01/11/10 The U. S. Food and Drug Administration (FDA) has approved tocilizumab, brand-named Actemra, a new kind of biologic drug to treat patients with moderate to severe rheumatoid arthritis (RA) that has not been well controlled by other medications.
Actemra is the first drug to block a protein called interleukin-6 (IL-6), which is overproduced in the joints of people who have rheumatoid arthritis.
According to Daniel Furst, MD, a rheumatologist at the University of California at Los Angeles who has been involved in the clinical trials of tocilizumab, the drug, which is given once monthly by intravenous infusion, is “powerful and rapidly acting,” but he also says that because of significant safety concerns, it should still be used with great care.
“You never get something for nothing,” Dr. Furst adds. “Here’s a drug that’s going to be very effective, but it’s also going to have consequences.”
In clinical studies, some people taking tocilizumab experienced serious side effects including elevated LDL or “bad” cholesterol, high blood pressure, elevated liver enzymes and gastrointestinal perforations – holes in the lining of the stomach or intestines.
“Actemra’s recommended use is limited to patients who have failed other approved therapies because of serious safety concerns that were noted in clinical studies,” says FDA spokesperson Karen Riley.
And because of those concerns, the FDA is requiring the drug’s manufacturer to continue to monitor the long-term safety of tocilizumab with ongoing clinical trials.
“Specifically, the FDA wants to evaluate the impact of elevated LDL cholesterol and blood pressure seen in some patients in shorter-term trials on the cardiovascular health of patients treated with Actemra,” Riley says.
Tocilizumab appears to be the first biologic drug to increase cholesterol. That’s a significant concern for people who have rheumatoid arthritis because the systemic inflammation caused by the condition already increases the risk of cardiovascular disease – nearly doubling the risk of a heart attack within 10 years of diagnosis.
In one clinical trial, in fact, about 2 percent of patients on tocilizumab saw their LDL cholesterol climb by about 100 points.
"Rheumatologists are likely to need to be much more attentive than they ever have been in the past to their patients' lipid levels on this drug," says Jeffrey R. Curtis, MD, a rheumatologist at the University of Alabama at Birmingham, who was involved in the clinical trials of tocilizumab.
“You have to watch this drug,” Dr. Furst agrees. “But with regular blood tests, it’s a drug that can be handled pretty comfortably.”
It’s been a long wait for tocilizumab in the United States. It had previously been approved in other countries, including Japan, the European Union, Mexico, Brazil, India and Australia.
An expert panel first voted to recommend approval for tocilizumab in July 2008, but six months later, the FDA delayed the drug’s approval, asking for more data.
Tocilizumab is a monoclonal antibody that blocks the protein interleukin-6, or IL-6, which is something of a double agent in the immune system, acting to both spur and calm inflammation. Beyond the joints, IL-6 acts in many other parts of the body including bone marrow, muscle cells and the lining of the blood vessels.
Most other biologics drugs for RA, including adalimumab (Humira), etanercept (Enbrel), infliximab (Remicade), golimumab (Simponi), and certoluzumab pegol (Cimzia), block the inflammatory protein tumor necrosis factor alpha or TNF-alpha.
Three more biologics used to treat RA work to interrupt other parts of the immune response. Anakinra (Kineret) blocks the inflammatory signal interleukin-1, or IL-1, abatacept (Orencia) prevents certain immune system cells, called T-cells from being activated, and rituximab (Rituxan) helps to eliminate immune system cells called B-cells, which are thought to be overly active in autoimmune diseases.
According to Roche, the drug’s manufacturer, tocilizumab will be available to patients starting the week of January 18, 2010.
I have had 6 joint replacement surgeries (right shoulder, joints in both feet, multiple wrist surgeries repairing ruptured tendons), have tried every mentioned drug and am currently on Actemra, methotrexate, prednisone and pain meds.
After losing my husband of 30 years to lymphoma 6 years ago, my sons have been my rock. So thanks Lana C for your sweet remarks on the love you have for your sister.
Yes, pain, joint deformity, fatigue etc. are unrelenting in RA but please don't underestimate the effectiveness of having and using your loved ones when you need help. It took me a long time to realize my RA did not improve as I suffered in silence. Also, that as I tire of hearing people go on about what's ailing them, not everyone likes to hear about my latest RA hurdle. Less really is best ;-)
I'm hopeful that Actemra will be a winning component in my arsenal to fight RA but also have learn to accept the limits and challenges we all face regardless of RA. Life is to short not to find joy in each day. Hope you all find yours today!
