Benlysta Shows Promise for Lupus
FDA Panel to Weigh Drug's Risks, Benefits This Week
Benlysta Reduces Lupus Flare-ups at 1 Year continued...
And although Benlysta was associated with a reduction in steroid use at one year, that advantage too seemed to wane at 76 weeks. One of the most important goals of treatment is to get patients off steroids, which cause many undesirable side effects, including bloating, weight gain, acne, and high blood pressure.
Merrill says, "It could be [patients] did very, very well on standard therapy. We don’t know how the drug would do against nothing. In any lupus treatment, when you get close to a 40% [response rate], you are doing very, very well.
"If [standard] treatment is in the 30%-40% range, you have a problem analyzing your data. ... The problem is the standard treatment group, not the drug," she says.
Benlysta for Lupus: Side Effect Profile
Nearly all patients in both the studies being considered by the FDA panel -- whether they were given Benlysta or placebo -- experienced some side effect, including headache, muscle pain, upper respiratory tract infection, urinary tract infection, and influenza.
However, "treatment with [Benlysta] appeared to be associated with an increase in death, serious adverse events, infections and serious infections, and neurologic and psychiatric adverse events/serious adverse events, including three suicides in Benlysta-treated patients," the FDA reviewers write.
Says Merrill, "In some of the areas where this drug was tested, those infections are not as uncommon as in the U.S. I looked at these data, and I thought they were low, terrific. ... The infections were well within the bounds of any other biologic [agent] and look better than most."
Although the number of deaths was numerically higher in the Benlysta group in the new study -- 11 vs. 3 in the standard treatment group -- the difference could have been due to chance.
"It is what you expect. It is less than 1% of patients," Merrill says. "You wouldn’t see an effect on mortality in one year."
Harvard Medical School's Elena Massarotti, MD, who moderated the session at which the most recent data were presented, tells WebMD that Benlysta may have a role in the treatment of lupus patients.
The drug met its primary goal in two major studies and seems to have a good safety profile, she says.
The FDA is expected to issue a final decision by Dec. 9.
Epratuzumab Also Shows Promise for Lupus
Also at the ACR meeting, researchers reported on the investigational drug epratuzumab, which is in earlier-stage testing.
In a study of 227 people with moderate to severe lupus, epratuzumab was associated with a meaningful reduction in disease activity compared with placebo, says study leader Daniel Wallace, MD, of the David Geffen School of Medicine at UCLA.
In the 12-week study, the rate of serious side effects, including infections, appeared to be similar among both groups, he says.