Rheumatology and Therapy最新文献

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Impact of the Sociodemographic Index on Efficacy/Safety of Tofacitinib in Patients with Rheumatoid Arthritis: Post Hoc Analysis of Phase 2/3/3b/4 Studies. 社会人口学指数对托法替尼治疗类风湿关节炎疗效/安全性的影响:2/3/3b/4期研究的事后分析
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-10-16 DOI: 10.1007/s40744-026-00881-y
Grace Wright, Eduardo Mysler, Kevin D Roberts, Ahmed Shelbaya, Lindsay Sweet, Karim R Masri
{"title":"Impact of the Sociodemographic Index on Efficacy/Safety of Tofacitinib in Patients with Rheumatoid Arthritis: Post Hoc Analysis of Phase 2/3/3b/4 Studies.","authors":"Grace Wright, Eduardo Mysler, Kevin D Roberts, Ahmed Shelbaya, Lindsay Sweet, Karim R Masri","doi":"10.1007/s40744-026-00881-y","DOIUrl":"https://doi.org/10.1007/s40744-026-00881-y","url":null,"abstract":"<p><strong>Introduction: </strong>We explored the impact of the Sociodemographic Index (SDI) on the efficacy/safety of tofacitinib and adalimumab in patients with rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>This post hoc analysis used data from phase 2/3/3b/4 studies of patients with RA receiving tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg every 2 weeks, or placebo. Patients were stratified into country-level SDI tertiles (low/medium/high; defined as Global Burden of Disease 2010 scores of ≤ 0.708/> 0.708-≤ 0.803/> 0.803). Efficacy/patient-reported outcomes were evaluated to month (M)3. We calculated incidence rates (IRs) for safety outcomes through M24. Pooled data are reported for tofacitinib 5 and 10 mg BID.</p><p><strong>Results: </strong>Patients: low SDI, N = 1969; medium SDI, N = 1538; high SDI, N = 3071. There was a higher percentage of patients aged ≥ 50 years, ever smokers, and prior biologic disease-modifying antirheumatic drug users, and RA duration was longer, in the high vs low/medium SDI tertiles. Across SDI tertiles, efficacy at M3 was generally greater with tofacitinib or adalimumab vs placebo. Odds ratios vs placebo showed that American College of Rheumatology 20/70 responses at M3 for tofacitinib or adalimumab were numerically greatest (i.e., 95% confidence intervals [CIs] overlapped) in the high SDI tertile. Placebo-adjusted least squares mean change from baseline in Disease Activity Score in 28 joints with C-reactive protein/erythrocyte sedimentation rate and Clinical Disease Activity Index at M3 was greater in the high vs low/medium SDI tertile (95% CIs overlapped) with tofacitinib or adalimumab. For tofacitinib or adalimumab, IRs for adverse events/serious adverse events were numerically greatest in the high SDI tertile.</p><p><strong>Conclusions: </strong>Efficacy at M3 was at least numerically greater with tofacitinib or adalimumab vs placebo, regardless of SDI. Placebo-adjusted efficacy responses were at least numerically greater in patients from high SDI countries. Safety IRs were also generally numerically greatest in the high SDI tertile with tofacitinib or adalimumab. Results were confounded by differences in demographics/baseline characteristics and associated lifestyle factors between SDI tertiles.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT00147498, NCT00413660, NCT00960440, NCT00550446, NCT00603512, NCT00687193, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT01164579, NCT01039688, NCT00976599, NCT01359150, and NCT02187055.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2026-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149207861","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
Effectiveness of Newly Initiated Tofacitinib and Biologic DMARDs in Patients with Rheumatoid Arthritis. 新启动的托法替尼和生物DMARDs在类风湿关节炎患者中的疗效。
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-10-15 DOI: 10.1007/s40744-026-00882-x
Katherine P Liao, Chandrasekar Gopalakrishnan, Jinoos Yazdany, Suraj Sarvode Mothi, Genevieve Gauthier, Griffith Bell, Arne Yndestad, Milena A Gianfrancesco
