Rheumatology and Therapy最新文献

{"title":"Burden of Glucocorticoid Use and Risk of Toxicities Among Patients with Immunoglobulin-G4-Related Disease: A Retrospective US-Based Claims Study.","authors":"Zachary S Wallace, Jenny Y Park, Elizabeth Serra, Patrick Gagnon-Sanschagrin, Annie Guérin, Kristina Patterson, Haridarshan Patel, Vikesh K Singh","doi":"10.1007/s40744-025-00763-9","DOIUrl":"10.1007/s40744-025-00763-9","url":null,"abstract":"<p><strong>Introduction: </strong>Glucocorticoids are commonly used to treat immunoglobulin G4-related disease (IgG4-RD), but there is limited real-world evidence describing glucocorticoid-related toxicities in this population. This study assessed glucocorticoid use and toxicities during the first year after diagnosis among patients with IgG4-RD.</p><p><strong>Methods: </strong>The IQVIA PharMetrics® Plus database was used to identify adults with IgG4-RD using a validated algorithm. Patients were stratified according to glucocorticoid use during the 12-month study period following the first observed IgG4-RD-related diagnosis (index date): low glucocorticoid use (prednisone equivalent daily dose [PEDD] < 5 mg/day) or high glucocorticoid use (PEDD ≥ 5 mg/day). Incident glucocorticoid-related toxicities were assessed during the study period and incidence was compared between groups using Chi-square tests.</p><p><strong>Results: </strong>Among 295 patients with IgG4-RD, 150 (50.8%) had low glucocorticoid use, and 145 (49.2%) had high glucocorticoid use during the study period. In each glucocorticoid group, mean PEDD was highest in the 3 months post-index and subsequently decreased. At 12 months post-index, 24.7% of the low glucocorticoid use group and 60.7% of the high glucocorticoid use group were receiving glucocorticoids. The high glucocorticoid use group had a significantly higher mean (± standard deviation) number of incident glucocorticoid-related toxicities (1.8 ± 1.7 vs. 1.2 ± 1.3) and more frequently had ≥ 3 glucocorticoid-related toxicities (29.0% vs. 13.3%; both p < 0.01) compared to the low glucocorticoid use group. Specifically, cardiovascular- (29.0% vs. 18.7%), gastrointestinal- (29.7% vs. 16.0%), and infection-related (31.0% vs. 17.3%) toxicities were significantly more common in the high glucocorticoid use group than the low glucocorticoid use group (all p < 0.05).</p><p><strong>Conclusions: </strong>In this retrospective, claims-based analysis, high glucocorticoid use was seen in half of patients with IgG4-RD during the first year following diagnosis. Patients with high glucocorticoid use experienced significantly more incident glucocorticoid-related toxicities than those with low use during this first year.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"547-560"},"PeriodicalIF":2.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084433/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143812218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Letter to the Editor Regarding the Article \"Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials\".","authors":"YanRan Qiu, Jing Sun","doi":"10.1007/s40744-025-00750-0","DOIUrl":"10.1007/s40744-025-00750-0","url":null,"abstract":"","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"593-594"},"PeriodicalIF":2.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084459/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143634607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Disease-Modifying Therapies in Lupus Nephritis: A Narrative Review Evaluating Currently Used Pharmacologic Agents.","authors":"Anca D Askanase, Richard Furie, Maria Dall'Era, Andrew S Bomback, Andreas Schwarting, Ming-Hui Zhao, Ian N Bruce, Munther Khamashta, Bernard Rubin, Angela Carroll, Roger Abramino Levy, Ronald van Vollenhoven, Murray B Urowitz","doi":"10.1007/s40744-025-00752-y","DOIUrl":"10.1007/s40744-025-00752-y","url":null,"abstract":"<p><p>As more lupus nephritis (LN) medications become available, identifying treatments that are disease-modifying is critical in making treatment decisions. Based on our 2022 published working definition of LN disease modification as 'minimizing disease activity with the fewest treatment-associated toxicities and slowing progression to end-stage kidney disease' (ESKD), the objective of this review was to classify current LN treatments according to the proposed kidney disease modification criteria, excluding toxicities. Based upon a selection of LN clinical trial (n = 27) and observational study (n = 20) publications, as well as the authors' clinical experiences, we evaluated the disease modification potential for 16 LN treatments (inclusive of antimalarials, glucocorticoids, immunosuppressants, calcineurin inhibitors and biologics) according to the proposed kidney disease activity and organ damage criteria at year 1, years 2-5, and > 5-year time points. Fulfilling criteria at year 1 and years 2-5 was considered evidence for disease modification potential. Satisfying criteria at > 5 years (slowing or preventing progression in SLICC/ACR Damage Index [SDI] and ESKD, and/or doubling of serum creatinine) was used to confirm disease modification. Each treatment was designated as one of the following at each time point: (a) criterion met; (b) inconclusive; (c) no available supportive data. This review excluded an assessment of potential toxicities. All LN treatments met at least one of the potential kidney disease-modification criteria at any time point, but limited relevant data in the literature meant disease modification > 5 years could only be confirmed for cyclophosphamide. Belimumab met more criteria across the three time points than any other biologic treatment but lacked > 5-year data to confirm disease modification. Further research is needed to support the classification of LN treatments as disease modifiers, particularly for > 5 years. We discuss considerations for future studies, challenges to the classification, and possible updates to published criteria.