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 | Research: After 10 years, 91% of Copaxone Users Still Walk Unaided |
Following on the heels of the research on long-term Betaseron use, this new study from Teva, makers of Copaxone, claims remarkable long-term treatment benefit.
Comparing people who used Copaxone continuously for 10 years versus those who quit after an average of 4.5 years, the 10 year Copaxone group had 91% still walking unaided versus 50% of the ex-Copaxone users. Another interesting stat shows that only 38% of the long-term Copaxone users demonstrated worsening of disability, versus 72% of those who had quit.
"Data presented at the 20th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Vienna, Austria, demonstrated that relapsing-remitting multiple sclerosis patients (RRMS) who remained on COPAXONEŽ (glatiramer acetate injection) therapy for an average of 10 years showed significantly less progression of disability when compared with patients who discontinued therapy...
'One of the most common questions I receive from my newly diagnosed MS patients is, 'Where am I going to be in 10 years, and am I going to be able to walk?' Long-term, prospectively controlled trials with MS therapies help address these questions. These data support the long-term clinical benefits, safety, and tolerability of COPAXONEŽ (glatiramer acetate injection) for an average of 10 years,' stated Kenneth P. Johnson, professor of neurology at the University of Maryland, director of the Maryland Center for MS, and lead investigator in the trial. 'The vast majority of COPAXONEŽ-treated patients did not reach the critical EDSS level of 6.0 when compared to those patients that withdrew from the long-term follow-up.'
Click "read more" for the full story...
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Ninety-One Percent of COPAXONE(R) Patients Continue to Walk Without Assistance After 10 Years of Treatment
Ten-Year Data Demonstrate MS Patients Treated Continuously with COPAXONE(R) Were Less Disabled Than Patients Who Discontinued Therapy
KANSAS CITY, MO -- (MARKET WIRE) -- 10/11/2004 -- Data presented at the 20th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Vienna, Austria, demonstrated that relapsing-remitting multiple sclerosis patients (RRMS) who remained on COPAXONEŽ (glatiramer acetate injection) therapy for an average of 10 years showed significantly less progression of disability when compared with patients who discontinued therapy. This prospective, long-term, open-label, organized study represents the longest continuous assessment of therapy in patients with MS.
Two hundred and thirty-two patients (92 percent of 251 originally randomized to the U.S. pivotal trial) receiving COPAXONEŽ from randomization or open-label switch were included in the long-term follow-up (LTF). In all, 155 of the 232 patients had an EDSS measurement at LTF. One hundred and eight patients were on COPAXONEŽ continuously from the start of the trial. Forty-seven patients withdrew at a mean of 4.5 years on COPAXONEŽ but returned for LTF at a mean of 10 years from the start of the trial. Ninety-one percent of the 108 COPAXONEŽ patients still on therapy did not show evidence of disease progression to an EDSS of 6.0 on the Expanded Disability Status Scale (EDSS). An EDSS score of 6.0 is the point at which patients require intermittent or unilateral (one-sided) constant assistance, such as a cane, crutch, or brace, to walk 100 meters with or without resting. Only nine percent of these continuously treated COPAXONEŽ patients reached this EDSS score, compared to 50 percent of patients who withdrew from COPAXONEŽ therapy after an average of 4.5 years but were evaluated at 10 years.
"One of the most common questions I receive from my newly diagnosed MS patients is, 'Where am I going to be in 10 years, and am I going to be able to walk?' Long-term, prospectively controlled trials with MS therapies help address these questions. These data support the long-term clinical benefits, safety, and tolerability of COPAXONEŽ (glatiramer acetate injection) for an average of 10 years," stated Kenneth P. Johnson, professor of neurology at the University of Maryland, director of the Maryland Center for MS, and lead investigator in the trial. "The vast majority of COPAXONEŽ-treated patients did not reach the critical EDSS level of 6.0 when compared to those patients that withdrew from the long-term follow-up."
The open-label, LTF trial evaluated patients who originally participated in the initial pivotal, double-blind, placebo-controlled study. The follow-up demonstrated significant safety and efficacy of COPAXONEŽ in reducing relapse rate and accumulated disability. Of 108 patients who continuously took COPAXONEŽ for an average of 10.1 years (range eight to 12 years), 62 percent were improved or stable, based on Expanded Disability Status Scale (EDSS) scores. Compared to 47 patients who withdrew from COPAXONEŽ therapy after an average of four and one-half years, but returned for LTF assessments, significantly fewer continuously treated COPAXONEŽ patients demonstrated worsening of disability -- 72 percent versus 38 percent, respectively (p < 0.05).
"If one considers the natural long-term debilitating effects of MS, these data are quite remarkable, since patients had experienced on average, seven years of MS when they entered the study. Now, after almost 20 years of disease, they still are walking without assistance," commented Dr. Johnson.
Teva Neuroscience has announced their commitment to extending the observation period of this trial to 15 years, which will add to the current pool of data expanding over 12 years demonstrating the well established safety and tolerability of COPAXONEŽ.
About COPAXONEŽ
Current data suggest COPAXONEŽ is a selective MHC class II modulator. COPAXONEŽ is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis. The most common side effects of COPAXONEŽ are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONEŽ (glatiramer acetate injection) is now approved in 43 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all the European countries. In Europe, COPAXONEŽ is marketed by Teva Pharmaceutical Industries Ltd. and Aventis Pharma. In North America, COPAXONEŽ is marketed by Teva Neuroscience.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 25 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 is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONEŽ. COPAXONEŽ is a registered trademark of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. is a subsidiary 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.
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current 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 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 their own generic products or successfully extend the exclusivity period of their branded products, Teva's ability to rapidly integrate the operations of acquired businesses, including its recent acquisition of Sicor Inc., the availability of product liability coverage in the current insurance market, 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 and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launched, currently being sold, or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, 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.
--------------------------------------------------------------------------------
Contact:
Melissa M. Nash
Teva Neuroscience
816-508-5149
melissa.nash@tevaneuro.com
Mandy Levings
Fleishman-Hillard
(816) 512-2379
levingsm@fleishman.com
SOURCE: Teva Pharmaceutical Industries Ltd.
Note: Please see commentary from community member Art for some very important counterpoints-- thanks Art!
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Re: After 10 years, 91% of Copaxone Users Still Walk Unaided (Score: 1) by art (art-at-bostoncure.org) on Monday, October 11 @ 15:49:04 EDT (User Info | Send a Message) | This is so misleading it's almost criminal. Of course people who are continuously on a therapy for 10 years will be doing better - people who don't do as well tend to stop the therapy!
This data can also be read that a majority of people taking Copaxone are not helped by it. I find it quite bothersome that an otherwise well regarded researcher would stoop to such levels to cater to a pharma company.
You can draw no reasonable conclusions from what they state in this press release. We need to know the reasons for drop out, the progression sustained by those who stayed (they are only counting progressing past 6.0, while it is well known that progression past 4.0 is the key trigger point), and the progression of those who dropped out while on treatment.
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