Seminars in arthritis and rheumatism最新文献

{"title":"Reply: Direct oral anticoagulants versus vitamin K antagonists in antiphospholipid syndrome: A systematic review and meta-analysis","authors":"Alessandra Ida Celia , Giovanni Maria Vescovo , Mattia Galli","doi":"10.1016/j.semarthrit.2025.152838","DOIUrl":"10.1016/j.semarthrit.2025.152838","url":null,"abstract":"","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"75 ","pages":"Article 152838"},"PeriodicalIF":4.4,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145227581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study design and protocol of a randomized, pragmatic, comparative effectiveness trial evaluating a sequenced strategy for improving outcomes in people with knee osteoarthritis pain (SKOAP): Conservative treatment evaluation.","authors":"Heavon M Allen, Melinda M Holena, Lauren E Allen, SiNing Zhao, Renan C Castillo, Steven P Cohen, Robert W Hurley, Daniel O Scharfstein, Jennifer A Haythornthwaite, Srinivasa N Raja, Stephen T Wegener, Christine M Rini, Francis J Keefe, Jordan Bridges, Ron Reeder, Richard E Thompson, Dan Hanley, Claudia M Campbell","doi":"10.1016/j.semarthrit.2025.152834","DOIUrl":"https://doi.org/10.1016/j.semarthrit.2025.152834","url":null,"abstract":"<p><strong>Background: </strong>Treatment guidelines for knee osteoarthritis (KOA) vary across organizations, partly due to the lack of high-quality evidence. Experts disagree on the role of psychological management, pharmacologic treatments including opioids, and interventional therapies.</p><p><strong>Methods/design: </strong>The Sequenced strategy for Knee OsteoArthritis Pain (SKOAP) trial is a multi-site, randomized, pragmatic clinical trial that uses a two-phase sequential design to evaluate the effectiveness of several interventions in individuals reporting KOA pain. Described here is the protocol for Phase 1 of the trial sequence which focuses on conservative treatments. All participants receive Best Practices (BP), a guideline-based approach to care that includes physical therapies, alternative treatments, and over-the-counter medications. Participants are then randomized to one of three groups: (1) BP alone, (2) BP plus duloxetine (30-120 mg/day), or (3) BP plus duloxetine and painTRAINER, a web-based, Cognitive Behavioral Therapy (CBT)-informed pain coping skills training. Phase 1 aims to determine whether the combination of duloxetine and BP improves pain compared to BP alone, and whether the combination of painTRAINER, duloxetine and BP provides additional benefit compared to duloxetine combined with BP. The analysis will include a modified Intention to Treat (mITT) approach and two Per-Protocol (PP) analyses; Receipt of Prescription (PP-ROP) and Minimum Effective Dose (PP-MinED). A third aim of Phase 1 is to identify clinical characteristics, patient-level factors, and psychosocial phenotypes that predict short- and long-term outcomes.</p><p><strong>Discussion: </strong>Findings from Phase 1 of the SKOAP trial will provide evidence on the effectiveness of non-opioid pharmacologic and psychological interventions for the treatment of painful KOA beyond established best practices. It may also help refine personalized treatment strategies.</p>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"75 ","pages":"152834"},"PeriodicalIF":4.4,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145252508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Disease activity predicts the development of cardiovascular events in patients with rheumatoid arthritis from the CARMA cohort","authors":"Javier Llorca ,&nbsp;Iván Ferraz-Amaro ,&nbsp;Santos Castañeda ,&nbsp;Zulema Plaza ,&nbsp;Fernando Sánchez-Alonso ,&nbsp;Carmen García-Gómez ,&nbsp;Carlos González-Juanatey ,&nbsp;Miguel Ángel González-Gay ,&nbsp;CARMA Project Collaborative Group","doi":"10.1016/j.semarthrit.2025.152833","DOIUrl":"10.1016/j.semarthrit.2025.152833","url":null,"abstract":"<div><h3>Objective</h3><div>To identify significant predictors of cardiovascular (CV) events in rheumatoid arthritis (RA) patients from the CARdiovascular in RheuMAtology (CARMA) project, followed prospectively for 10 years.