The results of a Phase 2 clinical trial conducted by Human Genome Sciences Inc. demonstrated that LymphoStat-B (belimumab) was safe, well tolerated, and showed signs of clinical effect in patients with systemic lupus erythematosus (SLE), although the drug did not meet the overall primary efficacy endpoints of reducing the signs and symptoms of the chronic inflammatory disease over a 24-week period and did not increase the time to the first "flare" of the disease over the 52-week treatment period.
While the trial failed to achieve it primary goals, LymphoStat-B reduced the signs and symptoms of SLE at week 52 at a level of statistical significance in seropositive patients, a subgroup that represented 75% of the study's patient population, claims a company release
The double-blind, placebo-controlled, dose-ranging Phase 2 trial was designed to evaluate the safety, optimal dosing and efficacy of LymphoStat-B, a human monoclonal antibody to B-lymphocyte stimulator (BLyS), in patients with SLE.
"The results add substantively to the evidence of LymphoStat-B's biological activity, as demonstrated by the targeted and statistically significant reductions in levels of circulating CD 20(+) and other B-cell subsets, and in anti-dsDNA autoantibody levels. Very importantly, the data confirm and extend previous clinical results by demonstrating that LymphoStat-B was safe and well tolerated during this 52- week exposure period," said David C. Stump, executive vice president, Drug Development
Systemic lupus erythematosus (SLE) is a chronic, life-threatening disease that can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels, and blood disorders.