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Clinical Trial
. 2006 Oct;62(4):435-45.
doi: 10.1111/j.1365-2125.2006.02581.x.

Pharmacokinetics of subcutaneously administered etanercept in subjects with psoriasis

Ivan Nestorov  1 , Ralph Zitnik, Todd DeVries, Arline M Nakanishi, Andrea Wang, Christopher Banfield
Affiliations
Clinical Trial

Pharmacokinetics of subcutaneously administered etanercept in subjects with psoriasis

Ivan Nestorov et al. Br J Clin Pharmacol. 2006 Oct.

Abstract

Aims: To present the results of the pharmacokinetic analysis of the concentration-time profiles of etanercept, a soluble receptor tumour necrosis factor (TNF) antagonist, in more than 1300 subjects with psoriasis.

Methods: Pharmacokinetic samples were collected in one phase-2 and two phase-3 placebo-controlled, randomized clinical trials. Study 1 evaluated a 25-mg twice weekly (BIW) etanercept dosing regimen administered by subcutaneous (s.c.) injection for 24 weeks. Study 2 evaluated 25-mg BIW and 50-mg BIW s.c. doses for 12 weeks. Study 3 evaluated 25 mg once weekly (QW), 25 mg BIW and 50 mg BIW s.c. doses for 24 weeks.

Results: The mean +/- SD steady-state predose serum concentrations of etanercept for the 25-mg BIW arm at 12 weeks in study 1 were 1590 +/- 885 ng ml(-1). In study 2, mean +/- SD etanercept steady-state concentrations at 12 weeks were 1900 +/- 1110 ng ml(-1) in the 25-mg BIW group and 3830 +/- 1870 ng ml(-1) in the 50-mg BIW group. The mean +/- SD steady-state predose serum concentrations of etanercept at 12 weeks in study 3 were 768 +/- 475 ng ml(-1) for the 25-mg QW regimen, 1990 +/- 1030 ng ml(-1) for the 25-mg BIW regimen and 4020 +/- 2100 ng ml(-1) for the 50-mg BIW regimen.

Conclusions: Pharmacokinetic results were highly consistent across clinical trials. The concentration-time profiles displayed dose proportionality. Etanercept concentrations in subjects with psoriasis are similar to the concentrations in subjects with rheumatoid arthritis.

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Figures

Figure 1
Figure 1
Mean (± SD) etanercept serum trough concentration–time profiles for the active dosing arms during the blinded period of study 2. 25 mg BIW (□), 50 mg BIW (♦)
Figure 2
Figure 2
Mean (± SD) etanercept serum trough concentration–time profiles for all dosing arms during the blinded period of study 3. 1Week 24 after receiving active 25 mg BIW for 12 weeks
Figure 3
Figure 3
Mean (± SD) etanercept serum concentration–time profiles at week 1 (a), week 12 (b) and week 24 (c) of the subjects from the PK subset of study 3. 1Week 24 after receiving active 25 mg BIW for 12 weeks
Figure 4
Figure 4
Mean (± SD) etanercept trough serum concentration–time profiles for the various dosing arms in all studies. (a) study 1 (•), study 2 (▾), study 3 (○); (b) study 2 (▾), study 3 (○)
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References

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