Tocilizumab treatment?

[Ozark]

A friend of mine recently suggested that I try the monoclonal antibody tocilizumab as a treatment for my PMR. My questions are as follows: Has tocilizumab brought anyone into remission and for how long? On balance, is treatment with tocilizumab preferable to the prednisone that I'm taking now? What is the safety profile of tocilizumab?

[DorsetLady PMRGCAuk volunteer]

TCZ is not used for PMR in the UK, but there are a few patients on it for GCA,

So you will need to rely on patients from your side of the pond for answers regarding treatment of PMR, although not sure there are many.

[Ozark in reply to DorsetLady]

Hopefully, there will be a few Americans from this side of the pond who will see this post and perhaps be able to provide some information. Thank you for your reply.

[PMRpro Ambassador]

Dad2Cue on here has been on it for PMR. It hasn't been trialed in PMR yet, just GCA, although there are a few pilot studies which show it seems to work well to control the symptoms with less pred. However, because it hasn't been through clinical trials it isn't approved for use in PMR anywhere in the world as far as I know so it is what is called off-label use. It is used in the USA though so you may be lucky if your insurance will cover it. Because there have not yet been any official clinical trials there is little documentation about how long remission lasts, whether it is achieved well enough to be able to discontinue the tocilizumab and see remission maintained.

[PMRpro Ambassador in reply to PMRpro]

Oh, and PS I think there have been a few pilot studies using other IL-6 inhibitors in PMR but I'm not sure.

[Ozark in reply to PMRpro]

Thank you very much for this information. I believe that some small studies have been done with tocilizumab in the treatment of PMR but no extensive randomized controlled trials. So you are correct in that regard. If my insurance will cover the treatment I may consult a rheumatologist for an opinion regarding the efficacy of this treatment. Fortunately, I have access to a good teaching hospital in the area where I live so I'm assuming the rheumatology department would be pretty up-to-date on this treatment.

[PMRpro Ambassador in reply to Ozark]

Being of a very sceptical nature I wouldn't assume anything ...

[Ozark in reply to PMRpro]

I agree. I am also of a very skeptical nature. So you can be assured that before I try any alternate treatment to the prednisone that I'm currently on I will give that treatment considerable thought, especially something as radically different as a monoclonal antibody infusion.

[mgrogers99 in reply to Ozark]

clinicaltrials.gov/ct2/show...

[PMRpro Ambassador in reply to mgrogers99]

Have you found anything about the results anywhere?

[mgrogers99 in reply to PMRpro]

It was just a small study - there are a few of them. ncbi.nlm.nih.gov/pmc/articl...

[Ozark]

I just want to thank you for imparting your quite extensive information concerning your experience with TCZ. It sounds promising and your posting lends support to my existing predisposition to give this treatment a try, assuming that it is available to me.

[Spanky2019]

I'm in midwest USA & been on Actemra 20 months to reduce prednisone use for GCA which was dx April 2019. I was on 80 mg prednisone at my highest use early on. I do weekly infusions of tocilizumab. Though an active 65 yr old when dx I had gca symptoms for several months prior to dx. Anyway, I've been completely off prednisone for 2 months after slow taper & a few adjustments up & down with prednisone. I think Actemra is successfully keeping GCA under control with no symptoms. I do have multiple other health issues so sometimes it's hard to figure out what pain is from what. However, I think some memory issues may be related to my Actemra use. It's hard to evaluate that and rheumatologist very reluctant to consider discontinuing based on my perception of this. It's a difficult decision to use medication that potentially has serious side effects.

My opinion is Actemra is worth a try (for many it needs to be several months to give it a true test) but be sure you have ALL recommended labs and try to develop your own system of monitoring your symptoms.

Also, Genentech has patient consultants that are knowledgable, and willing to discuss Actemra use, side effects, concerns. Genentech also has a very generous program to offset cost of the infusion. Best wishes to you.

