Actemra news (not the good kind) | Arthritis Information
http://www.fiercepharma.com/story/roches-actemra-linked-15-deaths/2009-03-18?utm_medium=rss&utm_source=rss&cmp-id=OTC-RSS-FP0
More from WSJ:
http://online.wsj.com/article/SB123735013931766981.html?mod=googlenews_wsj
They say this further down the article, but do you think it is an accurate statement? At least it needs clarification, I think:
"Hopes have been high for Actemra because of its new approach. There are
already many treatments for rheumatoid arthritis, including
Rituxan/MabThera, which is sold by Roche and its U.S. ally Genentech
Inc. But many of these drugs merely relieve pain--in some cases with
severe long-term side effects, including osteoporosis and high blood
pressure."
They talk like Actemra was the first and only dmard/biologic/non-NSAID, to me!
Actemra is a new one to me. Must be very new.I just saw, it's Japanese and marketed in Europe. Not U.S.A. as I can see.Still in trials, but open label now. Hubby's co-worker was asked to be in one, but said no.
Many of these drugs merely relieve pain? What? I thought Actemra was a biological drug.
Acterma went for approval from the FDA last summer. The committee asked for more risk information and there were issues with the manufacturing plant not being certified. Those two issues were responded to when the FDA requested more information on effects on pregnancy and more long term data. My rheumatologist beleived in Janurary it would probably gain approval sometime at the end of this year..but we'll see
Acterma would be the only med blocking the activity of interleuken 6. kineret acts against interleuken 1
[QUOTE=Suzanne]"Hopes have been high for Actemra because of its
new approach. There are
already many treatments for rheumatoid arthritis, including
Rituxan/MabThera, which is sold by Roche and its U.S. ally Genentech
Inc.
But many of these drugs merely relieve pain--in some cases with
severe long-term side effects, including osteoporosis and high blood
pressure."/QUOTE]
"But many of these drugs merely relieve pain--"I wish...sigh...and am still waiting for the mere pain relief.
Wouldn't that be nice.
Doesn't explain though how I had 42 swollen joints before my first Rituxan/Mabthera infusions and only 4 afterwards.
And I simply don't believe that my rheumy who's worked his tail off for four years to try and stabilize me, is going leave me open to the risk of such devastating side affects as you mention. It's simply not something he would risk.
All drugs have huge side effects NOT just the DMARD's. I am more concerned about the side effects of Pred than of any of the anti rheumatics. Pred's information sheet is five pages long to include all the possible side effects.
Suzanne, I know your little girl has JRA and I wish her only the very best. Sometimes though it shows, Suzanne that you aren't experiencing this disease yourself from within. Start walking the walk of it daily and things are very different.
I have a 7 year old daughter and of course, have worried about her at times. Thank goodness, she is fine. I wish nothing but the best for your darling girl, Suzanne. She is super blessed to have such a caring Mom, which if nothing else, will see her through.
A single dose of the cancer drug rituximab doubled the rate of rheumatoid arthritis patients' response to methotrexate, Paul Emery, M.D., reported at the annual meeting of the American College of Rheumatology.
The combination appears to have a unique synergy. Neither methotrexate monotherapy nor rituximab alone or with cyclophosphamide produces nearly as impressive results, said Dr. Emery, a professor of rheumatology at the University of Leeds, England.
Rituximab, a monoclonal antibody that targets CD20 on B cells, was approved in 1997 for the treatment of non-Hodgkin's lymphoma. And since its approval, B-cell depletion has been hypothesized to be of benefit for patients with a number of conditions, such as systemic lupus erythematosis and rheumatoid arthritis.
The 161 study participants had severe RA and were randomly assigned to one of four treatment groups: methotrexate alone, rituximab alone, rituximab plus cyclophosphamide, or rituximab plus methotrexate.
During the study, patients taking rituximab and methotrexate were twice as likely to achieve an American College of Rheumatology response of 70 (ACR70), compared with patients on methotrexate alone (45% versus 17%). At week 104, 21% of patients treated with the combination had maintained an ACR50 response, compared with 11% of patients on methotrexate alone.
