{"title":"Consideration of useful patient-reported outcome measures to identify the unmet medical needs of children and adults with autoimmune and autoinflammatory diseases.","authors":"Shuji Sumitomo, Toru Hirano, Akinori Moriichi, Yuzaburo Inoue, Hidehiko Narazaki, Mitsuyo Inoue, Naoto Yokogawa, Naotomo Kambe, Tomoyuki Mukai, Kazushi Izawa, Dai Kishida, Hajime Yoshifuji, Ken Yamaji, Ryuta Nishikomori, Masaaki Mori, Takako Miyamae","doi":"10.1093/mr/roaf036","DOIUrl":"10.1093/mr/roaf036","url":null,"abstract":"<p><p>Patients with autoimmune and autoinflammatory diseases experience difficult physical, mental, and social situations and have various unmet medical needs. To provide appropriate solutions for these patients, an accurate understanding of their unmet medical needs is necessary. Patient-reported outcomes (PROs) reflect the problems of patients and are highly likely to be useful in understanding patient needs. This article reviews established PRO measures from the perspective of determining those appropriate for identifying the unmet medical needs of patients with autoimmune and autoinflammatory diseases. To consider appropriate PRO measures, discussions were held by experts at the Ministry of Health, Labor and Welfare group meetings. The possibility of developing a method to collect PRO data electronically using information and communication technology was also considered. The experts proposed 28 measures, both disease-specific and non-disease-specific, as candidates. It was confirmed that linguistic validation was important and that measures obtained from adults and children could not be considered together. A migration from paper to digital PRO measures was not conducted due to the need for ensuring accuracy and the shortage of technical and financial support. Appropriate non-disease-specific PRO measures were considered to be the KINDL® and EQ-5D-Y for children and the SF-36v2® and EQ-5D™ for adults.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":"599-611"},"PeriodicalIF":1.8,"publicationDate":"2025-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788472","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":"Three-year safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Final analysis of an all-case postmarketing surveillance study.","authors":"Masataka Kuwana, Naonobu Sugiyama, Shigeki Momohara, Tatsuya Atsumi, Syuji Takei, Naoto Tamura, Masayoshi Harigai, Takao Fujii, Hiroaki Matsuno, Kazuhiko Yamamoto, Yoshinari Takasaki, Nami Okamoto, Nobunori Takahashi, Atsuo Nakajima, Ayako Nakajima, Miki Tanigawa, Yutaka Endo, Toshitaka Hirano, Masato Hoshi, Tsuneyo Mimori, Michiaki Takagi, Sakae Tanaka, Yoshiya Tanaka, Tsutomu Takeuchi","doi":"10.1093/mr/roaf017","DOIUrl":"10.1093/mr/roaf017","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate tofacitinib real-world safety/effectiveness in patients with rheumatoid arthritis (RA) in Japan in a 3-year all-case postmarketing surveillance study.</p><p><strong>Methods: </strong>All patients with RA who initiated tofacitinib (30 July 2013-03 December 2017) were registered in Japan. Serious infections/malignancy/mortality incidences were compared in patients with active RA after >8 mg methotrexate/week for ≥3 months who received tofacitinib or other drugs (control: methotrexate/other disease-modifying antirheumatic drugs/immunosuppressants). Disease activity was assessed over 3 years.</p><p><strong>Results: </strong>The adherent comparative safety analysis set included 3731/2419 (tofacitinib/control) patients. Baseline (tofacitinib/control) biologic disease-modifying antirheumatic drug history (53.3%/12.2%), methotrexate history (81.4%/98.6%), and RA stage (I-II: 45.3%/67.1%) and class (1-2: 76.5%/90.8%) varied between groups. For tofacitinib vs control, incidence rates [patients with event/100 patient-years (95% confidence interval)] were 6.86 (5.96-7.86) vs 1.42 (0.97-2.00) for serious infections (adjusted hazard ratios 3.25-3.80); 1.40 (1.18-1.66) vs 0.88 (0.66-1.15) for malignancies (adjusted hazard ratios 1.37-1.53); 0.89 (0.72-1.10) vs 0.26 (0.15-0.43) for mortality (unadjusted hazard ratio 3.29). Remission/low disease activity rates with tofacitinib increased over 3 years.</p><p><strong>Conclusions: </strong>Serious infection rates were higher, and malignancy rates were numerically higher with tofacitinib vs control. Results should be interpreted cautiously due to imbalanced groups and unmeasured confounders.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":"637-649"},"PeriodicalIF":1.8,"publicationDate":"2025-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143575771","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":"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":"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-risk and moderate-risk in the early-treatment group were more immunoglobulin-resistant than those in late-treatment group, with odds ratios (95% confidence interval) of 6.7 (1.6-28) and 3.7 (1.6-8.5), respectively. There was no difference in the low-risk 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":"707-714"},"PeriodicalIF":1.8,"publicationDate":"2025-07-05","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}