[Ozark in reply to Spanky2019]

First, thank you for taking the time to offer a reply and your generous advice. I will take all that you have said into consideration before reaching a final decision on TCZ.

I have been on prednisone for about two and a half to three years now and am currently at a 10 mg dose. I did try to reduce down to 5 mg but my inflammatory markers went way up at that dosage. If I have a primary complaint about PMR it is the chronic and incessant fatigue associated with it that plagues me everyday. If TCZ will eliminate or substantially reduced that fatigue I would be willing to assume whatever risks might be associated with potential side effects.

I know that TCZ has been FDA approved for the treatment of GCA, but to the best of my knowledge it has not been approved for the treatment of PMR. So I may have some difficulty finding a rheumatologist willing to prescribe this off label.

Also, I have determined that my health insurance will pay the vast majority of the cost of TCZ.

Again, thank you for taking the time to give a reply and telling me about your experience with TCZ.

[Chrisellie]

Hi I had GCA, LVV, PMR. (Scotland)

IN UNDER 1.5years I am off pred and off Tocilizumab injections .

I was diagnosed the end of 2018/ beginning of 2019.

I ended my 12 month, weekly injections of Tocilizumab March 2020.

The trial has said any relapse is most likely within 2 years, on a reducing basis, from ending the injections. I have another 6 months to go.

Although it does take a while to be completely normal, I would say I am there and no new symptoms ….touch wood.

I would recommend this as all three autoimmune illnesses “feel” gone.

Good luck with your decision .

From Roche

Actemra/RoActemra (tocilizumab)

actemra-740

Actemra/RoActemra is approved in 116 countries for the treatment of rheumatoid arthritis (RA). It is also approved for the treatment of paediatric juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), giant cell arteritis (GCA) and CAR-T cell-induced cytokine release syndrome (CRS). Actemra/RoActemra is available in both subcutaneous (SC) and intravenous (IV) formulations.

Actemra/RoActemra is a first-in-class anti-IL-6 receptor (aIL-6R) therapy. IL-6 is believed to play a key role in activating the inflammatory pathway that contributes to the signs and symptoms of RA and other inflammatory autoimmune conditions. Actemra/RoActemra binds to IL-6 receptors, blocking the pro-inflammatory effect of IL-6 cytokines.

[Ozark in reply to Chrisellie]

Your reply is very much appreciated.

[Louisa1840]

Hi Ozark.I am in Tasmania (Australia) and I know tocilizumab is available here but you have to have tried all other avenues first as it is expensive. I would think that it's a "horses for courses" situation and worth a try if all else has failed.

Every Blessing!

[PMRpro Ambassador in reply to Louisa1840]

Not for PMR I don't think - GCA only

[Ozark in reply to PMRpro]

True. To the best of my knowledge TCZ is not authorized for the treatment of PMR anywhere in the world. The only way to get it for PMR would be an off-label prescription if one can find a doctor willing to do that.

[PMRpro Ambassador in reply to Ozark]

It is used in the USA for PMR where a rheumy manages to get funding - or possibly with subsidised supply from the company.

The cost is what it is because development was and production is quite expensive. All the MABs are relatively expensive, even the biosimilars but they may not be quite the same.

[Ozark in reply to PMRpro]

👍

[Ozark in reply to Louisa1840]

Thank you so much for your reply. I have checked my health insurance coverage for TCZ and it would appear that my cost could be as low as $70 per month depending on the dosage regimen. But the cost of this monoclonal antibody is outrageous for the uninsured or underinsured. In those cases it is only for the rich. As I'm sure you know, we have no national health insurance in the U.S.A. (except for those over 65 years of age) which leads to many health inequities. So with that said, at least for me, cost is not an impediment to my further exploration of this treatment modality.

[mgrogers99]

I was on Actemra IV monthly for 6 months. The literature said if the medication didn't help in 6 months, it wasn't likely to. My insurance covered the $55,000 monthly cost (for the medication once monthly!!). After each treatment I would have a couple of days of very bad body aches which were not missed!!

