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Belimumab for systemic lupus erythematosus (SLE)

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

  • Belimumab is a fully humanized IgG1gamma monoclonal antibody directed against soluble B lymphocyte stimulator (BLyS), and approved for the treatment of SLE (Systemic Lupus Erythemtosus)
    • is the first drug to be registered for the treatment of SLE since 1955, when hydroxychloroquine was repurposed and approved (2)
    • Belimumab is indicated as an add-on therapy for the treatment of adult patients with active, autoantibody-positive, SLE, who are receiving standard therapy (1)

    • NICE state that:
      • Belimumab is recommended as an option as add-on treatment for active autoantibody-positive systemic lupus erythematosus in people with high disease activity despite standard treatment, only if:
        • high disease activity is defined as at least 1 serological biomarker (positive anti-double-stranded DNA or low complement) and a SELENA-SLEDAI score of greater than or equal to 10
        • treatment is continued beyond 24 weeks only if the SELENA-SLEDAI score has improved by 4 points or more

    • Belimumab is a recombinant, fully human, monoclonal antibody directed against the cytokine BLyS, also known as B-cell activating factor (BAFF)
      • belongs to the tumor necrosis factor (TNF) superfamily and plays a central role in B-cell survival and function
      • overexpression of BLyS promotes survival of B-cells (including autoreactive B-cells) whereas its inhibition results in autoreactive B-cell apoptosis
      • BLyS plays a key role in the pathogenesis of autoimmune diseases such as SLE
      • elevated circulating BLyS levels are common in SLE patients, in comparison with healthy individuals, and higher levels correlate with increased disease activity and antidouble-stranded DNA (dsDNA) antibody titers - thus, inhibiting the biological activity of BLyS is potentially helpful in the treatment of the disease
      • Belimumab acts by binding to soluble BLyS.
  • its dose is 10 mg/kg administered on days 0, 14, and 28, and then every 28 days thereafter


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