Date: Sunday, November 8, 2015
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Belimumab is a new approved treatment option for patients with lupus. Our objective was to perform a systematic review of benefits and harms of belimumab for systemic lupus erythematosus (SLE).
We searched multiple databases for eligible studies using a search strategy developed by a Cochrane librarian. We included randomized controlled trials (RCTs) or controlled clinical trials (CCTs) of belimumab (alone or in combination) compared to placebo/control treatment, in adults with lupus. Two authors independently assessed search results, trial quality and risk of bias, and extracted data. Review manager was used for data analyses.
Four studies (N=2205) qualified for qualitative and/or quantitative analyses. 5 studies pooled data from up to three of these original studies. Compared to placebo, belimumab 10mg/kg (approved dose) was associated with significantly higher likelihood of achieving improvement/reduction in SELENA-SLEDAI score (a validated SLE disease activity score) by >=4-points and SLE responder index (SRI) at 52-weeks (level of evidence, high for both outcomes; I2 =0% for both) with risk ratios of 1.29 (95% CI 1.10 to 1.51, I2= 0%) and 1.31 (95% CI 1.11 to 1.55, I2= 0%) , respectively. Change in HRQOL, assessed by SF-36 PCS score improvements, with belimumab 10mg/kg was a mean 1.35 units (95% CI 0.68 to 3.38) greater change than placebo, which did not meet statistical or clinical significance of 2.5-5 unit greater improvement (level of evidence, moderate; I2 =0%). The proportion of patients with >=1 serious AE, >=1 serious infection and withdrawals due to adverse events did not differ significantly between belimumab 10mg/kg and placebo;1.09 (95% CI 0.76 to 1.56), 0.97(95% CI 0.53 to 1.78); 1.40 (95% CI 0.32 to 6.22) (level of evidence, moderate; I2 =0% for all three ). Mortality was rare, and didn’t differ significantly between belimumab 10 mg/kg and placebo (level of evidence, low; I2=0%). Belimumab-treated patients were also more likely than placebo-treated patients to experience improvement (decrease of >=0.3) in patient global assessment (PGA) and were able to reduce corticosteroid dose by >=50% and less likely to have any SLE flare and severe SLE flare. Similar findings were noted for efficacy of belimumab 1 mg/kg compared to placebo.
The number needed to treat (NNT) for SRI at 52 weeks was 8 (95% CI: 5 to 23) and the number needed to treat (NNT) for SELENA-SLEDAI at 52 weeks was 8 (95% CI: 5 to 25). We found overall quality of evidence to be high. Belimumab at 10mg/kg dose was found to be associated with higher improvements in disease signs and symptoms and disease activity (greater effects on SRI, SELENA-SLEDAI, BILAG, PGA) than belimumab at 1mg/kg dose.
At the FDA-approved dose of 10mg/kg, belimumab was associated with significantly more benefits compared to placebo in patients with lupus based on well-designed high-quality RCTs that used validated outcomes. Evidence related to harms is inconclusive and of low quality.
To cite this abstract in AMA style:Singh JA, Shah N. Belimumab for Systemic Lupus Erythematosus: A Cochrane Systematic Review and Meta-Analysis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/belimumab-for-systemic-lupus-erythematosus-a-cochrane-systematic-review-and-meta-analysis/. Accessed July 15, 2020.
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