All I Want for Christmas Is My CRP
I thought I’d finally gotten out of Rheumatoid Arthritis / CRP purgatory, but I was wrong.
I got an early Christmas present after I got back from the ACR meeting, I got a certified letter from my rheum doc. It said I couldn’t have any more Actemra infusions because my insurance company would not pay properly.
It turns out it insurance companies are using a loophole related to Actemra’s “newly approved” status to reduce payment for this Biologic. So, it cost my doctor hundreds of dollars per patient per treatment. The doc was forced to pull patients off Actemra.
My infusion was cancelled. But don’t feel bad for me. Actemra hadn’t started to help yet, anyway. Last weekend I read a testimonial from a patient who improved after the fourth Actemra infusion. That’s the one that I didn’t get.
Why would someone already diagnosed with RA need a high CRP?
What’s next? A few things… I’m learning a lot about RA clinical trials and guidelines for inclusion, like CRP levels. My CRP tested “normal” last week, which may exclude me.
Do you want to know how I feel about CRP? I feel like I’m a detective solving a crime. If CRP is the culprit, here are some incriminating facts:
- There are genes that lower a person’s CRP. From what I read, the more of these type alleles you have, the lower your potential for CRP is. A Rheumatoid Arthritis patient can have severe inflammation with normal CRP. This recent study implores clinicians to consider this fact.
- According to a study in 2009, CRP was normal in 44% and 58% of Rheumatoid Arthritis patients in two groups studied by Sokka and Pincus.
- There is documentation that each of the medicines I’ve taken over the last several months and years reduces CRP levels: ibuprophen, methotrexate, prednisone, and Actemra.
- There are several things that raise CRP that aren’t technically inflammation: smoking, high BMI or obesity, diabetes, or poor diet. I have none of these going for me.
- I’ve never had a scary high CRP. It’s only been checked a few times in my life and I had an either normal or moderate result.
CRP has certainly implicated me as a liar in the past, so forgive me if I’m anxious to convict. I remember when Dr. Space Heater demanded I admit that a normal CRP proved my Rheumatoid Arthritis was non-existent or in remission. I’d love it if the CRP were right and I were fine, but I’m afraid I can’t lay my spear down yet.
Recommended reading:
- Someone please tell Dr. Space Heater to read these CRP links.
- Read more about CRP and other RA blood tests percentages
- Read the fever post: maybe it’s a more reliable, measurable marker as an alternative for CRP?
Kelly, Do you have a positive RF or anit-CCP? I finally got my doctor to perform these tests and I don’t have the results back yet. A low CRP and sed rate have driven me crazy for years. I have had lupus for 30 years and even in the midst of horrible flares, my sed rate and CRP are normal. Thank goodness I have been able to find doctors in the past who believed me when I said you can’t track my disease status through those tests. However, since moving to Oregon, I have seen three rheumys and they are all DEAD SET on making these tests the end-all be-all of whether I am flaring, or not. So, thanks for this post and the links!
Tamara,
I’m sorry if I left part of the story out – I tried to do phase 1 of ‘CRP on trial’ here so I didn’t distract by adding my whole story since its in other links. The video I mentioned a few times here tells that whole story – I have a great doc now. My doc is not the problem. The problem is the reliance upon CRP or ESR for clinical trials. I hope to write more soon to drive this point home even more clearly, but I wanted to “tell my secret” that I’ve been keeping last couple weeks, too. So, now it’s out there.
My other blood tests – yes – are high and I’m certain RA is the dx. Good docs know that a low CRP appears in some patients, but didn’t know why. The new research I highliight here today will show them why. Even though I have this good doc now, I’m getting copies studies to have it placed in my chart for any future doc I might have to face that is Un-enlightened. For now, my own battle is to get into a clinical trial AND then to help the rest of the medical profession to get themselves educated about CRP… and RA. No problem, right? 😉
I hope you can have time to watch the vid later; I do try to convince patients there are good rheum docs out there & we should go there. Hey, what would happen to the “bad” ones if we all only went to the “good” ones? Interesting thought.
