SEATTLE, WA -- October 13, 1999 -- Results from the first head-to-head study to compare the effect of the three FDA-approved therapies show that, compared to placebo, Copaxone® and Betaseron® significantly reduced relapses in patients with relapsing-remitting multiple sclerosis (MS), while patients on Avonex® failed to show a statistically significant therapeutic effect.
Dr. Omar Khan, director of experimental therapeutics and research at Wayne State University MS Center, reported the results of the 12-month treatment study at the American Neurological Association conference in Seattle.
"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. The patients could choose any one of the drugs or no therapy.
Patients were divided evenly among the drug therapies, with 40 choosing Avonex, 41 selecting Betaseron and 42 deciding on Copaxone. Thirty-three patients elected no treatment. Each group had similar age, relapse rate, neurologic examination and Expanded Disability Status Scale (EDSS) ratings prior to initiating therapy.
Patients entering the study had a relatively low average disability (EDSS) rating, which means that most participants had few noticeable physical symptoms. Last fall, the National Multiple Sclerosis Society recommended that all people with a confirmed diagnosis of relapsing-remitting MS discuss immediate therapy with their doctor.
"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® or Copaxone® 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 patients EDSS score. This rating system measures a patients ability to function physically through a series of tests based on strength, coordination, manual dexterity and other measure of neurologic function.
"Compared to patients on no treatment, there was a statistically significant improvement in disability scores in patients who received treatment with Betaseron® or Copaxone®. Patients who received treatment with Avonex® 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.
This study was supported by the Wayne State University Neuroscience Program.