with disease severity. This study aimed to measure salivary TAC and TOS levels in RA and SLE patients and compare them with healthy controls.
Methods: A cross-sectional study was conducted involving 90 participants: 30 RA patients, 30 SLE patients, and 30 healthy controls. Saliva samples were collected and analyzed using specialized TAC and TOS assay kits. Disease severity was evaluated using the Disease Activity Score-28 (DAS-28) for RA and the SLE Disease Activity Index (SLEDAI-2 K) for SLE. Statistical analyses included ANOVA, post-hoc tests, and Pearson correlation coefficients.
Results: Results showed that RA and SLE patients had significantly higher oxidative stress compared to healthy controls, with lower TAC levels (RA: 298.88 ± 31.21 µM, SLE: 287.98 ± 38.07 µM, Control: 461.22 ± 158.22 µM, P < 0.001) and higher TOS levels (RA: 5.81 ± 1.28 µM, SLE: 5.80 ± 1.36 µM, Control: 3.49 ± 1.56 µM, P < 0.001). The TOS/TAC ratio was also significantly elevated in RA (1.95 ± 0.44) and SLE (2.05 ± 0.64) patients compared to controls (0.84 ± 0.44, P < 0.001). A positive correlation was observed between TOS levels and age (R = 0.256, P = 0.016), while no significant gender-based differences were detected.
Conclusions: RA and SLE patients exhibit significant oxidative imbalance, as indicated by altered salivary TAC and TOS levels. These findings highlight the potential role of oxidative stress in these autoimmune diseases.
{"title":"Evaluation of salivary total antioxidant capacity and total oxidant status in patients with rheumatoid arthritis and systemic lupus erythematosus.","authors":"Mohadeseh Soltanian, Mohammad Hassan Kalantar Neyestanaki, Aida Mehdipour, Maryam Masoumi, Mohammad Aghaali, Ali Saleh, Mojtaba Hossein Nattaj","doi":"10.1186/s41927-025-00517-8","DOIUrl":"10.1186/s41927-025-00517-8","url":null,"abstract":"<p><strong>Background: </strong>Oxidative stress plays a critical role in the pathogenesis of autoimmune diseases, including rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Assessing total antioxidant capacity (TAC) and total oxidant status (TOS) in saliva offers a non-invasive method to evaluate oxidative stress and its relationship with disease severity. This study aimed to measure salivary TAC and TOS levels in RA and SLE patients and compare them with healthy controls.</p><p><strong>Methods: </strong>A cross-sectional study was conducted involving 90 participants: 30 RA patients, 30 SLE patients, and 30 healthy controls. Saliva samples were collected and analyzed using specialized TAC and TOS assay kits. Disease severity was evaluated using the Disease Activity Score-28 (DAS-28) for RA and the SLE Disease Activity Index (SLEDAI-2 K) for SLE. Statistical analyses included ANOVA, post-hoc tests, and Pearson correlation coefficients.</p><p><strong>Results: </strong>Results showed that RA and SLE patients had significantly higher oxidative stress compared to healthy controls, with lower TAC levels (RA: 298.88 ± 31.21 µM, SLE: 287.98 ± 38.07 µM, Control: 461.22 ± 158.22 µM, P < 0.001) and higher TOS levels (RA: 5.81 ± 1.28 µM, SLE: 5.80 ± 1.36 µM, Control: 3.49 ± 1.56 µM, P < 0.001). The TOS/TAC ratio was also significantly elevated in RA (1.95 ± 0.44) and SLE (2.05 ± 0.64) patients compared to controls (0.84 ± 0.44, P < 0.001). A positive correlation was observed between TOS levels and age (R = 0.256, P = 0.016), while no significant gender-based differences were detected.</p><p><strong>Conclusions: </strong>RA and SLE patients exhibit significant oxidative imbalance, as indicated by altered salivary TAC and TOS levels. These findings highlight the potential role of oxidative stress in these autoimmune diseases.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"9 1","pages":"67"},"PeriodicalIF":2.1,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12147316/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-06DOI: 10.1186/s41927-025-00520-z
Víctor Juan Vera-Ponce, Jhosmer Ballena-Caicedo, Fiorella E Zuzunaga-Montoya, Joan A Loayza-Castro, Lupita Ana Maria Valladolid-Sandoval, Luisa Erika Milagros Vásquez-Romero, Stella M Chenet, Rafael Tapia-Limonchi, Carmen Inés Gutierrez De Carrillo
Introduction: Osteoporosis is a disease characterized by decreased bone mineral density and deterioration of bone microarchitecture, which increases fracture risk. In the context of various chronic pathologies, this condition may present an even higher prevalence, impacting morbidity, mortality, and healthcare burden.