Kelly, I have extra for you as both my CRP and Sed rate flagged on my last blood work. What’s crazy is I don’t have any giant flares. My rheumy was surprised when I said I was fine. I think having pain and not having inflammatory markers or not having pain and having inflammatory markers is part of the puzzle of RA and needs to be recognized. Guess it’s time to start another poll. While we are waiting for docs to figure out what’s already obvious to us (because we’re the ones that actually HAVE RA) you best start adding butter to everything and build your own CRP. I’m so sorry about the Actemra….can the drug company help you at all? I know you’ve tried some of the TNFs but what about the knew ones like Simponi and Cimzia? This is such bs. I roll my eyes at the thought that an insurance co. can just stop treatment when it’s already started. Grrrrrrr.
Yes! Your situation just affirms what is in those other blood test posts – that symptoms & blood work do not correlate. My doc and I agree that looking at my chemistry / history (no response to the tnf’s really) that would be pointless.
Very good post and very true. My labs are never the same. I can have a very high CRP or be normal. The same holds true for being seronegative or positive. I can be one or the other. My doctor stated they don’t have clear reasons but in early clinic studies they believe it is directly related to the medications you are on at that time and nothing to do with the state of controlling the RA. They believe it is more of an indicator that your body is accepting the medications but does not necessarily mean they are working. I think this is why Mayo has taken the stance that every patient is different and clinical observations as well as patient input are critical to your care and management.
This just shows the reform needed. The standards being set and more doctors listening to their patients and thinking outside of that “criteria” they were taught in med school. My doctor said that unfortunately to many Physicians adopt the same beliefs and bad habits their mentors had and are not quick in changing there thinking.
Mel, that makes sense b/c CRP changes very quickly in matter of hours. So it also seems crazy to take a tiny snapshot and think it means anything with RA.
Your doctor is one of the good guys obviously. So is mine. But you’re right – reform – as I been writing here – is necessary.
ugh *hugs* I’m so sorry to hear that you hit a brick wall. I bet I have enough CRP to share with you. Want me to put a bow on it and send it? *giggles*
I couldn’t resist.
I’m singing the “All I Want for Christmas is My Two Front Teeth” replaced with CRP.
Singing with you Katie. And yes – please come with me & give them some of your blood instead! :rotfl:
My doctor had put me on mtx and humira shortly after being diagnosed. He was known for his aggressive treatment. This worked for awhile, about a year. When my flare ups worsened, I requested to try another type of treatment, he pulled up my numbers and quickly said no. My CRP was still normal. I was furious, now I am beginning to wonder if his hands were tied. hmm.
Rachel,
I want to be clear this post is about clinical trials & CRP. My good doc has treated me aggressively all along – please watch the video I mention, if you haven’t. I don’t agree any docs’ hands are tied. Not trying to stir up trouble, but this should not affect our regular clinic treatment & I refused to stay with those docs who treat by CRP / ESR since they claimed i had “no inflammation.” This new study says that’s WRONG. I actually had a rheum doc say: “All that matters is CRP / ESR.” He was the “no DIP” joint guy, too.
ah okay! Thanks!
This is a bit off the subject, but I keep running into battles with the supplementary Medicare drug program I’m in. When I was a member of an HMO before I turned 65, I couldn’t have the biologics because of the expense, and my doctor was told to tell me “They are not for you,” which was painful and embarrassing for him to have to do to a beloved patient. When the HMO folded, he went to another group practice and immediately started me on Enbrel, which has been amazing for me. Last year I had to fight for Cymbalta to be paid for. Why? Because I have NON-diabetic severe neuropathies, rather than diabetic neuropathies, which is the usual! On what planet does that make any sense?
I did win, but it is exhausting and distressing, which I don’t need.
Thanks for highlighting this issue, Kelly. It defies logic (at least mine) that medical/insurance folks are defining medical need or qualification for studies by metrics that are so clearly unreliable. It’s sort of like trying to measure the female population by counting only pregnant people. Makes me question the research that says a new drug is effective in studies – effective at what, giving them the results they have manipulated? This is the same old issue in my opinion – the medical community would rather rely on faulty data than patient input.
