Esraa Eloseily, Joy Elizabeth Baker, Grant Schulert, Alexei Grom
{"title":"Dr. Eloseily et al reply.","authors":"Esraa Eloseily, Joy Elizabeth Baker, Grant Schulert, Alexei Grom","doi":"10.3899/jrheum.2026-0555","DOIUrl":"10.3899/jrheum.2026-0555","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"1169"},"PeriodicalIF":3.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148457512","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}
Xenofon Baraliakos, Atul Deodhar, Désirée van der Heijde, Filip Van den Bosch, Marina Magrey, Walter P Maksymowych, Tetsuya Tomita, Huji Xu, Jason Coarse, Chetan Prajapati, Myriam Manente, Alexander Marten, Lianne S Gensler
{"title":"Bimekizumab Long-Term Safety and Efficacy Across the Spectrum of Axial Spondyloarthritis Over 3 Years: Results From 2 Phase III Studies.","authors":"Xenofon Baraliakos, Atul Deodhar, Désirée van der Heijde, Filip Van den Bosch, Marina Magrey, Walter P Maksymowych, Tetsuya Tomita, Huji Xu, Jason Coarse, Chetan Prajapati, Myriam Manente, Alexander Marten, Lianne S Gensler","doi":"10.3899/jrheum.2026-0113","DOIUrl":"10.3899/jrheum.2026-0113","url":null,"abstract":"<p><strong>Objective: </strong>The safety and efficacy of bimekizumab, a dual interleukin (IL)-17A and IL-17F inhibitor, have been demonstrated over 2 years across the full disease spectrum of axial spondyloarthritis (axSpA). We report long-term safety and efficacy of bimekizumab over 3 years.</p><p><strong>Methods: </strong>Patients who completed week 52 of the phase III BE MOBILE 1 (nonradiographic axial spondyloarthritis [axSpA]; ClinicalTrials.gov: NCT03928704) and BE MOBILE 2 (radiographic axSpA; NCT03928743) studies were eligible to enter an ongoing open-label extension (OLE; NCT04436640) and continue receiving subcutaneous bimekizumab 160 mg every 4 weeks. Safety outcomes for patients who received ≥ 1 dose of bimekizumab and efficacy outcomes for all randomized patients are reported over 3 years (164 weeks [112-week OLE]).</p><p><strong>Results: </strong>During the overall safety period, 90.4% (519/574) of patients had ≥ 1 treatment-emergent adverse event. Fungal infection exposure-adjusted incidence rate (EAIR) per 100 patient-years (PY) was 9.4 (the majority were <i>Candida</i> infections, 5.3/100 PY; most infections were mild or moderate, none were serious or systemic). The EAIRs per 100 PY for inflammatory bowel disease and uveitis were 0.5 and 1.5, respectively. No major adverse cardiovascular events or deaths occurred. EAIRs, including those for <i>Candida</i> infections, were generally lowest in the third year. The efficacy of bimekizumab observed through 2 years was sustained through week 164. At week 164, 57.0% of patients achieved an Axial Spondyloarthritis Disease Activity Score (ASDAS) indicating low disease activity (< 2.1), including 28.7% who achieved ASDAS inactive disease (< 1.3). Bimekizumab treatment also led to sustained improvements in Bath Ankylosing Spondylitis Functional Index (BASFI) and health-related quality of life scores and sustained control of magnetic resonance imaging (MRI) inflammation through week 164, with 59.4% and 77.8% of patients achieving Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joint scores < 2 and Berlin spine scores ≤ 2, respectively.</p><p><strong>Conclusion: </strong>Bimekizumab was well tolerated over 3 years, with no new safety signals observed. Across the full disease spectrum of axSpA, patients demonstrated sustained clinical efficacy and inflammation control over 3 years.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"1071-1082"},"PeriodicalIF":3.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148260352","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}
Ruth Ann Vleugels, Elena Peeva, Rohit Aggarwal, Myron Chu, Abigail Sloan, Natalie Rath, Emily Mangialardi, David Fiorentino
