Session Information
Date: Sunday, November 8, 2015
Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment Poster Session I
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose:
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).
Methods:
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.
Results:
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.
Conclusion:
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 .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/belimumab-for-systemic-lupus-erythematosus-a-cochrane-systematic-review-and-meta-analysis/