{"title":"Treatment persistence and clinical outcomes following subcutaneous methotrexate initiation in patients with rheumatoid arthritis: a real-world observational study.","authors":"Yusuke Miyazaki, Satoshi Kubo, Shunsuke Fukuyo, Ippei Miyagawa, Ayako Yamaguchi, Yurie Satoh-Kanda, Yasuyuki Todoroki, Hiroaki Tanaka, Masanobu Ueno, Ryuichiro Kanda, Yuya Fujita, Hidenori Sakai, Shingo Nakayamada, Yoshiya Tanaka","doi":"10.1093/mr/roag089","DOIUrl":"https://doi.org/10.1093/mr/roag089","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to evaluate treatment persistence and safety following subcutaneous methotrexate (MTX) initiation in Japanese patients with RA and to assess clinical outcomes among patients who directly switched from oral to subcutaneous MTX.</p><p><strong>Methods: </strong>This retrospective study included 101 patients with RA who initiated subcutaneous MTX at our institution. Efficacy and safety were analysed in patients who switched from oral MTX due to adverse events. The primary endpoint was the 26-week retention rate of subcutaneous MTX.</p><p><strong>Results: </strong>Gastrointestinal intolerance was the commonest reason for switching from oral to subcutaneous MTX. The overall retention rate was 87.1% (88/101). Among 88 patients who switched, the 26-week retention rate was 92.0% (81/88). During 26 weeks after switching, MTX dose increased in 46.6% (41/88). In patients not receiving biologic or targeted synthetic disease-modifying anti-rheumatic drugs at switching (n=50), the 26-week retention rate was 96.0% (48/50), and mean MTX dose increased (10.3±2.8 to 12.0±2.8 mg/week; p<0.0001). The Clinical Disease Activity Index improved by week 26 (13.2±10.1 to 8.2±7.8; p<0.0001), with 30.0% (15/50) achieving remission.</p><p><strong>Conclusions: </strong>Switching from oral to subcutaneous MTX in patients with RA who are intolerant to oral MTX may enable continued treatment and dose optimization and be associated with improved disease activity.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149216528","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}
Koji Suzuki, Mitsuhiro Akiyama, Kanako Shimanuki, Hiroyuki Fukui, Yuko Kaneko
{"title":"Clinical characteristics associated with pulmonary function decline despite sustained nintedanib therapy in systemic autoimmune rheumatic disease-related progressive pulmonary fibrosis.","authors":"Koji Suzuki, Mitsuhiro Akiyama, Kanako Shimanuki, Hiroyuki Fukui, Yuko Kaneko","doi":"10.1093/mr/roag088","DOIUrl":"https://doi.org/10.1093/mr/roag088","url":null,"abstract":"<p><strong>Objective: </strong>To identify clinical factors associated with pulmonary function decline despite sustained nintedanib treatment for ≥1 year in patients with systemic autoimmune rheumatic disease-associated interstitial lung disease (SARD-ILD) with progressive pulmonary fibrosis (PPF).</p><p><strong>Methods: </strong>We retrospectively analyzed 69 patients from the KEIO-SARD-ILD cohort who initiated nintedanib. Among those who continued treatment for ≥1 year, patients were classified into Decliner (absolute decline in %FVC >5% at 12 months) and Stable groups, and clinical characteristics were compared. Independent predictors of %FVC decline were identified using multivariable logistic regression.</p><p><strong>Results: </strong>Among 69 patients who initiated nintedanib, 18 (26.1%) showed a decline in %FVC >5% at 12 months. Discontinuation of nintedanib within 12 months and a UIP pattern were independently associated with %FVC decline in the overall cohort. Among patients who continued nintedanib for ≥1 year, 8 of 51 patients (15.7%) experienced %FVC decline despite sustained treatment (Decliner group). Compared with Stable group, Decliner group had significantly lower body surface area and lower eGFR. In multivariable analysis, low body surface area and chronic kidney disease were independently associated with %FVC decline. Patients with both risk factors had a significantly higher prevalence of pulmonary function decline than those without these factors. Decliner group had worse overall survival than Stable group.</p><p><strong>Conclusions: </strong>A subset of patients with SARD-ILD-related PPF experienced pulmonary function decline despite sustained nintedanib treatment. The decliner group had lower body surface area and higher prevalence of chronic kidney disease, suggesting that patients with these factors may be at increased risk of disease progression despite antifibrotic therapy.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149112100","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}
