GSK’s Benlysta shows positive outcome in Phase II continuation trial for SLE

19th June 2017 (Last Updated June 19th, 2017 18:30)

GlaxoSmithKline (GSK) reported positive data from the Phase II ten-year continuation clinical trial of Benlysta (belimumab) in combination with standard-of-care for patients suffering from systemic lupus erythematosus (SLE).

GlaxoSmithKline (GSK) reported positive data from the Phase II ten-year continuation clinical trial of Benlysta (belimumab) in combination with standard-of-care for patients suffering from systemic lupus erythematosus (SLE).

Developed specifically for SLE, Benlysta is a human monoclonal antibody that acts as a BLyS-specific inhibitor by binding to soluble BLyS.

The trial’s final efficacy and safety results showed that the combination therapy prolonged control of disease activity in patients with active SLE.

The multi-centre, open-label, continuation trial assessed 10mg/kg belimumab and standard of care combination in 298 patients who completed the double-blind, placebo-controlled, 52-week Phase II parent study with 1mg/kg, 4mg/kg or 10mg/kg of the drug.

"Unlike most treatments used for SLE, belimumab has a specific mode of action that targets the underlying disease process."

GSK R&D immuno-inflammation medicines development leader David Roth said: “Unlike most treatments used for SLE, belimumab has a specific mode of action that targets the underlying disease process.

“It has consistently proven its effectiveness, with four successful pivotal trials in SLE and data now shows that the disease control is sustained, helping to stabilise day-to-day symptoms and improve outcomes for patients in the longer term.”

During the trial, the proportion of patients responding to treatment was found to increase over time and the overall response at year ten was observed to be 65.1%.

Patients were able to reduce their corticosteroid dose over time from baseline to year ten and the adverse event (AEs) and serious adverse events (SAEs) observed in the trial were consistent with findings from the previous studies of belimumab.

Benlysta has been licensed in the European Union (EU) as an add-on therapy for adults with active autoantibody-positive SLE and is available for intravenous administration as 120mg in a 5mL single-use vial and 400mg in a 20mL single-use vial.