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Achievement and Maintenance of Remission with Upadacitinib in Patients with Moderate-to-Severe Rheumatoid Arthritis in Italy: 1-Year Data from UPHOLD, a Prospective Real-World Observational Study. Upadacitinib在意大利中重度类风湿关节炎患者中缓解的实现和维持:一项来自sustain的1年前瞻性观察性研究数据。
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-06-01 Epub Date: 2026-04-12 DOI: 10.1007/s40744-026-00845-2
Caterina Baldi, Eleonora Celletti, Serena Bugatti, Marcello Govoni, Massimiliano Cazzato, Andrea Picchianti Diamanti, Marco Fornaro, Giuliana Guggino, Luca Navarini, Maria Antonietta D'Agostino, Luca Quartuccio, Francesco Ciccia, Lorenzo Dagna, Paolo Stobbione, Massimo Triggiani, Ombretta Viapiana, Annarita Giardina, Gianluca Moroncini, Roberto Caporali, Chiara Bazzani, Enrico Tirri, Claudia Lomater, Sara Di Fino, Francesca Morello, Carlo Selmi
{"title":"Achievement and Maintenance of Remission with Upadacitinib in Patients with Moderate-to-Severe Rheumatoid Arthritis in Italy: 1-Year Data from UPHOLD, a Prospective Real-World Observational Study.","authors":"Caterina Baldi, Eleonora Celletti, Serena Bugatti, Marcello Govoni, Massimiliano Cazzato, Andrea Picchianti Diamanti, Marco Fornaro, Giuliana Guggino, Luca Navarini, Maria Antonietta D'Agostino, Luca Quartuccio, Francesco Ciccia, Lorenzo Dagna, Paolo Stobbione, Massimo Triggiani, Ombretta Viapiana, Annarita Giardina, Gianluca Moroncini, Roberto Caporali, Chiara Bazzani, Enrico Tirri, Claudia Lomater, Sara Di Fino, Francesca Morello, Carlo Selmi","doi":"10.1007/s40744-026-00845-2","DOIUrl":"10.1007/s40744-026-00845-2","url":null,"abstract":"<p><strong>Introduction: </strong>Upadacitinib (UPA) is approved for moderate-to-severe rheumatoid arthritis (RA) based on SELECT trials, but data on real-world effectiveness are limited. UPHOLD is a multicountry study of patients with RA receiving UPA 15 mg.</p><p><strong>Methods: </strong>The present interim analysis was based on the Italian cohort performed across 28 centers. Co-primary endpoints were (i) the proportion of patients receiving UPA who achieved DAS28(CRP) remission (< 2.6) at 6 months and (ii) the proportion of patients achieving DAS28(CRP) remission at 6 months who continued to receive UPA and maintained remission (or had no more than a 0.6-point increase in DAS28[CRP]) at 12 months, analyzed by modified non-responder imputation (mNRI) and as observed (AO). Modified full analysis sets (mFAS1 and mFAS2) included patients completing 6 and 12 months, respectively. Safety analysis included reporting of adverse events and treatment-emergent adverse events (TEAEs), as exposure-adjusted event rates (EAERs; events per 100 patient-years [E/100PY]).</p><p><strong>Results: </strong>Among 270 patients, 74 (27.4%) discontinued by 12 months because of lack of efficacy (13.7%) or adverse events (8.1%). In mFAS1 (N = 168), 50.6% (mNRI) and 62% (AO) achieved DAS28(CRP) remission at 6 months. In mFAS2 (N = 55), 80% (mNRI) and 91.7% (AO) maintained DAS28(CRP) remission at 12 months. CDAI and SDAI remission rates at 12 months were 31.3%. Patients on UPA monotherapy at 12 months showed remission rates of 49.5% (DAS28[CRP]), 27.2% (CDAI), and 27.4% (SDAI). Significant improvements in patient-reported pain and physical function were also observed. A total of 278 TEAEs were reported (80.8 E/100PY), including herpes zoster, liver disorders, and serious infections with EAERs of 2.0, 1.5, and 1.2 E/100PY, respectively.</p><p><strong>Conclusion: </strong>UPA 15 mg was observed to effectively treat moderate-to-severe RA in the real-world setting, with ≥ 80% maintaining DAS28(CRP) remission at 12 months, showing a favorable benefit-risk profile.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT04497597.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"767-784"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198592/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147676331","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 Mizoribine in the Treatment of Lupus Nephritis: A Systematic Review and Meta-Analysis. 米索比滨治疗狼疮性肾炎的疗效和安全性:系统评价和荟萃分析。
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-06-01 Epub Date: 2026-04-17 DOI: 10.1007/s40744-026-00851-4
