{"title":"Bridging the rheumatology resource gap in Africa.","authors":"Dzifa Dey, Bridget Hodkinson","doi":"10.1007/s10067-025-07362-7","DOIUrl":"https://doi.org/10.1007/s10067-025-07362-7","url":null,"abstract":"","PeriodicalId":10482,"journal":{"name":"Clinical Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457088","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Peyman Mirghaderi, Ali Mortezaei, Amin Javidan, Amirhossein Ghaseminejad-Raeini, Behrad Nematollahi
{"title":"Efficacy and safety of biological products in hip osteoarthritis: a systematic review and meta-analysis of randomized controlled trials.","authors":"Peyman Mirghaderi, Ali Mortezaei, Amin Javidan, Amirhossein Ghaseminejad-Raeini, Behrad Nematollahi","doi":"10.1007/s10067-025-07366-3","DOIUrl":"https://doi.org/10.1007/s10067-025-07366-3","url":null,"abstract":"<p><strong>Objective: </strong>This systematic review aims to evaluate the efficacy and safety of various biological products, such as platelet-rich plasma (PRP), hyaluronic acid (HA), and combination treatments, in alleviating pain and improving function in patients with hip osteoarthritis (OA).</p><p><strong>Methods: </strong>Our review followed the PRISMA guidelines. Literature was searched in PubMed, Scopus, Embase, Web of Science, and CENTRAL Cochrane databases from the beginning until July 2022 hinged upon the previously designed search strings, and citations were downloaded. We included randomized controlled trials (RCTs) involving patients over 18 years old with hip OA, comparing biological products to placebo or other interventions. Data were collected on pain, hip range of motion, functional status, quality of life, and radiological outcomes. Meta-analysis was done on the above-listed outcomes.</p><p><strong>Results: </strong>From 18 RCTs involving 1648 patients, we analyzed the efficacy of various biological products. The mean age of patients was 60.2 years (SD 2.4), and the mean follow-up period was 7.22 months. PRP and HA treatments showed no statistically significant differences in VAS scores in the short-term (SMD = - 0.49, 95% CI, - 1.34-0.36), mid-term (SMD = - 0.25, 95% CI - 1.64-1.15), and long-term (SMD = - 0.22, 95% CI - 1.57-1.12) follow-ups. However, significant differences were found in WOMAC pain short-term (SMD = 0.40, 95% CI - 0.06-0.87), mid-term (SMD = 0.49, 95% CI - 0.85-1.83), and long-term outcomes (SMD = - 0.42, 95% CI - 0.80 to - 0.04). Complications were observed in HA (8%), Hylan G-F (4.9%), and GP-C (50%) groups, while PRP and BCC did not report any complications.</p><p><strong>Conclusion: </strong>Our meta-analysis indicates that biological products, particularly PRP and HA, provide varying degrees of pain relief and functional improvement in hip OA patients, with a generally acceptable safety profile. The significant heterogeneity among studies underscores the need for further research to establish standardized treatment protocols and long-term efficacy.</p><p><strong>Trial registration: </strong>CRD42022312562.</p>","PeriodicalId":10482,"journal":{"name":"Clinical Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yipeng Han, Ruoyi Wang, Feng Sun, Ruiling Feng, Hao Li, Yuan Ning, Yan Zhu, Bei Wang, Xue Li, Kai Zhang, Jing He
{"title":"Anti-SSA/SSB antibody double-negative Sjögren's disease patients: a comprehensive clinical study and immune profile.","authors":"Yipeng Han, Ruoyi Wang, Feng Sun, Ruiling Feng, Hao Li, Yuan Ning, Yan Zhu, Bei Wang, Xue Li, Kai Zhang, Jing He","doi":"10.1007/s10067-024-07295-7","DOIUrl":"https://doi.org/10.1007/s10067-024-07295-7","url":null,"abstract":"<p><strong>Introduction/objectives: </strong>Anti-Sjögren's syndrome A (SSA/Ro60) and anti-Sjögren's syndrome B (SSB/La) antibodies are not present in up to 25% of patients with primary Sjögren's disease (SjD). Our observational study aims to provide a clinical perspective on the presentation, extra-glandular manifestations, as well as the immune profile of anti-SSA/SSB antibody double-negative SjD patients.