-Margaret
She loves life and people and is expecting a grandbaby this month. I pray she gets relief from the sctemara and lives to see her grandson graduate from hightschool. I am here for her and will try my best as always to help in her need and be there for her to lean on. i retired and moved to our home in Ponca City to be near her and help her. She is my sister, my best friend and my closest companion. We understand pain. Thanks you Arthritis Foundation
I've read through the posts and wanted to address some issues. I was diagnosed with RA August of 2010 but had symptoms for 4 years before. The flare that resulted in my diagnosis just continued to get worse and landed me in the hospital for 2 months on iv prednisone. I was on MTX 25 weekly injections, plaquenil 400, Prednsione 60 mg daily and a host of narcotic pain meds and laxatives. I started Actemra Nov 2010 on a 4mg/kg dosage that was raised over 2 months to 8 mg/kg. I am now on 12.5 prednisone and continuing to decrease and although had stopped MTX Jan 2011 recently started again end of Feb 2010 after a small flare in Feb which was treated with 3 day iv prednisone therapy. Actemra works well for me in combo with MTX. I get monthly blood tests and although my cholesterol spiked for 3 months after starting the actemra infusion like many side effects to medication it stabilized after my body got used to the Actemra. I have had one cold since. I am not yet able to go back to work and recently began to tackle stairs but every month I get a little better. I will add thought that my arthritis is severe and due to my sulphur allergies my dr decided not to waste time with other biologics and put me on actemra. Let me be clear, this is not a cure but I went from extensive pain therapy to 1-2 extra strength tylenol a day. Fatigue is my main issue now but I spent several months unable to move in bed and only recently started climbing stairs again. I am working on slowly building tolerance but its going to take time. To everyone reading this post who has just been diagnosed, this is a fight but as long as your alive there is hope. Start taking the drugs, it may help to check the disease early on. Who knows tomorrow there could be a cure.
Now...they tell me the copay is 150.00...per vial. And they couldn't tell me how much my monthly outlay would be but to provide a credit card number with a large balance. They said to prevent waste they will match up the vail quantity to prescription total. So instead of using four of the larger vials and have significant waste they will mix and match the three different size vials until a minimal waste is achieved.....and charge the 150.00 copay to each.
It is so nice to hear stories from people that i have things in common with. I was diagnosed with RA and Sjogrens syndrome a yr ago. One day I woke up with a life changing ordeal. I started having carpal tunnel symtoms with both wrists and both of my shoulders froze up where i could not raise them over my head, my elbows started screaming, both of my feet felt like someone had beat them with a board. I could not use my hands or walk for my job. I do a desk job so i was sent to a wcomp dr but after blood tests he found out it was RA. I do suffer some with the Sjogrens, dry mouth, dry eyes but not as bad as the RA. I also take 5m prednisone daily (which i am trying to get my rhematologist to wean me off of because it makes me gain weight). i also take oral Methrotrexiate 6 2.5mg pills weekly. I am checking to see if he will raise my Methro pills up bec i need more help with pain if i do get off the predisone. My RA is not severe as alot of you (i only missed work 3 days for flare ups last year)but if i have problems it is in the thumb joints, knees and my FEET. The bottoms of my feet hurt alot. Sometimes it does get me down but I love to garden and that is my therapy. My 7 yr old granddaughter keeps me going also. However i do rest and try not to over push myself because that can back fire on you also. I do understand about feeling tired of taking meds bec my dr has me on Prozac, a cholesterol pill, folid acid, calcium pills, vit-d, boniva, besides the predisone & methro pills. I don't think i am drepressed but sometimes i suffer with anxiety and there is times i wake up not wanting to go to work but i have to help my husband pay for our new home we built last yr. Having a new house has kept me active also. Boy i didn't expect to write this much but it does feel good to express yourself with people that understand what RA is.
I was diagnosed with RA when I was 21 but I had it since I was 15. It was really tough because of too much pain..there were times I cannot walk. I didn't really focus on this and now I'm already a doctor. I was on medications, stopped other meds and for months now I didn't take anything. My hands and feet were already deformed and lost strength. My dcotor wanted me to start Actemra for research purposes. i'm not sure if i'll go with it because of the side effetcs.
I'm 26 years old and have RA since 2005+. I live in Perú, I tried all kind of meds available here like MTX, prenisone, steroids, Reumine, and in 5 years is like I never took nothing, I was really depressed but inside I knew that it could be worst so little by little I got positive to face life, and it's what makes me wake up every day... just hope...
Now my doc recommends me ACTEMRA, so I need all the information that I can get.
Please help me.. I will thanks a lot!!!
