Actemra enroute soonish?

[Hindags]

I spoke to a rheumatologist the other day who has been in touch with Genentech, the drug company that makes Actemra. She said they are pushing for Actemra to be approved, for PMR by the FDA and are hoping to get the approval fast tracked, within a year or so.

I know there's many a slip, but sounds good. Apparently the issue is no longer whether Actemra works for PMR. The total Pred load is 1/2 on Actemra than on Pred. alone. Hence fewer side effects, etc. The question they are studying now is how long it needs to be administered.

I know no more. I should have asked if any studies had been done using Actemra as a solo agent. I don't remember seeing reference to any. On ClinicalTrials.gov (US website) iirc, the GCA study only took people who had been recently diagnosed and only on Pred for a pretty short time.

I know we've had a recent discussion here about the class action lawsuit against Genentech/LaRoche for not having disclosed or studied the longer term side effects of Actemra, some serious. I asked about her about this and she was unaware of it. She did say that all the biologics and all the diseases that are treated with them have some of those same serious side effects/outcomes.

Just an fyi.

[Jackoh]

Thank you hindbags for your information

[BonnyQuine]

Thanks for this. Will be interesting to see how things go. Always dubious re motives of 'Big Pharma'.

I had been thinking that tocilizumab (Actemra) would be a preferable alternative to Methotrexate. Then, w info re side effects, was no longer so sure. If Pred didn't have so many negative side effects, it wouldn't matter. But as things are, need as much info as possible. Seem to have plateaued on 10.5 -> 10mg. Waiting w bated breath!

[Hindags in reply to BonnyQuine]

I'm also at about the same level. Day 3 at 10.5. Even though I'm only tapering at .5, on a weekly basis, I can feel each step getting just a little harder.

I'm supposed to spend a month at 10 if/when I get there.. The things about Actemra that might be risk worthy to me are that it targets IL6, the cytokine that is problematic in PMR so presumably the PMR should be resolving. Also, those treated with it vs Pred alone or with Metho and Pred together are exposed to much less Pred over the course of the disease.

Right now I'm on Fosamax, and a statin, due to Pred. Also having to postpone dental work, wondering what will come up next.

[PMRpro Ambassador]

They couldn't do GCA with Actemra as a sole agent - not ethical. PMR is a very different matter if they can find people who are happy to try it before going to pred if it doesn't work.

The class action isn't because the side effects are any worse - but because they didn't disclose them so making it look better than others. Which is naughty!

[Hindags]

I can see that. GCA represents a medical emergency. The inflammation can cause blindness if untreated.

But how would patients who initially present with PMR be screened for lurking GCA? When I first saw my Rheumy we talked about a TA biopsy because my markers were so high and I did have headaches. She was concerned that I might have GCA, just not fully declared, so to speak. I declined when I read about the high false negative rate. We chose to treat for PMR, 20 mg, and watch carefully. Thankfully, I have not developed GCA to date, some 8 months into treatment.

I know that 20 mgs won't treat GCA.

I would have jumped at ultrasound but it was not available to me. I hope that patients opting for Actemra only treatment would have better options to rule out GCA.

[PMRpro Ambassador in reply to Hindags]

No, PMR isn't a medical emergency - it is only if you show any symptoms of GCA or the GP suspects it it should be considered an emergency. If you don't have visual involvement 20mg very possibly IS enough to reduce the inflammation. It is really only when the inflammation is affecting the blood supply to the optic nerve that high doses are needed to reduce the inflammation as quickly as possible in the hope that vision will be preserved.

There aren't any better options besides the ultrasound or TAB - it is a clinical diagnosis otherwise.

[christine2715]

Hello, I have GCA and have funding to have Actemera (tocilizumab) which I am having tomorrow at Southend Hospital by infusion. Injections weekly after. I think you can only apply if you have tried a number of other drugs to help with Predisilone reduction. I have tried everything and even a 1/2 mg reduction gives me bad flare ups - even at 11 mg. I looked into the court case which is not due to the number of deaths but the fact that the side effects were not reported on the packaging or notified to patients before they took it. In fact 700,000 have taken Actemra worldwide so the percentage is in fact low. The people who have taken it are mostly taking it for Rheumatoid arthritis.

[Hindags]

Thanks for the info, especially the info on the court case, the history of Actemra and how many people have already been treated with Actemra for various conditions.