Rheumatology and Therapy最新文献

{"title":"Real-World Effectiveness of Bimekizumab in Predominantly Difficult-to-Treat Patients with Psoriatic Arthritis Followed in a Combined Dermatology-Rheumatology Clinic: A 24-Week Multicenter Study.","authors":"Alen Zabotti, Nicola Cabas, Maria De Martino, Luca Idolazzi, Andrea Guiotto, Francesco Bellinato, Ivan Giovannini, Beatrice Gabrielli, Paolo Gisondi, Enzo Errichetti, Maurizio Rossini, Giuseppe Stinco, Luca Quartuccio","doi":"10.1007/s40744-025-00784-4","DOIUrl":"10.1007/s40744-025-00784-4","url":null,"abstract":"<p><strong>Introduction: </strong>Bimekizumab (BKZ), a monoclonal antibody targeting interleukin (IL)-17A and IL-17F, has shown high efficacy in clinical trials. However, real-world data on its use in psoriatic arthritis (PsA) are limited. This study aimed to evaluate the effectiveness and safety of BKZ over 24 weeks in a real-world setting.</p><p><strong>Methods: </strong>A retrospective, multicenter study was conducted at two Italian rheumatology centers, enrolling adult patients with PsA who initiated BKZ treatment between January 2023 and February 2025. Clinical data were collected at baseline, week 12, and week 24.</p><p><strong>Results: </strong>Forty patients with PsA were included. Of these, 75% had failed at least two biologic and/or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) prior to BKZ and 25/40 (62.5%) had failed at least one IL-17A inhibitor (IL-17Ai). Among these 25 patients, 32% experienced a primary failure and 68% a secondary failure. The median baseline Disease Activity in Psoriatic Arthritis (DAPSA) score was 22.9 (17.5-27.2), decreasing to 6.0 (3.1-12.8) at week 24 (p < 0.001). By week 24, 72.5% achieved DAPSA low disease activity (LDA), and 25% achieved DAPSA remission. The median swollen joint count (SJC) decreased from 3.0 (0.8-5.3) to 0.0 (IQR 0.0-1.0), and median tender joint count (TJC) decreased from 4.5 (3.0-7.3) to 1.0 (0.0-2.0) (both p < 0.001). Pain visual analog scale (VAS) and Patient Global Assessment (PGA) improved significantly, from 7.0 (6.0-8.0) and 7.5 (6.5-8.0) at baseline to 2.0 (1.0-5.0) and 2.0 (1.0-4.5) at week 24 (both p < 0.001). Skin involvement also improved, with 51.5% achieving Psoriasis Area and Severity Index (PASI) 100 by week 24. The safety profile was favorable; 15% of patients developed mild oral candidiasis, none of which required treatment discontinuation.</p><p><strong>Conclusion: </strong>BKZ demonstrated rapid and sustained improvements in PsA symptoms in a challenging real-world population, with a favorable safety profile.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"961-973"},"PeriodicalIF":2.9,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450189/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733014","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":"Characterization of Super-Responder Profile in Patients with Psoriatic Arthritis Treated with b/tsDMARDs: A Retrospective Study of a Longitudinal Cohort.","authors":"Fabio Massimo Perrotta, Ennio Lubrano","doi":"10.1007/s40744-025-00789-z","DOIUrl":"10.1007/s40744-025-00789-z","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriatic arthritis (PsA) is a complex disease in which remission or low disease activity is now an achievable target. This study aimed to evaluate \"super-responders\" (SR) among patients with PsA treated with advanced therapies and to explore possible clinical factors associated with the SR phenotype.</p><p><strong>Methods: </strong>This is a retrospective analysis of a longitudinal cohort of patients diagnosed with PsA and treated with biologic and targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs), with at least 2 years of follow-up. SR were defined as patients achieving very low disease activity (VLDA) within 6 months of therapy initiation and maintaining VLDA for at least 2 years. Data from all clinical visits were reviewed to confirm response patterns. Patients who initiated treatment for PsA were included, regardless of prior biologic use for psoriasis. SR were compared with non-SR patients to identify clinical differences. Logistic regression was performed to evaluate features associated with SR.</p><p><strong>Results: </strong>Among 177 evaluated patients, 29 (16.3%) were classified as SR. SR patients were more often of male sex, had significantly lower baseline pain visual analogue scale scores (p < 0.01), Patient Global Assessment score (p = 0.04), and shorter intervals between psoriasis and PsA diagnosis (p = 0.04). They were more frequently treated with interleukin-17 (IL-17) inhibitors at baseline (37.9% vs. 19.5%, p = 0.04) and had absence of cardiometabolic comorbidities. Logistic regression analysis confirmed associations between SR status and IL-17 treatment, absence of cardiometabolic comorbidities, and lower pain scores.