{"title":"Effectiveness of Newly Initiated Tofacitinib and Biologic DMARDs in Patients with Rheumatoid Arthritis.","authors":"Katherine P Liao, Chandrasekar Gopalakrishnan, Jinoos Yazdany, Suraj Sarvode Mothi, Genevieve Gauthier, Griffith Bell, Arne Yndestad, Milena A Gianfrancesco","doi":"10.1007/s40744-026-00882-x","DOIUrl":"https://doi.org/10.1007/s40744-026-00882-x","url":null,"abstract":"<p><strong>Introduction: </strong>This new-user, active comparator study of patients with rheumatoid arthritis (RA) evaluated the real-world effectiveness of tofacitinib versus biologic disease-modifying antirheumatic drugs (bDMARDs) using data from the US OM1 PremiOM™ RA dataset.</p><p><strong>Methods: </strong>This analysis included patients with RA aged ≥ 18 years initiating tofacitinib or bDMARDs (tumor necrosis factor inhibitors, TNFi; abatacept; interleukin-6 inhibitors, IL-6i) from January 1, 2013-March 13, 2024, with > 1 Clinical Disease Activity Index (CDAI) score in the 45 days prior to and including the index date. Propensity score weighting adjusted for differences in baseline characteristics between treatment groups. Crude incidence rates were calculated to estimate the first record of CDAI remission (CDAI ≤ 2.8) and low disease activity (LDA; CDAI ≤ 10.0) at 6 and 12 months. Cox regression was used to estimate weighted hazard ratios. Subgroup analyses assessed heterogeneity of treatment effects (HTE).</p><p><strong>Results: </strong>The final sample size across cohorts was 3681 (tofacitinib), 11,667 (TNFi), 3528 (abatacept), and 2464 (IL-6i). At baseline, the proportion of patients with observed RA disease duration ≥ 2 years was 48.7-70.0% across cohorts; use of 2/3/≥ 4 prior biologic/targeted synthetic (b/ts) DMARDs was 21.4%/10.2%/5.0% (tofacitinib), versus 8.1%/3.0%/2.4% (TNFi), 19.2%/8.3%/3.7% (abatacept), and 25.4%/13.7%/10.5% (IL-6i). In the overall and TNFi-experienced population, there were no statistically significant differences in CDAI remission and LDA rates between treatments at 6 and 12 months. Potential HTE was observed among subgroups of age ≥ 50 years, obesity, prior b/tsDMARD use, corticosteroid use, and Sjӧgren's disease.</p><p><strong>Conclusion: </strong>At 6 and 12 months, there were no significant differences in achieving or maintaining CDAI remission and LDA for tofacitinib versus TNFi, abatacept, and IL-6i among the overall and TNFi-experienced RA population in US clinical practice. Subgroup analyses suggest some potential HTE; however, interpretation is limited by the small number of outcome events.</p><p><strong>Clinicaltrials: </strong></p><p><strong>Gov id: </strong>NCT06418529.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149196350","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
Long-Term Safety and Efficacy of Upadacitinib in Patients with Psoriatic Arthritis: 5-Year Results from the Phase 3 SELECT-PsA 1 Study. Upadacitinib在银屑病关节炎患者中的长期安全性和有效性:来自3期SELECT-PsA 1研究的5年结果
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-10-07 DOI: 10.1007/s40744-026-00884-9
Iain B McInnes, Koji Kato, Marina Magrey, Joseph F Merola, Mitsumasa Kishimoto, Derek Haaland, Laura C Coates, Ivan Lagunes, Yanxi Liu, Erin Mancl, Bhumik Parikh, Charles Philips
{"title":"Long-Term Safety and Efficacy of Upadacitinib in Patients with Psoriatic Arthritis: 5-Year Results from the Phase 3 SELECT-PsA 1 Study.","authors":"Iain B McInnes, Koji Kato, Marina Magrey, Joseph F Merola, Mitsumasa Kishimoto, Derek Haaland, Laura C Coates, Ivan Lagunes, Yanxi Liu, Erin Mancl, Bhumik Parikh, Charles Philips","doi":"10.1007/s40744-026-00884-9","DOIUrl":"https://doi.org/10.1007/s40744-026-00884-9","url":null,"abstract":"<p><strong>Introduction: </strong>In the phase 3 SELECT-PsA 1 study, treatment with upadacitinib (UPA), an oral Janus kinase (JAK) inhibitor, improved signs and symptoms of psoriatic arthritis (PsA) from weeks 12 through 152. We now report the long-term extension phase, evaluating safety and efficacy of upadacitinib versus adalimumab (ADA) up to week 260 (~ 5 years).