Has anyone heard this news about Kevzara approved for PMR?

Posted by saltyg @saltyg, Mar 16, 2023
https://www.pharmacytimes.com/view/fda-approves-sarilumab-for-adults-with-polymyalgia-rheumatica

Interested in more discussions like this? Go to the Polymyalgia Rheumatica (PMR) Support Group.

Yes! I'm glad you posted this. I was going to mention this to @abbeyc and @redboat because we were discussing Actemra which I take for PMR. There is the possibility that Actemra will stop working so I'm happy there might be an alternative to Actemra. My rheumatologist has already said Kevzara might be a possibility in the future.

Kevzara (sarilumab) and Actemra (tocilizumab) both have the same mechanism of action and both are in the same classification of medications. They are both IL-6 receptor inhibitors.

Actemra was approved by the FDA for GCA in the injectable formulation several years ago. Last year, the IV formulation was approved.

"On February 28, 2022, the FDA approved Genentech's intravenous (IV) formulation of Actemra (tocilizumab), for treatment of giant cell arteritis (GCA) in adult patients. — Previously, only the subcutaneous (SC) formulation of Actemra was approved for this indication"

Now, Kevzara has been FDA approved for PMR.

https://www.ahdbonline.com/supplements/2438-kevzara-sarilumab-a-novel-il-6-receptor-antagonist-for-rheumatoid-arthritis
I didn't want to discourage you but, TNF-inhibitors like Humira and Embrel have not been shown to be effective for the treatment of PMR. I always hope for anything that works better than long term prednisone.

We are all different snowflakes as you say. I think TNF-inhibitors are worth a try as well. I think TNF-inhibitors have worked for people who have both RA and PMR. When you have both inflammatory arthritis and PMR, things get extremely complicated.

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Yes, I saw that sarimab was approved very recently for PMR.

There was a randomized control trial for Sarimabs use against covid. It didn't help, but at least the adverse events (including death) were about the same as placebo.

"The rates of treatment-emergent adverse events were 65% (55 of 84) in the placebo group, 65% (103 of 159) in the sarilumab 200 mg group, and 70% (121 of 173) in the sarilumab 400 mg group, and of those leading to death 11% (nine of 84) were in the placebo group, 11% (17 of 159) were in the sarilumab 200 mg group, and 10% (18 of 173) were in the sarilumab 400 mg group."

https://pubmed.ncbi.nlm.nih.gov/33676590/

As one would expect there are side effects in suppressing Il-6.

https://www.mayoclinic.org/drugs-supplements/sarilumab-subcutaneous-route/precautions/drg-20406298
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@dadcue

Yes! I'm glad you posted this. I was going to mention this to @abbeyc and @redboat because we were discussing Actemra which I take for PMR. There is the possibility that Actemra will stop working so I'm happy there might be an alternative to Actemra. My rheumatologist has already said Kevzara might be a possibility in the future.

Kevzara (sarilumab) and Actemra (tocilizumab) both have the same mechanism of action and both are in the same classification of medications. They are both IL-6 receptor inhibitors.

Actemra was approved by the FDA for GCA in the injectable formulation several years ago. Last year, the IV formulation was approved.

"On February 28, 2022, the FDA approved Genentech's intravenous (IV) formulation of Actemra (tocilizumab), for treatment of giant cell arteritis (GCA) in adult patients. — Previously, only the subcutaneous (SC) formulation of Actemra was approved for this indication"

Now, Kevzara has been FDA approved for PMR.

https://www.ahdbonline.com/supplements/2438-kevzara-sarilumab-a-novel-il-6-receptor-antagonist-for-rheumatoid-arthritis
I didn't want to discourage you but, TNF-inhibitors like Humira and Embrel have not been shown to be effective for the treatment of PMR. I always hope for anything that works better than long term prednisone.

We are all different snowflakes as you say. I think TNF-inhibitors are worth a try as well. I think TNF-inhibitors have worked for people who have both RA and PMR. When you have both inflammatory arthritis and PMR, things get extremely complicated.

