Plaque Psoriasis
Conditions
Brief summary
This study is to evaluate available local data in Iraq patients with moderate-to-severe plaque psoriasis on Enbrel treatment with regards to efficacy, treatment for PsO who have difficult to treat sites at presentation.
Interventions
As provided in real world practice
Sponsors
Study design
Eligibility
Inclusion criteria
* Moderate-to-severe plaque psoriasis patients whom have been receiving etanercept for at least 1 year duration. * Have difficult to treat sites at presentation. * Age ≥18 years. * No history of using other biological treatments, other than etanercept for the treatment of moderate-to-severe PsO.
Exclusion criteria
* Etanercept use for treatment of moderate-to-severe PsO less than 1 year duration. * Previous use of another biological treatment for treatment of moderate-to-severe PsO.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit | Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study) | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites. |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit | Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study) | DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites. |
| Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4 | Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study) | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites. |
| Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12 | Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study) | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites. |
| Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4 | Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study) | Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites. |
| Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12 | Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study) | Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites. |
| Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit | Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study) | Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites. |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4 | Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study) | DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites. |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12 | Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study) | DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment | Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study) | DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants adherent and not adherent to treatment. |
| Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study) | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment. |
| Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study) | Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment. |
Countries
Iraq
Participant flow
Recruitment details
Data of Iraq's participants aged greater than or equal to (\>=) 18 years, who received etanercept for at least 1 year (from August 2015 to April 2020) for treatment of moderate to severe psoriasis were included in the study. Data source was the local registry at dermatology center of Baghdad teaching hospital. Available data were evaluated for approximately 1.8 months for this retrospective, observational study.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept \[Enbrel\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied in this observational study. | 486 |
| Total | 486 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 114 |
Baseline characteristics
| Characteristic | Etanercept | — |
|---|---|---|
| Age, Continuous | 32.5 Years STANDARD_DEVIATION 10.6 | — |
| Disease duration | 10.6 Years STANDARD_DEVIATION 6.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 246 Participants | — |
| Sex: Female, Male Male | 240 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit
DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
Time frame: Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)
Population: Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept: Participants With Difficult to Treat Sites | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit | -17.49 Units on a scale | Standard Deviation 6.204 |
| Etanercept: Participants Without Difficult to Treat Sites | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit | -19.39 Units on a scale | Standard Deviation 4.604 |
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12
DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
Time frame: Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
Population: Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept: Participants With Difficult to Treat Sites | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12 | -15.66 Units on a scale | Standard Deviation 6.299 |
| Etanercept: Participants Without Difficult to Treat Sites | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12 | -17.39 Units on a scale | Standard Deviation 5.442 |
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4
DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
Time frame: Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
Population: Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, Number Analyzed signifies participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Participants With Difficult to Treat Sites | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4 | Baseline | 24.6 Units on a scale | Standard Deviation 4.303 |
| Etanercept: Participants With Difficult to Treat Sites | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4 | Change at Month 4 | -5.75 Units on a scale | Standard Deviation 5.306 |
| Etanercept: Participants Without Difficult to Treat Sites | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4 | Baseline | 24.42 Units on a scale | Standard Deviation 4.014 |
| Etanercept: Participants Without Difficult to Treat Sites | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4 | Change at Month 4 | -7.56 Units on a scale | Standard Deviation 5.797 |
Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit
Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
Time frame: Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)
Population: Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept: Participants With Difficult to Treat Sites | Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit | -23.78 Percent BSA | Standard Deviation 17.799 |
| Etanercept: Participants Without Difficult to Treat Sites | Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit | -24.4 Percent BSA | Standard Deviation 16.876 |
Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12
Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
Time frame: Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
Population: Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept: Participants With Difficult to Treat Sites | Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12 | -19.13 Percent BSA | Standard Deviation 17.451 |
| Etanercept: Participants Without Difficult to Treat Sites | Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12 | -18.93 Percent BSA | Standard Deviation 16.555 |
Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4
Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
Time frame: Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
Population: Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, Number Analyzed signifies participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Participants With Difficult to Treat Sites | Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4 | Baseline | 28.1 Percent BSA | Standard Deviation 19.603 |
| Etanercept: Participants With Difficult to Treat Sites | Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4 | Change at Month 4 | -6.79 Percent BSA | Standard Deviation 17.472 |
| Etanercept: Participants Without Difficult to Treat Sites | Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4 | Baseline | 29.21 Percent BSA | Standard Deviation 18.757 |
| Etanercept: Participants Without Difficult to Treat Sites | Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4 | Change at Month 4 | -6.38 Percent BSA | Standard Deviation 17.012 |
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
Time frame: Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)
Population: Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept: Participants With Difficult to Treat Sites | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit | -19.79 Units on scale | Standard Deviation 7.922 |
| Etanercept: Participants Without Difficult to Treat Sites | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit | -18.42 Units on scale | Standard Deviation 9.472 |
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
Time frame: Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
Population: Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept: Participants With Difficult to Treat Sites | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12 | -17.68 Units on a scale | Standard Deviation 7.934 |
| Etanercept: Participants Without Difficult to Treat Sites | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12 | -16.16 Units on a scale | Standard Deviation 9.334 |
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
Time frame: Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
Population: Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, Number Analyzed signifies participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Participants With Difficult to Treat Sites | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4 | Baseline | 24.68 Units on a scale | Standard Deviation 9.023 |
| Etanercept: Participants With Difficult to Treat Sites | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4 | Change at Month 4 | -8.22 Units on a scale | Standard Deviation 9.224 |
| Etanercept: Participants Without Difficult to Treat Sites | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4 | Baseline | 21.46 Units on a scale | Standard Deviation 10.621 |
| Etanercept: Participants Without Difficult to Treat Sites | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4 | Change at Month 4 | -6.22 Units on a scale | Standard Deviation 10.572 |
Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment
DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.
Time frame: Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
Population: Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, Number Analyzed signifies participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Participants With Difficult to Treat Sites | Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment | Baseline | 24.50 Units on scale | Standard Deviation 4.438 |
| Etanercept: Participants With Difficult to Treat Sites | Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment | Month 4 | 16.63 Units on scale | Standard Deviation 6.303 |
| Etanercept: Participants With Difficult to Treat Sites | Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment | Month 12 | 6.6 Units on scale | Standard Deviation 4.5 |
| Etanercept: Participants Without Difficult to Treat Sites | Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment | Baseline | 24.94 Units on scale | Standard Deviation 2.838 |
| Etanercept: Participants Without Difficult to Treat Sites | Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment | Month 4 | 21.19 Units on scale | Standard Deviation 6.886 |
| Etanercept: Participants Without Difficult to Treat Sites | Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment | Month 12 | 11.3 Units on scale | Standard Deviation 7.2 |
Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment
Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.
Time frame: Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
Population: Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, Number Analyzed signifies participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Participants With Difficult to Treat Sites | Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Baseline | 27.56 Percent BSA | Standard Deviation 19.03 |
| Etanercept: Participants With Difficult to Treat Sites | Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Month 4 | 20.06 Percent BSA | Standard Deviation 11.706 |
| Etanercept: Participants With Difficult to Treat Sites | Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Month 12 | 8.7 Percent BSA | Standard Deviation 6.8 |
| Etanercept: Participants Without Difficult to Treat Sites | Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Baseline | 32.84 Percent BSA | Standard Deviation 21.324 |
| Etanercept: Participants Without Difficult to Treat Sites | Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Month 4 | 31.74 Percent BSA | Standard Deviation 21.892 |
| Etanercept: Participants Without Difficult to Treat Sites | Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Month 12 | 11.1 Percent BSA | Standard Deviation 8.9 |
Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.
Time frame: Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
Population: Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, Number Analyzed signifies participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Participants With Difficult to Treat Sites | Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Baseline | 21.980 Units on scale | Standard Deviation 10.0055 |
| Etanercept: Participants With Difficult to Treat Sites | Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Month 4 | 14.520 Units on scale | Standard Deviation 8.8686 |
| Etanercept: Participants With Difficult to Treat Sites | Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Month 12 | 4.8 Units on scale | Standard Deviation 3.9 |
| Etanercept: Participants Without Difficult to Treat Sites | Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Baseline | 22.458 Units on scale | Standard Deviation 12.6765 |
| Etanercept: Participants Without Difficult to Treat Sites | Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Month 4 | 21.717 Units on scale | Standard Deviation 15.8263 |
| Etanercept: Participants Without Difficult to Treat Sites | Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Month 12 | 9.7 Units on scale | Standard Deviation 6.4 |