Why must we throw stones? Wasn’t there enough of that a couple days ago?
Sorry RARAP, I don’t mean to offend. However, I don’t feel I’m throwing stones…I feel I’m pointing out questionable research standards. If a study chooses to exclude a significant segment of the RA population simply because they aren’t easy to measure, how meaningful can the results be? Every medical authority I know of states that 20-40% of RA patients have one or more negative markers. And, what does that say about the measures? My greatest concern is that too many new drugs are ruled “effective” then rushed to market when in fact they may reduce CRP, RF, ESR labs, but don’t relieve pain, swelling, stiffness, etc. Will we find out in a few years that we have risked these wicked side effects without really slowing disease progression? I think you read anger into my post that is not there. Sorry if my choice of words caused you angst. But I stand firm in my opinions.
Thanks Jackie. I appreciate your comments. It’s hard for us to see why the Clinical Trials use populations that are not really “representative” & I’ve thought a lot about that too. Much of it is due to the standards set by FDA even worldwide standards I think (look here). So it’s not the pharm companies’ fault as much as we think. Also, it always takes time for organizations to catch up with new science (FDA). Also, from what i”ve learned, RA drugs are not “rushed” to market. It can take well over a decade and (edit here: ) over 1 Billion$ to bring a treatment to market & go thru all the FDA hoops – that are for our good, I know.
I’ve learned something over the past few weeks from RaRAP. You know, patients sometimes tend to assume the pharma companies have only their financial interests at heart. But really, the researchers themselves (I’ve talked with some in person) are people like us & even have personal stake in hoping to do well. Sometimes these folks work decades or their whole careers on trying to bring something useful to the market place & they never see it succeed. Many of these people are good people on our side.
Of course I agree with your bottom line about the Trials – I keep saying over & over, “Would it be okay to test a drug on only blue-eyed people & then give it to a different brown-eyed ‘population’ & consider it proven?” But we may need to be appealing to the FDA and the ACR more than pharma. I’m learning as i go & that’s how I see our position at this point. I hope I said that right – it’s really important to all of us. ♥
Thanks for the thorough explanation, Kelly. 🙂 Sure wish a pharma company would spend a billion dollars on research to isolate reliable disease metrics, then develop a drug to address them. I would sign up for the trials on that one.
My background is in Information Technology, so drug research is probably just too complex for me to understand. When we designed and developed software, the most important step was to identify the business & technical needs of our clients. Otherwise, we wound up with really flashy, elegant software that didn’t fulfill the needs of our clients. Likewise, if we only tested the software for desired results, we invariably missed all the little bugs in the code. (I could draw an analogy here, but that would be unnecessarily heavy-handed.)
I’m sure drug development and clinical trials are much more complicated, since they involve “pure” science. Whether it’s because of the ACR, the FDA (or the CIA!, lol), it seems to me that studies which exclude a significant portion of the “end users” are tweaking the science to fit a desired result, kind of like letting only the accountants test an enterprise software package that is going to be used by everyone in the corporation. But I’m just a simple girl…I guess there’s something involved here that I just can’t understand. But thanks for trying. 🙂
No, I think you and I agree: It should be changed. I’ve said so for a long time. I’m just saying it’s complicated. I love the idea of discovering “reliable disease metrics” – I’ve been looking for them too since what we see In Real Life is so different from what’s presented “about” RA. RA is so heterogenous though, it will probably never be fully nailed down.
Kelly and Jackie,
Thanks for the productive back and forth on this. Let me correct a figure. Last I heard it can take about $800 million to around $1.3 billion to bring a drug to market. And about 10-15 years to wind your way through clinical trials. And there is about a 10-20% success rate once you enter the final phase of clinical trials.
Drug discovery and development is probably one of the most complicated and difficult things that I can imagine to accomplish successfully.
