Mycophenolate Mofetil and New-Onset Systemic Lupus Erythematosus: A Randomized Clinical Trial

doi:10.1001/jamanetworkopen.2024.32131

科研成果详情

题名	Mycophenolate Mofetil and New-Onset Systemic Lupus Erythematosus: A Randomized Clinical Trial
作者	You, Yijun 1; Zhou, Zhuochao 1; Wang, Fan 1; Li, Jian 2; Liu, Honglei 1; Cheng, Xiaobing 1; Su, Yutong 1; Chen, Xiaowei 3; Zheng, Hui 4; Sun, Yue 1; Shi, Hui 1; Hu, Qiongyi 1; Xu, Jing 5; Teng, Jialin 1; Yang, Chengde 1; Ye, Junna 1
发表日期	2024-09-16
发表期刊	JAMA network open 影响因子和分区
语种	英语
原始文献类型	Article
其他关键词	DISEASE-ACTIVITY ; INTRAVENOUS CYCLOPHOSPHAMIDE ; MAINTENANCE THERAPY ; INDUCTION TREATMENT ; INITIAL VALIDATION ; AZATHIOPRINE ; NEPHRITIS ; MANAGEMENT ; FLARES ; IMMUNOSUPPRESSION
摘要	Importance Anti-double-stranded DNA (dsDNA) antibody has been reported to have a close relationship with systemic lupus erythematosus (SLE) flares and participates in the pathogenesis of lupus nephritis (LN) as well as causing damage to other organs. However, whether early use of mycophenolate mofetil (MMF) could prevent SLE flares is not clear. Objective To assess the efficacy and safety of MMF plus prednisone and hydroxychloroquine sulfate compared with prednisone and hydroxychloroquine sulfate alone in patients with SLE. Design, Setting, and Participants This investigator-initiated, multicenter, observer-blinded randomized clinical trial enrolled 130 participants aged 18 to 65 years and was conducted in 3 hospitals across China. Treatment-naive patients with newly diagnosed SLE, a high titer of anti-dsDNA antibody, and no major organ involvement were included. The study was started September 1, 2018, and the follow-up was completed September 30, 2021. Data were analyzed from December 1, 2021, to March 31, 2022. Interventions Patients were randomized 1:1 to receive oral prednisone (0.5 mg/kg/d) and hydroxychloroquine sulfate (5 mg/kg/d) (control group) or prednisone (0.5 mg/kg/d) and hydroxychloroquine sulfate (5 mg/kg/d) plus MMF (500 mg twice daily) (MMF group) for 96 weeks. Main Outcomes and Measures The primary outcome was the proportion of patients presenting with flares according to the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Flare Index. The secondary outcomes included the proportion with lupus low disease activity state at week 96, 36-Item Short Form Health Survey scores before and after treatment, proportion of adverse events (AEs), and changes in SLEDAI-2000 scores and prednisone doses. Results Among 130 randomized patients (mean [SD] age, 34.5 [12.5] years; 112 [86.2%] women), 119 (91.5%) completed the follow-up. The risk of severe flare was significantly lower in the MMF group (7 of 65 [10.8%]) vs the control group (18 of 65 [27.7%]) (relative risk [RR], 0.39 [95% CI, 0.17-0.87]; P = .01). Additionally, 1 of 65 patients in the MMF group (1.5%) and 9 of 65 in the control group (13.8%) manifested LN (RR, 0.11 [95% CI, 0.01-0.85]; P = .008). Most common serious study drug-related AEs were infections (20 of 65 [30.8%] in the control group and 22 of 65 [33.8%] in the MMF group). Conclusions and Relevance The findings of this randomized clinical trial suggest that MMF may reduce the rate of severe flare and lower the incidence of LN in patients with new-onset SLE and a high titer of anti-dsDNA antibody without major organ involvement.
资助项目	National Natural Science Foundation of China [82371798, 82101876]; Shanghai Rising-Star Program [23QA1406200]; Natural Science Foundation of Shanghai [23ZR1440500]; The 14th Five-Year National Key RD Program [2021YFC2501304]; Ruijin-Zhongmeihuadong Lupus Funding
出版者	AMER MEDICAL ASSOC
ISSN	2574-3805
卷号	7 期号:9
DOI	10.1001/jamanetworkopen.2024.32131
页数	12
WOS类目	Medicine, General & Internal
WOS研究方向	General & Internal Medicine
WOS记录号	WOS:001317155500010
收录类别	SCIE ; SCOPUS ; PUBMED
URL	查看原文
PubMed ID	3928364
SCOPUSEID	2-s2.0-85204418664
通讯作者地址	[Ye, Junna]Shanghai Jiao Tong Univ, Ruijin Hosp, Sch Med, Dept Rheumatol & Immunol, 197 Ruijin Second Rd, Shanghai 200025, Peoples R China.
Scopus学科分类	Medicine (all)
SCOPUS_ID	SCOPUS_ID:85204418664
引用统计
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/218642
专题	附属第一医院附属第一医院_风湿免疫科
通讯作者	Ye, Junna
作者单位	1.Shanghai Jiao Tong Univ, Ruijin Hosp, Sch Med, Dept Rheumatol & Immunol, 197 Ruijin Second Rd, Shanghai 200025, Peoples R China; 2.Shanghai Jiao Tong Univ, Ruijin Hosp, Clin Res Ctr, Sch Med, Shanghai, Peoples R China; 3.Wenzhou Med Univ, Affiliated Hosp 1, Dept Rheumatol & Immunol, Wenzhou, Zhejiang, Peoples R China; 4.Shandong First Med Univ, Affiliated Hosp 2, Dept Rheumatol & Immunol, Tai An, Shandong, Peoples R China; 5.Shanghai Jiao Tong Univ, Ruijin Hosp, Sch Med, Dept Nephrol, Shanghai, Peoples R China
推荐引用方式 GB/T 7714	You, Yijun,Zhou, Zhuochao,Wang, Fan,et al. Mycophenolate Mofetil and New-Onset Systemic Lupus Erythematosus: A Randomized Clinical Trial[J]. JAMA network open,2024,7(9).
APA	You, Yijun., Zhou, Zhuochao., Wang, Fan., Li, Jian., Liu, Honglei., ... & Ye, Junna. (2024). Mycophenolate Mofetil and New-Onset Systemic Lupus Erythematosus: A Randomized Clinical Trial. JAMA network open, 7(9).
MLA	You, Yijun,et al."Mycophenolate Mofetil and New-Onset Systemic Lupus Erythematosus: A Randomized Clinical Trial".JAMA network open 7.9(2024).