Objectives: To update the Japan College of Rheumatology Clinical Practice Guidelines for the Management of Rheumatoid Arthritis (CPG for RA).
Methods: The recommendations were developed based on the evidence published until the end of June 2022 using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). The steering committee, CPG panel, systematic review (SR) group, and SR support team were organised.
Results: The treatment goal and drug treatment algorithm required no modifications; however, the footnotes of the drug treatment algorithm were modified. SR of 21 new or updated recommendations for subcutaneous methotrexate (n=1), biological disease-modifying antirheumatic drugs (n=1), rituximab (n=5), Janus kinase inhibitors (n=6), biosimilars (n=2), older patients (n=4), and pregnancy and lactation (n=2) was conducted. The recommendations for comorbidities and surgery and rehabilitation remained unchanged from the 2020 CPG for RA.
Conclusion: The 2024 CPG for RA, which provide recommendations that reflect the current healthcare environment for RA in Japan, can be used effectively as a tool for shared decision-making between rheumatologists and patients in the treatment of RA.
目的:更新日本风湿病学会类风湿关节炎临床实践指南(CPG for RA)。方法:根据截至2022年6月底公布的证据,使用建议评估、发展和评估分级(GRADE)制定建议。组织了指导委员会、CPG小组、系统评审小组和系统评审支持小组。结果:治疗目标和药物治疗算法无需修改;但是,对药物治疗算法的脚注进行了修改。对21项新的或更新的建议进行了SR分析,包括皮下甲氨蝶呤(n=1)、生物疾病改善抗风湿药物(n=1)、美罗华(n=5)、Janus激酶抑制剂(n=6)、生物仿制药(n=2)、老年患者(n=4)以及妊娠和哺乳期患者(n=2)。对于合并症、手术和康复的建议与2020年RA CPG保持不变。结论:2024年RA CPG提供了反映日本RA当前医疗环境的建议,可以有效地作为风湿病学家和RA治疗患者之间共同决策的工具。
{"title":"2024 Update of the Japan College of Rheumatology Clinical Practice Guidelines for the Management of Rheumatoid Arthritis - secondary publication.","authors":"Masayoshi Harigai, Yuko Kaneko, Eiichi Tanaka, Shintaro Hirata, Hideto Kameda, Kayoko Kaneko, Mitsumasa Kishimoto, Masataka Kohno, Masayo Kojima, Toshihisa Kojima, Akio Morinobu, Ayako Nakajima, Takahiko Sugihara, Mie Fusama, Nobuyuki Yajima, Ryo Yanai, Yutaka Kawahito","doi":"10.1093/mr/roaf006","DOIUrl":"https://doi.org/10.1093/mr/roaf006","url":null,"abstract":"<p><strong>Objectives: </strong>To update the Japan College of Rheumatology Clinical Practice Guidelines for the Management of Rheumatoid Arthritis (CPG for RA).</p><p><strong>Methods: </strong>The recommendations were developed based on the evidence published until the end of June 2022 using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). The steering committee, CPG panel, systematic review (SR) group, and SR support team were organised.</p><p><strong>Results: </strong>The treatment goal and drug treatment algorithm required no modifications; however, the footnotes of the drug treatment algorithm were modified. SR of 21 new or updated recommendations for subcutaneous methotrexate (n=1), biological disease-modifying antirheumatic drugs (n=1), rituximab (n=5), Janus kinase inhibitors (n=6), biosimilars (n=2), older patients (n=4), and pregnancy and lactation (n=2) was conducted. The recommendations for comorbidities and surgery and rehabilitation remained unchanged from the 2020 CPG for RA.</p><p><strong>Conclusion: </strong>The 2024 CPG for RA, which provide recommendations that reflect the current healthcare environment for RA in Japan, can be used effectively as a tool for shared decision-making between rheumatologists and patients in the treatment of RA.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143008484","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}
Objectives: This study aimed to investigate the prevalence of radiographic hand osteoarthritis (HOA) in older Japanese individuals in three distinct regions with unique geographic and occupational characteristics and explore the regional variations and factors, including occupational workload, that affect HOA.