</p><p><strong>Methods: </strong>Data on treatment-emergent adverse events and all primary and secondary endpoints were collected through week 260 for patients who received a placebo or ≥ 1 dose of UPA at either 15 mg (UPA15) or 30 mg (UPA30) daily, or ADA 40 mg every other week. For non-radiographic binary endpoints, both observed data and non-responder imputation methods were used, whereas for radiographic binary endpoints, the observed data method was used. For continuous endpoints, observed data and mixed-effects model repeated-measures analyses were employed.</p><p><strong>Results: </strong>A total of 1704 patients received at least one dose of study drug, with 983 (57.7%) completing 260 weeks of treatment. The safety profile of UPA through week 260 was consistent with data from weeks 104 and 152. UPA treatment was associated with higher rates of serious infections, herpes zoster, lymphopenia, creatine kinase elevation, and non-melanoma skin cancer compared with ADA treatment. The exposure-adjusted incidence rates for major adverse cardiovascular events (n/100 PY [95% CI]: UPA15, 0.4 [0.2, 0.8]; UPA30, 0.4 [0.1, 0.9]; ADA, 0.3 [0.1, 0.7]) and venous thromboembolism (UPA15, 0.2 [0.0, 0.5]; UPA30, 0.4 [0.1, 0.9]; ADA, 0.2 [0.0, 0.6]) were low and comparable across treatment groups. Efficacy improvements observed with UPA at weeks 56 and 104 were maintained through week 260 and were comparable to those achieved with ADA.</p><p><strong>Conclusions: </strong>The safety profile of UPA over 5 years remained consistent with that observed at weeks 104 and 152, with no new signals identified.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT03104400.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149128229","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
Duration of Belimumab Therapy and Timing of Initiation as Predictors of Clinical Outcomes in Childhood-Onset Systemic Lupus Erythematosus: A Real-World Retrospective Study. 贝利姆单抗治疗的持续时间和起始时间作为儿童发病系统性红斑狼疮临床结局的预测因素:一项真实世界的回顾性研究。
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-10-01 Epub Date: 2026-07-11 DOI: 10.1007/s40744-026-00871-0
Baixu Sun, Shipeng Li, Fengqiao Gao, Shuo Liu, Wei Zhao, Junmei Zhang, Xiaohua Tan, Chao Li, Caifeng Li
{"title":"Duration of Belimumab Therapy and Timing of Initiation as Predictors of Clinical Outcomes in Childhood-Onset Systemic Lupus Erythematosus: A Real-World Retrospective Study.","authors":"Baixu Sun, Shipeng Li, Fengqiao Gao, Shuo Liu, Wei Zhao, Junmei Zhang, Xiaohua Tan, Chao Li, Caifeng Li","doi":"10.1007/s40744-026-00871-0","DOIUrl":"10.1007/s40744-026-00871-0","url":null,"abstract":"<p><strong>Introduction: </strong>Belimumab is the only biologic approved for childhood-onset systemic lupus erythematosus (cSLE), yet evidence on the optimal timing of initiation and duration of therapy remains limited. This study aimed to evaluate the impact of belimumab treatment duration and timing of initiation on clinical outcomes in cSLE.</p><p><strong>Methods: </strong>This retrospective study included 182 patients with cSLE treated with belimumab at Beijing Children's Hospital between September 2015 and September 2025. Patients were stratified by timing of initiation (≤ 6 months vs. > 6 months from diagnosis) and treatment duration. Primary outcomes included childhood Lupus Low Disease Activity State (cLLDAS) and childhood Clinical Remission (cCR). In a subgroup of 95 patients with ≥ 2 years of follow-up, outcomes were compared by treatment duration (< 1 year, 1-2 years, ≥ 2 years) and by timing of initiation. Multivariable logistic regression was performed to identify independent predictors.</p><p><strong>Results: </strong>Among 182 patients (81.9% female; median age 11.2 years), the median belimumab treatment duration was 14 months (IQR 7-23.8). Among 95 patients with ≥ 2 years of follow-up, cLLDAS rates increased with treatment duration: 50.0% (n = 10), 70.7% (n = 41), and 81.8% (n = 44); cCR rates were 20.0% (n = 10), 41.5% (n = 41), and 61.4% (n = 44), respectively (P = 0.101). Early initiation (≤ 6 months) was associated with significantly higher cCR rates (74.4% vs. 30.4%, P < 0.001) and lower SLEDAI-2K scores at last follow-up (0 vs. 2, P = 0.006) despite higher baseline disease activity. Multivariable logistic regression identified treatment duration as an independent predictor of cLLDAS (OR 1.17 per month, 95% CI 1.11-1.24; P < 0.001), cCR (OR 1.15, 95% CI 1.09-1.21; P < 0.001), and glucocorticoid reduction to ≤ 7.5 mg/day (OR 1.20, 95% CI 1.13-1.27; P < 0.001). Early initiation was independently associated with higher cCR rates (OR 4.31, 95% CI 1.26-14.79; P = 0.020).