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A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus

Arthritis & Rheumatism · 2011 · Vol. 63(12) · pp. 3918–3930

Richard Furie✉(Northwell Health)Michelle Petri(Johns Hopkins Medicine)Omid ZamaniRicard Cervera(Hospital Clínic de Barcelona)Daniel J. Wallace(University of California, Los Angeles)Dana Tegzová(Charles University)Jorge Sánchez‐Guerrero(Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán)Andreas SchwartingJoan T. Merrill(Oklahoma Medical Research Foundation)Winn Chatham(University of Alabama at Birmingham)William Stohl(University of Southern California)Ellen M. Ginzler(SUNY Downstate Health Sciences University)Douglas R. Hough(Human Genome Sciences (United States))Z. John Zhong(Human Genome Sciences (United States))William W. Freimuth(Human Genome Sciences (United States))Ronald van Vollenhoven(Karolinska Institutet)BLISS-76 Study Group

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Abstract

Belimumab plus standard therapy significantly improved SRI response rate, reduced SLE disease activity and severe flares, and was generally well tolerated in SLE.

Systemic Lupus Erythematosus Research T-cell and B-cell Immunology Monoclonal and Polyclonal Antibodies ResearchBelimumabMedicinePlaceboInternal medicineClinical endpointLupus erythematosusPost-hoc analysisSystemic lupus erythematosusRandomized controlled trialB-cell activating factor

MeSH terms

AdultAntibodies, MonoclonalAntibodies, AntinuclearDNADose-Response Relationship, DrugDouble-Blind MethodFemaleHumansLupus Erythematosus, SystemicMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeB-Cell Activating FactorAntibodies, Monoclonal, Humanized

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The British Society for Rheumatology guideline for the management of systemic lupus erythematosus in adults