Rheumatology and Therapy最新文献

{"title":"Achievement and Maintenance of Disease Targets with Upadacitinib in Rheumatoid Arthritis: 2-Year Outcomes from the UPHOLD Real-World Study.","authors":"Andrew Östör, Eugen Feist, Prodromos Sidiropoulos, Jérôme Avouac, Martin Rebella, Rajaie Namas, Frank Buttgereit, Philip G Conaghan, Ana B Romero, Erin L McDearmon-Blondell, Ivan Lagunes-Galindo, Tianming Gao, Aditi Kadakia, Tim Shaw, Suzan Attar","doi":"10.1007/s40744-026-00826-5","DOIUrl":"10.1007/s40744-026-00826-5","url":null,"abstract":"<p><strong>Introduction: </strong>Upadacitinib, an oral Janus kinase inhibitor, has shown a favorable benefit-risk profile in rheumatoid arthritis (RA) clinical trials. This analysis aimed to assess the long-term effectiveness and safety of upadacitinib through 24 months in the UPHOLD real-world observational study.</p><p><strong>Methods: </strong>The coprimary endpoints were: (1) proportion of patients achieving disease activity score in 28 joints using C-reactive protein (DAS28[CRP]) remission (< 2.6) at 6 months; and (2) proportion of those patients who maintained remission at 12 months. Additional endpoints assessed through 24 months included: achievement and maintenance of DAS28(CRP) low disease activity (LDA; ≤ 3.2); maintenance of response by treatment strategy and prior therapy; disease category by visit; improvements in patient-reported outcomes (PROs); and achievement of glucocorticoid (GC)-free remission. Endpoints were analyzed by modified nonresponder imputation (mNRI) and as observed (AO). Exposure-adjusted event rates (events/100 patient-years [E/100 PY]) for treatment-emergent adverse events (TEAEs) were reported through May 15, 2024.</p><p><strong>Results: </strong>In total, 1029/1715 (60.0%) patients completed the 24-month follow-up. DAS28(CRP) responses at 6 months were well maintained through 24 months (mNRI/AO remission, 62.9%/83.9%; and LDA, 65.7%/90.1%, respectively). Remission rates at 24 months were consistent between patients maintaining combination therapy and those maintaining monotherapy (81.1% and 87.4%, respectively; AO). Responses were also largely similar across prior therapy subgroups. Improvements in PROs achieved by 12 months were maintained through 24 months. Most patients receiving GCs at baseline who achieved GC-free remission maintained GC-free remission at 24 months. Among selected TEAEs of interest, herpes zoster, serious infection, and hepatic disorder occurred at 3.5, 3.1, and 2.6 E/100 PY, respectively. No new safety signals were identified.</p><p><strong>Conclusions: </strong>Upadacitinib was effective for the long-term treatment of RA in real-world practice, with responses achieved at 6 months maintained through 2 years, and no new safety findings.</p><p><strong>Trial registration: </strong>NCT04497597.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"659-676"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198608/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147487141","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":"Does Prior Exposure Affect Retention? A Real-World, Multicentre Assessment of IL-17 Inhibitor Cycling in Psoriatic Arthritis.","authors":"Valentino Paci, Alarico Ariani, Eleonora Celletti, Olga Addimanda, Alberto Lo Gullo, Camilla Mazzanti, Myriam Di Penta, Emanuela Sabatini, Francesco Cipollone, Gianluca Santoboni, Claudio Angrisani, Massimiliano De Simone, Valeria Nucera, Aurora Ianniello, Giulia Vallifuoco, Natalia Mansueto, Romina Andracco, Giulio Ferrero, Rosalba Caccavale, Marino Paroli, Patrizia Del Medico, Gianluca Smerilli, Antonella Farina, Palma Scolieri, Vincenzo Bruzzese, Cecilia Giampietro, Francesca Ometto, Gentiana Vukatana, Marica Trevisani, Rita Mulè, Elisa Rossi, Enrica Vandelli, Riccardo Bixio, Alessandro Volpe, Antonio Marchetta, Maddalena Larosa, Dario Camellino, Gerolamo Bianchi, Viviana Ravagnani, Federica Lumetti, Aldo Biagio Molica Colella, Veronica Franchina, Francesco Molica Colella, Elena Bravi, Ilaria Platè, Eugenio Arrigoni, Rosetta Vitetta, Francesca Serale, Alessia Fiorenza, Davide Murgia, Guido Rovera, Gabriele Amati, Elisa Visalli, Giorgio Amato, Francesco De Lucia, Ylenia Dal Bosco, Roberta Foti, Enrico Fusaro, Maria Chiara Ditto, Simone Bernardi, Francesco Girelli, Marta Priora, Alessandra Bezzi, Maria Cristina Focherini, Fabio Mascella, Andrea Becciolini, Eleonora Di Donato, Giuditta Adorni, Gianluca Lucchini, Daniele Santilli, Beatrice Gabrielli, Dilia Giuggioli, Bernd Raffeiner, Massimo Reta, Mirco Magnani, Luca Idolazzi, Gilda Sandri, Rosario Foti, Simone Parisi, Michele Maria Luchetti Gentiloni, Gianluca Moroncini","doi":"10.1007/s40744-026-00839-0","DOIUrl":"10.1007/s40744-026-00839-0","url":null,"abstract":"<p><strong>Introduction: </strong>Interleukin-17 inhibitors (IL-17i) represent a key therapeutic option for psoriatic arthritis (PsA), but real-world evidence regarding the effectiveness of cycling strategies within this class is lacking. This study evaluated the real-world retention of IL-17i in PsA, focusing on whether prior IL-17i exposure affects subsequent IL-17i persistence.