The rituximab in this study was given in two 1-g intravenous infusions administered 15 days apart. The cyclophosphamide was dosed twice at 750 mg, and methotrexate was dosed at 10 mg per week.
On the basis of European League Against Rheumatism response criteria, 33% of patients treated with the rituximab/methotrexate combination achieved a moderate to good response at 2 years, compared with 17% of those in the rituximab/cyclophosphamide group, 13% of those on methotrexate alone, and 10% of patients taking rituximab by itself.
At 2 years' follow up, 45% of the patients assigned to rituximab/methotrexate had completed the study and needed no adjustments to their regimen.
In contrast, only 22% of the patients treated with rituximab/cyclophosphamide who completed the study and stuck to the study regimen.
In the methotrexate group, 15% completed treatment with no change in treatment, and 10% of the rituximab-only group completed without change.
The bottom line is that 2 years after a single course of therapy, nearly half of patients in the rituximab/methotrexate group required no further therapy, as judged by their physicians, Dr. Emery noted.
It's still unclear how frequently rituximab will need to be administered.
Side-effect profiles and rates of infection were similar between all the groups. Rituximab did not appear to have any significant effect on immunoglobulin levels or antitetanus titers.
The 6-month results of this study were published previously (N. Engl. J. Med. 2004; 350:2572-81). The investigation was supported by Roche Products Ltd., which markets rituximab outside the United States.
[QUOTE=Cordelia]
Suzanne, I know your little girl has JRA and I wish her only the very best. Sometimes though it shows, Suzanne that you aren't experiencing this disease yourself from within. Start walking the walk of it daily and things are very different.
[/QUOTE]
The quote was from the article, not me. I didn't think it made sense, either.
Just because I don't have the disease doesn't make this news any less disappointing. Out of all the meds that have come on the market since my daughter was dx'd, the studies I have seen on this one had some results that made it look like it actually worked better than a placebo. I was hoping it would work
and have a better safety panel.
It's upsetting. Is there anything in the pipeline that will have benefits that will outweigh the risks for her?
Suzanne, I apologize. I was in a lot's of pain yesterday when I posted. I realize now it wasn't from you. Sorry.
No, your right it didn't make sense. And it is completely false. These drugs don't just relieve pain as we all know.
And yes, from Rituxan - high blood pressure is very rare side effect. Osteoporosis is NOT a side Rituxan at all.
I can feel your disappointment Suzanne. I have been on most of the DMARD's and honestly had very few side effects whatsoever. Any medication is a calculated risk. For me it's worth it because I have no choice. Although progress is slow when you have severe, aggressive RA as I do, I am still so much better than I was even a year ago.
When I was dxed four years ago, I couldn't pick Neve up, couldn't use a knife and fork, would wake up from a sleep completely locked up, and due to inflammation was nightblind and was having trouble speaking.
A year after I was dxed my marriage broke up and I became a single parent. It didn't matter much because my ex husband, hadn't been a involved parent anyway so I had been parenting alone since Neve was about nine months anyway. So crippled up as I was back then I continued on putting one foot after the other.
For me DMARD's weren't a choice, they were an absolute ruddy necessity.
I remember when I was dxed all the medications seemed so scary but once you start them and face that fear, it gets easier.
It must be very difficult making these decisions for you precious daughter. I've had JRA friends who have done fine with the medications over the years. In fact, from my observation is, they seem to deal with less as an adult, if they used medication as a child. One of them didn't get the treatment needed as a child and definitely seems to be faring worse in adulthood compared to the ones who did.
Suzanne, keep her moving. If you can access ballet lessons do. I believe I had JRA and it wasn't dxed but we kept it managed until I hit thirteen by ballet lessons without even knowing it. They give you strength and flexibility and help to some degree, with any pain she has.
And again, I apologize for being snappish at you, Suzanne. I was having a not so good day as I woke up with increased pain and by 9.30am I was a meltdown of tears. Thank goodness my friend Wendy was here and she just came and hugged me while I balled my eyes out for 20 minutes. I am so sorry you got caught up in that via my post.
I think the mother of a child with JRA would be as strongly affected by the disease as an adult who has it. I guess we all have our own opinions.
Suzanne- I like your posts.
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