Twenty-Six Year Data With COPAXONE

A board to discuss the Multiple Sclerosis modifying drug Copaxone

Twenty-Six Year Data With COPAXONE

Postby Dunmann » Mon Oct 03, 2005 7:51 am

An interesting long term study. This is the same post as before... I just wanted to include the text just in case the link went down.

Twenty-Six Year Data With COPAXONE(R) Reinforce Clinical Efficacy and Safety in Relapsing-Remitting Multiple Sclerosis
Monday October 3, 8:00 am ET

Study Represents Extensive, Continuous Clinical Experience With Immune Modulating Therapy

KANSAS CITY, MO--(MARKET WIRE)--Oct 3, 2005 -- Clinical experience and study data with COPAXONE® (glatiramer acetate injection) in relapsing-remitting multiple sclerosis (RRMS) patients with active disease (mean annual relapse rate of 2.9) now span more than a quarter of a century. In a long-term, open-label, compassionate use study of up to 26 years (prior to any immune modulating therapies approved by the Food and Drug Administration (FDA)), presented at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), clinical efficacy and safety data demonstrated reductions in relapse rates, slowed disease progression, and continued tolerability of COPAXONE®.

"To see the long-term positive impact on disease progression in these patients on COPAXONE® is very helpful for clinicians and patients making treatment decisions, especially since long-term data with other therapies are scarce," said Dr. Aaron Miller, professor of neurology, Department of Neurology, Mount Sinai School of Medicine, New York, and lead investigator on the study. "Long-term data reinforcing the clinical utility, such as this experience with COPAXONE®, can be reassuring for patients and physicians when making treatment choices."

The author reported the long-term clinical experience in 46 RRMS patients treated with COPAXONE® for 1-26 years (average 10.5 years). Assessment of clinical effectiveness included annual relapse rates and Extended Disability Status Scale (EDSS) scores.

Safety was determined by reports of adverse effects. Patients were seen every six months. Of the original 46 patients, 18 remain active in the study, and of the 28 who withdrew, patient decision to withdraw was the most common reason (54 percent).

At entry, based on a patient's entire history, mean annual relapse rate was 2.9+/-1.4 (range: 1-7). At last clinical observation, mean annual relapse rate for 24 of 42 patients on COPAXONE® (glatiramer acetate injection) was reduced (0.1+/-0.2, p < 0.0001). In terms of EDSS, 24 of 42 (57%) patients had improved or unchanged EDSS scores at last observation compared to pretreatment entry of 3.0+/-1.8 (range: 0-6.5). Over the long course of the study, a non-significant change in average EDSS score was observed (3.0+/-1.8 at entry vs. 3.8+/-2.5 at last observation). Only 8 of 34 (23.5 %) patients with entry EDSS scores less than six, progressed to an EDSS score of six or more with average disease duration of greater than 17 years. For those patients remaining in the study (at the time of data cut-off for this abstract, n=18) with average disease duration greater than 24 years, only 26.7 percent progressed to EDSS greater than or equal to six. This compares favorably to a natural history cohort, which shows 50 percent progressing to six or greater at 15 years after disease onset. Long-term COPAXONE® therapy was well tolerated, and patients reported adverse events similar to those experienced in short-term trials.

About COPAXONE®

Current data suggest COPAXONE® is a selective MHC class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® (glatiramer acetate injection) is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience.

Teva Pharmaceutical Industries Ltd. (NasdaqNM:TEVA - News), headquartered in Israel, is among the top 20 pharmaceutical companies in the world. Close to 90 percent of Teva's sales are in North America and Europe. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.

Teva Pharmaceuticals USA and Teva Neuroscience, Inc. are subsidiaries of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONE®. COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.

