the competition - REPORT OF RESULTS FROM HEAD-TO-HEAD CLINICAL TRIAL OF COPAXONE
October 14, 1999
Summary: A media release describes an unpublished report by researchers at Wayne State University of results from a "head-to-head" comparison of Avonex©, Betaseron©, Copaxone© and non-treatment in relapsing-remitting MS:
Although few details are available about the study, the report indicates that in 156 individuals followed for 12 months, those using Betaseron or Copaxone showed a statistically significant reduction in relapse rate, while those using Avonex experienced a reduction in relapse rate that was not statistically significant;
Individuals on Betaseron or Copaxone, but not Avonex, showed an "improvement in disability scores" compared to those using no treatment;
While a direct comparison of these agents is important in understanding their use for relapsing-remitting MS, the absence of more details about this study and its results makes it difficult to interpret the clinical and scientific significance of these findings.
Details: A recent media release describes a report at the annual meeting of the American Neurological Association on October 13, 1999 by Dr. Omar Khan and colleagues at Wayne State University (Detroit, Michigan) on results from a "head-to-head" clinical trial comparing Avonex, Betaseron, Copaxone as well as "no treatment" for individuals with relapsing-remitting multiple sclerosis (MS). While few details of the study or its analysis have been made public, the report indicates that use of Copaxone or Betaseron for 12 months resulted in statistically significant reduction of relapse rate and reduction of disability (measured by the Kurtzke Expanded Disability Status Scale -- EDSS), while Avonex did not show such effects. Because full details about this study and its results have not yet been published or scrutinized, they are difficult to interpret.
Information available about this study indicates that 156 individuals with a history of relapsing-remitting MS, and similar age, relapse rate and disability levels, were informed about the available therapies for relapsing-remitting disease and allowed to chose from among them for treatment. Forty chose Avonex, 41 Betaseron, 42 Copaxone and 33 chose to remain untreated. The study was not blinded (participants and examining physicians knew which individuals were using which treatments), and enrollment was not randomized (individuals were free to choose their own treatment). Individuals were followed for 12 months, after which relapse rate during the study and level of disability at its end were determined, and compared to pre-treatment values. Pre-treatment relapse rate was determined by an examination of each individual's relapse history over two years prior to treatment.
According to the media release, at the end of 12 months, a statistically significant reduction of relapse rate was found compared to relapse rate at study entry for individuals using Betaseron (from 1.21 relapses per year to 0.61) and Copaxone (from 1.10 relapses per year to 0.63). While a reduction in relapse was seen in individuals treated with Avonex (from 1.20 relapses per year to 0.85), this reduction was not statistically significant. Results for individuals who chose no treatment were not reported. A statistical comparison of relapse rate between the three agents and between any agent and "no treatment" was not reported in the media release.
The media release also indicated that there was a statistically significant "improvement in disability scores" in individuals treated with Betaseron and Copaxone, but not with Avonex, compared to those who had chosen no treatment. However, no specific disability data were provided, and details of statistical analysis were not reported. It is impossible to evaluate the true meaning of this result in the absence of such details. This is the first report of a head-to-head clinical study comparing Avonex, Betaseron and Copaxone. The details available at the time of the media release were inadequate to evaluate the specific results. Pivotal clinical trials, of longer duration and involving more study subjects, provided positive data that resulted in FDA approval of each of the three agents. Avonex was approved by the FDA based on results indicating a slowing of progression of disability and reduction of relapse rate in relapsing forms of MS; Betaseron and Copaxone were approved by the FDA based on results indicating reduction in relapse rate in relapsing-remitting MS.
A comparison of the currently available treatments for relapsing forms of MS is important to all individuals concerned about appropriate use of disease modifying agents. We look forward to additional information about this reported first study to better evaluate its conclusions.
-- Research Programs Department
¸ 1999 The National Multiple Sclerosis Society |
