Details

Autor(en) / Beteiligte

• Wallace, DJ
• Navarra, S
• Petri, MA
• Gallacher, A
• Thomas, M
• Furie, R
• Levy, RA
• van Vollenhoven, RF
• Cooper, S
• Zhong, ZJ
• Freimuth, W
• Cervera, R

Titel

Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus

Ist Teil von

• Lupus, 2013-02, Vol.22 (2), p.144-154

Ort / Verlag

London, England: SAGE Publications

Erscheinungsjahr

2013

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.