GSK announces positive results from phase III BLISS-SC study of Benlysta® (belimumab) administered subcutaneously in patients with systemic lupus erythematosus

GSK announced results from the BLISS-SC Phase III pivotal study in patients with active, autoantibody-positive systemic lupus erythematosus (SLE). These results, which are being presented at the American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting, showed that Benlysta® (belimumab) 200mg administered weekly via subcutaneous injection plus standard of care (SoC), showed significantly greater reductions in disease activity compared to placebo plus SoC.

“Despite use of current standard of care, such as glucocorticosteroids and immunosuppressants, about 60% of lupus patients continue to experience persistent symptoms and severe disease flares”, said Paul-Peter Tak, Senior Vice-President and Head of the Immuno-Inflammation Therapy Area Unit at GSK. “On the basis of these data, we expect to progress towards global regulatory filings for a belimumab subcutaneous formulation, which if approved, will provide appropriate patients with a new approach to treatment administration.”

Belimumab subcutaneous formulation is currently not approved for use anywhere in the world.