</p><p><strong>Conclusion: </strong>This study may identify a distinct subset of patients with PsA demonstrating rapid and sustained response to treatment. While promising, the clinical utility of the SR concept requires cautious interpretation, especially regarding potential treatment de-escalation. Further validation in multicenter prospective studies may be essential.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1007-1015"},"PeriodicalIF":2.9,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450152/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144856179","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 Sex on the Pattern and Clinical Response of Early Psoriatic Arthritis: Real-life Data from the Italian Prospective SIRENA Study.","authors":"Ennio G Favalli, Michele M Luchetti Gentiloni, Carlo Selmi, Roberta Ramonda, Rosa D Grembiale, Lorenzo Dagna, Salvatore D'Angelo, Roberto Gerli, Rosario Foti, Francesco Ciccia, Giuliana Guggino, Franco Franceschini, Maria S Chimenti, Maurizio Rossini, Ennio Lubrano, Bruno Frediani, Silvia Marelli, Alen Zabotti","doi":"10.1007/s40744-025-00787-1","DOIUrl":"10.1007/s40744-025-00787-1","url":null,"abstract":"<p><strong>Introduction: </strong>Limited data are available on sex differences in the disease characteristics, burden and treatment outcomes of early psoriatic arthritis (PsA). The \"Spondyloarthritis Italian Registry: Evidence from a National Pathway\" (SIRENA) study is a prospective, observational, Italian study conducted in 23 Rheumatology sites on patients with recent diagnosis of spondyloarthritis and naïve to any disease-modifying antirheumatic drugs (DMARDs).</p><p><strong>Methods: </strong>The study included 203 patients with early PsA, observed per clinical practice, who were studied regarding the influence of sex on the disease presentation and the likelihood of achieving minimal disease activity (MDA). Clinical and patient-reported outcome (PRO) measures were collected at both study entry and each follow-up visit until 24 months. Treatment was assigned by the treating rheumatologist based on standard clinical practice.</p><p><strong>Results: </strong>At baseline, 87% of patients with PsA received systemic treatment, mainly with conventional (49%) or biological (25%) DMARDs. Twenty-three of 158 (15%) patients were already in MDA status at study entry: this percentage increased to 55% (n = 83/150) at 6 months and 75% (n = 73/97) at 24 months. MDA was more frequent in males at baseline (20.0% vs. 8.2% in females, p = 0.036) and throughout the study. Significant improvements in clinical measures and PROs were reported in both sexes at all follow-up visits, but PRO scores were significantly worse in females at baseline and at most endpoints. Increasing age, male sex, new PsA diagnosis, mono-/oligoarticular involvement, low (≤ 14) Disease Activity index for PSoriatic Arthritis (DAPSA) and low Health Assessment Questionnaire Disability Index (HAQ-DI) values showed potential associations with MDA achievement at 6 months in univariate analysis, but this was not significant in the multivariate model.</p><p><strong>Conclusion: </strong>In patients with PsA naïve to DMARDs, sex considerably influences the clinical characteristics and outcomes.</p><p><strong>Trial registration number: </strong>NCT03131661.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"941-960"},"PeriodicalIF":2.9,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450140/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144718269","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 Analysis of Patient Characteristics, Adverse Events, and Economic Burden Among Patients with Giant Cell Arteritis Treated with Glucocorticoids.","authors":"Jeffrey R Curtis, Denise T Kruzikas, Ana Romero, Arathi R Setty, Yi Peng, Jayesh Patel, Pankti Reid, Frank Buttgereit","doi":"10.1007/s40744-025-00778-2","DOIUrl":"10.1007/s40744-025-00778-2","url":null,"abstract":"<p><strong>Introduction: </strong>Giant cell arteritis (GCA) typically requires long-term treatment with glucocorticoids (GC). However, prolonged use of GCs has been associated with increased risk of GC-related side effects and adverse events. This study assessed the burden of GCs in GCA across the comprehensive framework of 39 adverse events, across 11 clinical categories, and side effects commonly associated with GC use (GRAEs).