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Abstract
Given their pivotal role in autoantibody production, B-cells have become an attractive therapeutic target in systemic lupus erythematosus (SLE). Belimumab, a fully human monoclonal antibody against B lymphocyte stimulator (BLyS), a B-cell survival factor, was licensed in 2011 for the treatment of autoantibody-positive SLE. The BLISS-52 and BLISS-76 Phase III trials successfully demonstrated that belimumab (10 mg/kg) with standard therapy significantly decreased disease activity in SLE patients compared to placebo with standard therapy. Overall, belimumab has been found to be safe and well tolerated. While the BLISS-52 and BLISS-76 studies are the largest clinical trials in SLE to date, they mainly focused on musculoskeletal, mucocutaneous, hematologic and general constitutional features of the disease. Patients with severe lupus nephritis and severe central nervous system disease were excluded from these trials. Studies of belimumab in lupus nephritis are ongoing that may clarify the role of this agent in the clinical management of SLE.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.
Belimumab was approved by the FDA and European Medicines Evaluation Agency in 2011 for the treatment of autoantibody-positive adult systemic lupus erythematosus (SLE).
Belimumab is a monoclonal antibody targeting BLyS, a B-cell survival factor.
It is administered as a 10 mg/kg intravenous infusion every fortnight for the first three doses, followed by further infusions very 4 weeks.
Pivotal studies of belimumab in SLE are the BLISS-52 and BLISS-76 Phase III trials with a total of 1684 SLE patients enrolled.
These trials excluded patients with severe lupus nephritis and central nervous system lupus.
Musculoskeletal and mucocutaneous manifestations of SLE have responded most beneficially to belimumab in trials to date.
Belimumab has not been studies in combination with other biologic agents or intravenous cyclophosphamide.
Studies of belimumab in lupus nephritis are ongoing.