Biological response genes after single dose administration of interferon β-1b to healthy male volunteers

Treatment with interferon β-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 μg 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.