Benlysta Shows Promise for Lupus
FDA Panel to Weigh Drug's Risks, Benefits This Week
Nov. 15, 2010 (Atlanta) -- People with lupus given the first in a new class of experimental drugs that target the disease process did better than patients given standard treatment, according to one-year results of a large clinical trial.
Longer follow-up of the patients suggests that over time, the difference in response rates between people given the new drug, Benlysta, plus standard therapy and patients given standard therapy alone becomes less pronounced, suggests research reported here at the annual meeting of the American College of Rheumatology (ACR).
Still, the study investigators and makers of the drug hope the results of this and other research will lead to FDA approval of the drug for use in some adults with active lupus who are receiving standard therapy.
An FDA advisory panel of outside experts will meet Tuesday to discuss and vote on whether the benefits of Benlysta outweigh the drug's risks. The FDA is not required to follow the advice of its advisory committees, but typically does.
If approved, Benlysta would become the first new drug for lupus in five decades.
FDA Reviews Express Concern
In documents released on the FDA web site last week in advance of the advisory panel meeting, FDA reviewers expressed concern about whether the "somewhat marginal" effectiveness of the drug outweighs the potential increased risk of death, infection, and psychiatric effects, including suicide, associated with its use.
Researcher Joan T. Merrill, MD, medical director of the Lupus Foundation of America, tells WebMD that overall, Benlysta "has a very nice safety profile" and that its benefits clearly outweigh its risks.
In two studies being considered by the FDA panel, people given Benlysta did better on two different measures than people given standard treatment alone, she says.
About 1.5 million Americans have lupus, a complex disease in which the immune system inappropriately attacks a person’s own tissues, wreaking havoc on the joints, skin, and other organs. Benlysta dampens the abnormal immune signals, calming down the immune system.
Benlysta Reduces Lupus Flare-ups at 1 Year
The study presented at ACR involved more than 800 patients on standard therapy, including steroids, for lupus. One third were also given a high dose of Benlysta, one-third a low dose, and one-third got placebo.
One-year response rates -- the study's primary goal -- were 43% in the high-dose Benlysta group, compared with just 34% of those on standard treatment.
By 76 weeks, the gap had narrowed: 39% of patients on high-dose Benlysta responded vs. 32% of those on placebo, a difference that could have been due to chance.
Similarly, at one year, patients taking Benlysta had fewer disease flare-ups and fewer severe flare-ups. And they reported less fatigue. By 76 weeks, the figures between the high-dose Benlysta and standard treatment groups were similar, says researcher Richard Furie, MD, a rheumatologist from North Shore-Long Island Jewish Health System. He has received funding from for Human Genome Sciences Inc. and GlaxoSmithKline, which are developing the drug and funded the studies.