Marc Scherlinger, Yannick Dieudonné, Stéphane Hilliquin, Emmanuel Chatelus, Roberto d'Alessandro, Vincent Gies, Benoit Nespola, Thierry Martin, Jacques-Eric Gottenberg, Celestine Simand, Anne El Aatmani, Marie Laure Brandely-Piat, Eden Sebbag, Justine Decroocq, Jean Sibilia, Yannick Allanore, Jerome Avouac
{"title":"Safety and efficacy of blinatumomab in the treatment of refractory systemic sclerosis: a case series.","authors":"Marc Scherlinger, Yannick Dieudonné, Stéphane Hilliquin, Emmanuel Chatelus, Roberto d'Alessandro, Vincent Gies, Benoit Nespola, Thierry Martin, Jacques-Eric Gottenberg, Celestine Simand, Anne El Aatmani, Marie Laure Brandely-Piat, Eden Sebbag, Justine Decroocq, Jean Sibilia, Yannick Allanore, Jerome Avouac","doi":"10.1016/j.ard.2026.02.002","DOIUrl":"https://doi.org/10.1016/j.ard.2026.02.002","url":null,"abstract":"<p><strong>Objectives: </strong>This study aims to evaluate the safety, biological activity, and exploratory clinical effects of CD19-directed T-cell engagement with blinatumomab in patients with severe, treatment-refractory antitopoisomerase I-positive systemic sclerosis (SSc).</p><p><strong>Methods: </strong>We conducted an exploratory case series of 5 patients with refractory SSc who received a 14-day continuous intravenous infusion of blinatumomab (9 µg/d for 7 days, escalated to 28 µg/d for 7 days) in 2 tertiary hospitals. Safety assessments included cytokine release syndrome (CRS), neurotoxicity, infections, and serum immunoglobulin levels. Exploratory efficacy outcomes comprised modified Rodnan skin score (mRSS), pulmonary function tests, and patient-reported outcomes. Immunologic endpoints included serial peripheral CD19⁺ B-cell counts, B-cell subset phenotyping, and a 6-gene type I interferon signature. Patients' follow-up was a median of 8 months (range: 6-12).</p><p><strong>Results: </strong>Blinatumomab administration was generally well tolerated. Three patients experienced low-grade CRS (grade 1, n = 2; grade 2, n = 1), managed conservatively; no neurotoxicity or severe infections occurred. Rapid peripheral CD19⁺ B-cell depletion was achieved in all patients. B-cell repopulation occurred by 1 month in all but 1 patient and was dominated by naïve and transitional subsets. At 3 months, modest clinical improvements were observed, including a median mRSS change of -4 points (range: +1 to -8) from a baseline of 16 (range: 0-25) and a transient improvement in lung function and patient-reported outcomes. However, all patients experienced clinical relapse between months 3 and 6, leading to resumption of immunosuppressive therapy in most cases.</p><p><strong>Conclusions: </strong>CD19-directed T-cell engagement with blinatumomab induces rapid B-cell depletion and short-term clinical improvement in refractory SSc but lacks durability after a single treatment cycle.</p>","PeriodicalId":8087,"journal":{"name":"Annals of the Rheumatic Diseases","volume":" ","pages":""},"PeriodicalIF":20.6,"publicationDate":"2026-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147368785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Tenosynovium, the likely first inflamed joint tissue during the development of arthritis in emerging rheumatoid arthritis.","authors":"Dennis A Ton, Annette H M van der Helm-van Mil","doi":"10.1016/j.ard.2026.02.012","DOIUrl":"https://doi.org/10.1016/j.ard.2026.02.012","url":null,"abstract":"","PeriodicalId":8087,"journal":{"name":"Annals of the Rheumatic Diseases","volume":" ","pages":""},"PeriodicalIF":20.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pranjal Rai, James P Klaas, Kenneth J Warrington, Waleed Brinjikji, Girish Bathla
{"title":"Multimodality imaging in primary central nervous system vasculitis.","authors":"Pranjal Rai, James P Klaas, Kenneth J Warrington, Waleed Brinjikji, Girish Bathla","doi":"10.1016/j.ard.2025.10.012","DOIUrl":"10.1016/j.ard.2025.10.012","url":null,"abstract":"","PeriodicalId":8087,"journal":{"name":"Annals of the Rheumatic Diseases","volume":" ","pages":"575-576"},"PeriodicalIF":20.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145476558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marianne Uggen Rasmussen, Robin Christensen, Eva Ejlersen Wæhrens, Marius Henriksen, Pernille Hurup Duhn, Henning Bliddal, Kirstine Amris