</p><p><strong>Conclusion: </strong>Longer belimumab treatment duration was associated with a higher likelihood of achieving favorable clinical outcomes in cSLE. Early initiation within 6 months of diagnosis was also associated with an increased probability of achieving clinical remission. These findings suggest that both sustained therapy and earlier initiation may contribute to improved disease control in cSLE.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1241-1257"},"PeriodicalIF":3.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624214/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148423451","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
Persistence Among Biologic/JAKi-Naive Medicare Beneficiaries with RA Initiating Synthetic DMARDs. 生物/ jki - naive医疗保险受益人与RA启动合成DMARDs的持久性。
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-10-01 Epub Date: 2026-07-24 DOI: 10.1007/s40744-026-00861-2
Taylor T Schwartz, Hanke Zheng, Laetitia N'Dri, Sang Hee Park, Kristofer Norris, Vardhaman A Patel, Scott B Robinson, Keith Wittstock, Vadim Khaychuk, Alison R Silverstein, Jeffrey A Sparks
{"title":"Persistence Among Biologic/JAKi-Naive Medicare Beneficiaries with RA Initiating Synthetic DMARDs.","authors":"Taylor T Schwartz, Hanke Zheng, Laetitia N'Dri, Sang Hee Park, Kristofer Norris, Vardhaman A Patel, Scott B Robinson, Keith Wittstock, Vadim Khaychuk, Alison R Silverstein, Jeffrey A Sparks","doi":"10.1007/s40744-026-00861-2","DOIUrl":"10.1007/s40744-026-00861-2","url":null,"abstract":"<p><strong>Introduction: </strong>Persistence to therapy to treat rheumatoid arthritis (RA) is an indirect measure of tolerability and effectiveness in the real-world setting. Previous clinical trials suggested that seropositive patients with RA may particularly benefit from abatacept. The risk of non-persistence after initiating abatacept, tumor necrosis factor inhibitors (TNFi), and Janus kinase inhibitors (JAKi) as first-line biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) was examined.</p><p><strong>Methods: </strong>We utilized the 100% Medicare Fee-For-Service sample linked claims with Prognos laboratory data from 2012 to 2019. Newly-initiating, anti-cyclic citrullinated peptide (anti-CCP)-positive and rheumatoid factor-(RF) positive patients were identified. Index date was initiation of abatacept, TNFi, or JAKi as first-line b/tsDMARD treatment. Persistence (measured at 12 months post-index) was defined as the absence of a treatment gap ≥ 60 days, > 90 days off-treatment, or switch in therapy. Cox regression was used to investigate risk of non-persistence between the groups.</p><p><strong>Results: </strong>Of 3105 patients identified, 487 received abatacept (16%), 2330 TNFi (75%), and 288 JAKi (9%). Abatacept, TNFi, and JAKi twelve-month persistence was 48%, 33%, and 39%, respectively. Beneficiaries initiating with abatacept were more likely to be persistent than those initiating with TNFi or JAKi (hazard ratio [HR] for TNFi, 1.45, 95% CI 1.27-1.64; HR for JAKi, 1.43, 95% CI 1.19-1.72).</p><p><strong>Conclusion: </strong>These real-world findings suggest that abatacept as a 1L treatment has the potential to improve persistence in patients with anti-CCP+ and RF+RA compared to the most commonly used 1L alternatives.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1273-1285"},"PeriodicalIF":3.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624238/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148580066","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
Sociodemographic and Clinical Determinants of Colchicine Adherence in Adults with Familial Mediterranean Fever: A Cross-Sectional Study. 家族性地中海热成人秋水仙碱依从性的社会人口学和临床决定因素:一项横断面研究。
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-10-01 Epub Date: 2026-09-25 DOI: 10.1007/s40744-026-00883-w
