Rheumatology and Therapy最新文献

{"title":"Long-Term Effectiveness of Baricitinib and Other b/tsDMARDs in Patients with Rheumatoid Arthritis with Early Low Disease Activity or Remission: 2-Year Data from the RA-BE-REAL Study.","authors":"Rieke Alten, Andrew Östör, Christopher J Edwards, Josef S Smolen, Ewa Haladyj, Khai Jing Ng, Samuel Ogwu, Yuko Kaneko","doi":"10.1007/s40744-025-00815-0","DOIUrl":"10.1007/s40744-025-00815-0","url":null,"abstract":"<p><strong>Introduction: </strong>Treat-to-target strategies for rheumatoid arthritis (RA) aim for remission or low disease activity (LDA) and improve long-term outcomes. The objective of this analysis is to report early achievement of remission or LDA at 3 months (M) in a real-world RA population and explore the long-term (2 years) outcomes of achieving early remission/LDA.</p><p><strong>Methods: </strong>RA-BE-REAL is a 3-year, multinational, prospective, observational study of adult patients with RA. Patients initiated treatment with baricitinib (cohort A) or any biologic (b) disease-modifying anti-rheumatic drug (DMARD) or any other targeted synthetic (ts) (cohort B) for the first time. This analysis covers data from a European subpopulation of RA-BE-REAL. Effectiveness data at 3 months (early remission), and 24 months were presented descriptively. Logistic regression was used to determine associations between baseline characteristics and achievement of remission/LDA at 3 months and also associations between early remission/LDA and subsequent achievement of long-term remission/LDA at 24 months.</p><p><strong>Results: </strong>At 3 months, high proportions of patients in both cohorts (cohort A: 59.4%, cohort B: 49.3%) reached remission or LDA. Patients achieving early remission or LDA had greater improvement in short- and long-term pain, functioning (HAQ-DI), and quality of life (EQ-5D-5L) than those who did not. Logistic regression found that previous experience with ≥ 2 previous b/tsDMARDs, higher Clinical Disease Activity Index (CDAI) scores, and lower EQ-5D-5L scores at baseline were negative predictors for the achievement of early remission or LDA. Furthermore, achievement of remission or LDA at 3 months was associated with remission or LDA at 24 months.</p><p><strong>Conclusions: </strong>In a routine clinical practice population, achieving early remission/LDA was associated with maintained remission/LDA at 2 years as well as long-term improvement in pain, physical function, and quality of life in both cohorts.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"231-242"},"PeriodicalIF":2.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12816484/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145810803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"NSAID Use, Gastrointestinal Complications, and Burden of Disease in Osteoarthritis: Nordic Registry Study with Emphasis on Patients Below 60 Years.","authors":"Tore K Kvien, Johan L Hansen, Robert Böttger, Rita Freitas, Jan Jastorff, Elena Mascia, Manfred Gross","doi":"10.1007/s40744-025-00803-4","DOIUrl":"10.1007/s40744-025-00803-4","url":null,"abstract":"<p><strong>Introduction: </strong>Osteoarthritis (OA) is associated with joint pain and disability, with increasing prevalence and economic burden. This study explored non-steroidal anti-inflammatory drugs (NSAID) treatment patterns, gastrointestinal (GI) complications and burden of disease in patients with OA based on Nordic registry data, with emphasis on individuals aged 60 or younger.</p><p><strong>Methods: </strong>This non-interventional observational study analysed registry data from Norway, Finland, and Sweden. Adults with primary OA diagnosis in specialty care were matched 1:1 by age and sex with individuals of the general population. The primary outcome was NSAID treatment patterns, assessed by dispensations and daily defined doses (DDD) 1 year before and after diagnosis. Secondary outcomes included prevalence of comorbidities, the incidence of GI complications, sick leave, and joint replacements.</p><p><strong>Results: </strong>The study included 189,553 patients with OA from Norway, 341,548 from Sweden, and 218,253 from Finland, 34.1% to 40.4% aged ≤ 60. About half of patients had NSAIDs dispensed before and after diagnosis, (Norway 56.6% and 48.6%; Sweden 50.1% and 44.0%; Finland 58.8% and 58.2%), compared to about one-fifth of the matches (Norway 19.1% and 18.5%; Sweden 12.7% and 12.2%; Finland 22.5% and 21.7%). NSAID use increased with age until approximately 55 years, then declined. After diagnosis, fewer patients had NSAID dispensations, but mean DDDs per prescription were generally higher. Secondary analyses showed a higher comorbidity burden, higher rates of GI complications, more sick leave days, and more joint replacements in patients with OA than in matched individuals.