</p><p><strong>Methods: </strong>This multicentre, retrospective, observational study included consecutive patients with PsA treated with an IL-17i across 24 Italian rheumatology centres. The primary outcome was drug retention, analysed using Kaplan-Meier methods, with differences between IL-17i-naïve and IL-17i-experienced patients assessed with the log-rank test. Secondary outcomes included baseline clinical characteristics and predictors of discontinuation.</p><p><strong>Results: </strong>A total of 868 patients were included (59.3% female, 40.7% male; median age 56 [48-63] years; 89.3% IL-17i-naïve). The overall median IL-17i retention rate was 90.7% [95% CI 88.7-92.8] at 6 months, 77.5% [95% CI 74.6-80.6] at 12 months, 60.9% [95% CI 57.3-64.8] at 24 months, and 52.1% [95% CI 48.1-56.4] at 36 months. Among IL-17i-naïve patients, retention rates were 90.5%, 77.6%, 61.7%, and 53.9% at 6, 12, 24, and 36 months, respectively. Among IL-17i-experienced patients, the corresponding retention rates were 92.2%, 77.0%, 54.0%, and 33.9%. In multivariable Cox regression, male sex and prior IL-17 inhibitor exposure were associated with a lower risk of discontinuation, whereas axial involvement, a higher number of previous biologic/targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs), and later calendar year of IL-17i initiation predicted poorer retention.</p><p><strong>Conclusions: </strong>IL-17i showed high long-term retention in real-world PsA, with no significant difference between naïve and previously exposed patients. These findings support the sustained effectiveness of IL-17i therapy and suggest that cycling within the class may remain a reasonable option for selected cases.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"629-643"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198578/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147459502","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 Narrative Review of Secukinumab in Spondyloarthritis and Psoriatic Arthritis: Treating the Whole Patient.","authors":"Gurjit S Kaeley, Alan Kivitz, Philip Mease, Pamela F Weiss, Linda Grinnell-Merrick, Dafna D Gladman","doi":"10.1007/s40744-026-00833-6","DOIUrl":"10.1007/s40744-026-00833-6","url":null,"abstract":"<p><p>Spondyloarthritis (SpA), including axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA), comprises a diverse but interrelated family of inflammatory diseases characterized by inflammation of the joints and spine. Signs and symptoms of SpA vary widely, as patients experience a diverse spectrum of musculoskeletal and extra-musculoskeletal disease manifestations. Interleukin (IL)-17 is an inflammatory cytokine common to the pathogenesis of SpA disease development and progression. The IL-17A inhibitor secukinumab has been well established in clinical trials and real-world practice as an effective therapeutic tool to efficiently manage SpA indications axSpA and PsA in adults, as well as juvenile PsA (jPsA) and enthesitis-related arthritis (ERA), which are two subtypes of juvenile idiopathic arthritis. This review highlights the comprehensive response to IL-17 inhibition with secukinumab across SpA indications of PsA, axSpA, and ERA/jPsA and within each indication according to established disease domains. We provide context through expert commentary on the effect of inhibiting IL-17 with secukinumab on the full spectrum of SpA disease manifestations, as well as areas in need of further investigation.