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Treatments > Drug Guide > Drug News & Info > Biologics and DMARDs > New Biologics in the Pipeline
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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.

carmen
20 Oct 2011, 14:06
Is anyone currently on Benlysta for RA treatment? My doctor wants to start me on this drug but I read that is mainly for Lupuss. Any comments?
Sue
02 Oct 2011, 22:27
I have had AS since 04' and the only medication that alleviated my pain and stiffness was Enbrel. After 2 years I had a positive ppd test ( for Tuberculosis) and was taken off it. Has this happened to anyone else? Thanks so much.
Karen
21 Sep 2011, 11:06
David...I also have PA for the past 41 years. I have taken all Biologic drugs but Stelara. Do you have to take Methotrexate with it? I cannot take Methotrexate because I also have HepC. I have an appt. with Loma Linda Univ. next month to find out if there are any newer drugs.
Be well...Karen
kathleen
15 Aug 2011, 13:17
i was diagnosed with RA 2 yrs and had numerous tests ,xrays and others ,i was first put on methatrextate ,, side affects were it gave me low white blood cells ,,so was took off it as was dangerously low ,,sulphzalazine came next side affects were too big red blood cells , so now im waiting to go on the injections once per week of ,, GOLD AURALIN ,as any one had these injections and were they any good , i need to start them a,s,a,p because ive been off the dmards for a mth now , and my RA is flaring up really bad can hardly move in mornings now
David
14 Aug 2011, 15:27
To all, I am sorry any of you have to deal with arthritis in any form. I am 56, have had psoriatic arthritis for many years and have taken just about all biologics, somne of which fantastic for a few years and then lost their effectiveness. Currently trying Stelara, on multiple pain meds, literally a handfull every day. Doris I hope by now your son has gotten disability, it ain't easy. Might I think Methotrexate might be a relatively inexpensive drug, I recommend as much low impact exercise as possible like swimming, it helps.
DORIS
28 Mar 2011, 02:49
MY SON HAS A NEW DIAGNOSIS OF RA. HE WAS FIRED FROM HIS JOB AND LOST UNEMPLOYMENT. HE HAS NO HEALTH INSURANCE,THEREFORE CAN'T AFFORD ANY TREATMENT. HE IS AFRAID TO USE MOST OF THE MEDS DUE TO SIDE EFFECTS AND COST. HE TRIED THE NATURAL MEDS ROUTE BUT CAN'T EVEN AFFORD THAT. HE APPLIED FOR DISABILITY 1 MONTH AGO BUT NOW HAS TO GET A LAWYER TO PROGRESS AFTER FIRST DENIAL. HE IS 28. MOST DAYS HE CAN BARELY WALK AND HAS NIGHT FEVERS UP TO 102 AND JOINT SWELLING, ESPECIALLY HIS KNESS. CAN ANYONE GUIDE US???? PLEASE.
Debra
12 Aug 2010, 20:22
I have RA and have been on Plaquenil over a year. Inflammation taking a toll on my body and advised to start Humira. After reading side effects it's like there is no better choice. I'm heading downhill before I really start. Really concerned about not taking any biologics and see how far the disease will go. Any suggestions from Humira users?
Mary
27 Jul 2010, 00:11
This is to Christina..if it is not to late...I also have psoriatic arthritis and yes, these drugs,if approved for RA, are approved for psoriatic arthritis. Psoriatic deals with most of the same symtoms as RA, covers a few extra joints, but has a different root than RA. Most psoriatic paitients deal with leasions first and then the arthritis sets in, it is hereditary, the same as RA, and can be as deabilitating as RA. Most of the drug companies have some sort of financial help...ask your doctor for the numbers to contact the companies directly or other companies that offer help with these drugs, but don't give up, because they do help...alot...
gilbert
09 Jul 2010, 11:01
I have received a solicitation on-line for a "new" product for sufferers of arthritis. The claim is that their product "instaflex" is okayed by THE ARTHRITIS FOUNDATION for joint health & pain relief, plus that it supports cartilage repair. They want to send me a free sample to try (if I send them $4.99 for shipping). Is this a medication that you are aware of, or is this a scam???? Please respond ASAP. THANK YOU, GILBERT
John
03 Jun 2010, 07:32
Christina,
I have psoriatic arthritis, and have been on Humira for several years; my arthritis was not responsive to other drugs, and I was allergic to some as well. Humira has been unbelievably effective, practically overnight. I give myself an injection 2x a month. That's it. However, my insurance DOES cover it; if I ever lose coverage, it will be a steep price to pay, as generics will not likely be available for many years, if ever. But it is a remarkably effective treatment, at least in my case. Good luck!
Lisa Senters
20 May 2010, 19:31
I can certainly sympathize and identify with Christina about having psoriatic arthritis. I have taken Remicade for over a year, but recently stopped because it caused me bad side effects and I saw little improvement in my condition. I don't have the option of trying another biologic drug such as Humira or Simponi because they have only been approved for RA and not PA, so insurance plans won't cover the cost.
Carol Whiting
27 Mar 2010, 15:14
I was on Remicade for 6 years. It truly was a lifesaver for me. I could barely walk (even with a cane), pain level was off the charts and my joints were becoming "locked". I originally did not have to pay for the drug as it was intravenous. Then Medicare chaned the rules. In 2009 I was supposed to be paying $300 per infusion. In 2010 the coinsurance per infusion was to increase to 20% (or $600) per infusion. The cost was prohibitive so I joined a stage III clinical trial for Actemra. The medication has been good but the trial is coming to an end. The durg has been FDA approved. So now I am back to square 1 looking for another clinical trial where I don't have to pay for the medicines that I can't possibly afford. Many patient assistance programs are already full and it seems like most are not offering "limited" assistance which would pay for the portion of the drug the insurance company is not covering
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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