</p><p><strong>Conclusion: </strong>Across Nordic countries, patients with OA had more NSAID dispensations, and GI complications were more prevalent compared to matched individuals. Notably, this was already evident in younger patients under the age of 60, underscoring the need for comprehensive GI risk assessment for every patient with OA. The substantial burden of OA was also evidenced by considerable numbers of sick leave days and joint replacements.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"65-82"},"PeriodicalIF":2.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12816482/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145452802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Filgotinib Effectiveness in Rheumatoid Arthritis: Observational Analysis of a Large Multicenter Cohort.","authors":"Eleonora Celletti, Myriam Di Penta, Alarico Ariani, Simone Parisi, Romina Andracco, Bernd Raffeiner, Aurora Ianniello, Alberto Lo Gullo, Aldo Biagio Molica Colella, Marta Priora, Marino Paroli, Federica Lumetti, Viviana Ravagnani, Francesco Girelli, Rosetta Vitetta, Alessandro Volpe, Palma Scolieri, Alessandra Bezzi, Francesca Ometto, Elisa Visalli, Antonella Farina, Patrizia Del Medico, Elena Bravi, Matteo Colina, Maddalena Larosa, Francesca Serale, Veronica Franchina, Francesco Molica Colella, Giulio Ferrero, Gilda Sandri, Olga Addimanda, Massimo Reta, Fabio Mascella, Maria Cristina Focherini, Alessia Fiorenza, Guido Rovera, Cecilia Giampietro, Simone Bernardi, Natalia Mansueto, Dario Camellino, Rosalba Caccavale, Valeria Nucera, Emanuela Sabatini, Pietro Del Biondo, Maria Chiara Ditto, Ilaria Platè, Giuditta Adorni, Eleonora Di Donato, Daniele Santilli, Gianluca Lucchini, Giorgio Amato, Francesco De Lucia, Ylenia Dal Bosco, Roberta Foti, Gianluca Smerilli, Gerolamo Bianchi, Rosario Foti, Eugenio Arrigoni, Antonio Marchetta, Riccardo Bixio, Vincenzo Bruzzese, Enrico Fusaro, Dilia Giuggioli, Carlo Salvarani, Francesco Cipollone, Andrea Becciolini","doi":"10.1007/s40744-025-00805-2","DOIUrl":"10.1007/s40744-025-00805-2","url":null,"abstract":"<p><strong>Introduction: </strong>The efficacy and safety of filgotinib (FIL) for the treatment of patients with rheumatoid arthritis (RA) have been evaluated in a number of randomized controlled trials. However, there is a scarcity of real-world studies evaluating the effectiveness, persistence, tolerability, and safety of FIL in everyday clinical practice. This study aimed to assess the effectiveness and retention rate of FIL in a real-world cohort of patients with RA.</p><p><strong>Methods: </strong>A multicenter retrospective cohort study of patients with RA treated with FIL was conducted in 27 Italian tertiary referral rheumatology centers. The drug retention rate (DRR) was estimated by the Kaplan-Meier method, while multivariate Cox regression was used to detect potential factors affecting drug survival and persistence in therapy. Disease activity score (DAS28-CRP) was assessed at baseline and after 6 and 12 months.</p><p><strong>Results: </strong>We enrolled 204 patients (80% female). The DRR of FIL was 90.2% (95% confidence interval (CI) 86-94.6%), 75.1% (95% CI 68.5-82.4%), and 64.7% (95% CI 56.3-74.3%) at months 6, 12, and 18, respectively. The DRR was negatively associated with the line of treatment and the presence of rheumatoid factor. Effectiveness was evaluated as DAS28-CRP response. At 6 months, DAS28-CRP remission was observed in 65 (36.1%) patients, and remission or low disease activity in 98 (54.4%). At 12 months, DAS28-CRP remission was observed in 64 (50.0%) patients, and remission or low disease activity in 81 (63.2%).</p><p><strong>Conclusions: </strong>This analysis of real-world patients with RA demonstrated the effectiveness of FIL with a good DAS28-CRP response and high DRR at follow-up.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"179-193"},"PeriodicalIF":2.