Author Topic: Plegridy (PEGylated interferon beta-1a) (BIIB017)  (Read 773 times)

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Offline agate

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From PubMed, May 6, 2014:

Lancet Neurol. 2014 Apr 30. pii: S1474-4422(14)70068-7.

Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study

Calabresi PA1, Kieseier BC2, Arnold DL3, Balcer LJ4, Boyko A5, Pelletier J6, Liu S7, Zhu Y7, Seddighzadeh A7, Hung S7, Deykin A7; for the ADVANCE Study Investigators.

Author information

1Department of Neurology, Johns Hopkins University, Baltimore, MD, USA. Electronic address:
2Department of Neurology, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany.
3Montreal Neurological Institute, McGill University, Montreal, QC, Canada; NeuroRx Research, Montreal, QC, Canada.
4Department of Neurology, New York University, Langone Medical Center, New York, NY, USA.
5Moscow MS Center at 11 City Hospital and Department of Neurology & Neurosurgery of the RSMRU named by Pirogov, Moscow, Russia.
6Departments of Neurology and Research (CRMBM), CHU Timone, Marseille, France.
7Biogen Idec, Cambridge, MA, USA.


Subcutaneous pegylated interferon (peginterferon) beta-1a is being developed for treatment of relapsing multiple sclerosis, with less frequent dosing than currently available first-line injectable treatments. We assessed the safety and efficacy of peginterferon beta-1a after 48 weeks of treatment in the placebo-controlled phase of the ADVANCE trial, a study of patients with relapsing-remitting multiple sclerosis.


We did this 2-year, double-blind, parallel group, phase 3 study, with a placebo-controlled design for the first 48 weeks, at 183 sites in 26 countries. Patients with relapsing-remitting multiple sclerosis (age 18-65 years, with Expanded Disability Status Scale score ≤5) were randomly assigned (1:1:1) via an interactive voice response or web system, and stratified by site, to placebo or subcutaneous peginterferon beta-1a 125 μg once every 2 weeks or every 4 weeks. The primary endpoint was annualised relapse rate at 48 weeks. This trial is registered with, number NCT00906399.


We screened 1936 patients and enrolled 1516, of whom 1512 were randomly assigned (500 to placebo, 512 to peginterferon every 2 weeks, 500 to peginterferon every 4 weeks); 1332 (88%) patients completed 48 weeks of treatment. Adjusted annualised relapse rates were 0·397 (95% CI 0·328-0·481) in the placebo group versus 0·256 (0·206-0·318) in the every 2 weeks group and 0·288 (0·234-0·355) in the every 4 weeks group (rate ratio for every 2 weeks group 0·644, 95% CI 0·500-0·831, p=0·0007; rate ratio for the every 4 weeks group 0·725, 95% CI 0·565-0·930, p=0·0114). 417 (83%) patients taking placebo, 481 (94%) patients taking peginterferon every 2 weeks, and 472 (94%) patients taking peginterferon every 4 weeks reported adverse events including relapses.

The most common adverse events associated with peginterferon beta-1a were injection site reactions, influenza-like symptoms, pyrexia, and headache. 76 (15%) patients taking placebo, 55 (11%) patients taking study drug every 2 weeks, and 71 (14%) patients taking study drug every 4 weeks reported serious adverse events; relapse, pneumonia, and urinary tract infection were the most common.


After 48 weeks, peginterferon beta-1a significantly reduced relapse rate compared with placebo. The drug might be an effective treatment for relapsing-remitting multiple sclerosis with less frequent administration than available treatments.


Biogen Idec.

PMID: 24794721

The abstract can be seen here.
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