Maxime Beydon, Yann Nguyen, Rachael Gordon, Nathan Foulquier, Coralie Bouillot, Katherine M Hammitt, Simon J Bowman, Xavier Mariette, Divi Cornec, Sara S McCoy, Raphaèle Seror
{"title":"A Systematic Review of Clinical Trial Designs and Outcome Measures in Sjögren Disease Randomized Controlled Trials.","authors":"Maxime Beydon, Yann Nguyen, Rachael Gordon, Nathan Foulquier, Coralie Bouillot, Katherine M Hammitt, Simon J Bowman, Xavier Mariette, Divi Cornec, Sara S McCoy, Raphaèle Seror","doi":"10.3899/jrheum.2024-1012","DOIUrl":"10.3899/jrheum.2024-1012","url":null,"abstract":"<p><strong>Objective: </strong>To systematically review all existing Sjögren disease (SjD)-related instruments reported in clinical trials for SjD.</p><p><strong>Methods: </strong>We systematically searched Medline (PubMed) and EMBASE between January 2002 and March 2023 to identify all randomized controlled trials (RCTs) using both a manual approach and artificial intelligence software (Bibliography BOT). We extracted all the instruments used as primary or secondary outcomes and assessed whether the study succeeded in improving the outcome. We also classified the instruments according to the recently defined preliminary outcome domains.</p><p><strong>Results: </strong>Among 5420 references, 60 RCTs were included, focusing either on overall disease manifestations (53%) or on a single organ/symptom (eg, dry eyes [17%], xerostomia [15%], fatigue [12%], or pulmonary function [3%]). Primary outcomes included measures of oral or ocular dryness, patient-reported outcomes (PROs), systemic activity, and other outcomes. Common instruments used were European Alliance of Associations for Rheumatology (EULAR) Sjögren Syndrome Disease Activity Index (ESSDAI), EULAR Sjögren Syndrome Patient-Reported Index, Schirmer-I test for unstimulated salivary flow, and IgG levels. ESSDAI was a primary outcome in 11 studies, with 45% of studies reaching significance, whereas none of the 16 studies with ESSDAI as a secondary outcome reached significance. PROs were the primary outcome in 34 studies. Glandular function measurements varied, with unstimulated salivary flow as the most commonly measured outcome. Life impact was assessed more frequently as a secondary outcome. Only 2 studies focused on biological activity.</p><p><strong>Conclusion: </strong>Our review highlighted the heterogeneity of SjD RCTs in both the study designs and outcomes. The use of PROs and composite outcomes has increased in recent years, highlighting a shift from objective dryness measures to more holistic patient-centered outcomes.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143764383","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":"Seasonal Variations and Their Influence on Antineutrophil Cytoplasmic Antibody-Associated Vasculitis Relapse.","authors":"Gang Wang, Zhichun Liu","doi":"10.3899/jrheum.2024-1325","DOIUrl":"10.3899/jrheum.2024-1325","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"624"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143765473","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}
Caitrin M Coffey, Cassondra A Hulshizer, Cynthia S Crowson, Jay H Ryu, Floranne C Ernste
{"title":"Epidemiology of Antisynthetase Syndrome and Risk of Malignancy in a Population-Based Cohort (1998-2019).","authors":"Caitrin M Coffey, Cassondra A Hulshizer, Cynthia S Crowson, Jay H Ryu, Floranne C Ernste","doi":"10.3899/jrheum.2024-0945.C1","DOIUrl":"10.3899/jrheum.2024-0945.C1","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"627"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143812805","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}
Josefina Durán, Bernardo A Pons-Estel, Marta E Alarcón-Riquelme, Roberto Díaz Peña