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12816451/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145669783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 196-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Randomized Clinical Trials.","authors":"Andrew Östör, Filip Van den Bosch, Kim Papp, Mauro Keiserman, Ricardo Blanco, Angela Crowley, Douglas White, Ana Biljan, Tshepiso Madihlaba, Kyle Carter, Fang Liu, Ahmed M Soliman, Doug Ashley, Michael Chen, Lila Glotfelty, Alan Kivitz","doi":"10.1007/s40744-025-00793-3","DOIUrl":"10.1007/s40744-025-00793-3","url":null,"abstract":"<p><strong>Introduction: </strong>The ongoing KEEPsAKE 1 and 2 (KS1; KS2) trials evaluate the efficacy and safety of risankizumab in patients with psoriatic arthritis (PsA) who had an inadequate response to ≥ 1 conventional synthetic disease-modifying antirheumatic drug(s) (csDMARD-IR, KS1&2) and/or 1-2 biologic DMARDs (bDMARD-IR, KS2). Herein, we present week 196 efficacy and safety findings from KS1 and KS2.</p><p><strong>Methods: </strong>Patients were randomized 1:1 in a double-blind fashion to receive subcutaneous risankizumab 150 mg or placebo (weeks 0, 4, 16, and 24). All patients received open-label risankizumab at week 28 and every 12 weeks thereafter (i.e., continuous risankizumab, placebo/risankizumab). Assessments included ≥ 20%/50%/70% improvement in PsA symptoms using American College of Rheumatology criteria (ACR20/50/70) and achievement of minimal disease activity (MDA).</p><p><strong>Results: </strong>At week 196, 749 patients remained in KS1 and 289 in KS2. In KS1, 57.1% of patients receiving continuous risankizumab and 56.5% receiving placebo/risankizumab achieved ACR20, while 54.5% receiving continuous risankizumab and 50.2% receiving placebo/risankizumab achieved ACR20 in KS2 at week 196. Maintenance of ACR20 achievement in KS1 from week 52 to week 196 was observed for 71.0% of patients receiving continuous risankizumab and 72.7% receiving placebo/risankizumab. The same was observed in KS2 for 68.7% of patients receiving continuous risankizumab and 73.0% receiving placebo/risankizumab. The proportion of patients achieving MDA was 39.6% receiving continuous risankizumab and 35.2% receiving placebo/risankizumab in KS1, while 35.3% of patients receiving continuous risankizumab and 37.4% receiving placebo/risankizumab achieved MDA in KS2 at week 196. In KS1, maintenance of MDA at week 196 from week 52 was achieved by 72.8% of patients receiving continuous risankizumab and 72.2% receiving placebo/risankizumab. In KS2, 77.0% of patients receiving continuous risankizumab and 70.3% receiving placebo/risankizumab achieved the same. No new safety signals were reported.</p><p><strong>Conclusions: </strong>Risankizumab demonstrated durable efficacy and safety at week 196 in KS1 and KS2.</p><p><strong>Trial registration: </strong>KS1: ClinicalTrials.gov, NCT03675308; KS2: ClinicalTrials.gov, NCT03671148.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1103-1123"},"PeriodicalIF":2.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12638571/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145200952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neuroimmune Modulation for Drug-Refractory Rheumatoid Arthritis: Long-Term Safety and Efficacy in Patients Enrolled in a Pilot Vagus Nerve Stimulation Study.","authors":"Norman B Gaylis, David Sikes, Alan Kivitz, Diane Lewis Horowitz, Melissa Evangelista, Yaakov A Levine, David Chernoff","doi":"10.1007/s40744-025-00798-y","DOIUrl":"10.1007/s40744-025-00798-y","url":null,"abstract":"<p><strong>Introduction: </strong>Vagus nerve stimulation activates neuroimmune reflexes that modulate systemic inflammation and may represent a novel non-pharmacologic treatment modality for autoimmune diseases like rheumatoid arthritis (RA). In a 3-month first-in-human, double-blind trial, 50% of patients with drug-refractory RA improved clinically, two patients achieved remission, and pro-inflammatory cytokines declined by 30-50% with daily stimulation. The current study is a 36-month extension of that trial, designed to assess the sustained safety and efficacy of the neuroimmune modulation device in patients with multidrug-refractory RA.</p><p><strong>Methods: </strong>Patients (N = 14) with active RA and prior insufficient response to at least two different biological or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) with at least two mechanisms of action were implanted with a novel neuroimmune modulation device that stimulates the cervical vagus nerve, treated for 12 weeks, and then assessed for safety and clinical effectiveness in an open-label 36-month extension.