gca and Actemra

[cassey1879]

Anyone on Actemra monthly infusions and what can you tell me? Started 60 mgs. of pred. back in December of 2014 got down to 15 jan 2015 but since Feb back on 40 and last month 38, Rhumey prefers Methotrexate, but a lot os tomach problems now, and nuero opthomologist prefers Actemra. Got a lot of literature from Rhumey and don't think it is approved yet for GCA juyst under study only for RA But heard there is funding, etc, you can apply for I am in New Jersey. Just weighing the pros and cons of both. I am leaning towards the Actemra if can get some financial assistance. Plus am allergic to so many medications, and done in office. Any info greatly appreciated. This support group is truly a blessing!

[Joyful13]

I am on Actemra for GCA. I have been having monthly infusions for 4 months. I am with Kaiser Permanente which is a large health insurance and facilities throughout California. Kaiser is covering the cost of the Actemra. The company that makes Actemra is in South San Francisco and is called Gennentech. I have heard that they will help with the cost of drugs on an individual basis.

Yes, Actemra is still in trial for GCA, but the studies so far have been very encouraging. Perhaps your doctor can contact Gennentech in South San Francisco to see if they can help you with the finances.

I have had very good results with Actemra. My sed rate and CRP have gone down in to the normal range for the first time in years. I have not had any GCA flare ups since taking the Actemra. I am currently down to Prednisone 5mg.

This is a very stressful time for me as I fractured both the tibia and fibula above my left ankle 2 months ago. I had surgery with plates and screws to stabilize the severe fracture. Still the Actemra is working.

Initially, I had some severe headaches the night after receiving the infusion, and some heart palpatations. Overall, most symptoms are reducing the Prednisone under 5mg.

I hope you can work an arrangement out for you to be able to try the Actemra. I was also on Methotrexate for a while but had a lot of side effects.

I wish you the best.

Karen

[Gosingen in reply to Joyful13]

Hi Karen

Just been reading with interest you reply to casssey1879 re Actemra infusions for GCA. I have both PMR and CGA... never been below 8mg pred and trying different medications don't work because of side effects. Next time I see my rheumy in August I will ask her about this drug. I live in UK, so it may well be very different from you across the pond. I so wish I could even get down to 5mg pred and a normal CRP.

Perhaps this drug, if available in UK might do the trick. Nearly seven years on I'm "fed up" with this journey.

Good to read that it's working for you. So there is always hope. Tx for sharing.

Yvonne

[PMRpro Ambassador in reply to Gosingen]

See my reply to Joyful.

[Joyful13 in reply to Gosingen]

Dear Yvonne,

Please look at my reply to PMRpro.

As I told her, I can only hope and pray that Actemra will be used in other countries.

I can appreciate how frustrated you must be after 7 years!

Do you still have GCA symptoms?

Blessings and hope to you, Yvonne.

Karen

[Gosingen in reply to Joyful13]

Thanks Karen,

Yes, I do have GCA symptoms, particularly when I try and reduce, it's a struggle. Will check PMRpro reply.

Thanks also for your well wishes.

All the best to you too.

Yvonne

[casse in reply to Joyful13]

Thank you for your information. Very helpful if next blood work is not normal then I will have to go on something if normal then we'll go down to 37 mg and keep on trying. Thank you again.

[Joyful13 in reply to casse]

casse

I talked with my son who works for Gennentech.

He said that Actemra has not been submitted for FDA approval yet, but the plan is to submit it this year. It will probably take a year for the drug to be approved for GCA.

In the meantime, if you decide to try Actemra, he said to talk to your insurance to see if they will cover this drug, or to what extent they would cover the drug. Your doctor can also talk to the insurance company.

Once Actemra is FDA approved, patients in the U.S. can contact Gennentech at: genentech-access.com/patien... to see how Gennentech might be able to help. You may want to go to that website just see what it says.

Wishing you the best,

Karen

[casse in reply to Joyful13]

Thank you Karen for this information. My rheumatologist did say something about she can trying get some kind of funding, etc. and hoping I won't have to go on it, or her choice, methotrexate and I can try weaning off one more time. Know I can't continue to stay on these high doses much longer though it is starting to take a toll on my body with osteoporosis in the diabetes now. Again thank you very much for sharing this information.

[PMRpro Ambassador]

The trial for GCA is finished, the last patient completed the study in April - all that we are waiting for is the results. The rumours are it looks good - but we can't really know yet since I think it was a double blinded study for most of the time - neither the patient nor the doctor knew what they were on. Then it can be put forward for registration and that will allow the fundholders to decide whether to approve its use and reimbursement. It is very expensive - about $17-20,000 a year in the USA - and a very long way from approval in the UK. Any use is therefore off-label - no come-back to the drug company if anything goes wrong.

There is currently a public consultation going on regarding the NHS using it for Takayashu's arteritis and GCA. The recommendation is that it could be approved for Takayashu's (an even rarer form of arteritis than GCA) which only affects young patients and about 2 new patients per year in the UK but not for GCA. Tocilizumab (the name of the drug) is approved already for use in severe RA - after working your way through all the other DMARDs and failing them. Whether that will change after the results of the study are out I don't know - I doubt it to be honest, in the short term at least, given the potential cost to an NHS that is struggling because it is underfunded anyway.

[Joyful13 in reply to PMRpro]

Dear PMR pro,

Thank you for updating me on what is happening in the UK. I know this drug is so expensive. Each infusion I have is about $4,000 dollars. I would never be able to afford this drug myself.

I am going to talk with my son who works for Gennentech and see what kind of assistance their company gives on a patient to drug basis. Gennentech has been bought by Roche several years ago, but they have kept the name, Gennentech because it is well known here.

I am not familiar with Takayashu's arteritis, so will look it up.

I have heard that Actemra is to be FDA approved this year.

I will let you know if I find out any assistance that Gennentech can give in other countries besides the U.S.

I will continue to hope and pray that others will be able to benefit from this drug. In the US., it is used for adults and children with severe rheumatoid arthritis.

Take care.

[PMRpro Ambassador in reply to Joyful13]

It's used for RA and JiRA in the UK too - just not for other things yet. As to whether "Actemra is to be FDA approved this year" - the company may well hope so and I hope it does happen but it isn't uncommon for the FDA to take much longer to approve a drug than other countries.

Takayashu's is - to all intents and purposes - GCA. The pathological findings are the same but some doctors make a distinction on the basis of age. It is generally diagnosed in younger patients and is far more destructive than GCA is in older patients. However - I do know of one lady who discovered her diagnosis was changed from Takayashu's to GCA once she was 50! Go figure...

[casse in reply to PMRpro]

Thank you for this important information very much appreciated.