Objective: To synthesize and compare available evidence from systematic reviews on the prevalence of osteoporosis across different chronic diseases.
Methodology: An umbrella review following PRISMA guidelines was conducted, focusing on systematic reviews (with or without meta-analysis) reporting prevalence data of osteoporosis in adults with at least one chronic disease. Databases, including PubMed/MEDLINE, Scopus, Web of Science, and EMBASE, were searched, covering publications between 2009 and 2023, without language restrictions. Two independent reviewers performed study selection and data extraction, resolving discrepancies through consensus. A risk of bias assessment was conducted using the ROBIS tool. Prevalence estimates reported in each review were analyzed, classifying diseases according to the magnitude of the percentages found.
Results: Thirteen systematic reviews were evaluated (twelve included meta-analyses). The highest prevalence of osteoporosis was observed in patients with Chronic Obstructive Pulmonary Disease (up to 36.8%) and diabetes mellitus (approximately 27.7%). Other conditions, such as rheumatoid arthritis, multiple sclerosis, liver cirrhosis, and celiac disease, showed variable prevalence but were equally relevant in clinical terms. Methodological heterogeneity, both in diagnostic criteria and populations, was a notable factor.
Conclusions: The results highlight the need for systematic assessment of bone health in patients with chronic diseases, particularly those with a higher prevalence of osteoporosis. These findings underscore the importance of timely screening strategies and multidisciplinary approaches to prevent fractures and optimize comprehensive care.
Clinical trial number: Not applicable.
骨质疏松症是一种以骨密度降低和骨微结构恶化为特征的疾病,它增加了骨折的风险。在各种慢性疾病的背景下,这种情况可能呈现更高的患病率,影响发病率、死亡率和医疗负担。目的:综合和比较不同慢性疾病中骨质疏松症患病率的系统综述证据。方法:遵循PRISMA指南进行了一项综合综述,重点是报告至少患有一种慢性疾病的成人骨质疏松症患病率数据的系统综述(有或没有荟萃分析)。检索了PubMed/MEDLINE、Scopus、Web of Science和EMBASE等数据库,涵盖了2009年至2023年之间的出版物,没有语言限制。两名独立审稿人进行研究选择和数据提取,通过共识解决差异。使用ROBIS工具进行偏倚风险评估。对每篇综述中报告的患病率估计值进行分析,根据发现的百分比大小对疾病进行分类。结果:13个系统评价被评估(12个纳入meta分析)。骨质疏松症的患病率最高的是慢性阻塞性肺疾病(高达36.8%)和糖尿病(约27.7%)。其他疾病,如类风湿关节炎、多发性硬化症、肝硬化和乳糜泻,患病率不同,但在临床方面同样相关。诊断标准和人群的方法学异质性是值得注意的因素。结论:该结果强调了对慢性疾病患者,特别是骨质疏松症患病率较高的患者进行骨骼健康系统评估的必要性。这些发现强调了及时筛查策略和多学科方法预防骨折和优化综合护理的重要性。临床试验号:不适用。
{"title":"Prevalence of osteoporosis in chronic diseases: an umbrella review of 283 observational studies from 13 systematic reviews.","authors":"Víctor Juan Vera-Ponce, Jhosmer Ballena-Caicedo, Fiorella E Zuzunaga-Montoya, Joan A Loayza-Castro, Lupita Ana Maria Valladolid-Sandoval, Luisa Erika Milagros Vásquez-Romero, Stella M Chenet, Rafael Tapia-Limonchi, Carmen Inés Gutierrez De Carrillo","doi":"10.1186/s41927-025-00520-z","DOIUrl":"10.1186/s41927-025-00520-z","url":null,"abstract":"<p><strong>Introduction: </strong>Osteoporosis is a disease characterized by decreased bone mineral density and deterioration of bone microarchitecture, which increases fracture risk. In the context of various chronic pathologies, this condition may present an even higher prevalence, impacting morbidity, mortality, and healthcare burden.</p><p><strong>Objective: </strong>To synthesize and compare available evidence from systematic reviews on the prevalence of osteoporosis across different chronic diseases.