</p><p><strong>Results: </strong>Eleven patients completed the extension study through month 36. Patients had previously failed an average of 4.8 different drugs, with 64% (9/14) having failed a tsDMARD before enrolling in the study. The median change in clinical disease activity index (CDAI) score from day 0 to month 36 was - 17.8 (SEM 4.9). At month 36, 64% (7/11) of patients achieved a CDAI response that met or exceeded the minimal clinically important difference. Two of these seven patients were treated with daily stimulation alone, while five patients combined stimulation with an adjunctive b/tsDMARD. No device-related infections, cardiac events, surgical revisions, or device explants were reported. Two adverse events related to the device occurred in a single patient: a mild sore throat and moderate tenderness near the implant site. These events were non-serious, anticipated, and resolved.</p><p><strong>Conclusion: </strong>In this first-in-human long-term extension study, neuroimmune modulation was well tolerated among patients with multidrug-refractory RA, with reductions of clinical disease activity that were maintained through 36 months.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1125-1136"},"PeriodicalIF":2.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12638526/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Modern Management of Isolated Polymyalgia Rheumatica.","authors":"Patricia Harkins, Sharon Cowley, Eoghan Burke, Robert Harrington, Danielle Molloy, David Kane, Richard Conway","doi":"10.1007/s40744-025-00797-z","DOIUrl":"10.1007/s40744-025-00797-z","url":null,"abstract":"<p><p>Polymyalgia rheumatica (PMR) is a common inflammatory rheumatic disorder affecting those over 50 years of age. It is clinically heterogenous in both presentation and disease trajectory. Diagnostic complexity is heightened by the absence of a gold standard diagnostic test and the broad spectrum of disease mimics, posing challenges even for experienced rheumatologists. The primary goal of treatment is to restore health-related quality of life by achieving sustained symptom control, suppressing systemic inflammation, and minimising treatment-related toxicity. Despite advances in our understanding of PMR, glucocorticoids (GCs) remain the cornerstone of therapy. However, frequent relapses and prolonged treatment courses in many patients result in high cumulative GC exposure with associated adverse effects, which is of particular concern in this older, typically frailer and more vulnerable patient cohort. The urgent need for effective GC-sparing agents has resulted in pivotal developments over the past decade, notably the SAPHYR trial, which supported the US Food and Drug Administration (FDA) approval of sarilumab as the first biologic therapy for refractory PMR. This represents a major shift in the therapeutic landscape, with several biologic agents now under investigation. These advances, however, highlight gaps in the current management, including the need for rapid access pathways and specialist rheumatologist evaluation in all cases of suspected PMR to facilitate an early and accurate diagnosis, stratified treatment approaches and the accurate detection of a coexisting giant cell arteritis. Furthermore, standardised definitions of relapse and remission, alongside structured monitoring protocols, are lacking. This review explores current diagnostic and treatment strategies for isolated PMR. We also highlight unmet needs in PMR management, and discuss future directions aimed at improving outcomes and redefining the care pathway for PMR.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1017-1041"},"PeriodicalIF":2.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12638475/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145286897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Impact of Uncontrolled Gout on Healthcare Utilization and Health Outcomes for United States Veterans Affairs Patients.","authors":"Adriana Vargus, Corbyn M Gilmore, Jim M Koeller, Grace C Lee, Haridarshan Patel, Brian LaMoreaux, Xavier F Jones, Christopher R Frei","doi":"10.1007/s40744-025-00794-2","DOIUrl":"10.1007/s40744-025-00794-2","url":null,"abstract":"<p><strong>Introduction: </strong>Gout is an inflammatory arthritis that, when uncontrolled, can lead to chronic pain, disability, increased demand for healthcare, and poor health outcomes. This study sought to identify patients with gout and to describe the differences in epidemiology, pharmacotherapy, healthcare utilization, and outcomes for patients with controlled and uncontrolled gout in the United States (US) Veterans Affairs (VA) healthcare system.