Belimumab for systemic lupus erythematosus (SLE)

Last edited 12/2021 and last reviewed 01/2022

• 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

Reference:

• Srivastava A. Belimumab in Systemic Lupus Erythematosus. Indian J Dermatol. 2016;61(5):550-553. doi:10.4103/0019-5154.190107
• Samotij D, Reich A. Biologics in the Treatment of Lupus Erythematosus: A Critical Literature Review. Biomed Res Int. 2019;2019:8142368. Published 2019 Jul 18. doi:10.1155/2019/8142368
• NICE (December 2021). Belimumab for treating active autoantibody-positive systemic lupus erythematosus