Conflicts of interest B.E. is a clinical investigator and/or consultant for Amgen Inc., Biogen, Centocor Inc. and Genentech. C.L. is a consultant for Abbott, Amgen Inc., Bristol-Myers Squibb, Centocor Inc., Genentech and Serono. He has been an investigator for studies sponsored by 3M Pharmaceuticals, Abbott, Allergan, Amgen Inc., Astellis, Biogen, Bristol-Myers Squibb, CombinatoRx, Centocor Inc., Fujisawa, Galderma, Genentech, MedImmune, RTL, Schering-Plough Corp. and Serono. He has received educational grants from Amgen Inc. and Genentech. He is on the speakers’ bureau for Abbott, Amgen Inc., Centocor Inc., Genentech and Warner-Chilcott. A.B.G. is a consultant for several companies (Amgen Inc., BiogenIdec Inc., Centocor Inc., Wyeth Pharmaceuticals, Schering-Plough Corp., Eisai, Celgene Corp., Bristol Myers Squibb Co., Beiersdorf, Inc., Warner Chilcott, Abbott Labs, Roche, Sankyo, Medarex, Kemia, Celera, TEVA, Actelion, UCB, Novo Nordisk, Almirall, Immune Control) and is on the speaker's bureau for Amgen Inc. and Wyeth Pharmaceuticals. B.E.S. has been a speaker, consultant and investigator for Amgen Inc. M.A.S., M.D. and A.J. are employees of Amgen Inc.
Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis
Article first published online: 10 NOV 2006
British Journal of Dermatology
Volume 156, Issue 1, pages 138–142, January 2007
How to Cite
Elewski, B., Leonardi, C., Gottlieb, A.B., Strober, B.E., Simiens, M.A., Dunn, M. and Jahreis, A. (2007), Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis. British Journal of Dermatology, 156: 138–142. doi: 10.1111/j.1365-2133.2006.07585.x
- Issue published online: 10 NOV 2006
- Article first published online: 10 NOV 2006
- Accepted for publication 31 July 2006
- clinical trials;
Background Etanercept is a tumour necrosis factor antagonist that is approved in the U.S.A., Canada and Europe for treating adult patients with chronic moderate to severe plaque psoriasis.
Objectives To assess whether clinical efficacy, safety and pharmacokinetic (PK) profiles of etanercept 50 mg once weekly are comparable to etanercept 25 mg twice weekly.
Methods Patients from a U.S. phase 3 study and a global phase 3 study were subsequently enrolled in an open-label extension study (extension study) where they all received etanercept at a dose of 50 mg once weekly for an initial 12 weeks. Patients who had received at least 24 weeks of etanercept 25 mg twice weekly in the global phase 3 study and were enrolled in the extension study (n = 265) were assessed for efficacy and safety at extension study baseline and after 12 weeks of etanercept 50 mg once weekly. Efficacy endpoints included the Psoriasis Area and Severity Index (PASI), the Dermatology Life Quality Index and the Physician's Global Assessment of psoriasis. In addition, PK profiles from patients in the U.S. phase 3 study were compared with PK profiles from another set of patients in the extension study. Comparison was made between a subset of patients receiving etanercept 25 mg twice weekly dosing in the U.S. phase 3 study (n = 13) and those receiving etanercept 50 mg once weekly in the extension study (n = 84).
Results The mean PASI score was 5·77 at extension study baseline after treatment with etanercept 25 mg twice weekly, which was sustained at 5·82 after 12 weeks of etanercept 50 mg once weekly. Similar results were observed in other efficacy endpoints. Etanercept 50 mg once weekly was generally well tolerated. No new safety findings were reported. PK profiles overlapped extensively between the two dosing regimens.
Conclusions In this report, we demonstrate that efficacy, safety and PK profiles were comparable between etanercept 25 mg twice weekly and 50 mg once weekly in patients who had received at least 24 weeks of etanercept 25 mg twice weekly prior to receiving etanercept 50 mg once weekly in the extension study.