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"421-434"},"PeriodicalIF":2.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084441/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Impact of IL-17A Inhibition in Rheumatic and Musculoskeletal Diseases: Current Insights and Future Prospects.","authors":"Sofia Ramiro, Georg Schett, Helena Marzo-Ortega, Wolfgang A Schmidt","doi":"10.1007/s40744-025-00754-w","DOIUrl":"10.1007/s40744-025-00754-w","url":null,"abstract":"<p><p>Interleukin-17A (IL-17A) plays a pivotal role in many rheumatic immune-mediated inflammatory diseases. Targeting the IL-17 pathway has transformed the way psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) are managed, with a number of IL-17A inhibitors now available for treating rheumatic and musculoskeletal diseases. This narrative review will describe the opportunities presented by novel imaging techniques in understanding the metabolic and mechanical changes that characterize the pathogenesis of PsA and axSpA. It will look at the current consensus definitions of early disease in PsA and axSpA, present evidence for the benefit of early treatment, and highlight the gaps in current knowledge. Finally, it will describe novel treatment targets to address the unmet needs in giant cell arteritis (GCA) and polymyalgia rheumatica (PMR) and discuss the potential role of IL-17A inhibition in treating GCA and PMR.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"435-451"},"PeriodicalIF":2.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084204/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144009770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Safety and Efficacy of Targeted Therapies in Rheumatoid Arthritis: A 5-Year, 5130-Case Follow-Up from FIRST Registry.","authors":"Koshiro Sonomoto, Shingo Nakayamada, Hiroaki Tanaka, Atsushi Nagayasu, Yoshiya Tanaka","doi":"10.1007/s40744-025-00762-w","DOIUrl":"10.1007/s40744-025-00762-w","url":null,"abstract":"<p><strong>Introduction: </strong>This work aims to illustrate the evolution and ongoing challenges of rheumatoid arthritis (RA) management with targeted therapy over 20 years, using a cohort study from the world's oldest society.</p><p><strong>Methods: </strong>Data were obtained from FIRST registry, a multicenter cohort of patients with RA treated with biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). Patients were followed for 60 months and assessed for drug efficacy, retention, and reasons for discontinuation.</p><p><strong>Results: </strong>Analysis of 5130 treatments over 16,616 person-years revealed shifts in strategies and demographics. Despite an aging population (51.9-64.3 years) with increasing comorbidities (lung disease: 11.1-36.2%, malignancy: 2.2-13.1%), b/tsDMARD use expanded to include patients with lower disease activity. With better disease control, discontinuations due to adverse events decreased, and particularly infections fell from 2.1 to 0.7 per 100 person-years. Remission rates improved over time in the naïve group but remained largely unchanged in the prior b/tsDMARDs group. Retention rates varied by bDMARD class, with TNF inhibitors (TNFi) showing a decrease over time and IL-6 receptor inhibitors (IL-6Ri) and CTLA4-Ig showing an increase in retention. TNFi had high remission rates but low retention, whereas CTLA4-Ig and IL-6Ri had lower remission rates and higher retention. Changes in functional improvement were modest overall, and in patients aged 75 years and older, functional gains remained limited.</p><p><strong>Conclusions: </strong>The study highlights the evolving landscape of RA management in an aging society, noting gains in efficacy and safety. However, unmet needs persist, particularly for patients not fully achieving treat-to-target goals and those with limited functional improvement.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"561-580"},"PeriodicalIF":2.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084202/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144034629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies.","authors":"Philip J Mease, Joseph F Merola, Yoshiya Tanaka, Laure Gossec, Iain B McInnes, Christopher T Ritchlin, Robert B M Landewé, Akihiko Asahina, Barbara Ink, Andrea Heinrichs, Rajan Bajracharya, Vishvesh Shende, Jason Coarse, Laura C Coates","doi":"10.1007/s40744-025-00761-x","DOIUrl":"10.1007/s40744-025-00761-x","url":null,"abstract":"","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"597-599"},"PeriodicalIF":2.