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.
BLISS-SC builds on a robust clinical trial programme for belimumab, which is the largest conducted in SLE to date. BLISS-SC is a Phase III, multi-centre,
randomised, double-blind, placebo-controlled, 52-week study to evaluate
the efficacy and safety of belimumab administered subcutaneously to
patients with active, autoantibody-positive SLE who are receiving
standard therapy. The primary efficacy endpoint is the SRI response rate
at Week 52.
Benlysta is the first medicine specifically
developed and approved for SLE in over 50 years. It is a human
monoclonal antibody that selectively targets B-lymphocyte stimulator
(BLyS), an important factor in the survival of B cells
