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Evaluation of Injection Site Pain and Adherence in Patients Transitioning from a High to Low Volume Adalimumab Formulation (AVT02, Simlandi®) Across Multiple Indications (EASE PAIN). 多适应症(EASE Pain)患者从大剂量阿达木单抗制剂(AVT02, Simlandi®)过渡到小剂量阿达木单抗制剂(AVT02, Simlandi®)的注射部位疼痛和依从性评估
IF 2.9 3区 医学
Rheumatology and Therapy Pub Date : 2026-04-10 DOI: 10.1007/s40744-026-00846-1
Dara K Shahrokh, Ronald B Vender, Charles W Lynde, Jaggi Rao, Waqqas Afif, A Hillary Steinhart, Neeraj Narula, Evelyn Sutton, Carter Thorne, Louis Bessette
{"title":"Evaluation of Injection Site Pain and Adherence in Patients Transitioning from a High to Low Volume Adalimumab Formulation (AVT02, Simlandi®) Across Multiple Indications (EASE PAIN).","authors":"Dara K Shahrokh, Ronald B Vender, Charles W Lynde, Jaggi Rao, Waqqas Afif, A Hillary Steinhart, Neeraj Narula, Evelyn Sutton, Carter Thorne, Louis Bessette","doi":"10.1007/s40744-026-00846-1","DOIUrl":"https://doi.org/10.1007/s40744-026-00846-1","url":null,"abstract":"<p><strong>Introduction: </strong>Injection site pain (ISP) is a frequent concern with subcutaneous adalimumab therapy and may negatively affect treatment adherence and patient satisfaction. AVT02 is a high-concentration, low-volume (40 mg/0.4 mL), citrate-free biosimilar of reference product (RP) adalimumab (40 mg/0.8 mL; citrate-containing). The EASE PAIN study evaluated the real-world impact of switching from adalimumab RP or another biosimilar to AVT02 on ISP and patient-reported outcomes over 180 days.</p><p><strong>Methods: </strong>The EASE PAIN study (NCT05913817) was a national, observational, prospective phase IV study with a 6-month follow-up. The study enrolled Canadian patients with gastrointestinal conditions (Crohn's disease [CD], ulcerative colitis [UC]), rheumatological conditions (rheumatoid arthritis [RA], ankylosing spondylitis [AS], psoriatic arthritis [PsA]) or dermatological conditions (hidradenitis suppurativa [HS], psoriasis [PsO]). Participants were eligible if their treating physician had already decided to switch them from a high-volume RP or alternative adalimumab biosimilar to low-volume AVT02. The study assessed ISP measured via the Visual Analog Scale (VAS), adherence via the compliance rate, patient satisfaction and perception of change in pain via the Likert scale, injection site reactions (ISR) via a checklist (bleeding, burning, erythema, itching, soreness, swelling), quality of life based on EQ-5D-5L, and disease activity via the patient and physician global assessment scores for participants up to day 180 after switching. Healthcare utilization was measured as per the frequency, type, and volume of medical services accessed.</p><p><strong>Results: </strong>The intention-to-treat (ITT) population comprised 324 participants. Following the first administration of AVT02, mean ISP VAS scores improved by - 19.9 ± 26.1 mm compared with baseline. Adherence rate was 93.4% overall. More than 74.4% of patients reported being mostly or completely satisfied with treatment, and 76.9% of the participants perceived AVT02 as less painful as measured by the 5-Likert scale. Moreover, a lower number of patients experienced ISRs after their first dose of AVT02 (36 patients; 12.4%) compared with their last dose of high-volume adalimumab (124 patients; 42.3%). Quality-of-life scores remained stable throughout follow-up. No clinically meaningful changes were observed in disease activity or healthcare utilization.</p><p><strong>Conclusions: </strong>In this real-world Canadian study, switching from adalimumab RP or alternative biosimilar to AVT02 was associated with reductions in ISP and reactions while maintaining high adherence, patient satisfaction, quality of life, and disease control across multiple indications.</p><p><strong>Trial registration: </strong>This trial is registered with ClinicalTrials.gov: NCT05913817.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147654838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction: Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. 更正:使用匹配调整间接比较,比美珠单抗和Secukinumab在银屑病关节炎患者中52周的比较有效性。
IF 2.9 3区 医学
Rheumatology and Therapy Pub Date : 2026-04-08 DOI: 10.1007/s40744-026-00831-8
Philip J Mease, Richard B Warren, Peter Nash, Jean-Marie Grouin, Nikos Lyris, Damon Willems, Vanessa Taieb, Jason Eells, Iain B McInnes
