Pharmacokinetics and pharmacodynamics of interferon beta 1a in Cebus apella

Background  Recombinant human interferon (hIFNβ) 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 INFβ 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 IFNβ were evaluated in nine Cebus apella individuals. Results  A single subcutaneous injection of 12 × 106 IU of hIFNβ1a resulted in a median AUC(0–48) (area under the curve) of 14.82 ng/ml, a Cmax (maximum plasma concentrations) of 1.51 ng/ml and a Tmax (time to achieve maximum plasma concentrations) of 3 h. IFNβ 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 IFNβ pharmacology.