Modern Rheumatology最新文献_第3页

A multicentre, prospective registry of patients with systemic sclerosis in Japan: baseline patient characteristics. 日本系统性硬化症患者的多中心前瞻性登记：基线患者特征。

IF 1.9 4区医学

Modern Rheumatology Pub Date : 2026-04-13 DOI: 10.1093/mr/roaf109

Masataka Kuwana, Shinji Watanabe, Tohru Takeuchi, Yuko Kaneko, Yasushi Kawaguchi, Yoshiya Tanaka, Yukie Yamaguchi, Hiroaki Dobashi, Yusho Ishii, Hiroaki Niiro, Masanari Kodera, Hidekata Yasuoka, Tatsuya Atsumi, Hiroki Takahashi, Naoki Iwamoto, Yu Matsueda, Yohei Isomura, Yasuhiro Kondoh, Yuichi Tamura

{"title":"A multicentre, prospective registry of patients with systemic sclerosis in Japan: baseline patient characteristics.","authors":"Masataka Kuwana, Shinji Watanabe, Tohru Takeuchi, Yuko Kaneko, Yasushi Kawaguchi, Yoshiya Tanaka, Yukie Yamaguchi, Hiroaki Dobashi, Yusho Ishii, Hiroaki Niiro, Masanari Kodera, Hidekata Yasuoka, Tatsuya Atsumi, Hiroki Takahashi, Naoki Iwamoto, Yu Matsueda, Yohei Isomura, Yasuhiro Kondoh, Yuichi Tamura","doi":"10.1093/mr/roaf109","DOIUrl":"10.1093/mr/roaf109","url":null,"abstract":"Objectives: We established a multicentre prospective registry of patients with systemic sclerosis (SSc) in Japan to evaluate the outcomes in the modern treatment era. This report presents the baseline characteristics of patients enrolled in the registry.Methods: Adult SSc patients were prospectively enrolled from 20 medical centres across Japan. Baseline data, including demographics, organ involvement, autoantibody profiles, and patient-reported outcomes, were collected using a dedicated electronic data capture system.Results: A total of 835 patients were eligible for analysis. The cohort was predominantly female (85.1%), with a median age of 64 years at enrolment, and 35.0% had diffuse cutaneous SSc. Autoantibodies included anticentromere (38.9%), anti-topoisomerase I (topo I; 33.5%), anti-RNA polymerase III (RNAP III; 12.4%), and anti-U1 RNP (12.9%). Interstitial lung disease (ILD) was the most common organ manifestation (56.0%), followed by upper gastrointestinal (GI) involvement (42.5%), heart involvement (5.3%), pulmonary hypertension (3.4%), scleroderma renal crisis (1.9%), and lower GI involvement (1.2%). Patients with anti-topo I had the worst patient global assessment, whereas those with anti-RNAP III patients had the worst physician global assessment.Conclusions: This prospective registry captures real-world data on SSc patients, providing a valuable resource for understanding the clinical spectrum and outcomes in contemporary practice in Japan.","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":"396-406"},"PeriodicalIF":1.9,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145482572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Safety and effectiveness of ixekizumab in Japanese patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis in real-world use: a post-marketing safety study. ixekizumab在日本强直性脊柱炎和非影像学轴性脊柱炎患者中的安全性和有效性：上市后安全性研究

IF 1.9 4区医学

Modern Rheumatology Pub Date : 2026-04-13 DOI: 10.1093/mr/roaf108

Hideto Kameda, Jiayi Dong, Chie Yamamoto, Ayako Konomi, Yumiko Nishikawa, Tetsuya Tomita

