New Treatment for PMR authorized in US

[Jumpe]

Hi All,

I just saw this article today and thought I’d share in case it hasn’t come to anyone’s attention yet: medscape.com/viewarticle/98...

[DorsetLady PMRGCAuk volunteer]

That’s good, let’s hope the UK follows suit - but not sure that’s likely…

[suzy1959]

This looks exciting but why is the uk always behind the us ?

[PMRpro Ambassador in reply to suzy1959]

Approval for use and for funding are two different things. NICE has a tight hold on approval for funding. Also trials have been done for sarilumab in PMR - they were never done for tocilizumab in PMR, just originally RA and then GCA. To be approved for funding NICE will require the right information from the trials and, if TCZ is anything to go by, long term safety information. TCZ has been used for RA for more than 13 years - it was approved by the FDA in 2010. You'd think that was plenty of long term safety evidence wouldn't you? But NICE didn't.

My rheumy said on Monday he doesn't understand the UK attitude either - they have approved a far more expensive drug for ANCA vasculitis that isn't significantly better according to trial data but refuse to approve Actemra for PMR or even properly for GCA where it is quite clear it works wonderfully for at least half of patients and pretty well in the others.

[PMRpro Ambassador]

My rheumy mentioned it on Monday when I saw him. It's the same mechanism as tocilizumab/(Ro)Actemra so the best hope is that it will take the price of tocilizumab down as competition usually does - added to the fact that Roche is faced with the fact that the patent for Actemra has now lapsed. That means that other companies will be able to produce it and I believe at least one has already decided to do so, The same happened for Humira (another RA biologic) and its price has fallen from 17K euros to 800 euros per year. I would pay that myself!

[Bennijax]

Cannot access the full article as one neeeds to be a medical proessional - does any one have a copy of it to share?

[PMRpro Ambassador in reply to Bennijax]

I subscribe to Medscape, have done for years. It's free. That's for their info to know who looks at it. There used to be a choice for student and patient ...

[PMRpro Ambassador in reply to Bennijax]

This is what it says:

The US Food and Drug Administration (FDA) approved sarilumab (Kevzara) today for the treatment of polymyalgia rheumatica (PMR) in adults who have had an inadequate response to corticosteroids or could not tolerate a corticosteroid taper, joint developers Sanofi and Regeneron announced. The drug is the first and only FDA-approved biologic treatment for this inflammatory rheumatic disease.

The FDA previously approved sarilumab, an interleukin-6 receptor antagonist, in May 2017 for the treatment of moderate-to-severe active rheumatoid arthritis in adults who do not respond well or have an intolerance to disease-modifying antirheumatic drugs (DMARDs), like methotrexate.

The FDA approval for this new indication was based on results from the multicenter, phase 3 SAPHYR trial in patients with corticosteroid-resistant, active PMR. In the randomized, double-blind, placebo-controlled study, 59 participants received 200 mg of sarilumab plus a 14-week taper of corticosteroid treatment and 58 participants received placebo every 2 weeks along with a 52-week taper of corticosteroid treatment.

After 1 year, 28% of sarilumab patients achieved sustained remission, compared with 10% of the placebo group (P = .0193). Medscape Medical News previously reported these trial results in November when they were presented at the 2022 American College of Rheumatology Annual Meeting.

The most common adverse events in the sarilumab group were neutropenia (15%), leukopenia (7%), constipation (7%), pruritic rash (5%), myalgia (7%), fatigue (5%), and injection site pruritus (5%). Two patients had serious adverse reactions of neutropenia, which resolved after discontinuing treatment.

"Polymyalgia rheumatica can be an incapacitating disease, causing painful disease flares in multiple parts of the bodies that leave people fatigued and unable to fully perform everyday activities. Corticosteroids have been the primary treatment to date, but many patients do not adequately respond to steroids or cannot be tapered off steroids, which puts such patients at risk of complications from long-term steroid therapy," George D. Yancopolous, MD, PHD, president and chief scientific officer at Regeneron, said in the announcement. "With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependence on steroids."

[piglette]

It is used for rheumatoid arthritis in UK, as a sort of last resort. I believe it can cause liver damage. I am not sure I would rush in to using it.

[PMRpro Ambassador in reply to piglette]

So can paracetamol ... It's basically the same as Actemra

[piglette in reply to PMRpro]

I am sure Sanofi would not agree with you!!