This was a great week for Lupus research. Human Genome Sciences, Inc. and GlaxoSmithKline PLC announced that BENLYSTA™ (belimumab, formerly LymphoStat-B®) met the primary endpoint in a 52 week study. This is the first of two pivotal Phase 3 trials in patients with Systemic Lupus Erythematosus. This was a placebo-controlled study in which BENLYSTA™ showed significant improvement of disease activity when compared to placebo with adverse reaction rates comparable to placebo. The patients taking BENLYSTA™ were also able to reduce their steroid need.
BENLYSTA™ works by inhibiting BLyS. BLyS is a protein required for B-lymphocytes to mature into plasma B cells. Plasma B cells are white blood cells that produce antibodies and in Lupus they produce autoantibodies that attack the body’s own tissues. People with Lupus often have elevated BLyS levels.
The results of the second, longer trial will be announced this fall. If this trial is also successful and BENLYSTA™ gets FDA approval it will be the first new treatment for Lupus in over 50 years and the very first drug developed specifically for Lupus since it’s discovery over a century ago.
While a big step in the treatment of Lupus, this is only the beginning. This is not a cure for Lupus. Lupus is a complex, individualized disease that requires complex, individualized treatments. Much more research and more treatments are needed. BENLYSTA™’s success shows that there is hope and will hopefully help get some momentum going that will eventually lead to a cure!
