The study is using sarilumab, aka Kevzara - not the first study, I'm sure Dublin did a pilot study, but the SAPHYR study is bigger. It isn't enormous and only over a year and we know what NICE did about that for tocilizumab. The first announcements for Kevzara were a year ago and it is already approved and used in the USA. So much for world-leading Britain.
However - it is still a monoclonal antibody, a biologic, which does the same as tocilizumab/Actemra, and I imagine that means it is still pretty pricey. It will still have to provide documentation on long term effects to NICE even though, like tocilizumab, it has been in use for years in RA, since 2017 I think. The prices I can find quote £12K per year in 2017 - and NICE considers it cost-effective in RA for patients who can't take methotrexate.
And golly-gosh - how about THIS:
"Earlier this year, a review paper published in the journal Nature Reviews by Professor Dasgupta and colleagues highlighted the emerging view that relapsing PMR patients also have underlying Giant Cell Arteritis, where the main blood vessel aorta and its branches become inflamed. Researchers suggested the two should be treated as linked conditions under the term GCA-PMR Spectrum disease (GPSD)."
How long have we been saying this ...?
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I have no idea! I replied to someone the other day and had a light bulb moment as I wrote it so I sent it to Prof Mackie, She got what I was saying in a heartbeat - but she had never thought of it and to be honest, although I KNEW it and preach it, I hadn't linked it to other experiences.
My email to Sarah:
"I've just had a lightbulb moment - and it affects an awful lot of what is said about PMR. Someone on the forum said his rheumy claims 90% of patients are off pred in 2 years! I was trying to find the paper Sara and co did and found Jessica Leung's article and her discussion of the criteria jumped out at me. I mean, I know this but hadn't linked it to why doctors tell patients with what we know to be typical presentation that they are "atypical"
This is my reply to the guy on the forum
"He's talking rubbish. If you are going to quote 90% it is more likely to apply to the number who have PMR for more than 1 year though the Mayo study suggests that about 20% are off pred in a year, about a third in 2 years.
There are a few studies published in the last few years. The Mayo Clinic paper suggests a median treatment time of 5.9 years - that means half of patients are off pred in just under 6 years. The British study is more like 40% need pred for more than 5 years I think but I can't remember and can't find it.
comes from a particularly good group in Australia and clearly states
"Once thought to be a self-limiting condition universally responsive to a limited course of prednisolone, it is now clear that most people with PMR require prolonged corticosteroids beyond two years."
I think part of the problem we experience is mentioned here:
"Classification criteria for PMR exist (Box 1) but are primarily intended to define a homogeneous population in research settings rather than as diagnostic criteria in clinical practice. In practice, not all patients with PMR will fulfil these criteria, thus PMR remains a clinical diagnosis based on a construct of typical symptoms together with raised inflammatory markers, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).3 ESR is classically highly elevated in PMR, but cases do occur with normal levels."
That is the reason so many patients struggle to be diagnosed - we don't often fulfil the criteria to be included in studies and so they are looking at only a small proportion of patients - probably one of the phenotypes but only one. The rest of us - probably the majority in fact - are either told we are "atypical" or ignored altogether in terms of PMR. Women tend to be fobbed off as "fibromyalgia"
So many doctors - GPs and rheumies alike - take the research criteria as "what PMR presents as", And because of that, a skewed view of what makes a PMR patient results in a perpetuation of that definition. Patients are missed as any who don't fit are misdiagnosed or just told it is "old age" - and add to that the confusion between language used by patients and doctors. Pain restrictions are perceived by the PATIENT as weakness, doctors measure it and there is no weakness. Our perception of the pain is that it is worse than the doctor expects on the basis of disease activity - though actually you aren't really measuring disease activity when you prod joints. Patients who are not diagnosed for some time seem to develop a chronic form - is that because both body and immune system "learn" a pattern that it is difficult to break? We had someone sort of trolling the forum for some time but one of the things he banged on about was that one rheumy had told him the immune systems hangs on to its malfunction - I suppose in a similar way to how pain becomes learned.
