Discovery: Pioneering discovery to prevent, treat and cure lupus
July 2009

What's New at LRI

What the Doctors Are Saying about the Success of the Benlysta Trial.

And What Do You Have to Add?

The world of lupus is abuzz with news of the first large-scale Phase 3 lupus drug trial in decades to show effectiveness, improving quality of life and suppressing disease activity in a significant number of patients.

Could this finally signal the end to a 50-year drought in new FDA-approved drugs for lupus?

Stay tuned this November, when Human Genome Sciences (HGS) reports on its other Phase 3 study with Benlysta (belimumab). Only if results are positive in both trials can HGS apply to the FDA for drug approval. 

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Wondering What the Lupus Experts Are Saying?

Around the nation

“This is truly a day that will go down in lupus history…a major advance for patients, families, and physicians—the entire lupus community! Being the first positive study provides hope that Benlysta will get approved by the FDA. There is no doubt that a drug approval will foster further drug development and additional discoveries.” 

- Richard Furie, MD, chief of the division of rheumatology and allergy-clinical rheumatology at North Shore-LIJ Health System in New York

“Benlysta is the first ‘targeted biological agent’ developed specifically for systemic lupus that has the potential to obtain FDA approval…HGS took a very ambitious development approach—huge international concurrent trials which represent a large investment in systemic lupus therapy."

- Tammy O. Utset, MD, MPH, associate professor of medicine at the University of Chicago

"Everybody was getting a little discouraged….It's very exciting to finally have a trial in lupus showing efficacy.”

Betty Diamond, MD chief of the autoimmune disease center at North Shore-LIJ Health System in New York told the 
Los Angeles Times on Tuesday. 

See perspectives from others in the Los Angeles Times story, including
Dr. Daniel J. Wallace, who supports the LRI through Lupus LA, and
LRI President Margaret Dowd,0,46165.story


Dr. Diamond also added, in conversation with the LRI: “Clearly, it will take time to learn where this therapy might fit into our current management protocols: which patients, which symptoms, how long, etc, but it is a boost in the arm to learn of a successful scientifically based intervention in SLE.”

"There are several exciting contributions of this new study [including that] the treatment was safe, in that there were no more serious health problems in the Benlysta group than in the placebo group. And the Benlysta study shows the desire of people with SLE to find better treatments: 865 participated in this trial. Without them, none of these findings would have been possible." 

- Bevra Hahn, MD, professor of medicine at the University of California
at Los Angeles’ David Geffen School of Medicine. 
Read more of what Dr. Hahn has to say here.

If you have lupus, why not consider enrolling in a clinical trial yourself?
See for some guidance!

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About the LRI
The nation’s only nonprofit singularly dedicated to novel research in lupus, we champion innovation and scientific risk-taking in the hunt for solutions to this complex and dangerous autoimmune disease.

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