3/10/11 For the first time in more than 50 years, the U.S. Food and Drug Administration, or FDA, has approved a new drug to treat lupus, an autoimmune disease affecting as many as 1.5 million Americans.
Benlysta, or belimumab, is a biologic – the first to be approved and used for lupus. It’s an intravenous infusion that works to reduce the number of B cells that appear to be overactive in lupus patients.
The drug’s maker, Human Genome Sciences Inc., says the medication will be available by the end of March to patients with the painful and often difficult-to-treat disease.
“Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to manage symptoms associated with this disease,” says Erica V. Jefferson, an FDA spokesperson. “The disease can be debilitating, negatively impacting a patient's everyday life and can also be fatal.”
The FDA says it based its approval on two clinical studies of more than 1,600 lupus patients. An FDA press release says those studies show patients taking Benlysta and standard therapies had less disease activity than those not getting the medication, and there were some signs the medicine may also have reduced severe lupus flares.
“The first study wasn’t impressive in terms of any significant improvement. A second study showed it was effective. I don’t think anyone thinks it’s curing lupus, but it gives you something in your arsenal of drugs to try,” says Robert Katz, MD, a rheumatologist at Rush University Medical Center in Chicago and chairman of the medical advisory board for the Illinois chapter of the Lupus Foundation.
“I think it will be effective and I think it’s nice to have it available. But I don’t think it will be that helpful for the most challenging patients. I base that on the first trials, which weren’t that positive,” Dr. Katz says.
The last drug the FDA approved to treat lupus is the antimalarial Plaquenil, or hydroxychloroquine, in 1955. Lupus patients may take corticosteroids, such as prednisone, other antimalarials, immunosuppressive drugs and nonsteroidal anti-inflammatory drugs. But these medications don’t always help lupus patients, and they can cause serious or unpleasant side effects. Dr. Katz says Benlysta won’t necessarily replace these medications, but it might reduce the amount patients have to take.
“You might still have to take prednisone every day, but maybe you can take less of it,” Dr. Katz explains.
Side effects of Benlysta include nausea, diarrhea and fever. Because 17 percent of the trial participants had reactions to the infusion including headache and skin reactions – not uncommon with biologic infusions – the FDA recommends that patients first get treated with an antihistamine.
There were indications that African-American patients didn’t respond as well to Benlysta as other patients, though the numbers weren’t definitive, so the drug maker will conduct a study to evaluate Benlysta’s effectiveness for African-Americans. The FDA estimates that lupus occurs three times as often in African-American women as Caucasian women.
There will be other studies on the drug as well. “Human Genome Sciences will be conducting an additional controlled trial to further evaluate safety concerns such as serious infections, death and depression. The (FDA) is also requiring Human Genome Sciences to conduct additional studies including a pregnancy registry, a study in children with lupus and a study of the effect of Benlysta on vaccinations,” Jefferson adds.
Dr. Katz says now that the drug is approved, there’s an opportunity to see it used in a wider spectrum of patients than were involved in the clinical trial and that will shed more light on its effectiveness as well. “All kinds of lupus patients will be given it, so we’ll have a better way of gauging it with sicker patients,” Dr. Katz explains.
Benlysta is expected to come with an average yearly price tag of $35,000 without insurance – which is similar to other biologic medications used to treat autoimmune diseases.
Jerri
I read many of the comments that you all left for you to share what you are going through. I can emphasize with all of you. But you must try to remain positive. I can’t tell you how many doctors I have been to until I found the right one for me. I was seen by some stupid doctors; in fact I still can’t understand how some of them consider themselves as physicians.
My illness started with my feet, constant burning, and pain as if I was walking on a hot barbeque. I could hardly take one step without shedding a tear. That was the beginning. I went to a doctor who claims he was a Rheumatologist; I don’t feel he was adequate enough to take care of my dogs. He did not even know who I was and he is prescribing Cymbalta to take care of my nervous so called condition that he said I was hallucinating that my feet were in pain and burning. He said it was all in my head. That’s what they all say when they don’t have a remedy for you. In other words, time to move on and find someone that knows what they are doing and talking about.