</p><p><strong>Methodology: </strong>An umbrella review following PRISMA guidelines was conducted, focusing on systematic reviews (with or without meta-analysis) reporting prevalence data of osteoporosis in adults with at least one chronic disease. Databases, including PubMed/MEDLINE, Scopus, Web of Science, and EMBASE, were searched, covering publications between 2009 and 2023, without language restrictions. Two independent reviewers performed study selection and data extraction, resolving discrepancies through consensus. A risk of bias assessment was conducted using the ROBIS tool. Prevalence estimates reported in each review were analyzed, classifying diseases according to the magnitude of the percentages found.</p><p><strong>Results: </strong>Thirteen systematic reviews were evaluated (twelve included meta-analyses). The highest prevalence of osteoporosis was observed in patients with Chronic Obstructive Pulmonary Disease (up to 36.8%) and diabetes mellitus (approximately 27.7%). Other conditions, such as rheumatoid arthritis, multiple sclerosis, liver cirrhosis, and celiac disease, showed variable prevalence but were equally relevant in clinical terms. Methodological heterogeneity, both in diagnostic criteria and populations, was a notable factor.</p><p><strong>Conclusions: </strong>The results highlight the need for systematic assessment of bone health in patients with chronic diseases, particularly those with a higher prevalence of osteoporosis. These findings underscore the importance of timely screening strategies and multidisciplinary approaches to prevent fractures and optimize comprehensive care.</p><p><strong>Clinical trial number: </strong>Not applicable.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"9 1","pages":"66"},"PeriodicalIF":2.1,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12142958/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-04DOI: 10.1186/s41927-025-00521-y
Kun Lin, Qi Lin, Weifeng Lv, Yao Li, Rong Su
Background: The incidence of rheumatoid arthritis (RA) is rising. However, its pathogenesis has not been fully understood, and the current therapeutic regimens are still limited. The aim of this study was to investigate the causal effect of plasma proteins on RA using Mendelian randomization (MR) analysis.
Methods: We performed MR analysis with 4907 plasma protein genetic associations used for exposure and RA genome-wide association data used as outcomes. The method was dominated by Inverse Variance Weighting, in addition to MR-Egger and Weighted Median. Meanwhile, further external validation and reverse MR analysis were conducted to systematically assess the causal relationship between plasma proteins and RA.
Result: Preliminary MR analysis identified two proteins (SPAG11B and DEFB135) associated with RA, and elevated plasma levels of both proteins would reduce the risk of RA (for SPAG11B, OR = 0.49, 95% CI = 0.40-0.61, p = 1.19 × 10- 10; for DEFB135, OR = 0.28, 95% CI = 0.15-0.52, p = 4.51 × 10- 5, using the IVW method). In the external validation phase, the results were reproducible for SPAG11B, but not for DEFB135. Reverse MR analysis pointed out that RA exhibited reverse causality for plasma levels of SPAG11B (OR = 0.93, 95% CI = 0.89-0.98, p = 0.004), but not for DEFB135 (p = 0.93).
Conclusion: The results of MR analysis in this study supported that SPAG11B as a novel biomarker for RA was worthy of further investigation.