My neurosurgeon told me that my sciatica is back like a vengeance because my spine has alkalizing Spondylitis.
But my days for having surgery are over. I had a double spine fusion L4-L5 the end of November 2007. I was told that I needed two knee replacements last year, well that is not going to happen. I already had my both knees arthroscopedly repaired for meniscus rips. That did not help my severe pain in my knees with the intense swelling and constant draining of the knees to relieve the synovial fluid which develops around the knee and other joints will always be there. No matter how many times I get my knees drained, no sooner than a few days it starts to swell again.
I feel for all of you suffering as I am. I take anti-depressants along with Lyrica for my burning feet which I also have is peripheral neuropathy. This is how my RA started in 2003, but the thousands of doctors I went to were not able to actually diagnose my RA, they all thought it was in my mind that I was suffering from burning feet. I was neglected for 4.5 years and although my blood showed that I was suffering from RA, these doctors insisted that I did not have the disease.
I have to say without insulting these physicians that most of them should probably go back to med school and I don’t mean to just take a refresher course, I mean to start from scratch. The excuse of a physician is that if they can’t diagnose your condition they have to cover their own a-s, so they say it’s in your head. What a diagnosis that is “unbelievably”
If I am not suffering from 24/7 pain then I am suffering from choking and coughing my brains out. The RA that I have affects my lungs daily with severe congestion. Presently, I am having a horrible time sitting, standing, walking because my sciatica is in very sad shape. I wear two leg braces about 7 hours a day and I also have a metal back brace which I wear about 2-3 hours a day.
I would recommend to most of you who are feeling depressed to keep very busy and get into a warm pool. I am starting a new Hydrotherapy for lower back pain and sciatica and to help strengthen my legs. I feel better when walking in water. I try to get into a pool at least 4-5 times per week.
All of us who have this disease have to stay busy. I do crafts; I knit, and work on my computer doing research. I am an Ambassador to the Arthritis Foundation and advocate. I also volunteer my time to HOSPICE with my two pets that are also certified to go to nursing homes and other medical facilities. If I can bring some hope of laughter and sunshine to others who are suffering from incurable diseases and just share a sigh of hope, then I am going to go for it.
Stay well and think happy for a bit of sunlight to shine for you.
I just had my 2nd Actemra. It is too early to know if it is going to help.
Both times I have gotten the drug, I have had severe nausea, vomiting and diarrhea following the infusion. There is nothing in the literature about this. Has anyone else experienced this side effect?
Lastly, kudos to Sue Cameron. Thanks so much for sharing.
Thanks for listening
Many of you have asked, "What's the best exercise for arthritis?" The Arthritis Foundation offers several gentle yet effective exercise programs through its Life Improvement Series, including the Exercise Program, Aquatic Program, Walk With Ease Program and Tai Chi Program.
These programs have been studied by research experts - some in partnership with the Centers for Disease Control and Prevention (CDC) – and have been proven to reduce arthritis symptoms and increase mobility.
To find a program near you, contact your local Arthritis Foundation Chapter by visiting www.arthritis.org/chaptermap.php. Or to simply learn more about the programs visit www.arthritis.org/programs.php.
If the classes are full in your area, volunteer to be a program instructor to start a new class for you and others with arthritis to participate. But please remember always to consult your doctor, physical therapist and other members of your health-care team before starting any exercise routine.
All the best,
The Editors
Arthritis Today
Lisa, Northern Ireland
Had gone to emergency in middle of night and told I probably strained something. Won't be doing that again made me feel stupid. I am waiting to hear from a specialist as do to ohp have to be referred and then wait.....
I am also bi polar this has been really good for over a year. Thank god for meds. So hopefully depression will not be to much of an issue.
I found out I was for sure pregnant a week before RA and have only had one bad flare up since. But just read earlier that pregnancy can put it in remission. But only while pregnant. Has anyone heard of this or got pregnant since or before diagnosis?
Fortunatly my rhematologist helped me with every medicine out there beginning with the gold shot treatments..which as some of you know, are painful.
Thank you for this information...as I go to the doctor tomorrow we will talk about this and he will decide which and what is best for my condition as it is today.
God Bless...have faith..that is a plus, believe me.
Having any chronic decease is difficult, but the show must go on. I work full time, travel a lot and of course the long time mom job.
If you travel on business a lot, try the following:
1.hydrate well, replenish through out the flight
2.purchase the lightest suitecase with wheels (samsonite has one, as well as American Travel) if you can shrink the size ( I bought mine 17.5")
3.wear cotton and loose clothes your inflammation will go up during the flight, so having loose clothes help on giving you a chance to stretch.
