Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial

  title={Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial},
  author={Sandra V. Navarra and Renato Guzm{\'a}n and Alberto Gallacher and Stephen Hall and Roger Abramino Levy and Renato Jimenez and Edmund Kwok-Ming Li and Mathew Thomas and Ho‐Youn Kim and Manuel Gustavo Leon and Coman Tănăsescu and E. L. Nasonov and Joung-Liang Lan and Lilia Pineda and Z. John Zhong and William W. Freimuth and Michelle A. Petri},
  journal={The Lancet},
A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus.
Belimumab plus standard therapy significantly improved SRI response rate, reduced SLE disease activity and severe flares, and was generally well tolerated in SLE.
Low-dose belimumab for patients with systemic lupus erythematosus at low disease activity: protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial
The efficacy of low-dose belimumab for prevention of disease flares in patients with SLE with low disease activity is explored and key findings will be presented at national and international conferences.
Effectiveness and safety of belimumab in patients with systemic lupus erythematosus in a real-world setting
In patients with SLE, belimumab decreased disease activity and allowed tapering of the daily glucocorticoid dose with a good safety profile, and both SLEDAI-2K and clinical SLE2K improved over time at all time-points.
Belimumab: A Review in Systemic Lupus Erythematosus
Treatment with IV or SC belimumab plus standard therapy was effective in terms of reducing overall disease activity and reducing the incidence and severity of flares, without worsening of patients’ overall condition or the development of significant disease activity in new organ systems.
Safety and Efficacy of Belimumab to Treat Systemic Lupus Erythematosus in Academic Clinical Practices
Objective. To evaluate the use and efficacy of belimumab in academic practices. Belimumab is a human monoclonal antibody that inhibits soluble B lymphocyte stimulator and has been approved for the
Belimumab for systemic lupus erythematosus: a practice-based view
Post-hoc analyses indicate that treatment with belimumab lowers levels of autoimmune antibodies, normalizes low complement and improves SLE activity predominantly in musculoskeletal and mucocutaneous organ domains.
Belimumab for the management of systemic lupus erythematosus
The clinical efficacy, safety and tolerability of belimumab indicates a potential role for this drug in achieving disease control, reducing severity of recurrent flares, reducing morbidity and in the long- term achieving a positive long-term impact on quality of life.
Efficacy, pharmacokinetic and pharmacodynamic profile of belimumab for systemic lupus erythematosus
Two, large Phase III trials have demonstrated the clinical efficacy of belimumab in musculoskeletal, mucocutaneous, haematologic and constitutional features of SLE, but patients with severe disease manifestations such as lupus nephritis and CNS disease were excluded from these trials and hence the role of belicumab in the overall management of Sle has yet to be established.
The safety of belimumab for the treatment of systemic lupus erythematosus
As the only FDA-approved treatment for SLE in the past 60+ years, belimumab has demonstrated significant, albeit modest, efficacy and a reassuring safety profile, and should be seen as a valuable tool in the rheumatologist’s arsenal.


A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus.
Belimumab was biologically active and well tolerated and the effect of belimumab on the reduction of SLE disease activity or flares was not significant, however, serologically active SLE patients responded significantly better to belicumab therapy plus SOC than to SOC alone.
Novel evidence-based systemic lupus erythematosus responder index.
This evidence-based evaluation of a large randomized, placebo-controlled trial in SLE resulted in the ability to define a robust responder index based on improvement in disease activity without worsening the overall condition or the development of significant disease activity in new organ systems.
Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus.
The results lend support to the notion that BLyS is a candidate for therapeutic targeting in SLE, and a relationship between circulatingBLyS levels and SLE disease activity is demonstrated.
New directions in the treatment of systemic lupus erythematosus
Biologic compounds that target specific immunologic mechanisms offer a new paradigm in the treatment of SLE, one that may, at best, reverse the course of the disease and, at the very least, might provide some new alternatives to reduce symptoms and limit tissue damage without undue contribution to overall morbidity and mortality.
Damage in systemic lupus erythematosus and its association with corticosteroids.
SLE patients receiving long-term prednisone therapy were at significant risk of morbidity due to permanent organ damage and new steroid-sparing therapies are needed in order to treat disease activity and minimize cumulative and high-doseprednisone exposure.
Chronic administration of belimumab, a BLyS antagonist, decreases tissue and peripheral blood B-lymphocyte populations in cynomolgus monkeys: pharmacokinetic, pharmacodynamic, and toxicologic effects.
  • W. Halpern, P. Lappin, K. Baker
  • Biology, Medicine
    Toxicological sciences : an official journal of the Society of Toxicology
  • 2006
Data confirm the specific pharmacologic activity of belimumab in reducing B lymphocytes in the cynomolgus monkey, and the favorable safety profile and lack of treatment-related infections also support continued clinical development ofBelimumab.
Clinical trials in systemic lupus erythematosus (SLE): lessons from the past as we proceed to the future – the EULAR recommendations for the management of SLE and the use of end-points in clinical trials
Recommendations for the management of lupus and for points to consider in the design of SLE trials were developed using a combination of research-based evidence following a systematic literature search of trials and cohort studies, and expert consensus.
Decreases in anti-double-stranded DNA levels are associated with concurrent flares in patients with systemic lupus erythematosus.
A previous increase in anti-dsDNA levels occurred before SLE flares, as measured by the M-SLEDAI and M-LAI only, however, during lupus flares, anti-DSDNA levels frequently decreased, and it is hypothesized that this decrease represents deposition in tissue at the time of flare.
Elevated serum B lymphocyte stimulator levels in patients with systemic immune-based rheumatic diseases.
BLyS may be an important factor in driving polyclonal hypergammaglobulinemia and elevated autoantibody titers in patients with systemic immune-based rheumatic diseases.
Cutting Edge: A Role for B Lymphocyte Stimulator in Systemic Lupus Erythematosus1
The results suggest that BLyS may be a useful marker for early activation of an autoimmune diathesis and likely plays a critical role in triggering activation of self-Ag-driven autoimmune B cells in human SLE and may provide an effective therapeutic target in systemic autoimmunity.