Xingyun Wan, Xiaolong Wang, Shuang Liang, Qian Wang, Chao Liu, Zheyi Dong
{"title":"Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis: A Systematic Review and Meta-Analysis.","authors":"Xingyun Wan, Xiaolong Wang, Shuang Liang, Qian Wang, Chao Liu, Zheyi Dong","doi":"10.1007/s40744-026-00851-4","DOIUrl":"10.1007/s40744-026-00851-4","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;This study evalöuated the clinical efficacy and safety of mizoribine (MZR) in the treatment of lupus nephritis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a systematic review and meta-analysis in accordance with PRISMA 2020 guidelines. Literature searches were performed in PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov up to June 30, 2025. Two investigators independently screened studies, extracted data, and assessed risk of bias. Included studies enrolled patients with biopsy-confirmed lupus nephritis treated with mizoribine-containing regimens, including randomized controlled trials (RCTs), cohort studies, and single-arm designs. Primary and secondary outcomes were renal response rate (The proportion of patients achieving either complete response (CR) and partial response (PR). CR: 24-h urinary protein &lt; 0.5 g/day with normal/stable serum creatinine ≤ 25%. PR: ≥ 50% reduction in proteinuria to &lt; 3.5 g/day with stable serum creatinine ≤ 25%), and adverse reaction rate, 24-h urinary protein, and systemic lupus erythematosus disease activity index (SLEDAI) score, respectively. Data were analyzed in STATA 14.0 using fixed or random-effects models based on heterogeneity (random effects for I&lt;sup&gt;2&lt;/sup&gt; ≥ 25% and P ≤ 0.1). Prespecified subgroup analyses were performed by treatment duration (induction period ≤ 6 months vs. maintenance period &gt; 6 months) and control regimen (glucocorticoid group vs. glucocorticoid and immunosuppressants ).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Nineteen studies (four RCTs, one cohort, 14 single-arm) with 1489 patients were included. Meta-analysis of randomized controlled trials (RCTs) showed no significant differences in renal response rates or adverse reaction rates between MZR and control groups, but a higher SLEDAI score was observed with MZR (WMD = 1.75, 95% CI 0.33-3.16, P &lt; 0.05). Subgroup analysis indicated MZR was associated with a reduced renal response rates (RR = 0.83, 95% CI 0.71-0.97, P &lt; 0.05), elevated proteinuria (WMD = 0.62, 95% CI 0.22-1.03, P &lt; 0.05), and higher SLEDAI scores (WMD = 1.75, 95% CI 0.33-3.16, P &lt; 0.05) versus controls. These negative outcomes, including increased proteinuria (WMD = 0.73, 95% CI 0.11-1.36, P &lt; 0.05) and SLEDAI (WMD = 2.60, 95% CI 1.19-4.01, P &lt; 0.05), were significant only in the induction period use (P &lt; 0.05) and not sustained maintenance period (&gt; 6 months). Single-arm studies reported high response rates (59-100%) but widely variable adverse reaction rates (5-50%). The types of adverse events included hyperuricemia, respiratory tract infection, leukopenia, etc. CONCLUSIONS: Mizoribine demonstrates phased efficacy in lupus nephritis: it is less effective than standard regimens for the induction period (≤ 6 months) but comparable during the maintenance period (&gt; 6 months). Therefore, it is not a first-line induction agent but serves as a practical maintenance option, particularly for patients intolerant of convent","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"545-562"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198567/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147717863","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
Impact of Upadacitinib on Reducing Pain in Patients Across the Axial Spondyloarthritis Spectrum: A Post Hoc Analysis of the Phase 2/3 SELECT-AXIS Studies. Upadacitinib对减轻中轴性脊柱炎患者疼痛的影响:2/3期SELECT-AXIS研究的事后分析
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-06-01 Epub Date: 2026-03-13 DOI: 10.1007/s40744-026-00834-5
Xenofon Baraliakos, Louis Bessette, Kurt de Vlam, Peter C Taylor, Ana Biljan, Jamie Urbanik, Tianming Gao, Victoria S Jasion, Koji Kato, Ralph Lippe, Marina Magrey
