Tozilizumab/Actemra

[LizMitchell]

I am interested in anyone in the UK who has been prescribed Tozilizumab for "refractory GCA".

I was diagnosed with GCA and PMR in July 2015 and prescribed 40mg of Prednisolone with a 14 month reduction ptogramme.. if only 😣 I reluctantly started taking 10mg weekly of Methotrexate in Sep 2017 because I was struggling to get below 12.5mg of Prednisolone and had had two serious flares . The MTX was susequestly increased to 12.5mg in September last year as I continued to struggle. I am currently on 7mg of Prednisolone and my symptoms are bearable, just!

During a consultation with my Rheumatologist last year, we discussed TCZ and twice she has asked the supporting Medical Panel for the hospital and twice they have refused to provide me with this treatment, stating that on the first occasion I did not "qualify" and on the second occasion I was not "eligible" It is my understanding that when NICE approved TCZ in 2018 for the treatment of GCA, that it could be used for GCA patients with "refractory" symptoms as well as for newly diagnosed patients.

Your thoughts and experiences gratefully received, as always.

Take care and stay safe and well

[DorsetLady PMRGCAuk volunteer]

Hi Liz,

Sorry to hear you are still struggling, no advice to offer, but let’s hope someone else can give you a positive story on TCZ.

[LizMitchell in reply to DorsetLady]

Thank you Sue, really appreciate your support.

Hope you are keeping safe and well.

Liz x

[DorsetLady PMRGCAuk volunteer in reply to LizMitchell]

Yes thanks.... really quite good despite arthritic shoulders!

[PMRpro Ambassador]

Is it even for newly diagnosed patients?

[DorsetLady PMRGCAuk volunteer in reply to PMRpro]

Few and far between I think. .., and maybe it depends on the “clout” of your Rheumy.

[PMRpro Ambassador in reply to DorsetLady]

I was wondering that as well - or whether your hospital is one like Leeds or Southend where the rheumies were involved in the clinical trials?

[DorsetLady PMRGCAuk volunteer in reply to PMRpro]

Yes I think that’s a factor as well... shouldn’t be, of course; plus of course some NHS trusts have a little more cash to spend (not a lot, but a bit!)

[PMRpro Ambassador in reply to DorsetLady]

What is very unfair is that I don't think they have to beg for it for RA patients - same here. Christian could use it for me if I had a dx of RA, as it is he would have to go cap in hand to Rome!

[DorsetLady PMRGCAuk volunteer in reply to PMRpro]

Not to the Vatican one hopes!

[PMRpro Ambassador in reply to DorsetLady]

Nah - might get more response there!!!

[LizMitchell in reply to DorsetLady]

Now there's a thought 😃

[LizMitchell in reply to PMRpro]

What would be fair and right is that there is a "Standard" across the UK, not a "Lottery" as there appears to be now!

[PMRpro Ambassador in reply to LizMitchell]

'Twas ever thus I fear - for almost everything. It isn't a National health service however you look at it and it is getting worse.

[LizMitchell in reply to DorsetLady]

Following the appeal in December 2017 NICE agreed to fund TCZ for up to a period of 12 months with the caveat that anyone already taking it would not be affected by this decision. It would be very interesting to know exactly how many newly diagnosed GCA patients have been prescribed TCZ for either new or refractory GCA? As you say, probably not many. It is all about cost in the end and I am certain that a lot more GCA patients would be offered TCZ if it was a similar cost of Prednisolone!

[DorsetLady PMRGCAuk volunteer in reply to LizMitchell]

Yes they would... but unfortunately it’s not!

Plus, Pred is tried and tested - and usually does what it says on the tin! Of course, for some like you it’s not as good as you would like.

[PMRpro Ambassador in reply to LizMitchell]

But patients who were already on it in the trial did have it stopped - we had patients on here who were affected.

[LizMitchell in reply to PMRpro]

It is my understanding that TCZ can be introduced once Prednisolone has got the GCA under control, but I am uncertain as to the timescale as suspect it is specific to each individual patient and the decision of the GP or Rheumatologist.