4.Get a pair of good cotton, hummidity and bacterial control boby socks to wear during the flight, once you arrive you can always change back to your shoes ---- this works! 5.Reading is good but don't do this too long, RA affects your eye sight it may get a little blurry, try listening to music or watching a movie and relax.
6.Use an airline that works for you, my opinion (Continental) has woked great for me.
7. Book a flight time reasonable for you to get ready and not feel rush, running around with stress around the airport can upload a flare
8. always keep a face mask and hand sanitizers (your inmmune system is in hyperdrive trying to work with the RA you do not need to catch a cold or anything else)
9.when preparing your suitecase take what is truly necessary all things come in small sizes now, buy them!
10. If your meeting starts on tuesday, travel the day before, this way you can rest. RA is recognized as a dissability you can talk to your employer to help you achieve your goals for the company.
Well, I'm sorry this is so long, i hope the suggestions are usefull.
God bless you all, keep safe and healthy.
Sue, your post was amazing. I could not have said it better myself if I tried.
I think we need to have a mindset that we need these meds and should not be ashamed or feel like a junkie. On the other hand only a few people know what meds I am on as I don't want to be a target for a break in for my pain meds.
I work with my rheumatologist, my family doctor, my psychiatrist (I am also bipolar so I can't use prednisone), and my pain management doctor.
I know all of these meds are shortening my life but I will take quality of life over utterly dependent crippled longevity.
I appreciate everyones input. It just makes my decision for my health feel validated.
Good luck and good health to all of you.
I was blessed to have the opportunity to get into the clinical trial for Actemra. All I can say is this drug gave me back my life. I am now working full time, in school, and go to the gym 4-5 times a week. Actemra is now the only drug I take for my RA, and for the last 4 years in the study Actemra has never let me down.
It is disappointing that the FDA approved Actemra with the restriction of failing other therapies. From the first three years of trying the wide varieties of drugs, I am left with two knees that have significant damage. I would have avoided a lot of this damage had I had the option of Actemra from the start. As with all drugs, there are risks, but there are also risks with sitting on a couch unable to move.
Let's phrase that differently. How about, "...when doctors have failed to find an effective treatment."
Patients do not <i>fail</i> treatments. It's the <i>treatments</i> that fail to be effective.
As a nurse I would encourage everyone to be their own advocate for their well being.
Get a GOOD rheumatologist if you don't have one. I drive over 100 mi. to see mine on a regular basis. Much better than family or pain mgmt docs alone.
If the meds aren't working ask about another one or adding one. I'm on 4 and they work together to make my life easier.
DO NOT FEEL GUILTY, ASHAMED OR WEAK FOR TAKING PAIN MEDICATION. RA causes pain that is chronic and usually daily, sometimes unbearable pain. I was on 100 mg fentanyl patch with Lortab 10 for breakthrough pain before Remicade. I continue on Lortab 5 as needed, usually 1-2 per day. It helps keep me moving and that is most important in RA. You will not become addicted to pain meds because you take them regularly. You may become dependent which means you should not stop them abruptly. No human should suffer in pain because of the stigma that is often associated with use of pain meds. Find a pain management clinic if your doctor will not prescribe pain med for you. Since 1990 my RA has led to degenerative disc disease in my spine which led to 5 spinal surgeries. Each time I had to stop at least some of my RA meds for a while, increasing the pain. I am lucky to have a great family doc and rheumatologist who do all they can to help keep me comfortable.
Chronic disease often causes depression. It is not a sign of weakness that you cannot pull yourself out of it. Depression will cause an increase in chronic pain. There are many med which help depression. Talk to your doc about your depression/sadness.
Get a lawyer to walk you through SS disability. If your doctor won't recommend it find another doctor. Be persistent. If you are still able to work find the essential functions of you job that you are no longer able to do at all or unable to do as you should. These are the areas to focus on in your claim.
Find something that you have enjoyed doing in the past that you are still able to do, even if it is only for 15 or 30 minutes a day or a week. Listen to books on tape if you can't hold a book anymore, public libraries have great collections these days.
Do not be afraid of the side effects of RA meds. They are real and you need to be vigilant in watching for them. RA untreated can cause side effects that may be worse than the meds. Your doctor should be monitoring you lab values, if not ask why s/he doesn't.
Remember, you are your best advocate for great care for any problem you have. Doctors are not gods, question what they do and why. Find one who communicates well and monitors your care when you are feeling as well as you can, not just when you are in a flare.