Ertugrul Cagri Bolek, Emre Bilgin, Riza Can Kardas, Levent Kilic, Sedat Kiraz, Ali Ihsan Ertenli, Alper Sari, Ali Akdogan
{"title":"Sociodemographic and Clinical Determinants of Colchicine Adherence in Adults with Familial Mediterranean Fever: A Cross-Sectional Study.","authors":"Ertugrul Cagri Bolek, Emre Bilgin, Riza Can Kardas, Levent Kilic, Sedat Kiraz, Ali Ihsan Ertenli, Alper Sari, Ali Akdogan","doi":"10.1007/s40744-026-00883-w","DOIUrl":"10.1007/s40744-026-00883-w","url":null,"abstract":"<p><strong>Introduction: </strong>Colchicine is the cornerstone of familial Mediterranean fever (FMF) treatment, effectively preventing attacks and amyloid A (AA) amyloidosis. Its effectiveness depends on long-term adherence; however, data on adult adherence remain sparse. We aimed to evaluate colchicine adherence in adults with FMF and identify factors associated with low adherence.</p><p><strong>Methods: </strong>This cross-sectional study consecutively enrolled adults with FMF fulfilling Livneh/Tel-Hashomer criteria and receiving colchicine for ≥ 3 months. Adherence was assessed using the Turkish 8-item Morisky Medication Adherence Scale (MMAS-8™) alongside sociodemographic and clinical characteristics.</p><p><strong>Results: </strong>Of 104 patients (median age 37.6 years; 32.7% male), adherence was low, moderate, and high in 28.8%, 45.2%, and 26.0%, respectively. MMAS-8™ scores correlated with physician- and patient-rated adherence (r = 0.53 and 0.50, respectively; p < 0.001 for both). Low-adherence patients were younger (median ages of 31.2, 42.6, and 43.1 years; p < 0.001), and age increased across adherence categories (p = 0.001). In multivariable analysis, low income (≤ 1 × national minimum wage; odds ratio (OR) 4.78; 95% confidence interval (CI) 1.01-22.56; p = 0.04) was associated with higher odds of low adherence, whereas older age (OR 0.92 per year; 95% CI 0.87-0.96; p < 0.001) was associated with lower odds of low adherence (vs. moderate-high adherence). No statistically significant associations were detected between adherence and the evaluated disease activity measures, family history, or immune-mediated inflammatory diseases, and no robust association was identified between available Mediterranean fever gene (MEFV) genotype data and colchicine adherence.</p><p><strong>Conclusion: </strong>Nearly one-third of adult patients with FMF exhibit low adherence to colchicine. Younger age and low household income were associated with low adherence. Routine adherence assessment and targeted support for potentially vulnerable subgroups may help optimize long-term outcomes. Graphical Abstract available for this article.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1357-1377"},"PeriodicalIF":3.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064351","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
Filgotinib in Moderate to Severe Rheumatoid Arthritis in a Real-World Setting: Up to 6-Month Effectiveness, Patient-Reported Outcomes, and Persistence, and up to 24-Month Safety from More than 1400 Patients in the FILOSOPHY and PARROTFISH Studies. Filgotinib治疗中重度类风湿关节炎的临床研究:Filgotinib治疗中重度类风湿关节炎长达6个月的有效性、患者报告的结果、持续性和长达24个月的安全性,来自FILOSOPHY和PARROTFISH研究的1400多名患者
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-10-01 Epub Date: 2026-07-31 DOI: 10.1007/s40744-026-00874-x
Gerd R Burmester, James Galloway, Karen Bevers, Jérôme Avouac, Susana Romero-Yuste, Roberto F Caporali, Neil Betteridge, Carole Van der Donckt, Thomas P A Debray, Ouafia Tandjaoui Bouzid, Patrick Verschueren