背景:类风湿关节炎(RA)的发病率呈上升趋势。然而,其发病机制尚未完全了解,目前的治疗方案仍然有限。本研究的目的是利用孟德尔随机化(MR)分析探讨血浆蛋白对类风湿关节炎的因果关系。方法:我们对4907个血浆蛋白遗传关联进行MR分析,用于暴露和RA全基因组关联数据作为结果。除MR-Egger法和加权中位数法外,该方法以方差逆加权法为主。同时,进一步进行外部验证和反向MR分析,系统评估血浆蛋白与RA的因果关系。结果:初步MR分析鉴定出两种与RA相关的蛋白(SPAG11B和DEFB135),两种蛋白的血浆水平升高会降低RA的风险(SPAG11B, OR = 0.49, 95% CI = 0.40-0.61, p = 1.19 × 10- 10;DEFB135或= 0.28,95% CI -0.52 = 0.15, p = 4.51×10 - 5,使用IVW方法)。在外部验证阶段,结果对SPAG11B是可重复的,但对DEFB135不是。反向MR分析指出RA与血浆SPAG11B水平呈反向因果关系(OR = 0.93, 95% CI = 0.89-0.98, p = 0.004),但与DEFB135水平无反向因果关系(p = 0.93)。结论:本研究的MR分析结果支持SPAG11B作为RA的新型生物标志物值得进一步研究。
{"title":"SPAG11B, a potential biomarker for rheumatoid arthritis: a two-sample bidirectional Mendelian randomization analysis.","authors":"Kun Lin, Qi Lin, Weifeng Lv, Yao Li, Rong Su","doi":"10.1186/s41927-025-00521-y","DOIUrl":"10.1186/s41927-025-00521-y","url":null,"abstract":"<p><strong>Background: </strong>The incidence of rheumatoid arthritis (RA) is rising. However, its pathogenesis has not been fully understood, and the current therapeutic regimens are still limited. The aim of this study was to investigate the causal effect of plasma proteins on RA using Mendelian randomization (MR) analysis.</p><p><strong>Methods: </strong>We performed MR analysis with 4907 plasma protein genetic associations used for exposure and RA genome-wide association data used as outcomes. The method was dominated by Inverse Variance Weighting, in addition to MR-Egger and Weighted Median. Meanwhile, further external validation and reverse MR analysis were conducted to systematically assess the causal relationship between plasma proteins and RA.</p><p><strong>Result: </strong>Preliminary MR analysis identified two proteins (SPAG11B and DEFB135) associated with RA, and elevated plasma levels of both proteins would reduce the risk of RA (for SPAG11B, OR = 0.49, 95% CI = 0.40-0.61, p = 1.19 × 10<sup>- 10</sup>; for DEFB135, OR = 0.28, 95% CI = 0.15-0.52, p = 4.51 × 10<sup>- 5</sup>, using the IVW method). In the external validation phase, the results were reproducible for SPAG11B, but not for DEFB135. Reverse MR analysis pointed out that RA exhibited reverse causality for plasma levels of SPAG11B (OR = 0.93, 95% CI = 0.89-0.98, p = 0.004), but not for DEFB135 (p = 0.93).</p><p><strong>Conclusion: </strong>The results of MR analysis in this study supported that SPAG11B as a novel biomarker for RA was worthy of further investigation.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"9 1","pages":"65"},"PeriodicalIF":2.1,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12135468/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144224293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-29DOI: 10.1186/s41927-025-00515-w
Michel Moutschen, Cécile Boulanger, Joke Dehoorne, Rik Joos, Florence Roufosse, Vito Sabato, Jeroen van der Hilst, Eleonore Maury, Hilde Rabijns, Marijn Witterzeel, Carine Wouters
Background: Canakinumab, an IL-1β inhibitor, has demonstrated long-term efficacy and safety in patients with sJIA, FMF, TRAPS, and MKD/HIDS who experience inadequate disease control with conventional treatments. This non-interventional study aimed to gain insights into canakinumab use and treatment patterns for these diseases in Belgium.
Methods: Between July 1, 2018 and June 30, 2023, this national, non-interventional, retrospective/prospective study enrolled patients aged ≥ 2 years with sJIA, FMF, TRAPS, or MKD/HIDS reimbursed for, and treated with, canakinumab in Belgium. Part 1: retrospective data collection from first canakinumab administration in the initial 6-month reimbursement period until date of study inclusion. Part 2: prospective data collection following study inclusion. Canakinumab treatment and safety data were collected throughout.
Results: At data cut-off, 96 patients (7 sJIA, 70 FMF, 13 TRAPS, 6 MKD/HIDS) were enrolled, of whom 54.2% were female and 87.5% were adults (aged ≥ 18 years). Median age at first canakinumab administration was 34.0 years (20.0, 35.0, 37.0, and 42.0 years in sJIA, FMF, TRAPS, and MKD/HIDS, respectively). Eighteen patients discontinued treatment (3 sJIA, 11 FMF, 4 TRAPS), which was due to lack of efficacy (per investigator's judgment) in 10 (10.4%) patients. Median dose per administration was 289.1 mg in patients with sJIA, and 150.0 mg in patients with FMF, TRAPS, and MKD/HIDS, while median interval between two consecutive administrations was 28.0 days. Thirty-five (36.5%) patients with FMF, TRAPS, or MKD/HIDS received ≥ 1 dose increase (≥ 150 mg). No safety events were reported.
