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DIR Return to: PLEGRIDY (pegylated interferon beta-1a)
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#Post#: 747--------------------------------------------------
(AAN) Plegridy every 2 wks. effective for RRMS 3 months after s
tarting
By: agate Date: April 28, 2015, 3:07 pm
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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:
•
was 6.0% versus 9.5% (p = 0.041) for PEG-IFN dosed every two
weeks versus placebo, respectively;
•
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);
•
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
[/quote]
The abstract can be seen here
HTML http://www.abstracts2view.com/aan/view.php?nu=AAN15L1_S4.001.
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