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Treatments > Drug Guide > Types of Drugs > Drug Guide: Biologics
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Drug Guide: Biologics

Everything you need to know about biologic response modifiers

By Donna Rae Siegfried

What are biologics?

In general, biologics are genetically engineered medication made from a living organism, such as a virus, gene or protein, and then used to treat a problem occurring in a different organism, such as a human. Vaccines are one type of biologic agent. In contrast, other drugs are synthesized chemicals.

What conditions do biologics treat?

Because the biologics block triggers of inflammation, they are used to treat autoimmune forms of arthritis, such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis or psoriasis/psoriatic arthritis. Inflammation is the result of the immune system’s errant attack on the body’s tissues, causing joint pain and destruction, as well as other systemic effects, such as fatigue and heart and lung damage. Some biologics approved for rheumatoid arthritis are approved for, or are in development for, other conditions, ranging from Crohn’s disease to cancer.

How are biologics used?

Some biologics are used after a patient has “failed,” or not responded adequately to, traditional disease-modifying anti-rheumatic drugs (DMARDs) or other biologics. When a biologic drug is used for treatment, it is used often in combination with a traditional DMARD, such as methotrexate, for greater effectiveness.

Will biologics cure RA or other conditions?

Unfortunately, no! But the biologics, which work for about two-thirds of people who have rheumatoid arthritis, can induce remission in most people who respond favorably. A clinical remission is defined as fewer than 15 minutes of morning stiffness, and no tender or swollen joints for at least three months. Treating rheumatoid arthritis and other inflammatory forms of arthritis aggressively with DMARDs, including biologics, as soon as possible after diagnosis increases the chance of remission, as well as minimizes the risk of limited function due to permanent joint destruction.

Why can’t two biologics be taken together?

Biologics and other DMARDs decrease inflammation and disease activity by impairing the immune system’s activity. But suppress the immune system too much, and an overwhelming infection could take hold. Limited studies suggest that taking two biologics at the same time would increase the risk of infection markedly, without an increase in therapeutic benefit.

Why are biologics so expensive?

The materials required to create these agents are more expensive, and the manufacturing processes using live organisms are more complex than are required for traditional chemical pharmaceuticals. Other factors include the high cost of research and development. 

All of the current biologics are still under patent protection. After a traditional drug patent expires (20 years from the date the company applies for it), other companies can produce generic versions that cost less.