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"467-490"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198576/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147487166","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/Effectiveness, Safety and Treatment Persistence of Filgotinib in Rheumatoid Arthritis: A Narrative Review of Clinical Trials and Real-World Evidence.","authors":"Yoshiya Tanaka, Peter C Taylor, Jeffrey A S Ritsema, Akira Kondo, Toshihiko Kaise","doi":"10.1007/s40744-026-00828-3","DOIUrl":"10.1007/s40744-026-00828-3","url":null,"abstract":"<p><p>Filgotinib (FIL) is a Janus kinase preferential inhibitor, classified as a targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD). It is approved for patients with rheumatoid arthritis (RA) who have failed treatment with methotrexate (MTX), a conventional synthetic DMARD (csDMARD). Randomized controlled trials (RCTs) investigating 100 and 200 mg doses of FIL + MTX have demonstrated rapid effects in reducing disease activity, pain, and fatigue and improving functional outcomes compared with MTX monotherapy or adalimumab (a biologic) + MTX. FIL's efficacy in reducing disease activity and improving functional outcomes was sustained in the long-term (3 years), while also minimizing radiographic progression. In particular, 200 mg FIL + MTX significantly reduced radiographic progression uncoupled from disease activity, outperforming adalimumab + MTX in patients with medium or high disease activity. Adverse events were similar among FIL, MTX, and adalimumab over 52 weeks in RCTs, with a consistent safety profile in the long term (> 8 years). FIL persistence rates were generally high, regardless of dose. Evidence from real-world observational studies complements and underscores the effectiveness and safety of FIL demonstrated in RCTs. These findings support FIL's potential as a therapeutic option in the management of RA. Guidelines currently recommend a starting dose of 200 mg FIL ± MTX; a 100 mg starting dose can be used if the patient is elderly (Europe); at increased risk of venous thromboembolism, major adverse cardiovascular events or malignancy (Europe); or has impaired renal function (Japan). Furthermore, patients should only initiate FIL after inadequate response to MTX or other csDMARDs. In clinical practice, there may be additional considerations that could impact outcomes, including persistence and variations in patient profiles and treatment backgrounds. Future results from ongoing studies can be expected to provide further insights into the long-term effectiveness, such as joint outcomes and safety of FIL, in the real-world context.Graphical abstract available for this article.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"491-543"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198601/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147575175","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":"Outdated Frameworks, Missed Opportunities: A Call for Establishing Classification Criteria for Patients with Sarcoidosis.","authors":"Nadera J Sweiss, Arnaud Dominati, Mary McGowan, Tricha Shivas, Alexandra Ladouceur, Israel Rubinstein, Murray Baron","doi":"10.1007/s40744-026-00838-1","DOIUrl":"10.1007/s40744-026-00838-1","url":null,"abstract":"<p><p>Progress in sarcoidosis research is hampered by inconsistent definitions and study entry criteria that rely on variable local practice patterns and widely differing expert opinions. This, in turn, has resulted in a heterogeneous body of clinical trial data that often cannot be compared, replicated, or generalized. The rheumatology community has successfully distinguished between diagnostic and classification criteria for diseases such as systemic lupus erythematosus, IgG4-related disease, and systemic sclerosis. This task was also successfully accomplished for patients diagnosed with pulmonary diseases, such as pulmonary arterial hypertension, asthma, and chronic obstructive pulmonary disease, for which classification has established distinct treatment pathways between groups. Diagnostic criteria are used at the bedside, on a patient-by-patient basis. They reflect the needs of health care providers and clinicians to consider disease heterogeneity and exercise judgment. Classification criteria, however, are primarily used for research and aim for specificity to define homogeneous populations for study. Unfortunately, sarcoidosis does not have definite classification criteria. Their absence undermines proper interpretation of study outcomes and hampers development of novel therapies. Sarcoidosis can be thought of as \"constellations of patient populations\" that need to be unified. As clinician-researchers and, above all else, advocates for our patients, we must move beyond diagnosis of exclusion and define sarcoidosis by what it is rather than by not what it is not.