Methods: We analysed the radiographic images and data of 1642 participants aged ≥60 years (mean, 75.6 years). After grading the radiographs of both hands using the modified Kellgren-Lawrence (KL) classification, HOA was defined as at least one joint with a KL grade ≥2, and severe HOA was defined as at least one joint with a KL grade ≥3.
Results: The overall prevalence rates of HOA and severe HOA were 95.9% and 54.2%, respectively. Regional differences were observed: residence in the mountainous region was associated with HOA and severe HOA, whereas residence in the coastal region was associated with only HOA. Occupational workload was associated with severe HOA in a dose-dependent manner, and heavy work was associated with a higher number of osteoarthritis-affected joints.
Conclusion: The present study revealed a high prevalence of HOA in older Japanese individuals and highlighted regional variations in HOA prevalence. A higher occupational workload was associated with a higher risk of severe HOA.
{"title":"Effects of Regional Variations and Occupation on Hand Osteoarthritis: Insights from the Research on Osteoarthritis/Osteoporosis Against Disability Study.","authors":"Ichiko Kojima, Kosuke Uehara, Toshiko Iidaka, Rie Kodama, Shigeyuki Muraki, Hiroyuki Oka, Hiroshi Kawaguchi, Toru Akune, Hiroshi Hashizume, Hiroshi Yamada, Munehito Yoshida, Yutaka Morizaki, Kozo Nakamura, Sakae Tanaka, Noriko Yoshimura","doi":"10.1093/mr/roaf002","DOIUrl":"https://doi.org/10.1093/mr/roaf002","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to investigate the prevalence of radiographic hand osteoarthritis (HOA) in older Japanese individuals in three distinct regions with unique geographic and occupational characteristics and explore the regional variations and factors, including occupational workload, that affect HOA.</p><p><strong>Methods: </strong>We analysed the radiographic images and data of 1642 participants aged ≥60 years (mean, 75.6 years). After grading the radiographs of both hands using the modified Kellgren-Lawrence (KL) classification, HOA was defined as at least one joint with a KL grade ≥2, and severe HOA was defined as at least one joint with a KL grade ≥3.</p><p><strong>Results: </strong>The overall prevalence rates of HOA and severe HOA were 95.9% and 54.2%, respectively. Regional differences were observed: residence in the mountainous region was associated with HOA and severe HOA, whereas residence in the coastal region was associated with only HOA. Occupational workload was associated with severe HOA in a dose-dependent manner, and heavy work was associated with a higher number of osteoarthritis-affected joints.</p><p><strong>Conclusion: </strong>The present study revealed a high prevalence of HOA in older Japanese individuals and highlighted regional variations in HOA prevalence. A higher occupational workload was associated with a higher risk of severe HOA.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143008490","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}
Hiroshi Uda, Michihito Katayama, Keiji Maeda, Osamu Saiki
Objectives: We previously found that discrepancy between serum amyloid A (SAA) and C-reactive protein (CRP) levels linked to the difference of SAA/CRP ratio in patients with early rheumatoid arthritis, and the ratio varied among different patients. This study aimed to determine why the SAA/CRP ratio differed among different patients.
Methods: The patients (n=466) with most of inflammatory diseases were enrolled. After examined CRP and SAA concentrations, we compared the SAA/CRP ratio, and SAA and CRP concentrations in men and women.
Results: The SAA/CRP ratio varied dramatically among different patients (33.6-0.140). The 10 highest SAA/CRP ratios were all in women, and half of the 10 lowest ratios were found in men. The loge SAA/CRP ratio was significantly higher in women than in men (p<0.0001). The loge SAA concentration was not different between women and men (p=0.174), but the loge CRP concentration was significantly higher in men (p<0.0001).
Conclusions: The SAA/CRP ratio varies considerably among different patients. The SAA/CRP ratio in women is higher than in men because loge CRP but not SAA concentrations in men are higher than in women. The finding is against the conventional view and suggest the reference range of CRP concentration in women should be assessed lower than in men.
