Phase 3
Completed N=310
Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT01313221 ↗Enrolled (actual)
310
Serious AEs
1.3%
Results posted
May 2014
Primary outcomePrimary: Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24 — 17.02; 0.86 percent change
Summary
To estimate the difference in effectiveness between treatment with etanercept 50 mg twice weekly (BIW) and treatment with etanercept 50 mg once weekly (QW) plus an as needed (PRN) topical agent for 12 weeks in adults with moderate to severe plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24 |
17.02; 0.86 | — |
| SECONDARY Percent Change in PASI From Week 12 to Weeks 16 and 20 |
16.03; 4.80; 19.79; 3.23 | — |
| SECONDARY Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24 |
62.12; 65.48; 68.25; 72.67; 70.98; 73.25 | — |
| SECONDARY Percentage of Participants With a PASI 50 Response |
71.3; 75.4; 76.1; 86.2; 80.3; 86.5 | — |
| SECONDARY Percentage of Participants With a PASI 75 Response |
44.1; 52.1; 52.2; 58.7; 54.9; 58.9 | — |
| SECONDARY Percentage of Participants With a PASI 90 Response |
17.5; 12.7; 23.2; 22.5; 28.9; 22.0 | — |
| SECONDARY Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) |
40.6; 45.8; 50.4; 50.4; 51.4; 48.9 | — |
| SECONDARY Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24 |
18.77; 12.83; 22.89; 16.04; 15.60; 10.71 | — |
| SECONDARY Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24 |
58.13; 62.47; 65.75; 72.88; 70.37; 75.86 | — |
| SECONDARY Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score |
0.52; -0.03 | — |
| SECONDARY Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score |
10.01; 9.71; 10.71; 9.87 | — |
| SECONDARY Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24 |
-3.05; 0.09; -1.27; 2.57; -0.43; 2.22 | — |
| SECONDARY Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24 |
31.37; 32.64; 15.87; 16.47; 0.0; -0.15 | — |
| SECONDARY Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider |
52; 45; 28; 25; 9; 14 | — |
| SECONDARY Health Resource Utilization: Number of Participants With Home Healthcare Visits |
1; 2; 1; 1 | — |
| SECONDARY Health Resource Utilization: Number of Participants Requiring Paid Help With Chores |
12; 13; 5; 5 | — |
| SECONDARY Health Resource Utilization: Number of Participants Who Needed Friend or Family Care |
5; 6; 7; 6; 6; 8 | — |
| SECONDARY Health Resource Utilization: Out of Pocket Expenses |
1.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Health Resource Utilization: Employment Status |
81; 72; 26; 21; 16; 21 | — |
| SECONDARY Health Resource Utilization: Productivity While Working |
7; 6; 16; 13; 37; 28 | — |
| SECONDARY Health Resource Utilization: Number of Participants With Missed Hours From Work |
15; 19; 5; 6 | — |
| SECONDARY Health Resource Utilization: Ability to Perform Daily Activities |
11; 11; 14; 16; 23; 27 | — |
| SECONDARY Number of Participants With Adverse Events |
112; 92; 4; 0; 11; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).
- Has a body surface area (BSA) involvement ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline.
- Is a candidate for systemic therapy or phototherapy in the opinion of the investigator.
- Other inclusion criteria may apply.
Exclusion Criteria
- Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
- Has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept on psoriasis.
- Diagnosed with medication-induced or medication-exacerbated psoriasis.
- Significant concurrent medical conditions.
- Has any active localized infection; requiring local intervention or chronic or localized infections.
- Other exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01313221). 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.