Actemra approved in Europe | Arthritis Information

 

RoACTEMRA Approved In Europe To Treat Patients Suffering From Rheumatoid Arthritis

First in class therapy offers new treatment option to patients with moderate to severe form of the disease

Roche today announced that the European Commission has approved RoACTEMRA (tocilizumab, known as Actemra outside of the EU), to treat patients with rheumatoid arthritis (RA). RoACTEMRA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderate to severe RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoACTEMRA can be given as monotherapy in cases of intolerance to methotrexate (MTX) or where continued treatment with MTX is inappropriate. RoACTEMRA is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody developed for the treatment of RA and is a novel approach to help tackle this debilitating disease.

RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications such as fatigue and anemia. There are several key cytokines, or proteins, involved in the inflammatory process including tumor necrosis factor (TNF) alpha, interleukin-1 (IL-1) and interleukin-6 (IL-6). IL-6 has been identified as having a pivotal role in the inflammation process. The exact cause of RA is unknown and there is no cure currently available.

"Many patients suffering from rheumatoid arthritis fail to respond to any treatment and few actually achieve lasting remission, which is currently the ultimate goal of treatment for RA. The approval of RoACTEMRA offers new hope for patients suffering from the debilitating effects of rheumatoid arthritis" said William M. Burns, CEO of Roche's Pharmaceuticals Division. "Roche will work with the authorities in EU member countries to ensure that this groundbreaking therapy will be available to patients as quickly as possible."

The European Commission's approval for RoACTEMRA was based on results from the largest clinical program undertaken by a biologic in RA including, five multi-national Phase III studies which demonstrated that treatment with RoACTEMRA alone or combination with MTX or other DMARDs significantly reduced RA signs and symptoms, compared with current DMARDs alone. These benefits were regardless of previous therapy or disease severity.

The approval in the EU follows earlier approvals for the product in several countries, including Japan, India and Switzerland.

 

http://www.medicalnewstoday.com/articles/136254.php

I thought Actemra was supposed to have been approved here in the US too but then the FDA decided they wanted more clinical trials or something.  Lynn, do you know anything about when it might be available here?  Also, is Cimzia in any clinical trial for treatment of RA at this time?  I'm running out of options and these two sound promising from what I've read about them. Bob,

When you have sever RA any releif is good I suppose. At some point I wish they would stop and find a CUREi

[QUOTE=bob_h76]I thought Actemra was supposed to have been approved here in the US too but then the FDA decided they wanted more clinical trials or something.  Lynn, do you know anything about when it might be available here?  Also, is Cimzia in any clinical trial for treatment of RA at this time?  I'm running out of options and these two sound promising from what I've read about them. [/QUOTE] [QUOTE=bob_h76]I thought Actemra was supposed to have been approved here in the US too but then the FDA decided they wanted more clinical trials or something.  Lynn, do you know anything about when it might be available here?  Also, is Cimzia in any clinical trial for treatment of RA at this time?  I'm running out of options and these two sound promising from what I've read about them. [/QUOTE] "Many patients suffering from rheumatoid arthritis fail to respond to any treatment and few actually achieve lasting remission, which is currently the ultimate goal of treatment for RA."

 

This is a sobering line from this press release.  I am glad that it mentions anemia, which I feel isn't alluded to enough in American rheumatology, as I am the only one I have seen in here so far that was told they had inflammation anemia. 

[QUOTE=justsaynoemore]"Many patients suffering from rheumatoid arthritis fail to respond to any treatment and few actually achieve lasting remission, which is currently the ultimate goal of treatment for RA."

 

I wsa told the same thing by a few rheumatologists but they also mentioned that this is not a common situation.  The patients may not achieve remission, but most do experience a significant amount of relief for a time.  I sometimes wonder if the effect of any of these drugs is in the head of the patient.   You know, the old if I think it's true it must be thing.  I have to date not really failed any biologic so much as the effect has worn off over a time.  Kineret was the least helpful, Enbrel was a godsend for over 4 years for me.  No remission, but close.  Then it faded and Remicade was started.  I don't think it had great  benefit but it did work a little.  I should have gone with the rd's suggestion to up the dose but I wanted to try Humira instead.  It was helping, but the reason I'm off of it is a pretty long story.  So you see, I'm not stranger to drug failure either and have now only got Orencia and Rituxan left until the new stuff comes out.

 

Bob

[QUOTE=bob_h76][QUOTE=justsaynoemore]"Many patients suffering from rheumatoid arthritis fail to respond to any treatment and few actually achieve lasting remission, which is currently the ultimate goal of treatment for RA."

 

I wsa told the same thing by a few rheumatologists but they also mentioned that this is not a common situation.  The patients may not achieve remission, but most do experience a significant amount of relief for a time.  I sometimes wonder if the effect of any of these drugs is in the head of the patient.   You know, the old if I think it's true it must be thing.  I have to date not really failed any biologic so much as the effect has worn off over a time.  Kineret was the least helpful, Enbrel was a godsend for over 4 years for me.  No remission, but close.  Then it faded and Remicade was started.  I don't think it had great  benefit but it did work a little.  I should have gone with the rd's suggestion to up the dose but I wanted to try Humira instead.  It was helping, but the reason I'm off of it is a pretty long story.  So you see, I'm not stranger to drug failure either and have now only got Orencia and Rituxan left until the new stuff comes out.

 

Bob

[/QUOTE] http://www.arthritis.org/remission-is-possible.php

It's possible to achieve clinical remission.  Some stats show as high as 50% clinical remission on some of the combo of drugs. 

It's true that many patients don't achieve clinical remission but it's also true that many patients do achieve clinical remission, that's the reason you never give up.  After 10 years of moderate to severe disease activity I've been in clinical remission for the last year and I expect it to continue.  If it doesn't then we'll tweak the drugs once again.   I know it's possible.  Lindy

I need actemra, ive been waiting for it for years!I know it's possible too in fact I have a history of long standing disease remission.  After onset it seems like it would give me hell for a few months, then settle down to the point that I didn't know I still had it only to come back again.  Then, when my pediatric RD put me on MTX, I achieved remission in only about 4 months and was there for nearly 12 wonderful years.  Well, I thought it was an amazing statement to make in that press release.  I suspect it was just hype by a PR person to jazz up the lingo, but its very dangerous to make statements like that in the public realm regarding our common disease. JSNM-  the cause of RA has not been proven.  Autoimmunity is a theory granted its the current working theory but it has not been proven.  Nor has any other theory been proven to be the causeHubby's coworker was asked to be in an Actemra trial here.  We don't know if she did or not - she got very sick and was out of work forever, and we don't know if illness kept her out of the trial or if being in the trial made her ill. 

JSNM - rheums do not know the cause of any condition they treat except gout.  (You would think they would be all over diet, based on that, wouldn't you?)

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