</p><p><strong>Methods: </strong>This retrospective, observational study leveraged Merative MarketScan® databases (01/01/2009-12/31/2020), identified patient newly diagnosed with GCA, and assessed GC use, GRAE events, healthcare resource utilization (HCRU), and costs for ≥ 12 months up to 60 months post GC initiation. Eligible patients were ≥ 50 years old, with continuous plan enrollment for ≥ 12 months post-index GCA diagnosis (GCA + GC cohort) and were newly treated with GCs. Patients in the GCA + GC cohort were compared with a control cohort with no GCA and no GC (CC1) and a second control cohort of no GCA (CC2).</p><p><strong>Results: </strong>Patients with GCA + GC versus control cohorts had significantly (p < 0.001) higher occurrence of 38 of 39 GRAEs assessed, with absolute differences ranging from 3% among musculoskeletal events to 20% among bone-related events. Patients in the GCA + GC cohort had greater HCRU compared with both control cohorts; compared to CC1, patients with GCA + GC had two times higher rates of hospitalization, and greater mean all-cause medical costs ($37,936 ± $65,325 vs $12,498 ± $48,793; p < 0.001) and results were similar when compared to CC2. Accounting for GRAEs, GCA-related costs more than doubled ($6337 ± $14,460 vs $13,995 ± $30,987).</p><p><strong>Conclusion: </strong>Patients newly diagnosed with GCA and newly treated with GCs experience significantly higher rates of GRAEs in every category and two-fold higher healthcare costs. These data reflect the medical and financial burden for patients with GCA receiving GCs and establishes a comprehensive framework for assessing GC-related conditions for inflammatory diagnoses.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"835-854"},"PeriodicalIF":2.9,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450133/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144561030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Real-World Comparison of Clinical Effectiveness of Upadacitinib, Tumor Necrosis Factor Inhibitors or Interleukin-17 Inhibitors in Patients with Axial Spondyloarthritis After Switching from an Initial Tumor Necrosis Factor Inhibitor Treatment.","authors":"Xenofon Baraliakos, Christopher D Saffore, Xiaolan Ye, Jamie Urbanik, Jayne Stigler, Molly Edwards, Isabel Truman, Sophie Barlow, Atul Deodhar","doi":"10.1007/s40744-025-00786-2","DOIUrl":"10.1007/s40744-025-00786-2","url":null,"abstract":"<p><strong>Introduction: </strong>Tumor necrosis factor inhibitors (TNFi) may have insufficient efficacy in 40% of patients with axial spondyloarthritis (axSpA), leading to continued pain. We aimed to compare real-world effectiveness of switching from an initial TNFi to upadacitinib (TNFi-UPA), another TNFi (TNFi-TNFi), or an interleukin-17 inhibitor (TNFi-IL-17i) in patients with axSpA.</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 patients with axSpA in France, Germany, Italy, Spain, the UK, and the USA from March-November 2021 and June 2023-June 2024. Patients who switched treatment from an initial TNFi were stratified by subsequent therapy: TNFi-UPA, TNFi-TNFi, or TNFi-IL-17i. Physician-reported clinical outcomes including pain (rated 0-10) and number of joints affected by inflammation or stiffness (from 0 to 68) were evaluated ≥ 3 months from treatment switch. Differences in characteristics were adjusted at the point of switch via inverse-probability-weighted regression adjustment to compare outcomes in separate analyses by subsequent class of therapy: TNFi-UPA versus TNFi-TNFi or TNFi-UPA versus TNFi-IL-17i.</p><p><strong>Results: </strong>Overall, 310 physicians provided data for 557 patients; 108 were TNFi-UPA, 271 TNFi-TNFi, and 178 TNFi-IL-17i. A higher proportion of patients in the TNFi-UPA group achieved a ≥ 2 point and ≥ 33% reduction in pain than those in the TNFi-IL-17i (97.6% vs 86.4%; p = 0.002) or TNFi-TNFi (100.0% vs 80.1%; p < 0.001) groups. More patients achieved ≥ 50% reduction in pain in the TNFi-UPA group compared to TNFi-IL-17i (90.9% vs 74.0%; p = 0.004) or TNFi-TNFi (96.3% vs 72.3%; p = 0.024). More patients in the TNFi-UPA group had no affected joints than TNFi-IL-17i (93.1% vs 72.6%; p = 0.002) or TNFi-TNFi patients (100.0% vs 79.2%; p < 0.001).</p><p><strong>Conclusion: </strong>This real-world study demonstrated that more patients who switched from TNFi to UPA had improvements in pain and affected joints compared to those who switched to a second TNFi or IL-17i.