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

Daniel J. Wallace, S. Navarra, M. A. Petri, A. Gallacher, M. Thomas, R. Furie, R. A. Levy, R. F. Van Vollenhoven, S. Cooper, Z. J. Zhong, W. Freimuth, R. Cervera

Research output: Contribution to journalArticlepeer-review

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. ClinicalTrials.gov identifiers: LBSL02: NCT00071487; BLISS-52: NCT00424476; BLISS-76: NCT00410384.

Original languageEnglish (US)
Pages (from-to)144-154
Number of pages11
JournalLupus
Volume22
Issue number2
DOIs
StatePublished - Feb 1 2013

Keywords

  • Belimumab
  • safety
  • systemic lupus erythematosus

ASJC Scopus subject areas

  • Rheumatology

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