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Biologics Differ in Safety Risks - Infection ris... - PMRGCAuk
Biologics Differ in Safety Risks - Infection risks higher for Tocilizumab (aka Actemra)
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DorsetLadyPMRGCAuk volunteer
Sometimes better the devil you know!
PMRproAmbassador
As I keep saying - tocilizumab isn't sweeties. And frankly - the thought of it being used for PMR really does make me VERY concerned. There is very little to learn about pred - whatever the horror stories.
One US contributor, not on this forum I think, has already said her doctor won't even consider it for GCA in the earlier stages.
Pred has been used for over 60 years - will these biologics have such a long shelf life?
nejm.org/doi/full/10.1056/N...
New England Journal of Medicine Editorial July 27, 2017
“Although I believe that the report by Stone et al. is likely to herald the coming of more ecstasy and less agony for patients with giant-cell arteritis, pending longer-term evaluations, I will reserve tocilizumab for patients who are at high risk for serious side effects from prednisone and for patients who have repeated flares that are not manageable with low doses of prednisone.”
David B. Hellmann, M.D., John Hopkins University School of Medicine, Baltimore
Interesting and plenty of food for thought. It begs the question why it is regarded as a positive drug in relation to shortening the time one is on Prednisalone for GCA? Or is that a simplification of its benefits? We rarely see anything that makes a powerful case for the drugs we have to take. Except for us when we talk of the Pred miracle.
I guess a personal decision based on therapeutic value and adverse effects has to be made in tandem with your doctor, if and when the time comes. I am not swallowing anything without understanding risks and benefits.
Thanks for posting this Melissa. It makes me cleave more tightly to Pred in spite of the very real drawbacks.
I think because so far no-one has actually looked at the post-launch figures. It is then that the REAL adverse effect rates are found, once it is being used in large numbers of patients - and this is the first "Hello!!!". The clinical trials are mostly to show that it works in the case under study - and yes, it DOES work beautifully to reduce the amount of pred in GCA.
I think it should be a second line for really problematic GCA cases who can't reduce their pred or have other problems. And that is what is being proposed by NICE. Quite rightly. It will have a role - just not for everyone.
My doctor asked me to 'consider' it. I did -- ok, in all honesty, I really didn't. I had already made up my mind that I wasn't taking it: new drug for GCA (approved by the FDA on the same day I was diagnosed with GCA), scary side effects, my past medical history (surgery for bleeding ulcers) and I was/am doing ok with Pred. Why add another big bad boogieman drug to my already big bad drug when I was almost right where my doc wanted me to be regarding tapering? Yes, it might be another tool in his toolbox to use, but that didn't mean that I had to use it.
But, I went through some motions so I could say that I gave it at least a glance. I read articles and even joined an "Actemera" room in FB to see what others were saying. I took into consideration that people come to support rooms for assistance and not necessarily to praise. Some things that I remember from the short time I logged in there were LOTS of people with racing hearts, LOTS of complaints about EXTREME fatigue (I assume these people had been on Prednisone and that the fatigue was much worse on Actemera than Pred.), people with infections, people concerned that their docs weren't educated on the drug, people being pulled off of it for one reason or another, put back on, and pulled back off, itching, and pancreatitis issues. And there were praises for it!!
I said, "No, thanks" and gave my doc the reasons listed above. I agree with Dorset Lady: the unknown is scarier than the known. He said "It's not for everyone," and has never mentioned it again.
But, I sincerely hope people that do choose to try it gets relief without additional problems.
in reply to Insight329
Thanks for that.... helpful!
Insight329 in reply to
You're welcome. I'm not saying not taking it is the right answer for everyone. I just know that my journey has been relatively smooth so I'm staying on the Pred course.
Kate Gilbert, et al, would not be fighting so hard for it if it wasn't beneficial to some. I just don't feel that I'm in that population yet (hopefully never).
in reply to Insight329
Yes, I hear you... it is a very individual choice and all of our journeys are so very different. A couple months ago I would have shot Heroin into my veins if they told me it would alleviate the withdrawal symptoms and steroid side effects I was experiencing; and I think I'm probably a good candidate for "Actemera," but what I read, scares me to death!
Oh I'm not saying it won't be useful and beneficial for some patients - my concern has always been that there will be an outcry at the restrictions that SHOULD be imposed. You know, like the wails in the media when a new, realtively unproven, drug is not approved by NICE for advanced cancers because really it MIGHT add a week or two of poor quality life at a cost of tens of thousands of pounds...
I agree with your last statement Melissa. I'm probably a prime candidate for this. Have not successfully, significantly,reduced my steroids over a period of nearly two years with and without Leflounomide even following the DSNS approach and not attempting more than 1 mg per month. I was initially very excited that this would really help but have serious doubts and I do find the small print a bit frightening.