</div></div><div><h3>Methods</h3><div>Between July 2010 and January 2012, 708 RA patients were recruited from 67 hospitals across Spain. The study focused on patients with no prior CV events at the time of recruitment. At the 10-year follow-up, data on the occurrence of CV events, patient-years of follow-up and linearized event rates were analyzed. Cox regression analyses were conducted, both crude and adjusted for PREVENT-CVD.</div></div><div><h3>Results</h3><div>Over 6608 patient-years, 114 patients (16.1%) experienced CV events, yielding a linearized event rate of 1.73 per 100 patient-years. Patients with CV events were older (70.7± 10.6 vs. 62.1±12.8 years, p&lt;0.001), more frequently male (36.0% vs. 20.0%, p&lt;0.001), and had higher rates of hypertension (46.5% vs. 23.4%, p&lt;0.001), diabetes (14% vs. 4.9%, p=0.001), and dyslipidemia (37.7% vs. 27.4%, p=0.03). Higher baseline erythrocyte sedimentation rate (ESR) was also associated with future CV events. Those who developed CV events had a significantly higher predicted 10-year CV risk using the PREVENT-CVD score (18.0% vs. 10.3%, p&lt;0.001). Cox regression analysis adjusted for PREVENT-CVD showed that although higher crude C-reactive protein and uric acid levels were associated with increased CV risk, after adjustment these associations weakened and became non-significant. However, higher disease activity (DAS28-ESR) was linked to greater CV risk, with moderate/high disease activity (DAS28-ESR&gt;3.2) showing a significantly higher adjusted CV risk (HR 1.62; 95% CI: 1.06–22.47, p=0.03).</div></div><div><h3>Conclusions</h3><div>Disease activity is a key determinant of CV outcomes in RA patients. The PREVENT-CVD score is an effective tool for CV risk stratification in this population.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"75 ","pages":"Article 152833"},"PeriodicalIF":4.4,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145160076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Discontinuation versus continuation of maintenance treatment with tumor necrosis factor inhibitors in patients with rheumatoid arthritis with low disease activity or remission: A randomized double-blind placebo-controlled trial","authors":"Michael M. Ward ,&nbsp;Arthur Weinstein ,&nbsp;Paloma Alejandro-Silva ,&nbsp;Alan K. Matsumoto ,&nbsp;Rukmini Konatalapalli ,&nbsp;Neil Stahl ,&nbsp;Gail S. Kerr ,&nbsp;Jamal Mikdashi ,&nbsp;Phillip Kempf ,&nbsp;Nehal R. Shah ,&nbsp;Stamatina Danielides ,&nbsp;Mohsen Ghafouri ,&nbsp;Thomas P. Olenginski ,&nbsp;Alice Fike ,&nbsp;Denitza Balyozova-Dinkov ,&nbsp;Ralf Thiele ,&nbsp;Lawrence Yao ,&nbsp;Subrata Paul ,&nbsp;Florina Constantinescu","doi":"10.1016/j.semarthrit.2025.152831","DOIUrl":"10.1016/j.semarthrit.2025.152831","url":null,"abstract":"<div><h3>Objective</h3><div>Patients with rheumatoid arthritis (RA) in sustained remission/low disease activity with tumor necrosis factor inhibitor (TNFi) treatment may be candidates for treatment de-escalation. We compared the frequency of relapses and flares of RA after TNFi discontinuation with TNFi continuation among such patients. We also investigated predictors of relapse.</div></div><div><h3>Methods</h3><div>This randomized, double-blind, placebo controlled noninferiority trial enrolled adults with RA who were treated with either adalimumab, etanercept, or infliximab, and who had a Disease Activity Score 28-C-reactive protein (DAS-CRP) &lt; 2.6 for at least six months. Patients were randomly assigned 2:1 to either placebo injections/infusions (i.e. discontinuation) or active TNFi. Patients, investigators, and study staff were masked to treatment assignment. The primary endpoint was relapse over 48 weeks, defined as either DAS29-CRP ≥ 2.6 or treatment escalation. Secondary endpoints included flare, defined as an increase in DAS28-CRP ≥ 1.2 from baseline.