Psoriasis
Conditions
Keywords
Scalp, Psoriasis, Plaque Psoriasis, Skin Diseases, Moderate to severe plaque psoriasis, etanercept
Brief summary
The purpose of this study is to determine if etanercept is effective in the treatment of scalp involvement in moderate to severe plaque psoriasis.
Interventions
BIOLOGICALEtanercept
Etanercept for subcutaneous injection.
BIOLOGICALPlacebo
Placebo for subcutaneous injection.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must provide written informed consent before any study-specific procedure * Be male or female greater than or equal to 18 years of age at time of screening * Has stable moderate to severe plaque psoriasis for at least 6 months * Affected body surface area (BSA) greater than or equal to 10% * Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 * At least 30 percent affected scalp surface area * Psoriasis Scalp Severity Index (PSSI) score greater than or equal to 15 * Candidate for systemic therapy or phototherapy in the opinion of the investigator * Negative test for hepatitis B surface antigen, hepatitis C antibody, and Human Immunodeficiency Virus (HIV) * Negative serum pregnancy test for female subjects (unless 3 years post menopausal or surgically sterile) * Willing to use medically acceptable form of birth control for duration of study * Negative Purified Protein Derivative (PPD) within 30 days prior to first dose of study drug
Exclusion criteria
* Any active infection * Significant concurrent medical conditions, including: Insulin dependent diabetes mellitus; Congestive heart failure; Myocardial infarction within last year; Unstable angina pectoris; Uncontrolled hypertension; Severe pulmonary disease \[requiring oxygen therapy or hospitalization\]; Systemic lupus erythematosus; Multiple sclerosis or any other demyelinating disease; Active malignancy * Any condition, in opinion of study doctor, that might cause this study to be detrimental to subject * History of cancer within 5 years before first dose of study drug * Skin conditions other than psoriasis that would interfere with evaluations of the effect of study medications on psoriasis * Presence of guttate, erythrodermic or pustular psoriasis * Use of topical cyclosporine or calcineurin inhibitors within 14 days of first dose of study drug * Use of tar shampoos within 14 days of first dose of study drug * Use of following therapies within 28 days of first dose of study drug: IV or oral cyclosporine or calcineurin inhibitors, Ultraviolet Light A therapy, Psoralen plus ultraviolet A radiation, Oral retinoids, Ultraviolet Light B therapy, Topical steroids or steroid shampoo, Topical vitamin A or D analog preparations, Anthralin, other systemic psoriasis therapy, cyclophosphamide, sulfasalazine, anakinra * Use of Alefacept (Amevive), Efalizumab (Raptiva), Anti-tumor necrosis factor (TNF) biologic therapies within 3 months of the first dose of study drug. Prior anti-TNF use will not be permitted if discontinued due to lack of efficacy, an adverse event, or non-compliance. * Use of interleukin (IL)-12/IL-23 within 6 months of the first dose of study drug * Participation in another clinical trial within 90 days or 5 half-lives (whichever is longer) of randomization * Laboratory abnormalities at screening: hemoglobin less than 11 g/dL, platelet count less than 125,000/mm\^3, white blood cell count less than 3,500 cells/mm\^3, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) greater than or equal to 1.5 x the upper limit of normal, any other laboratory abnormality which will prevent patient from completing the study or interfere with interpretation of study results * Patient is pregnant or breast feeding * Presence of any condition that could compromise the patient's ability to participate in the study, such as a history of substance abuse or psychiatric condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12 | Baseline and Week 12 | The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With PSSI 75% Response at Week 12 | Baseline and Week 12 | Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline. |
| Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12 | Baseline and Week 24 | Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area. |
| Patient Satisfaction With Treatment at Week 12 | 12 Weeks | This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from very dissatisfied to very satisfied) to indicate his or her level of satisfaction with the medication's control of psoriasis. |
Participant flow
Recruitment details
Participants were enrolled from 5 December 2008 through 6 January 2010
Participants by arm
| Arm | Count |
|---|---|
| Placebo BIW/Etanercept 50 mg BIW Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW. | 62 |
| Etanercept 50 mg BIW/Etanercept 50 mg QW Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week. | 62 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Weeks 13 to 24 | Adverse Event | 0 | 3 |
