Efficacy of etanercept in an integrated multistudy database of patients with psoriasis - 09/08/11
, Neil Korman, MD b, Ellen Frankel, MD c, Huei Wang, PhD d, Angelika Jahreis, MD d, Ralph Zitnik, MD d, Ting Chang, PhD d
Correspondence to: Kenneth Gordon, MD, Division of Dermatology, Evanston Northwestern Healthcare, 9977 Woods Dr, Skokie, IL 60077.Maywood, Illinois; Cleveland, Ohio; Johnston, Rhode Island; and Thousand Oaks, California
Abstract |
Background |
The tumor necrosis factor (TNF) inhibitor etanercept has been demonstrated to be safe and effective for treating chronic plaque psoriasis in 3 clinical trials.
Objectives |
To refine efficacy results for etanercept on the basis of a larger population size through the integration of the 3 studies, and to determine if the efficacy profile across all 3 studies is consistent with efficacy profiles observed for individual trials.
Methods |
In these integrated analyses, data for 1187 patients from 3 blinded treatment groups were pooled to compare efficacy at 12 weeks: etanercept 50 mg weekly (equivalent to 25 mg twice weekly) subcutaneously, etanercept 50 mg twice weekly subcutaneously, and placebo. The primary efficacy end point in all 3 studies was at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75). Other measurements included PASI 50, PASI 90, patient’s and dermatologist’s global assessments, and Dermatology Life Quality Index.
Results |
In the integrated analyses, statistically significant, dose-dependent improvements in PASI 75 at 12 weeks were observed in patients treated with etanercept 50 mg weekly (33%) and 50 mg twice weekly (49%), compared with the placebo group (3%; P < .05). Significant improvements also were seen in all secondary end points (PASI 50 and PASI 90 responses, patient’s and dermatologist’s global assessments, and Dermatology Life Quality Index) at 12 weeks. Subgroup analyses of baseline patient characteristics demonstrated that there were no statistically significant treatment-by-covariate interactions.
Limitations |
A limitation of these integrated analyses is the relatively short (12-week) time frame.
Conclusion |
The efficacy profile of etanercept in patients with psoriasis was consistent across multiple studies as shown in the integrated analyses of the primary and secondary end points. Etanercept demonstrated rapid, dose-dependent improvements in disease severity and quality of life consistently over all studies.
Le texte complet de cet article est disponible en PDF.Abbreviations used : BSA, CI, DLQI, DSGAP, MTX, OR, PASI, PGA, PUVA, SC, TNF
Plan
| Supported by Amgen Inc and Wyeth Research. Funded by Immunex Corporation, Seattle, Wash, a wholly owned subsidiary of Amgen Inc, Thousand Oaks, Calif, and by Wyeth. Data were collected by Amgen and stored in a central repository. Amgen provided statistical and editorial support. Conflicts of interest: Dr Gordon has received support and honoraria from the following companies: Abbott, Amgen, Biogen, Centocor, and Genentech. He received an honorarium for this work. Dr Korman has received grants from Amgen, has served as a clinical investigator for Amgen, and is on the Amgen speakers bureau. Dr Frankel serves on a speakers bureau for Amgen. Drs Wang, Jahreis, Zitnik, and Chang are employees of and have been granted stock options in Amgen, Inc. Reprints not available from the authors. |
Vol 54 - N° 3S2
P. S101-S111 - mars 2006 Retour au numéro
Article précédent
- Etanercept monotherapy in patients with psoriasis: A summary of safety, based on an integrated multistudy database
- Alice B. Gottlieb, Craig L. Leonardi, Bernard S. Goffe, Jean-Paul Ortonne, Peter C.M. van der Kerkhof, Ralph Zitnik, Arline Nakanishi, Angelika Jahreis
- Patients with psoriasis respond to continuous open-label etanercept treatment after initial incomplete response in a randomized, placebo-controlled trial
- Gerald G. Krueger, Boni Elewski, Kim Papp, Andrea Wang, Ralph Zitnik, Angelika Jahreis
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