</p><p><strong>Method: </strong>A total of 615 SjD patients of age 53.21 (± 0.59) were enrolled without acute infection or ongoing treatment that could affect the immune system. Of our participants, 254 (41.3%) were seronegative for both SSA (Ro60) and SSB (La) autoantibodies (SSA/SSB double-negative). A 1:1 propensity score matching was performed to balance age at diagnosis, disease duration, and gender for extra-glandular involvement analyses and immune profiling. Peripheral blood mononuclear cells (PBMCs) were derived from all patients. Flow cytometry was performed to further define the immune cell subsets.</p><p><strong>Results: </strong>Our study revealed that anti-SSA/SSB seronegative patients had a delayed onset by an average of 7.43 years and exhibited a lower prevalence of parotid gland enlargement compared to the seropositive group (50.8% vs. 59%, p < 0.05). In terms of extra-glandular involvement, seronegative patients exhibited a lower prevalence of white blood cell (WBC), hemoglobin (HGB), and platelet (PLT) reduction (OR 0.406, 95% CI 0.314-0.523; OR 0.751, 95% CI 0.587-0.959; OR 0.56, 95% CI 0.383-0.818, respectively) compared to anti-SSA/SSB antibody-positive group. Additionally, the double-negative group tended to hold higher CD4 + T helper cells and lower CD8 + T cell proportions compared with the anti-SSA/SSB-positive group (40.52% vs. 37.38%, p < 0.001; 28.25% vs. 32.55%, p < 0.001 respectively). Higher proportions of NK cells (13.05% vs. 10.32%, p < 0.001) and CD161 + Treg cells (13.69% vs. 12.03%, p < 0.001) were found in the double-negative group.</p><p><strong>Conclusion: </strong>The observed higher frequency of CD161 + Tregs and NK cells, as well as the lower frequency of CD8 + T cells and B cells, in anti-SSA/SSB antibody double-negative patients suggests a potential role of innate immunity in this subgroup of Sjögren's syndrome. Our findings hint at the importance of serological and immune profiles in tailoring personalized management strategies for these patients. Key Points • Our analyses suggested a potential role of innate immunity in anti-SSA/SSB antibody double-negative SjD patients in comparison to seropositive counterparts. • Higher frequencies of CD4 + T cells, CD161 + Tregs, and NK cells were observed in the peripheral blood of double-negative patients, alongside lower proportions of CD8 + T cells and B cell subsets. • Double-negative patients exhibited a lower prevalence of reductions in white blood cell counts, hemoglobin level, and platelet level.</p>","PeriodicalId":10482,"journal":{"name":"Clinical Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Letter to the editor: Cardiovascular risk according to biological agent exposure in patients with ankylosing spondylitis: a nationwide population-based study.","authors":"Yusuf Ziya Sener, Seher Sener","doi":"10.1007/s10067-025-07375-2","DOIUrl":"https://doi.org/10.1007/s10067-025-07375-2","url":null,"abstract":"","PeriodicalId":10482,"journal":{"name":"Clinical Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A N Saidi, W B Theel, B Burggraaf, A J van der Lelij, D E Grobbee, J D van Zeben, E van der Zwan-van Beek, S P Rauh, M Castro Cabezas
