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New Lupus Treatment Benlysta: FAQ

A Look at the Benefits and Side Effects of a New Drug for the Treatment of Lupus

Which lupus patients might benefit most from Benlysta? continued...

There's no proof that all, or even most of these patients will benefit from Benlysta. But many just might, says Greidinger, who refers to the drug by its generic name: belimumab. "The hope is belimumab may allow some of these patients who are using substantial doses of steroids to bring their disease under better control, so they have less lupus activity and be able to take lower doses of steroids."

That's what happened in clinical trials of Benlysta. On average, patients taking the drug were able to reduce the doses of prednisone they were taking.

In those studies, most of the benefit of Benlysta seemed to come from improvement of skin rash and ulcers in the nose and mouth.

"These symptoms can be prominent drivers of the disability patients have, and prominent factors driving their ongoing steroid use. Patients of that sort may be the most appropriate ones to begin trying this drug," Greidinger says.

Which patients are least likely to benefit from Benlysta?

In clinical trials, it wasn't clear whether Benlysta helped patients whose lupus affected the kidneys, brain, and blood vessels.

Analysis of the data suggests that patients of African descent might not benefit from the drug -- but as Greidinger notes, there were too few such patients in the studies to know for sure.

What may be an issue for patients is that Benlysta is a biological treatment -- a man-made antibody -- that is expensive to produce. Most other such drugs carry a high price tag. However, reports in the financial press suggest that managed care organizations will cover Benlysta.

"Initially it is appropriate that not every rheumatologist rush out and put everyone of their patients on this drug, and not every patient should run out and ask for this drug," Greidinger says. "I think that as more experience develops with the drug, if the initial data is supported and supplemented by good clinical experiences, it may turn out to be cost-effective if it is preventing patients from getting serious complications of lupus, from getting side effects from prednisone therapy, and from being so disabled they cannot work."

Is Benlysta safe?

In clinical trials, there were more deaths and serious infections among lupus patients taking Benlysta than among those taking placebo plus standard therapy. People taking Benlysta cannot receive live vaccines. 

The most common side effects in clinical trials were nausea, diarrhea, and fever. Patients also commonly experienced infusion reactions, so treatment with an antihistamine may be needed before each infusion.

A medication guide explaining all risks of Benlysta will be provided to all patients.

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