Human Genome Sciences Inc said its experimental drug to treat lupus was successful in a late-stage clinical trial, a likely shock to many on Wall Street who had written the drug off as dead.
The results, which were announced just after midnight on Sunday, showed patients who took the drug, Benlysta, showed a statistically significant improvement in the symptoms of their disease compared to those taking a placebo.Results of the 52-week trial - the first of two requested by US regulators - showed 57.6% of patients taking a high dose of Benlysta experienced an improvement in their symptoms, compared with 43.6% who took a placebo. The result was statistically significant and met the main goal of the clinical trial. Of patients who took a low dose of the drug, which is administered once a month by IV infusion, 51.7% showed improvement in their symptoms, a figure that was also statistically significant. The main goal of the trial was to show a four-point or greater improvement in disease symptoms as measured by a scale known as Selena Sledai. 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. The trial also required that patients did not experience a worsening of their disease in any organ beyond the originally affected one. The trial met all of these goals at both doses. Lupus is a complex autoimmune 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. It is estimated that 1.5 million people in the United States and 5 million worldwide are affected by lupus, according to the Lupus Foundation of America