GSK’s phase III trials of the B-lymphocyte stimulator reduced disease activity by 61% and AZ’s phase II trials of anifrolumab reduced the activity by 51.5%.

GSK reported new phase III data on a new subcutaneous formulation of its market-leading Benlysta (belimumab) product that is the first new therapy for the disease in five decades.
In the phase III trial, a 200mg subcutaneous dose of the B-lymphocyte stimulator (BLyS) inhibitor given once a week was found to be more effective in reducing disease activity compared to placebo.
After a year, 61% of the Benlysta group showed reduced disease activity as measured by the SLE Responder Index (SRI) - a standard measure if efficacy - compared to 48% of patients on placebo.
"On the basis of these data, we expect to progress towards global regulatory filings for a belimumab subcutaneous formulation," commented Paul-Peter Tak, head of immuno-inflammation R&D at GSK.
A new phase II trial conducted by AZ on the drug - called anifrolumab (formerly MEDI-546) - is an antibody blocking the type I interferon (IFN) receptor, showed that the drug significantly reduced disease activity and improved symptoms of SLE, including rash and arthritis.
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"The lupus community has been disappointed too often with clinical trial results," commented principal investigator Richard Furie of North Shore-LIJ Health System. "We have been eagerly awaiting clinical data of this magnitude for many years," he added.
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