Remember no one knows how you actually feel, except you. Most important don’t be intimidated by what a doctor says to you. If you’re not satisfied with his answers to you, then of course it’s time to move on. Move on it is, and keep doing it until you find a doctor with compassion someone who really cares. I know there aren’t too many of them out there, but just don’t give up and keep looking. The most important thing you should always remember is YOU. Yes, only you know how you feel so don’t take no for an answer.
That was just the start for me. About 12 months after suffering with Peripheral Neuropathy and severe damage to both feet nerve endings, I was diagnosed with an Auto Immune Disease of my lower spine known as Ankylosing Spondylitis. I had to have my L4-L5 discs fused. That was an ordeal in itself. After my back operation I started to suffer with both my knees severe swelling of Synovial Fluid buildup and spinal stenosis on my left side. It gets better.
I had to go to see my Ophthalmologist because of the pain in both my eyes. When he looked into my eyes, he asked me who my Rheumatologist was and I said I don’t have one. He said you should since you have severe Sjogren’s syndrome of both eyes. Imagine an eye doctor telling me that I had a severe case of Rheumatoid Arthritis and it’s all over my body. So I was referred by my neuro surgeon to Dr. Christine Savage. I finally lucked out in finding a doctor that has a brain and is the best in her field. She is kind, considerate, understanding and a great listener.
She started me on prednisone, then methotrexate, then Enbrel, Orencia, Rituxan, Humira, and Cimzia and then when none of these medications did not make a dent in my pain and swelling of my legs and also could not stop some of the deformities’ of my joints. After 3 years of trying all these drugs, she finally put me on Actemra a drug that seems to be working along with Plaquinel.
So I am being treated for the following diseases and most of them that I now suffer from are due to having severe RA, OA. I have Peripheral Neuropathy, Rheumatoid Arthritis, Osteoarthritis, COPD, Sjogren’s syndrome, and Ankylosing Spondylitis of the spine, Gerds Acid Reflux and psoriasis of the skin. Constant itching in the evenings.
I don’t take any prednisone and I finally lost 27 pounds. Patients on prednisone will gain a ton of weight and that medication never did help my flare ups. I don’t take any pain killer at all. I don’t smoke or drink. I eat very healthy foods. No red meat, little chicken, mostly fish and vegetables, lots of fresh fruit daily.
Last August I decided to do Pilates and so ever since then I do one hour in the morning and one in the evening. I am now able to stretch my legs and I can get up from a chair a bit easier. I wear knee braces since I am not a candidate for any knee replacements at this time because of my auto immune system is compromised and I am dealing now with a very low white count. All I can say again to all of you that you need to try to fight these diseases and if you have the right doctor you will be able to have a better quality of life.
So don’t give up the ship and keep stroking and searching for the right doctor that will listen to you. And, if a doctor ever say’s to you that you need a shrink and that it’s all in your mind, all you have to do is never use him/her again.
Thank you in advance for your advice. I am really worried about my daughter.
Sincerely,
Barbara J.
Human Genome Sciences has stated all along, even before approval, that if someone needs the drug, they will make sure they can have access to it. Meaning, they are putting a program together, such as other pharma companies have, and will offer a discounted drug assistance program, so that everyone can have access to the drug, if they need it.
I have Lupus too, so I know how we've all waited so long for a drug, and now we have a new med for our arsenal. Good Luck to all of you, and I wish you all the best!
Kimberlyn
of you who think your insurance especially
medicare won't pay for this drug.
I have to take Orencia infusions which are almost $2800.00 an infusion. If this fell into Medicare D, our RX plan, there is no way I could afford it but my Rheumatologist told me before I ever started that she was going to put it through the Medical side of Medicare because it was an infusion. Medicare pays for it. It did not go over to the RX side so please I encourage all of you to talk to your doctors and have them submit it thru Medicare not Medicare D and for those of you who are on other insurance have your docs do the same thing; code it as medical not prescription.
I hope this info helps and hope this med is a blessing to all lupus patients.
God Bless,
Cindi
What other conditions might be studied?
thank you jessica.
In process of finding a job, but, right now impossible for me to afford.
Thanks for the information.
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