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Evaluation of belimumab in treatment of Chinese childhood-onset systemic lupus erythematosus: a prospective analysis from multicenter study

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机构: [1]Department of Pediatric Research Institute,Chongqing Key Laboratory of Child Infection and Immunity,Ministry of Education Key Laboratory of Child Development and Disorders,National Clinical Research Center for Child Health and Disorders (Chongqing), China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, China. [2]Department of Rheumatology and Immunology, Children's Hospital of Chongqing Medical University, Chongqing, China. [3]Clinical Epidemiology and Biostatistics Department, Children's Hospital of Chongqing Medical University, Chongqing, China. [4]Department of Rheumatology and Immunology, The First People's Hospital of Yunnan Province, Kunming, China. [5]Department of Pediatric Nephrology, Rheumatology and Immunology, the Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266000, China. [6]Rheumatology & Immunology Department of Shenzhen Children's Hospital, Shenzhen, China. [7]Department of Rheumatology and Immunology, Affiliated Children's Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, 710068, China. [8]Department of Pediatrics, The Second Hospital of Hebei Medical University, Hebei, Shijiazhuang, China. [9]Department of Rheumatology and Immunology, Guangzhou Women and Children's Medical Center, Guangzhou, China. [10]Department of Rheumatology and Immunology, Children's Hospital of Nanjing Medical University, No. 72 Guangzhou Road, Nanjing, Jiangsu Province, 210008, China. [11]Department of Rheumatology Immunology and Allergy, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China. [12]Department of Rheumatology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China. [13]Department of Pediatric Rheumatology, Immunology, and Allergy, the First Hospital of Jilin University, Changchun, Jilin province, China. [14]Department of Pediatrics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China. [15]Department of Rheumatology and Immunology, Children's Hospital of Urnmqi, No.1 Jiankang Rd, TianShan Distinct, Urumqi City, Xinjiang Uyghur Automenous Region, China. [16]Pediatric Immunology and Rheumatology Department, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, 611731, China. [17]Department of Pediatrics, The Second Xiangya Hospital, Central South University, Changhai, China. [18]Department of Nephrology, Children's Hospital of Chongqing Medical University, Chongqing, China.
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关键词: systemic lupus erythematosus belimumab lupus low disease activity status clinical remission prospective study clinical evaluation

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The aim of this study is to identify whether low lupus disease activity status (LLDAS) and clinical remission (CR) of belimumab plus standard of care (SoC) therapy are achievable goals in childhood-onset SLE (cSLE).This multicentre, one arm pre-post intervention study was conducted at 15 centers in China. The primary end point was to describe the proportion of patients who achieved LLDAS and CR after 3, 6, and 12 months after treatment with belimumab plus SoC therapy. A multiple regression model was used to impute missing data. A Poisson regression model was used to calculate the effect of belimumab treatment on the reduced risk of serious diseases and the incidence of new damage.193 (92.2% female) with active cSLE from 15 centers were included. At 3, 6 and 12 months, the proportion of LLDAS (CR) was 12.4% (1.0%), 25.6% (4.5%) and 70.3% (29.7%), respectively. The mean SELENA-SLEDAI score decreased from 11.0 at baseline to 3.7, 2.9 and 1.7 at 3, 6, and 12 months. At baseline, all patients received steroids at a mean (SD) prednisone equivalent dose of 31.0 (18.2) mg/day, which decreased to 19.4 (10.8) mg/day at month 3, 12.6 (7.2) mg/day at month 6 and 6.7 (5.3) mg/day at month 12. The symptoms and immunological indicators were also significantly improved.This is the first and largest sample size prospective clinical intervention study of cSLE patients treated with belimumab in China. LLDAS and CR were attainable treat-to-target of belimumab plus SoC therapy in cSLE.© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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大类 | 2 区 医学
小类 | 2 区 风湿病学
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Q1 RHEUMATOLOGY
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Q1 RHEUMATOLOGY

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第一作者机构: [1]Department of Pediatric Research Institute,Chongqing Key Laboratory of Child Infection and Immunity,Ministry of Education Key Laboratory of Child Development and Disorders,National Clinical Research Center for Child Health and Disorders (Chongqing), China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, China. [2]Department of Rheumatology and Immunology, Children's Hospital of Chongqing Medical University, Chongqing, China.
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通讯机构: [1]Department of Pediatric Research Institute,Chongqing Key Laboratory of Child Infection and Immunity,Ministry of Education Key Laboratory of Child Development and Disorders,National Clinical Research Center for Child Health and Disorders (Chongqing), China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, China. [2]Department of Rheumatology and Immunology, Children's Hospital of Chongqing Medical University, Chongqing, China.
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