{"title":"Safety and effectiveness of ixekizumab in Japanese patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis in real-world use: a post-marketing safety study.","authors":"Hideto Kameda, Jiayi Dong, Chie Yamamoto, Ayako Konomi, Yumiko Nishikawa, Tetsuya Tomita","doi":"10.1093/mr/roaf108","DOIUrl":"10.1093/mr/roaf108","url":null,"abstract":"Objectives: To evaluate the long-term safety and effectiveness of ixekizumab for axial spondyloarthritis in the real-world setting in Japan.Methods: This single-arm, multicentre, observational study was conducted from 26 May 2020 to 10 March 2023 on adult patients with axial spondyloarthritis who were administered ixekizumab under daily clinical practice in Japan. Baseline patient characteristics were summarized. Adverse events, adverse drug reactions, physician-rated overall improvement, and patient-reported Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores were assessed for 96 weeks after ixekizumab initiation.Results: Of the 39 enrolled patients, 29 consented to publication and were included in these analyses (n = 21 ankylosing spondylitis; n = 8 non-radiographic axial spondyloarthritis). Sixteen patients (55.2%) were male, with a median (range) age of 52.0 (32.0-76.0) years. Fourteen (48.3%) and 4 (13.8%) patients experienced adverse events and adverse drug reactions, respectively, most commonly infections and administration site reactions. No serious adverse events or adverse drug reactions were reported. Across 96 weeks, physicians rated ≥75.0% patients as showing improvement. BASDAI scores showed trends consistent with improvement.Conclusions: These findings are consistent with ixekizumab clinical trial data from other countries, showing the long-term safety and effectiveness of ixekizumab in patients with axial spondyloarthritis under routine clinical care in Japan.","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":"439-446"},"PeriodicalIF":1.9,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145476752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Real-world switching and discontinuation patterns for biologic disease-modifying antirheumatic drugs in patients with active psoriatic arthritis in Japan. 日本活动性银屑病关节炎患者生物疾病改善抗风湿药物的现实世界转换和停药模式

IF 1.9 4区医学

Modern Rheumatology Pub Date : 2026-04-13 DOI: 10.1093/mr/roaf099

Mitsumasa Kishimoto, Ahmed M Soliman, Dominic Nunag, Ralph Lippe, Manish Patel, Matthew Davis, Hideto Kameda

{"title":"Real-world switching and discontinuation patterns for biologic disease-modifying antirheumatic drugs in patients with active psoriatic arthritis in Japan.","authors":"Mitsumasa Kishimoto, Ahmed M Soliman, Dominic Nunag, Ralph Lippe, Manish Patel, Matthew Davis, Hideto Kameda","doi":"10.1093/mr/roaf099","DOIUrl":"10.1093/mr/roaf099","url":null,"abstract":"Objectives: To evaluate switching and discontinuation of biologic disease-modifying antirheumatic drugs (bDMARDs) among psoriatic arthritis (PsA) patients in Japan over 12 months.Methods: Claims data from the Japan Medical Data Centre (1/2005-10/2023) were analysed for patients with a PsA diagnosis on or before first bDMARD claim (index date) and ≥ 6 months of eligibility pre-index. Treatment switch (claim for another bDMARD) and discontinuation (treatment gap ≥150% days' supply of last prescription) were evaluated up to 12 months post-index. Hazard ratios for switching and discontinuation were estimated using multivariate Cox proportional hazards models adjusted for baseline characteristics.Results: Included patients received adalimumab (n = 323), brodalumab (n = 71), certolizumab pegol (n = 162), guselkumab (n = 157), ixekizumab (n = 239), risankizumab (n = 117), secukinumab (n = 250), or ustekinumab (n = 60). At 12 months, 21.7% switched bDMARDs and 38.1% discontinued their index bDMARD. Risankizumab had the lowest switching rate (18.4%), followed by secukinumab (19.1%) and ixekizumab (19.7%). Risankizumab had the lowest discontinuation rate (23.4%), followed by ustekinumab (27.6%) and ixekizumab (29.7%). Hazard ratios of switching and/or discontinuation were significantly higher for most bDMARDs (except ixekizumab, ustekinumab) versus risankizumab (P < .05).Conclusions: Switching and discontinuation were common within 1-year of bDMARD treatment for PsA patients in Japan. Risankizumab demonstrated the lowest rates of switching and/or discontinuation.","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":"430-438"},"PeriodicalIF":1.9,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145604990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Updated treatment approaches for eosinophilic granulomatosis with polyangiitis: A systematic scoping review. 嗜酸性肉芽肿病合并多血管炎的最新治疗方法：一项系统的范围审查。

