| Content Provider |
World Health Organization (WHO)-Global Index Medicus |
| Author |
Calabresi, Peter A. Kieseier, Bernd C. Arnold, Douglas L. Balcer, Laura J. Boyko, Alexey Pelletier, Jean Liu, Shifang Zhu, Ying Seddighzadeh, Ali Hung, Serena Deykin, Aaron |
| Description |
Author Affiliation: Calabresi PA ( Department of Neurology, Johns Hopkins University, Baltimore, MD, USA. Electronic address: pcalabr1@jhmi.edu.); Kieseier BC ( Department of Neurology, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany.); Arnold DL ( Montreal Neurological Institute, McGill University, Montreal, QC, Canada); Balcer LJ ( Department of Neurology, New York University, Langone Medical Center, New York, NY, USA.); Boyko A ( Moscow MS Center at 11 City Hospital and Department of Neurology & Neurosurgery of the RSMRU named by Pirogov, Moscow, Russia.); Pelletier J ( Departments of Neurology and Research (CRMBM), CHU Timone, Marseille, France.); Liu S ( Biogen Idec, Cambridge, MA, USA.); Zhu Y ( Biogen Idec, Cambridge, MA, USA.); Seddighzadeh A ( Biogen Idec, Cambridge, MA, USA.); Hung S ( Biogen Idec, Cambridge, MA, USA.); Deykin A ( Biogen Idec, Cambridge, MA, USA.) |
| Abstract |
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. |
| File Format |
HTM / HTML |
| ISSN |
14744422 |
| Issue Number |
7 |
| Volume Number |
13 |
| e-ISSN |
14744465 |
| Journal |
The Lancet Neurology |
| Language |
English |
| Publisher |
Elsevier |
| Publisher Date |
2014-07-01 |
| Publisher Place |
Great Britain (UK) |
| Access Restriction |
One Nation One Subscription (ONOS) |
| Subject Keyword |
Discipline Neurology Adjuvants, Immunologic Therapeutic Use Interferon-beta Multiple Sclerosis, Relapsing-remitting Diagnosis Drug Therapy Polyethylene Glycols Adult Double-blind Method Female Humans Interferon Beta-1a Male Middle Aged Treatment Outcome Clinical Trial, Phase Iii Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't |
| Content Type |
Text |
| Resource Type |
Article |
| Subject |
Neurology (clinical) |