{"title":"Metabolic dysfunction-associated steatotic liver disease and cardiovascular risk factors in rheumatoid arthritis.","authors":"A N Saidi, W B Theel, B Burggraaf, A J van der Lelij, D E Grobbee, J D van Zeben, E van der Zwan-van Beek, S P Rauh, M Castro Cabezas","doi":"10.1007/s10067-025-07364-5","DOIUrl":"https://doi.org/10.1007/s10067-025-07364-5","url":null,"abstract":"<p><strong>Objectives: </strong>Rheumatoid arthritis (RA) is a chronic autoimmune disease linked with metabolic dysfunction-associated steatotic liver disease (MASLD), which may increase cardiovascular (CV) risk. This study explores the association between liver fibrosis, assessed by the Fibrosis-4 (FIB-4) index, and CV risk factors in RA patients.</p><p><strong>Methods: </strong>Cross-sectional data from the Franciscus Rheumatoid Arthritis and Cardiovascular Intervention Study (FRANCIS), a randomized, cardiovascular single center, intervention study involving RA patients without cardiovascular disease (CVD) or type 2 diabetes (T2DM), were analyzed. Liver fibrosis was assessed using FIB-4, with a cut-off point of ≥ 1.3 to define high fibrosis risk, and its relationship with CV risk factors, medication use, and subclinical atherosclerosis, measured by carotid intima-media thickness (cIMT), was evaluated.</p><p><strong>Results: </strong>Among 326 patients (68.4% female, age 53 ± 11 years, BMI 26.5 ± 4.5 kg/m<sup>2</sup>), those with high FIB-4 (n = 49) had higher cIMT (p = 0.002), apolipoprotein B48 (p = 0.04), systolic blood pressure (p = 0.007), alkaline phosphatase (p = 0.002), and anti-CCP levels (p = 0.02). High FIB-4 was associated with lower leukocyte count and complement component 3. Statin use was linked to higher FIB-4 (OR = 4.49, p = 0.014), while hydroxychloroquine use was associated with lower FIB-4 (OR = 0.11, p = 0.004). Disease activity scores did not differ between low and high FIB-4 groups.</p><p><strong>Conclusions: </strong>Elevated FIB-4 in RA patients is associated with increased cIMT, higher blood pressure, and elevated atherogenic remnants. Incorporating FIB-4 measurements into routine clinical care for RA populations could effectively identify individuals at the highest CV risk, enabling the implementation of more intensive CV risk management strategies. Key Points • RA patients with liver fibrosis have higher cIMT, indicating greater risk of atherosclerosis. • RA patients with liver fibrosis show accumulation of circulating atherogenic chylomicron remnants, contributing to atherogenesis. • HCQ may provide a protective effect against liver fibrosis in RA patients.</p>","PeriodicalId":10482,"journal":{"name":"Clinical Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Influence of metabolic factors on systemic sclerosis complicated with severe interstitial lung disease based on high-resolution computed tomography grading.","authors":"Chengyu Qian, Jinling Liu, Jingzhi Xie, Hanqiu Yin, Linsheng Wang, Songlou Yin, Dongmei Zhou","doi":"10.1007/s10067-025-07305-2","DOIUrl":"https://doi.org/10.1007/s10067-025-07305-2","url":null,"abstract":"<p><strong>Objectives: </strong>Systemic sclerosis complicated with interstitial lung disease (SSc-ILD) is a rare autoimmune disease with a dismal prognosis. To analyze the common clinical indicators of systemic sclerosis (SSc) complicated with severe interstitial lung disease (ILD) patients based on the grading of lung high-resolution computed tomography (HRCT) and to explore the risk factors of severe (ILD).</p><p><strong>Methods: </strong>A retrospective analysis was performed on 72 newly diagnosed and treated SSc-ILD patients in the Affiliated Hospital of Xuzhou Medical University from June 2013 to August 2023. The interstitial lung disease was divided into grades 1, 2, and 3 according to the HRCT images. Grades 1 and 2 were classified as a non-severe group (42 cases), and grade 3 was a severe group (30 cases). The general data and laboratory examination results of the two groups were analyzed. A logistic regression model was established, and the receiver operating characteristic (ROC) curve was drawn to evaluate the predictive value of risk factors for severe SSc-ILD patients.