IF 1.9 4区医学

Modern Rheumatology Pub Date : 2026-04-13 DOI: 10.1093/mr/roaf126

Mayu Shiomi, Tomoaki Higuchi, Mitsuhiro Akiyama, Megumi Oshima, Ryu Watanabe, Ken-Ei Sada, Kenji Nagasaka, Akinori Hara, Yoshinori Matsumoto, Kiyoshi Sekiya, Takahiko Kurasawa, Shunsuke Furuta, Haruki Koike, Yoshinori Komagata, Hiroaki Dobashi, Naoto Tamura

{"title":"Updated treatment approaches for eosinophilic granulomatosis with polyangiitis: A systematic scoping review.","authors":"Mayu Shiomi, Tomoaki Higuchi, Mitsuhiro Akiyama, Megumi Oshima, Ryu Watanabe, Ken-Ei Sada, Kenji Nagasaka, Akinori Hara, Yoshinori Matsumoto, Kiyoshi Sekiya, Takahiko Kurasawa, Shunsuke Furuta, Haruki Koike, Yoshinori Komagata, Hiroaki Dobashi, Naoto Tamura","doi":"10.1093/mr/roaf126","DOIUrl":"10.1093/mr/roaf126","url":null,"abstract":"Objective: Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare antineutrophil cytoplasmic antibody-associated vasculitis causing multi-organ damage and long-term disability. Various treatments including IL-5-targeting agents and other biologics have recently emerged, prompting regular updates of clinical practice guidelines. This scoping review and systematic review (SR) aimed to evaluate the efficacy and safety of rituximab and benralizumab in EGPA.Methods: A scoping review was conducted to identify relevant clinical questions, followed by an SR of trials published between December 2018 and July 2023. Studies comparing rituximab or benralizumab with standard treatments were included. Risk of bias (RoB) was assessed using RoB 2 and quality of evidence was rated using GRADE.Results: One randomised controlled trial (RCT; n = 105) comparing rituximab with conventional therapy, showed a 180-day remission rate of 63.5% versus 60.4% (risk ratio: 1.05, 95% CI: 0.78-1.42), with very low certainty due to serious RoB and imprecision. Another RCT compared benralizumab with mepolizumab, showing similar rates of remission (58.6% versus 55.7%), relapse (30%), and glucocorticoid tapering, with low certainty owing to imprecision.Conclusions: Rituximab showed no clear benefit over conventional therapy, whereas benralizumab demonstrated comparable efficacy and safety to mepolizumab. However, evidence remains limited, and further EGPA-specific trials are needed.","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":"415-421"},"PeriodicalIF":1.9,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145804941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Beyond evidence supremacy: Reclaiming the Clinician's role through the integration of structural and existential approaches in daily practice. 超越证据至上：通过在日常实践中整合结构和存在主义方法来重塑临床医生的角色。

IF 1.9 4区医学

Modern Rheumatology Pub Date : 2026-04-13 DOI: 10.1093/mr/roag002

Hisashi Yamanaka

引用次数: 0

Predictors of the late recurrences of immunoglobulin A vasculitis due to clinical and laboratory features in children. 儿童免疫球蛋白A血管炎晚期复发的临床和实验室特征预测因素。

IF 1.9 4区医学

Modern Rheumatology Pub Date : 2026-04-10 DOI: 10.1093/mr/roag035

Deniz Gezgin Yildirim, Emine Nur Sunar Yayla, Cisem Yildiz, Nihal Karacayir, Batuhan Kucukali, Nuran Belder, Merve Kutlar Tanidir, Pelin Esmeray Senol, Khadija Ahmadova, Büsra Acun Sayili, Ovgu Ozenli Yagci, Sevcan A Bakkaloglu

