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PHARMACOKINETICS

Bioequivalence of Liquid and Reconstituted Lyophilized Etanercept Subcutaneous Injections

John T. Sullivan, MBChB, Liyun Ni, MS, Claudia Sheelo, MS, Margaret Salfi, MS and Paul M. Peloso, MD Msc

From Amgen Inc, Thousand Oaks, California.

The objective of this study was to compare the pharmacokinetics of liquid and reconstituted lyophilized etanercept. This single-center, open-label study had a 2-period crossover design in which 36 healthy subjects were randomly assigned in a 1:1 ratio to etanercept (liquid/lyo or lyo/liquid). The treatments were separated by 28 days. Blood samples were obtained predose and at 10 predetermined time points postdose. Serum concentrations were determined by enzyme-linked immunosorbent assay. Noncompartmental pharmacokinetic parameters were analyzed using a standard crossover analysis of variance model. Thirty-three subjects completed both treatment periods. Geometric mean values (adjusted) of area under the serum drug concentration-time curve from time zero to the time of the final quantifiable sample, area under the serum drug concentration-time curve from time zero to infinity, and maximum concentration obtained with the 50-mg/mL liquid etanercept injection were 93.0%, 90.7%, and 98.5% of the respective parameters for 2 injections of 25 mg/mL reconstituted formulation. All associated confidence intervals were within the predefined equivalence interval of 80% to 125%. No differences in safety profiles of the 2 formulations were apparent. Liquid etanercept was bioequivalent to the reconstituted lyophilized etanercept formulation.

Key Words: Arthritis • rheumatoid • receptors • tumor necrosis factor • bioequivalence • pharmacokinetics • etanercept

Address for reprints: John T. Sullivan, MBChB, Amgen Inc, One Amgen Center Drive, Mailstop 38-4-C, Thousand Oaks, CA, 91320; e-mail: jtsulliv{at}amgen.com.


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