{"title":"Impact of Upadacitinib on Reducing Pain in Patients Across the Axial Spondyloarthritis Spectrum: A Post Hoc Analysis of the Phase 2/3 SELECT-AXIS Studies.","authors":"Xenofon Baraliakos, Louis Bessette, Kurt de Vlam, Peter C Taylor, Ana Biljan, Jamie Urbanik, Tianming Gao, Victoria S Jasion, Koji Kato, Ralph Lippe, Marina Magrey","doi":"10.1007/s40744-026-00834-5","DOIUrl":"10.1007/s40744-026-00834-5","url":null,"abstract":"<p><strong>Introduction: </strong>This post hoc analysis evaluates the efficacy of upadacitinib (UPA), a Janus kinase inhibitor, across multiple pain endpoints in patients with axial spondyloarthritis (axSpA) through 104 weeks from the phase 2/3 SELECT-AXIS studies.</p><p><strong>Methods: </strong>Adult patients with radiographic axSpA (r-axSpA; historically ankylosing spondylitis; two studies) who were naïve or had an inadequate response (IR) to biologic disease-modifying antirheumatic drugs (bDMARDs), or with non-radiographic axSpA (nr-axSpA; one study), were randomized to UPA 15 mg (UPA15) once daily or placebo (PBO). Patients treated with PBO were switched to UPA15 at week 14 in the r-axSpA studies and week 52 in the nr-axSpA study. Pain outcomes were assessed through week 104 and analyzed using nonresponder imputation or mixed-model repeated measures and as observed data. Safety data were not evaluated in this analysis but have been published previously.</p><p><strong>Results: </strong>Across axSpA, higher proportions of patients achieved ≥ 30%/50%/70% reduction from baseline in the patient's global assessment of pain with UPA15 versus PBO as early as week 1; reductions in pain were generally maintained through week 104 in the continuous UPA15 groups. Patients who switched from PBO to UPA15 showed generally similar responses to the continuous UPA15 groups through week 104. Additional pain endpoints, including minimal clinically important difference and total back pain, showed similar results. Numerically higher proportions of patients who reported early pain improvement (≥ 30% at week 2 or ≥ 50% at week 14) following UPA15 treatment achieved stringent disease control targets, including Assessment of SpondyloArthritis international Society (ASAS) partial remission, Ankylosing Spondylitis Disease Activity Score (ASDAS) low disease activity, or ASDAS inactive disease at week 104 versus patients who did not report early pain improvement.</p><p><strong>Conclusions: </strong>These results from the SELECT-AXIS studies support the clinical benefit of UPA15 for reducing pain in patients with axSpA through 104 weeks (2 years). TRIAL REGISTRATION, CLINICALTRIALS.</p><p><strong>Gov identifier: </strong>NCT03178487 and NCT04169373.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"611-628"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198570/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147459511","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
Sex Differences in Treatment Expectations, Satisfaction and Tolerance After Switching to CT-P17, an Adalimumab Biosimilar: A Post Hoc Analysis of the YU-MATTER Study. 切换到CT-P17(一种阿达木单抗生物类似药)后治疗预期、满意度和耐受性的性别差异:YU-MATTER研究的事后分析
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-06-01 Epub Date: 2026-03-16 DOI: 10.1007/s40744-026-00840-7
Laure Gossec, Guillaume Bouguen, Azeddine Dellal, Lucile Foulley, Caroline Habauzit, Salim Benkhalifa, Hubert Marotte
{"title":"Sex Differences in Treatment Expectations, Satisfaction and Tolerance After Switching to CT-P17, an Adalimumab Biosimilar: A Post Hoc Analysis of the YU-MATTER Study.","authors":"Laure Gossec, Guillaume Bouguen, Azeddine Dellal, Lucile Foulley, Caroline Habauzit, Salim Benkhalifa, Hubert Marotte","doi":"10.1007/s40744-026-00840-7","DOIUrl":"10.1007/s40744-026-00840-7","url":null,"abstract":"<p><strong>Introduction: </strong>Data suggest that women and men differ in how they experience biological treatment. This post hoc analysis of the YU-MATTER study evaluated sex-related differences in patient satisfaction and perception when switching from adalimumab (reference or biosimilar) to CT-P17 (Yuflyma<sup>®</sup>; Celltrion, Inc.), a high-concentration, citrate-free adalimumab biosimilar.