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Jodi
18 Nov 2009, 08:16
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I have RA, OA, and Fibromyalgia. I was also diagnosed recently with Lymphedema is both legs. I had been on Remicade for 1.5 years along with methotrexate, lyrica, folic acid, prednisone and pain meds. I am fortunate to have a PCP that understands pain and helps keep it under control. I was going to a rheumatologist to handle the biologics. I have experienced that the rheumatologists I have went to don't want any part of managing the pain aspect of these diseases which is strange to me. I would think they would have a better understanding of the pain these diseases produce. But, after a year and a half with no improvement on the Remicade, we decided to try Rotuxin. The first infusion I needed some extra Benadryl during the infusion for some itching that had developed but it went away and the infusion went fine. You get another one 2 weeks later and all was fine. The next one is 6 months later, followed by one in two weeks. The third one was good, all of them had been infused over 6-7 hours. The fourth infusion was infused over 3-4 hours as I had been doing so well. Later that day, I began having involuntary movements of both my arms and legs. It was like I was having seizures but remained awake and aware while it was happening. The movements were so violent and uncontrollable that I bruised my arms hitting furniture. It was terrifying to me. I had to be taken by ambulance to the ER. It took three people to hold my arm still to get an IV going.They pumped me full of everything they could think of to stop what was happening but it took hours to stop. I was in the hospital 5 days on massive amounts of solumedrol IV to keep the reaction under control. At first my rheumatologist didn't believe it was a reaction to the Rotuxin but a pharmacist at the hospital looked it up and this was listed under the possible reactions. I was off work 2.5 months while I came down from the prednisone I had to take. I was on 5mg BID before this happened. I left the hospital at 60 mg BID and had to wean down slowly. I was in so much pain and the weakness was horrible. It took everything I had to get out of bed. I was successful in weaning down to my regular dose of prednisone and I'm now back to work but I am not the same. The pain is worse, because of course now that this happened, the rheumatologist won't give me any other biologics. My insurance will only pay for the infusion meds, not the injectables. My PCP is continuing the methotrexate and all my other meds for me because I was taken off everyting in the hospital and the rheumatologist won't let me go back on my regular maintenance meds. It's very difficult because the Rotuxin was working and making my pain less and my mobility increased. I don't know what is going to happen now, I'm trying to find another rheumatologist but there aren't many in my area. I wanted to relate this experience to you all in the hopes that it will allow you a little more information about this drug. I think that I had a reaction because it was infused faster than it had been before, that was the only difference in the four infusions. The physician doesn't agree with me and when I called the manufacturer of Rotuxin, they said that it can be infused over 3-4 hours. So maybe I'm wrong but perhaps I'm just someone that needs a slower infusion. It's a moot point anyway because I can't ever get this infusion again, I wouldn't want to go through that again. I'm just disappointed because it was helping. Good luck to all and thanks for all these posts. They really help me to cope.
Victoria C.
06 Nov 2009, 23:12
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I am 65 -- I was born w/o a rt. hip & had 3 operations... in a body cast from 16 mos. to almost 3 years. My orthopedic carved me a hip from my pelvis... didn't charge my mom one cent. I learned to walk, as mother was what I later called "the PT Whisperer"... besides taking therapy, I had swimming lessons, rode horses, climbed trees, rode my bike, and was a basic tom-boy until high school. Then my mom enrolled me in modeling school so I could better learn how to walk, to carry myself, since my rt. hip was stiff & I had a slightly pronouced limp. I took restricted PE, taking golf and archery classes. All in all, my childhood and middle thru high school life was pretty normal... if I don't include the falls, the injuries, & pain that would sometimes cry me to sleep. When I turned 18, my wonderful old miracle-maker doctor sat me down for a serious talk. He said I had the body of an 