How effective is belimumab (Benlysta) in the treatment of systemic lupus erythematosus (SLE)?

Updated: Aug 04, 2021
  • Author: Christie M Bartels, MD, MS; Chief Editor: Herbert S Diamond, MD  more...
  • Print
Answer

A multinational phase III study (BLISS-52) that evaluated the efficacy and safety of IV belimumab, in 867 patients with a minimum SELENA-SLEDAI score of 6, reported that patients given belimumab had significantly higher SRI scores at 52 weeks than did those given placebo. [125] All groups had similar rates of adverse events.

Similarly, a phase III trial of 819 SLE patients who were positive for either antinuclear antibody or anti–double-stranded DNA at baseline screening found that IV belimumab at 10 mg/kg plus standard therapy resulted in a significantly greater SRI score (43.2%) than placebo (33.5%) at 1 year (those who received belimumab 1 mg/kg plus standard therapy had a 40.6% response rate). [126] Overall, the addition of belimumab to standard therapy reduced SLE disease activity and severe flares, and the medication was well tolerated. [126]

Approval for SC belimumab was based on the BLISS-SC phase III study (n=839), which documented reduction in disease activity at week 52 in patients receiving belimumab plus standard of care, compared with those receiving placebo plus standard of care. SRI response with belimumab versus placebo was 61.4% vs 48.4%, respectively (P = 0.0006). In the belimumab group, both time to and risk of severe flare were improved (median 171 days vs 118 days; P = 0.0004), and more patients were able to reduce their corticosteroid dosage by ≥25% (to ≤7.5 mg/day) during weeks 40-52 (18.2% vs 11.9%; P = 0.0732), compared with placebo. [127]


Did this answer your question?
Additional feedback? (Optional)
Thank you for your feedback!