</p><p><strong>Methods: </strong>This analysis used data from the observational, multicentre, prospective YU-MATTER study. Patients had inflammatory bowel disease or chronic inflammatory rheumatic disease and switched from adalimumab (reference or low-concentration [< 50 mg/ml] biosimilar) to CT-P17. Patients completed online questionnaires monthly to month 3 (M3). The primary outcome was overall patient satisfaction (7-point Likert scale). Additional outcomes were expectations and perceptions of switching to CT-P17 (7- and 5-point Likert scale, respectively), beliefs about medicine (18-item Beliefs about Medicines Questionnaire), health literacy (16-item Health Literacy Survey Europe) and injection site reactions (pain and itching: 0-10 numerical rating scale; redness and haematoma: 4- and 3-point Likert scale, respectively).</p><p><strong>Results: </strong>YU-MATTER enrolled 115 women and 117 men. More men than women reported satisfaction with CT-P17 treatment at M3 (82.1% vs 68.7%). Beliefs about medicines, health literacy, and patient expectations and perceptions of CT-P17 treatment did not differ significantly between sexes, although more women expected CT-P17 to be less painful (73.0% vs 59.0%; p = 0.077). At baseline, women reported significantly higher incidences of injection site redness (60.9% vs 48.7%) and haematoma (50.4% vs 26.5%) than men, with similar trends at M3 (40.0% vs 20.2% and 32.6% vs 8.5%, respectively), as well as significantly higher severity of injection site pain and itching. Both sexes reported fewer and less severe injection site reactions with CT-P17 at M3 compared with baseline adalimumab.</p><p><strong>Conclusion: </strong>Most expectations and perceptions of CT-P17 treatment were similar between sexes, but women experienced more injection site reactions. Further research is needed to understand why women experience a higher incidence of these reactions with adalimumab and its biosimilars.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov identifier NCT05427942 (registered June 22, 2022).</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"645-658"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198574/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147469014","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 Obexelimab to Treat IgG4-Related Disease: Protocol for a Global, Randomized, Placebo-Controlled Trial. 奥贝昔单抗治疗igg4相关疾病的有效性和安全性:一项全球、随机、安慰剂对照试验方案
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-06-01 Epub Date: 2026-03-16 DOI: 10.1007/s40744-026-00835-4
Emma L Culver, Matthew C Baker, Emanuel Della-Torre, Wen Zhang, Cory A Perugino, Audrey Wells, Admasu Mamuye, Shauna M Quinn, Allen Poma, Thomas J Greene, John H Stone
{"title":"Efficacy and Safety of Obexelimab to Treat IgG4-Related Disease: Protocol for a Global, Randomized, Placebo-Controlled Trial.","authors":"Emma L Culver, Matthew C Baker, Emanuel Della-Torre, Wen Zhang, Cory A Perugino, Audrey Wells, Admasu Mamuye, Shauna M Quinn, Allen Poma, Thomas J Greene, John H Stone","doi":"10.1007/s40744-026-00835-4","DOIUrl":"10.1007/s40744-026-00835-4","url":null,"abstract":"<p><strong>Introduction: </strong>IgG4-related disease (IgG4-RD) is a chronic, multiorgan fibroinflammatory condition characterized by recurring flares that can lead to progressive organ damage and failure, impaired quality of life, and death. Glucocorticoids (GCs) remain the primary therapy despite their significant toxicity. Obexelimab is a humanized, bifunctional, monoclonal antibody designed to inhibit B cells by co-engaging CD19 and FcγRIIb (CD32b), mimicking natural inhibitory signaling triggered by antigen-antibody complexes. Following promising phase 2 results that demonstrated clinical improvement in 93% of patients with IgG4-RD, the phase 3 INDIGO trial was initiated.</p><p><strong>Methods: </strong>INDIGO is a multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of obexelimab in patients with IgG4-RD. The trial has enrolled adult patients ≥ 18 years old with active IgG4-RD meeting the 2019 ACR/EULAR classification criteria (score ≥ 20). Following standardized GC induction, patients are randomized 1:1 to weekly subcutaneous obexelimab 250 mg or placebo for 52 weeks. An independent adjudication committee (AC) ensures consistent application of IgG4-RD classification and organ-specific flare criteria developed for the trial.