</div></div><div><h3>Results</h3><div>The study was stopped early based on an interim analysis that rejected noninferiority. At study interruption, 102 patients (69 placebo; 33 active TNFi) were randomized. Relapses occurred in 59.4 % of the placebo group and 18.1 % of the active TNFi group (hazard ratio 4.88; 95 % confidence interval 2.05, 11.61). Flares occurred in 43.5 % and 15.1 % of these groups, respectively. Over 48 weeks, successful discontinuation was achieved in 55 % of patients who discontinued adalimumab and 26 % of patients who discontinued etanercept.</div></div><div><h3>Conclusion</h3><div>Discontinuation of maintenance TNFi resulted in higher rates of relapse of RA than continuation.</div></div><div><h3>Trial Registration</h3><div>Clinicaltrials.gov NCT01793519</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"75 ","pages":"Article 152831"},"PeriodicalIF":4.4,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145227582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Autonomic dysfunction symptoms in Sjögren’s Disease: A missed dimension linked to disease burden and work disability","authors":"Achten Helena ,&nbsp;Deroo Liselotte ,&nbsp;Vanhoof Sophie ,&nbsp;De Boeck Kristel ,&nbsp;Deprez Joke ,&nbsp;Dumas Emilie ,&nbsp;Genbrugge Eva ,&nbsp;Bauters Wouter ,&nbsp;Roels Dimitri ,&nbsp;Dochy Frederick ,&nbsp;Creytens David ,&nbsp;Elewaut Dirk ,&nbsp;Peene Isabelle","doi":"10.1016/j.semarthrit.2025.152832","DOIUrl":"10.1016/j.semarthrit.2025.152832","url":null,"abstract":"<div><h3>Background</h3><div>Autonomic dysfunction (AD) has been reported in Sjögren’s Disease (SjD), but its relationship with established objective and patient-reported outcome measures (PROMs) is unclear.</div></div><div><h3>Objectives</h3><div>The primary aim was to assess AD symptoms in a large SjD cohort and to examine their association with established SjD outcome measures. Secondary, the relationship between AD symptoms and symptom-based endotypes, work disability, and vaginal dryness was evaluated.</div></div><div><h3>Methods</h3><div>The Composite Autonomic Symptom Score 31 (COMPASS-31) was completed by 266 SjD patients from the Belgian Sjögren’s Syndrome Transition Trial. Objective measures included glandular involvement (ultrasound, focus score, sicca tests) and systemic disease activity (European Alliance of Associations for Rheumatology (EULAR) Sjögren’s Syndrome Disease Activity Index). PROMs included EULAR patient reported index, Hospital Anxiety and Depression scale, modified fatigue Impact scale, vaginal dryness and profession. The Newcastle Sjögren’s Stratification Tool stratified patients into 'Low Symptom Burden', 'Dryness Dominant with Fatigue', 'Pain Dominant with Fatigue (PDF)' and 'High Symptom Burden (HSB)'.</div></div><div><h3>Results</h3><div>COMPASS-31 did not correlate with objective measures, but showed significant associations with anxiety (ρ = 0.41), depression (ρ = 0.44), pain (ρ = 0.35), dryness (ρ = 0.29) and fatigue (ρ = 0.37), (<em>p</em> &lt; 0.001). Integrating these PROMS into symptom-based endotypes, COMPASS-31 was highest in HSB and PDF (<em>p</em> &lt; 0.001). COMPASS-31 independently predicted work disability (OR 2.10, 95 % CI 1.29–3.44, <em>p</em> &lt; 0.01) and was higher in premenopausal women with vaginal dryness (<em>p</em> &lt; 0.01).</div></div><div><h3>Conclusion</h3><div>AD symptoms are not captured by established outcome measures but meaningfully contribute to disease burden and work disability. COMPASS-31 may serve as a valuable complementary PROM. Future studies should objectify AD and clarify its pathophysiology.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"75 ","pages":"Article 152832"},"PeriodicalIF":4.4,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145186752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identification of idiopathic inflammatory myopathy research cohorts using international classification of disease (ICD) codes: A systematic review","authors":"Astia Allenzara ,&nbsp;Jill Stachowski ,&nbsp;Emily P. Jones ,&nbsp;Amanda E. Nelson ,&nbsp;Galen Foulke","doi":"10.1016/j.semarthrit.2025.152830","DOIUrl":"10.1016/j.semarthrit.2025.152830","url":null,"abstract":"<div><h3>Objective</h3><div>To summarize studies validating International Classification of Disease (ICD) coding for idiopathic inflammatory myopathies (IIM) case identification, focusing on dermatomyositis (DM) and polymyositis (PM).