</p><p><strong>Methods: </strong>This retrospective cohort study used electronic health record (EHR) data from VA patients from all US states and territories with gout from 1/1/2016 to 12/31/2022. The study included adult VA patients (18 +) with a diagnosis code for gout (ICD10 codes M10 or M1A) and two or more encounters 30 or more days apart. Uncontrolled gout was defined as one serum uric acid level (sUA) level > 8 mg/dl, tophi, or both in the study period.</p><p><strong>Results: </strong>Of the 331,664 patients who met study criteria, 42% (138,068) were considered to have uncontrolled gout and 58% (193,596) were controlled. The uncontrolled group was younger (mean age 64 vs. 70 years, p < 0.01), and both groups were predominantly white non-Hispanic (58% and 70%) and male (99% and 99%). Specialist visits were more common in the uncontrolled group during follow-up: podiatry (38% vs. 30%, p < 0.01), rheumatology (24% vs. 9%, p < 0.01), and nephrology (24% vs. 12%, p < 0.01). Patients with uncontrolled gout were also significantly more likely to be seen in the emergency room (55% vs. 38%, p < 0.01) or admitted to the hospital (47% vs. 37%, p < 0.01) during follow-up.</p><p><strong>Conclusions: </strong>Nearly half of VA patients with gout met criteria for uncontrolled gout, and these patients experienced greater healthcare utilization and worse health outcomes than patients with controlled gout. Patients with uncontrolled gout could benefit from additional/alternative approaches such as the adoption of a treat-to-target strategy and increasing referrals to a specialist.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1057-1081"},"PeriodicalIF":2.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12638621/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145086921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Letter to the Editor Regarding \"Evaluation of VTE, MACE, and Serious Infections Among Patients with RA Treated with Baricitinib Compared to TNFi: A Multi-Database Study of Patients in Routine Care Using Disease Registries and Claims Databases\".","authors":"Claudia A Salinas, Anthony Louder, Jennifer Polinski, Tancy C Zhang, Hannah Bower, Syd Phillips, Yufei Song, Emaan Rashidi, Rafia Bosan, Hsiu-Ching Chang, Nicole Foster, Bernice Gershenson, Hisashi Yamanaka, Mitsumasa Kishimoto, Yoshiya Tanaka, Peter Fischer, Baojin Zhu, Douglas Faries, Xiaodan Mai, Brett T Doherty, Angela Grelaud, Nicolas H Thurin, Johan Askling, Walter Deberdt","doi":"10.1007/s40744-025-00796-0","DOIUrl":"10.1007/s40744-025-00796-0","url":null,"abstract":"","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1187-1191"},"PeriodicalIF":2.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12638479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145150690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to Tofacitinib in Patients with Psoriatic Arthritis and Probable Anxiety/Depressive Disorder: A Post Hoc Analysis of Phase 3 Trials.","authors":"Laure Gossec, Agustí Sellas, David C Gruben, Mónica Valderrama, Susana Gómez, Cassandra Kinch, Gustavo Citera","doi":"10.1007/s40744-025-00800-7","DOIUrl":"10.1007/s40744-025-00800-7","url":null,"abstract":"<p><strong>Introduction: </strong>Mental health status potentially influences treatment responses. The effect of probable anxiety and/or depressive disorder (pADD) on tofacitinib efficacy, patient-reported outcomes (PROs), and safety in psoriatic arthritis (PsA) was assessed.</p><p><strong>Methods: </strong>This was a post hoc analysis of two phase 3 trials in patients with PsA receiving tofacitinib, adalimumab, or placebo, and an open-label extension study. Outcomes were stratified by presence/absence of baseline pADD (Short Form-36 Health Survey [SF-36] Mental Component Summary score ≤ 38/ > 38). American College of Rheumatology ≥ 20%, ≥ 50%, and ≥ 70% (ACR20/50/70) responses, remission and/or low disease activity based on Psoriatic Arthritis Disease Activity Score and Disease Activity Index for Psoriatic Arthritis score, minimal disease activity, and PROs (pain/Health Assessment Questionnaire-Disability Index/fatigue) were assessed through month 36. Safety was assessed through month 12.