New RA drug | Arthritis Information
This was in Arthritis Today magazine. Not sure if anyone had posted this yet...
New Rheumatoid Arthritis Drug
By Denise Mann
SAN
FRANCISCO, October 25, 2008 – When taken with methotrexate, a new pill
that blocks an inflammatory protein called syk kinase may be another
weapon in the ongoing war against rheumatoid arthritis (RA), finds new
research presented at the American College of Rheumatology Annual
Scientific Meeting.
Under development by Rigel
Pharmaceuticals, Inc., R788 (fostamatinib disodium) is part of a new
class of drugs that blocks syk kinase, which can trigger the
inflammation that is a hallmark of rheumatoid arthritis, thereby
stopping the progression of the disease. The same agent is also being
studied in other diseases including lymphoma, lupus and type I diabetes.
In
the new study of 189 people with active RA who were already taking the
older disease modifying anti-rheumatic drug methotrexate, those
participants who also took the 100 and 150 mg doses of the new syk
kinase inhibitor twice a day showed greater improvements in their
rheumatoid arthritis, than did their counterparts who took a dummy pill
or placebo. The improvement was seen as early as week one.
There
were also decreases in key biomarkers of RA disease activity including
interleukin-6 and matrix metalloproteinase-3 (mmp-3) levels among
people who took the 100 mg and 150 mg doses of the new drug. There was
not a significant effect in any measure seen among people randomized to
the 50 mg dose.
The new drug was also safe. The major side
effects were dose related and reversible. They included diarrhea and
low white blood cell count.
Unlike biologic drugs
which are given by injection or infusion, the new drug is taken by
mouth which is a huge plus, says Eric Matteson, MD, the chairman of the
rheumatology department at Mayo Clinic College of Medicine, in Rochester, Minn.
“The
preliminary studies are actually very encouraging in terms of clinical
effect and it is kind of exacting that they are oral,” he says,
If
the new findings are confirmed, the new drug and others in this class
may one day be used in conjunction with biologics since they act
differently. “Together with biologics, syk kinase inhibitors may be
even more powerful and synergistic,” he says.
Thanks. I'm googling this one as we speak and have found some info on it. I don't know what might have happened to it but some of the info I'm finding goes as far back as 2006.
Bob
I like the part about you are able to take it orally. Seems strange nothing more has been said since Oct though....see. I don't think taking it orally is a plus.. I'd rather not put anymore harmful things into my stomach and digestive system........
I read this in an email I received from another Arthritis site....
thanks for posting, wantto
It appeals to me because I have a stomach and digestive system like an iron drum and thought of having to prick my self makes me want to hide...
But what interested me about myself was...now why would I want to consider this drug that has not been around as long as the biologics and that's the reason I like to tell myself I am so afraid of biologics. The fact that they have not been around so long.
I think the fear of needles is a big part.
BUT! If I ever really have to step up I will. I certainly am not that stubborn or that much of a wus.
Here is the only completed study I found, but according to clinicaltrials.gov, the results have not been posted yet:
http://www.clinicaltrials.gov/ct2/show/NCT00326339?term=R788&rank=6
WanttobeRAfree,
Thanks for posting. will mention it to the RD since he is not happy with the rituxan results and see what he says.Thanks Suzanne. I printed it out to look over.I would consider this drug as a replacement for Humira. Even though I'm in clinical remission I would like to taper from Humira but I think I need something besides MXT. Will copy the clinical trial info and hopefully it will be released soon. LindyIt would be a wonderful thing if this would help some of our members here who have not yet responded to the rest of the drugs available too!
At this point, I'm willing to try anything if the rheumatologist said it would help. Over the last 8 months I've watched more and more of "me" slip away because of this disease and I want him to come back. I go for my second Remicade infusion tomorrow but I don't think it's going to do a thing for me. I was on it once about a year ago and it didn't do much then either but this time it's a much higher dose. I'd love to try Orencia as I believe it would work well at least for a while maybe. I think it has something to do with my body having been exposed to all the current TNF inhibitors and now they don't work because they are "familiar" to my RA and it knows how to get around them. That's the short non technical way for me to explain it.
Bob
I found this page about syk kinase and wondering if this has been out since 1999?
|
| Tuesday, 30 November 1999 00:00 |
| A new class of oral drugs for treatment of rheumatoid arthritis - Syk kinase inhibitors - produces a rapid reduction in disease activity, according to results of a phase II trial.
A new class of oral drugs for treatment of rheumatoid arthritis - Syk kinase inhibitors - produces a rapid reduction in disease activity, according to results of a phase II trial presented Monday at the American College of Rheumatology Annual Scientific Meeting in San Francisco.
"Clinical effect was noted as early as week one" in patients with active disease while taking methotrexate, the investigators report, and up to half of patients treated at the highest dose were in remission after three months of treatment.
