Pharmacokinetics, pharmacodynamics, and safety of peginterferon beta‐1a in subjects with normal or impaired renal function

• Published in: Journal of clinical pharmacology Vol. 55; no. 2; pp. 179 - 188
• Main Authors: Hu, Xiao, Seddighzadeh, Ali, Stecher, Scott, Zhu, Ying, Goyal, Jaya, Matson, Mark, Marbury, Thomas, Smith, William, Nestorov, Ivan, Hung, Serena
• Format: Journal Article
• Language: English
• Published: England 01.02.2015
• Subjects: Adult; Aged; Antibodies - blood; clinical trial; Female; Humans; Interferon-beta - adverse effects; Interferon-beta - blood; Interferon-beta - pharmacokinetics; Interferon-beta - pharmacology; Male; Middle Aged; Models, Biological; multiple sclerosis; Neopterin - blood; pegylation; Polyethylene Glycols - adverse effects; Polyethylene Glycols - pharmacokinetics; Polyethylene Glycols - pharmacology; Renal Insufficiency - blood; Renal Insufficiency - metabolism; clinical trial; pegylation; multiple sclerosis

Peginterferon beta‐1a was efficacious in a Phase 3 relapsing multiple sclerosis trial, and its safety profile was consistent with other beta interferons. This study evaluated the impact of renal impairment on the pharmacokinetics and pharmacodynamics (neopterin elevation; a biomarker of pharmacologi...