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dc.contributor.authorFurie, Richard A
dc.contributor.authorPetri, Michelle A
dc.contributor.authorWallace, Daniel J
dc.contributor.authorGinzler, Ellen M
dc.contributor.authorMerrill, Joan T
dc.contributor.authorStohl, William
dc.contributor.authorChatham, W Winn
dc.contributor.authorStrand, Vibeke
dc.contributor.authorWeinstein, Arthur
dc.contributor.authorChevrier, Marc R
dc.contributor.authorZhong, Z John
dc.contributor.authorFreimuth, William W
dc.date.accessioned2023-02-03T18:13:18Z
dc.date.available2023-02-03T18:13:18Z
dc.identifier.citationFurie RA, Petri MA, Wallace DJ, Ginzler EM, Merrill JT, Stohl W, Chatham WW, Strand V, Weinstein A, Chevrier MR, Zhong ZJ, Freimuth WW. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 2009 Sep 15;61(9):1143-51. doi: 10.1002/art.24698. PMID: 19714615; PMCID: PMC2748175.en_US
dc.identifier.issn0004-3591
dc.identifier.doi10.1002/art.24698
dc.identifier.pmid19714615
dc.identifier.urihttp://hdl.handle.net/20.500.12648/8242
dc.description.abstractTo describe a new systemic lupus erythematosus (SLE) responder index (SRI) based on a belimumab phase II SLE trial and demonstrate its potential utility in SLE clinical trials.
dc.description.abstractData from a randomized, double-blind, placebo-controlled study in 449 patients 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. The Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) version of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and British Isles Lupus Assessment Group (BILAG) SLE disease activity instruments, the Short Form 36 health survey, and biomarker analyses were used to create a novel SRI. Response to treatment in a subset of 321 serologically active SLE patients (antinuclear antibodies >/=1:80 and/or anti-double-stranded DNA antibodies >/=30 IU/ml) at baseline was retrospectively evaluated using the SRI.
dc.description.abstractSRI response is defined as 1) a >/=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 by >/=0.3 points. In serologically active patients, the addition of belimumab to SOC resulted in a response in 46% of patients at week 52 compared with 29% of the placebo patients (P = 0.006). SRI responses were independent of baseline autoantibody subtype.
dc.description.abstractThis 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 the overall condition or the development of significant disease activity in new organ systems.
dc.language.isoenen_US
dc.relation.urlhttps://onlinelibrary.wiley.com/doi/epdf/10.1002/art.24698en_US
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.titleNovel evidence-based systemic lupus erythematosus responder indexen_US
dc.typeArticle/Reviewen_US
dc.source.journaltitleArthritis and rheumatismen_US
dc.source.volume61
dc.source.issue9
dc.source.beginpage1143
dc.source.endpage51
dc.source.countryUnited States
dc.source.countryUnited States
dc.source.countryUnited States
dc.description.versionAMen_US
refterms.dateFOA2023-02-03T18:13:18Z
html.description.abstractTo describe a new systemic lupus erythematosus (SLE) responder index (SRI) based on a belimumab phase II SLE trial and demonstrate its potential utility in SLE clinical trials.
html.description.abstractData from a randomized, double-blind, placebo-controlled study in 449 patients 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. The Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) version of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and British Isles Lupus Assessment Group (BILAG) SLE disease activity instruments, the Short Form 36 health survey, and biomarker analyses were used to create a novel SRI. Response to treatment in a subset of 321 serologically active SLE patients (antinuclear antibodies >/=1:80 and/or anti-double-stranded DNA antibodies >/=30 IU/ml) at baseline was retrospectively evaluated using the SRI.
html.description.abstractSRI response is defined as 1) a >/=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 by >/=0.3 points. In serologically active patients, the addition of belimumab to SOC resulted in a response in 46% of patients at week 52 compared with 29% of the placebo patients (P = 0.006). SRI responses were independent of baseline autoantibody subtype.
html.description.abstractThis 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 the overall condition or the development of significant disease activity in new organ systems.
dc.description.institutionSUNY Downstateen_US
dc.description.departmentRheumatologyen_US
dc.description.degreelevelN/Aen_US
dc.identifier.journalArthritis and rheumatism


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