{"title":"Comparison of safety and effectiveness between etanercept biosimilar LBEC0101 and reference in patients with rheumatoid arthritis in real-world data using the KURAMA cohort.","authors":"Tomoya Kawakami, Sho Masui, Akira Onishi, Hideo Onizawa, Takayuki Fujii, Kosaku Murakami, Koichi Murata, Masao Tanaka, Takashi Shimada, Shunsaku Nakagawa, Shuichi Matsuda, Akio Morinobu, Tomohiro Terada, Atsushi Yonezawa","doi":"10.1093/mr/roae018","DOIUrl":"10.1093/mr/roae018","url":null,"abstract":"<p><strong>Objectives: </strong>Biosimilars are anticipated to be widely used in the treatment of rheumatoid arthritis (RA), owing to their cost efficiency; LBEC0101 was the first etanercept (ETN) biosimilar approved in Japan. However, there are limited real-world data comparing its safety and effectiveness with those of a reference product.</p><p><strong>Methods: </strong>This study used data from the Kyoto University Rheumatoid Arthritis Management Alliance cohort, including patients with RA who received ETN therapy-ETN reference product (ETN-RP) or LBEC0101-between 2015 and 2021. Serum ETN levels were measured using liquid chromatography-tandem mass spectrometry.</p><p><strong>Results: </strong>The 1-year continuation rates of ETN-RP and LBEC0101 were 58.7% and 74.4%, respectively. Effectiveness of treatment was evaluated in 18 patients; both products significantly reduced the 28-joint RA disease activity score and erythrocyte sedimentation rate (DAS28-ESR). Moreover, to determine equivalence, we analysed 11 patients who switched from ETN-RP to LBEC0101; the DAS28-ESR and serum ETN levels before and after switching were not significantly different.</p><p><strong>Conclusions: </strong>This real-world cohort study confirmed that the biosimilar of ETN, LBEC0101, was comparable to the reference product in terms of continuation rate, effectiveness at initiation of introduction, and effect persistence before and after switching in clinical practice.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140184953","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":"Safety and effectiveness of certolizumab pegol in Japanese patients with rheumatoid arthritis: Up to 3-year results from a postmarketing surveillance study.","authors":"Hideto Kameda, Keiichiro Nishida, Toshihiro Nanki, Akira Watanabe, Yukiya Oshima, Shigeki Momohara","doi":"10.1093/mr/roae019","DOIUrl":"10.1093/mr/roae019","url":null,"abstract":"<p><strong>Objectives: </strong>To report up to 3-year safety and effectiveness of certolizumab pegol (CZP) in Japanese patients with rheumatoid arthritis from a postmarketing surveillance study.</p><p><strong>Methods: </strong>Patients enrolled previously completed 24 weeks of CZP in the 24-week postmarketing surveillance study. Adverse drug reactions (ADRs) were recorded for patients who received ≥1 CZP dose. Effectiveness outcomes were 28-joint Disease Activity Score with erythrocyte sedimentation rate and European Alliance of Associations for Rheumatology response. Week 24-156 safety and Week 0-52 effectiveness data are reported here.</p><p><strong>Results: </strong>A total of 781 patients were enrolled, with 735 and 376 patients evaluated for safety and effectiveness, respectively. Within the safety set, 17.8% (131/735) of patients reported ADRs; 9.4% (69/735) reported serious ADRs. Among patients with history of respiratory, thoracic, and mediastinal disorders, 38.4% (28/73) reported ADRs. The most frequent ADRs were infections and infestations (11.8%; 87/735); skin and subcutaneous tissue disorders (1.9%; 14/735); respiratory, thoracic, and mediastinal disorders (1.6%; 12/735). Mean 28-joint Disease Activity Score with erythrocyte sedimentation rate reduced from 4.6 (Week 0) to 2.8 (Week 52). At Week 52, 51.8% (161/311) of patients achieved European Alliance of Associations for Rheumatology Good response.</p><p><strong>Conclusions: </strong>The long-term safety and effectiveness of CZP in the real-world setting in Japan were consistent with previously reported data; no new safety signals were identified.