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084428/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144009767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Experience with an Adalimumab Biosimilar (ABP 501) in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis in Europe: Results from the Adelphi Disease Specific Programme.","authors":"Ran Jin, James M Haughton, Emily J Goddard, Delphine Courmier, Waldemar Radziszewski, Rachael H Meadows, James Piercy, Stanley Cohen","doi":"10.1007/s40744-025-00755-9","DOIUrl":"10.1007/s40744-025-00755-9","url":null,"abstract":"<p><strong>Introduction: </strong>Biosimilars have provided additional treatment options for patients with immune-mediated inflammatory diseases. This study evaluated the real-world use of adalimumab biosimilar ABP 501 in European patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), or psoriasis (PsO).</p><p><strong>Methods: </strong>Data were drawn from the RA, spondyloarthritis, and PsO Adelphi Disease Specific Programmes (DSP)™, cross-sectional surveys conducted in France, Germany, Italy, Spain, and the UK between January 2020 and February 2022. Physicians completed patient record forms which collected data on demographics, treatment history, and clinical outcomes. Patients voluntarily completed questionnaires self-reporting health-related quality of life. Outcome measures were assessed for patients who initiated ABP 501 as the first advanced therapy (AT, \"ABP 501 initiators\") and patients who switched to ABP 501 from the first-line AT with reference product (RP) (\"RP-ABP 501 switchers\") in each indication.</p><p><strong>Results: </strong>Across disease cohorts, 868 initiators and 428 switchers were analyzed. At time of consultation, physicians reported that 77.1%, 63.2%, 67.8%, and 83.0% of initiators with RA, AS, PsA, and PsO, respectively, presented with mild disease after receiving ABP 501 for a median of 10.4-12.3 months. Among switchers, the most common reasons for switching were related to formulary or financial reasons and insurance restrictions. Most switching patients were assessed by physicians to have mild disease (75.0-87.5% across indications) at time of consultation having received ABP 501 for a median of 11.2-15.3 months. Patients' self-assessment, including EQ-5D and work productivity scores, indicated an overall good state of health while using ABP 501, regardless of indication and prior RP exposure. Overall, more than 89% of physicians and more than 86% patients reported being satisfied with the disease control provided by ABP 501.</p><p><strong>Conclusion: </strong>Across indications, both physicians and patients reported positive clinical outcomes and high levels of satisfaction with ABP 501 treatment, regardless of prior use of RP.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"469-492"},"PeriodicalIF":2.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084434/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143597515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Psychological Health in the Management of Patients with Psoriatic Arthritis: An Intricate Relationship.","authors":"Ennio Lubrano, Pasquale Ambrosino, Fabio Massimo Perrotta","doi":"10.1007/s40744-025-00759-5","DOIUrl":"10.1007/s40744-025-00759-5","url":null,"abstract":"<p><p>Psoriatic arthritis (PsA) is a chronic inflammatory disease that profoundly impacts both physical and psychosocial well-being. The disease can lead to a range of emotional difficulties, including anxiety, depression, and diminished self-esteem. The visible skin manifestations of psoriasis, coupled with the persistent pain and functional limitations of arthritis, can significantly affect body image and self-worth. Furthermore, the physical limitations and fatigue associated with PsA can affect social interaction, leading to isolation and exacerbating emotional distress. PsA can also disrupt work productivity as a result of pain, fatigue, and impaired physical function. Recognizing and addressing the psychosocial impact of PsA is paramount for comprehensive patient care. A multidisciplinary approach involving rheumatologists, psychologists, and other healthcare professionals is essential. Cognitive behavioral therapy, mindfulness-based stress reduction, and other psychological interventions can help patients with coping strategies for stress, anxiety, and depression. Support groups and peer-to-peer networks can provide invaluable emotional and practical assistance. Comprehensive disease management programs that address both physical and psychosocial needs could also be crucial for improving patient outcomes and overall quality of life. By acknowledging and addressing these concerns in conjunction with the physical symptoms, rheumatologist can facilitate improved patient outcomes and a better quality of life. This narrative review explores the intricate relationship between psychological health and PsA, highlighting the impact of psychological factors on disease outcomes and the potential benefits of integrating psychological interventions into routine clinical practice.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"407-419"},"PeriodicalIF":2.