</p><p><strong>Planned outcomes: </strong>The primary endpoint is time to first IgG4-RD flare requiring initiation of rescue therapy as determined by both the investigator and AC. Key secondary endpoints are time to first investigator-determined flare requiring rescue therapy, number of investigator- and AC-determined flares requiring rescue therapy, proportion of patients achieving complete remission, and cumulative dose of GC rescue therapy for active IgG4-RD through Week 52.</p><p><strong>Conclusion: </strong>The INDIGO trial achieved its global enrollment goal with 194 patients, making it the largest phase 3 trial in IgG4-RD to date and providing 90% power to detect a clinically meaningful reduction in flare risk. This trial will provide critical evidence on B-cell inhibition as a treatment strategy for IgG4-RD and assess obexelimab as a potential steroid-sparing option to address significant unmet needs of this patient population.</p><p><strong>Trial registration: </strong>NCT05662241.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"867-880"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198598/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147469074","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
Biologic Therapy Is Associated with Faster Bone Union After the Sauvé-Kapandji Procedure in Patients with Rheumatoid Arthritis. 类风湿性关节炎患者sauv<s:1> - kapandji手术后生物治疗与更快骨愈合相关
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-06-01 Epub Date: 2026-04-20 DOI: 10.1007/s40744-026-00847-0
Hinako Okabe, Kazuhiro Maeda, Yu Yamashita, Asami Zenitani, Tetsuro Nishizawa, Mitsuhito Yukawa, Reiji Nishimura, Hideaki Bo, Takeshi Miyawaki, Mitsuru Saito
{"title":"Biologic Therapy Is Associated with Faster Bone Union After the Sauvé-Kapandji Procedure in Patients with Rheumatoid Arthritis.","authors":"Hinako Okabe, Kazuhiro Maeda, Yu Yamashita, Asami Zenitani, Tetsuro Nishizawa, Mitsuhito Yukawa, Reiji Nishimura, Hideaki Bo, Takeshi Miyawaki, Mitsuru Saito","doi":"10.1007/s40744-026-00847-0","DOIUrl":"10.1007/s40744-026-00847-0","url":null,"abstract":"<p><strong>Introduction: </strong>Rheumatoid arthritis (RA) is characterized by chronic inflammation and impaired bone quantity and quality, which may delay postoperative bone healing. The Sauvé-Kapandji (SK) procedure is a common surgical strategy for distal radioulnar joint disorders, but the association between RA medications-particularly biologic and targeted synthetic disease-modifying antirheumatic drugs (b/ts DMARDs)-and bone union after SK is unclear. This study aimed to identify patient- and treatment-related factors associated with bone union time, with a special focus on biologic therapy.</p><p><strong>Methods: </strong>We retrospectively analyzed patients with RA who underwent SK. Bone union was assessed using serial wrist radiographs, and union timing was independently evaluated by multiple orthopedic specialists in a blinded manner. Patient characteristics-including demographics, disease activity, medication use, bone mineral density, and biomarkers-were analyzed. Correlations with bone union duration were examined using Pearson's test; intergroup comparisons used t tests, Fisher's exact test, or Wilcoxon tests. Multiple regression identified independent predictors of union time.</p><p><strong>Results: </strong>All patients achieved bone union. Higher matrix metalloproteinase-3 levels and methotrexate (MTX) dose were associated with prolonged healing, whereas biologic agents, specifically tumor necrosis factor (TNF) inhibitors, were associated with significantly shorter union time. Nonsteroidal anti-inflammatory drugs (NSAIDs) use was also linked to delayed healing. Multivariate analysis confirmed that MTX dose, biologic use, and NSAIDs use were independently associated with bone union duration.</p><p><strong>Conclusions: </strong>Biologic therapy was independently associated with faster bone union after SK, whereas higher MTX dosage and NSAIDs use were linked to delayed healing. In current clinical practice, biologic agents are often withheld during the perioperative period because of concerns regarding wound healing; however, our findings suggest that, from the standpoint of bone union, biologic therapy may have a favorable effect. Larger prospective studies are warranted to confirm these findings and clarify the optimal perioperative management of b/ts DMARDs in this setting.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"855-865"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198562/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147729731","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
