Lupus Low Disease Activity State (LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial: post-hoc analysis of the Phase IIb MUSE trial of anifrolumab

Lupus Low Disease Activity State (LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial: post-hoc analysis of the Phase IIb MUSE trial of anifrolumab
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DOI:
10.1136/annrheumdis-2017-212504
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发表时间:
2018-05-01
影响因子:
27.4
通讯作者:
Tummala, Raj
Tummala, Raj
中科院分区:
医学1区
文献类型:
--
作者:
Morand, Eric F.;Trasieva, Teodora;Tummala, Raj

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目的在一项事后分析中,我们旨在验证狼疮低疾病活动状态(LLDAS)定义作为系统性红斑狼疮(SLE)IIb期随机对照试验(RCT)的终点(MUSE [NCT 01438489]),然后利用LLDAS来区分阿尼福鲁单抗和安慰剂。(300 mg,n=99; 1,000 mg,n=104)Q4 W+标准治疗48周。获得LLDAS(SLE疾病活动指数2000
Objectives In a post-hoc analysis, we aimed to validate the Lupus Low Disease Activity State (LLDAS) definition as an endpoint in an systemic lupus erythematosus (SLE) Phase IIb randomised controlled trial (RCT) (MUSE [NCT01438489]) and then utilize LLDAS to discriminate between anifrolumab and placebo.Methods Patients received intravenous placebo (n=102) or anifrolumab (300 mg, n=99; 1,000 mg, n=104) Q4W plus standard of care for 48 weeks. LLDAS attainment (SLE Disease Activity Index 2000