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"909-923"},"PeriodicalIF":2.9,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450128/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144668263","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 Firsekibart Compared to Etoricoxib for Gout Flares: A Phase 2, Multicenter, Open-label, Active-controlled, Randomized Non-inferiority Trial.","authors":"Ning Kong, Yu Xue, Li Mao, Long Qian, Hongtao Guo, Jiankang Hu, Fenghong Yuan, Rongbin Li, Xinwang Duan, Jing Yu, Wei Gou, Lei Yang, Hua Wei, Rongping Li, Qian Xu, Tianhong Luo, Xu Zhang, Hejian Zou","doi":"10.1007/s40744-025-00790-6","DOIUrl":"10.1007/s40744-025-00790-6","url":null,"abstract":"<p><strong>Introduction: </strong>Firsekibart, an anti-interleukin (IL)-1β monoclonal antibody, has demonstrated more sustained control of gout flares compared with compound betamethasone in previous clinical studies. This study evaluated the efficacy and safety of firsekibart versus etoricoxib for the treatment of frequent gout flares.</p><p><strong>Methods: </strong>In this phase 2, randomized, open-label, active-controlled, multicenter study (NCT05936268), adults with gout according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2015 criteria experiencing frequent flares (≥ 2 flares within 12 months pre-screening) were randomized (1:1) to receive either a single subcutaneous injection of firsekibart 200 mg, or once-daily oral etoricoxib 120 mg administered until pain remission or treatment intolerance for up to 8 days. The primary endpoint was change from baseline in target joint pain intensity (0-100 mm visual analogue scale [VAS]) 72 h post-treatment. Non-inferiority (margin: 10 mm) was assessed first; if achieved, superiority was subsequently evaluated. Safety was also evaluated.</p><p><strong>Results: </strong>Overall, 123 patients received firsekibart (n = 61) or etoricoxib (n = 62). Firsekibart was non-inferior and superior to etoricoxib in change from baseline in target joint pain VAS scores at 72 h post-treatment (difference: - 10.91 mm; 95% confidence interval [CI]: - 18.11, - 3.72). Treatment-emergent adverse events (TEAEs) occurred in 77.0% (n = 47) and 51.6% (n = 32) of patients receiving firsekibart and etoricoxib, respectively. The most common TEAE in both groups was hypertriglyceridemia. No TEAEs led to treatment discontinuation or study withdrawal, and no treatment-related serious adverse events (AEs) or deaths were reported.</p><p><strong>Conclusions: </strong>Compared with etoricoxib, firsekibart provides superior target joint pain relief and is well-tolerated in patients with frequent gout flares.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT05936268; date of registration: 7 July 2023.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"975-990"},"PeriodicalIF":2.9,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450154/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144966569","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":"Patient Profile and Outcomes Among Patients with Rheumatoid Arthritis Treated with Baricitinib Versus Other Therapies in Spain: The RA-BE-REAL Study.","authors":"Mª Luz García-Vivar, Águeda Prior-Español, Walid Fakhouri, Silvia Díaz-Cerezo, Itxaso Aguirregabiria, Sebastián Moyano, Amelia Cobo, Samuel Ogwu, Pilar Trenor","doi":"10.1007/s40744-025-00781-7","DOIUrl":"10.1007/s40744-025-00781-7","url":null,"abstract":"<p><strong>Introduction: </strong>Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by joint inflammation and pain. Baricitinib, a targeted JAK inhibitor indicated for moderate to severe RA, has shown efficacy and safety, but real-world data on effectiveness and discontinuation rates are limited. This study aimed to report time to discontinuation, effectiveness, and patient-reported outcomes in patients initiating baricitinib or other biologic/targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) in the Spanish clinical practice.</p><p><strong>Methods: </strong>The subgroup from 11 Spanish hospitals in the multinational prospective RA-BE-REAL study was analysed. Patients treated for the first time with baricitinib or other b/tsDMARD were included. The primary objective was time to all-cause discontinuation of treatment at 24 months. Secondary objectives included assessing baseline characteristics, treatment patterns, and effectiveness on disease activity, health-related quality of life (HRQoL) and pain. Statistical analyses were descriptive in nature.