First Biologic Drug Approved for PMR: Good news for... - PMRGCAuk

PMRGCAuk

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First Biologic Drug Approved for PMR

Knit11 profile image
26 Replies

Good news for those struggling to reduce Pred. The FDA approved a biologic drug, Kevzara, for PMR sufferes in the beginning of March. Ot acts like Actemra, which is only approved for GCA.

At this point, it is approved in the United States. Hopefully other countries will follow.

drugs.com/newdrugs/kevzara-....

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Knit11 profile image
Knit11
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26 Replies
DorsetLady profile image
DorsetLadyPMRGCAuk volunteer

Good news -but perhaps you should clarify it’s for use in USA - and not applicable in the UK, or PMR patients will be getting excited, only to have their hopes dashed.

Knit11 profile image
Knit11 in reply toDorsetLady

Excellent point. Edited.

DorsetLady profile image
DorsetLadyPMRGCAuk volunteer in reply toKnit11

Thank you….

AuthorJ profile image
AuthorJ in reply toDorsetLady

my new rheumatologist ( a keeper I think!) in Mew York state mentioned Kezvara when I met him in June. He has done a huge amount of blood work ( 10 vials from my arm!) to test for all Kinda of things. Wi get results and see him on 7/11. Fingers crossed!

Knit11 profile image
Knit11 in reply toAuthorJ

Good luck!

AuthorJ profile image
AuthorJ in reply toKnit11

Thank you Knit11!

AuthorJ profile image
AuthorJ in reply toAuthorJ

saw the doc All bloodwork was excellent! And he had 79 blood tests done. Results were super. Other than PMR he told me I have the body of a 20 year old! Wahoo! Now to taper prednisone

AuthorJ profile image
AuthorJ in reply toAuthorJ

he didn’t mention Kevzara again.

Knit11 profile image
Knit11 in reply toAuthorJ

See how it works with reducing. If you encounter a problem you can ask him about Kevaza,

piglette profile image
piglette

There has been a bit of discussion about it on this forum recently. Kevzara was approved by the FDA for the treatment of polymyalgia rheumatica in February this year for patients who have had an inadequate response to corticosteroids.

Knit11 profile image
Knit11 in reply topiglette

Yes. Also for those who can't reduce it.

piglette profile image
piglette in reply toKnit11

Sorry bad wording on my part

Knit11 profile image
Knit11 in reply topiglette

All is well🙂

bonio profile image
bonio in reply topiglette

very interesting but guess this is just USA?

PMRpro profile image
PMRproAmbassador in reply tobonio

Yes - don't worry, we'll announce it if NICE sees their way to allowing it but don't hold your breath, And there will be a definition of "not responding/able to reduce" before you would qualify.

Knit11 profile image
Knit11 in reply toPMRpro

It is the caveat here too. First you need to start woth Pred. This is probably "price effective", as they term it.

PMRpro profile image
PMRproAmbassador in reply toKnit11

Do they also stipulate failing a DMARD?

Knit11 profile image
Knit11 in reply toPMRpro

I don't think so. When they mention PMR, they only talk about steroids, if ineffective or difficult to reduce. The failing DMRD relates only to patients with RA. This is not approved for GCA.

DorsetLady profile image
DorsetLadyPMRGCAuk volunteer in reply tobonio

At the moment...

piglette profile image
piglette in reply tobonio

yes it has only been approved by the FDA not NICE yet.

Dydee profile image
Dydee

I read all the info on the studies and not sure the possible side effects are worth it. They sound worse than Pred. side effects. Was sure hopeful. I have uncontrolled eye pressure and now osteoporosis after 3 years of Pred.

Knit11 profile image
Knit11 in reply toDydee

The side effects are bad, however, you can avoid them by periodical blood tests. Once the numbers are a bit off, you immediately stop taking the drug. With Pred, you can't do that. You may also manage to get off the Pred and the biologic before any side effect is evident (this is the idea).People with RA have been taking biologics regularly for years (this condition does not go into remission like PMR) and it has been a game changer for them. These meds seem to help much more than traditional ones.

Of course, it is a choice whether you would like to take it or not. But at least it is available for those who do.

Hope you will feel better and see the end of the disease, whichever path you take.

PMRpro profile image
PMRproAmbassador in reply toDydee

The possible effects are just that - possible. Those listed are all those that patients reported that couldn't be said to be nothing to do with the medication.

If you read the lists for paracetamol, ibuprofen and alcohol you wouldn't take them either.

Mayadill profile image
Mayadill in reply toPMRpro

Always struck me as slightly eyebrow-raising in the context of medical twitchiness about Pred that I can go into my local convenience store and buy enough Paracetamol to kill me, never mind side-effects, while poor old Pred never hurt anyone, at least with that immediacy. Fact-check

Panadol Extra Soluble 500mg Paracetamol Caffeine Tablets, pack of 24 = 12 g

Patients who have ingested more than 150 mg/kg of paracetamol in any 24-hour period are at risk of serious toxicity.

Poisoning, emergency treatment | Treatment summaries | BNF | NICE

For a 75 kg person 150 mg/kg is 11.25 g.

PMRpro profile image
PMRproAmbassador in reply toMayadill

"I can go into my local convenience store and buy enough Paracetamol to kill me"

The amount you can buy in most of Europe, including the UK, is limited if you don't have a prescription. Doesn't stop you going to 10 in a row of course ...

It would be all so easy to sort out - they can add the antidote to the tablets so while taking the paracetamol you also stop it doing the damage.

Knit11 profile image
Knit11

Good point, PMRpro!

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