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140850479","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: Nation-wide cohort study of remission induction therapy using rituximab in Japanese patients with antineutrophil cytoplasmic antibody-associated vasculitis: Effectiveness and safety in the first 6 months.","authors":"","doi":"10.1093/mr/roae094","DOIUrl":"10.1093/mr/roae094","url":null,"abstract":"","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142400754","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":"Dapagliflozin for rheumatic musculoskeletal disease in patients with chronic kidney disease.","authors":"Hironari Hanaoka, Jun Kikuchi, Kazuoto Hiramoto, Mitsuhiro Akiyama, Shutaro Saito, Yasushi Kondo, Tatsuhiko Azegami, Yuko Kaneko","doi":"10.1093/mr/roae090","DOIUrl":"https://doi.org/10.1093/mr/roae090","url":null,"abstract":"<p><strong>Objective: </strong>To elucidate the effectiveness of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, on renal function in patients with rheumatic musculoskeletal diseases complicated by chronic kidney disease (CKD) and identify factors associated with the response to dapagliflozin.</p><p><strong>Methods: </strong>We conducted a retrospective analysis of patients with rheumatic musculoskeletal disease and CKD who were treated with dapagliflozin for more than a year. The good response was defined as an improvement in the estimated glomerular filtration rate (eGFR) slope per year after dapagliflozin treatment compared to that before treatment. Additionally, we investigated the response rate and its predictive factors.</p><p><strong>Results: </strong>In this analysis, 43 patients were included. The average eGFR slope demonstrated a significant improvement after dapagliflozin treatment compared to that before the treatment (0.04 vs -0.55 mL/min/1.73m²/year, p=0.001). A good response rate was 69.8% and was associated with low average levels of C-reactive protein, a high frequency of angiotensin II receptor blocker (ARB) use, and a low frequency of tacrolimus use compared to non-response (0.08 ± 0.18 vs 0.25 ± 0.29 mg/dL, p=0.03; 80.0% vs 38.4%, p=0.01; 10.0% vs 76.9%, p<0.01).</p><p><strong>Conclusion: </strong>Dapagliflozin is effective for rheumatic musculoskeletal diseases patients with CKD for preventing deterioration of renal function. Antihypertensive treatment with ARBs and inflammation control without tacrolimus was associated with a high likelihood of favorable response to dapagliflozin.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142470023","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":"Knee joint dysfunction in the patients immediately before arthroplasty was well reflected by locomotive syndrome, not physical frailty.","authors":"Kentaro Inui, Shingo Maeda, Shuji Yamada, Koji Mandai, Yoshito Minami, Kentaro Ueno, Hirotsugu Ohashi, Tesshu Ikawa","doi":"10.1093/mr/roae093","DOIUrl":"https://doi.org/10.1093/mr/roae093","url":null,"abstract":"<p><strong>Objectives: </strong>We assessed physical function by three different methods in patients with knee osteoarthritis just before total knee arthroplasty (TKA) and investigated the relationship between impairment of mobility and preoperative factors.</p><p><strong>Methods: </strong>All patients scheduled to undergo TKA at our hospital were assessed for basic attributes, clinical assessment, radiography, whole-body mode DXA, knee muscle strength. And frailty, sarcopenia, and locomotive syndrome (LS) were evaluated.</p><p><strong>Results: </strong>Among 204 patients (213 knees),172 women, mean age 75.0 years, the overall distribution in frailty was <no: 14.6%, pre-frailty: 58.5%, and frailty: 26.8%>; in sarcopenia <no: 93.3%, yes: 3.4%, and severe: 3.4%>; and in LS <Stage 0: 0%, Stage 1: 3.3%, Stage 2: 11.4%, and stage 3: 85.3%>. Eighty-seven percent of the patients with frailty and 92% with LS stage 3 did not suffer from sarcopenia. Statistically significant relationships were observed between sarcopenia and frailty, while no relationship between LS and frailty or LS and sarcopenia. Multivariate analysis of related factors with severity level for frailty and LS revealed statistically significant correlations for frailty with gait speed and LS with KSS and muscle strength.