N/A
Completed N=2,511
Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis
Source: ClinicalTrials.gov NCT00322439 ↗Enrolled (actual)
2,511
Serious AEs
16.7%
Results posted
Mar 2014
Primary outcomePrimary: Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events — 0.2029; 0.0581 proportion of participants
Summary
This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for 5 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events |
0.2029; 0.0581 | — |
| SECONDARY Five-year Cumulative Incidence for Events of Medical Interest (EMIs) |
0.0659; 0.0283; 0.0074; 0.0018; 0.0013; 0.0006 | — |
| SECONDARY Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) |
12.0; 47.4; 51.5 | — |
| SECONDARY Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1 |
11.4; 53.2; 55.7 | — |
| SECONDARY Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response |
60.2; 64.5 | — |
| SECONDARY Euroqol-5D (EQ-5D) Total Score |
0.78; 0.86; 0.86 | — |
| SECONDARY Euroqol-5D (EQ-5D) Visual Analog Scale (VAS) |
74.05; 81.81; 82.51 | — |
| SECONDARY Healthcare Resource Use |
0.72; 0.35; 0.03; 0.46; 0.26; 0.63 | — |
| SECONDARY Work Productivity and Activity Impairment (WPAI) |
2.81; 1.34; 1.47; 18.50; 9.00; 7.90 | — |
| SECONDARY Percentage of Body Surface Area Affected by Psoriasis |
21.06; 6.59; 6.06 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with plaque psoriasis
Exclusion Criteria
- Prior exposure to any tumor necrosis factor (TNF)-inhibitor
- Patients for whom Enbrel is contraindicated
- Patients currently enrolled in or has not yet completed at least 30 days since ending other investigational drug study.
Data sourced from ClinicalTrials.gov (NCT00322439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.