{"title":"Long-Term Safety and Efficacy of Dazukibart in Dermatomyositis: Combined Phase II Results From Double-Blind and Open-Label Extension Studies.","authors":"Ruth Ann Vleugels, Elena Peeva, Rohit Aggarwal, Myron Chu, Abigail Sloan, Natalie Rath, Emily Mangialardi, David Fiorentino","doi":"10.3899/jrheum.2026-0146","DOIUrl":"10.3899/jrheum.2026-0146","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the long-term safety and efficacy of dazukibart, a novel antiinterferon β monoclonal antibody, in adults with moderate-to-severe dermatomyositis (DM).</p><p><strong>Methods: </strong>Participants from 2 cohorts of DM (skin-predominant [SP] and muscle-predominant [MP]) completing a 24-week phase II, double-blind study, were enrolled into a 52-week phase IIb, open-label extension (OLE) study, with a 16-week follow-up post treatment (combined study duration: 92 weeks). The pooled skin analysis set included all SP and MP DM participants with baseline Cutaneous Dermatomyositis Disease Area and Severity Index-Activity (CDASI-A) scores ≥ 14. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs) from week 24 through week 92. Key secondary endpoints were change in CDASI-A and Total Improvement Score (TIS) from week 0 through week 92.</p><p><strong>Results: </strong>Participants who received ≥ 1 dose of dazukibart (600 mg) during the OLE study (comprising 9, 15, and 16 participants from the SP cohort, MP cohort, and pooled skin analysis set, respectively) were analyzed (median age 49.5 years, 83% female, 96% White). TEAEs were mild (55%), moderate (38%), or severe (7%), with no treatment-related serious AEs or treatment discontinuations. At week 76, CDASI-A scores improved, with a median change from baseline of -24.0 (range -33 to -12), -9.0 (range -32 to 1), and -23.5 (range -33 to -12) for participants from the SP cohort, MP cohort, and pooled skin analysis set, respectively. In the MP cohort, TIS (median 65.0, range 2.5-95.0) and associated core set measures, including patient-reported outcomes, improved at week 76. Overall, the observed improvements in outcomes, as indicated by the slight reduction in outcome measures, persisted during the 16-week posttreatment follow-up.</p><p><strong>Conclusion: </strong>The safety and efficacy profiles of dazukibart observed at 24 weeks were sustained through 92 weeks. (ClinicalTrials.gov: NCT03181893, NCT05192200).</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"1125-1134"},"PeriodicalIF":3.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148655007","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}
Paula García-Escudero, Ainhara Iturricha Ochoa de Echaguen, Sara Beltrán de Otalora García, Marta López I Gómez
{"title":"Uncharted Territory: Adult-Onset Autoinflammatory Syndrome With a Newly Identified Mutation in the Coatomer WD-Associated Region of the <i>COPA</i> Gene.","authors":"Paula García-Escudero, Ainhara Iturricha Ochoa de Echaguen, Sara Beltrán de Otalora García, Marta López I Gómez","doi":"10.3899/jrheum.2025-1267","DOIUrl":"10.3899/jrheum.2025-1267","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"1163-1166"},"PeriodicalIF":3.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148260426","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}
Rudra P Goswami, Vamshikrishna Patel Kotha, Manupati Surya
{"title":"Multitarget Therapy With Rituximab Plus Mycophenolate Mofetil Versus Rituximab Monotherapy in Systemic Sclerosis-Associated Interstitial Lung Disease.","authors":"Rudra P Goswami, Vamshikrishna Patel Kotha, Manupati Surya","doi":"10.3899/jrheum.2026-0069","DOIUrl":"10.3899/jrheum.2026-0069","url":null,"abstract":"<p><strong>Objective: </strong>To compare the effectiveness and safety of rituximab (RTX) plus mycophenolate mofetil (MMF) vs RTX monotherapy in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).</p><p><strong>Methods: </strong>We performed a retrospective comparative analysis among adults with radiologically confirmed SSc-ILD treated with RTX monotherapy or RTX plus MMF (a multitarget approach [MTT]) as an RTX-based treatment strategy. The primary outcome was improvement in percent predicted forced vital capacity (FVC%) > 5 percentage points at the end of the second year (ΔFVC > +5). Secondary outcomes included longitudinal FVC trajectories over 3 years, skin involvement, and safety. Longitudinal analyses used linear mixed-effects models, with additional sensitivity analyses using inverse probability of treatment weighting.</p><p><strong>Results: </strong>Among 109 patients (MTT, n = 42; RTX, n = 67), baseline FVC% was lower in the MTT group (50.6 vs 61.0). At the end of 2 years, ΔFVC > +5 occurred in 69% of patients receiving MTT compared with 33% receiving RTX alone. Over 3 years, the adjusted mean increase in FVC% was greater in the MTT group than in the monotherapy group (+12.9% vs +4.4%), with early separation of lung function trajectories that was sustained throughout follow-up. The association between MTT and greater FVC improvement remained consistent across prespecified subgroups, including patients with severe baseline restriction (FVC% < 45%). Herpes zoster occurred more frequently in the MTT group, whereas serious infections were uncommon in both groups.