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"451-465"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198596/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147514560","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":"Patients' Perspectives Regarding Ankylosing Spondylitis Treatment Administration Features: Evidence from Qualitative Interviews and a Multinational Quantitative Preference Survey.","authors":"Atul Deodhar, Martine C Maculaitis, Lewis Kopenhafer, Kathleen Beusterien, You-Li Ling, Brett Hauber, Joseph C Cappelleri, Arne Yndestad, Lawrence Rick Phillips, Mostafa Zayed","doi":"10.1007/s40744-025-00824-z","DOIUrl":"10.1007/s40744-025-00824-z","url":null,"abstract":"<p><strong>Introduction: </strong>Advanced therapies (ATs) for ankylosing spondylitis (AS) vary in processes related to treatment administration. We hypothesized that treatment preferences for patients with AS vary based on AT experience and disease status.</p><p><strong>Methods: </strong>This cross-sectional, mixed-methods study collected data from adults (aged ≥ 18 years) in the United States, United Kingdom, and Italy who had a confirmed AS diagnosis and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and/or were currently taking AT. Burdensome aspects of AS and important AT administration attributes were identified in qualitative interviews with ten eligible patients. A cross-sectional online survey was also conducted, including a best-worst scaling (BWS) exercise with 12 treatment administration-related attributes and a series of six fixed-choice tasks, which presented two options varying only in mode and frequency of administration. Attribute relative importance was calculated from BWS data to sum to 100 across attributes. Frequencies and percentages were reported for fixed-choice tasks. Preferences from BWS data were compared by treatment/disease status (on AT/well controlled, on AT/not well controlled, not on AT/not well controlled) using one-way analysis of variance tests.</p><p><strong>Results: </strong>In qualitative interviews, patients reported pain (70.0%) and symptom unpredictability (50.0%) as the most bothersome aspects of AS. Overall, 210 patients (mean age 44.0 years) completed the survey; 37.6% were currently on AT. Patients not on AT/not well controlled preferred oral dosing, and patients on AT/well controlled preferred once-monthly injection and avoiding office/clinic visits; attribute relative importance estimates for patients currently on AT/not well controlled typically fell midway between the other groups. Most patients currently on AT/well controlled (range 78.6-100.0%) preferred injectable over oral options. Many on AT/not well controlled preferred once-daily pill over once-monthly (30.8%) or twice-monthly (40.0%) injections; once-monthly injection was preferred over oral options (range 60.0-69.2%). Many patients not currently on AT/not well controlled (range 50.4-68.7%) preferred oral over injectable options.</p><p><strong>Conclusions: </strong>Treatment preferences differed depending on whether AT was currently used and disease was well controlled. Findings enhance understanding of which patients may prefer different modes of AT administration.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"329-346"},"PeriodicalIF":3.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996488/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146012196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Renal Flares and Health-Related Quality of Life Among Patients with Lupus Nephritis: A Post Hoc Analysis of Control Arm Data from the LUNAR Phase 3 Clinical Trial.","authors":"Seitaro Yoshida, Christophe Toukam Tchakoute, Huiyan Ashley Mao, Gene Wallenstein, Jorge A Ross Terres, Lisa Lindsay","doi":"10.1007/s40744-026-00827-4","DOIUrl":"10.1007/s40744-026-00827-4","url":null,"abstract":"<p><strong>Introduction: </strong>Preserving kidney function and limiting renal flares are important treatment goals for patients with lupus nephritis (LN). The relationship between renal flares and health-related quality of life (HRQOL) was assessed in patients with LN receiving standard therapy in the LUNAR phase 3 clinical trial.</p><p><strong>Methods: </strong>A post hoc analysis was conducted on data collected from patients with biopsy-confirmed class III/IV ± V LN randomized to the control arm of the phase 3 LUNAR (NCT00282347) trial. Relationships between renal flare(s) (estimated glomerular filtration rate decrease > 20% and urine-to-creatinine ratio [UPCR] > 1 g/g; increase in UPCR > 1 if UPCR < 0.2 g/g or UPCR > 2 if UPCR ≥ 0.2 g/g; or receipt of rescue therapy compared with week 16 when steroid tapering occurred) and mean change in HRQOL score across eight 36-Item Short Form Health Survey (SF-36) domains and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) were assessed using multivariate analysis of covariance (ANCOVA) modeling.