Abstract:
OBJECTIVES:To assess the efficacy and safety of intravenous (IV) belimumab plus standard systemic lupus erythematosus (SLE) therapy standard of care (SoC) in Japanese patients with SLE. METHODS:A Phase 3, multicenter, double-blind, placebo-controlled, 52-week study (BEL 113750; NCT01345253) in patients with SLE, randomized 2:1 to belimumab 10 mg/kg plus SoC or placebo plus SoC to Week 48. RESULTS:Sixty of 707 randomized patients were enrolled from study centers in Japan (belimumab, n = 39; placebo, n = 21). In this cohort, more patients achieved SLE Responder Index 4 response at Week 52 in the belimumab group compared with placebo (46.2% [18/39] vs. 25.0% [5/20]; odds ratio, 2.57 [95% confidence interval: 0.78, 8.47]; p=.1204). Fewer patients receiving belimumab experienced a severe flare through Week 52, with longer median time to flare compared with placebo. More patients with baseline prednisone dose >7.5 mg/d receiving belimumab had a dose reduction of ≥25% from baseline to ≤7.5 mg/d during Weeks 40-52, compared with placebo. No new safety issues were identified within the Japanese cohort. CONCLUSION:In Japanese patients with SLE, belimumab improved disease activity, with efficacy and safety results similar and consistent to the pivotal Phase 3 trials, suggesting that belimumab is a potential treatment option in this population.
journal_name
Mod Rheumatoljournal_title
Modern rheumatologyauthors
Tanaka Y,Bass D,Chu M,Egginton S,Ji B,Struemper H,Roth Ddoi
10.1080/14397595.2018.1480915subject
Has Abstractpub_date
2019-05-01 00:00:00pages
452-460issue
3eissn
1439-7595issn
1439-7609journal_volume
29pub_type
杂志文章,多中心研究,随机对照试验abstract::A 68-year-old Japanese male presented with atrophic erythematous white lesions with peripheral dark reddish rims on his back. Multiple ulcers were detected from his stomach to his large intestine using endoscopy. Although the patient was given high doses of a steroid, aspirin, dipyridamole, and intravenous immunoglobu...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.3109/14397595.2013.874761
更新日期:2015-05-01 00:00:00
abstract::The aim of our study was to determine the spectrum of the 12 most common familial Mediterranean fever gene (MEFV) mutations in Iranian patients with heterogeneous ethnicity, using the familial Mediterranean fever (FMF) strip assay test. A total of 36 patients were diagnosed according to established clinical criteria. ...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1007/s10165-010-0317-3
更新日期:2010-12-01 00:00:00
abstract::Blau syndrome/early-onset sarcoidosis (Blau/EOS) is an autoinflammatory disease characterized by granulomatous arthritis, uveitis, and skin rash. It has been shown that gain-of-function NOD2 mutations cause Blau/EOS. In this paper, we describe a patient with a gain-of-function NOD2 mutation who developed infantile Tak...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1007/s10165-012-0720-z
更新日期:2013-07-01 00:00:00
abstract::Abstract Five cases of flexor tendon rupture in surgically treated rheumatoid wrists were studied. The tendon ruptures occurred in the thumb and index finger, and the ruptures site was in the carpal tunnel in all five cases. The main cause of rupture was the formation of bony irregularities in the form of bony spurs i...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.3109/s101650170025
更新日期:2001-06-01 00:00:00
abstract:OBJECTIVES:In this study, we aimed to assess the effect of combination of proliferative and membranous lesions (Class III + V or IV + V) on renal outcomes as an independent category distinct from Class III and IV. METHODS:We retrospectively analyzed 103 Japanese patients (14 male and 89 female) with Class III/IV LN, w...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.3109/14397595.2016.1158896
更新日期:2016-11-01 00:00:00
abstract:OBJECTIVES:To assess changes in salivary epidermal growth factor (EGF) levels within three years and investigate the correlation between these changes and the severity of intraoral manifestations in patients with Sjögren's syndrome (SS). METHODS:Twenty-three SS patients (14 primary SS and 9 secondary SS) and 14 contro...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.3109/14397595.2015.1034941
更新日期:2015-01-01 00:00:00
abstract:OBJECTIVES:In recent years, concern has been raised about Juvenile Idiopathic Arthritis (JIA) that it could be associated with an increased risk for malignancies. Therefore, the cancer incidence in the JIA patients was evaluated and compared to the cancer incidence in the German population. METHODS:A retrospective sin...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1080/14397595.2016.1204711
更新日期:2017-01-01 00:00:00