Hatice Kubra Zora, Osman Donmez, Hatice Ortac, Berkant Ersoy, Sara Sebnem Kilic
{"title":"Triggering Factors in Pediatric Familial Mediterranean Fever: A New Perspective on Colchicine Resistance.","authors":"Hatice Kubra Zora, Osman Donmez, Hatice Ortac, Berkant Ersoy, Sara Sebnem Kilic","doi":"10.1093/mr/roag086","DOIUrl":"https://doi.org/10.1093/mr/roag086","url":null,"abstract":"<p><strong>Objectives: </strong>In our study, we aimed to determine the frequency of attack-triggering factors in pediatric patients with colchicine-resistant familial Mediterranean fever (FMF), to examine their relationship with genotype, and to evaluate changes in these factors following treatment with an IL-1 antagonist.</p><p><strong>Methods: </strong>Between January 2024 and February 2025, 86 pediatric FMF patients (36 colchicine-resistant, 50 colchicine-responsive) who met the Eurofever criteria were included in this study. Patients were questioned for the presence of potential attack-triggering factors, including psychological stress, cold exposure, seasonal changes, physical activity, infections, fatigue, prolonged standing, long-distance travel, menstruation, starvation, sleeplessness, and the consumption of high-fat foods. In the colchicine-resistant group, triggering factors were assessed before and after anti-IL-1 treatment.</p><p><strong>Results: </strong>At least one triggering factor was identified in 82.6% of patients, which was more common in colchicine-resistant patients than in colchicine-responsive patients (94.4% vs. 74%, p=0.014). The most common triggers in resistant patients were cold exposure (88.2%), stress (70.6%), physical activity (67.6%), seasonal changes (65.6%), and infection (58.8%). Following IL-1 antagonist treatment, the frequency of patient-reported attacks associated with triggering factors decreased significantly (mean 29% to 14%, p<0.001). M694V homozygosity was associated with a higher frequency of specific triggering factors, including cold exposure, physical activity, and fatigue. Multivariable analysis revealed that severe disease activity (ISSF) (OR: 6.23) and longer disease duration (OR: 1.22) were independent predictors of the presence of triggering factors.</p><p><strong>Conclusions: </strong>Although triggering factors were more frequently reported in patients with colchicine-resistant pediatric FMF, disease severity and disease duration were independently associated with their presence. IL-1 antagonist therapy substantially reduced both trigger-associated attacks and triggering factors. Recognition of modifiable triggers and their genetic associations may support personalized management and improved disease control.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149112027","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}
{"title":"Human T-Cell Leukaemia Virus Type 1-Associated Myelopathy in Patients with Rheumatoid Arthritis: A Case Series Highlighting Functional Disability and Diagnostic Challenges.","authors":"Masayuki Murai, Kunihiko Umekita, Risa Kudo, Masatoshi Kimura, Chihiro Iwao, Kosho Iwao, Takeshi Kawaguchi, Motohiro Matsuda, Shunichi Miyauchi, Yayoi Hashiba, Toshihiko Hidaka, Taiga Miyazaki","doi":"10.1093/mr/roag087","DOIUrl":"https://doi.org/10.1093/mr/roag087","url":null,"abstract":"<p><strong>Objectives: </strong>Although rheumatoid arthritis (RA) and human T-cell leukaemia virus type 1 (HTLV-1)-associated myelopathy/tropical spastic paraparesis (HAM/TSP) occasionally coexist, their clinical characteristics and impact on patient outcomes remain poorly elucidated.</p><p><strong>Methods: </strong>We conducted a retrospective case series of five patients with RA complicated by HAM/TSP (HAM-RA) enrolled in the HTLV-1 Positive Rheumatoid Arthritis Miyazaki Registry. Data on clinical characteristics, disease course, functional status, quality of life and HTLV-1-associated parameters were reviewed. Age- and sex-matched patients with HTLV-1-positive RA and HTLV-1-negative RA served as comparison groups.