</p><p><strong>Results: </strong>Among 72 patients receiving standard therapy, renal flare occurred in 24 patients (33%) (flare rate 3.18 per 1000 person days). Domain-specific mean SF-36 HRQOL scores and FACIT-Fatigue scores improved over time among study participants receiving standard therapy. Multivariate analyses identified a significant impact of experiencing one or more renal flares on mean change in FACIT-Fatigue score as well as the following SF-36 domains: physical functioning, role physical, bodily pain, vitality, and social functioning.</p><p><strong>Conclusions: </strong>Renal flares in patients with LN significantly impact their HRQOL as measured by the SF-36 and the FACIT-Fatigue, highlighting the importance of preserving kidney function from the patient perspective among those with LN.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"375-387"},"PeriodicalIF":3.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996503/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147318147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Tofacitinib and Adalimumab in Rheumatoid Arthritis by Body Mass Index-Normalized Methotrexate Dose: A Post Hoc Analysis.","authors":"Tsutomu Takeuchi, Yoshiya Tanaka, Hisashi Yamanaka, Kunihiro Yamaoka, Naonobu Sugiyama, Noriko Iikuni, Shigeyuki Toyoizumi, Kenneth Kwok, Wen-Chan Tsai, Eduardo Mysler, Robert J Moots, Josef S Smolen, Roy Fleischmann","doi":"10.1007/s40744-025-00823-0","DOIUrl":"10.1007/s40744-025-00823-0","url":null,"abstract":"<p><strong>Introduction: </strong>This post hoc analysis assessed tofacitinib and adalimumab efficacy and safety, stratified by baseline methotrexate (MTX) dose, in patients with rheumatoid arthritis (RA) in the Oral Rheumatoid Arthritis triaL (ORAL) Strategy study.</p><p><strong>Methods: </strong>ORAL Strategy (NCT02187055) was a global, 1-year, phase 3b/4 study. Patients with RA and an inadequate response to MTX were randomized to tofacitinib 5 mg twice daily (BID), tofacitinib 5 mg BID plus MTX, or adalimumab 40 mg once every 2 weeks plus MTX, with MTX dosed per the last weekly dose pre-randomization. This post hoc analysis stratified patients by MTX dose in tertiles normalized by body mass index (BMI) and weight at baseline. Efficacy was assessed using American College of Rheumatology (ACR) 50 response rates at month 6 (primary endpoint); safety was assessed throughout. Efficacy and safety were analyzed descriptively.</p><p><strong>Results: </strong>Of 1146 patients, 97 received MTX < 15 mg/week at baseline, 712 received 15-17.5 mg/week, and 337 received > 17.5 mg/week. In the tofacitinib and adalimumab combination therapy groups, similar ACR50 response rates at month 6 were observed across the baseline BMI-normalized MTX dose tertiles. This trend was also observed in the tofacitinib monotherapy group; however, the ACR50 response rates at month 6 were numerically higher with combination versus tofacitinib monotherapy, regardless of baseline BMI-normalized MTX dose tertile. Generally similar results were observed for the baseline weight-normalized MTX data. No clear trends across baseline BMI-normalized MTX dose tertiles were observed for safety outcomes.</p><p><strong>Conclusions: </strong>In ORAL Strategy, tofacitinib efficacy was generally similar, and there were no clear safety trends regardless of baseline BMI-normalized MTX dose.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT02187055.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"423-434"},"PeriodicalIF":3.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996443/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146019514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quantifying Disease Activity Despite Treatment with Tumor Necrosis Factor Inhibitors Among Patients with Psoriatic Arthritis and Axial Spondyloarthritis: Real-World Results from the PPD CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry.","authors":"Philip Mease, Xiaolan Ye, Christopher D Saffore, Bhumik Parikh, Sandra Ciecinski, Taylor Blachley, Melissa Eliot, Nicole Middaugh, Alexis Ogdie","doi":"10.1007/s40744-025-00813-2","DOIUrl":"10.1007/s40744-025-00813-2","url":null,"abstract":"<p><strong>Introduction: </strong>Although tumor necrosis factor inhibitors (TNFis) have improved management of psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA); many patients experience suboptimal disease control. We quantified achievement of varying degrees of disease activity in patients with PsA and axSpA who initiated and maintained TNFi treatment for 12 months.