[Chrisellie]

HiI only had the one run at getting off everything. So started 40mg pred reducing to 0 while on Actemra weekly injections. It was never suggested reducing the frequency to every 2 weeks.

At the end of 12 months of weekly injections I was to stop the injections which I did albeit somewhat nervously.

18 months on all’s well.

If I was to relapse I would be straight back on the injections and poss some pred just to start with.

I don’t know how long this would be for🤔

You do have other issues to take into account making it a bit harder but there was no weening off the injections, just a full stop.

Really hope this works for you this time.

[Ozark]

Thank you for your reply.

[Chrisellie]

I would be inclined to see out the weekly injections for 12 months and then try to stop assuming nothing else interrupts the plan.Really hope it works for you this time.

[MsDirecto]

I am in the US, 78, with GCA. Ihave been on Prednisone for 20 months and had monthly infusions of TCZ for about17. The goal is the help with the reduction of prednisone. I am now at 4mg predisone and have stayed there for 2 months. I was planning to begin another very slow taperl last week after my infusion.. HOWEVER, per the manufacturer, because of the demands for covid patients, TCZ/Actemra is NOT currently available for us. I may be able to get it one syringe at a time, which can be adminitered at home. Or there may be another IL-6 monoclonal antibody that may be acceptable. I will be finding out more from my rheumatologust in about a week.

In the mean time, I got my 3rd Mpderna vaccine 6 days ago. It had been only 4 months since my last one, but because of being on immunosuppressants, my rheumatologist recommended that I not wait until the 8 month mark. As before, I had no side effects.

[Ozark in reply to MsDirecto]

Thank you very much for your reply. The highlighted area of your post, which seems to indicate that any immediate plans I may have to obtain TCZ treatment, will have to be put on hold. However, as you mentioned, there may be another monoclonal antibody treatment that can be substituted. Thank you again for this information.

[Ozark in reply to MsDirecto]

It does look like TCZ is available on a limited basis as an injectable as opposed to the IV form. The attached image is from the Genentech website just accessed. Expand and see the fourth paragraph down.

Current Genentech TCZ availability.

[MsDirecto in reply to Ozark]

Hello Ozark-Good news. My insurance approved the injectable form of TCZ. It will be sent to my home for self-injection. I should get my first dose in a few days and will get instructions from Rheumy nurse on administration. It has to be kept cold.

I usually get labs every 3 months: CBC, ESR, CRP and CMP ( Comprehensive Metabolic Panel). As expected, they have stayed within normal ranges for over a year. Because of change in TCZ (and remaining on 4 mg prednisone), they'll want to monitor a little more frequently. Hope I can get back to the prednisone very slow taper. They will probably continue TCZ for a while even if I get off prednisone.

The only drawback is that I won't be having in-person meeting with Dr every month during TCZ infusion; in-person visits are so infrequent these days. I have gotten close to staff and Dr's beautiful office dog (a husky who is a retired service dog)

🐬

[misha453]

I was put on tocilizumab for relapsing GCA 3 and a half years after I first developed PMR. tocilizumab controlled both the GCA and PMR symptoms very quickly and I easily tapered down to 2 mg Prednisone in 5 months. Adrenal issues seemed to make further tapering difficult but after almost 2 years on tocilizumab I am tapering from 1.5 to 1 mg while taking tocilizumab every 2 weeks.

I developed cataracts from the prednisone and had cataract surgery in March 2020. tocilizumab has caused a low WBC once and seemed to make me susceptible to upper respiratory infections. I found any issues could be corrected by taking doses every two weeks instead of every week.

Overall I feel like my quality of life on tocilizumab is better then when I was on prednisone alone. Good luck to you!

[Ozark in reply to misha453]

Thank you very much for providing information regarding your experience with TCZ.