</p><p><strong>Results: </strong>All patients were women, (median age, 67 years). HAM/TSP preceded RA onset in two patients, whereas RA developed first in three. Neurological disability substantially differed, with Osame Motor Disability Scores of 2-11; three patients necessitated wheelchair use. Despite comparable RA disease activity, patients with HAM-RA demonstrated worse physical function and health-related quality of life than matched controls. Patients with HAM-RA tended to have higher HTLV-1 proviral loads (PVLs) than those with HTLV-1-positive RA without HAM/TSP.</p><p><strong>Conclusions: </strong>HAM/TSP may develop before or after RA onset and cause substantial functional disability despite satisfactory control of arthritis. Knowledge of HTLV-1 infection status may facilitate consideration of HAM/TSP and timely neurological evaluation. Considering the high PVL in patients with HAM-RA and its association with elevated adult T-cell leukaemia/lymphoma (ATL) risk, cautious long-term monitoring for ATL development may be warranted.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149112075","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}
{"title":"Revisiting Liver Monitoring During Methotrexate Therapy in Rheumatoid Arthritis: Implications of HBV Reactivation, MASLD, and Non-invasive Fibrosis Assessment.","authors":"Ryuji Koike, Yuji Yamanishi, Mie Fusama, Shigeru Iwata, Masahiro Tada, Haruka Tsuchiya, Kunihiro Yamaoka, Hideto Kameda","doi":"10.1093/mr/roag085","DOIUrl":"https://doi.org/10.1093/mr/roag085","url":null,"abstract":"<p><p>Liver function monitoring remains a cornerstone of safety surveillance during methotrexate (MTX) therapy for rheumatoid arthritis (RA). Traditionally, monitoring has focused on hepatitis B virus (HBV) reactivation and chronic MTX hepatotoxicity. Because HBV persists in hepatocytes as covalently closed circular DNA (cccDNA) even after apparent clinical resolution of infection, all individuals with previous HBV exposure remain at risk of viral reactivation. Accordingly, screening for previous HBV infection before initiating MTX is essential, and regular monitoring of HBV DNA should be considered in patients with resolved or chronic HBV infection. Close collaboration with hepatology specialists is required to ensure timely initiation of nucleos(t)ide analogue therapy when indicated. In contrast, the conventional concept of chronic MTX-induced hepatotoxicity has been increasingly challenged. Recent studies employing non-invasive fibrosis assessment tools have demonstrated little or no association between cumulative MTX dose or treatment duration and the progression of liver fibrosis. These findings suggest that severe chronic liver injury caused solely by MTX is uncommon and that the hepatotoxic potential of MTX may have been substantially overestimated. Metabolic dysfunction-associated steatotic liver disease (MASLD) has emerged as the leading chronic liver disease worldwide and appears to be at least as prevalent among patients with RA than in the general population. Therefore, evaluation and management of MASLD should be considered as part of routine clinical care for patients with RA. Because liver fibrosis is the most important determinant of long-term hepatic outcomes, monitoring strategies should incorporate fibrosis assessment using non-invasive tools such as the fibrosis-4 (FIB-4) index and elastography-based liver stiffness measurement.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149112050","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}
Tsubasa Betsuyaku, Hideaki Tsuji, Mirei Shirakashi, Ryosuke Hiwa, Koji Kitagori, Shuji Akizuki, Ran Nakashima, Hajime Yoshifuji, Akio Morinobu