And I do wonder if this may be part of the reason for the north/south divide, Patients in the north put it down to old age, maybe tend to be outside the narrow definition as well. In Barnsley you have to be half dead to go to the GP who rarely plays golf, in Hampshire if your PMR upsets your golf swing you go the the GP who immediately understands your complaint. "
You make some extremely interesting points that bring a little clarity to some of the 'misnomers' put out there to patients by their medical practitioners.Definitely makes me feel inclined to put all this to my rheumatologist and GP.
Really wish I'd had this info a few weeks ago when I saw that very unpleasant rheumatologist!!
I haven't done mine yet either as he said he'd email me again shortly to discuss more options for communicating!! ...... maybe pigeon post?? 😄 Hopefully he'll glean a lot of useful information from all our accounts that'll progress even more positive moves forward.
Although diagnosed with PMR in Wales and not in the North of England I have sent my information to Lucas for comparison. Writing it down made me realise what a comedy of errors it all was back in late 2016. Sadly I don’t think there have been many improvements in understanding or treating PMR. Seven years later and still at 7/6 taper with few serious flares, just slow and steady but still recognising the pains I had to start with and no sign of remission.
Pmr pro, thank you so very much, your posts, your ideas, are enlightening. I hope my post in response below is not off subject.
But, may I ask if you might know, does Prof Mackie take on new cases for research? Can any one of us be in touch with her?
Diagnosed with PMR September 2019. Started with 80mg methyl medrone injections every five weeks - which seemed to work well until first Covid vaccination. So my GP started me on Preds at 7.5mg in March 2021.
Four years later since initial diagnosis I’m struggling with pmr, pain like I’ve not experienced before. I got down to 9mg in September after very slow tapering from January 2023, but the pains have worsened to the point where I feel disabled. A week ago I added 3.5 mg at night and the 9 in the morning on waking; that has helped. But a week on, the pain is returning. I have not found one doctor or Rheumy who understands what might be happening. Bad osteoporosis now, hospital endocrinology wants me stated on Denusamab injections twice a year from December 11. No one is suggesting I be given Tocx or other biological to help me taper. I’m scared. I wonder why things are going in the wrong direction. I eat carefully, live a healthy life, get out and walk regularly, look after myself but nothing I do is helping me to get better.
Not specifically, Studies have very strictly defined recruitment criteria so whoever is dealing with recruitment on a study will send the criteria to any relevant doctor for them to identify if they have patients who fit. Mostly they are new patients who are steroid-naive if it is to look at a new treatment - you have to have a level playing field to start. And they usually remain in the care of their current medical team, they are not moved to a central medical centre - the protocols are standardised, That is why research is slow to produce results - you have to acquire a population who fit the criteria and have to run it for often a few years and then analyse the results which also takes time.
You haven't been offered TCZ if what you have is PMR because it is not approved for use in PMR in the UK - nor anywhere else if it comes to that. When it is used, it is off-label. It is even very restricted for use in GCA. If you were to be offered anything it would be methotrexate or leflunomide, DMARDs not biologics. But they don't come with guarantees either, they work for some and not for others to reduce the pred dose and often that is not to zero pred.
At a guess you are simply on too low a dose to manage the disease activity of YOUR PMR at this time. Especially since you say increasing the dose has helped. Or it is possible that what you have isn't PMR at all but another inflammatory disorder that presented looking like PMR - what is called a polymyalgic presentation. 7.5mg is a very low starting dose and it is possible that simply allowed inflammation to continue building up. It is known that certain vaccines can be the final trigger for PMR - and the Covid vaccines are acknowledged to be one.
A good start might be to ask to start over again - find a pred dose that DOES manage the symptoms, get stable and then start to taper SLOWLY the way we talk about. If you have difficulty doing it in small steps and with management of your activities, the next step is to try methotrexate or leflunomide - which require a specialist to oversee and initiate them in the first place. But the entire clinical picture is significant, how you respond to pred, how you are able to taper, exactly what your symptoms are.