{"title":"Correction: Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison.","authors":"Philip J Mease, Richard B Warren, Peter Nash, Jean-Marie Grouin, Nikos Lyris, Damon Willems, Vanessa Taieb, Jason Eells, Iain B McInnes","doi":"10.1007/s40744-026-00831-8","DOIUrl":"https://doi.org/10.1007/s40744-026-00831-8","url":null,"abstract":"","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147634149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patients' Perspectives Regarding Ankylosing Spondylitis Treatment Administration Features: Evidence from Qualitative Interviews and a Multinational Quantitative Preference Survey. 患者对强直性脊柱炎治疗给药特点的看法:来自定性访谈和跨国定量偏好调查的证据。
IF 2.9 3区 医学
Rheumatology and Therapy Pub Date : 2026-04-01 Epub Date: 2026-01-20 DOI: 10.1007/s40744-025-00824-z
Atul Deodhar, Martine C Maculaitis, Lewis Kopenhafer, Kathleen Beusterien, You-Li Ling, Brett Hauber, Joseph C Cappelleri, Arne Yndestad, Lawrence Rick Phillips, Mostafa Zayed
{"title":"Patients' Perspectives Regarding Ankylosing Spondylitis Treatment Administration Features: Evidence from Qualitative Interviews and a Multinational Quantitative Preference Survey.","authors":"Atul Deodhar, Martine C Maculaitis, Lewis Kopenhafer, Kathleen Beusterien, You-Li Ling, Brett Hauber, Joseph C Cappelleri, Arne Yndestad, Lawrence Rick Phillips, Mostafa Zayed","doi":"10.1007/s40744-025-00824-z","DOIUrl":"10.1007/s40744-025-00824-z","url":null,"abstract":"<p><strong>Introduction: </strong>Advanced therapies (ATs) for ankylosing spondylitis (AS) vary in processes related to treatment administration. We hypothesized that treatment preferences for patients with AS vary based on AT experience and disease status.</p><p><strong>Methods: </strong>This cross-sectional, mixed-methods study collected data from adults (aged ≥ 18 years) in the United States, United Kingdom, and Italy who had a confirmed AS diagnosis and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and/or were currently taking AT. Burdensome aspects of AS and important AT administration attributes were identified in qualitative interviews with ten eligible patients. A cross-sectional online survey was also conducted, including a best-worst scaling (BWS) exercise with 12 treatment administration-related attributes and a series of six fixed-choice tasks, which presented two options varying only in mode and frequency of administration. Attribute relative importance was calculated from BWS data to sum to 100 across attributes. Frequencies and percentages were reported for fixed-choice tasks. Preferences from BWS data were compared by treatment/disease status (on AT/well controlled, on AT/not well controlled, not on AT/not well controlled) using one-way analysis of variance tests.</p><p><strong>Results: </strong>In qualitative interviews, patients reported pain (70.0%) and symptom unpredictability (50.0%) as the most bothersome aspects of AS. Overall, 210 patients (mean age 44.0 years) completed the survey; 37.6% were currently on AT. Patients not on AT/not well controlled preferred oral dosing, and patients on AT/well controlled preferred once-monthly injection and avoiding office/clinic visits; attribute relative importance estimates for patients currently on AT/not well controlled typically fell midway between the other groups. Most patients currently on AT/well controlled (range 78.6-100.0%) preferred injectable over oral options. Many on AT/not well controlled preferred once-daily pill over once-monthly (30.8%) or twice-monthly (40.0%) injections; once-monthly injection was preferred over oral options (range 60.0-69.2%). Many patients not currently on AT/not well controlled (range 50.4-68.7%) preferred oral over injectable options.</p><p><strong>Conclusions: </strong>Treatment preferences differed depending on whether AT was currently used and disease was well controlled. Findings enhance understanding of which patients may prefer different modes of AT administration.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"329-346"},"PeriodicalIF":2.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996488/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146012196","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}
引用次数: 0
