title: Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus.
abstract: Safety data were pooled and analyzed from one phase 2 and two phase 3 double-blind, placebo-controlled, repeat-dose systemic lupus erythematosus (SLE) trials of belimumab 1, 4 (phase 2 only), and 10 mg/kg. Types and rates of adverse events (AEs) were similar across treatment groups. Rates of patients experiencing any serious AE were 16.6%, 19.5%, 13.5%, and 18.0% with placebo, and belimumab 1, 4, and 10 mg/kg, respectively; rates of serious infusion reactions (including hypersensitivity reactions) occurring on the same days as infusions were 0.4%, 0.9%, 0%, and 0.9%, and rates of serious infections were 5.5%, 7.1%, 6.3%, and 5.3%. Malignancy rates/100 patient-years (excluding non-melanoma skin cancer) were 0.29 with placebo vs. 0.20 with all belimumab doses combined; mortality rates/100 patient-years were 0.43 vs. 0.73. These data support the conclusion that belimumab in combination with standard SLE therapy was generally well tolerated in a predominantly autoantibody-positive population with active SLE.
authors.affiliation: Cedars-Sinai Medical Center/David Geffen School of Medicine at UCLA, 8737 Beverly Blvd, W Hollywood, CA 90048, USA. dwallace@ucla.edu
authors.forename: D J
authors.initials: DJ
authors.lastname: Wallace
authors.forename: S
authors.initials: S
authors.lastname: Navarra
authors.forename: M A
authors.initials: MA
authors.lastname: Petri
authors.forename: A
authors.initials: A
authors.lastname: Gallacher
authors.forename: M
authors.initials: M
authors.lastname: Thomas
authors.forename: R
authors.initials: R
authors.lastname: Furie
authors.forename: R A
authors.initials: RA
authors.lastname: Levy
authors.forename: R F
authors.initials: RF
authors.lastname: van Vollenhoven
authors.forename: S
authors.initials: S
authors.lastname: Cooper
authors.forename: Z J
authors.initials: ZJ
authors.lastname: Zhong
authors.forename: W
authors.initials: W
authors.lastname: Freimuth
authors.forename: R
authors.initials: R
authors.lastname: Cervera
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; C511911:belimumab