Not immediately in the next days, but from today Nov 4, looking at my calendar, the Covid booster was October 9, the flu vaccine was about two weeks earlier but I can’t find the exact date. The worsening pain symptoms began about 23rd October. I upped Pred on night of the 27th Oct.
That is sufficiently close for me to consider that the booster poked your immune system enough to increase the PMR symptoms, If you were fine before then there was a buffer where the inflammation could increase without you feeling it much. It also takes about that long before the immune system gets its response to the vaccine going, it isn't instant.
If you are lucky it will last a few weeks and calm down. The flare I had after my second Covid jab lasted maybe 6 weeks but it was mainly fatigue rather than pain. But you can't guarantee that - I would have tried treating it as a flare first by adding 5mg to where it happened for up to a couple of weeks - you only added 3.5 and not together with the main dose, it might simply be not quite enough. But if it is just a temporary thing, you will be able to taper again easily.
Discuss it with your GP so you have enough pred to do that,
Thank you PMRpro for keeping up on all these studies! I liked the sound of it until I got to diverticulitis...which I have. Better to get to 1mg. of prednisone and stay put I should think rather than start something new....?
I think for us longhaulers, getting to 5mg or so is preferable to adding in a biologic. Tocilizumab has got me to 6mg - but the rest of the way is going to be adrenal-governed, pretty sure of that. I've lost a bit of weight not being on as much pred but not dramatic and otherwise - maybe a few less bruises but not much else is different.
How can one have GCA with PMR without the known recognized symptoms? Is this a low level GCA only now becoming acknowledged and how does it add to the usual symptoms and issues with PMR?
They are usually diagnosed by the clinical presentation. Until recently it was difficult to diagnose LVV, the extracranial form of GCA and what is probably occupies the place where PMR meets GCA on the spectrum.
The symptoms are likely to be similar - and without the right imaging which isn't routinely offered for PMR you won't identify it. The waiting lists for PET-CT are long if the potential diagnosis isn't cancer and it is an expensive test requiring specialist referral, adding to the waiting time and that could be a year or so in total at present and steroids affect the result. If you are lucky your rheumy may offer the ultrasound technique - and look at the subclavian and brachial arteries as well as the temporal artery. But it still depends on the LVV affecting those specific places that are accessible for the technique, it doesn't always.
PMRpro has answered while I've been out at my rug-making group!
My GCA is the extracranial Large Vessel Vasculitis (GCA-LVV). I was diagnosed in 2019 via a PET-CT scan, which showed my aorta and its branches were inflamed. My symptoms weren't the headaches etc associated with cranial GCA, but I was experiencing claudication in my legs and my inflammatory markers were sky high, with no real increase in the PMR symptoms.
Recently I was a subject on an ultrasound training day (teaching doctors and sonographers the techniques) and they saw the changes in my axillary artery in my armpit, even 4 years later. I think they thought these could be chronic changes, rather than active inflammation. I hope so and imagine this is the case, as my CRP and ESR are as low as they've ever been!
Just a comment about your pred doses. You say you started on 7.5mg, but then say you had tapered to 9mg by September, so I assume you have been on higher doses in between times. I am sorry you are struggling so much and hope you get some help soon.
Hmmm - now that is something they maybe should look at. If the changes do persist, it may be worth doing it at a later stage to see if a "just PMR" was rather more than they thought. You can have different drugs if GCA/LVV can be proven, would that validate a retrospective dx when a patient can't get off pred I wonder.
I was diagnosed with GCA-LVV after the PET-CT scan in 2019 and started on Tocilizumab in 2020, so I've had my NHS ration of that! After TCZ I had 6 months of Methotrexate, which didn't seem to do anything for my inflammation. I'm tapering pred to 1.5mg at the moment..... Blood test this coming week will show me what the CRP and ESR are at this low dose.
At my next appointment with Sarah Mackie in 3 months, I'll mention what they saw on the U/S training day and see if she'd like to repeat it at some point. (The training day was for the delegates' benefit, not ours, but it was very interesting!)
Thanks, yes, you are correct. Dr started me at 7.5 March 21, but a fall and broken wrist pushed me up. Each year I manage to taper down then something triggers pain and stiffness, and up I go. It’s a right bugger.