</div></div><div><h3>Methods</h3><div>PubMed, Scopus, Embase, and CINAHL search was performed with a medical librarian (Prospero #CRD4202452377). Inclusion criteria required: English language, use of ICD-9 and/or -10 coding to identify cases, and clear method for validating cases.</div></div><div><h3>Results</h3><div>3684 citations were screened by title/abstract resulting in 69 full-text publications reviewed with 11 articles meeting inclusion criteria. Of the included studies, 5 evaluated only ICD-9, 5 evaluated only ICD-10, and one study evaluated both. All but one study in the US were single center, while those in Europe (<em>n</em> = 4) and Canada (<em>n</em> = 1) were population based. Reference standards varied, including Bohan and Peter (<em>n</em> = 5), 2017 EULAR/ACR classification (<em>n</em> = 2), expert opinion (<em>n</em> = 3), enrollment in Rheumatology Quality Register (<em>n</em> = 1) and muscle biopsy (<em>n</em> = 1). Four studies had a positive predictive value (PPV) of 0.9 or higher; two of these studies used coding associated with inpatient admission, and another required at least 2 codes (710.3) 3 months apart. Multiple coding instances decreased the sensitivity but increased PPV.</div></div><div><h3>Conclusions</h3><div>ICD coding is a valuable tool for identifying cases in bioinformatic research. Only a few studies describe ICD code validation for IIM research cohort construction. The highest PPV’s are reported for DM and PM with the use of multiple coding instances, or those instances associated with inpatient admission.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"75 ","pages":"Article 152830"},"PeriodicalIF":4.4,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145160077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"2025 Consensus-based recommendations for the referral, diagnosis, monitoring, and management of axial spondyloarthritis in the Arabian Gulf countries","authors":"Khalid A. Alnaqbi ,&nbsp;Ghaydaa Aldabie ,&nbsp;Ahmad Al Enizi ,&nbsp;Saadeya Abdulkarim ,&nbsp;Eman Satti ,&nbsp;Talal Al Lawati ,&nbsp;Mohamed Bedaiwi ,&nbsp;Denis Poddubnyy","doi":"10.1016/j.semarthrit.2025.152828","DOIUrl":"10.1016/j.semarthrit.2025.152828","url":null,"abstract":"<div><h3>Background</h3><div>Standardized recommendations for managing axial spondyloarthritis (axSpA) in the context of the Arabian Gulf region are currently limited.</div></div><div><h3>Objective</h3><div>We aimed to develop evidence-based consensus recommendations for the referral, diagnosis, monitoring, and management of axSpA patients in the Arabian Gulf countries.</div></div><div><h3>Method</h3><div>A task force of seven expert rheumatologists from Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and United Arab Emirates, along with an advisor, drafted recommendations regarding axSpA patient care based on a systematic literature review (PROSPERO CRD42023403697) of PubMed, Medline, and Cochrane databases. Consensus required a level of agreement ≥70%. Patient research partners and rheumatologists from the region externally validated the statements.</div></div><div><h3>Results</h3><div>Six overarching principles and 21 recommendations, tailored to the needs of the region, were developed. Key principles discussed timely referral to rheumatologists, the diagnostic utility of HLA-B27, shared decision-making, and multidisciplinary management combining non-pharmacological and pharmacological treatment. Training rheumatologists and radiologists on imaging is recommended. MRI of sacroiliac joints is preferred for diagnosis, with spinal MRI or CT of SIJs as alternatives. Cost-effective treatments, such as biosimilars, and alternative routes of drug administration should be prioritized. Treatment failure should prompt reassessment of diagnosis and evaluation of comorbidities. Regularly monitoring cardiovascular risk, pregnancy planning, disease activity monitoring during pregnancy, and use of electronic patient-reported outcome measures for informed decisions are recommended. Regional and national axSpA registries can facilitate evidence generation and enhance management.