| Weeks 13 to 24 | Disease progression | 0 | 1 |
| Weeks 13 to 24 | Lost to Follow-up | 1 | 2 |
| Weeks 13 to 24 | Other | 0 | 1 |
| Weeks 13 to 24 | Protocol deviation | 2 | 0 |
| Weeks 13 to 24 | Withdrawal by Subject | 2 | 1 |
| Weeks 1 to 12 | Adverse Event | 0 | 1 |
| Weeks 1 to 12 | Disease progression | 3 | 0 |
| Weeks 1 to 12 | Ineligibility determined | 0 | 3 |
| Weeks 1 to 12 | Lost to Follow-up | 1 | 0 |
| Weeks 1 to 12 | Physician Decision | 1 | 0 |
| Weeks 1 to 12 | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Etanercept 50 mg BIW/Etanercept 50 mg QW | Total | Placebo BIW/Etanercept 50 mg BIW |
|---|---|---|---|
| Age, Continuous | 41.55 years STANDARD_DEVIATION 13.93 | 42.11 years STANDARD_DEVIATION 13.81 | 42.68 years STANDARD_DEVIATION 13.79 |
| Body Mass Index Group ≤ 35 kg/m^2 | 44 participants | 90 participants | 46 participants |
| Body Mass Index Group > 35 kg/m^2 | 18 participants | 34 participants | 16 participants |
| Race/Ethnicity, Customized Aborigine | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 11 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 8 Participants | 14 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White or Caucasian | 43 Participants | 90 Participants | 47 Participants |
| Sex: Female, Male Female | 29 Participants | 55 Participants | 26 Participants |
| Sex: Female, Male Male | 33 Participants | 69 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 62 | 27 / 59 |
| serious Total, serious adverse events | 1 / 62 | 2 / 59 |
Outcome results
Primary
Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12
The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.
Time frame: Baseline and Week 12
Population: Intention-to-Treat population (all patients who were randomized to investigational product) with available data; last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo BIW/Etanercept 50 mg BIW | Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12 | 20.4 Percent change | Standard Error 5 |
| Etanercept 50 mg BIW/Etanercept 50 mg QW | Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12 | 86.8 Percent change | Standard Error 2.3 |
p-value: <0.0001van Elteren's test
Secondary
Patient Satisfaction With Treatment at Week 12
This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from very dissatisfied to very satisfied) to indicate his or her level of satisfaction with the medication's control of psoriasis.
Time frame: 12 Weeks
Population: Intention-to-Treat with available data at week 12; last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo BIW/Etanercept 50 mg BIW | Patient Satisfaction With Treatment at Week 12 | Dissatisfied | 20 participants |
| Placebo BIW/Etanercept 50 mg BIW | Patient Satisfaction With Treatment at Week 12 | Satisfied | 5 participants |
| Placebo BIW/Etanercept 50 mg BIW | Patient Satisfaction With Treatment at Week 12 | Neither satisfied nor dissatisfied | 13 participants |
| Placebo BIW/Etanercept 50 mg BIW | Patient Satisfaction With Treatment at Week 12 | Very satisfied | 6 participants |
| Placebo BIW/Etanercept 50 mg BIW | Patient Satisfaction With Treatment at Week 12 | Very dissatisfied | 15 participants |
| Etanercept 50 mg BIW/Etanercept 50 mg QW | Patient Satisfaction With Treatment at Week 12 | Very satisfied | 27 participants |
| Etanercept 50 mg BIW/Etanercept 50 mg QW | Patient Satisfaction With Treatment at Week 12 | Very dissatisfied | 9 participants |
| Etanercept 50 mg BIW/Etanercept 50 mg QW | Patient Satisfaction With Treatment at Week 12 | Dissatisfied | 1 participants |
| Etanercept 50 mg BIW/Etanercept 50 mg QW | Patient Satisfaction With Treatment at Week 12 | Neither satisfied nor dissatisfied | 4 participants |
| Etanercept 50 mg BIW/Etanercept 50 mg QW | Patient Satisfaction With Treatment at Week 12 | Satisfied | 17 participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With PSSI 75% Response at Week 12
Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline.
Time frame: Baseline and Week 12
Population: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo BIW/Etanercept 50 mg BIW | Percentage of Participants With PSSI 75% Response at Week 12 | 11 Percentage of participants |
| Etanercept 50 mg BIW/Etanercept 50 mg QW | Percentage of Participants With PSSI 75% Response at Week 12 | 86 Percentage of participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12
Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area.
Time frame: Baseline and Week 24
Population: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo BIW/Etanercept 50 mg BIW | Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12 | 79.1 Percent change | Standard Error 4.3 |
Comparison: Comparison of week 24 outcome to week 12 outcome (see Outcome Measure 1)p-value: <0.00012-sided pairwise van Elteren's test