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Updated: May 26, 2026
12:04
The bm12 Inducible Model of Systemic Lupus Erythematosus (SLE) in C57BL/6 Mice
Published on: November 1, 2015
Belimumab: in systemic lupus erythematosus.
Celeste B Burness1, Paul L McCormack
1Adis, a Wolters Kluwer Business, Auckland, New Zealand. demail@adis.co.nz
Drugs
|December 7, 2011
Summary
Belimumab treatment improved outcomes for active systemic lupus erythematosus (SLE) patients at 52 weeks. While generally well-tolerated, further investigation into reported deaths is warranted.
Area of Science:
- Immunology
- Rheumatology
- Pharmacology
Background:
- Systemic lupus erythematosus (SLE) is a chronic autoimmune disease.
- Belimumab is a biologic therapy targeting B-cell pathways.
Purpose of the Study:
- To evaluate the efficacy and safety of belimumab in adult patients with active, autoantibody-positive SLE.
- To assess belimumab's impact on disease activity and response criteria.
Main Methods:
- Randomized, double-blind, multinational Phase III trials (BLISS-52 and BLISS-76).
- Inclusion of adult patients with active, seropositive SLE receiving standard therapy.
- Assessment using SLE Responder Index and SELENA-SLEDAI scores.
Main Results:
- Significantly greater response rates with belimumab versus placebo at 52 weeks based on SLE Responder Index.
- Greater reduction in SELENA-SLEDAI scores at week 52 in belimumab recipients.
- No significant difference in SLE Responder Index response rates at 76 weeks in BLISS-76.
Conclusions:
- Belimumab demonstrates efficacy in improving SLE disease activity at 52 weeks.
- Belimumab was generally well-tolerated, with no significant differences in serious infections or malignancies.
- A higher incidence of deaths was observed with belimumab compared to placebo during trial periods.
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