[Devoid in reply to LizMitchell]

Hi I have large vessel vasculitis that started with Gca symptoms but negative biopsy, then cat pet scan gave the LVV diagnosis. Started on 40 pred, then added 30 of methotrexate,still inflammation not controlled, tocilizumab after nearly 6 months of pred and 4 months of methotrexate. Huge improvement after 3 weeks.

[PMRpro Ambassador in reply to LizMitchell]

In the clinical trials they were introduced concurrently.

[alvertta]

GCA. SINCE OCTOBER 2018. Started at 60 mg.

I just had a bad flare in July 2020 and my rheumatologist wants me to start actemra in September. I was down to 9 mg daily. Happily on my way when 1/3 of my right eye went. Then up To 50. Now on 45. Rheumatologist says actemra will allow me to reduce prednisone faster.

I live in Ontario Canada. We have applied for a government program. Roche is the drug company. Cost $500 per shot. Shot every second week. If I am Approved cost will be covered I think. Roche has access to data from my blood tests. Need to do more research on this drug.

[LizMitchell in reply to alvertta]

I wish you well and hope that it works out for you.

[Carriemetz in reply to alvertta]

Good to hear from u after a while. As a fellow GCA sufferer have been thinking about you and wondering how u were. Still engaged and feisty I see! Go girl! All best wishes, Carrie

[LizMitchell in reply to Carriemetz]

Hi Carrie

Good to hear from you too.

Hope you are keeping well.

Liz x

[Iwillwin123]

Hello ,

I can say with confidence that Actemra has only helped me get off pred better . Actemra is steroid -sparing and it has only benefitted me. It reduced the inflammation quickly . I started on 60 mg Prednisone imm after being diagnosed in Jan 2018 . Started with Actemra 162 mg injection in May 2018 .

Since then .I have only had good things to say of Actemra.

Also at risk of being accused of doling out unproven advice - I am saying that , taking Valcivir tablets against the chicken pox ( Varicella Zoster ) virus has also played a role in ramping down my GCA inflammation .

I wish to qualify clearly that the Valcivir experience and opinion is mine alone and NOT supported by any medical authority today . There is some research on this but is ongoing and so cannot be held up as proof of effectiveness.

If anyone wishes to , you could read research papers on Varicella Zoster virus and inflammation .

Regards

[alvertta in reply to Iwillwin123]

Thank you. Good to know.

[alvertta in reply to Iwillwin123]

What is your plan for going off prednisone? Do you have one? Thanks.

[Iwillwin123 in reply to alvertta]

While taking the Actemra 162 mg injections every 15 days , I am using the DSNS method to taper prednisolone . Am at 3.5 mg right now and carefully hope to come to zero - but not in a mad rush at all . I will keep on the Actemra till I am stable at zero , and the plan to phase out Actemra once the inflammation indicators show a clear green signal to do so . For that I plan to regularly do an USG of the axillary armpit artery as well as check for Serum Amyloid A protein as inflammation indicators . This was recommended by Prof Dasgupta in his recent webinar.

[alvertta in reply to Iwillwin123]

Thanks. Good to know.

[PMRpro Ambassador in reply to Iwillwin123]

The markers of ESR and CRP are meaningless as indicators of inflammation when you are on Actemra because of the way it works.

[LizMitchell in reply to PMRpro]

I have always found the inflammation markers confusing, in that you could have low ESR and CRP, but the underlying condition is still very much active and causing challenging symptoms. If the primary symptoms of PMR /GCA is inflammation, how can the markers be low when the conditions are active and causing pain?

[PMRpro Ambassador in reply to LizMitchell]

Because of the way Actemra/tocilizumab works. It stops the IL-6 binding to the receptors that mediate its action - so that doesn't produce inflammation or the CRP in response to the inflammation and so the ESR also doesn't rise. However, GCA is known to be caused by 3 different mechanisms - if yours is just the IL-6 one then the result will probably be good. But if the others are involved then there may still be a need for pred to suppress the inflammation that causes.

I did manage to explain it somewhere recently - I'd got my head round it at the time but I don't know where it is.

This

researchgate.net/figure/Mec...

explains it using a bathtub and tap analogy ...

[LizMitchell in reply to PMRpro]

Thank you for the link, most informative!

