Injectable Drug Demonstrates Efficacy with Reduced Dosing Schedule

An injectable treatment for relapsing-remitting MS (RRMS) designed to significantly reduce the dosing schedule typical of standard interferon drugs has shown favorable results in a late-stage clinical trial, according to drug manufacturer Biogen Idec.

The phase III ADVANCE study evaluated the efficacy, safety, and tolerability of peginterferon beta-1a (also known as Peg-Avonex) compared to placebo at one year. More than 1,500 people with RRMS participated in the study and were divided into arms of dosing every two weeks or dosing every four weeks. Results showed that Peginterferon beta-1a:

Reduced the risk of 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS) by 38 percent in both dosing arms.

Reduced the proportion of patients who relapsed by 39 percent in the once every two-week dosing arm and by 26 percent in the once every four-week dosing arm.

Reduced the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans by 67 percent in the once every two-week dosing arm and by 28 percent in the once every four-week dosing arm.

Adverse events (AEs), serious adverse events (SAEs) and discontinuations due to AEs were similar across both dose groups in ADVANCE and both dosing regimens showed favorable safety and tolerability profiles. The overall incidence of SAEs and AEs was similar among the peginterferon beta-1a and placebo groups. The most common SAE was infections, which was balanced across all treatment groups. The most commonly reported AEs with peginterferon beta-1a treatment were redness at the injection site and influenza-like illness.

Biogen said the results “support peginterferon beta-1a as a potential treatment dosed every two weeks or every four weeks for relapsing-remitting multiple sclerosis.”

Biogen said it plans to submit the drug for approval in 2013.

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