</p><p><strong>Results: </strong>Patients in the severe group had lower height (1.610 ± 0.059 vs 1.574 ± 0.078, P = 0.031), triglyceride (TG) (1.796 ± 0.743 vs 1.265 (1.04, 1.63), P = 0.026) and total protein (TP) (77.96 ± 8.784 vs 72.709 ± 8.042, P = 0.011)than those in the non-severe group. The area under the curve of height, TG, and TP combined with the diagnosis of systemic sclerosis complicated with severe interstitial lung disease was 0.839, and the sensitivity and specificity were 0.750 and 0.781, respectively.</p><p><strong>Conclusion: </strong>Low TG and TP may be the risk factors for SSc patients with severe interstitial lung disease. Therefore, it is promising as a potential therapeutic target for SSc-ILD and warrants appropriate follow-up in further studies of patients. Key Points • We hoped to pay attention to the influence of metabolic factors on connective tissue disease complicated with interstitial lung disease due to the relationship between metabolism and immunity is complicated.</p>","PeriodicalId":10482,"journal":{"name":"Clinical Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Increased macrophage migration inhibitory factor is associated with inflammation in patients with rheumatoid arthritis.","authors":"Haolin Wu, Fanzhang Yin, Yue Wang, Zhicheng Tang, Huiming Hong, Tingting Jiang, Junqiao Guo, Xiaolei Ma, Genhong Yao, Huayong Zhang","doi":"10.1007/s10067-025-07361-8","DOIUrl":"https://doi.org/10.1007/s10067-025-07361-8","url":null,"abstract":"<p><strong>Objective: </strong>The macrophage migration inhibitory factor (MIF) in the plasma, hydrops articuli, and synovium, and its relationship with laboratory indexes in patients with rheumatoid arthritis (RA) were determined, for the purpose to reveal the role of MIF on the pathogenesis of RA.</p><p><strong>Methods: </strong>MIF mRNA expression in PBMCs was detected by qPCR. Plasma MIF was measured by enzyme linked immunosorbent assay (ELISA). MIF in hydrops articuli and synovium from RA patients and OA patients was evaluated by immunofluorescence (IF) and immunohistochemistry (IHC). The relationship between MIF and laboratory indexes of RA patients was analyzed. Human fibroblast-like synoviocytes (FLS) were treated with recombinant human MIF, and expression of inflammatory factors was determined by qPCR. The matrix metalloproteinase (MMP) 9 and extracellular regulated protein kinases (ERK)1/2 in FLS with MIF treatment were detected.</p><p><strong>Results: </strong>MIF is significantly increased in plasma and hydrops articuli in RA patients. The expression of multiple inflammatory factors and MMPs was increased in RA patients and in FLS with rhMIF treatment. MIF was correlated with laboratory indexes in RA patients. Mechanistically, MIF promoted production of MMP9 by FLS through the ERK1/2 pathway.</p><p><strong>Conclusion: </strong>Our results indicated that increased MIF was correlated with disease activity of RA patients. These findings also suggested that MIF induced multiple inflammatory factors and MMP 9 in FLS via ERK 1/2 pathway. Key Points • MIF plays a key role in the initiation of RA by promoting the expression of various inflammatory factors in FLS and MMPs. • This study provides a basis for MIF-targeted RA clinical therapy and for exploring the feasibility of MIF as a therapeutic target for RA. • Increased MIF correlates with disease activity in RA patients.</p>","PeriodicalId":10482,"journal":{"name":"Clinical Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Matija Bajželj, Nina Visočnik, Katjuša Mrak Poljšak, Matjaž Hladnik, Katja Lakota, Alojzija Hočevar
