This new study shows remarkable efficacy for Copaxone in a 10 year trial. Even so, take it with a grain of salt, as these long-term studies can easily be skewed (e.g., if someone was not doing well even on therapy and quit the drug, they look the same as someone who quit the drug and then began doing worse).
"Relapsing-remitting multiple sclerosis (RRMS) patients who remained on COPAXONEŽ (glatiramer acetate injection) therapy for an average of 10 years experienced significantly less progression of disability than patients who withdrew from the open-label, long-term follow-up study...
According to data presented late yesterday at the 56th annual meeting of the American Academy of Neurology, more than 90 percent of the 108 patients still on COPAXONEŽ did not show evidence of disease progression to an EDSS of 6.0 on the Expanded Disability Status Scale (EDSS). In comparison, 50 percent of the 47 patients who withdrew from COPAXONEŽ therapy after an average of 4.5 years progressed to this score."
Click "read more" for the full article-- if you're considering getting on Copaxone, this is a very important read.
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Longest Running Multiple Sclerosis Trial Shows COPAXONE(R) Effective Over 10 Years -- Study to Be Extended to 15 Years
MS Patients Who Withdrew From COPAXONE(R) Therapy During Long-Term Follow Up Demonstrated Increased Disease Progression
KANSAS CITY, MO -- (MARKET WIRE) -- 04/28/2004 -- Relapsing-remitting multiple sclerosis (RRMS) patients who remained on COPAXONEŽ (glatiramer acetate injection) therapy for an average of 10 years experienced significantly less progression of disability than patients who withdrew from the open-label, long-term follow-up study. Two hundred and thirty-two patients (92 percent of 251 originally randomized) receiving COPAXONEŽ from randomization or open-label switch were included in the long-term follow up. According to data presented late yesterday at the 56th annual meeting of the American Academy of Neurology, more than 90 percent of the 108 patients still on COPAXONEŽ did not show evidence of disease progression to an EDSS of 6.0 on the Expanded Disability Status Scale (EDSS). In comparison, 50 percent of the 47 patients who withdrew from COPAXONEŽ therapy after an average of 4.5 years progressed to this score. The other 77 patients who withdrew from the study were not available for long-term follow up.
"This is the longest-running continuous assessment of a drug treatment in RRMS patients, and this data continues to substantiate the long-term clinical benefits of COPAXONEŽ," said Dr. Kenneth P. Johnson, professor of neurology, University of Maryland, and director of the Maryland Center for MS. "The slowing of disability in the ongoing COPAXONEŽ group was especially pronounced at an average of 10 years on therapy."
Average EDSS scores for the continuously followed COPAXONEŽ (glatiramer acetate injection) patients, at the start of therapy, four years later, and 10 years later, were 2.56, 2.55, and 3.06 compared to 2.84, 3.77, and 5.11 in those patients who withdrew (p < 0.0001 at year 10). When patients reach an EDSS score of 6.0, they require intermittent or unilateral (one-sided) constant assistance, such as a cane, crutch, or brace, to walk a distance of 100 meters with or without resting.
The open-label study is a long-term follow-up to an original pivotal safety and efficacy trial, which is now in its 12th year. In the original placebo-controlled study which lasted approximately 30 months, a 32 percent reduction in relapse rates was seen compared to placebo, and 81.6 percent of patients were stable or improved in terms of EDSS scores. As patients moved into the long-term open-label follow-up phase, in all those receiving COPAXONEŽ, relapse rate reductions from a baseline of 72 percent, 86 percent, and 85 percent were observed after six, eight, and 10 years of follow up, respectively. Similarly, percentages of patients remaining stable or improving from baseline on EDSS scores were 69.3, 65.3, and 64.4. During years four through 10, the relapse rate was approximately 0.2 per year, or one relapse every five years.
"We can not overestimate the importance of following patients systematically in an organized study where patients are evaluated every six months for a long period of time," said Dr. Johnson. "By extending the observation period to 15 years, we will continue to learn more about how MS progresses and how COPAXONEŽ may slow this progression."
COPAXONEŽ is indicated for the reduction of the frequency of relapses in relapsing-remitting MS. 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 is now approved in 42 countries worldwide, including the United States, Canada, 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., headquartered in Israel, is among the top 30 pharmaceutical companies in the world. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Close to 90 percent of Teva's sales are in North America and Europe. 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. is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONEŽ (glatiramer acetate injection).
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.
COPAXONEŽ is a registered trademark of Teva Pharmaceutical Industries Ltd.
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.
Original article can be found here