[Devoid in reply to PMRpro]

Hi can it be caused by more than 1 in an individual or is it 1 of the 3

[PMRpro Ambassador in reply to Devoid]

It can be more than one - that is why only half of patients respond 100% to tocilizumab. The other half-ish continue to require pred to manage the inflammation and symptoms due to the other mechanism involved. Pred deals with everything, tcz only deals with the part due to IL-6.

[Devoid in reply to PMRpro]

Thanks for that, now on 3mg pred and 10 mg of methotrexate, just occasionally getting some niggles that feel similar to at the beginning,

[DorsetLady PMRGCAuk volunteer in reply to Devoid]

Might be worth staying at 3mg for a while and see if the niggles resolve before reducing again.

[Devoid in reply to DorsetLady]

That’s what I am planning, the problem is I’m not sure if what I’m experiencing is the illness or side effects. I really don’t think methotrexate benefits me but my consultant has been pretty insistent that I will need it for when the year is up for tocilizumab. Personally I feel I would be better on low dose pred . I think he’s still intent on getting me off steroids due to how badly they effected me at higher dose. From 5 mg they don’t appear to bother me at all. It’s just so difficult with telephone consultation, I have written to him but that didn’t get me any answers

[DorsetLady PMRGCAuk volunteer in reply to Devoid]

Can’t help on MTX but not sure I would want it - as you say better a small dose of Pred. Plus as you say very little, if any side effects below 5mg whereas you don’t know what with MTX.

Like you been on high doses of Pred - and there is no comparison between the high and low doses re side effects.

[PMRpro Ambassador in reply to Devoid]

If methotrexate does not reliably replace pred in PMR/GCA (and it doesn't) - I don't understand how it will magically work post tcz. PMR/GCA is not RA - however much they want it to be.

[Devoid in reply to PMRpro]

That’s what I don’t get,it’s a steroid sparer not replacement!!! ,and it didn’t reduce inflammation at 30 mg so I don’t trust 10 mg to do anything other than the awful side effects. I think I will contact the rheumatology nurse because by my next appointment I would be taking just the methotrexate and I really worry that it won’t be enough

[DorsetLady PMRGCAuk volunteer in reply to Devoid]

For some it works as a “sparer “- but my view, much like PMRpro’s (I think) is why add in another drug with more side effects if you are managing on Pred (albeit a bit slower than Rheumy would like).

[Lee1945 in reply to DorsetLady]

Do NOT try to reduce too quickly- your body must adjust to each reduction or you will be back up on highest dosage again!

Slow tapering helps you to be more comfortable. If you reduce by 1 mg and start to suffer again you can go back up or try reducing by only .5 mg..

[alvertta in reply to PMRpro]

Thank you.

[Iwillwin123 in reply to PMRpro]

Yes agree that ESR and CRP may become meaningless after Actemra is started. That is the reason why I plan to use the axillary artery USG and serum Amyloid A as markers for GCA activity and inflammation . This is as per the webinar of Prof Dasgupta. Please do correct me if there something wrong in the way I have comprehended what he said .

[alvertta in reply to PMRpro]

Good to know. I found they were useless w my current sight loss on July 6. Nothing in my ESR. Or CRP. that indicated I was in as much trouble as I was. Scary.

[LizMitchell in reply to alvertta]

I am really sorry to hear this!

Take care x

[alvertta in reply to LizMitchell]

Yes. For 22 months I relied on the blood work. Oops. Now what?

[PMRpro Ambassador in reply to alvertta]

Prof Mackie says "symptoms" ...

[LizMitchell in reply to Iwillwin123]

Interesting!! Thank you

[tangocharlie in reply to Iwillwin123]

I've read a lot of anecdotal stories in Facebook groups about people claiming anti-virals have helped with PMR and GCA. Maybe they do for types of PMR that are triggered by viruses? I wonder if any research is being done?

[Iwillwin123 in reply to tangocharlie]

Well there are also research papers available on responsible websites such as Pubmed about this. However the outcomes are still in preliminary stages and hence cannot be stated as a proven statement yet I suppose. I took that chance since I found the research convincing and that Valcivir is mostly harmless ( though there are known side effects too) . But then we as GCA/PMR patients are all at cutting edge anyway - esp with the use of TCZ ....... please do look at some research and then decide.

It worked for me . Will it work for others ??? It depends on many factors .......

