Pharmacokinetics and pharmacodynamics of interferon beta 1a in Cebus apella.

ABSTRACT

BACKGROUND: Recombinant human interferon (hIFN beta) is indicated for the treatment of multiple sclerosis. Its effect presents species restriction, thus lacking biological activity on most mammals. Although there have been previous studies of the pharmacology of INF beta in Old World primates, no data exists on New World primates. Therefore, we explored its effect on Cebus apella, a New World monkey, describing the pharmacology of this molecule when injected by subcutaneous route in this species. METHODS: Safety, pharmacokinetics and pharmacodynamics of IFN beta were evaluated in nine Cebus apella individuals. RESULTS: A single subcutaneous injection of 12 x 10(6) IU of hIFN beta 1a resulted in a median AUC((0-48)) (area under the curve) of 14.82 ng/ml, a C(max) (maximum plasma concentrations) of 1.51 ng/ml and a T(max) (time to achieve maximum plasma concentrations) of 3 h. IFN beta was biologically active as demonstrated by an increase in neopterin levels. There were no safety concerns. CONCLUSIONS: New World non-human primates are a suitable animal model for the study of IFN beta pharmacology.