GlaxoSmithKline is looking at whether its lupus therapy Benlysta (belimumab) can prevent flares or relapses in people with ANCA vasculitis, a condition that causes inflammation or damage to small blood vessels.

How Benlysta works

Benlysta is an antibody-based drug that blocks a chemical messenger in the blood known as BLyS or BAFF.

BLyS stimulates B-cells, white blood cells that can promote vasculitis, or blood vessel inflammation. BLyS also produces anti-neutrophils cytoplasm antibodies, or ANCAs. These harmful autoantibodies target another type of white blood cell known as neutrophils.

An autoantibody is an immune-system-generated protein that is directed against a person’s own proteins instead of an invader. Neutrophils are vital in fighting infections. But when ANCA binds to them, they release toxins that damage the walls of small blood vessels, leading to vasculitis.

Benlysta in clinical trials for ANCA vasculitis

GlaxoSmithCline conducted a Phase 3 clinical trial (NCT01663623) of Benlysta as a maintenance therapy for ANCA vasculitis. The BREVAS study involved 106 patients with Wegener’s granulomatosis or microscopic polyangiitis, two types of ANCA vasculitis.

The patients’ disease had gone into remission. The trial’s main objectives were to see whether Benlysta could maintain the remission, and whether it was safe.

Researchers also evaluated the effectiveness of a combination of Benlysta and azathioprine as an ANCA maintenance therapy. The main objective was to compare the effectiveness of the combo, which some patients received, with the effectiveness of the Benlysta-placebo combo that others received. GlaxoSmithCline completed the study but has yet to release results.

Other details

Benlysta is already used to treat lupus, an autoimmune disease whose hallmark is the immune system mistakenly attacking healthy tissue.

It has side effects ranging from nausea and diarrhea to a life-threatening brain infection known as progressive multifocal leukoencephalopathy.

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