</p><p><strong>Methods: </strong>Patients with PsA or axSpA enrolled in the PPD™ CorEvitas™ PsA/Spondyloarthritis Registry were included in the study. Varying degrees of disease control were quantified based on minimal disease activity (MDA) status for PsA and BASDAI50 (≥ 50% improvement in Bath Ankylosing Spondylitis Disease Activity Index) status for axSpA at 6 and 12 months. Patients were categorized into four groups: sustained (MDA/BASDAI50 at 6 and 12 months), improved (MDA/BASDAI50 at 12 months only), worsened (MDA/BASDAI50 at 6 months only), and never achieved (no MDA/BASDAI50 at 6 or 12 months).</p><p><strong>Results: </strong>For PsA, 338 patients initiated and persisted on TNFis. At 6 months, the majority (65%, n = 221) did not achieve MDA status; of these, 86% (n = 189) still did not achieve MDA at 12 months. For axSpA, 152 patients initiated and persisted on TNFis. At 6 months, 80% (n = 121) did not achieve BASDAI50; among these patients, 91% (n = 110) still did not achieve BASDAI50 status at 12 months. For both PsA and axSpA initiators, the risk of not achieving clinical or quality of life outcomes was two- to threefold lower in patients who never achieved versus patients who achieved and sustained MDA/BASDAI50.</p><p><strong>Conclusion: </strong>More than 80% of patients with PsA or axSpA who did not achieve low disease activity at 6 months still did not achieve low disease activity by 12 months even though they persisted on TNFi treatment. These findings underscore the importance for physicians to consider modifying therapy if treatment targets with TNFi have not been achieved in the first 6 months.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"403-421"},"PeriodicalIF":3.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996473/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145912836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Effectiveness of Canakinumab in Patients with Systemic Juvenile Idiopathic Arthritis in Japan: A Post-Marketing Surveillance Study.","authors":"Fumio Akita, Noriko Seko, Tomohiro Yoneda","doi":"10.1007/s40744-025-00822-1","DOIUrl":"10.1007/s40744-025-00822-1","url":null,"abstract":"<p><strong>Introduction: </strong>Canakinumab was approved in Japan for the treatment of patients with systemic juvenile idiopathic arthritis (sJIA) in 2018, following an open-label, single-arm phase III study performed in 19 Japanese patients with sJIA. Given this limited sample size, Japanese regulatory authorities required an all-case post-marketing surveillance study as part of the approval conditions, aiming to assess the long-term safety and effectiveness of canakinumab in Japanese patients with sJIA in clinical practice and characterise the clinical course of any cases of macrophage activation syndrome (MAS).</p><p><strong>Methods: </strong>This was a multicentre, central registration, all-case, uncontrolled, open-label, special drug use investigation, including all patients who received canakinumab for the treatment of sJIA between 2 July 2018 and 20 December 2024. Patients were treated according to the investigators' routine clinical practice and observed for up to 104 weeks.</p><p><strong>Results: </strong>The safety analysis population included 125 patients with a median duration of treatment (including interruptions) of 710.0 (range 1-729) days and median total number of doses of 25.0 (range 1-29). Adverse events (AEs) occurred in 91 out of 125 patients (72.8%), with the most common being relapse, worsening or exacerbation of Still's disease (24 patients, 19.2%), followed by upper respiratory tract inflammation (18 patients, 14.4%). Serious related AEs occurred in 22 patients (17.6%), with the most common being haemophagocytic lymphohistiocytosis (HLH; 5 patients, 4.0%). A total of ten MAS-related AEs were reported; all were cases of HLH and were considered serious, and all were resolved or were resolving at the time of reporting. Effectiveness outcomes, including glucocorticoid tapering, disease activity reduction and inflammatory marker normalisation, were durable through 2 years of treatment.</p><p><strong>Conclusion: </strong>Canakinumab showed a favourable long-term safety profile and sustained effectiveness in Japanese patients with sJIA inadequately controlled by existing therapies. No new safety concerns emerged, and the safety profile was comparable to that observed in the earlier phase III study.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"361-373"},"PeriodicalIF":3.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12996504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146086908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}