{"title":"Cannabidiol versus placebo in patients with fibromyalgia: a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial.","authors":"Marianne Uggen Rasmussen, Robin Christensen, Eva Ejlersen Wæhrens, Marius Henriksen, Pernille Hurup Duhn, Henning Bliddal, Kirstine Amris","doi":"10.1016/j.ard.2025.07.008","DOIUrl":"10.1016/j.ard.2025.07.008","url":null,"abstract":"<p><strong>Objectives: </strong>Cannabidiol (CBD) is used to alleviate fibromyalgia pain despite limited evidence for efficacy. This study assessed the efficacy and safety of CBD vs placebo in patients with fibromyalgia, hypothesising that CBD would be superior to placebo in reducing pain.</p><p><strong>Methods: </strong>In this single-centre, double-blind, randomised, placebo-controlled trial, patients diagnosed with fibromyalgia were recruited from a specialised outpatient clinic in Denmark. Eligible participants were randomised 1:1 and stratified by sex, defined as biological sex assigned at birth based on physical anatomy. Age (<45 vs ≥45), and pain level (<7 vs ≥7) on a 0 to 10 numeric rating scale (NRS) to receive 50 mg plant-derived CBD or placebo tablets. The primary outcome was change in pain intensity at week 24, assessed on the NRS pain subitem in the revised Fibromyalgia Impact Questionnaire in the intention-to-treat population. Adverse events were monitored throughout the study in the safety population.</p><p><strong>Results: </strong>Of 273 participants screened for eligibility, 200 were included and randomised to receive CBD (n = 100) or placebo (n = 100). At week 24, mean change in pain intensity was -0.4 points (95% CI: -0.82 to 0.08) in the CBD group and -1.1 points (95% CI: -1.53 to -0.63) in the placebo group, corresponding to a between-group difference of -0.7 points (95% CI: -1.2 to -0.25; P = .0028) favouring placebo. Adverse events were generally mild and evenly distributed between groups.</p><p><strong>Conclusions: </strong>The findings do not support CBD 50 mg daily as an analgesic supplement for patients with fibromyalgia.</p><p><strong>Clinicaltrials: </strong>gov number: NCT04729179.</p>","PeriodicalId":8087,"journal":{"name":"Annals of the Rheumatic Diseases","volume":" ","pages":"566-574"},"PeriodicalIF":20.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144940161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ana Belén Moreno-Cárdenas, Javier Ros, Albert Gil-Vila, Debayan Datta, Roberta Fasani, Garazi Serna, Jose Jimenez, Ernesto Trallero-Araguás, Cristina Viaplana, Julia Lostes, José César Milisenda, Josep Maria Grau-Junyent, Raquel Lopez-Perez, Iago Pinal-Fernández, Paolo Nuciforo, Rodrigo A Toledo, Albert Selva-O'Callaghan
{"title":"Frequent genetic alterations in myositis autoantigen genes in cancer-associated dermatomyositis.","authors":"Ana Belén Moreno-Cárdenas, Javier Ros, Albert Gil-Vila, Debayan Datta, Roberta Fasani, Garazi Serna, Jose Jimenez, Ernesto Trallero-Araguás, Cristina Viaplana, Julia Lostes, José César Milisenda, Josep Maria Grau-Junyent, Raquel Lopez-Perez, Iago Pinal-Fernández, Paolo Nuciforo, Rodrigo A Toledo, Albert Selva-O'Callaghan","doi":"10.1016/j.ard.2025.10.018","DOIUrl":"10.1016/j.ard.2025.10.018","url":null,"abstract":"<p><strong>Objectives: </strong>One-third of patients diagnosed with dermatomyositis harbour an occult cancer, a rare condition named cancer-associated dermatomyositis (CAD). Emerging evidence suggests that genetic alterations in autoantibody-related genes give rise to neoantigens and specific autoantibodies that initiate an autoimmune response characteristic of CAD. This study evaluated the prevalence of such genetic alterations and elucidated molecular mechanisms that may underlie their role in triggering autoimmunity.</p><p><strong>Methods: </strong>Fifteen patients with CAD were included in the study. We conducted genomic and transcriptomic analyses of available leukocyte (germline), muscle, skin, and tumour samples. T-cell receptor (TCR) repertoire profiling and multiplex immunophenotyping were performed to characterise immune responses in tumoural and nontumoural tissues.