Author Topic: Plegridy (PEGylated interferon beta-1a) (BIIB017)  (Read 747 times)

0 Members and 0 Guests are viewing this topic.

Offline agate

  • Administrator
  • *****
  • Posts: 8246
  • MS diagnosed 1980
  • Location: Pacific Northwest
From PubMed, May 6, 2014:

Quote
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: pcalabr1@jhmi.edu.
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.


BACKGROUND:


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.

METHODS:

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 ClinicalTrials.gov, number NCT00906399.

FINDINGS:

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.

INTERPRETATION:

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.

FUNDING:

Biogen Idec.

PMID: 24794721

The abstract can be seen here.
MS Speaks--online for 13 years

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