Recombinant Human Interferon--1a (Rebif) vs Recombinant Interferon--1b (Betaseron) in Healthy Volunteers: A Pharmacodynamic and Tolerability Study

Authors: Buraglio M.¹; Trinchard-Lugan I.²; Munafo A.²; Macnamee M.¹

Source: Clinical Drug Investigation, Volume 18, Number 1, July 1999 , pp. 27-34(8)

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Abstract:

Objectives: This study compared the pharmacodynamics and tolerability of subcutaneous 6MU (22µg) interferon (IFN)- beta -1a (Rebif) and 8MU (250µg) IFN- beta -1b (Betaseron).

Participants and Methods: Twelve healthy volunteers received a single injection of each treatment in this randomised crossover study. Vital signs and treatment tolerability were monitored and blood samples taken for assay of the serum markers of immune activation, beta -microglobulin and neopterin.

Results: Both treatments produced similar increases in beta -microglobulin and neopterin with areas under the concentration-time curves (AUC) of 2177 ± 669 µg/ml·h for IFN- beta -1a and 2323 ± 649 µg/ml·h for IFN- beta -1b. Headache was the most common adverse event in both treatment groups, with 15 episodes in the IFN- beta -1a group and 11 episodes in the IFN- beta -1b group. Both treatments produced increases in body temperature, and mild fever was a common adverse event associated with the treatments. However, 10 volunteers in the IFN- beta -1b group experienced fever at WHO grade 2 compared with one in the IFN- beta -1a group. Overall, IFN- beta -1a had a more favourable adverse-event profile and produced a lower incidence of fever and a smaller increase in body temperature than IFN- beta -1b.

Conclusions: Both treatments had equivalent pharmacodynamic effects, but IFN- beta -1a may be better tolerated.

Keywords: Interferon-beta-1A-Serono, pharmacodynamics; Interferon-beta-1B-Chiron-Schering, pharmacodynami; Biotechnology; Antivirals, pharmacodynamics

Language: English

Document Type: Original article

Affiliations: 1: LCG Bioscience, Bourn, Cambridge, England 2: Ares-Serono International S.A., Geneva, Switzerland *

Publication date: 1999-07-01