First New Lupus Drug in 56 Years; Reduces Lupus Activity, May Cut Steroid Need
The fantastic news was reported this week; on March 9, 2011 ... we have all been waiting to hear this... finally... The FDA has approved Benlysta, the first new lupus drug since 1955.
Benlysta is approved for the treatment of patients with active, autoantibody-positive lupus who are getting standard therapy. Standard therapy includes corticosteroids, antimalarial drugs, immunosuppressive agents, and NSAID (non-steroidal anti-inflammatory drugs).
As many as 1.5 million Americans have systemic lupus erythematous (SLE), commonly called lupus. Lupus is an autoimmune disease in which a particular type of white blood cell -- B lymphocytes -- turns the body's immune defenses against the body's own cells.
Benlysta inhibits the maturation of these B cells. Because B cells are crucial elements of the immune system, Benlysta carries serious risks. There were more deaths and serious infections among patients taking Benlysta than among patients taking placebo. Common side effects of the drug included nausea, diarrhea and fever.
The drug may work best for patients with moderate disease, says lupus expert Eric L. Greidinger, MD, chief of rheumatology and immunology at the University Of Miami Miller School Of Medicine.
"The hope is that Benlysta may allow some of these patients who have persistently active lupus who are using substantial doses of steroids to bring their disease under better control, so they have less lupus activity and can take less steroids, exposing them to fewer of the many steroid-associated side effects," Greidinger tells WebMD.
Lupus is particularly common among African-American women. In clinical trials, African-American patients did not appear to respond to Benlysta as well as other patients -- so the manufacturer has agreed to conduct a new study of the drug in this subgroup of patients. Benlysta was developed by Human Genome Sciences,, based in Rockville, Md., and will be co-marketed by Philadelphia-based GlaxoSmithKline "It's a very exciting time in lupus," says Richard Furie, a rheumatologist at the North Shore-Long Island Jewish Health System in New York, who has conducted clinical trials of belimumab. "There's an awful lot of activity right now."
Several companies have similar drugs in the pipeline, and are likely to be spurred on by belimumab's success, notes Furie. Before 2009, when data from two large, successful clinical trials of belimumab were released, no drug developed for lupus had ever made it through a phase III clinical trial. "It was a little hard for these programmes to raise money when all the studies were failing," says Furie. "People said, 'you're never going to have a positive study'."
See how Lupus affects our internal and external organs:
[A 1902 watercolor of a man with Lupus erythematous - by Mabel Green. Wellcome Library, London]
Also see the WebMD Slideshow: A Visual Guide to Understanding Lupus
Lupus is a mysterious chronic inflammatory disease that can affect various parts of the body, especially the skin, joints, blood, and kidneys because the immune system attacks healthy tissues. Almost all Lupus patients have some degree of joint pain and will face life threatening complications from this disease.
Some familiar faces of those diagnosed with Lupus...
The number of celebrities with lupus is growing almost every day, especially since the autoimmune disease does not distinguish between class, gender, race or riches. Some of the celebrities listed have already lost the battle to the dreadful disease or health complications.
The King of Pop: Michael Jackson
Musician: Seal
Singer: Toni Braxton
Actress: Portia de Rossi
Baseball great: Tim Raines
Rapper: Trick Daddy (Maurice Young)
Producer: Lauren Shuler Donner
Musician/Singer: Lady Gaga (Stefani Germanotta) tested borderline positive.
Award winning American journalist: Charles Kuralt
Former First Lady, Barbara Bush
Backstreet Boys, Howie Dorough founded The Dorough Lupus Foundation in memory of his sister, Caroline Dorough-Cochran
Former president of the Philippines: Ferdinand Marcos
If you suspect that you may have Lupus, you should make an appointment to see your doctor. Your doctor may order an ANA test (Antinuclear Antibody) that will help determine whether the possibility of Lupus exists. Depending on the results, your doctor may decide to order further testing or refer you to a Rheumatologist. Many times Lupus is masked by various symptoms and often times patients are not properly diagnosed for several years. If you have already been diagnosed with RA (Rheumatoid Arthritis) , Psoriatic Arthritis, CFS (Chronic Fatigue Syndrome), Fibromyalgia, Lyme disease, Bursitis, Gout, any other auto-immune disease or chronic pain syndrome, just ask your doctor to do the ANA test especially if you have any rashes, skin disorders, new or unusual symptoms. There are different types of Lupus [Drug-induced lupus Erythematous (DIL or DILE), Lupus Erythematous, Systemic Lupus Erythematous (SLE) , Lupus nephritis, Lupus pernio, Lupus vulgaris] and each patient has different signs and symptoms
Don’t be afraid to get tested – not knowing is very frightening.
For books about Lupus go to Amazon.com
For more information about Lupus, please ask your doctor and go to The Lupus Foundation
THERE IS SO MUCH MORE TO RESEARCH FOR THIS DISEASE
PLEASE CONTINUE TO SUPPORT RESEARCH EFFORTS FOR A CURE.
Lupus Foundation of America
The Dorough Lupus Foundation
The Lupus Research Institute
Buy the purple wristband to show your support: You can purchase through the Lupus Foundation, click here