See additional important information at http://www.copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the beliefs and expectations of Teva's management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include whether and when the proposed acquisition with Ivax Corporation will be consummated and the terms of any conditions imposed in connection with such closing, the terms and conditions of the financing utilized by Teva for the Ivax acquisition, Teva's ability to rapidly integrate Ivax's operations and achieve expected synergies, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell or license their own generic products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic products, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final court decision, including that relating to the generic version of Neurontin®, the effects of competition on Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations outside the United States that may be adversely affected by terrorism or major hostilities, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

05270508/050970


Contact:

Contacts:
John Shaw
Teva Neuroscience
(816) 508-5062
Email Contact

Mandy Levings
Fleishman-Hillard
(816) 512-2379
Email Contact


Source: Teva Pharmaceutical Industries Ltd.

Orig Link:
http://biz.yahoo.com/iw/051003/096732.html
Last edited by Dunmann on Tue Apr 04, 2006 10:20 am, edited 1 time in total.
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Postby bebe » Sat Oct 08, 2005 5:44 pm

Not sure how good of a study this is- only 46 patients, and its not controlled in any way.
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Postby bromley » Sun Oct 09, 2005 10:22 am

Bebe,

I'm with you.

Of the original 46 patients, 18 remain active in the study, and of the 28 who withdrew, patient decision to withdraw was the most common reason (54 percent).


I'd like to know about 28 and why they withdrew.

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Postby LisaBee » Sat Oct 29, 2005 3:29 pm

The drop-outs in these long follow-ups are a real analysis problem, and I am not sure how the trial analysts interpret them.

I suspect that many of the people who dropped out of the study were progressing, and perhaps felt like the daily injections of Copaxone weren't helping them. Those that had a milder disease on Copaxone felt like the drug was helping them, and they kept taking it. If that assumption on the reason for dropping out is true, it leads to a couple of possibilities, that in a subgroup of MS patients Copaxone does actually help, or, the more negative possibility, the patients that stuck with Copaxone had milder disease anyway, which Copaxone only gave the appearance of helping. I don't know if there is any way to determine which is the correct answer, other than to have a large enough group of people taking the drug for 20+ years and hanging with it no matter what. Such a study is impossible, because people who get really ill with MS are not going to keep up the Copaxone.

There needs to be a lot more information on markers for progression in the natural history of MS, that is, some way to know which people are far more likely to have a mild disease and which ones are more likely to have a severe disease. Then, the people with severe disease markers that stayed with Copaxone and did far better than expected would indicate a true effect from Copaxone. If, however, the only people who stay stable on Copaxone are those with mild disease markers, it suggests Copaxone isn't the reason they did better, they were slated to naturally do better. Unfortunately, the indicators for prognosis are not very reliable for this level of analysis.

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Postby Melody » Sat Oct 29, 2005 5:31 pm

That is the problem that must be faced all MS affected people are different. I believe each and everyone needs to first decide where their system first went haywire. Hubby's was allergies IMO which then compromised his immune system. Some of you might be bacteria or environmental as well as a host of other's. Hubby is on copaxone but it is not the answer IMO. We will continue to count on our own knowledge of hubby's body and the reactions he has to different foods and stimuli
John was diagnosed Jan 2005. On lipitor 20mg .On Copaxone since July 4,2005. Vitamin D3 2000iu-4000iu (depending on sunshine months)June 10 2005(RX::Dr. O'Connor) Omega 3 as well Turmeric since April 2005. Q10 60mg. 1500mg liquid Glucosamine Nov 2005.
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Postby pinda » Sun Oct 30, 2005 2:52 pm

Hello Melody. Notice your husband is taking Tumeric. Is this in pill form. or do you cook with it, or both? Have been thinking of taking for inflamation and checking into Vit. D again. Was on 800 and stopped this Aug. because of research re toxic but now looking at again after seeing the video with Dr. Reinhold Veth. Also asking my Family Dr. for a blood test to see what it says for Vit. D. I am not dx. but dealing with MS like symptoms for over 2 years. Have a good Neurologist, well known to be one of the best for MS, and he sees me every 6 months. Does not want to dx until sure and I do not have the right test markers but do have the symptoms. He has not ruled out other things so still in limbo land. Being older does not help either, have lesions on the brain that could be related to age. I'm 58 now, started when 55. Maybe had symptoms before that related but hard to say. Thanks for any input, Linda
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Postby Melody » Sun Oct 30, 2005 4:00 pm

