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Comparative pharmacokinetics and pharmacodynamics of recombinant human interferon beta‐1a after intramuscular and subcutaneous administration

The pharmacokinetics and pharmacodynamics of recombinant human interferon beta (IFN‐β‐la) were compared after intramuscular administration of two preparations (Rebif® and Avonex™) and subcutaneous administration of Rebif®. Healthy volunteers (n= 30) received a single dose (6O μg) of each of the three treatments in a randomised crossover study. Serum concentrations of IFN‐β were measured by enzyme‐linked immunosorbent assay over 24 h after dosing. Pharmacodynamics were assessed by measurement of intracellular 2′,5′‐oligoadenylate synthetase activity, and serum neopterin and β2‐microglobulin concentrations, over 144 h after dosing. There was no significant difference between the three treatments in peak serum IFN‐β concentrations (Cmax) or area under the concentration‐time curve (AUC). No significant differences in pharmacodynamic measures were observed between the three treatments. It is concluded that the bioavailability of IFN‐β‐1a is equivalent after subcutaneous or intramuscular administration of Rebif®, and intramuscular administration of Avonex™.