It is recommended that such a low dose not be used as the starting dose - in the end patients usually end up taking more pred than if they have a good clear out to start with. You need to have a springclean before you can get away with just a light dust!
Annual Ultrasound scans of the Aorta - actually the recent one was less than a year, following some sort of conference between the cardiology team. They don’t involve me. I am only the patient.
Thanks Pro for the article and your email to SM. My question is, when they talk relapse, is that when you've gone into remission for a while and the symptoms return? Or is it a flare?
And are the side effects of these biologics different/fewer or much less than pred?
Ah - now THERE is a question!!!! We had a very funny meeting with Sarah Mackie, Max Yates and Christian Dejaco and a few patients debating the definition of relapse and flare and "a few other R-words" as Max put it - it wasn't what the meeting was about initially.
MY definition is 2 or 3-fold: there is medication-induced remission and there is full remission. Medication-induced remission is achieved as soon as you start pred just about - and then there is a second stage achieving the lowest effective dose stage. The final stage is getting to zero pred, full remission. The problems most of us suffer is that their definition of relapse is rather more general than mine. Where we would use the word flare because of the patient being on too low a dose of pred to manage the inflammation - they immediately define it as a relapse. It isn't a relapse, the disorder never went away, you just didn't go carefully enough with the titration of the dose. You relapse when you actually got off pred for 6 months without a flare of symptoms but then it appears again.
As for side effects of the biologics - depends on the person I think. SJ has had side effects with tocilizumab. I can't really say I have - but then, I had pred side effects until I learned how to deal with them and when it comes to pred overall, very few. Methyl pred, on the other hand, was a whole different matter. The POTENTIAL adverse effects are rather different.
My Tocilizumab side effects are on-going Diverticulitis and I was very prone to cold type viruses, nasal infections, Blepharitis, UTI. I terminated it at just over a year of use, rightly or wrongly.
All of this rings so true for me. Having had 7 years on Prednisolone and three major flares or “relapses” with very high inflammatory markers. “Back to the past” syndrome I call it! I seem to have always been born ten years too early. Too early for IVF, too early for key hole surgery, etc. etc and now too early for Kevzara, in the UK. I am convinced that I have GCA and/or LVV but the US have been neg, although my rheumatologist admits the pred may confound the results. He won’t do a PET CT scan until I get below 5 mg. I am on Leflunomide but only every day because my liver is misbehaving.
I don’t understand why they can’t at least prescribe Kevzara for chronic remitting PMR. I was a believer in pred and a bit nonchalant about side effects. Now I have Avascular necrosis, cataracts and difficult to control BP and DM2. All Pred related. Surely it would be cost effective to prescribe it for me rather than treating multi joint replacement, possible stroke and chronic bad health and poor mobility. Sorry to pitch in with nothing more than moan but I have just dropped to ten mg, trying to be positive but this is when the flair usually starts. Also, I have just been diagnosed with a full thickness tear in the gluteus medius and severe Meralgia parasthetica so lots of pain and no choice but to continue to taper.
It hasn't been through the process yet so it may happen - but NICE really seem to drag their feet, I accused them of discrimination - elderly ladies who don't figure much in the economics, assumptions of far too many things, - and the reaction confirmed my feelings. Methinks the lady doth protest o'er much ... I'm not alone in thinking that.
He is right about not doing the PET-CT on the dose you are on - a negative is the most likely result because of the pred and that would be even worse. I don't understand NICE's position about longterm safety - been used for years in RA.
I have tocilizumab for my chronic non-remitting (as far as we can tell) PMR - but that is thanks to Italy and a world name in the field rheumy, I would lose both the drugs that work so well for me if I came back to the UK. They don't stop all the pain but they make quite a contribution.
Yes. I am afraid the attitude that we are doddery old ladies is still alive and well. I physically feel like I am being patted on the head.🥴 I am doubtful about getting to 5mg because I flare under 10 mg. It’s Catch 22. I am glad your meds help. There does seem to be more attention around PMR so I am hoping it won’t be too long.
