Human Genome Sciences, Inc. (NASDAQ:HGSI) today announced publication by the journal Arthritis Care & Research of an article describing the development and use of a novel evidence-based systemic lupus erythematosus (SLE) Responder Index selected as the primary endpoint of two pivotal Phase 3 clinical trials of BENLYSTA™ (belimumab) in serologically active patients with SLE. This primary endpoint was accepted by the FDA under a Special Protocol Assessment agreement for the Phase 3 trials.
“The lack of a gold standard to measure SLE disease activity endorsed by international rheumatology societies or national health authorities has impeded the development of SLE therapies,” said Richard A. Furie, M.D., lead author of the article and Chief, Division of Rheumatology and Allergy-Clinical Immunology, North Shore Long Island Jewish Health System, Lake Success, NY, and Professor of Medicine, Albert Einstein College of Medicine. “In other diseases where manifestations are heterogeneous, combined responder instruments have been used to assess disease activity. We believe the SLE Responder Index may play an important role in drug development for this potentially devastating disease.”
The primary efficacy endpoint of both Phase 3 trials of belimumab is the SLE Responder Index at Week 52, as defined by: (1) a reduction from baseline of at least 4 points on the SELENA SLEDAI disease activity scale (which indicates a clinically important reduction in SLE disease activity); (2) no worsening of disease as measured by the Physician’s Global Assessment (worsening defined as an increase of 0.30 points or more from baseline); and (3) no new BILAG A organ domain score (which indicates a severe flare of lupus disease activity) and no more than one new BILAG B organ domain score (which would indicate a moderate flare of disease activity).