{"title":"Enhancing Genetic Studies on Rheumatic Diseases in Latin America: The IARGE-RD Initiative.","authors":"Josefina Durán, Bernardo A Pons-Estel, Marta E Alarcón-Riquelme, Roberto Díaz Peña","doi":"10.3899/jrheum.2024-1233","DOIUrl":"10.3899/jrheum.2024-1233","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"614-617"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425999","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":"Understanding Fatigue and Sleep Disturbance in Polymyalgia Rheumatica: Redefining the Patient Experience and Opportunities for Intervention.","authors":"Patricia Harkins, Sebastian E Sattui","doi":"10.3899/jrheum.2025-0524","DOIUrl":"https://doi.org/10.3899/jrheum.2025-0524","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144200712","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}
Jayne M MacMahon, Mohammad Massumi, Trang T Duong, Rose H Garrett, Audrey Bell-Peter, Kristi Whitney, Jo-Anne Marcuz, Y Ingrid Goh, Rae S M Yeung, Brian M Feldman
{"title":"Correlation Between Interferon Response Gene Score and Disease Activity in Juvenile Dermatomyositis.","authors":"Jayne M MacMahon, Mohammad Massumi, Trang T Duong, Rose H Garrett, Audrey Bell-Peter, Kristi Whitney, Jo-Anne Marcuz, Y Ingrid Goh, Rae S M Yeung, Brian M Feldman","doi":"10.3899/jrheum.2024-0806","DOIUrl":"10.3899/jrheum.2024-0806","url":null,"abstract":"<p><strong>Objective: </strong>Type 1 interferons (IFNs) have been identified as potentially important measures of disease activity in juvenile dermatomyositis (JDM). An IFN response gene (IRG) score has been defined using NanoString technology and appears to correlate with disease activity in cross-sectional samples of patients with JDM. This study aimed to determine if there is evidence of a correlation between disease activity and IRG score in patients with JDM, both early in the disease course and longitudinally.</p><p><strong>Methods: </strong>All patients attending the JDM clinic at The Hospital for Sick Children (SickKids), in Toronto, Canada, were approached to enroll in the Childhood Arthritis and Rheumatic Diseases (CARD) biobank. We identified patients with a diagnosis of JDM, enrolled between January 2015 and June 2022. NanoString IRG score was calculated from extracted RNA. The modified Disease Activity Score was calculated based on clinical data collected prospectively through SickKids's JDM registry. Spearman correlation was calculated using all enrollment visit samples, and linear mixed model regression was used for subjects with multiple samples.</p><p><strong>Results: </strong>Forty-three subjects with 87 biosamples were identified, including 18 treatment-naïve subjects. Spearman correlation at the enrollment visit was strong (<i>r<sub>s</sub></i> 0.78) with similar results seen in the treatment-naïve cohort (<i>r<sub>s</sub></i> 0.63). This relationship persisted over time, with linear mixed modeling of the treatment-naïve cohort showing β coefficient for the IRG score of 0.004 with <i>P</i> < 0.001.</p><p><strong>Conclusion: </strong>This study shows evidence of a significant correlation between IRG score and disease activity, which is maintained over time. This highlights the potential for IRG score to be an important biomarker in JDM.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"604-612"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143634787","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}
Tiphaine Goulenok, Maria Carvalho, Arthur Mageau, Benjamin Terrier, Eric Hachulla, Thomas Papo, Karim Sacré
{"title":"Varicella Zoster Virus Vaccination in Patients With Immune-Mediated Inflammatory Diseases: Drivers and Barriers.","authors":"Tiphaine Goulenok, Maria Carvalho, Arthur Mageau, Benjamin Terrier, Eric Hachulla, Thomas Papo, Karim Sacré","doi":"10.3899/jrheum.2025-0016","DOIUrl":"https://doi.org/10.3899/jrheum.2025-0016","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144200714","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}
Marion Pons, Stylianos Georgiadis, Merete Lund Hetland, Zohra Faizy Ahmadzay, Simon Rasmussen, Sara N Christiansen, Daniela Di Giuseppe, Johan K Wallman, Karel Pavelka, Jakub Závada, Catalin Codreanu, Bente Glintborg, Anne G Loft, Helena Santos, Maria H Lourenço, Michael J Nissen, Adrian Ciurea, Laura Kuusalo, Vappu Rantalaiho, Brigitte Michelsen, Pawel Mielnik, Katja P Pirkmajer, Ziga Rotar, Bjorn Gudbjornsson, Olafur Palsson, Irene van der Horst-Bruinsma, Marleen van de Sande, Isabel Castrejón, Gary J Macfarlane, Karin Laas, Mikkel Østergaard, Lykke M Ørnbjerg
