Efficacy of etanercept in an integrated multistudy database of patients with psoriasis.
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.


OBJECTIVE
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.


CONCLUSIONS
A limitation of these integrated analyses is the relatively short (12-week) time frame.


CONCLUSIONS
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.
Gordon
Kenneth
K
Loyola University Medical Center, Maywood, Illinois, USA. kgordon@enh.org
Korman
Neil
N
Frankel
Ellen
E
Wang
Huei
H
Jahreis
Angelika
A
Zitnik
Ralph
R
Chang
Ting
T
D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011565:Psoriasis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage / Q000037:antagonists & inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept