TY - JOUR
T1 - Safety profile of belimumab
T2 - Pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus
AU - Wallace, Daniel 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.
PY - 2013/2
Y1 - 2013/2
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. ClinicalTrials.gov identifiers: LBSL02: NCT00071487; BLISS-52: NCT00424476; BLISS-76: NCT00410384.
AB - 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. ClinicalTrials.gov identifiers: LBSL02: NCT00071487; BLISS-52: NCT00424476; BLISS-76: NCT00410384.
KW - Belimumab
KW - safety
KW - systemic lupus erythematosus
UR - http://www.scopus.com/inward/record.url?scp=84872529430&partnerID=8YFLogxK
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U2 - 10.1177/0961203312469259
DO - 10.1177/0961203312469259
M3 - Article
C2 - 23213069
AN - SCOPUS:84872529430
SN - 0961-2033
VL - 22
SP - 144
EP - 154
JO - Lupus
JF - Lupus
IS - 2
ER -