Wouldn't that be something then PMRpro that Rod Hughes would have muted? I don't know- I suppose I've thought that at least up to now I know what I'm dealing with- I.e cranial GCA and PMR but often get infections that take me back to 18mg which is around which I seem stuck.
in reply to Jackoh
I do have this ongoing fear, that it's NOT ONLY GCA & PMR and that freaks me out!!!!!
I keep thinking they are missing something... However, two Rheumy's (Rod Hughes one of them!) a GP and two A&E doctors all agreed; GCA & PMR.
The "diagnoses" was however based on the fact that my blinding headache, skull pain and temple tenderness, went away after 12 hours on Pred... No scan. No biopsy. ESR sightly raised and CRP normal. (?)
Who knows?
Jackoh, you might not be a candidate for it due to your history of infections. Actemra has a ‘black box warning’ regarding infections.
Not at an early stage possibly not. And it may not be obvious to anyone. I wonder how you fit into Fig 1 in this:
academic.oup.com/rheumatolo...
Dejaco thinks that those of us with the version in the middle are the ones who struggle to reduce the dose to low levels or require lower doses for much longer. And if you are a "50% bioavailability" person then you will apparently need a far higher oral dose than your neighbour who is a 90% person (doctors tend to work on the average of 70% rather than the full range).
How do you do on the side effect front?
Yes read that - although must admit found some of it difficult to understand but can see the overlap of these conditions. Also agree re 50% bioavailability which I had forgotten. When I just had PMR when I reached the stage of 11mg I experienced what many in this forum have described at 7/8 mg with regard to utter debilitating fatigue which after a few weeks improved - had wondered if that pointed to 50% bioavailability. Also Dr Hughes says I'm like the princess and the pea. I seem to absorb pred doses with very little side effects at all and the same for the Leflounomide ( on the highest dose for that) but seem to react quite strongly on reduction and have to go very very slowly. Find it very difficult to reduce. Got quite upset this morning thinking "what am I doing wrong?" Which is quite irrational really and not really like me- know you have to just go with the flow. Thanks for your input. Jackie
Not you doing anything wrong - like me, it just doesn't go simply. I've been offered leflunomide which I really am not enthusiastic about. PMR-wise I'm fine at 8mg-ish - about time after 14 years! 7mg, wading through treacle...
But even I get p*$$"% off occasionally.
Understandable re your frustration( and mine but my time on this see saw is nothing compared to yours) actually haven't had any problems with the Leflounomide up to now but now have some tendon problems. I think it has helped the PMR side. This time when I flared after the cold virus it was the GCA symptoms that flared, ear ache and tongue and head. Have just caught another mild version of that virus that's why I think I was so cheesed off. I suppose though for consideration is the possibility of catching more infections being on the Leflounomide.
Mmmmmmm - are there any real downsides (like no wine...)
Yes had thought of that Insight but thank you for raising it again
I’m going to be a different voice on this thread. Have been on Actemra weekly self injection since January. Have had no side effect other than a little itching here and there. Have been able to taper from 20mg to 6mg of Pred in 3 months. And I feel soo much better. PMR in 2011 then GCA in 2017 and unable to taper below 20mg since then until the Actemra. Have worked really hard to minimize the side effects of Pred but still have much muscle wasting and know my tendons/joints are weaker. Vary glad to be below the 10mg mark!
If you think of the literature on Pred and it’s side effects, sounds just as scary, except we know it and have worked with it.
In my 7th year on this journey am happy to have the Actemra.
in reply to PMR2011
That is GREAT to hear... I hope the Actemra journey continues to be easy for you!!!!
PMR2011 in reply to
Thank you for the words of support. It was definitely not an easy decision! But one at this point I’m glad I made.
It’s up to each individual and what’s the best course for them.
in reply to PMR2011
Absolutely! ...and in the end I may end up trying Actimera, if I'm a candidate! I need to get off these high doses of Pred, as they as they are killing me!
I too am on high dose of Pred and feel it is killing me, going on Actemra next week, the lesser of 2 evils I think.
in reply to gtate1914
Hi gtate1914, Best of luck!! I hope it works for you! Many have said they are quite happy with results and have had no problems.. I hope you fall into that category!!!!
Please let me know how you make out.
gtate1914 in reply to
Thanks, I will.
Diagnosed with pmr January 2018 and GCA and osteoporosis March 2018. Currently on 50 mg Pred and trying to reduce.
in reply to gtate1914
I was diagnosed in November 2017; GCA & PMR. Started on 60, tapered to 45, crashed and burned. Was put on 80... have been tapering down and now at 45mg.
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