FDA advisory panel approves new drug for lupus, Benlysta

Author: alam.md

FDA advisory panel approves new drug for lupus, Benlysta A Food and Drug Administration advisory panel recently voted 13-2 to recommend approval of Benlysta, the first new drug to treat lupus in more than half a century.  The FDA has set Dec. 9 as the date to make a final decision on the drug. It doesn’t have to follow the advice of its advisory panels, but it generally does.

Benlysta is not a wonder drug that will provide relief to everybody with the debilitating disease, but it may provide benefits for some and allow them to taper off existing drugs, which have powerful side effects that some think are nearly as bad as the disease itself. Systemic lupus erythematosus, commonly known as SLE or simply lupus, is a chronic inflammatory disease that occurs when the body’s immune system attacks its own tissues and organs. As many as 90% of patients are women, usually in their 30s and 40s when it first strikes. No two cases of lupus are identical, but symptoms can include fatigue, fever, joint pain, stiffness and swelling, rashes, skin lesions, mouth sores, hair loss and chest pain. The disease can attack many internal organs, leading eventually to death.

Only three drugs are currently approved for treating lupus: aspirin, the steroid prednisone and the antimalarial drug hydroxychloroquine, all approved during the Eisenhower administration. All can have severe side effects. Other drugs, including the anti-rejection drugs cyclophosphamide and azathioprene, are sometimes used off label, but they can have even more serious side effects.

Benlysta is a monoclonal antibody known generically as belimumab. It was developed by Human Genome Sciences Inc. of Rockville, Md. and is being tested jointly by that company and GlaxoSmithKline. Studies released last year indicated that the drug helped about 30% of those who took it. For some reason, however, the drug does not appear to benefit African Americans, who are more susceptible to the disease than whites.

If the FDA approves Benlysta next month, it could be available early next year
. The main drawback is expected to be cost. While the companies have not revealed what they expect to charge for the drug, other monoclonal antibodies on the market sell for thousands of dollars per dose.

Article Source: http://www.articlesbase.com/medicine-articles/fda-advisory-panel-approves-new-drug-for-lupus-benlysta-3687352.html

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10 thoughts on “Lupus Arthritis

  1. Tonya

    Is it possible to have lupus arthritis without systemic lupus disease?
    My ANA was positive with rheumatoid factor, with other painful symptoms. Is it possible that I just have lupus arthritis, without the actual lupus disease?

    1. Linda R

      Systemic lupus erythematosus affects you internally, that includes your joints. Some people also have organ involvement, others don’t.

      A positive ANA does not mean that you have lupus. It means that you have antinuclear antibodies. 10 million Americans have a positive ANA but only 1.5 million have lupus.

      In lupus, the pattern of the positive ANA matters more than the number. Lupus presents a speckled pattern. It should be listed on your lab report. Ask the doctor for a copy. You have a right to it.

      A positive ANA and a positive rheumatoid factor points to rheumatoid arthritis, not necessarily lupus. However, you can have lupus and rheumatoid arthritis in overlap.

      Regardless of the name for your condition, you have a chronic illness. One of the most important things you can do to manage it is to have good communication with your doctor. When you go to an appointment, write down you questions. You can expect that the first three will be answered, so put them in priority order. But do write all you questions down because the doctor will scan them and may notice something important.

  2. Hannah

    If you have iron deficiency, lupus, and arthritis, can you still be a model?
    If you have iron deficiency, lupus, and arthritis, can you still be a model?

  3. mai

    If you were home sick with lupus,arthritis,asthma what would you do with your time?
    I’m trying to make of list of activities for a friend of mine who suffers from chronic pain, has good and bad days but is mostly at home. What activities can you suggest? Keep in mind that they must not be activities that are too strenuous.

    1. SSA Registered Disabled PWD KING ♕♛

      I use a large part of my computer time at home to do Disability research and to do Disability Rights Activism-Advocacy-Self Advocacy work and also to raise Disability awareness and to answer Disability related questions.

  4. pink69ranger

    Can you join the Military (marines) if you have MCTD/Lupus/& Arthritis?
    I’m only 16, but i have MCTD, Lupus, Rheumatoid Arthritis + more. My dad was in the Marine Corps. and i want to follow in his footsteps. I just don’t know if I am able to can you please help me. I also had heart surgery when i was 12 does that matter?

    1. sarge927

      Sorry to be the bearer of bad news, but both Lupus and Rheumatoid Arthritis are automatic disqualifiers for ANY branch of the service. Your desire to serve your country is very much appreciated. There are other ways to serve that don’t require a physical though. Volunteering at a VA Hospital jumps to mind…

  5. Enzi_Raver!

    My mom has Lupus and Rheumatoid Arthritis. Can I be home bound to take care of her?
    She has lupus seizures and seems to be very unstable when she has these. I can’t focus in school because of this. My counselor at school knows about my mom and she has brought up homeschooling before. So what do I do?

    1. Linda R

      Talk with your counselor about the rules concerning home schooling where you live. Who is qualified to help you and teach you things you don’t understand? Will the school send a tutor? What is the process for getting approved to home school where you live? Will institutions of higher learning accept your diploma if you are home schooled? Will you have to take a high school equivalency test? What are your future plans?

      Have an honest discussion with your mom. She may not want this for you. She might feel guilty and stressed that you are giving up your normal school experience, and stress makes both diseases worth. Your mom gets to be part of this decision. She is sick, not a baby.

      There are many considerations. I suggest that you talk with your mom. If she agrees, then have a meeting with your counselor and your mom together.

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