The Lancet journal publishes BENLYSTA BLISS-52 study against SLE

Feb 7 2011

Human Genome Sciences, Inc. and GlaxoSmithKline PLC (GSK) today announced publication of the BLISS-52 study of BENLYSTA® (belimumab) in autoantibody-positive patients with active systemic lupus erythematosus (SLE) in The Lancet (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61354-2/abstract).

The BLISS-52 study, one of two pivotal Phase 3 trials, was a double-blind, placebo-controlled, multi-center superiority trial to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in autoantibody-positive patients with active SLE. BLISS-52 randomized and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. The Phase 3 program for belimumab is the largest clinical program ever conducted in patients with SLE.

A Comment accompanying The Lancet article was authored by John H. Stone, M.D., of Massachusetts General Hospital and Harvard Medical School (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61354-2/abstract).

Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. It is being developed by HGS and GSK under a co-development and commercialization agreement entered into in 2006. The FDA has assigned BENLYSTA a Prescription Drug User Fee Act target date of March 10, 2011.