Conclusions: These non-interventional study data highlight that canakinumab treatment patterns are generally aligned with the summary of product characteristics (SmPC) and reimbursement criteria in Belgium and further support the well-tolerated safety profile of canakinumab. However, Belgian reimbursement criteria require long-term glucocorticoids prior to canakinumab therapy; if it were possible to align treatment more closely with EULAR/PReS guidance, which recommends early initiation of anti-IL-1 or anti-IL-6 therapy, glucocorticoid treatment would be limited and improved outcomes for these patients would likely be possible.
{"title":"Canakinumab treatment patterns in sJIA, FMF, TRAPS, and MKD/HIDS: real-world insights from a Belgian non-interventional study.","authors":"Michel Moutschen, Cécile Boulanger, Joke Dehoorne, Rik Joos, Florence Roufosse, Vito Sabato, Jeroen van der Hilst, Eleonore Maury, Hilde Rabijns, Marijn Witterzeel, Carine Wouters","doi":"10.1186/s41927-025-00515-w","DOIUrl":"10.1186/s41927-025-00515-w","url":null,"abstract":"<p><strong>Background: </strong>Canakinumab, an IL-1β inhibitor, has demonstrated long-term efficacy and safety in patients with sJIA, FMF, TRAPS, and MKD/HIDS who experience inadequate disease control with conventional treatments. This non-interventional study aimed to gain insights into canakinumab use and treatment patterns for these diseases in Belgium.</p><p><strong>Methods: </strong>Between July 1, 2018 and June 30, 2023, this national, non-interventional, retrospective/prospective study enrolled patients aged ≥ 2 years with sJIA, FMF, TRAPS, or MKD/HIDS reimbursed for, and treated with, canakinumab in Belgium. Part 1: retrospective data collection from first canakinumab administration in the initial 6-month reimbursement period until date of study inclusion. Part 2: prospective data collection following study inclusion. Canakinumab treatment and safety data were collected throughout.</p><p><strong>Results: </strong>At data cut-off, 96 patients (7 sJIA, 70 FMF, 13 TRAPS, 6 MKD/HIDS) were enrolled, of whom 54.2% were female and 87.5% were adults (aged ≥ 18 years). Median age at first canakinumab administration was 34.0 years (20.0, 35.0, 37.0, and 42.0 years in sJIA, FMF, TRAPS, and MKD/HIDS, respectively). Eighteen patients discontinued treatment (3 sJIA, 11 FMF, 4 TRAPS), which was due to lack of efficacy (per investigator's judgment) in 10 (10.4%) patients. Median dose per administration was 289.1 mg in patients with sJIA, and 150.0 mg in patients with FMF, TRAPS, and MKD/HIDS, while median interval between two consecutive administrations was 28.0 days. Thirty-five (36.5%) patients with FMF, TRAPS, or MKD/HIDS received ≥ 1 dose increase (≥ 150 mg). No safety events were reported.</p><p><strong>Conclusions: </strong>These non-interventional study data highlight that canakinumab treatment patterns are generally aligned with the summary of product characteristics (SmPC) and reimbursement criteria in Belgium and further support the well-tolerated safety profile of canakinumab. However, Belgian reimbursement criteria require long-term glucocorticoids prior to canakinumab therapy; if it were possible to align treatment more closely with EULAR/PReS guidance, which recommends early initiation of anti-IL-1 or anti-IL-6 therapy, glucocorticoid treatment would be limited and improved outcomes for these patients would likely be possible.</p><p><strong>Clinical trial number: </strong>Not applicable.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"9 1","pages":"64"},"PeriodicalIF":2.1,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12121185/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144180637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-27DOI: 10.1186/s41927-025-00510-1
Najlae El Ouardi, Ihsane Hmamouchi, Redouane Abouqal, Fadoua Allali, Rachid Bahiri, Imane El Bouchti, Imad Ghozlani, Hasna Hassikou, Linda Ichchou, Saadia Janani, Taoufik Harzy, Radouane Niamane, Ahmed Bezza, Abdellah El Maghraoui
Background: Regional variability in the effectiveness and safety of biologic therapies for rheumatoid arthritis (RA) and spondyloarthritis (SpA) underscores the need for comprehensive assessment. The aim of this study was to provide real-world evidence of the effectiveness and the safety of biologic for RA, SpA including psoriatic arthritis, in the daily clinical practice.
