Retrospective Observational Study and its Three Year Extension Evaluated Relapse Rate, Relapse-free and Disability Measures for all Four Therapies
October 30, 2003
Source: Teva Neuroscience, Inc.
Kansas City, Mo
In a 16-month study published in the November European Journal of Neurology, Copaxone® (glatiramer acetate injection) was associated with a significant reduction in relapse rate and a high proportion of relapse-free patients compared to an untreated group. The Argentinean retrospective, observational study looked at 134 relapsing-remitting multiple sclerosis (RRMS) patients comparing Copaxone or Interferon treatment effects to a group of untreated patients.
A significant fall in the annual relapse rate (compared with pretreatment values) was observed for all four treatments and included reductions of: Copaxone - 81 percent (n=30); Rebif® - 66 percent (n=20); Betaseron® - 65 percent (n=20); Avonex® - 49 percent (n=26); no treatment - 31 percent increase (n=38).
The percentages of relapse-free patients in each group were: Copaxone - 83 percent; Avonex - 65 percent; Rebif - 60 percent; Betaseron - 60 percent; no treatment - 37 percent.
Adriana Carra, M.D., Department of Neurology, Hospital Britanico de Buenos Aires, Argentina, spoke about the results. "It is clear that immunomodulatory therapy is beneficial in the long-term treatment of relapsing-remitting patients compared to no treatment. Our data are similar to those observed in other studies published or presented." (1-4)
The 16-month open-label study was extended for up to three years. In a poster presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference in Milan, Italy, on the three year extension, the following relapse rate reductions were observed: Copaxone (glatiramer acetate injection) - 78 percent; Rebif - 70 percent; Betaseron - 65 percent; Avonex - 60 percent; no treatment - 31.5 percent increase.
Copaxone is indicated for the reduction of the frequency of relapses in relapsing-remitting MS. 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 is now approved in 42 countries worldwide, including the U.S., Canada, Australia, Israel, and all the European countries. In Europe, Copaxone is marketed by Teva Pharmaceutical Industries Ltd., and Aventis Pharma. In North America, Copaxone is marketed by Teva Neuroscience, Inc.
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.
Copaxone® (glatiramer acetate injection) is a registered trademark of Teva Pharmaceutical Industries Ltd.
1. Panitch H, Goodin DS, Francis G, et al. Randomized, comparative study of interferon beta 1a treatment regimens in MS: The EVIDENCE Trial. Neurology 2002; 59: 1496-1506.
2. Durelli L, Verdun E, Barbero P, et al. Independent Comparison of Interferon (INCOMIN) Trial Study Group. Lancet 2002 Apr. 27; 359 (9316): 1453-60.
3. Khan OA, et al. A prospective, open-label treatment trial to compare the effect of IFNB-1a (Avonex) IFNB-1b (Betaseron), and glatiramer acetate (Copaxone) on the relapse rate in relapsing- remitting multiple sclerosis. European Journal of Neurology 2001; 8: 141-148.
4. Haas J et al. Onset of Clinical Benefit of Copaxone in Patients with
Relapsing-Remitting Multiple Sclerosis. Poster Presentation at the American
Academy of Neurology Annual Meeting 2003.
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