GlaxoSmithKline ( GSK ) and Human Genome Sciences have announced that the European Commission ( EC ) has granted marketing authorization for Benlysta ( Belimumab ) 10mg/kg as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus ( SLE ), with a high degree of disease activity ( e.g. positive anti-dsDNA and low complement ), despite standard therapy.

The European summary of product characteristics ( SmPC ) lists patient groups which have not been studied with Belimumab, including severe active CNS lupus or severe active lupus nephritis. Use of Belimumab is therefore not recommended to treat these conditions. Caution should be exercised if Belimumab is co-administered with other B-cell targeted therapy or Cyclophosphamide, as it has not been studied in combination with these agents.

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) reviewed data from two pivotal Phase 3 studies of Belimumab ( BLISS-52 and BLISS-76 ), which enrolled nearly 1700 adult patients with autoantibody-positive active systemic lupus erythematosus.
Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses.

Those receiving Benlysta during clinical studies reported more deaths and serious infections compared with placebo.
The most common side effects in the studies included nausea, diarrhea, and fever. Patients also commonly experienced infusion reactions, so pre-treatment with an antihistamine should be considered.

Belimumab is an investigational human monoclonal antibody drug. It is the first in a new class of drugs called BLyS-specific inhibitors that recognize and inhibit the biological activity of B-lymphocyte stimulator, or BLyS, which was discovered by Human Genome Sciences ( HGS ) in 1996.

Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues. It disproportionately affects women, and usually develops between ages 15 and 44. The disease affects many parts of the body including the joints, the skin, kidneys, lungs, heart, and the brain. When common lupus symptoms appear (flare) they can present as swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss, and fatigue.

Source: Human Genome Sciences, 2011

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