Materials and methods: RBSMR registry was a multicenter, cohort study conducted in 10 university departments of rheumatology. The study included RA and SpA patients receiving biotherapy, either as an initiation or ongoing treatment, and investigated for 3 years. The statistical analysis was performed using JAMOVI software (T student test, Mann-Whitney U test, Chi-squared test, Fisher's exact test, Paired T test and Wilcoxon test).
Results: 223 RA and 194 SpA were eligible. After 3 years of follow-up, DAS28 CRP (3.6 ± 1.4 versus 5.8 ± 1.0 at baseline) and ASDAS CRP (1.8[1-2.4] versus 3.5[2.5-4.4] at baseline) significantly improved; 13.8% of RA patients achieved remission based on DAS28 CRP and 20.1% of SpA patients achieved remission based on ASDAS CRP. Overall, 163 and 126 adverse events were reported in RA and SpA patients respectively. Infections were the most frequently reported events with an incidence of 11.8 and 13.4/100 patients-year in RA and SpA respectively. Total incidence rate of tuberculosis was 0.80 patient/100 patients-year.
Conclusions: The RBSMR registry provides real-world insights into the effectiveness of biologics in the practice of rheumatology for RA and SpA patients in Morocco. It underscores the critical need for continued vigilance in monitoring and addressing adverse events, with a particular focus on tuberculosis infection.
{"title":"Real-world evidence of biological treatments in rheumatoid arthritis and spondyloarthritis in Morocco: results of the RBSMR registry.","authors":"Najlae El Ouardi, Ihsane Hmamouchi, Redouane Abouqal, Fadoua Allali, Rachid Bahiri, Imane El Bouchti, Imad Ghozlani, Hasna Hassikou, Linda Ichchou, Saadia Janani, Taoufik Harzy, Radouane Niamane, Ahmed Bezza, Abdellah El Maghraoui","doi":"10.1186/s41927-025-00510-1","DOIUrl":"10.1186/s41927-025-00510-1","url":null,"abstract":"<p><strong>Background: </strong>Regional variability in the effectiveness and safety of biologic therapies for rheumatoid arthritis (RA) and spondyloarthritis (SpA) underscores the need for comprehensive assessment. The aim of this study was to provide real-world evidence of the effectiveness and the safety of biologic for RA, SpA including psoriatic arthritis, in the daily clinical practice.</p><p><strong>Materials and methods: </strong>RBSMR registry was a multicenter, cohort study conducted in 10 university departments of rheumatology. The study included RA and SpA patients receiving biotherapy, either as an initiation or ongoing treatment, and investigated for 3 years. The statistical analysis was performed using JAMOVI software (T student test, Mann-Whitney U test, Chi-squared test, Fisher's exact test, Paired T test and Wilcoxon test).</p><p><strong>Results: </strong>223 RA and 194 SpA were eligible. After 3 years of follow-up, DAS28 CRP (3.6 ± 1.4 versus 5.8 ± 1.0 at baseline) and ASDAS CRP (1.8[1-2.4] versus 3.5[2.5-4.4] at baseline) significantly improved; 13.8% of RA patients achieved remission based on DAS28 CRP and 20.1% of SpA patients achieved remission based on ASDAS CRP. Overall, 163 and 126 adverse events were reported in RA and SpA patients respectively. Infections were the most frequently reported events with an incidence of 11.8 and 13.4/100 patients-year in RA and SpA respectively. Total incidence rate of tuberculosis was 0.80 patient/100 patients-year.</p><p><strong>Conclusions: </strong>The RBSMR registry provides real-world insights into the effectiveness of biologics in the practice of rheumatology for RA and SpA patients in Morocco. It underscores the critical need for continued vigilance in monitoring and addressing adverse events, with a particular focus on tuberculosis infection.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"9 1","pages":"62"},"PeriodicalIF":2.1,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12107801/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144156966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}