Belimumab Plus Standard Therapy Shows Safety, Efficacy in Systemic Lupus Erythematosus

Belimumab in combination with standard therapy is safe and effective in patients with systemic lupus erythematosus (SLE) and has a similar safety effect compared with placebo plus standard therapy, according to study results published in Clinical Therapeutics.

Biologic therapies offer new options for the treatment of SLE. Belimumab is a biologic that targets SLE pathology by inhibiting soluble B-lymphocyte stimulator, which is correlated to increased disease activity. Clinical trials have shown a greater benefit with belimumab plus standard SLE therapy compared with placebo plus standard therapy; however, these studies used different disease activity indices.

Study authors of a meta-analysis analyzed data from randomized controlled trials (RCTs) to assess the safety and efficacy of belimumab, based on the incidence of adverse events and a consistent disease activity index (SLE response index [SRI]).

They identified studies by searching PubMed, Cochrane Library, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Science Citation Index databases for RCTs published before June 2015 that assessed the safety and efficacy of belimumab as a treatment for SLE. The SRI and adverse event rate at 52 weeks for the included studies were calculated.

A random-effects model was used to calculate the odds ratio (OR) between the belimumab plus standard therapy and placebo plus standard therapy treatment groups.

Of 149 publications identified, 4 randomized control studies were included in the analysis (n=4692). The SRI response rate was significantly higher at 52 weeks in the belimumab plus standard therapy group compared with the placebo plus standard therapy group (pooled ORs, 1.49; 95% CI, 1.26-1.77; P <.001). The incidence of adverse events and serious adverse events was similar between the groups (pooled OR, 1.08; 95% CI, 0.83-1.39; P =.573 and OR, 1.07; 95% CI, 0.88-1.29; P =.506, respectively). When assessed by the incidence of serious adverse events, the treatment vs placebo group had a slightly significantly higher OR (1.23; 95% CI, 1.02-1.48; P =.029).

Limitations of the study included the potential for information and selection biases and unidentified confounders, and the inclusion of studies that were mainly from Western countries and published in English or Chinese.

The researchers concluded, “Our meta-analysis shows that belimumab with standard therapy is more effective than placebo with standard treatment in controlling progress in patients with SLE. Inhibition of soluble [B-lymphocyte stimulator] with belimumab would represent major progress in the treatment of SLE, paving the way for the development of new biological agents, potentially revolutionizing the treatment of SLE.”


Wei LQ, Liang YG, Zhao Y, Liang HT, Qin DC, She MC. Efficacy and safety of belimumab plus standard therapy in patients with systemic lupus erythematosus: a meta-analysis. Clin Ther. Published online March 25, 2016. doi:10.1016/j.clinthera.2016.02.022