Copaxone (Glatiramer acetate) and Betaseron® (Interferon beta-1b) Yield Statistically Significant Results In Relapsing-Remitting Multiple Sclerosis

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Title: Copaxone (Glatiramer acetate) and Betaseron® (Interferon beta-1b) Yield Statistically Significant Results In Relapsing-Remitting Multiple Sclerosis
URL: http://www.pslgroup.com/dg/210CDE.htm
Doctor's Guide
December 27, 2001

KANSAS CITY, MO -- December 27, 2001 -- Only Copaxone® (glatiramer acetate for injection) and Betaseron® (Interferon beta-1b) significantly reduced the mean annualized number of relapses compared to the untreated group of patients with relapsing-remitting multiple sclerosis, according to a study published in the December 2001 issue of Multiple Sclerosis, a peer-reviewed scientific journal focusing on multiple sclerosis treatment and research.

The 18-month prospective, non-randomized, open-label study was conducted by researchers at Wayne State University in Detroit, Michigan. The authors have previously reported the results at the end of 12 months. The current report is the final conclusion of the study at the end of 18 months. Its primary endpoint was to determine the differences in the mean annualized relapse rate of patients with relapsing-remitting MS treated with Copaxone, Betaseron, and Avonex® (Interferon beta-1a) compared with those not choosing an immunomodulating therapy.

"Foremost, the study indicates that treatment does make a difference and physicians should encourage early treatment," said Omar Khan, M.D., Department of Neurology, Wayne State University School of Medicine.

At the end of the study period, 122 out of 156 study patients remained in their original treatment groups. Compared to the untreated group's mean annualized relapse rate (1.02), the rate was reduced for Copaxone-treated patients to 0.49 (p<0.001) and Betaseron patients to 0.55 (p=0.001). The Avonex group did not show a statistically significant reduction, 0.81 (p=0.106).

The mean changes from baseline in expanded disability status scale (EDSS) scores also were reduced significantly compared to untreated patients only in patients treated with Copaxone (p<0.003) or Betaseron (p=0.010).

"We observed that treatment with Copaxone (glatiramer acetate for injection) and Betaseron significantly reduced the relapse rate whereas Avonex did not. It is important to note that this reduction in the relapse rate was not at the expense of increasing EDSS," said Dr. Khan. "Mean EDSS showed an increase of 0.60 in the untreated group while in contrast the mean EDSS of the Copaxone group decreased by 0.44 (p=0.003) and the Betaseron patients decreased by 0.25 (p=0.010)."

This study enrolled 156 patients with clinically definite relapsing-remitting MS. All patients had an EDSS score of 4 or less (indicating they were only mildly affected by MS) and at least a two-year history of confirmed relapses. The treating physician consulted with each of the patients and outlined the three immunomodulating therapy choices and the option of no drug therapy. Patients were allowed to make the final treatment selection decision or choose no therapy.

There were originally 33 patients selecting no therapy as an option. Of the others, 41 chose Betaseron, 40 started Avonex and 42 began Copaxone. There were no statistically significant demographic differences between the four groups at enrollment. Patients were permitted to switch therapies, however calculations in the paper were only done on the 122 patients who did not switch therapies. The study was conducted without support from any pharmaceutical company.

"Our study was intended to mirror how neurologists practice by involving the patients in making the treatment choices and not using routine serial MRI scans," said Dr. Khan. "A comparison of the three immunomodulating treatments for relapsing-remitting MS is timely and much sought after by patients and physicians."

The results indicate that treating people with relapsing-remitting MS with an immunomodulating therapy is beneficial compared to no treatment in patients who have not previously been on drug therapy. This is consistent with the consensus statement issued by the National Multiple Sclerosis Society that encourages treatment with an immunomodulating therapy as soon as the diagnosis of relapsing-remitting MS is confirmed.

Dr. Khan indicated that this study points to the need for further comparative research on the three currently approved immunomodulating therapies. This study was not intended to be definitive or conclusive as far as the issue of relative efficacy of each immunomodulating therapy is concerned. However, he believes this study provides meaningful information for the neurologist treating RRMS patients.

Copaxone (glatiramer acetate for injection) is indicated for the reduction 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, flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. These reactions are usually mild and seldom require professional treatment. Patients should be sure to tell their doctor about any side effects.

Some patients report a short-term reaction right after injecting Copaxone. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems.

SOURCE Teva Neuroscience

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