Biogen Idec announced new data from the second year of its Phase 3 ADVANCE clinical trial for Plegridy (peginterferon beta-1a), pegylated beta interferon in patients with relapsing forms of multiple sclerosis (RMS).
ADVANCE was a two-year, multi-center, randomized, double-blind, parallel-group, placebo-controlled (for the first year) study that evaluated the efficacy, safety, and tolerability of Plegridy compared to placebo. The primary endpoint of ADVANCE was to determine the efficacy of Plegridy in reducing annualized relapse rate (ARR). After completing two years in the ADVANCE study, patients had the option of enrolling in an open-label extension study called ATTAIN and may be followed for up to four years.
Post-hoc analyses confirmed that Plegridy’s positive effects on reducing disease activity and disability progression were maintained in year two of the study. A significantly higher proportion of patients taking Plegridy during both years of the study experienced no evidence of disease activity, defined as the absence of clinical and MRI disease activity over two years of treatment, compared to those who switched to Plegridy from placebo. Also, those treated with PLEGRIDY for both years of the study had significant reductions in the risk of 24-week confirmed disability progression compared to patients treated with placebo during the first year.
In addition, new data from the second year of ADVANCE demonstrated that patients who took Plegridy throughout the study experienced statistically significant improvements in clinical and MRI outcomes, including ARR, risk of relapse, risk of 24-week confirmed disability progression, and number of brain lesions when compared to those who switched to Plegridy after taking placebo for the first year. This new data also showed that the safety profile of PLEGRIDY was consistent between years one and two of the study.
Plegridy is already approved for the treatment of relapsing forms of multiple sclerosis.
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