</p><p><strong>Conclusion: </strong>In the patients with knee OA immediately before arthroplasty, physical frailty and LS was not related with by sarcopenia. Knee joint dysfunction without sarcopenia was well reflected by LS, not by physical frailty.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142350226","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":"The use of biologic disease-modifying anti-rheumatic drugs does not increase surgical site infection or delayed wound healing after orthopaedic surgeries for rheumatoid arthritis.","authors":"Yohei Kiso, Keiichiro Nishida, Ryozo Harada, Yoshihisa Nasu, Ryuichi Nakahara, Yoshifumi Hotta, Shuichi Naniwa, Toshifumi Ozaki","doi":"10.1093/mr/roae089","DOIUrl":"https://doi.org/10.1093/mr/roae089","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the effect of the use of biologic disease-modifying anti-rheumatic drugs (bDMARDs) on surgical site infection (SSI) and delayed wound healing (DWH) in rheumatoid arthritis (RA) patients undergoing orthopaedic surgery.</p><p><strong>Patients and methods: </strong>We retrospectively reviewed the records of 965 elective orthopaedic procedures undertaken in RA patients. The incidences of SSI and DWH were compared between the bDMARDs user and non-user groups. Subsequently, univariate and multivariate logistic regression analyses were performed to evaluate risk factors for SSI and DWH after propensity score (PS) matching. The incidence of postoperative flare-up was also examined.</p><p><strong>Results: </strong>In 965 procedures, SSI and DWH were identified in 12 and 28 cases, respectively. SSI and DWH were identified in 3 and 17 of 414 procedures treated with bDMARDs, respectively. Flare-up occurred in 21 cases. PS matching identified 315 cases in both groups, with no significant difference in incidence between the two groups. No risk factors for SSI were identified, whereas age, diabetes mellitus, foot and ankle surgery and a history of musculoskeletal-related infection were identified as risk factors for DWH.</p><p><strong>Conclusion: </strong>The use of bDMARDs was not associated with an increased incidence of SSI or DWH, with the incidence of flare-up being relatively low.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142350229","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":"Spondyloarthritis and Tietze’s syndrome: A Re-evaluation","authors":"Yasunori Matsuki, Tadashi Nakamura","doi":"10.1093/mr/roae086","DOIUrl":"https://doi.org/10.1093/mr/roae086","url":null,"abstract":"Spondyloarthritis comprises a number of related but different disorders with distinct phenotypes: psoriatic arthritis, reactive arthritis, arthritis related to inflammatory bowel disease, undifferentiated arthritis, and ankylosing spondylitis (the well-known prototypic subtype). Differentiating rheumatic diseases, such as rheumatoid arthritis, synovitis-acne-pustulosis-hyperostosis-osteitis syndrome, pustulotic arthro-osteitis, gout and spondyloarthritis, is difficult because they all may manifest swelling at the upper anterior chest wall, often involve the sternocostal and/or sternoclavicular joints, and clearly show cutaneous nodular symptoms, so that they may mimic Tietze’s syndrome in the presentation. Tietze’s syndrome is a benign, self-limiting entity with tender, non-suppurative swelling in the upper anterior chest wall, especially at the second and third costosternal junctions and the sternoclavicular joint. Therefore, distinguishing spondyloarthritis from Tietze’s syndrome during an entire disease course is important, even after an initial tentative diagnosis. This article aims to re-evaluate the importance of Tietze’s syndrome in the differential diagnosis of spondyloarthritis, while keeping in mind information about rheumatic diseases affecting the upper anterior chest wall.","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142261824","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":"Efficacy and safety of febuxostat in Japanese paediatric patients with hyperuricaemia including gout: phase 2, single arm, open‑label, multicentre studies.","authors":"Shuichi Ito, Yo Morita, Makoto Nitami, Ryutaro Iwama, Akihiro Nakajima, Hisashi Yamanaka, Masataka Honda","doi":"10.1093/mr/roae056","DOIUrl":"https://doi.org/10.1093/mr/roae056","url":null,"abstract":"<p><strong>Objectives: </strong>Urate-lowering efficacy and safety of febuxostat was evaluated in paediatric patients with hyperuricaemia including gout.