</p><p><strong>Conclusion: </strong>In this real-world study, RTX plus MMF was associated with favorable longitudinal FVC% trajectories compared with RTX monotherapy in a nonrandomized cohort, despite greater baseline disease severity in the MTT group. These findings support prospective evaluation of MTT, particularly in high-risk patients.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148763591","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":"Plasma Exchange for Alveolar Hemorrhage in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: Reframing the Evidence Through Bayesian Analysis.","authors":"Lisa Uchida, David R W Jayne","doi":"10.3899/jrheum.2026-0582","DOIUrl":"10.3899/jrheum.2026-0582","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"1055-1057"},"PeriodicalIF":3.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148654955","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":"Phoenixin-14 as a Potential Limiting Neuropeptide for Exaggerated Inflammation in Familial Mediterranean Fever and Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis: A Comparative Study.","authors":"Semra Ayduran, Gülşah Kılbaş, Saadet Nilay Tığrak, İlknur Kaleli, Melek Demir, Serkan Türkuçar","doi":"10.3899/jrheum.2026-0178","DOIUrl":"10.3899/jrheum.2026-0178","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to evaluate serum phoenixin-14 (PNX-14) levels in patients with familial Mediterranean fever (FMF) and periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis (PFAPA) during both attack and attack-free periods to investigate its potential biomarker value.</p><p><strong>Methods: </strong>In total, 140 children were included in this cross-sectional study: 46 with FMF, 48 with PFAPA, and 46 healthy children. Blood samples were collected during both febrile and attack-free periods in the patients with FMF and PFAPA, whereas samples from healthy controls were collected at a single timepoint. C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), fibrinogen, and serum PNX-14 levels were evaluated. Serum PNX-14 levels were measured using ELISA. SPSS 25 (IBM) was used for statistical analyses.</p><p><strong>Results: </strong>PNX-14 levels were significantly higher during attack periods in FMF and PFAPA patients compared to attack-free periods and healthy controls (<i>P</i> < 0.001). PNX-14 levels during attack-free periods were also higher in both patient groups than in healthy controls (<i>P</i> < 0.001). Although a positive correlation was observed between PNX-14 levels and CRP (ρ 0.222, <i>P</i> = 0.04), no significant correlation was observed with ESR, SAA, or fibrinogen. No significant associations were observed between PNX-14 levels and disease severity (Pras disease severity score), colchicine treatment duration, or daily colchicine dose in the FMF group.</p><p><strong>Conclusion: </strong>PNX-14 may be part of a neuroimmune response aimed at resolving inflammation in autoinflammatory processes and could be a potential immunomodulatory biomarker. PNX-14 may be a complementary indicator reflecting inflammatory burden or the healing process.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148764382","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":"Distinction Between Anti-Ro52/TRIM21 and Anti-Ro60/TROVE2 in the Ro/SSA Autoantibody System.","authors":"Adrian Y S Lee","doi":"10.3899/jrheum.2026-0478","DOIUrl":"https://doi.org/10.3899/jrheum.2026-0478","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148978556","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":"Drs. Wei and Mo reply.","authors":"Xiuning Wei, Yingqian Mo","doi":"10.3899/jrheum.2026-0800","DOIUrl":"https://doi.org/10.3899/jrheum.2026-0800","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148978602","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":"From Detection to Prediction: Toward Prevention of Structural Progression in Rheumatoid Arthritis.","authors":"Shigeru Ohno","doi":"10.3899/jrheum.2026-0805","DOIUrl":"https://doi.org/10.3899/jrheum.2026-0805","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148978638","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}