80 year old woman now. I can remember sitting there, stunned. Perhaps I said something flippant like 'you don't know who you're talking to... I'm going to prove you wrong'. Can't remember the whole thing... I just wanted to get out of there FAST. And that's what I did -- I lived my life fast too, like a shadow was chasing me. For 10 years, things went pretty good... then it all started to catch up to me. I hate to admit this, but I have now had 39 surgeries. Amazing. But each time when I was in PT feeling sorry for myself perhaps, for some reason God would show me someone else who was in worse trouble then me. I've learned a lot of lessons while going thru this. I'm married now, we have a 37 year old son & we're finally grandparents... I'm so happy. But I'm also frustrated... I have tried so many different procedures & treatments. I have 3 artifical joints, 2 hips & a knee... the other knee is what they call 'inoperatable' as I was only 28 when I had my 1st hip replacement (that rt. one). Since it was a 'teaching hospital' they said I was going to be the youngest patient to get a total hip. Back then, they had to heat the glue very, very hot so it would attach to the femur. However, the glue seeped out of the femor, running into the femoral nerve and destoying it. Within 6 mos. I had no quads. I went to 26 doctors in 10 years, desperately trying to find the doctor 'who could fix it'... and believe me when I say there were a lot who wanted to 'try'. I finally desided that I would have the knee replacement... scheduled it. But 1 week before that surgery I drempt that I should talk to the surgeon again. So I did -- I asked how many of these surgerys he'd done. Would you believe he told me he had never done even one??? Well, it's the truth... however, he did say he'd been 'talking with his collegues, and he thought he could do it'. The saddest part is how angry he (& even his nurse!) got when I said I'd changed my mind!
About 6 mos. later, I was seen my a doctor who only worked on knees... when I told him my tale of woe, especially the part about almost having that knee replacement... whoa. The only thing I can say is how very,very lucky I was. To begin with, he explained that when I had my hip replacement there were very few doctors who knew how to do the surgery since so few had been done. Because of this, at teaching hospitals especially, sales reps who were selling those new doctors hip joints were actually showing the doctors how to do the surgery... lots of times they were the ones doing the surgery while the doctors watched! And my problem with hot glue burning out my femoral nerve was NOT unusual... lots of patients had this problem. But my biggest miracle -- not having that knee replaced. Because the femoral nerve was burned, I lost my quads... quads hold our knees together, and w/o quads... I would have lost my leg within 6 months! He said there was nothing there to hold it all together. So dear people, patients who are going thru hell and back -- beware. Trust your gut & your dreams. Don't be so anxious to have it 'fixed' that you make the problem bigger then it already is. At 18 I didn't understand how I could have an 80 years old body... but at 65, it all makes sense to me. It was a warning... yes, I'd won a lot of battles, but what I didn't allow myself to see was how many more battles were going to be ahead of me. And I also have learned to accept what I have and to honor it. I now have severe OA, RA, PSa, Fibro, Shogren's Syndrome, Uveitis (3 surgeries so far, another coming up in Jan. 10), and Chronic Pain. I have been on Humira for 3 1/2 years... since it's starting to lose it's punch now & not doing as well as it use to the Rhuematoid doc is trying to get it for me once weekly... the insurance company is balking again. I have tried several other DMARD's, but had allergic reactions (from heart problem to out of body experience). It's really important to find a good pain specialist. My primary care had handled this problem for over 15 years, but I had a lot of stigma regarding taking medication. Finally I have a specialist who has truly helped me get over that stupid 'shame' thing I was going thru -- hey, this is a real problem... nobody should have to go through unrelenting pain. Keep looking for a good doctor who can help you understand it... the trick is to 'stay ahead of the pain'. And when you get to use to one type, switch to another kind... then you can go back to the other one when you get use to the 2nd one. I'm not ashamed anymore... I'm a survivor!
Sue ellen
15 Sep 2009, 10:57
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To Terri,