Don’t think that people running trials are trying to contrive or manipulate patient populations. The studies must be well defined and approved upfront, including the patient populations as well as the statistical analysis and primary and secondary end points. All of these things must be strictly adhered to and companies are held accountable by regulators to do so. Bad things do happen to companies that do not act properly in conducting their research or promoting their products. Anything from massive governmental fines, loss of credibility and trust, civil lawsuits and even criminal procecution.
Every drug company I know of is looking for ways to find the right patients to treat with their medicines. This is typically called a patient tailoring strategy. These types of strategies are important to drug companies, doctors, patients and payers and they serve to benefit all involved. One of the best examples of this type of strategy is with Herceptin (breast cancer drug) and the Her2 protein marker diagnostics.
We’re working on it, but these things are new and they’ll take some time until you see more of them. I would predict that in the future most new drugs will have some kind of method to better identify what patients to treat.
THANK you. Those #’s quoted somewhere on this site & I didn’t go look them up. I spend so many hours looking up stuff, I might as well memorize more #’s. Need to.
Do you agree we learn from the work on genes will be a help in this?
Genetics are but one component of patient tailoring strategies. So the answer to your question is yes, maybe.
Thanks to advances in technologies it is much cheaper and faster now to sequence a patient’s DNA thus enabling patient stratification due to their genes. The biggest problem with gene research is that we just don’t know that much about how a lot of our genes work and how they affect things like disease. In a recent interview with Craig Venter (he was first to sequence the human genome) he noted that his entire personal genome is online for all to see and that even with this code we don’t know enough yet to use it to tell what color his eyes are.
Here is a link to that interview:
http://www.spiegel.de/international/world/0,1518,709174,00.html
He’s a little brash in some of his comments, but he’s probably not that far off the mark.
Arrrgh…I wish I could reply to this one. But I must bite my tounge. :teeth:
I suspect it has something to do with the label and/or mechanism for this medicine.
RaRAP,
I’m worried that my short humorous post was unclear. This is not in regard to any specific mechanism.
I’m taking the position that based on current research, CRP should go the way of Rf. It should not be a hard guideline for any CT any longer due to the current knowledge of genes and RA. More data & discussion here soon. I have not been excluded from any specific medicine for reason of CRP. I’ve only been told repeatedly by my doctor and trial co-ordinators that “it could be a problem.”
I see now. You pulled a fast one on me. 🙂 I thought your first topic and second topic in your main post were connected.
For any study you need to define the populations of interest. Thus, the inclusion criteria needs to be defined such that you capture this population of interest objectively. In a disease like RA where, even with objective measures, there is murkiness in the classificaiton of having the disease and its severity or activity, the job of defining these inclusion criteria are difficult. I’m curious to see what you have about new strategies for enrolling patients in trials for RA.
Thanks
For any new readers who don’t know, RaRAP stands for “Researcher and RA Patient.”
Kelly I am so sorry that you are having the CRP battle…I have had a similar battle. As when I had my worst symptoms my CRP was normal…and I had to fight to be taken seriously! Then my first DMARD stopped working and my symptoms worsened and I finally got a CRP that was mildly elevated…but my sed was 28 which was not too impressive (because I am over 50) So when I went back to my recently fired Rheumy, all excited, thinking that I just might be treated with another DAMARD…He claimed he saw no sign of active inflammatory arthritis or RA…even though he “presumes” I have RA because of a past diagnosis. He spent more time looking at the lab results and his laptop than he did examining me. I questioned him in regard to the CRP…he said..’Oh it is probably due to something else” end of story…One week later I was in the Emergency Room, had a Steroid injection in the butt and started high dose steroids…Now I can walk…and walking is good…My new Rheumy appointment is Dec 8th I hope I get some answers…I don’t’ know why we have to fight so much…but I pray every day for all of us…Hang in There <3
Hi Kelley, sorry to hear the news. I am in an Actemra trial that is focused on evaluating its effectiveness in combination with MTX. There are 4 groups: 1. MTX alone (Actemra placebo), 2. Actemra alone (MTX placebo), 3. MTX plus Actemra low dose, 4. MTX plus Actemra high dose. Double blind study, so I don’t know for sure which group I am in.
