HGS BLISSful with Early Results in Lupus Drug Study
Human Genome Sciences (HGS) Inc announced early results in BLISS-52 trial using BENLYSTA (belimumab, formerly LymphoStat-B). The results have left them blissful as the study results showed patients who took Benlysta demonstrated a statistically significant improvement in the symptoms of their disease compared with those taking a placebo.
BLISS-52 is the first of two pivotal Phase 3 trials in patients (867 patients) with serologically active systemic lupus erythematosus (SLE). Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. For the study, the drug was administered once a month by IV infusion.
Results of the 52-week trial by the Human Genome Sciences showed 57.6% of patients taking a high dose of Benlysta (10 mg/kg) experienced an improvement in their symptoms. Only 43.6% who took a placebo did so. Patients who were given low dose Benlysta (1 mg/kg) showed an improvement of 51.7% in their symptoms.
The Human Genome Sciences trial used the Selena Sladai Scale to measure improvement of the disease symptoms. A four-point reduction on a scale of 10 constitutes a good, or meaningful, response. The lower the score, the less disease activity a patient has. All patients entering the trial had a score of six or higher.
None of the patients in the BLISS-52 trial had any worsening of their disease in any organ beyond the originally affected one.
Lupus is a complex disease that causes the immune system to attack the body's own tissue and organs, including the joints, kidneys, heart, lungs, brain, blood or skin. Symptoms include achy joints, fever, arthritis, kidney damage, chest pain and skin rash, among others.
The disease affects an estimated 1.5 million people in the United States and 5 million worldwide, according to the Lupus Foundation of America. Lupus most often strikes women of childbearing age (15-44), but may strike men and children. Lupus affects all races and ethnic groups.
The late-stage, or Phase III, trials were designed in conjunction with the U.S. Food and Drug Administration to test those patients most likely to benefit from the drug.