Efficacy of etanercept in an integrated multistudy database of patients with psoriasis. J Am Acad Dermatol 2006 Mar;54(3 Suppl 2):S101-11
Date
02/21/2006Pubmed ID
16488320DOI
10.1016/j.jaad.2005.11.1088Scopus ID
2-s2.0-32644441215 (requires institutional sign-in at Scopus site) 88 CitationsAbstract
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.
Author List
Gordon K, Korman N, Frankel E, Wang H, Jahreis A, Zitnik R, Chang TAuthor
Kenneth Brian Gordon MD Chair, Professor in the Dermatology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdultDose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Etanercept
Female
Humans
Immunoglobulin G
Immunosuppressive Agents
Logistic Models
Male
Middle Aged
Multicenter Studies as Topic
Psoriasis
Randomized Controlled Trials as Topic
Receptors, Tumor Necrosis Factor
Treatment Outcome
