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Kelly – once again you’ve hit the nail on the head. Clinical trials are not really designed to produce “cures” OR to treat patients. They are designed to “prove” that the drug at hand 1) won’t kill patients, 2) or at least not kill too many, 3) while reducing some of the disease effects. In order to “prove” these things, they need to control all extraneous variables as tightly as possible. The definitions of “disease state” for clinical trials are not the clinical definitions and may not be related to clinical manifestations at all! They are simply used to limit the trial “tightly.” But frequently they are not even related to the disease!
Good points on the purpose of trials, Elizabeth. On the other hand, half of the rheum docs I’ve met say that CRP is *the* measure of disease activity & that’s becoming more prevalent according to what I read. There are more 2 points where the CT intersect real / clinical life. 1) When an RA patient has no further treatment options – those 30% of patients who don’t respond to any of the approved treatments – getting into CT is the only option for treatment. 2) The recommendations for how to use the drugs and their so-called success rates are applied to the general RA population, even though they are not tested on a representative sample. This causes improper expectations about success rates w/ tx. This is why patients tell us they are not better, but the docs tell them that they are better since their numbers are improved – and since the statistics that come from the trials say they “should” be “better.” That was off the top of my head but I’ll think about this more.
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More and more i find ur pages so interesting and learn alot from you…i already had my blood checked and went to the Rheumy and she wanted more blood! The nurse came in and said dont worry..she just wants ur crp..in a low voice! Whats the secret all about nursy? Cant wait to get my copy of med.records w/doctors notes!!!! I learned from you that half of all Rhuematiods(because i wont say arthritis anymore) have normal Crp levels!! This revelation is huge for me! Thanks again Kelly!! you work so hard for us! Im eternally grateful for you and this site!..
Good luck with your crp Judi. whispering is funny – haha – who knows. As long as your doctor treats you either way, hopefully you won’t need to worry about it too much. (see Julie’s comments.)
What huge discrepancies between reality and practice. I must say that my rheumatologist doesn’t take my normal CRP ,as evidence I am in remission. He looks at those other factors such as ongoing fever, synovitis, joint pain, fatigue, anemia, etc. It is a relationship of him knowing my disease pattern, over 15 years. His theory seems very contrary to the qualifications needed to get into a clinical trial.
I don’t understand why there are not clinical trials designed for those RAers who have exhausted the current FDA-approved medicines, without the elevated CRP being that gold standard of clinical trial eligibility. I think Elizabeth had a pretty good answer, but we need to somehow bridge this huge gap. So many are going without any hope of new meds and are losing valuable time.
Look at how many cancer patients (several who i know personally) who, having exhausted current FDA-approved chemotherapeutic agents, seem to commonly be able to move onto experimental drug trials fairly easily(if the patient desires and a clinical trial is available). I wonder if they have such an unobtainable lab standard to meet, before they are able to begin the drug trials.
Julie that is a fantastic statement. I agree. My kids asked me about “compassionate use” even. With CT, there is sometimes something called “expanded access.” But i have no idea what is required to trigger that. It would have to come from the FDA, with the agreement of the pharm company, I suspect. I’ve never heard of it with RA yet.
Excellent read! I feel so privileged to have a provider that understands my medication will alter and suppress clinical labs. Despite having a relatively low Interluekin 6 result my physician stated it does not prohibit me from the trials. That my medications are most likely suppressing my results. He went on to state the negative lab results and why if any reason for them are part of the study as well.
It is so refreshing to hear this for myself but disheartening as well knowing that is not the case for far too large of the majority out there.
Mel – that is good to hear. It is not the norm. Did you see this?
You already have some of these points made in previous comments, but I wanted to give you the actual criteria that are used to calculate the ACR20, 50 and 70.
The ACR70, ACR50 and ACR20 are criteria that have been developed to demonstrate the comparable effectiveness of certain therapies. It is used primarily in clinical trials. In order for a drug to be deemed effective and thus get FDA approval it needs to demonstrate that it actually works. Not only that it works, but that is significantly better than placebo or simple aspirin.
So the ultimate goal is not to declare someone cured, but to demonstrate that one therapy has a higher probability of improving someone’s condition. It is important that all researchers use the same criteria for improvement so that we can compare the effectiveness of one drug to another.
Unfortunately, these criteria are not as straightforward as they sound. While they do include an improvement in the number of swollen joints, this is not the only factor that is used to demonstrate improvement.
The ACR criteria actually require improvement in tender or swollen joint counts AND improvement in three of the following five criteria:
1. acute phase reactant (i.e. sedimentation rate)
2. patient assessment
3. physician assessment
4. pain scale
5. disability/functional questionnaire
As you can see patient assessment, pain scale, and disability/functional questionnaire are all included in the criteria. These 3 areas are highly dependent on patient input. So rather than run a simple CRP and declare you have no disease, your physician should be familiar with these other parameters.
For example, if a study reported that 55 percent of patients achieved ACR 20, that means 55 percent of patients in the study achieved a 20 percent improvement in tender or swollen joint counts as well as 20 percent improvement in three of the other five criteria.
It is important to note that for patients to be assessed using ACR criteria, they must have participated in a clinical trial. These specific criteria are not used in everyday practice. You will not hear your doctor say, “Hey it looks like you achieved the ACR50 today.” The main reason for this is that when you participate in a clinical trial they take some baseline information and then future outcomes measures are compared to your baseline.
The ACR web site actually has a nice collection of criteria and practice guidelines for various rheumatic diseases: http://www.rheumatology.org/practice/clinical/classification/index.asp
Thank you, Steve. I agree. Unfortunately there can be an intersection between what happens in clinical trials and real life in some ways as I mentioned to Elizabeth above.
I guess this is off track somewhat, but many doctors label patients with “clinical remission” if CRP results are in normal range. There are of course treatment implications to that and most patients I talk with do not agree with the label.
For the acute phase reactant, I’ve been reading that the CRP is interchangeable with ESR & more preferred now. Is that wrong?
My CRP has always been normal. Tell that to my shoulders, knees, hands and feet. Thanks for continuing to champion truth.
I know my rheumy goes by my labs and says I’m “stable” but she doesn’t take into account my fatigue, pain and my functional ability – I tell her about the first two, often overlook or understate the last one, as I work full time, and figure if I can “get out there and work full time, then I must be ok???” (I think I am deceiving myself there). I wish I could be taken seriously when it comes to my pain and fatigue with this disease….
Thanks Kelly for another great article!!!
Facts do not cease to exist because they are ignored.
– Aldous Huxley
Look at abstract 1051 from that meeting to see that those in clinical remission do still show signs of active disease on biopsy, ultrasound and MRI – though there was ‘less’ activity on those on TNF inhibitors. They all still showed active disease. Kelly, how’s the prednisone going, and have you considered adding plaquenil? I resisted that one for years, thinking it’s a whimpy DMARD and won’t do anything for me, and because of potential side effects, until my doc FINALLY corrected one of my misconceptions, and because I’m less controlled than before on mtx, and it IS helping some with pain levels. Not sure it’s stopping progression, but is helping some with pain if nothing else and I’m hoping I’ll be able to taper off prednisone with it. It’s still far from perfect, but is helping.
Yes, I attended the long sessions on remission. I hope to write about that soon. Yes, I’m considering certain dmards as options for a triple therapy. I’m glad you are doing better.
Still, Dr. Bili and colleagues conclude, “Although HCQ has only modest disease-modifying effects in the treatment of RA (rheumatoid arthritis), its apparent effects on lipid profiles, and elsewhere reported inhibition of platelet aggregation and reduction in diabetes risk, along with its excellent safety profile and low cost, make it a beneficial first-line or an adjunct therapy for RA patients, particularly those with traditional cardiovascular disease risk factors.” http://www.medscape.com/viewarticle/733758?src=rss
Thought you might like the above info.
yeah I do like that info. The RA can & may often be attacking the heart in all patients, even those who don’t have bad joint symptoms – I saw similar reports at ACR about biologics giving protection regarding CVD. May be true even when we don’t notice a postive response to joint symptoms – that is why I say we ought to treat – even if the RA seems recalcitrant (like mine). Another reason to consider dmards.
I have a relatively high CRP (whatever that means)…I didn’t know they knew anything about it, my doc’s certainly haven’t told me it means I’m “more sick” or anything.
I just wanted to say as well that I have been battling pleuritis recently (think it’s gone now) and haven’t had any infections or anything – just from RA we think.
I hope it’s gone for good Michael. “just the RA” – yeah. Well, at least you have that CRP in your back pocket if you ever need it. 😉 It’s when its normal that sometimes insurance or diagnosis or treatment decisions are affected. That’s what patients say.
Never thought of it that way…maybe I can gift you some of mine – keep your eyes out for a package in the mail!
Your right, the pleuritis better be gone – that was more painful than any pain from RA!
I am one of those who is seronrg withnl crp and sed rate. At diagnosis had visibly swollen joints and synovitis on mri of ankle. I did well on enbrel and mtx for 8 mos before symptoms started to come back. Did not have as much swelling this time but on medication. Grinned and beared it for a while then had bone scan that had 5 positive joints. So yes you can obviously be inflammed with normal blood tests. Too bad this point of view not more accepted even though it is taught in medical school. This is such a good educational point. If you are suffering and ‘tests’ do not geha with your symptoms, do not give up on yourself bc ur made to feel crazy!
I have had RA problems for 10 years. The treatment plan for me after an extreemly high RA factor was steriods large doses and very large doses of narcotics. It took 6 years to get and MRI that proved my hip pain was legit and had one hip replaced. It helped but one leg was shorter and I developed a terrible limp. In 2010 I had the other hip done and I am walking better but everything else is going to hell. I have started to use pain meds again after stopping the large doses and a new RA dr. visit in August promises new RA meds. At this point I feel like I am back at square 1 relying on Narcotics to get through the day. Everyone thinks I am being a drama queen when it comes to my pain level and it is really getting old. Has anyone had a noticeable change after starting the new RA meds and did you still need narcotics to help with pain and stiffness? Anything to look forward to will help.
So you have never been other dmards or biologics? The combination of high dose, split dose methotrexate plus Plaquenil helped get me off of prednisone after being on it for over a decade. Of course this long dry/hot spell has probably helped too, and will have to see hOw I do this fall/winter being off of prednisone.