{"title":"Filgotinib in Moderate to Severe Rheumatoid Arthritis in a Real-World Setting: Up to 6-Month Effectiveness, Patient-Reported Outcomes, and Persistence, and up to 24-Month Safety from More than 1400 Patients in the FILOSOPHY and PARROTFISH Studies.","authors":"Gerd R Burmester, James Galloway, Karen Bevers, Jérôme Avouac, Susana Romero-Yuste, Roberto F Caporali, Neil Betteridge, Carole Van der Donckt, Thomas P A Debray, Ouafia Tandjaoui Bouzid, Patrick Verschueren","doi":"10.1007/s40744-026-00874-x","DOIUrl":"10.1007/s40744-026-00874-x","url":null,"abstract":"<p><strong>Introduction: </strong>FILOSOPHY (NCT04871919) and PARROTFISH (NCT05323591) are ongoing, prospective observational European phase 4 studies of filgotinib in patients with rheumatoid arthritis (RA) in a real-world setting. We report the study design, baseline characteristics, and interim results for disease activity measures, patient-reported outcomes (PROs), and treatment persistence up to 6 months and safety up to 24 months.</p><p><strong>Methods: </strong>Eligible patients had moderate to severe RA and were prescribed filgotinib for the first time in daily practice. In this interim analysis, measures include the proportion of patients achieving low disease activity (LDA), according to Disease Activity Score for 28 joint count using C-reactive protein (DAS28-CRP) or Clinical Disease Activity Index (CDAI), and the proportion achieving a clinically meaningful change from baseline in visual analog scale (VAS) pain (≥ 10 mm reduction) and in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score (≥ 4.0 increase). Treatment persistence was estimated using the Kaplan-Meier method. Treatment-emergent adverse events (TEAEs) are reported.</p><p><strong>Results: </strong>From May 2021 to April 2025, 1431 patients initiated filgotinib treatment; 93.0% had completed at least 6 months of follow-up (median follow-up 706 days). Improvements in DAS28-CRP and CDAI occurred from month 1. By month 6, DAS28-CRP ≤ 2.6 was reported for 58.1% (494/850) of patients and CDAI remission for 25.7% (221/859). The proportion with LDA was 71.4% (607/850) based on DAS28-CRP and 69.8% (600/859) based on CDAI. The proportion with a clinically meaningful change from baseline in VAS pain and FACIT-Fatigue score was 44.1% (178/404) and 43.8% (176/402), respectively, at week 1, increasing to 69.6% (227/326) and 62.5% (202/323), respectively, at month 6. Treatment persistence (95% CI) at month 6 was 84.0% (82.0, 85.8). Up to month 24, the exposure-adjusted incidence rates per 100 patient-years of exposure (95% CI) of any TEAEs and serious TEAEs were 89.8 (84.1, 95.8) and 9.4 (8.0, 10.8), respectively.</p><p><strong>Conclusion: </strong>Interim data from FILOSOPHY/PARROTFISH showed improvement of disease activity from month 1 and PROs from week 1, high treatment persistence at 6 months, and no new safety signals. These findings continue to support the safety and effectiveness of filgotinib in daily clinical practice.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT04871919 (2021-04-29), NCT05323591(2022-04-05).</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1287-1308"},"PeriodicalIF":3.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624248/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148631432","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
Longitudinal Instability of Minimal Disease Activity Domains in Psoriatic Arthritis with Fluctuating Response: A Trajectory Analysis of a Real-World Cohort. 银屑病关节炎最小疾病活动域的纵向不稳定性与波动反应:现实世界队列的轨迹分析。
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-10-01 Epub Date: 2026-07-31 DOI: 10.1007/s40744-026-00876-9
Mauro Fatica, Fabio Massimo Perrotta, Noemi Italiano, Eneida Çela, Maria Sole Chimenti, Ennio Lubrano
{"title":"Longitudinal Instability of Minimal Disease Activity Domains in Psoriatic Arthritis with Fluctuating Response: A Trajectory Analysis of a Real-World Cohort.","authors":"Mauro Fatica, Fabio Massimo Perrotta, Noemi Italiano, Eneida Çela, Maria Sole Chimenti, Ennio Lubrano","doi":"10.1007/s40744-026-00876-9","DOIUrl":"10.1007/s40744-026-00876-9","url":null,"abstract":"<p><strong>Introduction: </strong>Minimal disease activity (MDA) is a composite tool used to measure disease state in psoriatic arthritis (PsA), but its longitudinal stability across individual domains remains insufficiently understood. We aimed to investigate domain-specific instability of MDA components over time in patients with fluctuating disease states.