Impact of belimumab on antiphospholipid antibodies in patients with Systemic Lupus Erythematosus

Proposal
5862

Title of Proposed Research

Lead Researcher

Katerina Chatzidionysiou

Affiliation

1st Department of Propaedeutic and Internal Medicine, Laiko Hospital, Medical School, National and Kapodistrian University of Athens, Greece

Funding Source

Potential Conflicts of Interest

Data Sharing Agreement Date

24 April 2019

Lay Summary

Antiphospholipid antibody syndrome (commonly called antiphospholipid syndrome or APS) is an autoimmune disease present mostly in young women. Those with APS make abnormal proteins called antiphospholipid autoantibodies in the blood. This causes blood to flow improperly and can lead to dangerous clotting in arteries and veins, problems for a developing fetus and pregnancy miscarriage. People with this disorder may otherwise be healthy, or they also may suffer from an underlying disease, most frequently systemic lupus erythematosus (commonly called lupus or SLE).APS affects women five times more commonly than men. It is typically diagnosed between the ages of 30 and 40. While up to 40% of patients with SLE will test positive for the anti-phospholipid autoantibodies, only half will develop thrombosis and/or experience miscarriages. Belimumab is a biologic treatment approved by FDA and EMA for the treatment of SLE. It has been shown that it reduces the titers of autoantibodies found in SLE patients, such as antibodies against dsDNA. However, its impact on antiphospholipid antibodies has not been studied. If treatment with belimumab would be shown to reduce the titers of antiphospholipid antibodies, that might have impact on clinical practice.

Study Data Provided

GSK-HGS1006-C1056: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)

GSK-HGS1006-C1057: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Statistical Analysis Plan

Publication Citation

Chatzidionysiou K, Samoli E, Sfikakis PP, et alEffect of belimumab treatment on antiphospholipid antibody levels: post-hoc analysis based on two randomised placebo-controlled trials in systemic lupus erythematosus Annals of the Rheumatic Diseases 2020;79:304-307.

http://dx.doi.org/10.1136/annrheumdis-2019-216367