{"title":"The serum amyloid A to C-reactive protein ratio is lower in men than in women because of higher-C-reactive protein concentrations in men.","authors":"Hiroshi Uda, Michihito Katayama, Keiji Maeda, Osamu Saiki","doi":"10.1093/mr/roaf004","DOIUrl":"https://doi.org/10.1093/mr/roaf004","url":null,"abstract":"<p><strong>Objectives: </strong>We previously found that discrepancy between serum amyloid A (SAA) and C-reactive protein (CRP) levels linked to the difference of SAA/CRP ratio in patients with early rheumatoid arthritis, and the ratio varied among different patients. This study aimed to determine why the SAA/CRP ratio differed among different patients.</p><p><strong>Methods: </strong>The patients (n=466) with most of inflammatory diseases were enrolled. After examined CRP and SAA concentrations, we compared the SAA/CRP ratio, and SAA and CRP concentrations in men and women.</p><p><strong>Results: </strong>The SAA/CRP ratio varied dramatically among different patients (33.6-0.140). The 10 highest SAA/CRP ratios were all in women, and half of the 10 lowest ratios were found in men. The loge SAA/CRP ratio was significantly higher in women than in men (p<0.0001). The loge SAA concentration was not different between women and men (p=0.174), but the loge CRP concentration was significantly higher in men (p<0.0001).</p><p><strong>Conclusions: </strong>The SAA/CRP ratio varies considerably among different patients. The SAA/CRP ratio in women is higher than in men because loge CRP but not SAA concentrations in men are higher than in women. The finding is against the conventional view and suggest the reference range of CRP concentration in women should be assessed lower than in men.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143008493","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}
[Objective] To investigate differences in autoantibodies, clinical features, and long-term outcomes between juvenile- and adult-onset systemic sclerosis (SSc). [Methods] Autoantibodies and survival rates over a maximum of 20 years were retrospectively analyzed in 504 Japanese patients with SSc (juvenile-onset SSc, n=17; adult-onset SSc, n=487) using data from Kyoto University Registry. [Results] The autoantibodies observed were anti-topoisomerase-I (71% vs. 26%), anti-centromere (24% vs. 54%), and anti-RNA-polymerase-III (0% vs. 12%). A diffuse type and multi-organ involvement were observed in patients with anti-topoisomerase-I in both juvenile- and adult-onset SSc. In patients with anti-centromere, a diffuse type (juvenile-onset SSc vs. adult-onset SSc, 75% vs. 28%) and pulmonary fibrosis (50% vs. 17%) were more frequently observed in juvenile-onset SSc than in adult-onset SSc. Cox-proportional hazard analyses showed that older onset (hazard ratio: 1.06, 95% confidence interval: 1.03-1.09) was associated with death, while autoantibodies were not significantly associated with death. Cumulative survival rates for 20 years were similar between juvenile- and adult-onset SSc when classified based on the presence of anti-centromere (100% vs. 89%, p=0.20) and anti-topoisomerase-I (90% vs. 90%, p=0.70). [Conclusions] Juvenile-onset SSc had more frequent diffuse-type and anti-topoisomerase-I. An older onset was slightly associated with mortality, whereas autoantibodies were not associated with mortality.