Validation of the Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) in a Chinese Cohort: Comparison with SLEDAI-2-K. 系统性红斑狼疮疾病活动评分(slei - das)在中国队列中的验证:与SLEDAI-2-K的比较
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-06-01 Epub Date: 2026-03-09 DOI: 10.1007/s40744-026-00832-7
Tingting Ding, Yamin Li, Dai Gao, Lanlan Ji, Xiaohui Zhang, Zhuoli Zhang
{"title":"Validation of the Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) in a Chinese Cohort: Comparison with SLEDAI-2-K.","authors":"Tingting Ding, Yamin Li, Dai Gao, Lanlan Ji, Xiaohui Zhang, Zhuoli Zhang","doi":"10.1007/s40744-026-00832-7","DOIUrl":"10.1007/s40744-026-00832-7","url":null,"abstract":"<p><strong>Introduction: </strong>Accurate assessment of disease activity in systemic lupus erythematosus (SLE) remains a persistent challenge. We aimed to validate the SLE disease activity score (SLE-DAS) in Chinese patients.</p><p><strong>Methods: </strong>We analyzed the agreement between SLE-DAS and SLEDAI-2 K using our prospective STAR cohort. Construct validity was assessed through correlations with physician global assessment (PGA), as well as through known-group discrimination (PGA-cut off ≥ 1 for active). Factors associated with classification discordance and the association between baseline SLE-DAS and 12-month organ damage accrual were assessed using logistic regression.</p><p><strong>Results: </strong>Among 507 SLE patients, SLE-DAS demonstrated strong correlations with PGA (r = 0.726, P < 0.001) and SLEDAI-2 K (r = 0.750, P < 0.001), with an overall agreement of 83.0% between SLE-DAS and SLEDAI-2 K. Both instruments demonstrated comparable discriminative power for active disease (SLE-DAS AUC = 0.832; SLEDAI-2 K AUC = 0.860). Among 211 patients with mild disease activity classified by SLEDAI-2 K, 61 were reclassified into higher categories by SLE-DAS. These patients exhibited higher PGA (0.8 ± 1.0 vs. 0.3 ± 0.7; P < 0.001) and glucocorticoid doses (25.7 ± 22.3 vs. 11.3 ± 15.5; P < 0.001) than those with concordant classifications. Lupus nephritis (45.9% vs. 18.0%; P < 0.001) and hematological involvement (32.8% vs. 18.0%; P = 0.020) were more frequent in them. We identified that nephritis (OR = 4.57, 95% CI 2.18-9.57, P < 0.001) and hematological involvement (OR = 2.76, 95% CI 1.27-6.02, P = 0.011) were associated with classification discordance. Baseline SLE-DAS was positively associated with SLE SLICC/ACR Damage Index (SDI) accrual at 12 months of follow-up (OR = 1.38, P = 0.038).</p><p><strong>Conclusions: </strong>SLE-DAS demonstrates superior accuracy in assessing disease activity compared to SLEDAI-2 K, likely attributable to refinements in assessing nephritis and hematological manifestations. Baseline SLE-DAS also exhibited a positive association with short-term organ damage accrual, though long-term validation is required.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"563-580"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198580/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147390903","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
Prospective Quantification of Glucocorticoid Toxicity Across Dosage Ranges in Systemic Lupus Erythematosus: Insights from the Glucocorticoid Toxicity Index. 系统性红斑狼疮不同剂量范围糖皮质激素毒性的前瞻性量化:来自糖皮质激素毒性指数的见解。
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-06-01 Epub Date: 2026-04-28 DOI: 10.1007/s40744-026-00857-y
Jiaying Zhang, Dai Gao, Yong Fan, Zhuoli Zhang