"Syk kinase, an intracellular protein that functions as a key mediator of Fc-gamma and B cell signaling, is thought to be an essential player in activation of immune cells," presenter Dr. Michael E. Weinblatt told Reuters Health. "It has been detected in rheumatoid synovial lining cells, and in an animal model of inflammatory arthritis, an inhibitor of Syk kinase suppressed arthritis activity."
The Treatment of Arthritis with Syk Kinase Inhibition (TASKI-1) trial included 189 patients randomly assigned to the investigational drug R788 (Rigel Pharmaceuticals) at doses of 50, 100, or 150 mg, all twice daily, or placebo.
The two highest doses were associated with significantly superior response compared to placebo, reported Dr. Weinblatt, who is with Brigham and Women's Hospital in Boston. The ACR 20 response rates at 12 weeks in the 100 mg bid and the 150 mg bid groups were 65 per cent and 72 per cent, respectively, compared with 32 per cent in the 50 mg bid group and 38 per cent with placebo.
Corresponding rates of ACR 70 response were 33 per cent, 40 per cent, two per cent and four per cent, respectively.
Furthermore, one third of patients on 100 mg twice daily and half of those taking 150 mg twice daily achieved remission, whereas no more than one in five in the other two groups did so.
The major adverse effects were dose-related and reversible and included diarrhea and neutropenia.
"The rapid onset of effect, the improvement in arthritis parameters and serum biomarkers show that inhibition of Syk kinase is a viable new target for the treatment of rheumatoid arthritis," the investigators conclude in their abstract.
"Larger phase two studies are now in progress to help define the best dose and the longer term response rate and tolerability profile," Dr. Weinblatt added. |
sorry forgot to post where I read that.here it is.
interesting- and basically the same info reported in Oct 2008? I wonder what's going on with this drug?Where's Lynn49 when you need her? She usually knows about all of this good stuff and has some really great links to info. What about it Lynn have anything about this drug?
I'll ask at the next RD appointment but that's at the beginning of April.
Bob
I have an appointment with my RD Thursday- I'll bring it in and ask him what he knows too. Lets see...I need a new blood work prescrip, meds refills, discuss high inflammation markers on last blood test, discuss increasing MTX over starting biologic, what is this new drug.... I better get a list together.
My opinion is that if there is only one completed study and the results of it have not been published, the articles we are seeing must be more like press releases.
[QUOTE=bob_h76]Where's Lynn49 when you need her? She usually knows about all of this good stuff and has some really great links to info. What about it Lynn have anything about this drug?
I'll ask at the next RD appointment but that's at the beginning of April.
Bob
[/QUOTE]
Sorry Bob
Here's some info....
Okay, you have to punch in R788 (fostamatinib disodium) to the search engine at www.mskreport.com/search to get the info.... Lynn492009-02-25 09:54:58Sometimes one can glean a wealth of info from press releases or a very small amount, but it's always good to investigate any legitimate lead, no matter. There's so few things going on in RA research now - especially in the "cure" area that I guess any info we find we should investigate it further and hopefully with your doctor's help you can sort it all out. There may be more completed studies and they're just not available to the public. It would be interesting to get an answer or direction from the makers. Lindy From Lynn's link:
http://www.mskreport.com/articles.cfm?articleID=3208
"Inhibition of Syk signaling with a relatively selective inhibitor of
Syk kinase produced significant clinical benefits in a population of RA
patients with active disease on MTX therapy,” Dr. Weinblatt concluded.
“We are able to define a therapeutic dose based on the efficacy and
toxicity results. The 100 mg BID and the 150 mg BID doses were both
effective with similar degrees of clinical response; however, there
were more clinical and laboratory adverse events with the 150 mg dose.
The rapid onset of effect, the improvement in arthritis parameters and
serum biomarkers show that inhibition of Syk kinase is a viable new
target for the treatment of rheumatoid arthritis. Longer term studies
are needed to further define the safety and efficacy profile of this
drug.”
Two phase IIb studies of R788 are underway. The first trial (TASKI 2)
will evaluate approximately 420 RA patients receiving 100 mg of the
agent PO BID or 150 mg PO QD, compared with those receiving placebo in
a multicenter, randomized, double-blind, placebo-controlled,
parallel-dose study of R788 in patients who have failed to respond to
MTX. Patients will continue to receive a stable dose of MTX throughout
the course of the 6-month clinical trial. Primary outcome results are
expected in November 2009, and the estimated study completion date is
March 2010.
The second trial (TASKI 3) will evaluate a group of RA patients
receiving 100 mg of R788 PO BID compared with a group receiving placebo
in a multicenter, randomized, double-blind, placebo-controlled,
parallel-dose study of the agent in patients who have failed at least
one marketed biologic agent. Approximately 195 patients will be
enrolled in the trial, each of whom will receive R788 or placebo over a
3-month treatment period. Patients may continue on their stable dose of
MTX and/or other (nonbiologic) therapies. Primary outcome results are
expected in August 2009, and the estimated study completion date is
November 2009."
So it looks like two more small studies should be completed by this time next year.
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