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A Novel PEGylated Interferon Beta-1a for Multiple Sclerosis: Safety, Pharmacology, and Biology.
- Source :
-
Journal of Clinical Pharmacology . Jun2012, Vol. 52 Issue 6, p798-808. 11p. - Publication Year :
- 2012
-
Abstract
- This study clinically evaluated a novel PEGylated form of interferon beta-1a (PEG-IFN beta-1a), a potential first-line treatment for relapsing multiple sclerosis, in healthy volunteers. Two randomized, blinded phase I studies were conducted: a single-dose study (n = 60) comparing subcutaneous or intramuscular PEG-IFN beta-1a (63, 125, or 188 µg) with intramuscular unmodified IFN beta-1a 30 µg and a multiple-dose study (n = 69) comparing subcutaneous PEG-IFN beta-1a dosed once every 2 or 4 weeks with placebo. Assessments included pharmacokinetic and pharmacodynamic (serum neopterin and 2′,5′-OAS) measures, exploratory immune assessments, safety, and tolerability. A dose-proportional increase in PEG-IFN beta-1a exposure was observed, with a 4-fold greater exposure at 63 µg (6 million international units [MIU]) of PEG-IFN beta-1a than with 30 µg (6 MIU) intramuscular unmodified IFN beta-1a. Increases in neopterin and 2′,5′-OAS levels and changes in T helper cell pathway gene expression and lymphocyte subsets were greater and more sustained with PEG-IFN beta-1a than with unmodified IFN beta-1a. PEG-IFN beta-1a was well tolerated, with only transient reductions in absolute neutrophils and some lymphocytes. Flu-like symptoms were a commonly reported adverse event. These data support the continued clinical development of PEG-IFN beta-1a as a potentially effective treatment for patients with relapsing multiple sclerosis. [ABSTRACT FROM PUBLISHER]
- Subjects :
- *THERAPEUTIC use of interferons
*BIOLOGICAL assay
*COENZYMES
*ENZYME-linked immunosorbent assay
*FLOW cytometry
*IMMUNOGENETICS
*INTERFERONS
*MULTIPLE sclerosis
*POLYMERASE chain reaction
*RESEARCH funding
*STATISTICAL sampling
*TRANSFERASES
*RANDOMIZED controlled trials
*BLIND experiment
*DATA analysis software
*DESCRIPTIVE statistics
*INVESTIGATIONAL drugs
Subjects
Details
- Language :
- English
- ISSN :
- 00912700
- Volume :
- 52
- Issue :
- 6
- Database :
- Academic Search Index
- Journal :
- Journal of Clinical Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 76331774
- Full Text :
- https://doi.org/10.1177/0091270011407068