</p><p><strong>Results: </strong>Eighty patients initiating baricitinib (cohort A, n = 31) or any b/tsDMARD (cohort B, n = 49) were included. Most patients were women, with mean age 62.6 and 57.0 years, respectively; 58.1% in cohort A and 40.8% in cohort B had prior b/tsDMARD treatment. After 24 months, 61.3% and 44.9% continued their initial treatment, respectively. Main reason for discontinuation was secondary loss of response (19.4% and 26.5%, respectively). After 3 months, both cohorts showed improvements in disease activity, swollen and tender joint counts, physician and patient global assessments, disability, pain, and HRQoL. This trend to improvement was maintained for up to 24 months, suggesting a rapid and sustained response. At 24 months, 46.4% and 29.3% achieved low disease activity; 10.7% and 26.8% achieved remission, respectively.</p><p><strong>Conclusion: </strong>The study suggests that baricitinib, despite being used in an older and more treatment-experienced cohort, shows comparable effectiveness and a trend towards lower discontinuation rates for up to 24 months, reinforcing its potential as a treatment option.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"889-907"},"PeriodicalIF":2.9,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450180/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144576210","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":"https://doi.org/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":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","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":"https://doi.org/10.1007/s40744-025-00796-0","url":null,"abstract":"","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Assessment of Systemic Disease Activity in Seropositive and Seronegative Patients with Sjögren's Disease and Association with Patient-Reported Outcomes.","authors":"Jacques-Eric Gottenberg, Raphaele Seror, Nicola Massey, Megan Hughes, Victoria Barton, Sarah Weatherby, Federico Zazzetti, Andras Borsi, Wim Noel, Harman Dhatt, Angelina Villasis-Keever, Anna Sheahan, Urbano Sbarigia","doi":"10.1007/s40744-025-00792-4","DOIUrl":"https://doi.org/10.1007/s40744-025-00792-4","url":null,"abstract":"<p><strong>Introduction: </strong>Sjögren's disease (SjD) is often characterized by the presence of anti-SSA/Ro and anti-SSB/La autoantibodies. The Clinical European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ClinESSDAI) and Patient-Reported Index (ESSPRI) assess disease activity and patient-reported symptomatology; however, their association with patient-reported outcome measures (PROMs) remains unclear. We aimed to describe systemic disease activity in seropositive and seronegative SjD patients and evaluate the association between proxy ClinESSDAI and ESSPRI scores with PROMs.</p><p><strong>Methods: </strong>Data were drawn from the Adelphi Real World SjD Disease Specific Programme™, a cross-sectional survey conducted in France, Germany, Italy, Spain and the United States between June and October 2018. Physicians reported patient demographics and clinical characteristics. Patients completed the EQ-5D-3L and Visual Analogue Scale (EQ-VAS), and the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F). Proxy ClinESSDAI and ESSPRI scores were calculated using physician-reported organ activity and averaged patient ratings of dryness, pain, and fatigue, respectively. Associations between ClinESSDAI, ESSPRI, physician-reported disease severity, and PROMs were determined using linear and logistic regression modeling. Statistical significance was p < 0.05 for all tests.</p><p><strong>Results: </strong>Overall, 319 rheumatologists provided data on 1879 patients with SjD. Mean (standard deviation) patient age was 53.2 (12.2) years, 89% were female, and 89% were White. Of patients who received serum antibody testing for both anti-SSA/Ro and anti-SSB/La antibodies (n = 1344), 69% were double seropositive and 6% were double seronegative. The most common symptoms experienced by double seropositive and double seronegative SjD patients, respectively, included dry eyes (94% and 74%), and physical fatigue (82% and 60%). ClinESSDAI and ESSPRI were significantly associated with EQ-5D-3L, EQ-VAS, and FACIT-F (all p < 0.001).</p><p><strong>Conclusions: </strong>Systemic disease activity and patient-reported symptomatology were significantly associated with health-related quality of life measures, highlighting the need for disease management that considers both clinical outcomes and the patient experience.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145125910","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}