TY - JOUR T1 - Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. AU - Wallace,D J, AU - Navarra,S, AU - Petri,M A, AU - Gallacher,A, AU - Thomas,M, AU - Furie,R, AU - Levy,R A, AU - van Vollenhoven,R F, AU - Cooper,S, AU - Zhong,Z J, AU - Freimuth,W, AU - Cervera,R, AU - ,, Y1 - 2012/12/04/ PY - 2012/12/6/entrez PY - 2012/12/6/pubmed PY - 2013/6/7/medline SP - 144 EP - 54 JF - Lupus JO - Lupus VL - 22 IS - 2 N2 - 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. SN - 1477-0962 UR - https://www.unboundmedicine.com/medline/citation/23213069/full_citation DB - PRIME DP - Unbound Medicine ER -