TY  - BOOK
AU  - Weinstein, Arthur
TI  - Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus
SN  - 0315-162X
PY  - 2014///
KW  - *Antibodies, Monoclonal, Humanized/tu [Therapeutic Use]
KW  - *Immunosuppressive Agents/tu [Therapeutic Use]
KW  - *Lupus Erythematosus, Systemic/dt [Drug Therapy]
KW  - Adult
KW  - Antibodies, Monoclonal, Humanized/ad [Administration & Dosage]
KW  - Antibodies, Monoclonal, Humanized/ae [Adverse Effects]
KW  - Autoantibodies
KW  - Double-Blind Method
KW  - Drug Administration Schedule
KW  - Drug Therapy, Combination
KW  - Female
KW  - Humans
KW  - Immunosuppressive Agents/ad [Administration & Dosage]
KW  - Immunosuppressive Agents/ae [Adverse Effects]
KW  - Longitudinal Studies
KW  - Lupus Erythematosus, Systemic/im [Immunology]
KW  - Male
KW  - Middle Aged
KW  - Severity of Illness Index
KW  - Treatment Outcome
KW  - MedStar Washington Hospital Center
KW  - Medicine/Rheumatology
KW  - Clinical Trial, Phase II
KW  - Journal Article
KW  - Randomized Controlled Trial
N1  - Available online from MWHC library: 2001 - present
N2  - 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
UR  - http://dx.doi.org/10.3899/jrheum.121368
ER  -