But I figure I am getting Actemra in some way. The RA symptoms were reduced about 2 weeks after the 2nd infusion (or about 6 weeks into the medicine). Then at about the 9 week point (after the 3rd infusion) all the symptoms are essentially completely gone. From what I learned about MTX is doesn’t typically provide results so quickly, which is why I am concluding I am in one of the actual Actemra groups. Last summer I was limping instead of walking, very difficult to get out of a chair, slept only an hour or 2 each night. Now I am back to normal, no pains anywhere, can crawl under my cars to fix them, can walk a few miles.
I think it is shameful for the insurance companies to “play doctor” with our health. I know Actemra is expensive, but we have the insurance to actually pay for the health care. I’ve heard other people give positive testimony for Actemra, so with enough momentum this could all change soon if it works so well.
Hi Kelly, Two separate issues really insurance and then research study inclusion/exclusion criteria. I have two thoughts which may be random but thought I would float them out there anyway. Insurance: I have heard people appealing to their State’s Insurance Commissioner. I don’t know the process or if it will even help. But it is the job of the office to regulate the insurance business. If the insurance companies have found a loop hole and you are being prevented care they should help you close it. In theory anyway….You are in FL right? Here’s the link http://www.floir.com/
As far as the clinical trials. Have you thought about contacting the researchers directly? They will not be able to change their criteria for ongoing trials but a good researcher should be concerned about the external validity of his/her experiment. This is a HUGE concern for research and I would think they would be concerned. Maybe not but most researchers are committed to ethical and sound research. They may not realize what is going on in reality.
I am happy to help you if you need it you are quite a warrior but if you need a “wingman” let me know ♥
Kelly: I was so disheartened to read your post about no longer receiving Actemra. You and I have been on a similar timeframe with Actemra and I’ve been curious to hear your results and was hoping for the best for you and your family. I just received my 5th monthly infusion, with the dosage upped from 320 mg. to 640 mg. since I had no improvement the first four months. This seemed like a big jump, but at this point, with the pain I have been in for the last three years and having tried almost everything else on the market, I didn’t seem to care about the amount of meds going into my body, I just 1) want the daily pain to go away; 2) have some hope to resume some kind of life. Also, during my last rheumy visit, one day prior to my infusion, I had a cortisone shot in each of my hands as my knuckles were so inflamed. I have an occasional cortisone shot (3xs/yr) and have found relief for about a week, so much that I can actually forget about RA for a short time, which you can imagine is an incredible, joyful feeling.
Almost two weeks after my last Actemra infusion (and Cortisone injections), I am still feeling good. I know everyone has different results to similar meds, but is anyone having a positive response from Actemra? And how can we get Kelly back on the med 🙂
Here in the UK the NHS are highly unlikely to fund biologics if your ESR and CRP are non-remarkable.
For a long time now my bloods have been pretty normal, my first Rheumatologist discharged me saying there was nothing else to do. I asked for a referral to a second rheumatologst who actually listened and examined me and put me on hydroxychloroquine and methotrexate. Although I’m much better than I was back then I still get inflammation and a lot of pain but my ESR and CRP are normal so I can’t get anything stronger to help my disease. It is quite a relief to know I am not alone in not having the typical blood results all the papers and research says inflammatory arthritis’ must have.
That’s sad Amy. I hope they can be educated. Maybe show some of your doctors the studies that are linked to here.
Kelly, regarding the clinical trials you couldn’t get in (so sorry), oh, my word, how much pain, fever, inflammation, joint damage, etc., etc. does a patient have to have before people running the trials will admit that whatever meds that the patient is taking aren’t working? When my insurance tried to pull out of paying for Embrel for me, my rheumy went to bat for me and it worked. Any hope that yours will do that for you?
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I always feel like you are taking about me. Thanks for putting into words the perplexity that I feel often. Thank you for making me feel less like a RD fraud. ( I do have a fantastic rheumie though) 🙂