abstract::A 24-year-old Japanese woman was admitted to our hospital suffering from high fever and progressive paralysis in both legs. Magnetic resonance imaging of the spinal cord showed high-intensity signals from C5 to Th4 and from Th7 to L1 on T2-weighted images. The patient was diagnosed as having acute transverse myelitis ...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1007/s10165-004-0376-4
更新日期:2005-01-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1080/14397595.2016.1177926
更新日期:2017-01-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章,随机对照试验
doi:10.1080/14397595.2017.1307899
更新日期:2018-01-01 00:00:00
abstract:OBJECTIVES:To understand the status of mizoribine use in patients with lupus nephritis (LN) and to collect safety- and efficacy-related data on 2-year treatment with mizoribine. METHODS:A continuous survey was conducted between March 2010 and July 2015. RESULTS:The analysis set included 559 patients (mean age 39.5 ye...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1080/14397595.2017.1349573
更新日期:2018-01-01 00:00:00
abstract:OBJECTIVE:To assess the utilities of ultrasonography (US) and low-field magnetic resonance imaging (compacTscan, cMRI) in the diagnosis of subclinical synovitis of hand joints of patients with rheumatoid arthritis (RA). METHODS:A total of 1,540 joints of 77 RA patients were examined clinically, using US, using cMRI, a...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.3109/14397595.2013.854050
更新日期:2014-01-01 00:00:00
abstract::A 61-year-old woman was admitted for long-lasting fever and recurrent opportunistic infections during the treatment of SLE. She had been diagnosed as SLE and type-IV nephritis based on a renal biopsy and serological findings. A colonoscopy and liver biopsy revealed disseminated Mycobacterium avium complex infection. H...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.3109/14397595.2014.997822
更新日期:2017-05-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1007/s10165-009-0266-x
更新日期:2010-06-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.3109/14397595.2013.879416
更新日期:2014-09-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1007/s10165-012-0619-8
更新日期:2013-01-01 00:00:00
abstract::Pneumatosis cystoides intestinalis (PCI), which is characterized by the presence of multiple gas-filled mucosal, submucosal, or subserosal cysts located throughout the colon and/or small intestine, is an unusual complication of systemic lupus erythematosus (SLE). We report a case of a 33-year-old woman with a 5-year h...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1007/s10165-005-0437-3
更新日期:2005-01-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1080/14397595.2018.1481566
更新日期:2019-05-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1007/s10165-006-0533-z
更新日期:2007-01-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1007/s10165-010-0372-9
更新日期:2011-04-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1007/s10165-011-0439-2
更新日期:2011-10-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.3109/14397595.2014.988197
更新日期:2015-07-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.3109/14397595.2015.1069444
更新日期:2016-01-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1080/14397595.2018.1442171
更新日期:2019-01-01 00:00:00
abstract::The development of multiple large tophi in patients with gout is rare. We report magnetic resonance (MR) and histological features of large subcutaneous tophi in a 32-year-old male patient with no known arthritis. His subcutaneous lesions were confused with a neoplastic process, evaluated by MR imaging, and surgically...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1007/s10165-005-0401-2
更新日期:2005-01-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1080/14397595.2016.1245238
更新日期:2019-05-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.3109/14397595.2014.974881
更新日期:2015-05-01 00:00:00
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journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.3109/s101650300011
更新日期:2003-03-01 00:00:00
abstract:OBJECTIVES:To provide evidence for the revision of clinical practice guideline (CPG) for the management of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) by the Japan Research Committee for Intractable Vasculitis. METHODS:PubMed, CENTRAL, and the Japan Medical Abstracts Society were searched fo...
journal_title:Modern rheumatology
pub_type: 杂志文章,meta分析
doi:10.1080/14397595.2018.1500111
更新日期:2019-01-01 00:00:00
abstract::The purpose of this study was to describe the prevalence of total joint arthroplasty (TJA) in Japanese rheumatoid arthritis (RA) patients undergoing conventional drug treatment in a large observational cohort in Japan. A total of 5,177 RA patients were studied for the prevalence of TJA, who were enrolled in the NinJa ...
journal_title:Modern rheumatology
pub_type: 杂志文章
doi:10.1007/s10165-009-0163-3
更新日期:2009-01-01 00:00:00