March 2011  

 

Welcome to the First FDA-Approved Drug for Lupus in 50 Years!


On Wednesday the U.S. Food and Drug Administration approved BENLYSTA® (belimumab) for adults with active systemic lupus, which means we have the first new treatment approved for this chronic autoimmune disease in more than half a century!

It’s an historic moment.

“This is a major breakthrough in the care and treatment of lupus, and one that I have been waiting for, for 30 years," said Lupus LA Founder Daniel J. Wallace, MD, a clinical professor of medicine at the University of California, Los Angeles.


“The availability of Benlysta means that patients with moderate to severe disease activity who are on steroids and other immune system suppressants now have an alternative that is safe and effective and could limit the toxicity of their current treatment—while at the same time improving the way they feel, their quality of life, and decreasing their inflammation and drug requirements.”


Los Angeles Doctors, Trials, and Participants Moved the Research Forward

Dr. Wallace was a top enroller in the two major clinical trials of Benlysta—and still has 45 patients on the drug.

One of them is Katrina, who was a successful corporate executive until excruciating joint pains, fatigue, and a lingering viral infection led her and her doctors to a lupus diagnosis.

“The bad news is you have one of the most aggressive lupus flares I've seen in awhile,” Dr. Wallace told her. “The good news is that, so far, there is no organ involvement."

In 2004 he enrolled her in a Benlysta trial, and she’s now in remission. “I have my life back,” she said recently.

Thanks to Katrina and the countless other people with lupus who participated in these and other clinical trials for lupus, answers on how best to treat the disease are finally emerging! (To learn more about participating in clinical trials to bring safe and effective treatments to market, visit http://www.LupusTrials.org).

William Stohl, MD, PhD, at the Keck School of Medicine at the University of Southern California
was integral in demonstrating the importance of BLyS—a key molecule targeted by Benlysta—in basic science experiments that led to the clinical trials.

And Jennifer Grossman, MD, an assistant clinical professor in UCLA’s division of rheumatology, was one of the top enrollers and made important suggestions at HGS advisory board meetings that resulted in an improved and ultimately successful trial design.

What Is Benlysta—and Who Is It For?

Human Genome Sciences discovered the key to Benlysta in 1996, and now, with GlaxoSmithKline has stockpiles of the drug ready for prescription-fulfillment later in March.

Two very large clinical trials showed the drug to be effective in lessening lupus signs and symptoms with relatively few side effects. Many study participants were also able to reduce their use of steroids (prednisone) and other medicines.

Now the FDA has ruled that the drug can be prescribed for people with active lupus (autoantibody-positive) who are receiving standard lupus therapy.

But Benlysta is not for everyone, so check with your doctor. Dr. Wallace also answers questions about the drug here.

More Options in the Lupus Toolbox—and Inspiration!

Not only did the tool box for lupus treatments just get bigger with Benlysta, but other drug companies will likely be encouraged to invest in finding new lupus treatment.

“It’s important to the field to have an approved product,” Duke University Professor of Medicine and LRI Scientific Adviser Dr. David. S. Pisetsky told the the New York Times