Pharmaceutical Companies Latest Drug Reports

The 19th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) was held in Milan, Italy in September. This prompted pharmaceutical companies to send out press releases with the latest information on their drugs and studies with MS. The following summarizes some of the reports from the pharmaceutical companies.

About Betaseron… Betaseron’s® European marketer, Schering AG® of Germany, announced the completion of the first phase of their MS BEYOND program (Betaferon® Efficacy Yielding Outcomes of a New Dose). This initial study examined the safety and tolerability of a new, double-dose of Betaferon (Europe’s name for Betaseron) in individuals with relapsing-remitting MS (RRMS). The results showed that both the approved Betaferon dose and the new, higher-dose regimen were safe and well tolerated, with no new side effects reported. The study’s next step will be to determine if this higher-dose Betaferon can exert an even greater therapeutic effect than the presently prescribed dose. For this portion of the multinational Phase III trial, more than 2,000 individuals with RRMS will take part in one of three arms: the new higher dose of Betaferon, the currently approved dose of Betaferon, and Copaxone®.

Berlex® (marketer of Betaseron in the United States) announced that the United States Food and Drug Administration (FDA) approved a new pre-mixing diluent injection system for Betaseron in North America. This adds another level of convenience for Betaseron users, while keeping the drug at a neutral acid-base level to reduce burning at the injection site.

About Avonex… Biogen® (marketer of Avonex®) announced findings from their five-year CHAMPIONS study (Controlled High Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance). CHAMPIONS is an open-label extension of CHAMPS, a Phase III trial that enrolled 383 patients who had just experienced their first MS attack and who had brain MRI scan abnormalities characteristic of MS. In this initial study, Avonex-treated patients experienced a 44 percent decrease in the rate of developing a second attack when compared to placebo over a three-year period.
In the CHAMPIONS study, those who stayed on Avonex since the beginning had a lower probability of developing clinically definite MS compared to the group originally assigned to placebo. Biogen also announced that the CHAMPIONS study would be extended for an additional five years to determine if the effects of early treatment can be sustained for up to 10 years.

In 2003, the FDA approved Avonex for the treatment of individuals who have their first clinical MS attack and a brain MRI scan that suggests MS. In addition, Avonex recently joined Copaxone and Rebif® by offering convenient, pre-filled syringes.

About Copaxone… Teva Neuroscience® (marketer of Copaxone), announced the results of two studies, which followed individuals with RRMS for up to 10 years in North America and up to seven years in Argentina. Annual relapse rates during the 10th year in the North American study were .22 (for participants on Copaxone from the start) and .23 (for participants who later crossed over from placebo to Copaxone). This is roughly one-sixth of the pretreatment rate of 1.52 and 1.46, respectively. From the outset, 64.4 percent remained stable or improved in terms of accumulated disability as measured by the Extended Disability Status Scale (EDSS) scores. This study is now in its 12th year.

Similar results were observed with the Argentinean study, where annual relapse rates were reduced from .89 before treatment to .24 after treatment (average follow-up time was 3.8 years; some data available for up to seven years). Nearly 60 percent of the participants on Copaxone (without interruption) remained relapse-free, and 65.9 percent showed no change in EDSS scores during treatment. Overall, Copaxone was well-tolerated and no unexpected adverse effects were observed.

Data from another study demonstrated that antibodies to Copaxone do not interfere with its biological functions. These results are consistent with findings from three studies done previously in Israel.

About Rebif… New long-term study results were also announced by Serono® in Switzerland for its MS drug, Rebif. The eight-year extension data come from an open-label follow-up of the PRISMS study (Prevention of Relapses and disability by Interferon beta-1a Subcutaneously in MS), which began in 1994 and involved 560 patients with RRMS at 22 centers in nine countries. Of those participants taking Rebif who returned for long-term follow-up assessment, approximately one in five (20 percent) progressed to secondary-progressive MS (SPMS), versus the possible one in two (50 percent) as suggested by two population-based studies in Canada and Sweden.

Other long-term benefits for those on Rebif from the beginning of the study, compared to those initially randomized to placebo and later given Rebif, included: delayed time to progression on a disability scale; delayed time to SPMS; lower annualized relapse rate; and change (reduction) in lesion area as measured on an MRI. Neutralizing antibody (NAb) rate was 12 percent (clinical implications of NAbs remain unknown), and Rebif was generally well-tolerated. Study results also suggest long-time treatment compliance to Rebif. Seventy-four percent of patients originally randomized to the high-dose Rebif group and who were seen up to eight years since the beginning of the study, were still on Rebif.

In a follow-up to the EVIDENCE (Evidence for Interferon Dose-response: European-North American Comparative Efficacy) trial where Rebif was compared to Avonex, Rebif maintained a higher efficacy versus Avonex at 16 months. Avonex-treated patients who switched to Rebif had a reduction in relapse rate and MRI lesions by the end of the 16 months. A two-year, head-to-head trial of Rebif versus Copaxone is planned to begin next year.