</p><p><strong>Results: </strong>Somatic mutations and loss of heterozygosity (LOH) in autoantibody-related genes as tripartite motif containing 33, tripartite motif containing 66, MORC family CW-type zinc finger 3 (MORC3), Chromodomain Helicase DNA Binding Protein 4, and IFIH1, interferon-induced helicase C domain-containing protein 1-corresponding to known myositis-specific autoantibodies Anti-transcriptional intermediary factor 1 gamma, anti-nuclear matrix protein 2, (anti-transcriptional intermediary factor 1 gamma (anti-TIF1γ), anti-nuclear matrix protein 2 (anti-NXP2), anti-Mi2, antimelanoma differentiation-associated gene 5 protein), were detected in the majority of tumours from patients with CAD (75%). Tumour-specific missense mutations gave rise to highly immunogenic neoantigens, while LOH resulted in enriched allelic expression not observed in nontumoural lesions (skin and muscle). Immunophenotyping revealed a clonally expanded lymphocyte population within tumours, but not in nontumoural lesions, suggesting a distinct cellular immune response.</p><p><strong>Conclusions: </strong>We detected highly frequent genetic alterations in autoantibody-related genes, supporting their role in the CAD pathogenic mechanisms. Moreover, our findings suggest that distinct TCR repertoire and immune signatures between tumoural and nontumoural tissues may underlie divergent cancer and dermatomyositis outcomes.</p>","PeriodicalId":8087,"journal":{"name":"Annals of the Rheumatic Diseases","volume":" ","pages":"519-533"},"PeriodicalIF":20.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13137219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145601752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jonathan Thaler, Michael Parides, Danieli Castro Oliveira de Andrade, Diana Paredes Ruiz, Maria G Tektonidou, Vittorio Pengo, Savino Sciascia, Cecilia Nalli, Guilherme de Jesús, Paul R Fortin, Maria Efthymiou, H Michael Belmont, Michelle Petri, Ricard Cervera, Leslie Skeith, Tatsuya Atsumi, Chary López-Pedrera, Yu Zuo, D Ware Branch, Rohan Willis, Nina Kello, Zhuoli Zhang, Esther Rodriguez Almaraz, Bahar Artim-Esen, Jose Pardos-Gea, Guillermo Pons-Estel, Giulia Pazzola, Hui Shi, Ali Duarte-Garcia, Medha Barbhaiya, Cecile Yelnik, Pierluigi Meroni, Robert Roubey, Maria Laura Bertolaccini, Hannah Cohen, Jacob H Rand, Doruk Erkan
{"title":"Clinical and biologic predictors of thrombosis in persistently antiphospholipid antibody-positive patients: Prospective analysis of the International APS ACTION Clinical Database and Repository ('Registry').","authors":"Jonathan Thaler, Michael Parides, Danieli Castro Oliveira de Andrade, Diana Paredes Ruiz, Maria G Tektonidou, Vittorio Pengo, Savino Sciascia, Cecilia Nalli, Guilherme de Jesús, Paul R Fortin, Maria Efthymiou, H Michael Belmont, Michelle Petri, Ricard Cervera, Leslie Skeith, Tatsuya Atsumi, Chary López-Pedrera, Yu Zuo, D Ware Branch, Rohan Willis, Nina Kello, Zhuoli Zhang, Esther Rodriguez Almaraz, Bahar Artim-Esen, Jose Pardos-Gea, Guillermo Pons-Estel, Giulia Pazzola, Hui Shi, Ali Duarte-Garcia, Medha Barbhaiya, Cecile Yelnik, Pierluigi Meroni, Robert Roubey, Maria Laura Bertolaccini, Hannah Cohen, Jacob H Rand, Doruk Erkan","doi":"10.1016/j.ard.2025.10.019","DOIUrl":"10.1016/j.ard.2025.10.019","url":null,"abstract":"<p><strong>Objectives: </strong>There is a lack of high-quality data to inform risk-stratified long-term thrombosis prevention strategies in patients with persistently positive antiphospholipid antibodies (aPL). We aimed to determine independent clinical and biologic predictors of thrombosis among persistently aPL-positive patients.</p><p><strong>Methods: </strong>Patients positive for aPL according to the Revised Sapporo Classification Criteria are eligible for inclusion in the Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Registry. Registrants with at least 1 year of follow-up were included in this study. We fit Cox proportional hazards models to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) for independent predictors of thrombosis.</p><p><strong>Results: </strong>In unadjusted analyses, based on 1067 patients with a mean follow-up of 4.43 years (4,727 person-years), history of thrombosis, hematologic disease (autoimmune haemolytic anaemia and/or thrombocytopenia), microvascular disease, obesity, renal disease, sedentary lifestyle, baseline anticoagulant use, and family history of early cardiovascular disease occurred more frequently (P < .05) among patients with new thrombosis (n = 93) than among those without new thrombosis (n = 974). After adjustment, independent predictors of new thrombosis were history of thrombosis (HR 2.34, 95% CI 1.14 to 4.81, P = .02) and hematologic disease (HR 1.95, 95% CI 1.19 to 3.18, P = .01); there was a trend for history of microvascular disease (P = .06) and obesity (P = .08).