Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2013 Jul 19;3(7):e002852.
doi: 10.1136/bmjopen-2013-002852. Print 2013.

Belimumab: a technological advance for systemic lupus erythematosus patients? Report of a systematic review and meta-analysis

Ngianga-Bakwin Kandala  1 , Martin Connock, Amy Grove, Paul Sutcliffe, Syed Mohiuddin, Louise Hartley, Rachel Court, Ewen Cummins, Caroline Gordon, Aileen Clarke
Affiliations

Belimumab: a technological advance for systemic lupus erythematosus patients? Report of a systematic review and meta-analysis

Ngianga-Bakwin Kandala et al. BMJ Open. .

Abstract

Objectives: To undertake a systematic review and meta-analysis to investigate clinical effectiveness of belimumab for patients with systemic lupus erythematosus (SLE) and antinuclear and/or anti-double-stranded DNA (dsDNA) autoantibodies.

Methods: We searched eight electronic databases and reference lists for randomised controlled trials (RCTs) of belimumab against placebo or best supportive care. Quality assessment and random effects meta-analysis were undertaken.

Design: A meta-analysis of RCTs.

Participants: 2133 SLE patients.

Primary and secondary outcome measures: SLE Responder Index (SRI) at week 52.

Results: Three double-blind placebo-controlled RCTs (L02, BLISS-52 BLISS-76) investigated 2133 SLE patients. BLISS-52 and BLISS-76 trials recruited patients with antinuclear and/or anti-dsDNA autoantibodies and demonstrated belimumab effectiveness for the SRI at week 52. Ethnicity and geographical location of participants varied considerably between BLISS trials. Although tests for statistical heterogeneity were negative, BLISS-52 results were systematically more favourable for all measured outcomes. Meta-analysis of pooled 52-week SRI BLISS results showed benefit for belimumab (OR 1.63, 95% CI 1.27 to 2.09). By week 76, the primary SRI outcome in BLISS-76 was not statistically significant (OR 1.31, 95% CI 0.919 to 1.855).

Keywords: Clinical Pharmacology; Epidemiology; Preventive Medicine; Public Health.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Summary of the major clinical measures used in systemic lupus erythematosus trials.
Figure 2
Figure 2
PRISMA 2009 flow diagram for belimumab in systemic lupus erythematosus randomised controlled trials and on-going trials.
Figure 3
Figure 3
Differing centre locations in the BLISS 52 and BLISS 76 multicentre trials.
Figure 4
Figure 4
Summary of results for major binary and time to event outcomes in belimumab randomised controlled trials.
Figure 5
Figure 5
Summary of results for major continuous outcomes in BLISS 52 and BLISS 76 trials.
Figure 6
Figure 6
Meta-analysis of major outcomes in the two BLISS trials.
See this image and copyright information in PMC

References

    1. Bernatsky S, Joseph L, Pineau CA, et al. A population-based assessment of systemic lupus erythematosus incidence and prevalence—results and implications of using administrative data for epidemiological studies. Rheumatology (Oxford) 2007;46:1814–18 - PubMed
    1. Pons-Estel GJ, Alarcon GS, Scofield L, et al. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum 2010;39:257–68 - PMC - PubMed
    1. Gordon C, Li CK, Isenberg DA. Systemic lupus erythematosus. Medicine 2010;38:73–80
    1. Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997;40:1725. - PubMed
    1. Tan EM, Cohen AS, Fries JF, et al. The 1982 revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1982;25:1271–7 - PubMed

LinkOut - more resources