New two-year data from Biogen Idec’s Phase 3 trial for peginterferon beta-1a presented at AAN annual meeting
May 5, 2014
New two-year data from the Phase 3 ADVANCE clinical trial for peginterferon beta-1a in adults with relapsing forms of multiple sclerosis (RMS) has been presented at the 66th American Academy of Neurology (AAN) annual meeting.
The data indicated that peginterferon beta-1a dosed once every two weeks demonstrated favourable results on relapse rates, magnetic resonance imaging (MRI) findings and disease progression. Over two years, the safety profile of peginterferon beta-1a was consistent with other multiple sclerosis (MS) interferon therapies.
“The two-year data from ADVANCE further establish the efficacy and safety profile of peginterferon beta-1a demonstrated in the first year of the pivotal trial,” said Terry O’Regan, Vice President and Managing Director at Biogen Idec. “If approved, we believe that peginterferon beta-1a dosed once every two weeks will provide MS patients with one of the most significant developments in the interferon class in over a decade.”
ADVANCE was a two-year, Phase 3, placebo-controlled (in year one) study that evaluated the efficacy and safety profile of peginterferon beta-1a administered subcutaneously. The analysis for all primary and secondary efficacy endpoints occurred at the end of year one. After the first year, patients on placebo received peginterferon beta-1a for the duration of the study.
New Analysis of ADVANCE Data Showed Peginterferon Beta-1a Benefits Maintained Over Two Years
A new analysis of data from the second year of ADVANCE presented at AAN demonstrated:
A new analysis of data from the second year of ADVANCE presented at AAN demonstrated:
- The efficacy of peginterferon beta-1a dosed once every two weeks was maintained throughout year two. Relative to year one, the annualised relapse rate (ARR) was further reduced and the number of new or newly-enlarging T2 lesions was numerically lower in year two
- The safety and tolerability profile of peginterferon beta-1a was consistent between years one and two
These data were presented in a platform presentation on Tuesday, April 29 at 2:00 p.m. EDT:
- Analysis of 2-year Clinical Efficacy and Safety of Peginterferon Beta-1a in Patients with Relapsing-Remitting Multiple Sclerosis: Data from the Pivotal Phase 3 ADVANCE Study (S4.005)
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