Jan. 24, 2013– Biogen Idec (NASDAQ: BIIB) released the primary efficacy analysis and safety data from its Phase 3 pivotal clinical trial, ADVANCE. Results support peginterferon beta-1a as a potential treatment dosed every two weeks or every four weeks for relapsing-remitting multiple sclerosis (RRMS). Peginterferon beta-1a is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body, enabling study of a less frequent dosing schedule.
The ADVANCE study included more than 1,500 patients with RRMS and was designed to evaluate the efficacy, safety and tolerability of peginterferon beta-1a compared to placebo at one year. Results showed that when administered via subcutaneous (SC) injection, peginterferon beta-1a 125 mcg demonstrated a significant reduction in ARR at one year. Compared to placebo, ARR reduction with two-week dosing was 35.6 percent (p<0.001) and with four-week dosing was 27.5 percent (p<0.02).
Results showed that peginterferon beta-1a also met all secondary endpoints compared to placebo for both dose regimens. 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 (p<0.04).
Peginterferon beta-1a reduced the proportion of patients who relapsed by 39 percent in the once every two-week dosing arm (p<0.001) and by 26 percent in the once every four-week dosing arm (p<0.03).
In ADVANCE, 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 (≤1 percent per group).
The most commonly reported AEs with peginterferon beta-1a treatment were redness at the injection site and influenza-like illness.
“These results are not unexpected. Pegylation increases the circulating life of interferon-beta and therefore allows MSers to get away with injecting the drug every 2 or 4 weeks. Are you up for it?”