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Biologics in The Pipeline

By Mary Anne Dunkin

1/11/10 Since 1998, eight biologic response modifiers, known as biologics, have been approved by the Food and Drug Administration for inflammatory forms of arthritis. Biologics are genetically engineered medications made from living organisms that are then used to treat humans. Two biologics were approved in 2009, and several more are in various stages of development and clinical testing. Some of these agents that hold promise as future arthritis treatments include:

• Baminnercept (BG9924), an agent in development for rheumatoid arthritis (RA) and lupus, which targets lymphotoxin-beta, a component on the surface of cells that signals the inflammatory process to begin.

• Denosumab (AMG 162), which targets RANK ligand, a protein involved in the development of bony erosions in RA and bone loss in osteoporosis.

• Ofatumumab (HuMax-CD20), an infused biologic designed to reduce the number of B cells, which may decrease disease activity in RA

• Belimumab (Benlysta), which inhibits the activity of B-lymphocyte stimulator (BLys), a protein that causes B cells to grow in number and perhaps produce antibodies. Belimumab is in development for lupus as well as RA.

• Canakinumab (Ilaris), which targets the proinflammatory cytokine interleukin-1 beta (IL-1β). Approved for a rare autoimmune disorder called cryopyrin-associated periodic syndrome (CAPS), canakinumab is currently in clinical trials for RA and JIA.

• Fostamatinib disodium, an agent that works by blocking the effects of a protein called syk kinase, which helps B-cells to mature. Fostamatinib disodium is in clinical trials for RA.

• Masitinib, which inhibits the activity of mast cells, which become activated and contribute to joint inflammation in RA. Masitinib is taken orally and has been in clinical trials for RA.

Kathy England

26 Feb 2010, 10:13

I had a rather severe "viral illness" in Dec. 2000. By April 2001 I could hardly walk. Nothing seemed to help with the rapidly increasing symptoms and pain. Although I had a negative RA factor (and still do) the sr4ays indicated a far advanced Arthritis. We began replacing joints - one knee, one ankle, bilateral shoulders, the other ankle, then repaired the first ankle that continued to deteriorate. Then we did two spinal fusions because of stress fractures. Finally ended up on morphine for generalized pain. In the meantime, we tried all of the biologics with no significant relief. Now waiting to start Symponi but need to clear an infection before we can try. Still have significant pain. While Medicare has been good (and Thank God for a good secondary that covers most of the meds), my Physical Therapist tells me that Medicare is now capping PT for the year, not by the diagnosis or procedure (after each surgery or separate episode of pain). If Medicare doesn't pay, the secondary doesn't pay, no matter how helpful it might be. While the meds (out of pocket) are stacking up, paying for PT out of pocket two or three times a week is prohibitive, no matter how good it is. We invested in a hot tub but I can no longer use the stairs. Any thoughts or ideas - Using a Hoyer lift to get into the pool? Moving to a ranch style home (we are in a tri-level and have been for the past 25 years) with an in ground pool in a warmer climate? Move to Assisted Living with a pool? Petition Congress to not change the PT benefits? Any suggestions?

Devron

18 Feb 2010, 18:03

I have severe OA in my right knee, 4 surgeons have said replacement. I am only 50 and a karate instructor. Two of the doctors said no problem keep going and two have said no way you are done. Who do I believe. Also is there any new meds out there that might releive my pain so I can avoid a replacement for a few years.

thank you,

Devron

Rebecca

11 Feb 2010, 11:14

This is in response to Christina.

Christina, you should be able to get some type of assistance along with your doctor writing a letter for you that you require to be on Enbrel or any other type of medication they want you to take. If you go on the internet and research all the drug manufacturers who develop the medications, they most probably with assist you in receiving your meds. Just as long as you qualify for assistance within your yearly income. It's your W2 or social security which will determine your qualifications. It's all about money and how much you earn.
So give it a try. Good Luck and feel well.

Beth

11 Feb 2010, 10:54

Robert -
My daughter had been on many biologics for JIA and then was diagnosed with AS. So her doctor prescribed golimumab, a newer biologic. She has done well with this - her pain from AS is virtually gone. Many pharmaceutical companies have programs to help people who cannot afford their medicine. Sometimes they even have programs where the first several months are free of cost to the patient. Do research on www.arthritis.org, speak with your doctor, and check out the websites of the pharmaceutical companies. Don't give up, and good luck!

christina

11 Feb 2010, 10:21

I hear so much about RA but hardly anything about psoriatic arthritis, which is what I have. Most likely this is because my form of arthritis is more rare than RA, but does anyone know, in the descriptions above, do these medicines also apply to psoriatic arthritis? It's hard to get any info about my disease because so much time is spent on the others. Not complaining :-) just observing. Any thoughts would be appreciated, especially from someone who shares my form of the disease. Particularly because I am hoping generic, or less expensive forms of Enbrel come out soon. It's a miracle drug, but so expensive.

Rich Porcher

11 Feb 2010, 09:42

I have ankylosing spondylitis and it has devastated my life at 34 years of age. I was on remicade for several months...enbrel for several months with no improvement. I am currently on cymbalta and lyrica. Has anyone found another combination that has alleviated pain in the slightest?

FLORENCE LAURA BARANEK

28 Jan 2010, 09:34

I was involved with several clinical trials and when I would ask questions about what I was feeling the doctors in charge all gave me a responce to the effect of "We ask the questions here". I felt that this was not a fair way to treat someone who had a lot on the line. I felt very disrespected. And ultimately their disrespect led to my leaving the trials before they were over. While I understand that certain questions can color the outcome of a study but if you are feeling unwell in body or mind and ask a pertinent question you are owed an answer.

arti

14 Jan 2010, 19:17

I was on a clinical trial of Ocrelizumab for about a year and a half.
I do believe that the drug was helpful to me at the outset, since I was bedridden by RA. The four hour infusions are very tough, however, and the amount of blood drawn for the clinical trial records is enough to make you weak. By the end of a year and a half, the infusions put me to bed for a day after feeling very toxic and affected my moods.

I say all this not to scare others away, but rather to give a realistic image of my experience. I was not adequately prepared by the clinician, but truthfully I was too sick in the beginning to care. Later, though, I began to believe that my experience was not to be considered normal but I was not able to get a square answer from the clinicians. After I quit the study, the doctor informed me that there is a stroke/heart attack increased risk for those at increased risk anyway.

Don't let my words stop you from joining this clinical trial especially if you are as desperate as I was. However, you have to BE YOU OWN ADVOCATE. Keep some sort of notebook of your visits and your reactions. Really, you'll be helping the study and yourself.

Good luck.

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Biologics in The Pipeline

Biologics in The Pipeline

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