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PHARMACOKINETICS

The Comparability of Etanercept Pharmacokinetics in Healthy Japanese and American Subjects

Shinichi Kawai, MD, PhD, Hisayuki Sekino, MD, PhD, Noriaki Yamashita, PhD, Shinichi Tsuchiwata, MS, Hanjui Liu, PhD and Joan M. Korth-Bradley, PharmD, PhD

From the Division of Rheumatology, Department of Medicine, Toho University School of Medicine, Tokyo, Japan (Dr Kawai); the Sekino Clinical Pharmacology Clinic, Tokyo, Japan (Dr Sekino); Wyeth K. K., Tokyo, Japan (Dr Yamashita, Mr Tsuchiwata); Wyeth Pharmaceuticals, Pearl River, New York (Dr Liu); and Wyeth Research, Philadelphia, Pennsylvania (Dr Korth-Bradley).

Thirty Japanese (J) and 32 American (A) healthy subjects received single doses of etanercept by subcutaneous injection, in 3 separate trials. Serum samples were collected for 480 hours after dosing. Concentrations were determined using enzyme-linked immunosorbent assay methods. Pharmacokinetic parameters were calculated using both non-compartmental and compartmental methods. Etanercept was slowly absorbed, with mean ± SD time to maximum serum concentration of 47 ± 15 hours (J), and 51 ± 20 hours (A). The maximum serum concentration and area under the concentration time curve increased for doses 10 mg, 25 mg, and 50 mg, in a linear relationship. Etanercept was slowly eliminated, with observed mean ± SD half-life of 80 ± 25 hours (J) and 75 ± 15 hours (A) and mean ± SD apparent clearance of 144 ± 65 mL/h (J) and 132 ± 74 mL/h (A). Very low concentrations of etanercept were observed in the urine samples collected in the Japanese subjects. All adverse reactions observed resolved without issue, and none required discontinuation from the study.

Key Words: Etanercept • Japanese • pharmacokinetics • TNFR • rheumatoid arthritis

Address for reprints: Joan M. Korth-Bradley, PharmD, PhD, PO Box 42528, Philadelphia, PA 19101.






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