There are foundations that can help with payment for the biologics. I have psoriatic arthritis, and went through 2 knee replacements and then it went to the hands, I left my job in January and am waiting for SS. We are living on one, very small income, my insurance through hubby only covers part of my remicade infusion (which by the way has helped a lotespecially for fatigue) and a foundation that my rhemy referred me to is picking up that other portion, which wld have been 2,500 a month for me, I cld still not afford even if I was working. so don't worry there is help out there, also hang in there. I have really bad days too, pain don't feel like going on anymore, appreciate the good days. God bless
Jean H.
02 Sep 2009, 14:06
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Claudette, you should check with Enbrel directly. Drug companies usually have financial assistance in a case such as your's.
claudette
26 Aug 2009, 13:37
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i have been reading these and now i seem more afraid. I am on enbrel and methotrexate and for awhile it seemed o.k.but not so good now. my doctor is thinking of switching to infusion. i am a little worried. my doctor does not pr escribe pain meds but sends me to pain clinic. she keeps up with blood work every other month, now i have lost COBRA and medicare does not kick in for 7 mos. where do i go for financial help?
Judith
17 Aug 2009, 14:51
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The high cost of biologic modifiers is horrifying, and hardest on people without any insurance. For those with low enough income, some of the drug companies will help to subsidize their biologics. Although I do have Medicare part D insurance, and am taking enbrel monthly at what will be a cost to me this year of at least $1500 a month, I wondered if there is any subsidy for people of lower middle income?
terri
06 Aug 2009, 20:04
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i like reading everyones text;however I am so confused on what to take next. i have Fibro OA RA.It has gotton where I work and almost nothing else just rest in evenings I fell isolated because I cant really be social I dont have the energy. I have three dogs that keep me company and a great husband, two kids 21 and 18 both in college.Struggling with pain and depression. I am taking plaquinil, nsaids ultram,lunesta to sleep and muscle relaxer.Go to Rhemotoid dr, end of August wants me to start methotexate. I already get sick all the time........
Angel
05 Aug 2009, 15:29
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Pss..
Please people take the time to write the FDA & your local congressman/respresentitives. It takes all of us "together" to make changes. They need to know how we feel about the medications we are or are not being prescribed.