This is such an interesting post - thanks for posting it. I wouldn't be at all surprised at the discovery of underlying GCA in those with relapsing PMR.I would be equally interested to know whether those who don't have the typical raised markers for PMR (and therefore don't get treated, or only get treated at a late stage) also have, or end up with, GCA.
A close friend now in her late 70s has GCA. She was ill for years (over 25 years) with negative bloods before being diagnosed with GCA in her late 60s. She, like me, had been diagnosed with M.E. previously and at one stage, when she dragged one leg walking, was diagnosed with 'benign MS' . This seemed like a category of MS devised to fit her atypical symptoms and was soon dropped again in favour of an M.E. diagnosis.
We both got ill with a virus at the same time roughly and while working in the same hospital. Quite a few of us never recovered properly and either had to give up work or go part time because of post-viral syndromes (typically diagnosed with M.E., fibromyalgia, or both).
I do increasingly wonder if what we were all left with from that infection was an illness that if not sero-negative PMR itself , was for all practical purposes very similar. The symptoms certainly matched even if the blood tests didn't.
Before joining this forum, doctors had lead me to believe that post-exertional malaise was unique to M.E. , but now I see from the good people posting here that it isn't.
I do wish there could be some concerted efforts to look at how women with these conditions are treated. It seems M.E. and fibromyalgia do seem to be used as bucket diagnoses, deserving pain clinic referrals but no attempt to actually treat the condition e.g. with steroids , Hydroxychloroqine etc. to exclude the possibility that they are suffering sero-negative autoimmune disease.
What a waste of life and what a waste of resources to not try such treatment up front. It seems there are so many NICE guidelines that require revision in terms of their diagnostic criteria and treatment criteria.
WlFor example, when I had viral meningitis 10 years ago, the doctors who discharged me after 4 daysfrom the hospital (when I still couldn't walk more than 10 metres by the way!) told me that I'd recover in 2 weeks because this is what their guidance suggests. I was given no follow up appointment or review.
I wasn't anywhere near recovered in 2 months let alone 2 weeks and wondered what I was doing wrong. Thankfully, I found the charity meningitis.org.uk who happened to be running a viral meningitis awareness campaign at the time which highlighted the fact most patients do not spring back to health within 2 weeks post viral meningitis. It takes months and years, and some never recover.
It's rotten being female in a medical context - when you're young, your an hysterical woman, when you're older and post -menopausal your just irrelevant it seems! 😠😡
I also had something in my mid 20s that these days would be identified as ME, it was still Yuppie flu then, I was ill for a few months and then recovered while on holiday in France - not a relaxing holiday by any means, wandering around chateaux in April! It was about 4 years before I could get to the top of the stairs without then stopping to get my breath. I didn't HURT with that, just the fatigue, had to sit to do anything taking more than a few minutes. There are several I know of with a similar history.
But no - ME is by no means the only thing where you experience post-exertional malaise. And now there is Long Covid - this century's version of ME. No idea why it took them so long to recognise what it is, they've know about post-viral nasties for long enough.
I also had a bout of post viral fatigue (ME?) 35 years ago. A very busy time of my life - one year old, returned from maternity leave a few months earlier, throat virus, then boom- took months to recover and gain some energy. Nothing was ever properly diagnosed. A friend’s daughter in her 30s is suffering from long covid well over a year on.
I was referred to a liver specialist, only thing they could find was raised liver enzymes. That took 6 months even then and I had just started to improve, He was very good actually - open referral if I relapsed but it didn't. And said, almost certainly post-viral and it could take time to get over it entirely.
So true that they have known about post- viral nasties for ages. Seems that they've known but not cared enough.Interesting that you had a similar experience. I wonder if it's something in our immune systems that single us out for these and other autoimmune disease? I'm glad you recovered from it.
My early expertise M.E. was also predominantly about weakness and muscle fatigue, plus sore throats and swollen glands, not the pain. The pain became a problem from 2001 onwards - and how!
I remember that vile classification of 'yuppie -flu'! The idiots didn't realise that children were getting it too.
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