【目的】探讨青少年和成人发病的系统性硬化症(SSc)自身抗体、临床特征和长期预后的差异。[方法]回顾性分析504例日本SSc患者的自身抗体和最长20年的生存率(少年发病SSc, n=17;成人发病SSc, n=487),数据来自京都大学登记处。【结果】观察到的自身抗体为抗拓扑异构酶- i(71%对26%)、抗着丝粒(24%对54%)和抗rna聚合酶- iii(0%对12%)。抗拓扑异构酶- 1在青少年和成人发病的SSc患者中均观察到弥漫性和多器官受累。在抗着丝粒患者中,弥漫性SSc(青少年发病的SSc vs成人发病的SSc, 75% vs 28%)和肺纤维化(50% vs 17%)在青少年发病的SSc中比在成人发病的SSc中更常见。Cox-proportional hazard analysis分析Cox-proportional hazard analysis分析显示,发病年龄较大(风险比:1.06,95%可信区间:1.03-1.09)与死亡相关,而自身抗体与死亡无显著相关。根据抗着丝粒(100%对89%,p=0.20)和抗拓扑异构酶i(90%对90%,p=0.70)的存在进行分类,幼年和成年发病的SSc的20年累积生存率相似。[结论]青少年发病的SSc弥漫性和抗拓扑异构酶i更常见。年龄较大的发病与死亡率略有相关,而自身抗体与死亡率无关。
{"title":"Differences in the autoantibody phenotypes and long-term outcomes between juvenile- and adult-onset systemic sclerosis.","authors":"Hideaki Tsuji, Mirei Shirakashi, Ryosuke Hiwa, Shuji Akizuki, Ran Nakashima, Akira Onishi, Hajime Yoshifuji, Masao Tanaka, Akio Morinobu","doi":"10.1093/mr/roaf005","DOIUrl":"https://doi.org/10.1093/mr/roaf005","url":null,"abstract":"<p><p>[Objective] To investigate differences in autoantibodies, clinical features, and long-term outcomes between juvenile- and adult-onset systemic sclerosis (SSc). [Methods] Autoantibodies and survival rates over a maximum of 20 years were retrospectively analyzed in 504 Japanese patients with SSc (juvenile-onset SSc, n=17; adult-onset SSc, n=487) using data from Kyoto University Registry. [Results] The autoantibodies observed were anti-topoisomerase-I (71% vs. 26%), anti-centromere (24% vs. 54%), and anti-RNA-polymerase-III (0% vs. 12%). A diffuse type and multi-organ involvement were observed in patients with anti-topoisomerase-I in both juvenile- and adult-onset SSc. In patients with anti-centromere, a diffuse type (juvenile-onset SSc vs. adult-onset SSc, 75% vs. 28%) and pulmonary fibrosis (50% vs. 17%) were more frequently observed in juvenile-onset SSc than in adult-onset SSc. Cox-proportional hazard analyses showed that older onset (hazard ratio: 1.06, 95% confidence interval: 1.03-1.09) was associated with death, while autoantibodies were not significantly associated with death. Cumulative survival rates for 20 years were similar between juvenile- and adult-onset SSc when classified based on the presence of anti-centromere (100% vs. 89%, p=0.20) and anti-topoisomerase-I (90% vs. 90%, p=0.70). [Conclusions] Juvenile-onset SSc had more frequent diffuse-type and anti-topoisomerase-I. An older onset was slightly associated with mortality, whereas autoantibodies were not associated with mortality.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143008489","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}
Objectives: This study aimed to describe the characteristics, inflammatory markers as surrogates for disease activity, and treatment of patients with polymyalgia rheumatica (PMR) in Japan.
Methods: This cohort study analysed the data of 373 patients with PMR retrieved from an electronic medical records database in Japan. Patients were classified into quartiles, based on the daily glucocorticoid dose over the initial 90 days of treatment (Q1-Q4).
Results: The low glucocorticoid dose group (Q1) had more patients aged ≥90 years (11.7%), and a higher prevalence of comorbidities. At 52 weeks, glucocorticoid-free remission was achieved in 10% of patients, and higher C-reactive protein levels were observed during the follow-up period. In contrast, the high glucocorticoid dose group (Q4) exhibited a slower decline in C-reactive protein levels and more events of increased glucocorticoid dose compared to Q1-Q3. The introduction of methotrexate was low, with 4.3% to 7.3% of patients. The incidence of osteoporosis and diabetes was higher in patients <75 years, whereas the incidence of hypertension was higher in patients ≥75 years.
Conclusions: Patients refractory to high glucocorticoid doses were identified. Patients receiving inadequately low doses of glucocorticoids were older with more comorbidities. This study highlights the unmet medical needs for PMR.