</p><p><strong>Methods: </strong>This post hoc analysis of a real-world longitudinal cohort included patients with PsA treated with biologic or targeted synthetic disease-modifying anti-rheumatic drugs (bDMARDs or tsDMARDs) who exhibited fluctuating trajectories over 24 months. MDA was assessed at 6-month intervals across seven domains. For each domain, an instability score (IS) was calculated as the number of transitions across the MDA cutoff between consecutive visits. Domains were also grouped into objective, tenderness-based, and subjective categories. Longitudinal instability patterns were analyzed and compared across domains.</p><p><strong>Results: </strong>Among 289 patients in the parent cohort, 107 (37.0%) exhibited fluctuating MDA trajectories and were included in the analysis. Objective domains showed the lowest instability over time, whereas tenderness-based and subjective domains demonstrated higher and more variable instability patterns. Domain-level analyses revealed marked heterogeneity across individual MDA components.</p><p><strong>Conclusions: </strong>In patients with PsA and fluctuating disease states, MDA instability is predominantly associated with subjective and tenderness-based domains, whereas objective inflammatory measures remain relatively stable. Domain-level analysis provides additional insight beyond composite MDA and may improve interpretation of longitudinal disease dynamics.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1309-1323"},"PeriodicalIF":3.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624249/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148649138","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
Long-term Comparative Adherence and Switch Rates in Patients Receiving Advanced Therapies for Rheumatoid Arthritis After Use of One TNF Inhibitor. 类风湿关节炎患者在使用一种TNF抑制剂后接受先进治疗的长期比较依从性和转换率
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-10-01 Epub Date: 2026-07-14 DOI: 10.1007/s40744-026-00872-z
Christina Charles-Schoeman, Kurt Oelke, Patrick M Zueger, Yi Peng, Gregory Markley, Richard Thielen, Siran Fang, Martin Bergman
{"title":"Long-term Comparative Adherence and Switch Rates in Patients Receiving Advanced Therapies for Rheumatoid Arthritis After Use of One TNF Inhibitor.","authors":"Christina Charles-Schoeman, Kurt Oelke, Patrick M Zueger, Yi Peng, Gregory Markley, Richard Thielen, Siran Fang, Martin Bergman","doi":"10.1007/s40744-026-00872-z","DOIUrl":"10.1007/s40744-026-00872-z","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with rheumatoid arthritis (RA) often fail to achieve treatment targets with first-line treatment because of poor efficacy or tolerability. However, comparative long-term adherence and switching data among patients initiating a second-line therapy after a first-line tumor necrosis factor inhibitor (TNFi) remain limited.</p><p><strong>Methods: </strong>Retrospective data were from the Merative MarketScan<sup>®</sup> claims database, August 2018-October 2024. Eligible patients were aged ≥ 18 years; diagnosed with RA; initiated upadacitinib (UPA), tofacitinib (TOF), adalimumab (ADA), etanercept (ETA), abatacept (ABA), or tocilizumab (TOC); and had discontinued a first-line TNFi within 12 months prior to index. Treatment adherence and switching outcomes were reported at 1- and 3-year follow-up.</p><p><strong>Results: </strong>Overall, 3782 and 1182 patients were included for the 1- and 3-year analyses, respectively. The proportion of patients with adherence ≥ 80% was highest with UPA at 1-year (49.5%) and 3-year follow-up (35.7%) versus other treatments. Compared with UPA through 3 years, odds of being adherent were significantly lower for TOF (adjusted odds ratio [95% confidence interval]: 0.45 [0.29-0.71]), ADA (0.50 [0.33-0.75]), ETA (0.37 [0.24-0.58]), ABA (0.43 [0.26-0.73]), and TOC (0.46 [0.22-0.99]; p < 0.05). Switch rates were lowest for UPA versus other treatments at 1 year (28.6%) and remained lowest through 3 years (47.6%), while rates for all other treatments increased to approximately 60%. Through 3 years, patients were also significantly (p < 0.05) more likely to switch treatment when receiving TOF (adjusted hazard ratios [95% confidence interval]: 1.40 [1.07-1.84]), ADA (1.44 [1.12-1.86]), ETA (1.57 [1.21-2.03]), ABA (1.56 [1.16-2.10]), and TOC (1.54 [1.03-2.32]) compared with UPA. Median 3-year time to switch was not reached for UPA and was 528-660 days for all other treatments.