{"title":"Predictors of the late recurrences of immunoglobulin A vasculitis due to clinical and laboratory features in children.","authors":"Deniz Gezgin Yildirim, Emine Nur Sunar Yayla, Cisem Yildiz, Nihal Karacayir, Batuhan Kucukali, Nuran Belder, Merve Kutlar Tanidir, Pelin Esmeray Senol, Khadija Ahmadova, Büsra Acun Sayili, Ovgu Ozenli Yagci, Sevcan A Bakkaloglu","doi":"10.1093/mr/roag035","DOIUrl":"https://doi.org/10.1093/mr/roag035","url":null,"abstract":"Objectives: This study aims to evaluate the frequency and predictors of immunoglobulin A vasculitis (IgAV) late relapses based on clinical and laboratory features in children.Methods: We retrospectively reviewed the medical records of IgAV patients. To assess the severity of the disease, the Pediatric Vasculitis Assessment Score (PVAS) was calculated for each patient during the initial visit. Late recurrence of IgAV was defined as the reappearance of skin lesions and/or systemic involvement after a symptom-free period of at least six months. Patients were divided into two subgroups: Group 1 consisted of IgAV patients who experienced at least one recurrence, while Group 2 included those with no recurrence.Results: A total of 40 (7.3%) patients were in Group 1. Male gender, mean age at diagnosis, gastrointestinal and testicular involvement, WBC count, creatinine level, and pediatric vasculitis, PVAS at first visit were significantly higher in Group 1 than in Group 2 (p=0.033, p=0.015, p=0.047, p=0.003, p=0.012, p=0.012, and p=0.000, respectively). Male sex, diarrhea, testicular involvement, WBC value, and PVAS were found as independent risk factors to predict IgAV late recurrence (p=0.033, p=0.015, p=0.003, p=0.025, and p=0.005, respectively).Conclusions: Close follow-up is essential, particularly in male patients and in the presence of testicular involvement, diarrhea, or a high PVAS at the initial visit, given the potential for late disease recurrence in the long term.","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147674994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Upadacitinib monotherapy versus methotrexate monotherapy in methotrexate-naïve Japanese patients with rheumatoid arthritis: long-term efficacy and safety through 5 years in the SELECT-EARLY study. Upadacitinib单药治疗与甲氨蝶呤单药治疗methotrexate-naïve日本类风湿性关节炎患者：通过5年的SELECT-EARLY研究的长期疗效和安全性

IF 1.9 4区医学

Modern Rheumatology Pub Date : 2026-04-10 DOI: 10.1093/mr/roag031

Tsutomu Takeuchi, Ronald Vollenhoven, Yukitaka Ueki, Tatsuya Atsumi, Sebastian Meerwein, Xianwei Bu, Kazuya Hirata, Vibeke Strand