{"title":"Characteristics of patients with polymyalgia rheumatica based on glucocorticoid dose in Japan: A cohort study using routinely collected health data.","authors":"Yoshiya Tanaka, Toshiya Takahashi, Shoichiro Inokuchi, Hidetoshi Uenaka, Akiko Fujita, Kazuhito Sakamoto","doi":"10.1093/mr/roaf001","DOIUrl":"https://doi.org/10.1093/mr/roaf001","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to describe the characteristics, inflammatory markers as surrogates for disease activity, and treatment of patients with polymyalgia rheumatica (PMR) in Japan.</p><p><strong>Methods: </strong>This cohort study analysed the data of 373 patients with PMR retrieved from an electronic medical records database in Japan. Patients were classified into quartiles, based on the daily glucocorticoid dose over the initial 90 days of treatment (Q1-Q4).</p><p><strong>Results: </strong>The low glucocorticoid dose group (Q1) had more patients aged ≥90 years (11.7%), and a higher prevalence of comorbidities. At 52 weeks, glucocorticoid-free remission was achieved in 10% of patients, and higher C-reactive protein levels were observed during the follow-up period. In contrast, the high glucocorticoid dose group (Q4) exhibited a slower decline in C-reactive protein levels and more events of increased glucocorticoid dose compared to Q1-Q3. The introduction of methotrexate was low, with 4.3% to 7.3% of patients. The incidence of osteoporosis and diabetes was higher in patients <75 years, whereas the incidence of hypertension was higher in patients ≥75 years.</p><p><strong>Conclusions: </strong>Patients refractory to high glucocorticoid doses were identified. Patients receiving inadequately low doses of glucocorticoids were older with more comorbidities. This study highlights the unmet medical needs for PMR.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143008487","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}
Objectives: The early administration of immunoglobulin in Kawasaki disease occasionally results in treatment failure. However, whether this is because severe cases are diagnosed and treated early or due to other factors remains unclear. In this study, we examined the timing of initial immunoglobulin administration and immunoglobulin resistance in cases classified by severity of illness.
Methods: This study was a single-hospital, retrospective cohort study of 608 patients who received immunoglobulin within 4 (Early-treatment group, n=225) or between 5 and 7 days (Late-treatment group, n=383) following treatment onset. Cases were classified into four groups: high (n=55), moderate (n=96), low (n=197), and very-low (n=260) risk, based on the Kobayashi score, modified to exclude the day of illness factor. Within each risk group, immunoglobulin resistance was compared between the early- and late-treatment groups.
Results: The early-treatment group showed greater immunoglobulin-resistance than the late-treatment group. After severity classification, the cases of high and moderate-risk in the early-treatment group were more immunoglobulin-resistant than in late-treatment group, with odds ratios (95% CI) of 6.7 (1.6-28) and 3.7 (1.6-8.5), respectively. There was no difference in the low and very-low-risk groups.
Conclusion: Earlier illness day was a risk factor of immunoglobulin resistance in severe cases.
{"title":"Association between the timing of intravenous immunoglobulin treatment and severity of Kawasaki disease.","authors":"Mitsuji Iwasa, Gaku Aoki, Sachiko Inukai","doi":"10.1093/mr/roaf003","DOIUrl":"https://doi.org/10.1093/mr/roaf003","url":null,"abstract":"<p><strong>Objectives: </strong>The early administration of immunoglobulin in Kawasaki disease occasionally results in treatment failure. However, whether this is because severe cases are diagnosed and treated early or due to other factors remains unclear. In this study, we examined the timing of initial immunoglobulin administration and immunoglobulin resistance in cases classified by severity of illness.</p><p><strong>Methods: </strong>This study was a single-hospital, retrospective cohort study of 608 patients who received immunoglobulin within 4 (Early-treatment group, n=225) or between 5 and 7 days (Late-treatment group, n=383) following treatment onset. Cases were classified into four groups: high (n=55), moderate (n=96), low (n=197), and very-low (n=260) risk, based on the Kobayashi score, modified to exclude the day of illness factor. Within each risk group, immunoglobulin resistance was compared between the early- and late-treatment groups.</p><p><strong>Results: </strong>The early-treatment group showed greater immunoglobulin-resistance than the late-treatment group. After severity classification, the cases of high and moderate-risk in the early-treatment group were more immunoglobulin-resistant than in late-treatment group, with odds ratios (95% CI) of 6.7 (1.6-28) and 3.7 (1.6-8.5), respectively. There was no difference in the low and very-low-risk groups.</p><p><strong>Conclusion: </strong>Earlier illness day was a risk factor of immunoglobulin resistance in severe cases.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143008486","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}
Objectives: To describe the efficacy of anifrolumab vs. placebo in Japanese systemic lupus erythematosus (SLE) patients with low complement (C3 or C4) and/or who are positive for anti-double stranded DNA (anti-dsDNA) antibodies.