</p><p><strong>Conclusion: </strong>Among patients with RA who discontinued a first-line TNFi, second-line UPA was associated with significantly greater long-term adherence and lower switching rates than other advanced therapies.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1259-1271"},"PeriodicalIF":3.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624200/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148437663","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
Updates on the Evaluation of Lupus Arthritis. 狼疮关节炎评估的最新进展。
IF 3.1 3区 医学
Rheumatology and Therapy Pub Date : 2026-10-01 Epub Date: 2026-09-04 DOI: 10.1007/s40744-026-00879-6
Wei Tang, Alberto Nordmann-Gomes, Leila Khalili, Giovanna Rosas, Ellen Montgomery, Laurel Zhang, Stephen Suh, Robert Clancy, Anca D Askanase
{"title":"Updates on the Evaluation of Lupus Arthritis.","authors":"Wei Tang, Alberto Nordmann-Gomes, Leila Khalili, Giovanna Rosas, Ellen Montgomery, Laurel Zhang, Stephen Suh, Robert Clancy, Anca D Askanase","doi":"10.1007/s40744-026-00879-6","DOIUrl":"10.1007/s40744-026-00879-6","url":null,"abstract":"<p><p>Lupus arthritis is the most common manifestation of systemic lupus erythematosus (SLE), affecting up to 95% of patients. Clinical presentations range from inflammatory arthralgia and non-deforming non-erosive (NDNE) synovitis to Jaccoud arthropathy and erosive arthritis, reflecting substantial clinical heterogeneity. Despite its high prevalence, widely used outcome measures lack the granularity to distinguish between these phenotypes or accurately quantify disease severity. This narrative review integrates clinical phenotypes, serologic biomarkers, imaging advances, and emerging therapies to provide a framework for evaluating lupus arthritis. Besides distinct clinical phenotypes, we propose a conceptual hypothesis-generating model describing the evolution of lupus arthritis. In an early, preclinical stage, genetically predisposed individuals may develop pathogenic autoantibodies and alterations in the gut microbiome that can lead to increased inflammation within the synovium. The intermediate stage is characterized by progressive leukocyte accumulation within the joint space, leading to clinical symptoms and early abnormalities on imaging including joint effusions, synovitis, and tenosynovitis. In the late stage, persistent inflammation results in clinically evident joint damage, including synovial hypertrophy, joint capsular swelling, and bone erosions. Biomarkers such as anti-citrullinated protein antibodies (ACPAs), anti-carbamylated protein (anti-carP) antibodies, interleukin (IL)-6, IL-17, and metalloproteinases may help identify patients at risk for erosive or deforming disease and those prone to rapid progression. Advances in imaging technologies including musculoskeletal ultrasound (MSK-US), MRI, and optical tomography may enable earlier detection before clinical manifestations or physical exam findings, creating opportunities for earlier intervention. Therapeutically, hydroxychloroquine (HCQ) remains the foundation of treatment. Belimumab and anifrolumab are US Food and Drug Administration (FDA)-approved biologics now recommended as standard of care for persistent disease, alongside conventional immunosuppressants such as methotrexate, mycophenolate, or azathioprine when indicated. Additional targeted therapies including obinutuzumab and Janus kinase (JAK) inhibitors are closely following behind. Chimeric antigen receptor T cell (CAR-T) represents a promising approach that may transform the future management of SLE.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1223-1240"},"PeriodicalIF":3.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624230/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148892330","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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