{"title":"Subcutaneous Administration of Methotrexate in Children with Pediatric Rheumatic Diseases.","authors":"Yuko Hayashi, Masaaki Mori, Hiroshi Takase, Masaki Shimizu","doi":"10.1093/mr/roaf058","DOIUrl":"https://doi.org/10.1093/mr/roaf058","url":null,"abstract":"","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144553948","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}
Fatma Temiz, Yeşim Ağyol, Kerem Abacar, Berdan Özdemir, Hacer Sevim, Muhammed Güner, Çagatay Çimşit, Özge Keniş Çoşkun, Fatma Alibaz-Oner, Haner Direskeneli
{"title":"Upper extremity function and strength, assessed with unsupported upper limb exercise test (UULEX), is impaired in patients with Takayasu Arteritis.","authors":"Fatma Temiz, Yeşim Ağyol, Kerem Abacar, Berdan Özdemir, Hacer Sevim, Muhammed Güner, Çagatay Çimşit, Özge Keniş Çoşkun, Fatma Alibaz-Oner, Haner Direskeneli","doi":"10.1093/mr/roaf057","DOIUrl":"https://doi.org/10.1093/mr/roaf057","url":null,"abstract":"<p><strong>Objectives: </strong>We aimed to assess the upper extremity (UE) muscle function/strength of TAK patients compared to healthy controls (HC) and the factors affecting functional outcomes.</p><p><strong>Methods: </strong>Patients with TAK (n=51, F/M: 42/9, mean age: 44 (13.3) years) were compared cross-sectionally with HC (n=51), 24 patients also had a follow-up. Muscle outcomes were assessed by Unsupported Upper Limb Exercise Test (UULEX), handgrip strength (HS), and QuickDASH.</p><p><strong>Results: </strong>UULEX completion time was 171.1 (103.5) seconds in TAK patients, and 432 (44.7) seconds in the HC group (p<0.001). Both right HS (TAK: 22.9 (7.25) vs HC: 27.3 (2.7) kg, p=0.002) and left HS (TAK: 21.9 (6.8) vs HC: 25.4 (7.5) kg, p=0.014) were reduced in TAK patients. UULEX was significantly decreased in patients with active disease (104.4 (62.1) sec. vs. 183.5 (105.3) sec., p=0.023). In follow-up measurements, HS and QuickDASH scores were similar, while UULEX completion time increased significantly. UULEX completion time decreased significantly in patients who had a relapse during the follow-up (-37.6 (62.9) sec. vs 73.2 (87.5) sec., p=0.001).</p><p><strong>Conclusion: </strong>UE muscle function/strength is impaired in TAK patients, associated with disease relapses. UULEX appears to be a promising functional test that shows an association with clinical and radiological parameters and may have potential for monitoring disease activity or progression.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540869","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}
Kunihito Hirotomi, Shu Takagawa, Yohei Yukizawa, Kengo Harigane, Ken Kumagai, Yuichi Mochida, Yutaka Inaba, Naomi Kobayashi
{"title":"A comparison of coronal plane and rotational alignments of the knees between rheumatoid arthritis and osteoarthritis: a retrospective cohort study.","authors":"Kunihito Hirotomi, Shu Takagawa, Yohei Yukizawa, Kengo Harigane, Ken Kumagai, Yuichi Mochida, Yutaka Inaba, Naomi Kobayashi","doi":"10.1093/mr/roaf056","DOIUrl":"https://doi.org/10.1093/mr/roaf056","url":null,"abstract":"<p><strong>Objectives: </strong>Kinematic alignment (KA) in total knee arthroplasty (TKA) has been extensively studied in osteoarthritis (OA) knees but remains unexplored in rheumatoid arthritis (RA) knees. We compared the coronal and rotational alignments in knees with RA and OA.</p><p><strong>Methods: </strong>In total, 433 patients (69 with RA and 364 with OA) who underwent TKA were included. The hip-knee-ankle angle HKA), lateral distal femoral angle LDFA), medial proximal tibia angle (MPTA), and coronal plane alignment of the knee (CPAK) classification were measured using full length anteroposterior radiographs. The difference between the posterior condylar axis (PCA) and surgical epicondylar axis (SEA) angle was measured with computed tomography.</p><p><strong>Results: </strong>Patients with RA exhibited different CPAK classifications compared to those with OA. The mean PCA-SEA was significantly different between the RA and OA groups. Furthermore, the RA group had significantly larger HKA, smaller LDFA, and larger MPTA compared to the OA group.</p><p><strong>Conclusions: </strong>CPAK classification distribution between patients with RA and OA were different. The average PCA-SEA for RA is larger than that for OA, warranting caution of the complications associated with internal rotation placement. Understanding these differences allows for the consideration of RA knee characteristics and informs future evaluations of KA techniques.