{"title":"Prospective Quantification of Glucocorticoid Toxicity Across Dosage Ranges in Systemic Lupus Erythematosus: Insights from the Glucocorticoid Toxicity Index.","authors":"Jiaying Zhang, Dai Gao, Yong Fan, Zhuoli Zhang","doi":"10.1007/s40744-026-00857-y","DOIUrl":"10.1007/s40744-026-00857-y","url":null,"abstract":"<p><strong>Introduction: </strong>Despite the European Alliance of Associations for Rheumatology (EULAR) recommendation to minimize glucocorticoid (GC) use in systemic lupus erythematosus (SLE), prospective data quantifying toxicity across low-dose ranges are lacking. This study aimed to assess toxicity using the GC toxicity index (GTI) in SLE patients and compare toxicity profiles among dose-defined subgroups.</p><p><strong>Methods: </strong>Patients from the STAR cohort (May 2023-May 2024) were prospectively followed up for 1 year. Stratified by average daily prednisone (PDN) dose, toxicity was assessed using GTI comprising the aggregate improvement score (AIS) and the cumulative worsening score (CWS) at baseline and 1 year. Three pre-planned stepwise comparisons used dose thresholds of 7.5 mg, 5 mg, and 2.5 mg, with a Bonferroni-corrected significance level of P < 0.0167 (α = 0.05/3). Quantile regression evaluated the association between average daily PDN dose and CWS/AIS.</p><p><strong>Results: </strong>Of 302 patients, the PDN ≤ 7.5 mg/day group (n = 223) showed statistically lower median CWS [0 (IQR 0-19) vs. 48 (IQR 19-84), P < 0.001] and AIS [0 (IQR - 19-10) vs. 40 (IQR 9-74), P < 0.001] compared to the PDN > 7.5 mg/day group (n = 79). Within the low-dose group, patients with 5 < PDN ≤ 7.5 mg/day (n = 52) exhibited higher median CWS [10.5 (IQR 0-29) vs. 0 (IQR 0-19), P = 0.002] and wider AIS interquartile range [0 (IQR - 18.75-29) vs. 0 (IQR - 20-0), P = 0.010] than the PDN ≤ 5 mg/day subgroup (n = 171). No significant differences in CWS or AIS were observed between the PDN ≤ 2.5 mg/day (n = 90) and 2.5 < PDN ≤ 5 mg/day (n = 81) subgroups. Quantile regression indicated that each 1 mg/day increase in PDN dose raised median CWS by 3.33 points and median AIS by 3.42 points.</p><p><strong>Conclusions: </strong>To our knowledge, this study provided the first prospective and quantitative evidence using the GTI to demonstrate that PDN dose reduction to ≤ 5 mg/day was linked to reduced toxicity. Moreover, we found that no dose was entirely safe, which strongly supported the EULAR strategy of rigorous GC minimization.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"829-841"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198556/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147779694","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
Diuretic-Induced Hypomagnesemia May Play a Key Role in the Development of Calcium Pyrophosphate Arthritis. 利尿剂诱导的低镁血症可能在焦磷酸钙关节炎的发展中起关键作用。
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-06-01 Epub Date: 2026-03-25 DOI: 10.1007/s40744-026-00842-5
Joana Atxotegi-Saenz de Buruaga, Consuelo Modesto-Caballero, Fernando Perez-Ruiz
{"title":"Diuretic-Induced Hypomagnesemia May Play a Key Role in the Development of Calcium Pyrophosphate Arthritis.","authors":"Joana Atxotegi-Saenz de Buruaga, Consuelo Modesto-Caballero, Fernando Perez-Ruiz","doi":"10.1007/s40744-026-00842-5","DOIUrl":"10.1007/s40744-026-00842-5","url":null,"abstract":"<p><strong>Introduction: </strong>The objective of this study is to determine the prevalence of hypomagnesemia in patients with calcium pyrophosphate (CPP) arthritis and the role of diuretics on inducing hypomagnesemia.</p><p><strong>Methods: </strong>This was an observational, cross-sectional, prospectively recruited, case-control study. Cases were confirmed by both chondrocalcinosis in plain X-ray and CPP crystals in synovial fluid. Serum creatinine, magnesium, calcium, phosphate, 25-OH-vitamin D, parathyroid hormone, ferritin and transferrin saturation were measured. Diuretic use, class, and dosage were also recorded.