Efficacy and Safety of Tofacitinib and Adalimumab in Rheumatoid Arthritis by Body Mass Index-Normalized Methotrexate Dose: A Post Hoc Analysis. 托法替尼和阿达木单抗对类风湿关节炎的疗效和安全性:体重指数-标准化甲氨蝶呤剂量的事后分析。
IF 2.9 3区 医学
Rheumatology and Therapy Pub Date : 2026-04-01 Epub Date: 2026-01-22 DOI: 10.1007/s40744-025-00823-0
Tsutomu Takeuchi, Yoshiya Tanaka, Hisashi Yamanaka, Kunihiro Yamaoka, Naonobu Sugiyama, Noriko Iikuni, Shigeyuki Toyoizumi, Kenneth Kwok, Wen-Chan Tsai, Eduardo Mysler, Robert J Moots, Josef S Smolen, Roy Fleischmann
{"title":"Efficacy and Safety of Tofacitinib and Adalimumab in Rheumatoid Arthritis by Body Mass Index-Normalized Methotrexate Dose: A Post Hoc Analysis.","authors":"Tsutomu Takeuchi, Yoshiya Tanaka, Hisashi Yamanaka, Kunihiro Yamaoka, Naonobu Sugiyama, Noriko Iikuni, Shigeyuki Toyoizumi, Kenneth Kwok, Wen-Chan Tsai, Eduardo Mysler, Robert J Moots, Josef S Smolen, Roy Fleischmann","doi":"10.1007/s40744-025-00823-0","DOIUrl":"10.1007/s40744-025-00823-0","url":null,"abstract":"<p><strong>Introduction: </strong>This post hoc analysis assessed tofacitinib and adalimumab efficacy and safety, stratified by baseline methotrexate (MTX) dose, in patients with rheumatoid arthritis (RA) in the Oral Rheumatoid Arthritis triaL (ORAL) Strategy study.</p><p><strong>Methods: </strong>ORAL Strategy (NCT02187055) was a global, 1-year, phase 3b/4 study. Patients with RA and an inadequate response to MTX were randomized to tofacitinib 5 mg twice daily (BID), tofacitinib 5 mg BID plus MTX, or adalimumab 40 mg once every 2 weeks plus MTX, with MTX dosed per the last weekly dose pre-randomization. This post hoc analysis stratified patients by MTX dose in tertiles normalized by body mass index (BMI) and weight at baseline. Efficacy was assessed using American College of Rheumatology (ACR) 50 response rates at month 6 (primary endpoint); safety was assessed throughout. Efficacy and safety were analyzed descriptively.</p><p><strong>Results: </strong>Of 1146 patients, 97 received MTX < 15 mg/week at baseline, 712 received 15-17.5 mg/week, and 337 received > 17.5 mg/week. In the tofacitinib and adalimumab combination therapy groups, similar ACR50 response rates at month 6 were observed across the baseline BMI-normalized MTX dose tertiles. This trend was also observed in the tofacitinib monotherapy group; however, the ACR50 response rates at month 6 were numerically higher with combination versus tofacitinib monotherapy, regardless of baseline BMI-normalized MTX dose tertile. Generally similar results were observed for the baseline weight-normalized MTX data. No clear trends across baseline BMI-normalized MTX dose tertiles were observed for safety outcomes.</p><p><strong>Conclusions: </strong>In ORAL Strategy, tofacitinib efficacy was generally similar, and there were no clear safety trends regardless of baseline BMI-normalized MTX dose.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT02187055.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"423-434"},"PeriodicalIF":2.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996443/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146019514","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}
引用次数: 0
Renal Flares and Health-Related Quality of Life Among Patients with Lupus Nephritis: A Post Hoc Analysis of Control Arm Data from the LUNAR Phase 3 Clinical Trial. 狼疮性肾炎患者的肾脏耀斑和健康相关生活质量:LUNAR 3期临床试验对照组数据的事后分析
IF 2.9 3区 医学
Rheumatology and Therapy Pub Date : 2026-04-01 Epub Date: 2026-02-28 DOI: 10.1007/s40744-026-00827-4
Seitaro Yoshida, Christophe Toukam Tchakoute, Huiyan Ashley Mao, Gene Wallenstein, Jorge A Ross Terres, Lisa Lindsay
{"title":"Renal Flares and Health-Related Quality of Life Among Patients with Lupus Nephritis: A Post Hoc Analysis of Control Arm Data from the LUNAR Phase 3 Clinical Trial.","authors":"Seitaro Yoshida, Christophe Toukam Tchakoute, Huiyan Ashley Mao, Gene Wallenstein, Jorge A Ross Terres, Lisa Lindsay","doi":"10.1007/s40744-026-00827-4","DOIUrl":"10.1007/s40744-026-00827-4","url":null,"abstract":"<p><strong>Introduction: </strong>Preserving kidney function and limiting renal flares are important treatment goals for patients with lupus nephritis (LN). The relationship between renal flares and health-related quality of life (HRQOL) was assessed in patients with LN receiving standard therapy in the LUNAR phase 3 clinical trial.