Turmeric I cook with and there are 4 in the house. I use at least 2 TBS per day. Keep in mind Turmeric is best used at the end of cooking as it does not react well with heat. I was just out to Victoria and went to the East Indian district to get this 3 months supply of turmeric. Remember the fresher the better so make sure where you buy it has a quick turnover. Vitamin D3 we have just pumped up for winter months and like you after watching that video even I started on a modest 1000iu per day and will get my levels checked regular. :D
John was diagnosed Jan 2005. On lipitor 20mg .On Copaxone since July 4,2005. Vitamin D3 2000iu-4000iu (depending on sunshine months)June 10 2005(RX::Dr. O'Connor) Omega 3 as well Turmeric since April 2005. Q10 60mg. 1500mg liquid Glucosamine Nov 2005.
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Postby pinda » Sun Oct 30, 2005 4:44 pm

Thank you Melody for your quick reply. Will try cooking with tumeric. Just bought some organic from my brother. We both have organic farms but we do not sell anything but veg. and fruit we grow and some fruit we bring in. He sells most everything.

Must of been a good time to visit Victoria. Some winds, sun, and colour with the leaves changing. Not like Ontario though :) Linda
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Copaxone 26 year study PWMS who dropped out

Postby Observant » Thu Dec 29, 2005 11:37 pm

I have known countless people who have taken Copaxone for a short period of time and then quit because it didn't help their symptoms. It's too bad that no one ever explained to them that Copaxone is not a drug that alleviates symptoms. It's a drug that slows the progression of the disease, which simply means you won't get worse as fast as you would have without it.

I was on it for several years and doing well. Then I quit, convinced that my diet was what was helping me. (I hadn't had any new lesions for all those years I was on it.) After a year or so off it, I started getting worse, had an MRI, and I had new lesions. I'm back on it now, and plan to stay on it.
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Postby LisaBee » Thu Jan 05, 2006 6:34 pm

I'm glad to hear Copaxone has helped you! I do believe that Copaxone works really well for some people with MS, although there are problems with interpreting the long-term studies as noted in an earlier post. It doesn't seem to work as well for others, which is why people who have been taking it for awhile may quit taking it. I haven't seen much on reasons why longer-term users quit, other than the drop-out rate in the long term studies seems to be really high.

My neuro explained that Copaxone didn't help symptoms but slowed progression, and seemed to work better the longer it was taken. Most people who seem to quit do it after a relatively short period of time, days to months, and my impression from posts is because of the injection site reactions. That was my reason to give it up, plus my blood pressure would drop and stay down for at least an hour. After only about five days I was starting to feel pretty sick. Either my reactions were worse than average or I'm just a bigger wimp, or some combination. I didn't even get the chance to see if it would help any MS symptoms or not.

As far as injection site reactions go, I don't know if they get less with time with Copaxone. I get the impression from posts that people either have no to tolerable reactions, or they have bad reactions that don't ever become less severe so they give it up. I don't know. I just wish, in the absence of having better drugs, the ones currently available were easier to take.

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Postby Melody » Fri Jan 06, 2006 2:43 pm

Injection site reaction from what I understand is mainly from improper injection. Chance the depth to suit each injection site. Wash with soap and water if the alcohol bother's you. Make sure your needle is room temperature before injecting. Rotate sites and on an on it goes. Every time John has had a reaction we can tell exactly where he went wrong on that injection. Every time I hear the ping of the needle on exit I know I'm writing down stinging in my charting book for John. That is caused by not pulling the needle straight out. Every time I think he is to close to the muscle and he disregards my advice I write down ouch and 1/2 hour soreness as he soon admits to it and has to lie down. : :lol: So many variables. If you feel you might not be injecting properly get Shared Solutions or your Ms nurse or your GP to help till you have it right.
John was diagnosed Jan 2005. On lipitor 20mg .On Copaxone since July 4,2005. Vitamin D3 2000iu-4000iu (depending on sunshine months)June 10 2005(RX::Dr. O'Connor) Omega 3 as well Turmeric since April 2005. Q10 60mg. 1500mg liquid Glucosamine Nov 2005.
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Copaxine injecting