Find a faith you can believe in. Find a RA or chronic disease group in your area. If you can no longer get out by yourself, find a virtual group whose members are positive, as active as their disease will allow, and want to help each other, not just complain and moan. The positive group will be there to help you through the bad times and encourage you in the good times.
I hope this hasn't been too long and is of some help. Feel well and stay as active as possible. Sue
I had my hip replaced at 1985 the revised at 2000. Kneee replacement 1996. Worse surgery was my shoulder replacement. I can't raise my arm over my head. But there no pain anymore.
I've got a great family that there to help when I need things done.
I need to fine a support group for my age group for RA people.
But I keep busy doing my crafts.
Hope this new medince will help young people who find out they have RA
Diane
I too took minocycline for several years. I was in a remission, until I fell and broke a bone. Does your skin, have a yellowish tint to it? Mine did. It went away, after I stopped taking it. I'm now on Arava(every other day) and Methotrexate (3 tablets weekly). My WBC is low, so the Dr. has decreased the dosage. I take the generic brands, since they are cheaper. I can tell a difference, when Mfg. are changed. I have Osteoporosis and I wonder if the Minocycline may have contributed to the disease. Have you had a Bone Density Test?
for those who want a chatroom for illnesses try Rest ministries online. Great group of people who all have chronic illnesses, that is alwasy my prayer that what I am going through can help someone else, that it has meaning and I can help comfort someone else.
Take care everyone
Beware of collagen injections and breast implants!! Your body will reject any foreign object. There have been tv shows with people like me who have acquired RA, Lupus, and other life-shortening diseases from these procedures
Have been on all kinds of medicines over the years.
Gold injections and Plaquenil seemed to help me better than most other things. I'm taking Doxycycline and 3 mg of Prednisone daily. Just started taking Plaquenil again, but am worried about it worsening my vision. I have some cataracts. (Notice when you're sick and how antibiotics help your pain!)
Enbrel injections did lessen the swelling in my finger joints, but did not help with fatigue. I quit taking them because I was afraid of cancer. My father died at age 56 from colon cancer. (Get your colonoscopies every five years!)
Want to look into Sulfasalazine, as I have seen several post about taking that. Actuallly, I may have taken it in the past. lol
Just take one day at a time.
Blessings to You All!!
Now, a Specialist at a Pain Management Center prescribed Morphine,Gabapentin and Tylenol 500mg, which I've been taking for 2 weeks. I don't feel any improvement in my degree of pain. My left knee and both ankles hurt a lot. I use a walker to get around, but can't walk too far or too much due to constant pain.
Iam desperate to find some relief for my constant pain. Any suggestions?
My question is how are you guys dealing with the depression? My life is limited to home, friends houses and church now because I can't walk that far. Please HELP!!
My mother who is in the advanced stages of RA, too was on Methotrexate. Mostly because she feared the side effects of other drugs that she saw advertised on tv. After about 7 years on Methotrexate we began to notice that her endurance/stamina was deteriorating. She would get short of breath just walking to the bathroom. Unfortuantely her doctor was not monitoring her very well. She was hospitalized with what was first thought to be pneumonia, but it turned out to be pulmonary fibrosis due to the Methotrexate. After being off Methotrexate a few weeks & with agressive pulmonary treatments she saw a marked improvement. I'm happy to report she is doing much better now & is on Humiria with no adverse side effects & it is controlling her RA. She has changed doctors too, who is monitoring her closely.
I am constantly searching for a new RX for her, but to date, have been unsuccessful. Every time I find something new, it seems, upon researching it, that the side effects, are usually far worse than the medication!
Any suggestions?
do'es it take so long for a med. to work,my dr.
says to just keep taking a med i'm on after 3 month's i would think that is long enough to know that it's not working for me, i was still waking up at night crying and can't lift the cover's to cover myself. went to the emergency
room and they gave me a script for celebrex it
has helped a lot but still have swollen joints
and pain. help me please
I am just like the rest of you. I don't mind trying the drug, but how costly is it, and how hard is it to get insurance to pay for it?
However, since it has just been approved by the FDA, I guess it will be awhile before anyone can find out how much this drug will cost out of pocket, how insurance companies will approve its use towards a specific patient, and/or if it works out of the "clinical trial" period.
I guess I'm just fed up with all of the hipe about these new drugs and nothing seems to work.
what kind of financial support do you offer people whose insurance does not cover speciality medications??
None of the biologics are affordable and being on a clinical trial is not very friendly.
Please let us hear that you have a better way for the working class!
and other anti-inflamatory drugs--is this the answer to Ankylosing Spondolitis??
Thanks for your attention to the above.
Pete
hope this drug will help us.
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