A study has evaluated a novel PEGylated form of Interferon beta-1a ( PEG-IFN beta-1a; Plegridy ), 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-Interferon beta-1a ( 63, 125, or 188 mcg ) with intramuscular unmodified Interferon beta-1a 30 mcg and a multiple-dose study ( n=69 ) comparing subcutaneous PEG-Interferon 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-Interferon beta-1a exposure was observed, with a 4-fold greater exposure at 63 mcg ( 6 million international units [ MIU ] ) of PEG-Interferon beta-1a than with 30 mcg ( 6 MIU ) intramuscular unmodified Interferon 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-Interferon beta-1a than with unmodified Interferon beta-1a.
PEG-Interferon 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-Interferon beta-1a as a potentially effective treatment for patients with relapsing multiple sclerosis. ( Xagena )
Hu X et al, J Clin Pharmacol 2012;52:798-808