Teva: Copaxone reduced relapses, stabilized disability when Avonex failed

By Elaine Rigoli

Tampa, Fla., May 31 - Teva Pharmaceutical Industries Ltd. said Wednesday that relapsing-remitting multiple sclerosis patients failing Avonex (interferon beta-1a) therapy as defined in the study achieved significant reductions in relapse rates and in expanded disability status scale scores, a measure of disability, upon switching to Copaxone (glatiramer acetate injection).

In a study published in the June issue of the European Journal of Neurology, Copaxone was shown to reduce annual relapse rate by an additional 57% over Avonex, and that neurologic disability, as measured by the EDSS, did not worsen in 86% of patients.

"Our data demonstrated the benefits of Copaxone in reducing relapse rate in patients who were not effectively treated or could not tolerate other immune modulating therapies," Omar Khan, a professor and senior author of the study, said in a news release.

A series of 85 consecutive relapsing-remitting multiple sclerosis patients treated with Avonex for at least 18 months who experienced suboptimal clinical efficacy (at least one relapse in the previous year) or persistent intolerable toxicity (elevated liver function tests, low white blood cell counts or post-injection fever, weakness or fatigue for more than 24 hours after every injection), were switched to Copaxone in this open-label study and followed prospectively for an additional 36 to 42 months (average 37.5 months).

Annualized relapse rate for the entire patient group after switching to Copaxone (glatiramer acetate injection) was reduced by 57% from 1.23 on Avonex to 0.53.

In the subset of patients who switched to Copaxone because of insufficient efficacy on Avonex, the reduction was even more significant (61%), from 1.32 to 0.52.

Patients who switched to Copaxone because of persistent toxicity on Avonex experienced an additional 23% reduction, which did not reach statistical significance, the release said.

"We recognize the limitations of our study, such as the open-label design and lack of prospective follow-up in patients while receiving IFN beta-1a," Khan added.

However, results corroborated another larger prospective open-label study that demonstrated reductions in relapse rates in patients switched from Betaseron to Copaxone and suggested that clinical observations including relapse rates, patient tolerability and toxicities assessed by serum laboratory parameters are valuable criteria for determining when a switch in therapy is warranted, officials said.

Teva, based in Petach Tikva, Israel, is an international pharmaceutical company.

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