{"title":"The association between cardiac arrhythmia and autoantibodies in systemic sclerosis.","authors":"Tsubasa Betsuyaku, Hideaki Tsuji, Mirei Shirakashi, Ryosuke Hiwa, Koji Kitagori, Shuji Akizuki, Ran Nakashima, Hajime Yoshifuji, Akio Morinobu","doi":"10.1093/mr/roag082","DOIUrl":"https://doi.org/10.1093/mr/roag082","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to investigate the association between specific autoantibodies and cardiac arrhythmias in Japanese patients with systemic sclerosis (SSc).</p><p><strong>Methods: </strong>Arrhythmias of patients with SSc treated at Kyoto University Hospital were retrospectively analyzed, focusing on anti-topoisomerase I antibody (ATA), anti-centromere antibody (ACA), anti-RNA polymerase III (RNAPIII), and anti-U1-ribonucleoprotein (RNP). Logistic regression analyses were performed to assess the relationships between autoantibodies and arrhythmias.</p><p><strong>Results: </strong>Cardiac arrhythmias were observed in 153 of 389 SSc patients (39%), including premature atrial contraction (PAC, 25.2%), premature ventricular contraction (PVC, 23.9%), atrial fibrillation (AF, 4.6%), atrial tachycardia/atrial flutter (AT/AFL, 1.5%), ventricular tachycardia/ventricular fibrillation (VT/VF, 0.3%), bradyarrhythmia (5.9%), and pacemaker implantation (1.5%) during 12.62±1.06-year observation periods. The highest frequency was observed in anti-RNAPIII (42.4%), followed by ATA (38.7%), ACA (35.8%), and anti-U1-RNP (30.0%). After age- and sex-adjustment, ACA was negatively associated with the occurrence of arrhythmia (odds ratio [OR]=0.51, P=0.007), especially PAC (OR=0.47, P=0.004) among patients with SSc. Conversely, anti-U1-RNP was positively associated with AF (OR=4.7, P=0.04). There were no significant differences in the frequencies of PVC, AT/AFL, VT/VF, or tachyarrhythmias overall among autoantibodies.</p><p><strong>Conclusion: </strong>Distinct SSc-related autoantibodies were differentially associated with the occurrence of arrhythmias, suggesting that autoantibody profiles influence arrhythmic risk in SSc.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148990671","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}
{"title":"Correction to: Factors associated with treatment discontinuation and age-stratified safety of abatacept in Japanese patients with rheumatoid arthritis: 5-year results of the ORIGAMI study.","authors":"","doi":"10.1093/mr/roag081","DOIUrl":"https://doi.org/10.1093/mr/roag081","url":null,"abstract":"","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955769","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}
Tatsuya Atsumi, Sang-Cheol Bae, Wen-Nan Huang, Yoshihiro Fukumoto, Edmund M Lau, Mengtao Li, Mandana Nikpour, Robert Bagnall, Petya Kodjamanova, Jingya Li, David Bin-Chia Wu, Yogeshwar Makanji
{"title":"Early detection, treatment initiation, and long-term health outcomes in patients with connective tissue disease-associated pulmonary arterial hypertension: A systematic literature review and expert consensus.","authors":"Tatsuya Atsumi, Sang-Cheol Bae, Wen-Nan Huang, Yoshihiro Fukumoto, Edmund M Lau, Mengtao Li, Mandana Nikpour, Robert Bagnall, Petya Kodjamanova, Jingya Li, David Bin-Chia Wu, Yogeshwar Makanji","doi":"10.1093/mr/roag076","DOIUrl":"https://doi.org/10.1093/mr/roag076","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to explore evidence related to long-term health outcomes for patients with connective tissue disease (CTD)-associated pulmonary arterial hypertension (PAH) and any clinical practices associated with screening, early detection, and initiation of treatments.</p><p><strong>Methods: </strong>We conducted a systematic literature review (SLR) of observational studies and randomised controlled trials of adult patients with confirmed CTD-PAH, including systemic lupus erythematosus (SLE)-PAH, systemic sclerosis (SSc)-PAH, and mixed CTD (MCTD)-PAH. Based on the findings from our SLR, we conducted a Delphi panel to develop recommendations and consensus around early detection and initiation of appropriate treatment for patients with CTD-PAH.</p><p><strong>Results: </strong>Sixty-three publications (54 studies and 9 guidelines) were included in the SLR, with 22 involving Asia-Pacific populations. Combination therapy reduced clinical worsening and mortality versus monotherapy. After three Delphi rounds, consensus was reached on the importance of early PAH screening in CTD, with disease-specific recommendations for SLE, SSc, and MCTD. Consensus was also achieved on appropriate treatments, including endothelin receptor antagonists (ERA), phosphodiesterase-5 (PDE5) inhibitors, and pulmonary vasodilators. However, long-term outcomes remain uncertain due to limited evidence.</p><p><strong>Conclusion: </strong>This study highlights the need for early screening and timely treatment initiation in CTD-PAH to potentially reduce adverse long-term outcomes.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148912873","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}