</p><p><strong>Results: </strong>A total of 568 patients were included, 298 cases and 270 controls. Lower serum magnesium levels were found more frequently among cases, 16% with hypomagnesemia, than in controls [6.4%, (p = 0.01)]. Cases received almost twice as many diuretics as controls (p < 0.001). Comparing cases and controls on diuretic treatment, there were no differences in either magnesium or prevalence of hypomagnesemia. To evaluate the impact of diuretics on serum magnesium, we performed an overall analysis using the entire population. Patients on diuretics showed lower serum magnesium levels compared to patients not on diuretics (1.97 vs 2.05 mg/dl, p < 0.001). Thiazides were associated with lower serum magnesium levels (1.86 vs 2.05 mg/dl; p < 0.001) and hypomagnesemia than loop diuretics (32.1% vs 14.9%; p < 0.004), respectively. Thiazide doses over 12.5 mg/day were associated with higher rate of hypomagnesemia (70.0% vs 11.1%, p = 0.035).</p><p><strong>Conclusion: </strong>Patients with CPP crystal deposition disease (CPPD) showed lower magnesium levels and higher rate of hypomagnesemia than controls, and were prescribed almost twice as many diuretics. Both classes of diuretics were associated with lower magnesium levels and clinical significant hypomagnesemia. Thiazides induced hypomagnesemia more frequently than loop diuretics, showing dose-dependent association.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"691-699"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198597/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147514476","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
Prescription Patterns in Psoriatic Arthritis: Insights from a Sex-Based Perspective. 银屑病关节炎的处方模式:从性别角度的见解。
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-06-01 Epub Date: 2026-03-26 DOI: 10.1007/s40744-026-00844-3
Mauro Fatica, Fabio Massimo Perrotta, Paola Conigliaro, Maria Sole Chimenti, Ennio Lubrano
{"title":"Prescription Patterns in Psoriatic Arthritis: Insights from a Sex-Based Perspective.","authors":"Mauro Fatica, Fabio Massimo Perrotta, Paola Conigliaro, Maria Sole Chimenti, Ennio Lubrano","doi":"10.1007/s40744-026-00844-3","DOIUrl":"10.1007/s40744-026-00844-3","url":null,"abstract":"<p><strong>Introduction: </strong>Emerging evidence suggests sex-related differences in disease presentation, response to therapy, and treatment patterns in psoriatic arthritis (PsA). This study aimed to assess sex-related differences in PsA management, focusing on the use of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), and phosphodiesterase-4 (PDE4) inhibitors, as well as the frequency and factors associated with treatment switches and swaps.</p><p><strong>Methods: </strong>We conducted a cross-sectional analysis of two longitudinal PsA cohorts, collecting comprehensive clinical, laboratory, and patient-reported data. Treatment patterns, including the number and type of therapies administered over time and treatment modifications, were evaluated in male and female patients. Univariate analyses identified clinical factors associated with treatment switches and swaps.</p><p><strong>Results: </strong>During the enrollment period, 272 patients with PsA (141 male patients, 131 female patients) were evaluated. Overall, 128 patients (47.1%) received at least one csDMARD, yet only 49 (18%) were managed exclusively with csDMARDs, while 223 (82%) were treated with bDMARDs or PDE4 inhibitors. Male patients were more likely to be treated with csDMARDs monotherapy (22.7% vs. 12.9%, p = 0.03), whereas female patients more frequently received bDMARDs, particularly tumor necrosis factor inhibitors (72.55% vs. 53.2%, p = 0.001). Moreover, female patients received a greater number of bDMARDs (1.1 ± 1.1 vs. 1.5 ± 1.3), and experienced more treatment switches (40.4% vs. 25.7%, p = 0.02) than male patients. Obesity and cardiometabolic comorbidities were associated with therapy switching in male patients, whereas fibromyalgia and anxiety-depression were significant factors in female patients.</p><p><strong>Conclusions: </strong>Our findings highlight significant sex-based differences in PsA management, with female patients requiring more adaptive therapeutic strategies despite similar pharmacological approaches to male patients. Future studies should explore sex-specific variations in disease biology and treatment response to optimize care.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"719-730"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147521938","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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