New lupus drug shows promise in trial

BOSTON: Human Genome Sciences Inc said yesterday that its experimental lupus drug Benlysta was successful in a late-stage clinical trial, paving the way for approval of the first treatment for the disease in 50 years.

Results of the trial announced yesterday showed patients who took a high dose of the drug, Benlysta, experienced a statistically significant improvement in symptoms compared with those taking a placebo.

Data from a composite of three measures showed that after 52 weeks, 43.2 percent of patients taking 10 milligrams of Benlysta in combination with standard of care achieved an improvement in symptoms, with no significant worsening of disease in individual organs.

That compared to a figure of 33.8 percent for patients taking Benlysta in combination with a placebo.

The result met the main goal of the clinical trial.

"This is a pivotal moment in lupus research," said Margaret Dowd, president of the Lupus Research Institute, an organization that funds lupus research but did not fund Human Genome Science's trial.

"It demonstrates the power of innovative science to drive discovery and achieve solid clinical results in the complex autoimmune disease of lupus."

Lupus causes the immune system to attack the body's own tissue and organs, including the joints, kidneys, heart, lungs, brain, blood and skin. It can cause arthritis, kidney damage, chest pain and skin rash, among other disorders.

Results from the trial showed that 46.9 percent of patients taking Benlysta, which is known generically as belimumab, experienced an improvement in symptoms as measured by a scale known as Selena Sledai, a component of the composite measure. That compared with 35.6 percent of patients taking standard of care plus a placebo.

Meeting statistical significance as measured by the Selena Sledai scale was a pre-specified major secondary goal of the study.

"This is spectacular news for the world-wide lupus community," said Tammy Utset, an associate professor of medicine at the University of Chicago, who was involved with the clinical studies. "These trials should encourage further interest in drug development for lupus, an area of great unmet need."

The trial also measured patients who took a low dose of the drug. The results of that part of the trial were not statistically significant.

Serious side effects were reported in 26.8 percent of patients taking Benlysta, compared with 24 percent of patients taking a placebo.

The trial, known as BLISS-76, is the second of two required by the US Food and Drug Administration in order for the drug to be considered for approval. Human Genome and partner GlaxoSmithKline Plc said they plan to file for approval in the first quarter of next year.

The results follow similarly successful data from a trial known as BLISS-52 that were released in July. That trial showed that 57.6 percent of patients taking a high dose of Benlysta in combination with standard of care showed an improvement in symptoms compared with 43.6 percent of patients taking standard of care plus a placebo.

The results showed an improvement of 58.3 percent of patients taking Benlysta plus standard of care, versus 46.0 percent in patients taking standard of care plus placebo, as measured by the Selena Sledai scale.

Analysts predict Human Genome's shares will rise sharply on the news. The company's shares closed on Friday at $18.69 on Nasdaq.

Reuters

(China Daily 11/03/2009 page11)