{"title":"Predictors of Secukinumab Treatment Response and Continuation in Axial Spondyloarthritis: Results From the EuroSpA Research Collaboration Network.","authors":"Marion Pons, Stylianos Georgiadis, Merete Lund Hetland, Zohra Faizy Ahmadzay, Simon Rasmussen, Sara N Christiansen, Daniela Di Giuseppe, Johan K Wallman, Karel Pavelka, Jakub Závada, Catalin Codreanu, Bente Glintborg, Anne G Loft, Helena Santos, Maria H Lourenço, Michael J Nissen, Adrian Ciurea, Laura Kuusalo, Vappu Rantalaiho, Brigitte Michelsen, Pawel Mielnik, Katja P Pirkmajer, Ziga Rotar, Bjorn Gudbjornsson, Olafur Palsson, Irene van der Horst-Bruinsma, Marleen van de Sande, Isabel Castrejón, Gary J Macfarlane, Karin Laas, Mikkel Østergaard, Lykke M Ørnbjerg","doi":"10.3899/jrheum.2024-0920","DOIUrl":"10.3899/jrheum.2024-0920","url":null,"abstract":"<p><strong>Objective: </strong>In patients with axial spondyloarthritis (axSpA) initiating secukinumab (SEC), we aimed to identify baseline (treatment start) predictors of achieving low disease activity (LDA) after 6 months, as measured by the Axial Spondyloarthritis Disease Activity Score using C-reactive protein (ASDAS-CRP) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), as well as treatment continuation after 12 months.</p><p><strong>Methods: </strong>From 11 European registries, patients with axSpA who initiated SEC treatment in routine care, with available data on 6-month ASDAS-CRP and BASDAI assessments were included. Logistic regression analyses on multiply imputed baseline data were performed; potential baseline predictors included demographic, diagnosis, lifestyle, clinical, and patient-reported variables.</p><p><strong>Results: </strong>In a pooled cohort of 1174 patients with axSpA, 5 of 19 potential assessed variables were mutually predictive for achieving LDA by ASDAS-CRP and BASDAI: higher physician global assessment score, noncurrent smoking, lack of prior exposure to biologic/targeted synthetic disease-modifying antirheumatic drugs, and lower Health Assessment Questionnaire scores and BASDAI scores. Moreover, radiographic axSpA and CRP ≤ 10 mg/L were associated with achieving ASDAS-CRP LDA, and HLA-B27 positivity and history of psoriasis with achieving BASDAI LDA, whereas earlier time of secukinumab initiation (2015-2017) was associated with treatment continuation.</p><p><strong>Conclusion: </strong>In this European real-world study of patients with axSpA initiating SEC, predictors of achieving LDA by ASDAS-CRP and BASDAI at 6 months and remaining on treatment at 12 months included both clinical, patient-reported, and lifestyle factors, underscoring the complex mechanisms of real-world drug effectiveness.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"572-582"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076121","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}
Charmaine Tze May Wang, Jing-Yang Huang, Pei-Lun Liao, James Cheng-Chung Wei, Ying Ying Leung
{"title":"Risk of Mortality of People With Psoriasis and Psoriatic Arthritis in Taiwan: A Nationwide Cohort Study.","authors":"Charmaine Tze May Wang, Jing-Yang Huang, Pei-Lun Liao, James Cheng-Chung Wei, Ying Ying Leung","doi":"10.3899/jrheum.2024-1032","DOIUrl":"10.3899/jrheum.2024-1032","url":null,"abstract":"<p><strong>Objective: </strong>Residual confounding effects and disease severity are attributed to controversial results in studies of psoriatic disease (PsD) and mortality. We aimed to evaluate the risk of mortality in patients with incident PsD, compared to matched controls from the population.</p><p><strong>Methods: </strong>We used the nationwide, population-based insurance claim datasets in Taiwan from 2010 to 2018. Incident cases of PsD were identified by International Classification of Diseases (ICD) codes. A nonexposed cohort was established through propensity score matching (PSM). Deaths were identified via the National Mortality Database. We evaluated the risk of all-cause mortality in PsD compared to the PSM nonexposed individuals using Cox regression. The mortality risk was evaluated in patients with more severe disease stratified by systemic therapy use and having psoriatic arthritis (PsA).