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Here's a paper describing a randomized control trial showing the effectiveness of Actemra (tocilizumab) against Giant Cell Arteritis. GCA is closely related to PMR, with much of the same pathology.

Compared to prednisone only, tocilizumab really helped with reducing remission , and also reduced the total adverse events.

https://www.nejm.org/doi/full/10.1056/nejmoa1613849

The graph shows the results, with % of people that did not have flares plotted as a function of time. So higher is better on the plot. The best group received tapered prednisone for 26 weeks combined with weekly injection of tocilizumab. 2nd best was prednisone plus tocilizumab. The worst results were prednisone only (26 weeks or 52 weeks.)

https://www.nejm.org/doi/full/10.1056/nejmoa1613849

There are side effects in suppressing IL-6, as tocilizumab does, but in the study the overall adverse events were (surprisingly) LESS when tocilizumab and prednisone were combined when compared with prednisone only.

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Kaiser Permanente Northern California seems to be treating Actemra and Kevzara as interchangeable with Actemra their preference, and Kevzara as a backup. I think this is becasue they get Actemra at lower cost. My rheumatologist says the cost to the patient is the same for either. Both corporations that produce these drugs offer a $15,000 annual subsidy if you have a condition for which the drug is FDA approved to treat. This can make the cost to the patient near zero. Actemra is approved for GCA (but not PMR) and Kevzara is approved for PMF (but not GCA).

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Where do I go to apply for Kevzara assistance?

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@redboat

Kaiser Permanente Northern California seems to be treating Actemra and Kevzara as interchangeable with Actemra their preference, and Kevzara as a backup. I think this is becasue they get Actemra at lower cost. My rheumatologist says the cost to the patient is the same for either. Both corporations that produce these drugs offer a $15,000 annual subsidy if you have a condition for which the drug is FDA approved to treat. This can make the cost to the patient near zero. Actemra is approved for GCA (but not PMR) and Kevzara is approved for PMF (but not GCA).

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Thanks so much. Do you know which corporate office or whatever I would contact for Kevzara? I have PMR, which I believe is covered. I also took Actemra without success earlier this year. I would think that the folks who sell Kevzara would like to see me get a success since their competition failed.
I was not able to get any assistance with Actemra, by the way.

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@jnwwells

Thanks so much. Do you know which corporate office or whatever I would contact for Kevzara? I have PMR, which I believe is covered. I also took Actemra without success earlier this year. I would think that the folks who sell Kevzara would like to see me get a success since their competition failed.
I was not able to get any assistance with Actemra, by the way.

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There isn't a competition between Actemra and Kevzara. The way they work is basically the same. If Actemra failed then Kevzara will likely fail too. They are both IL-6 receptor inhibitors.

Actemra works for me for PMR and I have taken it for 4 years. There is a chance that my body will form antibodies against Actemra so it might not work forever. If Actemra stops working, my rheumatologist says Kevzara might be another option for me. The molecules of Actemra and Kevzara are slightly different but Kevzara should work about the same as Actemra.

https://www.verywellhealth.com/antibodies-to-biologics-4846279#:~:text=Because%20biologics%20are%20created%20using,different%20for%20each%20individual%20drug.

Not everyone will have the same response to any medication owing to our own individual chemistry and other factors.

https://www.drugs.com/compare/actemra-vs-kevzara
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@jnwwells

Where do I go to apply for Kevzara assistance?

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@jnwwells, my experience was that when my rheumatologist prescribed the medication the pharmacy got the ball rolling. My insurance company initially declined to pay for the prescription but when my doctor appealed based on my medical history and the new FDA approval for PMR, it was approved and assistance was part of that. I am no longer taking the medication due to a medical complication (benign hepatic cysts) but I did not have any “side effects”. Hope it will work for you!

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Thanks! I hope I have the same experience, but it certainly didn't happen last time.
Cant wait for open season to get rid of my johns hopkins health (non) insurance.

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@jnwwells

Where do I go to apply for Kevzara assistance?

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I got Kevzara assistance through Kevzara Connect.
https://www.kevzara.com/

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