</p><p><strong>Conclusions: </strong>In this prospective analysis, history of thrombosis and hematologic disease each conferred an approximately twofold increased risk of new thrombosis in persistently aPL-positive patients. These findings can guide future clinical trial designs and inform patient management decisions.</p>","PeriodicalId":8087,"journal":{"name":"Annals of the Rheumatic Diseases","volume":" ","pages":"497-506"},"PeriodicalIF":20.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145562565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anna-Maria Hoffmann-Vold, Katerina Antoniou, Oliver Distler, Bruno Crestani
{"title":"Correspondence on the 'ERS/EULAR 2025 CTD-ILD Guideline: Queries from an Indian Perspective' and on the 'ERS/EULAR clinical practice guidelines for connective tissue disease-associated interstitial lung disease' by Antoniou et al.'","authors":"Anna-Maria Hoffmann-Vold, Katerina Antoniou, Oliver Distler, Bruno Crestani","doi":"10.1016/j.ard.2025.11.026","DOIUrl":"10.1016/j.ard.2025.11.026","url":null,"abstract":"","PeriodicalId":8087,"journal":{"name":"Annals of the Rheumatic Diseases","volume":" ","pages":"e39-e41"},"PeriodicalIF":20.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146008554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Simin Chen, Kai Sun, Chenxi Peng, Yu Kuang, Shuoyang Zhang, Ruiru Li, Huijuan Hu, Suling Liu, Fan Su, Qian Qiu, Liuqin Liang, Ligang Jie, Youjun Xiao, Hanshi Xu
{"title":"METTL1-mediated internal m<sup>7</sup>G methylation of cathepsin B mRNA promotes synovial aggression in rheumatoid arthritis.","authors":"Simin Chen, Kai Sun, Chenxi Peng, Yu Kuang, Shuoyang Zhang, Ruiru Li, Huijuan Hu, Suling Liu, Fan Su, Qian Qiu, Liuqin Liang, Ligang Jie, Youjun Xiao, Hanshi Xu","doi":"10.1016/j.ard.2025.09.010","DOIUrl":"10.1016/j.ard.2025.09.010","url":null,"abstract":"<p><strong>Objectives: </strong>Recent studies show that methyltransferase-like 1 (METTL1)-mediated internal messenger ribonucleic acid (mRNA) N<sup>7</sup>-methylguanosine (m<sup>7</sup>G) modification has a unique role in cancer metastasis. Here, we aimed to uncover the role of METTL1-mediated internal mRNA m<sup>7</sup>G in controlling fibroblast-like synoviocytes' (FLSs') functions in rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>FLSs were separated from patients with active established RA. Western blot, immunohistochemistry, and immunofluorescence were used to measure protein expression in synovium. The Boyden chamber was used to detect cell migration and invasion. m<sup>7</sup>G RNA immunoprecipitation sequencing was performed to seek the potential target of METTL1. Dual-luciferase reporter gene assay was used to investigate the m⁷G-dependent regulation of cathepsin B (CTSB) by METTL1. The protein translation efficiency was detected by polysome profiling. METTL1 heterozygous knockout or intra-articular injection of METTL1 short hairpin ribonucleic acid adenovirus (Adv-shRNA-METTL1) was used to inhibit arthritis in RA models.</p><p><strong>Results: </strong>We observed increased levels of METTL1 and internal mRNA m<sup>7</sup>G in FLSs and synovial tissues from patients with RA. METTL1 knockdown or overexpression decreased or increased the migration and invasion of RA FLSs. Synovial METTL1 level was positively correlated with the disease activity score on 28 joints-erythrocyte sedimentation rate scores in patients with RA. METTL1 knockdown in vivo mitigated the severity of arthritis in RA animal models. Mechanistically, we probed that METTL1 promotes the aggressive action of RA FLSs through regulating the translation efficiency of the internal mRNA m<sup>7</sup>G modification of CTSB. CTSB knockdown also suppressed the aggression of RA FLSs.</p><p><strong>Conclusions: </strong>Our findings reveal an important role of METTL1-mediated internal mRNA m<sup>7</sup>G modification in promoting synovial aggression of RA, suggesting that METTL1 might be a potential target for therapy of RA, even other dysregulated FLS-associated diseases.</p>","PeriodicalId":8087,"journal":{"name":"Annals of the Rheumatic Diseases","volume":" ","pages":"435-446"},"PeriodicalIF":20.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maria G Tektonidou, Ricard Cervera, Angela Tincani, Guillermo J Pons-Estel, Savino Sciascia, Jaume Alijotas-Reig, Tadej Avcin, Maria Laura Bertolaccini, Tiina Jasinski, Francesca Marchiori, Arsene Mekinian, Pier-Luigi Meroni, Vittorio Pengo, Massimo Radin, Anisur Rahman, Guillermo Ruiz-Irastorza, Karen Schreiber, Stefka Stoilova, Lucas van den Hoogen, Ronald van Vollenhoven, Denis Wahl, Tanja Stamm, Robert B M Landewé, Michael M Ward