Arthritis Advocate
Angel
05 Aug 2009, 15:24
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I totally agree with Jean.."If you can't cure it, at least let the pain be less!" There is no cure for RA. The meds they have "suck". There are all kinds of side effects to these drugs whether you get them sooner or later is the only question. These docs can kiss my A**! They are all out for kickbacks anyways..its true. Even the pharmacies are getting kickbacks off the prescriptions they sale. Its like we cant trust our own doctors or pharmacies...thats really sad! Its all about the $! Looks like every doc out there is prescribing Lyrica..hmmm..they dont even know the long term effects of this drug. Yet, we cant get pain meds that have been around forever and ever. FDA is so afraid "we" are all addicts out here that we are having to suffer in pain because the govt has their fingers in everyones pie! I have RA, Fibromyalgia,bursitis in my hip, and nerve entrapment in my elbow, so I understand pain. Im telling you...I just dont think they care.
jingyi ou
04 Aug 2009, 20:01
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i have RA for only a year.i used to be a international student.now because of my RA,i have to quit my school and go back to China. being alone in the u.s. is so helpless to me.after searching all kinds of information, i find out the place where i born, guangzhou,China,the doctors treating RA are much more skillful than the u.s.doctors!never think of the benifit due to the large population.every time i got pain,they will have ways to help me out by only using DMARD and MTX.now i am living without pain.
Kim Knight
04 Aug 2009, 13:18
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My son has just turned 14. He was diagnosed with arthritis (still unknown what type) when he was 8. He is currently on Feldene. It isn't working. He is in so much pain. He is now quitting sports at school. He complains of pain to his temples, jaw, back, neck, right shoulder, right knee and both feet. I have to wait 3 months at a time to see the pediatric rheumatologist. I feel helpless. It seems that with each visit we are getting nowhere. Does anyone know where I can get help for my son. I will go anywhere.
Bob M
04 Aug 2009, 12:29
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I was diagnosed with Psoriatic Arthritis 40 years ago, very mild, mostly in my hands. Over that time I have been on almost all anti-inflamatory drugs. In the early 80's I was put on Methotrexate. I was on it off-and-on since then. Since 2005 I have tried Enbrel, Humira, Remicade, and Methotrexate. Since 2008 I have just been on Methotrexate and have gotten good results. In May of 2009 I developed what appeared to be the flu and went to the emergency room. I was diagnosed with Renal Failure due to Methotrexate poisoning. I will now most likely be on dialysis for the rest of my life. I had the appropriate lab tests every other month, and saw my Rhuematologist regularly.

Don't take Methotrexate for granted, it can be very dangerous.
Marti
23 Jul 2009, 15:06
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Well after readig these I am not sure what will happen. I was diagnosed a long time ago when I was 7 but my parents made the decision to not tell me. I caught conversations some time where I did hear someone say I would be lucky if I was not in a wheelchair by 30. I am fifty years old ad I am not in a wheelchair and have worked hard as an RN for years. I had a accident which for some reason made what I had been living with unbearable. I have never had a day without pain and stiffness that I can remeber but now its a different story. After my accident my neurologist put me on fentanyl for my pain. I could not stand the effects from other pain relievers---pain fog, zoneing out and not recalling what I did just a few minutes before. I had been sent to a rheumatologist who confirmed that I had the autimmune disease and also told me that due to my allergies I could not take anything else. I lived with the fentanyl, lyrica, amytriptaline, and other meds. My pain stayed under control until due to insurance I had to swithch Dr. I do not know if any of you live in TN but it is a pain to find pain control here. So I went looking for a new Dr. Many turned me down ,some refued to see me after I gave them a list of diagnoses. I finally found a doctor but by then I was hurting sooo bad and my hands were totally useless because of the extreme pain that he also put me on hydromorphone along with the patch. Well after 5 months he goes into practice with another Dr. and I have been given 23 days to find a DR who will prescribe my meds for me because they will no longer precribe class 2 meds. I have osteochondritis dessecans and Alkylosing spondalytis with neuro effects fron a right temporal brain injury with neck and back injury. So After reading all of this does someone have any suggestions. When the Dr. told me I had less rthan a month to find one I lost it in his office. Not yelling at him but getting upset that I would have to go through finding another Dr. when I had just done it 6 months ago and it was so hard. well I will say goodby and maybe someone knows a med that would work and at least keep the edge off the pain.
Dian Ryburn
22 Jul 2009, 15:36
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I was diagnosed with Rheumatoid Arthritis over 10 years ago. Originally, I started out on various oral medications. These included methotrexate and folic acid. Over the years, I have progressed to different medications to control my flare-ups. I have been on Enbrel and methotrexate, then switched to Remicade & methorexate. At one point, my bone marrow quit producing new blood cells. They managed to save my life (it was in question) and I was told never to take any more methotrexate. I was on it for 10 years before it nearly did me in. I can sure tell I no longer take it, though the Remicade seems to be working pretty well at this point. I take it every 6 weeks. In addition, I have a pain killer I take regularly. God bless my rheumatologist. Some days, I don't need any....other days, I need several. I have been extremely lucky in the selection of my doctors. Having had one knee replacement, I am still in better condition than I was 5 or 10 years ago. I think a certain amount of pain and swelling and stiffness just go with the problem. Positive thinking and determination help.
JennS
11 Jul 2009, 17:21
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I was diagnosed with severe PA a little over 3 years ago, at 27. I was started on NSAIDs (several different kinds), then moved onto methotrexate (with increasing dosages) and eventually Humira. I had horrible, excruciating pain in my jaw, upper back, shoulders, elbows, wrists, hands, knees and feet (heels and balls of feet) along with inflammation (swelling) of all my fingers and toes - to the point that my rings had to be cut off.

