Positive Results for Peginterferon Beta-1a in MS

Susan Jeffrey

January 24, 2013

Biogen Idec today announced positive topline results from a phase 3 trial of peginterferon beta-1a in relapsing-remitting multiple sclerosis (RRMS). The treatment is a pegylated version of interferon beta-1a that extends its half-life, potentially allowing a less frequent dosing schedule.

In the ADVANCE trial, a 2-year phase 3 randomized trial, treatment was given every 2 weeks or every 4 weeks. The company reports today that peginterferon beta-1a met all primary and secondary endpoints for both dose regimens.

On the basis of these results, the company plans regulatory submissions in both the United States and European Union in 2013, a release from Biogen Idec notes.

Full results of the trial will be presented at the upcoming American Academy of Neurology 65th Annual Meeting in March in San Diego.

ADVANCE

ADVANCE was a multicenter, randomized, double-blind, placebo-controlled trial of peginterferon beta-1a in 1516 patients with RRMS. Patients were randomly assigned to receive 125 μg of peginterferon beta-1a every 2 weeks or every 4 weeks or placebo for 1 year. After the first year, patients in the placebo group were re-randomly assigned to 1 of the 2 dose regimens for the remaining year of the study.

The primary endpoint was the annualized relapse rate (ARR) at 1 year; secondary endpoints included 12-week confirmed progression on the Expanded Disability Status Scale (EDSS), proportion of patients who relapsed, and MRI assessments.

Results showed significant reductions in the primary endpoint, as well as significant favorable changes on all secondary endpoints, the company reports.

Table. ADVANCE: Primary and Secondary Endpoints vs Placebo

Endpoint Peginterferon Beta-1a, 125 μg Every 2 Weeks P Value Peginterferon Beta-1a, 125 μg Every 2 Weeks P Value
Reduction in ARR at 1 year (%) 35.6 <.001 27.5 <.02
12-week confirmed disability progression (%) 38 <.04 38 <.04
Proportion of patients who relapsed (%) 39 <.001 26 <.03
Reduction in new or newly enlarging T2-hyperintense lesions (%) 67 <.001 28 <.001

 

In terms of safety, both regimens were associated with favorable safety and tolerability, with the overall incidence of adverse events and serious adverse events similar between treated and placebo groups, the release notes. The most common serious adverse event was infections, occurrence of which was balanced across groups at 1% per group or less, the company reports.

The most common adverse events were redness at the injection site and influenza-like illness. The most commonly reported adverse events with peginterferon beta-1a treatment were redness at the injection site and influenza-like illness.

After completing 2 years in the ADVANCE study, patients have the option of enrolling in an open-label extension study called ATTAIN and will be followed for up to 4 years.

"If approved, peginterferon beta-1a will represent an innovation that offers patients a less frequent dosing schedule of no more than 26 doses annually, as well as a significant reduction in relapses and disability progression," said Gilmore O'Neill, vice president, Global Neurology Late Stage Clinical Development at Biogen Idec, in the release.

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