</p><p><strong>Methods: </strong>A post hoc analysis was conducted on data collected from patients with biopsy-confirmed class III/IV ± V LN randomized to the control arm of the phase 3 LUNAR (NCT00282347) trial. Relationships between renal flare(s) (estimated glomerular filtration rate decrease > 20% and urine-to-creatinine ratio [UPCR] > 1 g/g; increase in UPCR > 1 if UPCR < 0.2 g/g or UPCR > 2 if UPCR ≥ 0.2 g/g; or receipt of rescue therapy compared with week 16 when steroid tapering occurred) and mean change in HRQOL score across eight 36-Item Short Form Health Survey (SF-36) domains and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) were assessed using multivariate analysis of covariance (ANCOVA) modeling.</p><p><strong>Results: </strong>Among 72 patients receiving standard therapy, renal flare occurred in 24 patients (33%) (flare rate 3.18 per 1000 person days). Domain-specific mean SF-36 HRQOL scores and FACIT-Fatigue scores improved over time among study participants receiving standard therapy. Multivariate analyses identified a significant impact of experiencing one or more renal flares on mean change in FACIT-Fatigue score as well as the following SF-36 domains: physical functioning, role physical, bodily pain, vitality, and social functioning.</p><p><strong>Conclusions: </strong>Renal flares in patients with LN significantly impact their HRQOL as measured by the SF-36 and the FACIT-Fatigue, highlighting the importance of preserving kidney function from the patient perspective among those with LN.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"375-387"},"PeriodicalIF":2.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996503/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147318147","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}
引用次数: 0
Efficacy of Ixekizumab in Chinese Patients with Radiographic-Axial Spondyloarthritis by Baseline Inflammation Status on Magnetic Resonance Imaging. 依谢珠单抗在中国中轴性脊柱炎患者的基线炎症状态磁共振成像的疗效。
IF 2.9 3区 医学
Rheumatology and Therapy Pub Date : 2026-04-01 Epub Date: 2026-01-06 DOI: 10.1007/s40744-025-00819-w
Xiaoxia Zhu, Jiankang Hu, Dongzhou Liu, Jingyang Li, Huaxiang Wu, Lingyun Sun, Lie Dai, Chunyu Tan, Zhijun Li, Zhengyu Xiao, Yongfu Wang, Lingli Dong, Yan Yan, Hongying Li, Hejian Zou
{"title":"Efficacy of Ixekizumab in Chinese Patients with Radiographic-Axial Spondyloarthritis by Baseline Inflammation Status on Magnetic Resonance Imaging.","authors":"Xiaoxia Zhu, Jiankang Hu, Dongzhou Liu, Jingyang Li, Huaxiang Wu, Lingyun Sun, Lie Dai, Chunyu Tan, Zhijun Li, Zhengyu Xiao, Yongfu Wang, Lingli Dong, Yan Yan, Hongying Li, Hejian Zou","doi":"10.1007/s40744-025-00819-w","DOIUrl":"10.1007/s40744-025-00819-w","url":null,"abstract":"<p><strong>Introduction: </strong>We report an exploratory subgroup analysis of a Chinese phase 3 study to investigate the effect of baseline inflammation measured by magnetic resonance imaging (MRI) on ixekizumab efficacy in radiographic axial spondyloarthritis (r-axSpA).</p><p><strong>Methods: </strong>Adults with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W) or placebo for 16 weeks. Endpoints analyzed by baseline Spondyloarthritis Research Consortium of Canada (SPARCC) MRI spine or sacroiliac joint (SIJ) inflammation score (< 2 or ≥ 2; elevated inflammation defined as score ≥ 2) were: Assessment of SpondyloArthritis International Society 40 (ASAS40); Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50); Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1; ASDAS clinically important improvement (CII; change from baseline ≥ 1.1); Patient Global Assessment of Disease Activity (PtGA); spinal pain; nocturnal spinal pain; stiffness/inflammation; function; fatigue; Short Form-36 Physical Component Score (SF-36 PCS); European Quality of Life 5 Dimensions 5 Levels visual analog scale (EQ-5D-5L VAS).