{"title":"Upadacitinib monotherapy versus methotrexate monotherapy in methotrexate-naïve Japanese patients with rheumatoid arthritis: long-term efficacy and safety through 5 years in the SELECT-EARLY study.","authors":"Tsutomu Takeuchi, Ronald Vollenhoven, Yukitaka Ueki, Tatsuya Atsumi, Sebastian Meerwein, Xianwei Bu, Kazuya Hirata, Vibeke Strand","doi":"10.1093/mr/roag031","DOIUrl":"https://doi.org/10.1093/mr/roag031","url":null,"abstract":"Objective: To evaluate the long-term (5-year) efficacy and safety of upadacitinib monotherapy compared with methotrexate (MTX) monotherapy in Japanese patients with rheumatoid arthritis included in the Phase 3 SELECT-EARLY study.Methods: Japanese patients were randomised 2:1:1:1 to upadacitinib 7.5, 15, or 30 mg daily or MTX 7.5 mg/week (titrated to ≤ 15 mg/week). Efficacy assessments through Week 260 are reported as observed for patients receiving continuous upadacitinib or MTX, and by randomised group using non-responder imputation. Treatment-emergent adverse events (TEAEs) were collected over 5 years and reported as events per 100 patient-years.Results: Of the 138 Japanese patients treated, 123 (89%) completed Week 48 and 121 (88%) entered the long-term extension on study drug. Patients receiving upadacitinib had better overall long-term efficacy outcomes compared with patients receiving MTX. Similarly, treatment with upadacitinib resulted in numerically greater inhibition of structural joint progression through 5 years, relative to MTX. Higher TEAE rates were observed in the 30 mg upadacitinib group compared with all other treatment groups, and no new safety signals were identified overall.Conclusion: This sub-analysis of the SELECT-EARLY Japanese population corroborates findings from the global study population on the long-term clinical efficacy and safety of upadacitinib.","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147675059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Umbilical cord-derived mesenchymal stem cell therapy for knee osteoarthritis and cartilage repair: Current evidence and clinical applications. 脐带间充质干细胞治疗膝关节骨关节炎和软骨修复：目前的证据和临床应用。

IF 1.9 4区医学

Modern Rheumatology Pub Date : 2026-04-01 DOI: 10.1093/mr/roag034

Jin Kyu Lee, Norimasa Nakamura

{"title":"Umbilical cord-derived mesenchymal stem cell therapy for knee osteoarthritis and cartilage repair: Current evidence and clinical applications.","authors":"Jin Kyu Lee, Norimasa Nakamura","doi":"10.1093/mr/roag034","DOIUrl":"https://doi.org/10.1093/mr/roag034","url":null,"abstract":"Osteoarthritis is fundamentally a whole-joint disease, and a critical pathological feature is the limited capacity of articular cartilage for self-regeneration, leading to accelerated joint degeneration once breakdown begins. Current therapeutic strategies are primarily palliative, and conventional marrow stimulation procedures such as microfracture often yield suboptimal, short-lived outcomes. Stem cell-based biologic augmentation using mesenchymal stem cells has emerged as a promising approach through direct chondrocyte differentiation, paracrine stimulation, and immunomodulation. Umbilical cord-derived mesenchymal stem cells offer robust proliferative capacity, enhanced biological potency, and lower immunogenicity than adult mesenchymal stem cells, and can be obtained with minimal ethical concerns. Clinical trials of human umbilical cord blood-derived mesenchymal stem cells combined with hyaluronic acid hydrogel (CARTISTEM®) have demonstrated excellent safety, improved patient-reported outcomes, and durable hyaline-like cartilage regeneration. Emerging evidence further suggests that combining high tibial osteotomy with human umbilical cord blood-derived mesenchymal stem cells-based cartilage regeneration for medial compartment osteoarthritis with varus malalignment creates a synergistic biological and mechanical environment that promotes structural cartilage repair. In conclusion, surgically transplanted human umbilical cord blood-derived mesenchymal stem cells show therapeutic potential in arthritic knees, although the role of intra-articular injections and the optimal indications for combined high tibial osteotomy remain to be clarified.","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147593334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Rheumatoid arthritis at a turning point in the era of targeted therapies. 类风湿关节炎处于靶向治疗时代的转折点。

