- Connect with LRI:
- YouTube
- Change.org
Lupus Research Institute Highly Encouraged by Benlysta™ Trial Results
First Phase 3 Lupus Drug Trial in Decades to Show Effectiveness
Monday, July 20, 2009
July 20, 2009 — The Lupus Research Institute (LRI) and its National Coalition of state and local organizations congratulate Human Genome Sciences (HGS) and GlaxoSmithKline on the highly promising results of this landmark clinical trial of Benlysta™ (belimumab) for people with systemic lupus.
“We are very hopeful that we now are strongly on our way to the first new treatment for lupus in 50 years,” said LRI President, Margaret G. Dowd. “We look forward to the impact that a new drug for lupus will have on the lives of the 1.5 million Americans, and millions more worldwide, who suffer from this devastating autoimmune illness.”
“This is a major advance for patients, families, and physicians—the entire lupus community!” said Richard Furie, MD, chief of the division of rheumatology and allergy-clinical rheumatology at North Shore-LIJ Health System in New York. “There is no doubt that a drug approval will foster further drug development and additional discoveries.”
In the double-blind, placebo-controlled, multi-center trial, known as BLISS-52, both dose levels of Benlysta™ plus standard of care were more effective than a placebo plus standard of care in people with serologically active systemic lupus. A total of 867 participants at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe, were enrolled in the trial.
“This is the first drug shown to be effective in ameliorating the signs and symptoms of lupus in decades,” said Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA. “It represents a breakthrough for finally utilizing a methodology that enables researchers to demonstrate disease improvement. This will benefit lupus patients and their doctors.”
Results of a second Phase 3 trial of Benlysta™, known as BLISS-76, are expected later this year. That trial has enrolled 826 participants at 133 clinical sites in 19 countries, primarily in North America and Europe.
BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in people with lupus.
First of its kind
“Benlysta™ is the first ‘targeted biological agent’ developed specifically for systemic lupus that has the potential to obtain FDA approval…with the positive results of this 52-week trial and pending the results of the 76-week trial,” said Tammy O. Utset, MD, MPH, an associate professor of medicine at the University of Chicago.
“HGS took a very ambitious development approach—huge international concurrent trials which represent a large investment in systemic lupus therapy," Utset added.
“The lupus community commends HGS and GlaxoSmithKline for their commitment and perseverance in finally bringing this potential new lupus treatment to trial,” said Dowd. “And we thank the hundreds of people with lupus who enrolled and took part in this important trial. Participation like theirs is critical to finding answers to this illness.”
The LRI builds the research pipeline and assists in recruiting patients to participate in trials to bring safe and effective treatments to market for people with lupus.
To learn more about lupus clinical trials, log on to www.LupusTrials.org.
Bookmark or share this page with:
On the go?
Text INFO to 50555 and opt-in to receive breaking news about lupus on your mobile phone.
Message and Data Rates May Apply. Text STOP to 50555 to STOP. Text HELP to 50555 for HELP. Full Terms
We'll get there. We have
We'll get there. We have to...
Lupus
I agree. There should be more awareness about Lupus. 1.5 million Americans have it. 5 million worldwide have a form of Lupus and not too many know about this debilitating, life threatening disease. The scary part about Lupus is it has a brain of its own. It is systemic, meaning it can attack your heart, nervous system, kidneys, brain and so on. A person inflicted with Lupus can have a stroke at 15. There are drugs to mask the symptoms and not cure it. These drugs carry very adverse side effects and wreak havoc on the body. I remain hopeful that through spreading the word, more funding will become available and new medicines which treat the disease itself will surface soon. Benlysta and Lupuzor. These drugs give me hope. Stay strong and stay positive. There is light at the end of the tunnel!
It's About Time for a Group That's Running Out of Time...
I hope my doctor can prescribe this for me if it becomes available after FDA approval. Like another poster here, I am in a flare myself and it's lasted almost a week now. Between this constant rainy cool weather, the stress of raising a 12-year-old minor child as a blind mother with lupus & Sjogren's disease, and the additional stress of a husband who is in the process of filing for disability due to multiple health conditions that prevent him from working (his doctor recommended filing for disability for him based on medical reports & clinical exams as well as lab tests) and the added fear that his disability could quite literally kill him if he's not careful, I feel as if I have the weight of the world on my shoulders. The thoughts of being left a widow and my children orphaned is tough to take on any day but even worse since the diagnoses of Lupus and Sjogren's disease some 9 years ago.
This is a part of the miracle we've all been hoping would happen. Oh please please let this drug be safe enough to take and strong enough to give those of us with lupus a better, less-painful existence than we have now. I am sick of Plaquenil. I'm tired of it making me sick to my stomach to the point where I spend a great part of the day in the bathroom puking my guts up then the rest of the day so exhausted I can't get out of bed. This isn't living and I want to live again, especially without the fear of worrying about whether or not I will make it to my youngest child's graduation from high school or someday be at both of their college graduations as well as one day having the opportunity to meet my grandchildren if either of my girls decide to have children of their own. This drug's success will open up so many opportunities for us Lupies to hope and to dream of the future without that dark cloud named lupus hanging over our heads.
I've got my proverbial fingers crossed...
Lupus
Now I must convince my Dr. to help me get this. I have been diagnosed for 25 years and I basically just deal with flareups. I am on prednisone but don't want any of the other such as plaquniel because of the side effects. I wish there was a way to get info about this disease out to the public as it is so hard for people to understand.
New Beginnings on the horizon
I hzve lived with Lupus for 30 years and this is just what I needed to hear today - I am having a very painful flare up right now - and the hope that this allows me to have is immeasurable. Thank you. I have suffered through open heart surgery to replace my mitral valve and had a stroke two years ago. Mine seems to be worsening as I age - my joint pain has increased recently. I am now and have been on Plaquenil (malaria medicine - which has pretty horrible side affects on your eyesight - so would be grateful to some day get off of it and stop taking Prednisone. Just to be able to get in the sun for an hour would thrill me beyond explanation - I would be interested in any comments from others on this. I am almost 56 years old and mine started at 25 years of age with platelet issues and having my spleen removed. It has been a long arduous journey - one I am determined to win. Patricia
Thanks God.
Thanks God.