Date: 2014-09-11
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS) in Boston
Company: BiogenIdec (USA - MA)
Product: Plegridy™ (peginterferon beta-1a)
Action
mechanism: Plegridy®is a peginterferon beta-1a, a pegylated form of an interferon (L03AB13) with immunomodulatory activity. The exact mechanism of action in the treatment of multiple sclerosis is not fully understood, but beta interferons have been shown to increase anti-inflammatory and reduce pro-inflammatory immune responses.
Disease: relapsing forms of multiple sclerosis
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country:
Trial details:
Latest
news: * On September 11, 2014, Biogen Idec announced new data from the second year of its Phase 3 ADVANCE clinical trial that show the positive treatment effects of Plegridy™ (peginterferon beta-1a) were maintained in people with relapsing forms of multiple sclerosis (RMS) beyond the first year of the study. These results were presented at the sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS) in Boston.
Post-hoc analyses from the two-year, Phase 3 ADVANCE clinical trial confirm 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 (NEDA) – 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 show that patients who took Plegridy™ throughout the study experienced statistically significant improvements in clinical and MRI outcomes – including annualized relapse rate (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.