Methods: This was a descriptive post hoc analysis of Japanese SLE patients with serological manifestations in the TULIP-2 trial who received either anifrolumab or placebo.
Results: Of the 43 patients enrolled, 79.2% (19/24) and 73.7% (14/19) had low C3, low C4, and/or were positive for anti-dsDNA antibodies at baseline in the anifrolumab and placebo groups, respectively. At week 52, 52.6% (10/19) and 7.1% (1/14) patients in the anifrolumab and placebo groups, respectively, achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response. The proportion of patients who tapered their glucocorticoid (GC) dose throughout the study, without increasing their dose, or who sustained baseline GC doses of ≤7.5 mg/day was numerically higher in the anifrolumab group (78.9% [15/19]) than in the placebo group (50.0% [7/14]).
Conclusions: In line with the clinical profile of anifrolumab in the TULIP-2 study, the efficacy of anifrolumab was shown in Japanese SLE patients with serological manifestations achieving a BICLA response, and with tapered GC dose or sustained GC doses of ≤7.5 mg/day.
{"title":"Efficacy of anifrolumab on systemic lupus erythematosus patients with serological manifestations: A post hoc analysis of the Japan subgroup of the TULIP-2 Trial.","authors":"Yoshiya Tanaka, Tatsuya Atsumi, Masato Okada, Tomoya Miyamura, Tomonori Ishii, Susumu Nishiyama, Ryutaro Matsumura, Nobuya Hayashi, Takahiro Matsumoto, Toshiki Yabe-Wada, Yoshiyuki Yamaguchi, Gabriel Abreu, Catharina Lindholm, Tsutomu Takeuchi","doi":"10.1093/mr/roae111","DOIUrl":"https://doi.org/10.1093/mr/roae111","url":null,"abstract":"<p><strong>Objectives: </strong>To describe the efficacy of anifrolumab vs. placebo in Japanese systemic lupus erythematosus (SLE) patients with low complement (C3 or C4) and/or who are positive for anti-double stranded DNA (anti-dsDNA) antibodies.</p><p><strong>Methods: </strong>This was a descriptive post hoc analysis of Japanese SLE patients with serological manifestations in the TULIP-2 trial who received either anifrolumab or placebo.</p><p><strong>Results: </strong>Of the 43 patients enrolled, 79.2% (19/24) and 73.7% (14/19) had low C3, low C4, and/or were positive for anti-dsDNA antibodies at baseline in the anifrolumab and placebo groups, respectively. At week 52, 52.6% (10/19) and 7.1% (1/14) patients in the anifrolumab and placebo groups, respectively, achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response. The proportion of patients who tapered their glucocorticoid (GC) dose throughout the study, without increasing their dose, or who sustained baseline GC doses of ≤7.5 mg/day was numerically higher in the anifrolumab group (78.9% [15/19]) than in the placebo group (50.0% [7/14]).</p><p><strong>Conclusions: </strong>In line with the clinical profile of anifrolumab in the TULIP-2 study, the efficacy of anifrolumab was shown in Japanese SLE patients with serological manifestations achieving a BICLA response, and with tapered GC dose or sustained GC doses of ≤7.5 mg/day.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143008492","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, Tatsuya Atsumi, Masato Okada, Tomoya Miyamura, Tomonori Ishii, Susumu Nishiyama, Ryutaro Matsumura, Yosuke Morishima, Yoshiyuki Yamaguchi, Gabriel Abreu, Catharina Lindholm, Eric F Morand, Tsutomu Takeuchi
Objectives: To investigate the efficacy of anifrolumab on disease activity and glucocorticoid tapering patterns in Japanese patients with systemic lupus erythematosus (SLE).
Methods: We analysed disease activity and glucocorticoid tapering in the Japanese subpopulation (anifrolumab, n = 24; placebo, n = 19) of the TULIP-2 trial, which showed the efficacy and safety of anifrolumab in patients with moderate-to-severe active SLE.