</div></div><div><h3>Conclusion</h3><div>These are the first consensus recommendations tailored to the Arabian Gulf setting, integrating current evidence and regional expertise to optimize the care of axSpA patients.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"75 ","pages":"Article 152828"},"PeriodicalIF":4.4,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145227580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The prognostic importance of worsening dyspnoea in systemic sclerosis related interstitial lung disease","authors":"Kathleen Morrisroe ,&nbsp;Dylan Hansen ,&nbsp;Wendy Stevens ,&nbsp;Laura Ross ,&nbsp;Joanne Sahhar ,&nbsp;Gene-Siew Ngian ,&nbsp;Lauren V Host ,&nbsp;Susanna Proudman ,&nbsp;Murray Barron ,&nbsp;Mandana Nikpour","doi":"10.1016/j.semarthrit.2025.152826","DOIUrl":"10.1016/j.semarthrit.2025.152826","url":null,"abstract":"<div><h3>Objectives</h3><div>To determine the prognostic importance of worsening dyspnoea in systemic sclerosis (SSc) related interstitial lung disease (ILD).</div></div><div><h3>Methods</h3><div>SSc patients were recruited from the Australian Scleroderma Cohort Study. ILD was defined as present if characteristic fibrotic changes on high-resolution computer tomography (HRCT) scan lung were seen, performed based on clinical suspicion. Determinants of survival in SSc-ILD were analysed, specifically the prognostic impact of ILD progression, defined according to the ATS, INBUILD and spirometric definitions of progressive pulmonary fibrosis, and the presence of worsening dyspnoea using accelerated failure time survival analysis.</div></div><div><h3>Results</h3><div>In our cohort of 2198 SSc patients, 17.7% (<em>n</em> = 389) developed incident ILD over a median (IQR) follow-up period of 5.8 (2.8–9.9) years. A third of our incident ILD cohort (38.3%, <em>n</em> = 149) experienced progressive ILD. In those who experienced progressive ILD, mortality was significantly higher in those who reported recent worsening dyspnoea in the prior month irrespective of a decline in spirometric parameters.</div></div><div><h3>Conclusion</h3><div>38.8% of those with incident ILD experienced ILD progression over follow-up. Patient-reported worsening dyspnoea in the month prior, irrespective of changes in spirometry, was strongly associated with mortality, with a magnitude equivalent to that of the presence of progressive ILD as defined by the ATS, INBUILD and spirometric definitions of progressive ILD. This study has highlighted the prognostic importance of patient-reported symptoms in the evaluation of SSc-ILD.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"75 ","pages":"Article 152826"},"PeriodicalIF":4.4,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145102925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"No disproportionate reporting of inflammatory arthritis following COVID-19 vaccination: a pharmacovigilance study using VAERS data","authors":"Jacopo Ciaffi ,&nbsp;Ginevra Torrigiani ,&nbsp;Piero Ruscitti ,&nbsp;Antonella Zambon ,&nbsp;Francesco Ursini","doi":"10.1016/j.semarthrit.2025.152827","DOIUrl":"10.1016/j.semarthrit.2025.152827","url":null,"abstract":"<div><h3>Objectives</h3><div>To assess whether inflammatory arthritis was disproportionately reported as an adverse event following COVID-19 vaccination compared to other vaccines, using data from the Vaccine Adverse Event Reporting System (VAERS).</div></div><div><h3>Methods</h3><div>We performed a retrospective analysis of VAERS data from December 2020 to December 2024, focusing on inflammatory arthritis as adverse event following administration of the BNT162b2, mRNA-1273, and Ad26.COV2.S vaccines. Data on vaccine dose, demographic characteristics, and symptom onset were collected. A structured query based on MedDRA terms was used to identify the reports of inflammatory arthritis. Crude reporting rate of arthritis was calculated. Disproportionality analysis was conducted using the proportional reporting ratio (PRR), reporting odds ratio (ROR), and Bayesian information component (IC), initially comparing COVID-19 vaccines to all other vaccines in VAERS, and then with stratification by age, sex, and comparator vaccine (influenza and herpes zoster).