New Long-Term Data Reported for MS Drug Plegridy (Peginterferon Beta-1a)
Treatment reduces relapse in phase III study (October 1)
New data analyses have been reported from year 1 of the 2-year, pivotal, phase III ADVANCE study of Plegridy (peginterferon beta-1a, Biogen Idec). Plegridy is an investigational subcutaneous injectable for relapsing forms of multiple sclerosis (RMS), in which interferon beta-1a is pegylated to prolong the molecule’s exposure in the body and to enable the study of a less frequent dosing schedule.
Clinical and magnetic resonance imaging (MRI) data from the study demonstrated reductions in relapses, in disability progression, and in the number of MS lesions when compared with placebo. The new findings will be presented at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which is being held Oct. 2–5 in Copenhagen, Denmark.
Over 1 year, the absence of measured disease activity (defined as no relapses, no disability progression, no gadolinium-enhancing [Gd+] lesions, and no new or newly enlarging T2-hyperintense lesions compared with baseline) among patients was significantly higher with Plegridy: 34% in the 2-week dosing arm (P < 0.0001) and 22% in the 4-week dosing arm (P = 0.01) compared with 15% in the placebo arm.
In the intent-to-treat population, Plegridy, when administered every 2 weeks, significantly reduced the number of new or newly-enlarging T2-hyperintense lesions, new T1-hypointense lesions, new Gd+ lesions, and new active lesions compared with placebo at 48 weeks. Specifically, Plegridy reduced the number of:
- New T1-hypointense lesions by 53% in the 2-week dosing arm (P < 0.0001) and by 18% in the 4-week dosing arm (P = 0.082)
- New active lesions by 67% in the 2-week dosing arm (P < 0.0001) and by 35% in the 4-week dosing arm (P < 0.0001)
Source: Biogen Idec; October 1, 2013.