[PMR2011]

Hi LizMitchell,

Am in the States, PMR for 6 yrs then GCA. Have been on Actemra for 2+ yrs and it has worked very well for me. I was on 20mg Pred and couldn’t get below that dose. Am curious how your rheumie defines “refractory”? 14 months seems a very ambitious tapering time schedule. Could it be you are simply on not enough Pred? I worry what about uncontrolled inflammation and the damage it can do. Hope you get it sorted soon.

[LizMitchell in reply to PMR2011]

Glad to hear that Actemra has worked for you, which is really encouraging. Long may it continue.

The interpretation of "refractory" is completely open to a GP/Rheumy, but my understanding is any patient struggling with regular flares and not being able to reduce Prednisolone to an acceptable level over a long period of time.

From the information I have now gathered during this unwelcome journey, 14 months to taper from 40mg of Pred to 0mg was clearly wishful thinking. My Rheumy didn't give me any indication at the outset that this may not be achievable, which is very disappointing to say the least, as it didn't prepare me at all for what was to come! It is my understanding that PMR will endure for 16 months to 2 years, with 1 in 4 patients 4 years plus. Not sure if this applies to GCA though as I have not communicated with anyone who has had it for less than 5 years!

After the first few years of this condition I expected a target of 5 years was realistic, so now that I am into year 6 I am feeling very deflated that this didn't happen and wondering if I will ever be rid of PMR and GCA. I live in hope.

Stay safe and well x

[PMRpro Ambassador in reply to LizMitchell]

I do know of patients successfully getting off pred after 11 years!!

[alvertta in reply to PMRpro]

There is hope. 🙏🙏🙏

[LizMitchell in reply to PMRpro]

This is not a prospect that I relish and probably best not to dwell on its possibility!

[alvertta in reply to LizMitchell]

My rheumatologist said if I got to 5 I might be there for the rest of my life. I could live w that. I wonder how actemra and prednisone work and on what schedule?

[aladymo]

Was not sure if I should write this , delete if it’s inappropriate. My experience with actemra is not at all positive. I was taken off after 4 months , acute abscess in my colon and stomach. Am on heavy duty antibiotics , hoping they will heal the damage and I can avoid surgery.

My future will only be prednisone , no more steroid sparser !

If I’m on pred For an extra year ( or so!) I’m ok with that ✔️

[LizMitchell in reply to aladymo]

Thank you for responding, it is important that we know when something doesn't work so that we can make an informed decision when considering to take on a new medication. Whilst my Rheumy has tried on two occasions to get TCZ approved, there is a chance that it won't work for me as it hasn't for you, but I would at least like the opportunity to put it to the test. If it doesn't work, then I will just have to stick with Prednisolone.

[Iwillwin123 in reply to aladymo]

Every input here is extremely valuable and that is why we are here ....... it is imp to know if you had a bad outcome - since we know we must watch out for that too .........

[LizMitchell in reply to Iwillwin123]

Absolutely!

[PMRpro Ambassador in reply to aladymo]

It makes a change for it not to be me warning it may not be the perfect answer!!! When it's good it is very very good - but when it's bad, it can be horrid!

[aladymo in reply to PMRpro]

I have curl on my forehead too ! ( pred)

[LizMitchell in reply to PMRpro]

Indeed, as with so many things we experience in life!

[PMRpro Ambassador in reply to LizMitchell]

Very true!

[aladymo]

Tough decisions to make for sure. Everything we take will have its side effects , hopefully they aren’t too hard to live with. But we all have choices , and I am learning that now. I found the trial was all about them , I was just a number. (Better stop while I’m ahead!) Anyway , good good luck , stay safe 🙏🏻

[PMRpro Ambassador in reply to aladymo]

Poor staff recruitment that - they are usually good.

[LizMitchell in reply to aladymo]

Thank you, you too

[Lee1945]

PLEASE do research on any meds the doctors/consultants want to prescribe!!

MOST, if not ALL, have terrible side effects and once started need to be taken for two years or more!!

Ask Douglas Johnson for advice!! He does not personally 'benefit' financially for his advice as do many doctors/consultants who receive 'perks' from BigPharma!!

I had GCA and PMR and was treated with Steroids for a short period of time and was regularly advised to reduce the dosage in very small reductions!