</p><p><strong>Results: </strong>There were 108,642 patients with incident PsD (40.2% women) and an equal number of PSM non-PsD individuals. Compared to the age- and sex-matched controls, there was a higher risk of mortality among patients with PsD (adjusted hazard ratio [aHR] 1.73, 95% CI 1.68-1.77, <i>P</i> < 0.001). After PSM, we found an attenuated but persistent higher risk of mortality in PsD compared to controls (aHR 1.20, 95% CI 1.16-1.24). There was a trend of higher mortality in patients exposed to biologic therapies, but not for PsA.</p><p><strong>Conclusion: </strong>There was an increased risk of all-cause mortality in individuals with PsD compared to individuals without PsD before and after both PSM and adjustment for comorbidities. The risk of mortality was higher in patients with psoriasis but not in patients with PsA as compared to controls.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"590-597"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143426445","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}
Gonul Hazal Koc, Agnes E M Looijen, Irene E van der Horst-Bruinsma, Pascal H P de Jong
{"title":"Sex Differences in Rheumatoid Arthritis: New Insights From Clinical and Patient-Reported Outcome Perspectives.","authors":"Gonul Hazal Koc, Agnes E M Looijen, Irene E van der Horst-Bruinsma, Pascal H P de Jong","doi":"10.3899/jrheum.2024-1258","DOIUrl":"10.3899/jrheum.2024-1258","url":null,"abstract":"<p><strong>Objective: </strong>The disease course and burden of rheumatoid arthritis (RA) may differ between female and male individuals, but existing data on these differences are limited and often contradictory. Therefore, we investigated whether clinical outcomes and patient-reported outcomes (PROs) differ between female and male patients with RA over time.</p><p><strong>Methods: </strong>All female (n = 286) and male (n = 139) patients with RA according to 1987 and/or 2010 criteria from Treatment in the Rotterdam Early Arthritis Cohort (tREACH), a stratified single-blinded trial with a treat-to-target (T2T) approach and fixed medication protocol, were included. Clinical outcomes include disease activity, medication usage, sustained disease-modifying antirheumatic drug (DMARD)-free remission (SDFR), and radiographic progression. In addition, the following PROs were investigated: general health, pain, functional ability, health-related quality of life, fatigue, productivity loss, and a possible depression or anxiety disorder. For comparisons over time, a mixed model or Cox proportional hazard model was used. The mixed models were adjusted for age, initial treatment, and disease activity (Disease Activity Score in 44 joints [DAS44]).</p><p><strong>Results: </strong>Female patients had a higher DAS44 over time compared to male patients (β 0.36, 95% CI 0.25-0.47, <i>P</i> < 0.001), which also resulted in more treatment adjustments including use of biologic DMARDs (bDMARDs; 36% vs 24%, <i>P</i> < 0.001). Although not significant, first bDMARD survival seemed shorter in female patients (hazard ratio [HR] 1.4, 95% CI 0.8-2.6, <i>P</i> = 0.24). However, no differences were found in SDFR and radiographic progression. With regard to PROs, only functional ability differed significantly between sexes after adjusting for confounders, including disease activity (Health Assessment Questionnaire-Disability Index, β 0.10, 95% CI 0.04-0.17, <i>P</i> < 0.001).</p><p><strong>Conclusion: </strong>Clinical outcomes and PROs are intertwined, and both improve with a T2T management approach. Nevertheless, female patients with RA have higher disease activity, a greater need for bDMARDs-although these have lower efficacy-and more functional impairment over time, underscoring the need for sex-specific management recommendations. (Trial registration number: ISRCTN26791028).</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"553-562"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143558055","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}