Phase 4
Completed N=60
Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis
Moderate to Severe Psoriasis
Source: ClinicalTrials.gov NCT00936065 ↗
Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Apr 2012
Primary outcomePrimary: Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 — 52.38; 57.89; 22.22 percentage of participants — p=0.0672
Summary
To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 |
52.38; 57.89; 22.22 | 0.0672 |
| SECONDARY Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score |
4.76; 0; 0; 47.62; 15.79; 11.11 | 1.0000 |
| SECONDARY Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear |
0; 0; 0; 0; 0; 0 | 1.0000 |
| SECONDARY Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear |
0; 0; 0; 0; 0; 5.56 | 0.3103 |
| SECONDARY Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild |
14.29; 5.26; 16.67; 33.33; 26.32; 11.11 | 0.6061 |
| SECONDARY Time to Achieve a PASI 50 Score |
56; 56; 126 | 0.0033 sig |
| SECONDARY Time to Achieve a PASI 75 Score |
126; 146; NA | 0.0448 sig |
| SECONDARY Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild |
57; 57; 169 | 0.0041 sig |
| SECONDARY Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear |
167; 165; NA | 0.3536 |
| SECONDARY Change From Baseline in the PGA of Psoriasis |
3.40; 3.38; 3.50; -0.51; -0.35; 0.02 | 0.0203 sig |
| SECONDARY Change From Baseline in the PASI Score |
20.83; 19.75; 26.31; -5.38; -3.27; -3.17 | 0.0329 sig |
| SECONDARY Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 |
32.98; 32.50; 39.75; -2.64; -1.55; -0.36 | 0.1385 |
| SECONDARY Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 |
0.67; 0.56; 0.94; 0.00; 0.00; -0.44 | 0.1723 |
| SECONDARY Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 |
3.90; 3.94; 4.72; -0.90; -0.33; -0.72 | 0.1079 |
| SECONDARY Change From Baseline in SGA of Itching at Each Visit |
3.33; 3.11; 3.72; -0.67; 0.28; -0.39 | 0.1229 |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 |
0.67; 0.74; 0.44; 0.81; 0.79; 0.28 | 0.3112 |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 |
1.00; 0.84; 0.56; 1.14; 1.21; 0.39 | 0.1774 |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 |
0.90; 0.63; 0.72; 0.86; 1.32; 0.17 | 0.0302 sig |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 |
1.33; 1.11; 1.83; 1.48; 0.42; -0.11 | 0.0060 sig |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 |
2.81; 2.84; 2.89; 0.57; 0.68; 0.28 | 0.6904 |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 |
2.81; 2.37; 2.28; 0.57; 0.37; -0.44 | 0.1144 |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 |
2.95; 2.21; 2.72; 0.48; 0.89; 0.28 | 0.3287 |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 |
4.43; 3.79; 4.17; -0.33; -0.05; 0.17 | 0.4760 |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 |
1.14; 0.79; 0.83; 0.43; 0.63; -0.11 | 0.2691 |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 |
2.29; 1.89; 2.22; 1.05; 0.63; -0.39 | 0.0512 |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 |
2.43; 1.95; 2.33; 0.95; 1.11; -0.11 | 0.0202 sig |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 |
2.95; 1.74; 2.78; 0.48; 0.89; -0.72 | 0.0409 sig |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 |
2.29; 1.53; 1.83; 0.00; 0.53; -0.39 | 0.3355 |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 |
0.95; 0.89; 1.39; 0.57; 0.74; -0.06 | 0.3402 |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 |
1.19; 1.37; 1.41; 1.24; 1.00; 0.18 | 0.0894 |
| SECONDARY Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 |
3.10; 3.42; 2.82; 0.48; 0.11; 0.00 | 0.4407 |
| SECONDARY Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 |
9.52; 15.79; 22.22; 14.29; 42.11; 27.78 | 0.5377 |
| SECONDARY Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 |
38.10; 42.11; 33.33; 80.95; 78.95; 50.00 | 0.9429 |
Eligibility Criteria
Inclusion Criteria
- Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 10.
- In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) therapy.
- Negative urine pregnancy test before the first dose of study drug in all female patients
Exclusion Criteria
- Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
- Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab (Raptiva®) and alefacept (Amevive®) is also prohibited.
Data sourced from ClinicalTrials.gov (NCT00936065). 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.