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144528912","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: Anti-arthritic effects of polyunsaturated fatty acid-rich supplementation combined with selective soluble epoxide hydrolase inhibitors in a collagen-induced arthritis mouse model.","authors":"","doi":"10.1093/mr/roaf055","DOIUrl":"10.1093/mr/roaf055","url":null,"abstract":"","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144333515","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: Anti-arthritic effects of polyunsaturated fatty acid-rich supplementation combined with selective soluble epoxide hydrolase inhibitors in a collagen-induced arthritis mouse model.","authors":"","doi":"10.1093/mr/roaf039","DOIUrl":"10.1093/mr/roaf039","url":null,"abstract":"","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144266725","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}
Shohei Anno, Tadashi Okano, Yuko Sugioka, Shigeyuki Wakitani, Takahiro Iida
{"title":"Romosozumab increases bone mineral density in Japanese older adults with osteoporosis.","authors":"Shohei Anno, Tadashi Okano, Yuko Sugioka, Shigeyuki Wakitani, Takahiro Iida","doi":"10.1093/mr/roaf054","DOIUrl":"https://doi.org/10.1093/mr/roaf054","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to evaluate the efficacy of romosozumab in older Japanese patients with osteoporosis.</p><p><strong>Methods: </strong>Bone mineral density (BMD) was measured at 0, 4, 6, and 12 months after romosozumab treatment.</p><p><strong>Results: </strong>Of 125 patients with osteoporosis (mean age: 77.6 ± 7.5 years), 115 completed BMD measurements at the lumbar spine, total hip, and femoral neck. The BMD at the lumbar spine (11.5%, p < 0.01), total hip (3.0%, p < 0.01), and femoral neck (3.7%, p < 0.01) increased 12 months after treatment. There were no differences in the improvement ratio of BMD after 12 months of treatment at the lumbar spine, total hip, and femoral neck among 76 patients aged ≥75 years and 39 aged < 75 years (11.0 versus 12.5%: p = 0.48, 3.0 versus 3.0%: p = 0.83, 3.6 versus 4.1%: p = 0.92), 48 with prior treatment of osteoporosis and 67 without prior treatment of osteoporosis (10.8 versus 12.1%: p = 0.56, 2.1 versus 3.7%: p = 0.25, 2.8 versus 4.5%: p = 0.61), and 55 patients with a history of fragility fracture and 60 without a history of fragility fracture (11.8 versus 11.3%: p = 0.88, 2.4 versus 3.5%: p = 0.51, 2.0 versus 5.3%: p = 0.11).</p><p><strong>Conclusions: </strong>Romosozumab improved BMD at the lumbar spine, total hip, and femoral neck in older adults with osteoporosis.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144248769","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":"Nation-wide cohort study of Japanese patients with ANCA-associated vasculitis using rituximab: effectiveness and safety after two years.","authors":"Kenji Nagasaka, Koichi Amano, Hiroko Nagafuchi, Ken-Ei Sada, Yoshinori Komagata, Masahiro Yamamura, Masaru Kato, Tomomi Endo, Izaya Nakaya, Tsutomu Takeuchi, Yohko Murakawa, Takahiko Sugihara, Masaya Saito, Taichi Hayashi, Shunsuke Furuta, Kazunori Karasawa, Shogo Banno, Shuichiro Endo, Masako Majima, Hiroaki Dobashi, Shinya Kaname, Naoto Tamura, Yoshiriro Arimura, Masayoshi Harigai","doi":"10.1093/mr/roaf052","DOIUrl":"https://doi.org/10.1093/mr/roaf052","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the efficacy and safety of rituximab (RTX) for microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) in Japan.</p><p><strong>Methods: </strong>Patients with MPA and GPA treated with RTX at each institution were enrolled and followed-up prospectively. Two years of data were analysed.</p><p><strong>Results: </strong>Seventy-five patients were received RTX for remission induction therapy and 57 were observed beyond 6 months. Thirty-five did and 22 did not receive any additional RTX treatment. RTX dosing patterns were diverse. During the 2-year observation period, 56 (74.7%) patients achieved remission; however, 11 (19.6%) patients relapsed. Five patients experienced major relapses, three experienced minor relapses, and three experienced unclassified relapses. Of the 75 patients treated with RTX as remission induction therapy, 63 severe adverse events (SAEs) were observed in 33 patients during the 2-year observation period. Thirty-nine SAEs occurred by 6 months and 24 SAEs were observed after 6 months. Of the 12 patients with SAEs after 6 months, four received RTX after 6 months, resulting in six events. The most common SAE was infection during the first six months and after six months.</p><p><strong>Conclusions: </strong>The effectiveness and safety of RTX for MPA and GPA in Japan were demonstrated over a 2-year observation period.</p>","PeriodicalId":18705,"journal":{"name":"Modern Rheumatology","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144248768","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}