Biotechnology company Human Genome Sciences and GlaxoSmithKline have reported positive results for an experimental lupus drug, the first breakthrough in the fight against the disease in over a decade.
In a placebo-controlled, multi-centre trial known as BLISS-52, dose levels of Benlysta (belimumab) plus standard of care were shown to be more effective than a placebo plus standard of care in people with serologically active systemic lupus.
For patients that took 1mg of Benlysta for every kilogram of body weight 51.7% experienced a significant improvement. Of patients who took 10mg per kilogram, 57.6%showed a significant improvement compared to 43.6% for the placebo patients.
Systemic lupus erythematosus (SLE) or lupus is a largely unrecognised but potentially fatal autoimmune disease, where the body’s own immune system forms antibodies that can attack virtually any healthy organ or tissue from the kidneys to the brain, heart, lungs, skin, joints and blood.
Lupus Research Institute president Margaret G Dowd said: “We are very hopeful that we now are strongly on our way to the first new treatment for lupus in 50 years.
“We look forward to the impact that a new drug for lupus will have on the lives of the 1.5 million Americans, and millions more worldwide, who suffer from this devastating autoimmune illness,” Dowd said.
A total of 867 participants at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe, were enrolled in the trial.
Results of a second Phase III trial of Benlysta, known as BLISS-76, are expected later in 2009.