</p><p><strong>Results: </strong>Overall, 145 patients were included. At Week 16, ASAS40 response rates were numerically improved with IXEQ4W versus placebo in the SPARCC MRI spine score < 2 subgroup (40.9% vs. 14.3%; p = 0.088) and significantly improved in the ≥ 2 subgroup (37.3% vs. 5.9%; p < 0.001). ASAS40 response rates were significantly improved in the SPARCC MRI SIJ score < 2 (34.4% vs. 8.6%; p < 0.05) and ≥ 2 (41.5% vs. 8.1%; p < 0.001) subgroups. Similar results were obtained on BASDAI50, ASDAS < 2.1, and ASDAS CII. IXEQ4W significantly improved PtGA, inflammation, and fatigue across all subgroups. Spinal and nocturnal spinal pain were significantly improved in the SPARCC MRI spine score ≥ 2 subgroup and both SPARCC MRI SIJ score subgroups. Function and SF-36 PCS were significantly improved in the SPARCC MRI spine score ≥ 2 subgroup. There were no significant differences in EQ-5D-5L VAS.</p><p><strong>Conclusion: </strong>These findings support IXEQ4W as an effective treatment for Chinese patients with r-axSpA, irrespective of baseline MRI inflammation.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT04285229.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"313-327"},"PeriodicalIF":2.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996569/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145912707","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}
引用次数: 0
Quantifying Disease Activity Despite Treatment with Tumor Necrosis Factor Inhibitors Among Patients with Psoriatic Arthritis and Axial Spondyloarthritis: Real-World Results from the PPD CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. 量化银屑病关节炎和轴性脊柱炎患者的疾病活动性,尽管使用肿瘤坏死因子抑制剂治疗:来自PPD CorEvitas银屑病关节炎/脊柱炎登记的真实世界结果
IF 2.9 3区 医学
Rheumatology and Therapy Pub Date : 2026-04-01 Epub Date: 2026-01-07 DOI: 10.1007/s40744-025-00813-2
Philip Mease, Xiaolan Ye, Christopher D Saffore, Bhumik Parikh, Sandra Ciecinski, Taylor Blachley, Melissa Eliot, Nicole Middaugh, Alexis Ogdie
{"title":"Quantifying Disease Activity Despite Treatment with Tumor Necrosis Factor Inhibitors Among Patients with Psoriatic Arthritis and Axial Spondyloarthritis: Real-World Results from the PPD CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry.","authors":"Philip Mease, Xiaolan Ye, Christopher D Saffore, Bhumik Parikh, Sandra Ciecinski, Taylor Blachley, Melissa Eliot, Nicole Middaugh, Alexis Ogdie","doi":"10.1007/s40744-025-00813-2","DOIUrl":"10.1007/s40744-025-00813-2","url":null,"abstract":"<p><strong>Introduction: </strong>Although tumor necrosis factor inhibitors (TNFis) have improved management of psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA); many patients experience suboptimal disease control. We quantified achievement of varying degrees of disease activity in patients with PsA and axSpA who initiated and maintained TNFi treatment for 12 months.</p><p><strong>Methods: </strong>Patients with PsA or axSpA enrolled in the PPD™ CorEvitas™ PsA/Spondyloarthritis Registry were included in the study. Varying degrees of disease control were quantified based on minimal disease activity (MDA) status for PsA and BASDAI50 (≥ 50% improvement in Bath Ankylosing Spondylitis Disease Activity Index) status for axSpA at 6 and 12 months. Patients were categorized into four groups: sustained (MDA/BASDAI50 at 6 and 12 months), improved (MDA/BASDAI50 at 12 months only), worsened (MDA/BASDAI50 at 6 months only), and never achieved (no MDA/BASDAI50 at 6 or 12 months).</p><p><strong>Results: </strong>For PsA, 338 patients initiated and persisted on TNFis. At 6 months, the majority (65%, n = 221) did not achieve MDA status; of these, 86% (n = 189) still did not achieve MDA at 12 months. For axSpA, 152 patients initiated and persisted on TNFis. At 6 months, 80% (n = 121) did not achieve BASDAI50; among these patients, 91% (n = 110) still did not achieve BASDAI50 status at 12 months. For both PsA and axSpA initiators, the risk of not achieving clinical or quality of life outcomes was two- to threefold lower in patients who never achieved versus patients who achieved and sustained MDA/BASDAI50.</p><p><strong>Conclusion: </strong>More than 80% of patients with PsA or axSpA who did not achieve low disease activity at 6 months still did not achieve low disease activity by 12 months even though they persisted on TNFi treatment. These findings underscore the importance for physicians to consider modifying therapy if treatment targets with TNFi have not been achieved in the first 6 months.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"403-421"},"PeriodicalIF":2.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996473/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145912836","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}