Results: The percentage of patients who achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment response at Week 52 was greater in the anifrolumab group than placebo [50.0% (12/24) vs. 15.8% (3/19); p = 0.014]. Lupus low disease activity state (LLDAS) was achieved at Week 52 by 9/24 (37.5%) and 3/19 (15.8%) patients receiving anifrolumab and placebo, respectively. During the 52-week study period, in the anifrolumab vs. placebo groups, 5/24 (20.8%) patients were in LLDAS ≥50% of observed time vs. 0/19 (0.0%), and 14/24 (58.3%) vs. 6/19 (31.6%) patients were classified into favourable glucocorticoids tapering pattern. Anifrolumab had an acceptable tolerability profile, consistent with the overall population.
Conclusions: In the Japanese subpopulation of the TULIP-2 trial, anifrolumab resulted in an improvements in disease activity to those reported for the overall population, suggesting a beneficial effect for disease control.
目的:探讨anfrolumab对日本系统性红斑狼疮(SLE)患者疾病活动性和糖皮质激素逐渐减少模式的疗效。方法:我们分析了日本亚群的疾病活动性和糖皮质激素逐渐减少(anifrolumab, n = 24;TULIP-2试验显示了anfrolumab对中重度活动性SLE患者的有效性和安全性。结果:在第52周,anifrolumab组达到基于不列颠群岛狼疮评估组的综合狼疮评估反应的患者比例高于安慰剂组[50.0%(12/24)比15.8% (3/19);P = 0.014]。狼疮低疾病活动状态(LLDAS)在第52周分别由接受anifrolumab和安慰剂治疗的9/24(37.5%)和3/19(15.8%)患者实现。在52周的研究期间,在anifrolumab组和安慰剂组中,5/24(20.8%)患者的LLDAS≥50%的观察时间,0/19(0.0%),14/24(58.3%)和6/19(31.6%)患者被分类为有利的糖皮质激素逐渐减少模式。Anifrolumab具有可接受的耐受性,与总体人群一致。结论:在TULIP-2试验的日本亚群中,anifrolumab改善了总体人群的疾病活动性,表明对疾病控制有有益的影响。
{"title":"Disease activity and glucocorticoid tapering patterns in Japanese patients with systemic lupus erythematosus treated with anifrolumab: post hoc analysis of the Japanese subpopulation of the TULIP-2 study.","authors":"Yoshiya Tanaka, Tatsuya Atsumi, Masato Okada, Tomoya Miyamura, Tomonori Ishii, Susumu Nishiyama, Ryutaro Matsumura, Yosuke Morishima, Yoshiyuki Yamaguchi, Gabriel Abreu, Catharina Lindholm, Eric F Morand, Tsutomu Takeuchi","doi":"10.1093/mr/roae105","DOIUrl":"https://doi.org/10.1093/mr/roae105","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate the efficacy of anifrolumab on disease activity and glucocorticoid tapering patterns in Japanese patients with systemic lupus erythematosus (SLE).</p><p><strong>Methods: </strong>We analysed disease activity and glucocorticoid tapering in the Japanese subpopulation (anifrolumab, n = 24; placebo, n = 19) of the TULIP-2 trial, which showed the efficacy and safety of anifrolumab in patients with moderate-to-severe active SLE.</p><p><strong>Results: </strong>The percentage of patients who achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment response at Week 52 was greater in the anifrolumab group than placebo [50.0% (12/24) vs. 15.8% (3/19); p = 0.014]. Lupus low disease activity state (LLDAS) was achieved at Week 52 by 9/24 (37.5%) and 3/19 (15.8%) patients receiving anifrolumab and placebo, respectively. During the 52-week study period, in the anifrolumab vs. placebo groups, 5/24 (20.8%) patients were in LLDAS ≥50% of observed time vs. 0/19 (0.0%), and 14/24 (58.3%) vs. 6/19 (31.6%) patients were classified into favourable glucocorticoids tapering pattern. Anifrolumab had an acceptable tolerability profile, consistent with the overall population.</p><p><strong>Conclusions: </strong>In the Japanese subpopulation of the TULIP-2 trial, anifrolumab resulted in an improvements in disease activity to those reported for the overall population, suggesting a beneficial effect for disease control.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142971621","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}
Jang Woo Ha, Jason Jungsik Song, Yong-Beom Park, Sang-Won Lee
Objectives: We applied the 2022 American College of Rheumatology (ACR)/European Alliance of Association for Rheumatology (EULAR) criteria to Korean patients previously diagnosed with giant cell arteritis (GCA) according to the 1990 ACR criteria and validated its clinical efficiency.