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084442/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143710128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High Neutrophil Alkaline Phosphatase Activity in Adult-Onset Still's Disease.","authors":"Nana Ding, Haiye Ren, Jialin Teng, Xiaobing Cheng, Junna Ye, Yutong Su, Hui Shi, Qiongyi Hu, Yue Sun, Jianfen Meng, Huihui Chi, Zhuochao Zhou, Jinchao Jia, Chengde Yang, Hong-Lei Liu","doi":"10.1007/s40744-025-00756-8","DOIUrl":"10.1007/s40744-025-00756-8","url":null,"abstract":"<p><strong>Introduction: </strong>Adult-onset Still's disease (AOSD) is an autoinflammatory disorder characterized by reactive neutrophilia and dysregulated cytokine release. Mature neutrophils exhibit increased alkaline phosphatase enzyme activity within cytoplasmic granules, particularly in response to inflammation or acute infection. However, whether neutrophil alkaline phosphatase (NAP) activity is elevated in active AOSD, a hyperinflammatory state, remains unclear.</p><p><strong>Methods: </strong>We enrolled 114 patients diagnosed with AOSD, 47 patients with diffuse large B-cell lymphoma (DLBCL), 25 patients with antiphospholipid syndrome (APS), 25 patients with systemic lupus erythematosus (SLE), and 30 healthy controls. Blood samples were collected and smears were prepared, stained, and analyzed to calculate the NAP score.</p><p><strong>Results: </strong>Our findings demonstrated that NAP scores were significantly elevated in patients with active AOSD compared to those with inactive disease, other rheumatic diseases, and healthy controls (HCs). Further analysis revealed strong positive correlations between the NAP score and white blood cell (WBC) count, neutrophil ratio (NE%), absolute neutrophil count (ANC), ferritin, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), alkaline phosphatase (ALP), and systemic disease activity score. Additionally, among patients with AOSD-pre-macrophage activation syndrome (MAS), NAP scores were significantly higher than in those with active AOSD without MAS. Receiver operating characteristic (ROC) curves showed that NAP scores were more effective than other clinical features in distinguishing active AOSD without MAS from patients with AOSD-pre-MAS. Unexpectedly, in patients with AOSD-MAS, NAP scores were significantly reduced compared to those with active AOSD without MAS, likely due to leukopenia.</p><p><strong>Conclusions: </strong>Our findings revealed that NAP scores were elevated in active AOSD and positively correlated with disease activity.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"513-527"},"PeriodicalIF":2.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084481/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143721301","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product.","authors":"Hans C Ebbers, Peter C Taylor, Xiaomei Leng, Wei Wei, Niamh M Kinsella, Yinbo Zhou, Xiaolei Yang, Paul Chamberlain","doi":"10.1007/s40744-025-00760-y","DOIUrl":"10.1007/s40744-025-00760-y","url":null,"abstract":"<p><strong>Introduction: </strong>Biosimilars need to demonstrate similarity in terms of quality, pharmacokinetics (PK), efficacy, safety, and immunogenicity. Here, we report the outcome of a comprehensive evaluation of the immunogenicity of the biosimilar BAT1806 compared with the tocilizumab reference product (TCZ).</p><p><strong>Methods: </strong>We conducted a post hoc analysis of study BAT1806-001-CR, a comparative PK study in healthy male volunteers (n = 129), and BAT1806-002-CR, a phase III, 52-week trial in patients with rheumatoid arthritis (n = 621). Anti-drug antibodies (ADA), ADA titers, and neutralizing ADA were measured, and their impact on PK, safety, and efficacy parameters were assessed.</p><p><strong>Results: </strong>In BAT1806-001-CR, treatment-induced ADA were observed in 37.8% of participants for the BAT1806 group, 28.6% for the EU-sourced TCZ group, and 31.0% for the US-sourced TCZ group, without an impact on PK and safety. In BAT1806-002-CR after 52 weeks, 28.2% of participants in the BAT1806 group developed treatment-induced ADA, compared with 24.0% in the TCZ group and 19.7% of participants who initiated TCZ and switched to BAT1806 at week 24. ADA-positive participants reported lower geometric mean serum tocilizumab trough concentrations than ADA-negative participants in all treatment groups. ADA-positive participants achieved similar efficacy outcomes to ADA-negative participants in all treatment groups. ADA were not associated with an incremental risk of treatment-emergent adverse events or hypersensitivity in any of the treatment groups.</p><p><strong>Conclusions: </strong>The results of these post hoc analyses did not indicate any clinically relevant differences in the immunogenicity profile of intravenously administered BAT1806 compared with TCZ.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifiers, NCT03606876, NCT03830203.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"529-546"},"PeriodicalIF":2.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084431/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143812133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}