Abstract

Belimumab (Benlysta®), a human immunoglobulin (Ig) G1λ monoclonal antibody targeting B lymphocyte stimulator, is effective as an add-on to standard therapy in patients with active, autoantibody-positive systemic lupus erythematosus (SLE). Belimumab was first approved in 2011 as an intravenous (IV) treatment for adults with SLE. Since then, a subcutaneous formulation of belimumab has been approved in adults and, most recently, IV belimumab has been approved in children aged ≥ 5 years. In adults with active, autoantibody-positive SLE, add-on belimumab improves overall disease activity and flare rates. Belimumab appears to have a steroid-sparing effect and disease control is maintained over long-term use. The clinical benefits of IV belimumab in children with SLE are consistent with those in adults. Belimumab is generally well tolerated in both adults and children.

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