The Humira began working almost immediately (within 2 weeks). I was on a combination of Humira and Methotrexate for a year, I then went off the Methotrexate and was only the Humira every other week. I was doing so well that my Rheumatologist moved me to taking the injection every 3 weeks. Last November (9 mos ago), I started to have pain in my knees and feet but no swelling. I would have random pain on and off in my legs and feet.

I moved back to taking Humira every other week, but within the last 2 months, extreme pain and inflammation has come back and I don't think the Humira is working anymore. It's awful bc I was pain-free for almost 2 years. I now feel worse than I did before I was diagnosed. I have terrible pain in my shoulders and upper back, elbows, wrists and my fingers are swollen again. At night, I hate to fall asleep because I know I will wake up several times a night with extreme pain and in the morning. I also experience terrible pain in my knees.

My Rheumatologist started me on NSAIDs again (with Humira) a month ago, with no change and I started Methotrexate again this week. I hope the combo of Methotrexate and Humira will help me. Has anyone else experienced something similar? I wonder if this disease will go into remission again and I will just get random flare-ups and then go back into remission from time-to-time (fingers crossed). I can't imagine being in this much pain and having it get worse for the rest of my life. I'm only 30!
Diane
07 Jul 2009, 15:48
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Last July I was diagnosed with psoriatic arthritis. I was barely able to walk, had pains in shoulders, hips and feet and some fingers and toes had stiffened. Went to a Rheumotologist and she stared me on Methotrezate injections. After several months of limitied improvement, in February I started Remicade infusions. Wow, after my second one, I was so much better. Now after 4 infusions, I am so happy to say that I am about 90% back to normal.
And thank goodness, with no side effects, either! I am on an 8 week program.
Still on Methotrexate pills, folic acid and iron supplements, but no pain pills. I am keeping my fingers crossed (yes I can do that again without pain).
C. Meadow
19 Jun 2009, 15:16
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My mother is in the process of switching rheumatologists, in search of another medication for her pain. Her pain until recently had diminished, but returned after taking a Tai Chi class to relieve anxiety. She has noticed that many of the newer medications, although effective, are not safe for older people (that over 60.) People should heed these warnings and consider alternatives where needed.
Griselda M
16 Jun 2009, 12:26
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I was diagnosed with juvenile rheumatoid arthritis when I was 16 years old, I'm turning 30 soon. I feel like I have been an experiment for the doctors with all the trials of medications...In the last few years I was taking Enbrel it started pretty good but then I started getting sick lots of sinus infections, I was off Enbrel more than what I was on it, but the rheumotologist wouldn't change it, it was very frustruated. Finally I had to see another Doctor and even though he didn't think Humira would be any different he change my medications. Humira has worked for me, I don't take it with methotrexate, i wan't to not take a lot of meds, there are still those days that are horrible and people don't seem to understand what I'm going thru...I won't give up I will continue with the Humira hopeful that it won't give me any problems in the future
marty conquest
16 Jun 2009, 10:10
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I've ben taking Embrel for several years now and have noticed a significant improvement in my ability to do everyday tasks. I was originaly given methotrexate and this really upset my stomach to the point of being hospitalized. Talk to your health care provider and choose the right treatment, whatever it may be
C. Meadow
02 Jun 2009, 16:57
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My mother has had rheumatoid arthritis for over 30 years now, and her hands are severely deformed. When she was first diagnosed, doctors only gave her aspirin to treat the symptoms. There wasn't adequate treatment available back then and RA was difficult to detect in the blood, as well. About 5 years ago she was given Enbrel injections. She later developed shingles, which is a viral infection, and had to stop taking immuno-suppressants (Enbrel). Since, then she switched rheumatologists, and has been taking Arava, which seems to have put her in a remission, though she recently stopped taking it due to some side effects. I would strongly encourage those with RA or any rheumatic disease to continue your search for better and safer medications, and to strive for remission. Improve your diet, get extra rest and keep a positive mental attitude by reducing stress. Best of luck to you all!
Deb
23 May 2009, 23:36
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I have been fighting psoriatic arthritis and fibromyalgia for 4 years. My joints totally locked up and I was in terrible pain. I found Humira was Wonderful with Methotrexate and Nabumetone for my Problems. I was feeling the Best I had felt in years. However, I had side effects from the Humira and had to stop using it. :( I am now using Embrel with Methotrexate and Nabumetone. It is helping but not as well as the Humira, but the side effects from they Humira have gone away... I started having Problems with my weight & my Regular Physician put me on Phentermine, I take a half a dose - I haven't lost any weight but interesting enough I found that it has helped my fibromyalgia and I have less fatigue. Due to Insurance going up so high, I just spoke to my Regular Physician to see if he can prescribe my medications & he said he can, so long as my Rheumatologist agrees. I will talk to my Rheumatologist about it next month about seeing her once a year. I tried Celebrex and I hate to say, but it did Nothing for me. Maybe your p/c can switch you to something else like Nabumetone or another nonsteroidal anti-inflammatory drug. I take each day as it comes and I have always been a fighter, so I am hopeful one day I will be pain free, I am better than I was 4 years ago, but I do deal with my pain and lock ups daily. I just try not to dwell on them and try to me Positive. I remind myself daily how much better I am than I was and it could be worst. I know I have good days and bad days, but I look forward to the good ones. Good Luck and I hope they find a cure for us soon.
Jean L
19 May 2009, 22:39
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I have been diagnosed with psoriatic arthritis and osteoarthritis by a rheumatologist after being treated by my pc for over 15 years for fibromyalgia. The only differance I see from the primary care to the rheumatologist is the addition on Enbrel and trying to decrease the lortab 10 to one a day from 2-3 a day. I also take Lyrica and celebrex daily. At this point I am getting very upset with the rheumatologist because I don't understand where the progression of my disease is and feel my primary physician worked with me better on controling the pain at least. Does anyone else have this kind of problem? I have tried to avoid going to multiple drs. I now see why people do go to more than one for pain meds. If you can't cure it at least let the pain be less!
sue ellen
05 May 2009, 11:53
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Jan,

Saw your text, I don't know either as I will be getting my fourth infusion for PA and have not seen pain relieved yet. am going on 5-13 and having a heart to heart with dr. My PA has caused 1 knee replacement and I am getting the other one this year. Had to quit work due to this.
Jan S
17 Apr 2009, 15:17
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I just started Remicade treatments for AS. I've had two infusions so far and take weekly injections of Methotrexate as well. My doctor and rheumatologist say the affects are often felt after the second infusion. But I still have more that 15 minutes of stiffness in the morning and my ankle swelled up just the other day. Will things get better or am I doomed to have pain and stiffness forever?

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