Author Topic: (AAN) Plegridy every 2 wks. effective for RRMS 3 months after starting  (Read 111 times)

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Offline agate

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This study, sponsored by Biogen, was presented at the annual AAN conference recently held in Washington, DC.

Quote
S4.001] Peginterferon Beta-1a is Effective as Early as Twelve Weeks Following Treatment Initiation in Patients With Relapsing Multiple Sclerosis

Scott Newsome,1Bernd Kieseier,2Shulian Shang,3Shifang Liu,3Serena Hung,3Bjoern Sperling3

1Baltimore, MD, USA, 2Duesseldorf, Germany, 3Cambridge, MA, USA.

OBJECTIVE:

To investigate the early effects of subcutaneous peginterferon beta-1a (PEG-IFN) dosed every two weeks in patients with relapsing remitting multiple sclerosis (RRMS).

BACKGROUND:

In the Phase 3 ADVANCE study in patients with RRMS, PEG-IFN dosed at 125 μg every two weeks was more effective than placebo and had a safety profile similar to other beta interferons. This analysis evaluated the efficacy of PEG-IFN in patients following the initial three months of treatment in the same study.
DESIGN/METHODS: ADVANCE was a two-year, multi-national, double-blind, placebo-controlled, Phase 3 study, in patients aged 18-65 years with RRMS. The current analysis evaluated the efficacy of PEG-IFN dosed every two weeks versus placebo within the first three months of treatment. Efficacy assessments, evaluated at 12 weeks, included the proportion of patients who relapsed, the annualized relapse rate (ARR), and the onset of 24-week confirmed disability progression (CDP).

RESULTS:

The intent-to-treat population comprised 512 patients who received PEG-IFN and 500 patients who received placebo. At 12 weeks of treatment:

   The estimated proportion of patients who experienced a relapse was 6.0% versus 9.5% (p = 0.041) for PEG-IFN dosed every two weeks versus placebo, respectively;

   There was a 37.1% (p=0.048) reduction in adjusted ARR in patients receiving PEG-IFN every two weeks (0.240, 95% CI 0.160-0.359) versus placebo (0.381, 95% CI 0.268-0.540);

   The estimated proportion of patients with an onset of 24-week CDP was 0.0% versus 1.0% (p = 0.026) for PEG-IFN every two weeks versus placebo, respectively.

CONCLUSIONS:

As early as three months after treatment initiation, PEG-IFN dosed every two weeks showed superior efficacy in reducing relapse, ARR, and CDP when compared with placebo.

__________________
Study sponsored by: Biogen Idec Inc. (Cambridge, MA, USA).

Category - MS and CNS Inflammatory Disease: Clinical Science

Session: S4: Platform Session: Clinical Trial Outcomes in Multiple Sclerosis (1:00 PM-2:45 PM)
Date/Time: Tuesday, April 21, 2015 - 1:00 pm
 

The abstract can be seen here.
MS Speaks--online for 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.