www.msnews.org/study10_13_99.htm -
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Published on: 7/24/1999
Last Visited: 8/13/2000
Dr. Omar Khan, director, experimental therapeutics and research, at Wayne State University MS Center, reported that, compared to patients on no therapy,.
COPAXONE (R) and Betaseron (R) significantly reduced relapses in patients with relapsing-remitting multiple sclerosis, while patients on Avonex (R) failed to show a statistically significant therapeutic effect in this 12-month treatment study.
The results are significant because this study compares the drug therapies and the choice of no therapy in a real-life situation, said Dr. Khan.We presented patients with information on all treatment options, after which they chose a therapy.Then, we evaluated whether the drugs reduced relapses during a prospective 12-month period..
The study involved 156 patients with relapsing-remitting multiple sclerosis.Study physicians evaluated the two-year history of relapses for each patient to determine the relapse rate prior to the initiation of therapy.Then, patients were presented with information on the three therapies approved for relapsing-remitting multiple sclerosis.
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These results support the rationale behind early initiation of treatment in patients with relapsing-remitting MS, said Dr. Khan.Even in a relatively early stage of the disease, patients on Betaseron (R) or COPAXONE (R) showed a benefit over those patients who chose no treatment..
Evaluation of the patients' disability progression was a secondary study measurement.Researchers conducted a disability assessment at the beginning of the study to determine each patient's EDSS score.This rating system measures a patient's ability to function physically through a series of tests based on strength, coordination, manual dexterity and other measure of neurologic function.
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Patients who received treatment with Avonex (R) did not show any significant improvement during the 12-month period, said Dr. Khan.
This study comes closer to approximating what neurologists see in clinical practice because it was not blinded.In a non-blinded and non-randomized study, both the study participants and the researchers know which drug the patients are taking.However, the results from this study are similar to those results previously reported in randomized, placebo-controlled Phase III studies.
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-- Dr. Omar Khan, director, experimental therapeutics and research, Wayne State University MS Center, reported the results at the American Neurology Association's conference held October 9-13 in Seattle.The three-year study, supported by Wayne State University's Neuroscience Program, involved 156 patients with RRMS.
-- Between August 1996 and September 1999, 156 consecutive patients with clinical definite RRMS prior to initiating immunomodulating therapy were invited to participate in the study.Patients elected to receive the therapy of their choice.Patients were divided evenly among the drug therapies, with 40 choosing Avonex (R), 41 selecting Betaseron (R) and 42 deciding on COPAXONE (R).Thirty-three patients elected no treatment.
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