</p><p><strong>Methods: </strong>A phase 2 study of febuxostat in paediatric patients aged 6-18 years with hyperuricaemia including gout was conducted. We evaluated the proportion of patients achieving serum uric acid (sUA) level ≤6.0 mg/dL at Week 26, and long-term safety and efficacy at Week 52. We also considered efficacy stratified by renal function.</p><p><strong>Results: </strong>Thirty patients (10 at <40 kg and 20 at ≥40 kg) were enrolled. Twenty-four were male, 29 had asymptomatic hyperuricaemia, and 1 had gout. Age was 8 to 18 years. Of these, 63.3% (95% confidence interval 43.9-80.1%) achieved a sUA level of ≤6.0 mg/dL at Week 26. sUA level (mean ± standard deviation) was 5.55 ± 0.87 mg/dL, reduced from 9.01 ± 1.23 mg/dL at baseline. Febuxostat efficacy appeared similar for mild to moderate renal dysfunction and with normal renal function. There were no major safety issues.</p><p><strong>Conclusions: </strong>In paediatric patients with hyperuricaemia including gout, febuxostat showed long-term, well-controlled urate-lowering efficacy with no major safety issues. Findings suggest that no dose adjustment is required for paediatric patients with mild to moderate renal dysfunction.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142133196","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":"Rheumatoid arthritis increases complication risks in elderly hip fracture patients.: A Japanese nationwide medical claims database study.","authors":"Yu Mori, Kunio Tarasawa, Hidetatsu Tanaka, Naoko Mori, Ryuichi Kanabuchi, Kiyohide Fushimi, Toshimi Aizawa, Kenji Fujimori","doi":"10.1093/mr/roae088","DOIUrl":"https://doi.org/10.1093/mr/roae088","url":null,"abstract":"<p><strong>Objectives: </strong>Rheumatoid arthritis (RA) is a common autoimmune disorder characterized by chronic inflammation and periarticular bone loss, leading to systemic osteoporosis and heightened fracture susceptibility, especially hip fractures among the elderly. This study aimed to evaluate the outcomes and complications associated with hip fractures in patients with RA relative to those without RA.</p><p><strong>Methods: </strong>Using the Japanese National Administrative Diagnosis Procedure Combination (DPC) database, we examined cases of femoral neck fractures from April 2016 to March 2023. After one to three propensity score matching for age, sex, and complications, we examined the association between RA, complications, and mortality during hospitalization in elderly patients with hip fractures.</p><p><strong>Results: </strong>The findings revealed that elderly Japanese RA patients with hip fractures had significantly higher complications of pneumonia than elderly hip fracture patients without RA, with a ratio of 1.232 (95% CI: 1.065-1.426, p=0.0056), and pulmonary embolism, with a ratio of 1.155 (95% CI: 1.036-1.287, p=0.009) in multivariate logistic regression analyses. Although not significantly elevated, it also found a trend toward higher mortality during hospitalization, with a ratio of 1.179 (95% CI: 0.973-1.429, p=0.096).</p><p><strong>Conclusions: </strong>A substantial study based on the Japanese DPC database revealed a significant association between RA and increased complications, including pneumonia and pulmonary embolism. On the other hand, there was a nonsignificant but higher trend for risk of mortality during hospitalization for hip fracture in elderly RA patients. Implementing preventive strategies is essential to minimizing complications in the treatment of hip fractures in patients with RA.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142133197","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}