Biological response genes after single dose administration of interferon beta-1b to healthy male volunteers.
Treatment with interferon beta-1b (IFNB-1b) is clinically effective in multiple sclerosis patients. However, the mechanism of action is only partially understood, and validated biological response markers are lacking. We assessed IFNB-1b-induced transcriptional changes by microarray technology. Healthy male volunteers received 250 mug IFNB-1b or placebo in a double-blind, randomized controlled trial (n=5 per group). Most transcripts demonstrated peak levels after 6-12 h and returned to baseline after 48 h. We identified 227 differentially regulated genes including novel and previously described markers. This panel may become a valuable tool for development of new IFNB-1b formulations and assessment of clinical drug effects.
Clinical Pharmacology, Bayer Schering Pharma AG, Berlin, Germany.
Jan
J
Hilpert
Johanna M
JM
Beekman
Susanne
S
Schwenke
Kristin
K
Kowal
David
D
Bauer
Johannes
J
Lampe
Rupert
R
Sandbrink
Jürgen F
JF
Heubach
Steffen
S
Stürzebecher
Joachim
J
Reischl
D000276:Adjuvants, Immunologic / Q000494:pharmacology*; D000328:Adult; D004311:Double-Blind Method; D015870:Gene Expression / Q000187:drug effects*; D020869:Gene Expression Profiling; D006801:Humans; D007155:Immunologic Factors / Q000235:genetics*; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000494:pharmacology*; D008297:Male; D020411:Oligonucleotide Array Sequence Analysis; D025341:Principal Component Analysis; D020133:Reverse Transcriptase Polymerase Chain Reaction
D000276:Adjuvants, Immunologic; D007155:Immunologic Factors; D000068576:Interferon beta-1b; D016899:Interferon-beta