</p><p><strong>Results: </strong>Overall, 323/706 (45.8%) patients had baseline pADD; of these, a higher proportion were female versus male (61.9% vs. 38.1%). Numerically higher proportions achieved efficacy/PRO responses with tofacitinib versus placebo, regardless of baseline pADD (month 3). Responses with tofacitinib were generally similar in patients with versus without baseline pADD (e.g., month 3 ACR20 responses: 54.0% vs. 58.5%); some differences were observed at later time points (e.g., month 9 minimal disease activity: 25.0% vs. 43.8%; p < 0.05). Baseline pADD did not appear to affect the incidence of treatment-emergent adverse events.</p><p><strong>Conclusions: </strong>Baseline pADD was frequent in patients with PsA initiating tofacitinib and was higher in female patients. Tofacitinib-treated patients had generally similar efficacy/safety outcomes, regardless of baseline pADD. Some differences in efficacy outcomes were noted in the longer term (9-12 months). Limitations of this study include small numbers in some analyses and use of SF-36 as pADD proxy.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT01877668; NCT01882439; NCT01976364.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1175-1186"},"PeriodicalIF":2.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12638500/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145392542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Effectiveness and Satisfaction with Risankizumab for the Treatment of Psoriatic Arthritis in Biologic-Naïve Patients: A Population Survey in the United States and Europe.","authors":"Jessica A Walsh, Christopher D Saffore, Xiaolan Ye, Manish Patel, Ana Biljan, Jamie Vora, Isabel Truman, Molly Edwards, Gary Milligan, Andrew Ostor","doi":"10.1007/s40744-025-00801-6","DOIUrl":"10.1007/s40744-025-00801-6","url":null,"abstract":"<p><strong>Introduction: </strong>This study assessed the real-world effectiveness of risankizumab (RZB) and treatment satisfaction in biologic-naïve patients with psoriatic arthritis (PsA) across the USA and Europe.</p><p><strong>Methods: </strong>Data were drawn from the Adelphi Real World Spondyloarthritis Disease Specific Programme™, a cross-sectional survey of physicians and their adult patients with PsA receiving RZB 150 mg subcutaneous injections in Europe (France, Germany, Italy, Spain, UK) and the US, conducted from June 2023-June 2024. Physicians reported changes in body surface area (BSA), dactylitis, enthesitis, TJC68, and SJC66 and assessments of pain and fatigue on a 0-10 scale (higher scores indicating worse outcomes) from initiation to data collection, evaluated using McNemar or t-tests (p < 0.05 considered significant). Clinically meaningful improvements were complete resolution of dactylitis, enthesitis, TJC68, and SJC66 and pain (≥ 1.0-unit) and fatigue (≥ 3.0-unit) reductions. Physician and patient satisfaction with disease control was also reported. Outcomes were analyzed for the full cohort and stratified by prescription of a conventional synthetic disease-modifying antirheumatic drug (csDMARD) prior to the survey or at data collection vs csDMARD-naïve.</p><p><strong>Results: </strong>Overall, 127 physicians reported on 192 patients with PsA (Europe 64%, US 36%). Mean ± SD patient age was 44.2 ± 10.7 years, and 45% were female. From RZB treatment initiation to time of data collection, resolution of dactylitis (82%) and enthesitis (90%), and improvements to TJC68 (- 3.7 ± 6.3), SJC66 (- 2.5 ± 5.1), pain (- 3.9 ± 2.4), fatigue (- 2.7 ± 2.6), and BSA (- 10 ± 10%) were observed (p < 0.001 for each) for the full cohort, with significant changes observed in both csDMARD subgroups. Patient and physician satisfaction with disease control was 95% and 98%, respectively.</p><p><strong>Conclusion: </strong>Biologic-naïve patients with PsA starting RZB demonstrated significant and meaningful improvements in joint symptoms, pain, and fatigue in real-world settings. High levels of satisfaction with RZB for disease control were reported by both patients and physicians.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1159-1174"},"PeriodicalIF":2.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12638470/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145346705","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}