引用次数: 0
Safety and Effectiveness of Canakinumab in Patients with Systemic Juvenile Idiopathic Arthritis in Japan: A Post-Marketing Surveillance Study. Canakinumab在日本系统性青少年特发性关节炎患者中的安全性和有效性:一项上市后监测研究
IF 2.9 3区 医学
Rheumatology and Therapy Pub Date : 2026-04-01 Epub Date: 2026-01-30 DOI: 10.1007/s40744-025-00822-1
Fumio Akita, Noriko Seko, Tomohiro Yoneda
{"title":"Safety and Effectiveness of Canakinumab in Patients with Systemic Juvenile Idiopathic Arthritis in Japan: A Post-Marketing Surveillance Study.","authors":"Fumio Akita, Noriko Seko, Tomohiro Yoneda","doi":"10.1007/s40744-025-00822-1","DOIUrl":"10.1007/s40744-025-00822-1","url":null,"abstract":"<p><strong>Introduction: </strong>Canakinumab was approved in Japan for the treatment of patients with systemic juvenile idiopathic arthritis (sJIA) in 2018, following an open-label, single-arm phase III study performed in 19 Japanese patients with sJIA. Given this limited sample size, Japanese regulatory authorities required an all-case post-marketing surveillance study as part of the approval conditions, aiming to assess the long-term safety and effectiveness of canakinumab in Japanese patients with sJIA in clinical practice and characterise the clinical course of any cases of macrophage activation syndrome (MAS).</p><p><strong>Methods: </strong>This was a multicentre, central registration, all-case, uncontrolled, open-label, special drug use investigation, including all patients who received canakinumab for the treatment of sJIA between 2 July 2018 and 20 December 2024. Patients were treated according to the investigators' routine clinical practice and observed for up to 104 weeks.</p><p><strong>Results: </strong>The safety analysis population included 125 patients with a median duration of treatment (including interruptions) of 710.0 (range 1-729) days and median total number of doses of 25.0 (range 1-29). Adverse events (AEs) occurred in 91 out of 125 patients (72.8%), with the most common being relapse, worsening or exacerbation of Still's disease (24 patients, 19.2%), followed by upper respiratory tract inflammation (18 patients, 14.4%). Serious related AEs occurred in 22 patients (17.6%), with the most common being haemophagocytic lymphohistiocytosis (HLH; 5 patients, 4.0%). A total of ten MAS-related AEs were reported; all were cases of HLH and were considered serious, and all were resolved or were resolving at the time of reporting. Effectiveness outcomes, including glucocorticoid tapering, disease activity reduction and inflammatory marker normalisation, were durable through 2 years of treatment.</p><p><strong>Conclusion: </strong>Canakinumab showed a favourable long-term safety profile and sustained effectiveness in Japanese patients with sJIA inadequately controlled by existing therapies. No new safety concerns emerged, and the safety profile was comparable to that observed in the earlier phase III study.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"361-373"},"PeriodicalIF":2.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146086908","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}
引用次数: 0
Unravelling Fibromyalgia in Psoriatic Arthritis. 银屑病关节炎中的纤维肌痛。
IF 2.9 3区 医学
Rheumatology and Therapy Pub Date : 2026-04-01 Epub Date: 2026-02-27 DOI: 10.1007/s40744-026-00825-6
Kate E Findeisen, Emma K Guymer, Geoffrey O Littlejohn
{"title":"Unravelling Fibromyalgia in Psoriatic Arthritis.","authors":"Kate E Findeisen, Emma K Guymer, Geoffrey O Littlejohn","doi":"10.1007/s40744-026-00825-6","DOIUrl":"10.1007/s40744-026-00825-6","url":null,"abstract":"<p><p>Fibromyalgia is a common condition causing widespread pain, fatigue, sleep disturbance, and cognitive dysfunction. It frequently coexists with chronic rheumatic diseases, including psoriatic arthritis (PsA), complicating diagnosis and management. This narrative review explores the interaction between fibromyalgia and PsA, highlighting recent studies that demonstrate that between 18% and 64% of patients with PsA have fibromyalgia with significant impact on disease assessment and quality of life. Patients with fibromyalgia have markedly higher scores for pain, tenderness, fatigue, poor sleep, and standard PsA disease activity measures. Where this overlap occurs \"disease activity\" indices often reflect