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

作者全名："Wang, Li; Liang, Xiaohua; Cao, Zhilang; Wang, Dahai; Luo, Ying; Feng, Yuan; Luo, Chong; Zhi, Shufeng; Huang, Yiling; Fan, Zhidan; Wang, Chaoying; Liu, Haimei; Liu, Jinxiang; Zhang, Tianyu; Cheng, Qiuting; Xie, Xue; Shuai, Lanjun; Rong, Zanhua; Zeng, Ping; Yu, Haiguo; Lu, Meiping; Sun, Li; Yang, Sirui; Zhao, Dongmei; Zhang, Wei; Wu, Xiaochuan; Li, Qiu; Wang, Yajun; Zhang, Qiuye; Yang, Jun; Li, Xiaoqing; Song, Hongmei; Tang, Xuemei"

作者地址："[Wang, Li; Liang, Xiaohua; Luo, Chong; Li, Qiu; Tang, Xuemei] Chongqing Med Univ, Dept Pediat Res Inst, Natl Clin Res Ctr Child Hlth & Disorders Chongqing, Childrens Hosp,Chongqing Key Lab Child Infect & Im, Chongqing, Peoples R China; [Wang, Li; Luo, Chong; Tang, Xuemei] Chongqing Med Univ, Dept Rheumatol & Immunol, Childrens Hosp, Chongqing, Peoples R China; [Liang, Xiaohua] Chongqing Med Univ, Clin Epidemiol & Biostat Dept, Childrens Hosp, Chongqing, Peoples R China; [Cao, Zhilang; Wang, Yajun] First Peoples Hosp Yunnan Prov, Dept Rheumatol & Immunol, Kunming, Peoples R China; [Wang, Dahai; Zhang, Qiuye] Qingdao Univ, Dept Pediat Nephrol Rheumatol & Immunol, Affiliated Hosp, Qingdao, Shandong, Peoples R China; [Luo, Ying; Yang, Jun] Shenzhen Childrens Hosp, Rheumatol & Immunol Dept, Shenzhen, Peoples R China; [Feng, Yuan; Li, Xiaoqing] Xi An Jiao Tong Univ, Affiliated Childrens Hosp, Dept Rheumatol & Immunol, Xian, Shanxi, Peoples R China; [Zhi, Shufeng; Rong, Zanhua] Hebei Med Univ, Hosp 2, Dept Pediat, Shijiazhuang, Hebei, Peoples R China; [Huang, Yiling; Zeng, Ping] Guangzhou Women & Childrens Med Ctr, Dept Rheumatol & Immunol, Guangzhou, Peoples R China; [Fan, Zhidan; Yu, Haiguo] Nanjing Med Univ, Dept Rheumatol & Immunol, Childrens Hosp, Nanjing, Jiangsu, Peoples R China; [Wang, Chaoying; Lu, Meiping] Zhejiang Univ, Childrens Hosp, Natl Clin Res Ctr Child Hlth, Dept Rheumatol Immunol & Allergy,Sch Med, Hangzhou, Peoples R China; [Liu, Haimei; Sun, Li] Fudan Univ, Natl Childrens Med Ctr, Childrens Hosp, Dept Rheumatol, Shanghai, Peoples R China; [Liu, Jinxiang; Yang, Sirui] First Hosp Jilin Univ, Dept Pediat Rheumatol Immunol & Allergy, Changchun, Jilin, Peoples R China; [Zhang, Tianyu; Song, Hongmei] Chinese Acad Med Sci, Peking Union Med Coll Hosp, Peking Union Med Coll, Dept Pediat, Beijing, Peoples R China; [Cheng, Qiuting; Zhao, Dongmei] Childrens Hosp Urnmqi, Dept Rheumatol & Immunol, Urumqi, Xinjiang, Peoples R China; [Xie, Xue; Zhang, Wei] Univ Elect Sci & Technol China, Chengdu Womens & Childrens Cent Hosp, Sch Med, Pediat Immunol & Rheumatol Dept, Chengdu 611731, Peoples R China; [Shuai, Lanjun; Wu, Xiaochuan] Cent South Univ, Xiangya Hosp 2, Dept Pediat, Changsha, Peoples R China; [Li, Qiu] Chongqing Med Univ, Dept Nephrol, Childrens Hosp, Chongqing, Peoples R China; [Tang, Xuemei] Chongqing Med Univ, Dept Rheumatol & Immunol, Childrens Hosp, Chongqing 400014, Peoples R China; [Song, Hongmei] Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Pediat, Beijing 100730, Peoples R China"

通信作者："Tang, XM (通讯作者)，Chongqing Med Univ, Dept Rheumatol & Immunol, Childrens Hosp, Chongqing 400014, Peoples R China.; Song, HM (通讯作者)，Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Pediat, Beijing 100730, Peoples R China."

来源：RHEUMATOLOGY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001062932000001

JCR分区：Q1

影响因子：4.7

年份：2023

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：SLE; belimumab; lupus low disease activity status; clinical remission; prospective study; clinical evaluation

摘要："Objective 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).Methods This multicentre, one arm pre-post intervention study was conducted at 15 centres 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.Result A total of 193 (92.2% female) with active cSLE from 15 centres 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 (s.d.) 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.Conclusion 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."

基金机构：National Key Ramp;D Program of China [2021YFC2702003]

基金资助正文：This work was supported National Key R & D Program of China (2021YFC2702003).