{"title":"Haptoglobin as a novel predictor of visceral involvement and relapse in adult IgAV patients.","authors":"Matija Bajželj, Nina Visočnik, Katjuša Mrak Poljšak, Matjaž Hladnik, Katja Lakota, Alojzija Hočevar","doi":"10.1007/s10067-025-07363-6","DOIUrl":"https://doi.org/10.1007/s10067-025-07363-6","url":null,"abstract":"<p><strong>Introduction: </strong>IgA vasculitis (IgAV) can present as skin-limited or systemic disease, which can be severe in adults. Predictive markers for visceral involvement are suboptimal. Considering haptoglobin's role as an acute phase reactant, we evaluated whether its differential expression in IgAV patients' skin and leukocytes is also reflected systemically in a larger cohort of adult IgAV patients. Additionally, soluble form of haptoglobin scavenger receptor CD163 was measured in IgAV patient serum.</p><p><strong>Methods: </strong>We re-analyzed RNA sequencing data from leukocytes and skin biopsies of treatment-naïve adult IgAV patients: (1) IgAV nephritis (n = 3), (2) skin-limited IgAV (n = 3), and healthy controls (n = 3). Haptoglobin serum level was measured in 178, and haptoglobin genotyping was performed in 91 treatment-naïve adult IgAV patients. Serum sCD163 was measured in 60 IgAV patients and 22 HC.</p><p><strong>Results: </strong>Transcriptomic data of leukocytes and skin of IgAV nephritis patients identified haptoglobin as a hub gene, based on protein-protein interaction network. Haptoglobin serum level was elevated in IgAV patients with nephritis or gastrointestinal involvement compared to other IgAV patients. Patients who relapsed during follow-up had decreased haptoglobin serum level at disease presentation compared to non-relapsing patients. Haptoglobin genotyping did not show differences between genotype groups regarding clinical presentation and laboratory parameters. Serum sCD163 was significantly higher in IgAV nephritis patients compared to HC.</p><p><strong>Conclusion: </strong>We identified haptoglobin as a novel marker of visceral involvement and relapse in adult IgAV, while sCD163 is linked to renal involvement. Further studies will confirm the clinical utility of haptoglobin as biomarker in IgAV. Key Points • Haptoglobin expression is upregulated in leukocytes and skin of adult IgAV with renal involvement. • Haptoglobin serum level is elevated in IgAV patients with visceral involvement. • Patients with IgAV relapse have lower haptoglobin at disease presentation.</p>","PeriodicalId":10482,"journal":{"name":"Clinical Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ying Xu, Yufeng Yin, Wenting Li, Jin Zhou, Yan Wang, Yan Huang, TianDan Xiang, Wei Sun, Chuancai Xu, Xiaoping Huang
{"title":"Salvage treatment of AOSD-associated macrophage activation syndrome with bariticinib following conventional immunosuppressive therapy.","authors":"Ying Xu, Yufeng Yin, Wenting Li, Jin Zhou, Yan Wang, Yan Huang, TianDan Xiang, Wei Sun, Chuancai Xu, Xiaoping Huang","doi":"10.1007/s10067-025-07352-9","DOIUrl":"https://doi.org/10.1007/s10067-025-07352-9","url":null,"abstract":"<p><strong>Objectives: </strong>Adult-onset Still's disease (AOSD)-associated macrophage activation syndrome (MAS) is a highly inflammatory condition. Currently, the main treatment method for AOSD-associated MAS is high-dose glucocorticoid shock therapy, but the effect is not satisfactory, and new therapeutic methods or drugs are urgently needed. The aim of this study was to evaluate the efficacy and safety of salvage baricitinib therapy for AOSD-associated MAS following conventional immunosuppressive therapy.</p><p><strong>Method: </strong>Data from nine patients with MAS treated in the Department of Infection and the Department of Rheumatology, First Affiliated Hospital of Soochow University, from January 2020 to December 2022, were retrospective analysed. Salvage therapy with baricitinib was administered, with an initial dose of 8 mg/day. The patients' clinical symptoms and MAS indices (blood counts and triglyceride, fibrinogen, lactate dehydrogenase, sCD25, and Fer levels) were observed. After a complete response was achieved, the baricitinib dose was gradually reduced to 2-4 mg/day and maintained.