Novel evidence-based systemic lupus erythematosus responder index.
Novel evidence-based systemic lupus erythematosus responder index.
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DOI：
10.1002/art.24698
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发表时间：
2009-09-15
影响因子：
--
通讯作者：
Freimuth, William W.
中科院分区：
文献类型：
--
作者：
Furie, Richard A.;Petri, Michelle A.;Wallace, Daniel J.;Ginzler, Ellen M.;Merrill, Joan T.;Stohl, William;Chatham, W. Winn;Strand, Vibeke;Weinstein, Arthur;Chevrier, Marc R.;Zhong, Z. John;Freimuth, William W.
To describe a new systemic lupus erythematosus (SLE) Responder Index (SRI) based on the belimumab phase II SLE trial and demonstrate its potential utility in SLE clinical trials. Data from a 449-patient randomized, double-blind, placebo-controlled study of 3 doses of belimumab (1, 4, 10 mg/kg) or placebo plus standard of care therapy (SOC) over a 56-week period were analyzed. SELENA-SLEDAI and BILAG SLE disease activity instruments, SF-36 Health Survey, and biomarker analyses were used to create a novel SRI. Response to treatment in a subset of SLE patients (n=321) who were serologically active (ANA ≥1:80 and/or anti-dsDNA antibody ≥30 IU) at baseline was retrospectively evaluated using the SRI. SRI response is defined as: 1) ≥4-point reduction in SELENA-SLEDAI score; 2) no new BILAG A or no more than 1 new BILAG B domain score; and 3) no deterioration from baseline in the Physician’s Global Assessment (PGA) by ≥0.3 points. In serologically active patients, addition of belimumab to SOC resulted in a response in 46% of patients at week 52 compared with 29% for the placebo patients (P=0.006). SRI responses were independent of baseline autoantibody subtype. Evidence-based evaluation of a large randomized, placebo-controlled trial in SLE resulted in the ability to define a robust responder index based on improvement in disease activity without worsening of the overall condition or the development of significant disease activity in new organ systems.
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影响因子：
--
作者：
Cardiel, Mario H.;Tumlin, James A.;Linnik, Matthew D.
通讯作者：
Linnik, Matthew D.
影响因子：
2.6
作者：
Bertsias, G.;Gordon, C.;Boumpas, D. T.
通讯作者：
Boumpas, D. T.
影响因子：
--
作者：
Baker, KP;Edwards, BM;Albert, VR
通讯作者：
Albert, VR
DOI：
10.1016/j.berh.2005.03.010
发表时间：
2005-10-01
影响因子：
5.2
作者：
Griffiths, B;Mosca, M;Gordon, C
通讯作者：
Gordon, C
影响因子：
2.5
作者：
Ong, LM;Hooi, LS;Morad, Z
通讯作者：
Morad, Z