Show simple item record

dc.contributor.authorGinzler, Ellen
dc.contributor.authorGuedes Barbosa, Luiz Sergio
dc.contributor.authorD'Cruz, David
dc.contributor.authorFurie, Richard
dc.contributor.authorMaksimowicz-McKinnon, Kathleen
dc.contributor.authorOates, James
dc.contributor.authorSantiago, Mittermayer Barreto
dc.contributor.authorSaxena, Amit
dc.contributor.authorSheikh, Saira
dc.contributor.authorBass, Damon L
dc.contributor.authorBurriss, Susan W
dc.contributor.authorGilbride, Jennifer A
dc.contributor.authorGroark, James G
dc.contributor.authorMiller, Michelle
dc.contributor.authorPierce, Amy
dc.contributor.authorRoth, David A
dc.contributor.authorJi, Beulah
dc.date.accessioned2023-01-11T19:28:15Z
dc.date.available2023-01-11T19:28:15Z
dc.date.issued2021-12-09
dc.identifier.citationGinzler E, Guedes Barbosa LS, D'Cruz D, Furie R, Maksimowicz-McKinnon K, Oates J, Santiago MB, Saxena A, Sheikh S, Bass DL, Burriss SW, Gilbride JA, Groark JG, Miller M, Pierce A, Roth DA, Ji B. Phase III/IV, Randomized, Fifty-Two-Week Study of the Efficacy and Safety of Belimumab in Patients of Black African Ancestry With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2022 Jan;74(1):112-123. doi: 10.1002/art.41900. Epub 2021 Dec 9. PMID: 34164944; PMCID: PMC9300099.en_US
dc.identifier.eissn2326-5205
dc.identifier.doi10.1002/art.41900
dc.identifier.pmid34164944
dc.identifier.urihttp://hdl.handle.net/20.500.12648/8090
dc.description.abstractEnrollment of patients of Black African ancestry with systemic lupus erythematosus (SLE) in phase II and phase III of the belimumab trials was not reflective of the racial distribution observed in the lupus population. This study was undertaken to assess the efficacy and safety of intravenous (IV) belimumab plus standard therapy in patients of self-identified Black race.
dc.description.abstractEMBRACE (GSK Study BEL115471; ClinicalTrials.gov identifier: NCT01632241) was a 52-week multicenter, double-blind, placebo-controlled trial in adults of self-identified Black race with active SLE who received monthly belimumab 10 mg/kg IV, or placebo, plus standard therapy. The optional 26-week open-label extension phase included patients who completed the double-blind phase. The primary end point of the study was SLE Responder Index (SRI) response rate at week 52 with modified proteinuria scoring adapted from the SLE Disease Activity Index 2000 (SLEDAI-2K) (SRI-SLEDAI-2K). Key secondary end points included SRI response rate at week 52, time to first severe SLE flare, and reductions in prednisone dose.
dc.description.abstractThe modified intent-to-treat population comprised 448 patients, of whom 96.9% were women and the mean ± SD age was 38.8 ± 11.42 years. The primary end point (improvement in the SRI-SLEDAI-2K response rate at week 52) was not achieved (belimumab 48.7%, placebo 41.6%; odds ratio 1.40 [95% confidence interval 0.93, 2.11], P = 0.1068); however, numerical improvements favoring belimumab were observed, in which the SRI-SLEDAI-2K response rates were higher in those who received belimumab compared with those who received placebo, especially in patients with SLE who had high disease activity or renal manifestations at baseline. The safety profile of belimumab was generally consistent with that observed in previous SLE trials. Adverse events were the primary reasons for double-blind phase withdrawals (belimumab 5.4%, placebo 6.7%).
dc.description.abstractThe primary end point of this study was not achieved, but improvement with belimumab versus placebo was observed, suggesting that belimumab remains a suitable treatment option for SLE management in patients of Black African ancestry.
dc.language.isoenen_US
dc.relation.urlhttps://onlinelibrary.wiley.com/doi/10.1002/art.41900en_US
dc.rights© 2021 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.titlePhase III/IV, Randomized, Fifty-Two-Week Study of the Efficacy and Safety of Belimumab in Patients of Black African Ancestry With Systemic Lupus Erythematosus.en_US
dc.typeArticle/Reviewen_US
dc.source.journaltitleArthritis & rheumatology (Hoboken, N.J.)en_US
dc.source.volume74
dc.source.issue1
dc.source.beginpage112
dc.source.endpage123
dc.source.countryUnited States
dc.description.versionVoRen_US
refterms.dateFOA2023-01-11T19:28:15Z
html.description.abstractEnrollment of patients of Black African ancestry with systemic lupus erythematosus (SLE) in phase II and phase III of the belimumab trials was not reflective of the racial distribution observed in the lupus population. This study was undertaken to assess the efficacy and safety of intravenous (IV) belimumab plus standard therapy in patients of self-identified Black race.
html.description.abstractEMBRACE (GSK Study BEL115471; ClinicalTrials.gov identifier: NCT01632241) was a 52-week multicenter, double-blind, placebo-controlled trial in adults of self-identified Black race with active SLE who received monthly belimumab 10 mg/kg IV, or placebo, plus standard therapy. The optional 26-week open-label extension phase included patients who completed the double-blind phase. The primary end point of the study was SLE Responder Index (SRI) response rate at week 52 with modified proteinuria scoring adapted from the SLE Disease Activity Index 2000 (SLEDAI-2K) (SRI-SLEDAI-2K). Key secondary end points included SRI response rate at week 52, time to first severe SLE flare, and reductions in prednisone dose.
html.description.abstractThe modified intent-to-treat population comprised 448 patients, of whom 96.9% were women and the mean ± SD age was 38.8 ± 11.42 years. The primary end point (improvement in the SRI-SLEDAI-2K response rate at week 52) was not achieved (belimumab 48.7%, placebo 41.6%; odds ratio 1.40 [95% confidence interval 0.93, 2.11], P = 0.1068); however, numerical improvements favoring belimumab were observed, in which the SRI-SLEDAI-2K response rates were higher in those who received belimumab compared with those who received placebo, especially in patients with SLE who had high disease activity or renal manifestations at baseline. The safety profile of belimumab was generally consistent with that observed in previous SLE trials. Adverse events were the primary reasons for double-blind phase withdrawals (belimumab 5.4%, placebo 6.7%).
html.description.abstractThe primary end point of this study was not achieved, but improvement with belimumab versus placebo was observed, suggesting that belimumab remains a suitable treatment option for SLE management in patients of Black African ancestry.
dc.description.institutionSUNY Downstateen_US
dc.description.departmentRheumatologyen_US
dc.description.degreelevelN/Aen_US
dc.identifier.journalArthritis & rheumatology (Hoboken, N.J.)


Files in this item

Thumbnail
Name:
Arthritis Rheumatology - 2021 ...
Size:
409.4Kb
Format:
PDF

This item appears in the following Collection(s)

Show simple item record

© 2021 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.
Except where otherwise noted, this item's license is described as © 2021 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.