</p><p><strong>Results: </strong>The MAS blood test results of all nine patients improved to varying degrees within 1 week post-treatment. The MAS indices gradually returned to normal approximately 8 weeks after discharge; at the 12-month outpatient follow-up, seven patients did not develop MAS again, but two patients (patients 5 and 9) had MAS recurrence. The follow-up period ended with salvage treatment with emapalumab.</p><p><strong>Conclusions: </strong>Baricitinib can effectively inhibit the inflammatory response and improve outcomes in the treatment of MAS secondary to rheumatic immunity-related diseases; moreover, this drug treatment is safe. Our study provides a new strategy for MAS salvage therapy. Key Points • Bariticinib may be a palliative treatment option for recurrent/refractory MAS.</p>","PeriodicalId":10482,"journal":{"name":"Clinical Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bahar Mikaeili, Zuhair A Alqahtani, Ana L Hincapie, Jeff Jianfei Guo
{"title":"Safety of Janus kinase inhibitors in rheumatoid arthritis: a disproportionality analysis using FAERS database from 2012 to 2022.","authors":"Bahar Mikaeili, Zuhair A Alqahtani, Ana L Hincapie, Jeff Jianfei Guo","doi":"10.1007/s10067-025-07360-9","DOIUrl":"https://doi.org/10.1007/s10067-025-07360-9","url":null,"abstract":"<p><strong>Introduction/objective: </strong>Janus kinase (JAK) inhibitors have expanded treatment options for rheumatoid arthritis (RA), particularly for patients unresponsive to traditional disease-modifying antirheumatic drugs (DMARDs). However, safety concerns necessitate a thorough post-market evaluation. This study is aimed at comparing the safety profiles of tofacitinib, baricitinib, and upadacitinib using adverse event (AE) reports from the FDA Adverse Event Reporting System (FAERS).</p><p><strong>Methods: </strong>A retrospective disproportionality analysis was performed using the FAERS data from 2012 to 2022. The AE reports were categorized into cardiovascular, cancer, respiratory, gastrointestinal, musculoskeletal, and arthralgia-related events. Proportional reporting ratio (PRR) and reporting odds ratios (RORs) with 95% confidence intervals (CIs) were calculated to identify significant safety signals.</p><p><strong>Results: </strong>Of 273,657 AE reports, tofacitinib had the most (227,144), with increased musculoskeletal-related events (ROR = 1.53, 95% CI 1.49-1.57) and a reduced cancer risk (ROR = 0.44, 95% CI 0.41-0.47). Baricitinib (9305 reports) showed the highest risk of cardiovascular events (ROR = 1.63, 95% CI 1.50-1.78) and cancer (ROR = 2.17, 95% CI 1.83-2.58). Upadacitinib (37,208 reports) had elevated risks for respiratory events (ROR = 2.04, 95% CI 1.88-2.21) and cancer (ROR = 2.24, 95% CI 2.05-2.43).</p><p><strong>Conclusion: </strong>The distinct safety profiles of these JAK inhibitors suggest that baricitinib poses higher cardiovascular and cancer risks, whereas upadacitinib increases the risk of respiratory and gastrointestinal events. Tofacitinib may be safer for patients with a history of cancer but requires monitoring for musculoskeletal AEs. Personalized risk assessments are critical for safe use of JAK inhibitors. Key Points • This study provides a comprehensive post-market safety assessment of three JAK inhibitors-tofacitinib, baricitinib, and upadacitinib-using the FAERS data from 2012 to 2022. • Distinct safety profiles were identified, with baricitinib showing a higher risk of cardiovascular events and cancer, while upadacitinib posed an increased risk of respiratory and gastrointestinal events. • Tofacitinib demonstrated a lower cancer risk than other JAK inhibitors but was associated with more musculoskeletal-related adverse events. • These findings emphasize the importance of personalized risk assessment and vigilant monitoring when prescribing JAK inhibitors for rheumatoid arthritis.</p>","PeriodicalId":10482,"journal":{"name":"Clinical Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}