Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus.

MedStar author(s):
Citation: Journal of Rheumatology. 41(2):300-9, 2014 Feb.PMID: 24187095Institution: MedStar Washington Hospital CenterDepartment: Medicine/RheumatologyForm of publication: Journal ArticleMedline article type(s): Clinical Trial, Phase II | Journal Article | Randomized Controlled TrialSubject headings: *Antibodies, Monoclonal, Humanized/tu [Therapeutic Use] | *Immunosuppressive Agents/tu [Therapeutic Use] | *Lupus Erythematosus, Systemic/dt [Drug Therapy] | Adult | Antibodies, Monoclonal, Humanized/ad [Administration & Dosage] | Antibodies, Monoclonal, Humanized/ae [Adverse Effects] | Autoantibodies | Double-Blind Method | Drug Administration Schedule | Drug Therapy, Combination | Female | Humans | Immunosuppressive Agents/ad [Administration & Dosage] | Immunosuppressive Agents/ae [Adverse Effects] | Longitudinal Studies | Lupus Erythematosus, Systemic/im [Immunology] | Male | Middle Aged | Severity of Illness Index | Treatment OutcomeYear: 2014Local holdings: Available online from MWHC library: 2001 - presentISSN:
  • 0315-162X
Name of journal: The Journal of rheumatologyAbstract: CONCLUSION: Disease control and safety profile were maintained in patients with active SLE taking belimumab plus standard therapy for up to 7 years. [ClinicalTrials.gov numbers: NCT00071487 and NCT00583362].METHODS: Patients (n = 345) who completed a double-blind, placebo-controlled, 52-week study of belimumab 1, 4, or 10 mg/kg and 24-week extension of belimumab (placebo switched to 10 mg/kg; belimumab same dose or switched to 10 mg/kg) could receive belimumab 10 mg/kg in an open-label continuation study (n = 296). Disease activity was analyzed in patients with active SLE at baseline of the initial study. Biomarker and SLE medication 141111s were evaluated, and adverse events (AE) were monitored throughout the study.OBJECTIVE: To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with active systemic lupus erythematosus (SLE) treated up to 7 years (n = 177 currently ongoing).RESULTS: Total belimumab exposure over 7 years (double-blind and open-label periods): 1746 patient-years. SLE Responder Index (SRI) response rates at Week 52 in autoantibody-positive patients: placebo, 29%; belimumab, 46% (p < 0.05). In the continuation study, 57% of auto-antibody-positive patients had an SRI response by Year 2 and 65% by Year 7; severe flares occurred in 19% with placebo and 17% with belimumab during the first year, with the annual rate declining to 2%-9% during years 2-7. Anti-dsDNA autoantibodies in patients positive for them at baseline had a progressive decline of 40%-60% from baseline over 2-7 years with belimumab. Corticosteroid use decreased over time with > 50-55% reduction in median dose during years 5-7. Serious and overall annual AE rates, including infections, were generally stable or decreased during 7-year treatment.All authors: Chatham WW, Freimuth WW, Furie RA, Ginzler EM, LBSL02/99 Study Group, McCune WJ, McKay JD, Merrill JT, Petri MA, Stohl W, Wallace DJ, Weinstein A, Zhong ZJFiscal year: FY2014Digital Object Identifier: Date added to catalog: 2014-11-11
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 24187095 Available 24187095

Available online from MWHC library: 2001 - present

CONCLUSION: Disease control and safety profile were maintained in patients with active SLE taking belimumab plus standard therapy for up to 7 years. [ClinicalTrials.gov numbers: NCT00071487 and NCT00583362].

METHODS: Patients (n = 345) who completed a double-blind, placebo-controlled, 52-week study of belimumab 1, 4, or 10 mg/kg and 24-week extension of belimumab (placebo switched to 10 mg/kg; belimumab same dose or switched to 10 mg/kg) could receive belimumab 10 mg/kg in an open-label continuation study (n = 296). Disease activity was analyzed in patients with active SLE at baseline of the initial study. Biomarker and SLE medication 141111s were evaluated, and adverse events (AE) were monitored throughout the study.

OBJECTIVE: To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with active systemic lupus erythematosus (SLE) treated up to 7 years (n = 177 currently ongoing).

RESULTS: Total belimumab exposure over 7 years (double-blind and open-label periods): 1746 patient-years. SLE Responder Index (SRI) response rates at Week 52 in autoantibody-positive patients: placebo, 29%; belimumab, 46% (p < 0.05). In the continuation study, 57% of auto-antibody-positive patients had an SRI response by Year 2 and 65% by Year 7; severe flares occurred in 19% with placebo and 17% with belimumab during the first year, with the annual rate declining to 2%-9% during years 2-7. Anti-dsDNA autoantibodies in patients positive for them at baseline had a progressive decline of 40%-60% from baseline over 2-7 years with belimumab. Corticosteroid use decreased over time with > 50-55% reduction in median dose during years 5-7. Serious and overall annual AE rates, including infections, were generally stable or decreased during 7-year treatment.

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