</div></div><div><h3>Results</h3><div>Among 651,850 valid reports, 5580 events of inflammatory arthritis were identified, yielding a CRR of 13.8 cases per million doses administered. Most reports involved females (72 %) and occurred within a median of 2 days post-vaccination. In the overall population, inflammatory arthritis was not disproportionately reported after COVID-19 vaccination (PRR: 0.999, 95 % CI: 0.883 to 1.130; ROR: 0.878, 95 % CI: 0.777 to 0.994; IC: –0.008, 95 % CrI: –0.046 to 0.030). Disproportionality analysis in subgroups confirmed the absence of signal across age and sex strata.</div></div><div><h3>Conclusion</h3><div>Our findings demonstrate that there is no disproportionate reporting of inflammatory arthritis following COVID-19 vaccination compared to other vaccines, supporting the overall safety of COVID-19 vaccines.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"74 ","pages":"Article 152827"},"PeriodicalIF":4.4,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145044701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Non-canonical manifestations of FMF in homozygous M694V MEFV genotype: Insights from a large patient cohort","authors":"Eitan Giat ,&nbsp;Avi Livneh ,&nbsp;Merav Lidar ,&nbsp;Danielle Bar ,&nbsp;Lee Gilad Dor ,&nbsp;Shada Azem ,&nbsp;Ilan Ben-Zvi ,&nbsp;Amit Druyan","doi":"10.1016/j.semarthrit.2025.152821","DOIUrl":"10.1016/j.semarthrit.2025.152821","url":null,"abstract":"<div><h3>Objectives</h3><div>The homozygous M694V genotype is associated with the most severe form of familial Mediterranean fever (FMF). This study aims to explore whether this genotype is linked not only to classical FMF features, but also to additional, non-canonical manifestations.</div></div><div><h3>Methods</h3><div>A hypothesis-generating study was conducted using an automated algorithm to extract data from structured medical records of patients followed at the FMF clinic of Sheba Medical Center between 2010 and 2020. Patients homozygous for the M694V genotype (study group) were compared with those having other genotypes (control group).</div></div><div><h3>Results</h3><div>Of 3866 patients, 517 (13.4 %) were homozygous for the M694V mutation, while 3349 (86.6 %) had other genotypes. Homozygous M694V patients required higher colchicine doses and exhibited higher rates of inflammatory markers, colchicine treatment failure, Behcet's disease (BD), ankylosing spondylitis (AS), and chronic renal failure (CRF, in all <em>p</em> &lt; 0.01). New findings included higher rates of deep vein thrombosis (<em>p</em> = 0.03), liver dysfunction (<em>p</em> = 0.02), abnormal liver enzymes (<em>p</em> &lt; 0.001), and congestive heart failure (CHF, <em>p</em> = 0.01). Consequently, more patients in the study group received biologic agents and had more emergency department visits and higher hospitalization rates (<em>p</em> ≤ 0.001 in both).</div></div><div><h3>Conclusions</h3><div>This study expands the scope of the homozygous M694V-associated phenotype by identifying new non-canonical features and reinforcing previous knowledge on a larger scale. We hypothesized that heightened systemic inflammation may underlie many of these associations. However, further exploration is needed to determine whether these novel findings are indeed attributed to the higher inflammatory nature of the M694V homozygous genotype, or is mediated by established and novel conditions prevailing in this subset of FMF, such as BD, AS, CHF, CRF, and higher colchicine exposure.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"74 ","pages":"Article 152821"},"PeriodicalIF":4.4,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144925753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}