IF 1.9 4区医学

Modern Rheumatology Pub Date : 2026-03-31 DOI: 10.1093/mr/roag033

Satoshi Kubo

{"title":"Rheumatoid arthritis at a turning point in the era of targeted therapies.","authors":"Satoshi Kubo","doi":"10.1093/mr/roag033","DOIUrl":"https://doi.org/10.1093/mr/roag033","url":null,"abstract":"The expansion of targeted therapies and the widespread adoption of treat-to-target (T2T) strategies have substantially improved outcomes for rheumatoid arthritis (RA). However, patient populations remain highly heterogeneous in routine clinical practice. This diversity makes risk-stratified therapeutic selection and shared decision-making essential, particularly when accounting for infection risk, cardiovascular disease, malignancy, thromboembolism, and reproductive considerations. This paper reviews current standard-of-care management and unmet needs while highlighting three priority challenges that may represent future inflection points. First, it proposes a framework for reappraising the pathophysiology of treatment-refractory disease. This model captures the discordance between inflammation and symptoms through persistent inflammatory refractory RA and non-inflammatory refractory RA constructs while explicitly incorporating reasons for treatment discontinuation. Second, the text addresses the identification of high-risk populations across the continuum from preclinical to early RA and discusses monitoring strategies designed to minimize the risk of overtreatment. Finally, it delineates barriers to implementing precision medicine, including limited access to local biospecimens, challenges in outcome definition, and complexities in trial design. The paper then outlines a pragmatic, phased roadmap to overcome these hurdles. Translating these concepts into clinical practice would extend and refine conventional T2T paradigms. This approach offers a pathway toward more optimized and individualized therapeutic strategies.","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147581642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Efficacy and safety of canakinumab in patients with Adult-Onset Still's Disease: Results from an open-label Phase III study in Japan. canakinumab在成人发病斯蒂尔氏病患者中的疗效和安全性：来自日本一项开放标签III期研究的结果

IF 1.9 4区医学

Modern Rheumatology Pub Date : 2026-03-24 DOI: 10.1093/mr/roag026

Tatsuya Atsumi, Yohei Kirino, Mitsumasa Kishimoto, Shunsuke Furuta, Yuko Kaneko, Yasunori Iwata, Keishi Fujio, Toshihide Mimura, Satoshi Kawaai, Ryota Wakabayashi, Noriko Seko, Wataru Hongo, Manmath Patekar, Atsushi Kawakami

{"title":"Efficacy and safety of canakinumab in patients with Adult-Onset Still's Disease: Results from an open-label Phase III study in Japan.","authors":"Tatsuya Atsumi, Yohei Kirino, Mitsumasa Kishimoto, Shunsuke Furuta, Yuko Kaneko, Yasunori Iwata, Keishi Fujio, Toshihide Mimura, Satoshi Kawaai, Ryota Wakabayashi, Noriko Seko, Wataru Hongo, Manmath Patekar, Atsushi Kawakami","doi":"10.1093/mr/roag026","DOIUrl":"https://doi.org/10.1093/mr/roag026","url":null,"abstract":"Objectives: To evaluate the efficacy and safety of canakinumab 4 mg/kg every 4 weeks administered subcutaneously in Japanese AOSD patients.Methods: Fourteen participants were included in this open-label, single-arm active-treatment study. The primary endpoint was adapted ACR30 response, with a pre-defined 95% CI lower limit requirement of 40% at week 8. Secondary endpoints included glucocorticoid tapering from weeks 8 to 28; adapted ACR30/50/70/90/100 responses over time; systemic feature score (SFS) over time.Results: The primary endpoint was not met (6/11 patients [54.5%]; 95% CI: 20.6-88.5; one-sided P = 0.249). From weeks 8 to 28, 6/11 patients (54.5%) successfully tapered oral glucocorticoids. At week 28, among the 11 patients assessed, 70% achieved adapted ACR30 and adapted ACR50, 60% achieved adapted ACR70 and adapted ACR90, and 40% achieved adapted ACR100. At week 28, mean (SD) change from baseline in SFS was -4.3 (2.06). All 14 patients had at least one treatment-emergent adverse event. Six participants (42.9%) had SAEs. Three patients had serious infections; all were considered treatment-related and all recovered.Conclusion: Although the primary endpoint was not met, week 28 analysis showed that canakinumab treatment led to improvements in various efficacy outcome measures in Japanese patients with AOSD, with no unexpected safety signals.","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147504415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0