fibromyalgia symptoms rather than true inflammation, leading to potential overtreatment with disease-modifying drugs rather than appropriate pain-modulating or lifestyle interventions. Additionally, fibromyalgia symptoms exist along a continuum, with many patients showing subthreshold manifestations that still affect function and well-being. Tools such as the Fibromyalgia Impact Questionnaire and Polysymptomatic Distress Scale help distinguish the central sensitization symptoms that characterize fibromyalgia from inflammatory activity and damage in joints and tendon sheaths that characterize PsA. Both peripheral and central pain-related neural mechanisms, including comorbid factors such as obesity and disease burden, contribute to fibromyalgia in PsA. Activation of the stress response likely contributes significantly to fibromyalgia in this setting. Fibromyalgia itself is seen not simply as a comorbidity but as part of the body's neurobiological stress response to chronic illness. Recognizing fibromyalgia within PsA is crucial to tailor management, improve outcomes, and avoid unnecessary treatments. This complex clinical picture requires nuanced management beyond that of inflammation alone.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"299-311"},"PeriodicalIF":2.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996466/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147309623","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}
引用次数: 0
Serum SCUBE1 and SCUBE2 Levels in Children with Immunoglobulin A Vasculitis: An Exploratory Study. 免疫球蛋白A血管炎患儿血清SCUBE1和SCUBE2水平的探索性研究
IF 2.9 3区 医学
Rheumatology and Therapy Pub Date : 2026-04-01 Epub Date: 2026-03-06 DOI: 10.1007/s40744-026-00836-3
Gulbahar Kurt Bayir, Ferhat Demir, Suleyman Caner Karahan, Mukaddes Kalyoncu
{"title":"Serum SCUBE1 and SCUBE2 Levels in Children with Immunoglobulin A Vasculitis: An Exploratory Study.","authors":"Gulbahar Kurt Bayir, Ferhat Demir, Suleyman Caner Karahan, Mukaddes Kalyoncu","doi":"10.1007/s40744-026-00836-3","DOIUrl":"10.1007/s40744-026-00836-3","url":null,"abstract":"<p><strong>Introduction: </strong>SCUBE1 and SCUBE2 are vascular-associated proteins involved in endothelial processes. Although these molecules have been investigated in several vascular and inflammatory disorders, their potential involvement in pediatric immunoglobulin A vasculitis (IgAV) has not yet been elucidated. IgAV is the most common systemic vasculitis of childhood, characterized by leukocytoclastic vasculitis and immune complex deposition, yet its biomarker profile remains incompletely understood. We explored the association of SCUBE proteins with inflammatory markers in pediatric IgAV.</p><p><strong>Methods: </strong>Twenty-six children diagnosed with IgAV according to the Ankara 2008 criteria were prospectively included. Serum SCUBE1, SCUBE2, interleukin (IL)-1, IL-6, and tumor necrosis factor alpha (TNFα) levels were measured during both the active and recovery phases of the disease. Findings were compared with age- and sex-matched healthy controls using enzyme-linked immunosorbent assay (ELISA) methods.</p><p><strong>Results: </strong>IL-1 and IL-6 levels were significantly elevated in patients during the active phase compared with healthy controls (p = 0.006 and p = 0.01, respectively), supporting their role in acute inflammation. SCUBE1 and SCUBE2 levels did not significantly differ between active and recovery phases. However, SCUBE2 levels were significantly lower in the recovery phase than in controls (p = 0.008), suggesting potential downregulation following acute inflammation.</p><p><strong>Conclusions: </strong>Our findings indicate that SCUBE2 may be more closely related to late-stage vascular stabilization or tissue repair mechanisms rather than acute inflammatory activity in IgAV. This preliminary finding suggests that SCUBE2 may be associated with post-inflammatory processes; however, further studies are required to clarify its clinical relevance.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"389-402"},"PeriodicalIF":2.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996460/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147370036","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}
引用次数: 0
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