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05 Approved biologics for SLE: which to try first and in which patients? – The case for belimumab
  1. Ronald van Vollenhoven
  1. Amsterdam University Medical Centers, and Amsterdam Rheumatology and Immunology Center, The Netherlands


The monoclonal anti-Blys antibody belimumab was approved for the treatment of systemic lupus erythematosus more than ten years ago, based on findings in two large, randomized trials demonstrating clinical efficacy and safety.1 2 A further analysis of these two trials clarified that patients with anti-DNA and low complement had the highest likelihood of benefitting from the treatment.3 In subsequent years, many additional studies have further defined the efficacy of belimumab: it was shown to be effective in a subcutaneous formulation as well as intravenously, to reduce flares, maintain responses for many years, allow glucocorticoid dose reductions, reduce the accrual of damage, and last but not least, as an add-on to conventional treatment, to improve the renal response in patients with lupus nephritis – leading to approval for this indication as well.4–6 Belimumab has an excellent safety profile, and is associated with slight increases in infections and an increase in certain psychiatric adverse events.

For the clinician, the main reasons to consider belimumab are:

  • Proven efficacy both for general lupus and for lupus nephritis

  • Biomarkers for higher likelihood of response

  • More than a decade of experience

  • Safety

  • Flexibility in administration: subcutaneous or intravenous

As with all treatments available today, response in the individual patient is impossible to predict. Therefore, a trial of belimumab may reasonably be considered for any patients who are not responding sufficiently to conventional therapy.


  1. Furie R, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011 Dec;63(12):3918–30. doi: 10.1002/art.30613.

  2. van Vollenhoven RF, et al. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012 Aug;71(8):1343–9. doi: 10.1136/annrheumdis-2011-200937.

  3. Bruce IN, et al. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016 Jun;25(7):699–709. doi: 10.1177/0961203315625119.

  4. van Vollenhoven RF, et al. Cumulative corticosteroid dose over fifty-two weeks in patients with systemic lupus erythematosus: Pooled analyses from the phase III belimumab trials. Arthritis Rheumatol. 2016 Sep;68(9):2184–92. doi: 10.1002/art.39682.

  5. van Vollenhoven RF, et al. Clinical response beyond the Systemic Lupus Erythematosus Responder Index: post-hoc analysis of the BLISS-SC study. Lupus Sci Med. 2018 Nov 26;5(1):e000288. doi: 10.1136/lupus-2018-000288.

  6. van Vollenhoven RF, et al. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281–291. doi: 10.1093/rheumatology/kez279.

Learning Objectives

  • Describe the demonstrated efficacy and safety of belimumab in the treatment of SLE

  • Explain the established biomarker combination anti-DNA and low complement for identifying patients at higher likelihood to benefit from belimumab

  • Discuss the evidence base for use of belimumab in practice, both for general SLE and lupus nephritis

  • Recognize the features of belimumab that may, in practice, help choose this therapeutic option for the patient

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