{"title":"Methotrexate and Malignancy in Rheumatoid Arthritis: Evidence, Risks, and Clinical Considerations.","authors":"Shigeru Iwata, Masahiro Tada, Ryuji Koike, Yuji Yamanishi, Mie Fusama, Haruka Tsuchiya, Kunihiro Yamaoka, Hideto Kameda","doi":"10.1093/mr/roag080","DOIUrl":"https://doi.org/10.1093/mr/roag080","url":null,"abstract":"<p><p>In this review, we summarized the current evidence on the risks of incident malignancy and cancer recurrence in patients with rheumatoid arthritis (RA) treated with methotrexate (MTX). Before considering the effect of MTX, it is important to recognize the malignancy risk associated with RA itself. The overall risk of malignancy in patients with RA modestly increased, as per two meta-analyses, although Japanese studies report inconsistent findings, with one showing a slightly decrease and another a slight increase. The risk of malignant lymphoma has increased, whereas the risk of colorectal cancer appears reduced. Additionally, there are concerns regarding the increased risk of lung and skin cancers. However, there is limited evidence specific to patients with RA treated with MTX. According to an Australian report, patients have a higher risk of overall malignancy, with an increased risk of malignant lymphoma, lung cancer, and melanoma. Studies comparing MTX with tumor necrosis factor inhibitors have reported no significant difference in the overall malignancy risk or increased malignancy risk. In White patients, MTX has been associated with an increased risk of recurrence in patients with RA and a history of non-melanoma skin cancer. There is insufficient evidence regarding the risks of MTX use in patients with RA and malignancy. Therefore, decisions regarding MTX use should be made individually based on shared decision-making, and careful follow-up is necessary.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148874555","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}
Yoshiya Tanaka, Akira Kondo, Hisaaki Isaji, Katrien Van Beneden, Roger Mutter, Tsutomu Takeuchi
{"title":"Integrated safety analysis of filgotinib in Japanese patients with moderately to severely active rheumatoid arthritis over a treatment duration of up to 5 years.","authors":"Yoshiya Tanaka, Akira Kondo, Hisaaki Isaji, Katrien Van Beneden, Roger Mutter, Tsutomu Takeuchi","doi":"10.1093/mr/roag029","DOIUrl":"10.1093/mr/roag029","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the long-term safety of filgotinib as a treatment for moderately to severely active rheumatoid arthritis for up to 5 years in Japanese patients.</p><p><strong>Methods: </strong>Safety was assessed in Japanese patients receiving filgotinib 200 mg (FIL200) or filgotinib 100 mg (FIL100) in three Phase 3 multinational trials (NCT02889796, NCT02873936, and NCT02886728) and a long-term extension trial (NCT03025308) through May 2022.</p><p><strong>Results: </strong>The pooled Japanese population included 124 patients receiving FIL200 and 107 receiving FIL100, with 413.6 and 352.9 patient-years of exposure [median (maximum) of 3.9 (5.0) and 3.7 (5.1) years], respectively. Overall, 97% of patients experienced treatment-emergent adverse events [EAIR 29.1 (95% confidence interval: 25.5-33.2)], and 73% experienced treatment-related adverse events [21.8 (18.7-25.4)]; rates were similar between FIL200 and FIL100. In the FIL200 and FIL100 groups, EAIRs (95% confidence intervals) were 2.7 (1.5-4.8) and 2.0 (0.9-4.2) for serious infections and 3.1 (1.8-5.4) and 2.6 (1.3-4.9) for herpes zoster. No venous or arterial systemic thromboembolism occurred. There were 0 and 2 incidents of all-cause mortality in the FIL200 and FIL100 groups, respectively.</p><p><strong>Conclusions: </strong>Long-term filgotinib treatment was well tolerated at 200 and 100 mg in Japanese patients with rheumatoid arthritis over a period of up to 5 years, confirming previous global analyses.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":"716-723"},"PeriodicalIF":2.1,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147499339","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}