Postby Observant » Fri Jan 06, 2006 2:55 pm

I've been on it since 1999, (back when you had to mix it yourself), and I can tell you it's not just injecting wrong that causes injection site reactions. (Although doing it wrong is possible.) I talked to the nurses, rotate the 7 areas, have tried icing before and/or after, changed angles of injection, tried auto-inject and non auto-inject, let the bubbles go in or not, tried it straight in or at various angles, injected slowly or quickly, tried it with the drug cold or at room temp., punctured quickly or slowly, removed quickly or slowly, alcohol swab or no alcohol swab, removed straight out or at an angle and still had injection site reactions every single time. (They didn't start until I'd been on it about a week.) Finally, I talked to the neuro., telling him I thought it was odd that a woman of 110 lbs would take the same dose as a man of 250 lbs. I told him I'd talked to Shared Solutions nurse and she said the drug stays in the body for 36 hours. So, I started injecting evey other day instead of daily, (with his blessing), and haven't had an injection site reaction since. My current Neuro. isn't as happy about it, but he says he'd rather have me doing it every other day than not at all.
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Postby LisaBee » Sun Jan 08, 2006 5:20 pm

When I tried Copaxone, the stomach shots and hip shots were like bee-stings, which were uncomfortable but not horrible, but the limb shots were much worse. The Shared Solutions nurse said I had to rotate through seven different locations, and suggested that I was maybe "too thin" - if interested see posts under topic of injection-site reactions related to body weight.

No one at Shared Solutions offered me an option or suggestion to inject every other day, it was 7 days a week using all injection sites or a no-go. If I could have done it every other day, rotating to either side of stomach or either hip (4 different locations) I might could have pulled it off.
I still wonder if body size/weight isn't part of the injection site problems, although people much bigger than I am also reported problems.

It is interesting to hear that other alternative recommendations were made by Shared Solutions.

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Copaxone injecting

Postby Observant » Sun Jan 08, 2006 7:11 pm

Lisa,
Shared Solutions was responsible for very little of what I wrote about. But, the seven different injections sites are right in the literature that comes with every order of Copaxone, including pictures and detailed instructions.

The only part Shared Solutions played in my skipping every other day, was in that I asked them how long Copaxone stayed in the system. They said 36 hours. I got off the phone and made up my own mind to inject every other day. I got the ok from my neurologist. Shared Solutions had nothing to do with that. And, he felt that every other day was better than no days at all.

I believe that we, as patients, need to take some control in our own treatments. We need to research everything and do some logical thinking about everything. There are many reasons for that, not the least of which is that "experts" make many mistakes and will not be as careful about my care as I know I will be.

I don't even rotate to ALL the locations, because it's too difficult for me to do my arms. I did for a long time, but it's too easy to screw it up. (And, I'm definitely not good at injecting with my left hand.) So, I only use 6 different places. And, in fact, there is a large half circle area 2 inches out from the navel that can be used, so if you take that into consideration, you have a lot more different places to inject. I used the front of each thigh and that's got a big range too, and each hip, plus all the stomach areas in that half circle.

I believe it's more difficult with injection site rections when one is thin. I was 112 lbs until several months ago and it's easier now that I weigh 125 than it was then. When you're too thin, there just isn't all that much flesh to plump up and inject into.
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Postby LisaBee » Tue Jan 10, 2006 4:02 pm

Thanks for the clarification about level of Shared Solutions input. I mentioned the option of injecting every other day to my neuro's PA and she seemed unenthusiastic, but her lack of enthusiasm seemed to stem more from the severity of my injection site reactions, i.e. Copaxone maybe not an option for me.

I'll check with the neuro again in the spring.

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