{"title":"Development and validation of a EULAR disease activity score in antiphospholipid syndrome.","authors":"Maria G Tektonidou, Ricard Cervera, Angela Tincani, Guillermo J Pons-Estel, Savino Sciascia, Jaume Alijotas-Reig, Tadej Avcin, Maria Laura Bertolaccini, Tiina Jasinski, Francesca Marchiori, Arsene Mekinian, Pier-Luigi Meroni, Vittorio Pengo, Massimo Radin, Anisur Rahman, Guillermo Ruiz-Irastorza, Karen Schreiber, Stefka Stoilova, Lucas van den Hoogen, Ronald van Vollenhoven, Denis Wahl, Tanja Stamm, Robert B M Landewé, Michael M Ward","doi":"10.1016/j.ard.2025.10.006","DOIUrl":"10.1016/j.ard.2025.10.006","url":null,"abstract":"<p><strong>Objectives: </strong>To develop and validate a European Alliance of Associations for Rheumatology (EULAR) disease activity score in antiphospholipid syndrome (EAPSDAS).</p><p><strong>Methods: </strong>Twenty-four Task Force members and an international group of 53 antiphospholipid syndrome (APS) experts/collaborators, 65 patients with primary APS, and 21 healthcare professionals participated. EAPSDAS development proceeded in 4 phases: (i) item generation using a systematic literature review and 2 surveys; (ii) item reduction by rating items on their importance to be included in EAPSDAS and using Delphi methodology; (iii) item scoring based on real-world clinical vignettes and using as criterion standard the physician global assessment (PhysGA); and (iv) validation.</p><p><strong>Results: </strong>One hundred seventy items representing APS activity were generated, and 140 deduplicated candidate items were rated by participants. Using a ≥75% vote threshold and Delphi consensus among Task Force members, 24 items were included in the EAPSDAS thrombotic/microvascular/nonthrombotic (TMN) scale and 6 in the obstetric scale. Item scoring was based on ratings of 3 versions of 60 vignettes with new/worsening manifestations (30 single TMN or obstetric manifestations, 26 combinations of 2 TMN manifestations, 2 inactive cases, 2 testing cases) by physicians. Item scores were calculated as the adjusted mean PhysGA in linear regression analysis. A 1-month time frame was defined for the TMN scale and the entire pregnancy for the obstetric scale. Scores for stable or improved TMN manifestations were also included. High face and content validity, construct validity (internal/external standard), and reliability were demonstrated using real-world clinical vignettes.</p><p><strong>Conclusions: </strong>Using data-driven and consensus methodology, EAPSDAS was developed and initial validation was performed. Further validation in prospective studies is warranted.</p>","PeriodicalId":8087,"journal":{"name":"Annals of the Rheumatic Diseases","volume":" ","pages":"399-411"},"PeriodicalIF":20.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145581533","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andriko Palmowski, Anne Elisabeth Beenken, Anne Pankow, Judith Oldenkott, Henriette Käding, Edgar Wiebe, Zhivana Boyadzhieva, Eric L Matteson, Ioanna Minopoulou, Thorben Witte, David Simon, Maarten Boers, Arnd Kleyer, Frank Buttgereit
{"title":"Confounding by indication in observational studies investigating glucocorticoid-associated adverse events in patients with rheumatoid arthritis: a systematic literature review including an assessment of E-values.","authors":"Andriko Palmowski, Anne Elisabeth Beenken, Anne Pankow, Judith Oldenkott, Henriette Käding, Edgar Wiebe, Zhivana Boyadzhieva, Eric L Matteson, Ioanna Minopoulou, Thorben Witte, David Simon, Maarten Boers, Arnd Kleyer, Frank Buttgereit","doi":"10.1016/j.ard.2025.10.008","DOIUrl":"10.1016/j.ard.2025.10.008","url":null,"abstract":"","PeriodicalId":8087,"journal":{"name":"Annals of the Rheumatic Diseases","volume":" ","pages":"580-583"},"PeriodicalIF":20.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145522660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}