Methods: Nine patients with GCA were included in this study. The proportion of patients meeting each item of the 1990 ACR criteria and the 2022 ACR/EULAR criteria were assessed. fluorodeoxyglucose-positron emission tomography (FDG-PET), and temporal artery biopsy were performed in eight, and four of the nine patients, respectively.
Results: The median age was 65.0 years, and 77.8% of the patients were women. Seven (77.8%) patients had polymyalgia rheumatica. All nine patients were reclassified as having GCA according to the 2022 ACR/EULAR criteria. Among the 10 items of the 2022 ACR/EULAR criteria, the item contributing the most to the reclassification was elevated acute-phase reactant levels (100%), followed by new temporal headache (77.8%), and FDG-PET activity throughout the aorta (77.5%). Positive temporal artery biopsy findings were observed in 75.0% of the patients; however, only four patients underwent biopsy, which was insufficient to assess its efficacy. An item of sudden visual loss did not make a considerable contribution to the reclassification of GCA because of its rare frequency (11.1%).
Conclusion: In this study, for the first time, we demonstrated a concordance rate of 100% between the two criteria in Korean patients previously diagnosed with GCA. Moreover, we also clarified the major contributors to the reclassification according to the 2022 ACR/EULAR criteria.
{"title":"Validation of the 2022 ACR/EULAR classification criteria for giant cell arteritis in Koran patients with giant cell arteritis.","authors":"Jang Woo Ha, Jason Jungsik Song, Yong-Beom Park, Sang-Won Lee","doi":"10.1093/mr/roae110","DOIUrl":"https://doi.org/10.1093/mr/roae110","url":null,"abstract":"<p><strong>Objectives: </strong>We applied the 2022 American College of Rheumatology (ACR)/European Alliance of Association for Rheumatology (EULAR) criteria to Korean patients previously diagnosed with giant cell arteritis (GCA) according to the 1990 ACR criteria and validated its clinical efficiency.</p><p><strong>Methods: </strong>Nine patients with GCA were included in this study. The proportion of patients meeting each item of the 1990 ACR criteria and the 2022 ACR/EULAR criteria were assessed. fluorodeoxyglucose-positron emission tomography (FDG-PET), and temporal artery biopsy were performed in eight, and four of the nine patients, respectively.</p><p><strong>Results: </strong>The median age was 65.0 years, and 77.8% of the patients were women. Seven (77.8%) patients had polymyalgia rheumatica. All nine patients were reclassified as having GCA according to the 2022 ACR/EULAR criteria. Among the 10 items of the 2022 ACR/EULAR criteria, the item contributing the most to the reclassification was elevated acute-phase reactant levels (100%), followed by new temporal headache (77.8%), and FDG-PET activity throughout the aorta (77.5%). Positive temporal artery biopsy findings were observed in 75.0% of the patients; however, only four patients underwent biopsy, which was insufficient to assess its efficacy. An item of sudden visual loss did not make a considerable contribution to the reclassification of GCA because of its rare frequency (11.1%).</p><p><strong>Conclusion: </strong>In this study, for the first time, we demonstrated a concordance rate of 100% between the two criteria in Korean patients previously diagnosed with GCA. Moreover, we also clarified the major contributors to the reclassification according to the 2022 ACR/EULAR criteria.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142951781","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":"Late-onset rheumatoid arthritis: Justifying the need for international practice guidelines and classification criteria.","authors":"Chokan Baimukhamedov, Marina Baimukhamedova","doi":"10.1093/mr/roae117","DOIUrl":"https://doi.org/10.1093/mr/roae117","url":null,"abstract":"","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142951779","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}