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Study To Evaluate The Impact Of Difficult To Treat Sites On Biological Response In Moderate-To-Severe Plaque Psoriasis(PsO).

The Impact of Difficult to Treat Sites on Biological Treatment Response in Patients With Moderate-to-Severe Plaque Psoriasis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04428411
Enrollment
486
Registered
2020-06-11
Start date
2020-07-05
Completion date
2020-08-30
Last updated
2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

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

DRUGEnbrel

As provided in real world practice

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last VisitBaseline (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 VisitBaseline (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 4Baseline (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 12Baseline (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 4Baseline (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 12Baseline (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 VisitBaseline (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 4Baseline (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 12Baseline (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

MeasureTime frameDescription
Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline (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 TreatmentBaseline (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 TreatmentBaseline (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

ArmCount
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
Total486

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up114

Baseline characteristics

CharacteristicEtanercept
Age, Continuous32.5 Years
STANDARD_DEVIATION 10.6
Disease duration10.6 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 typeEG000
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

Primary

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.

ArmMeasureValue (MEAN)Dispersion
Etanercept: Participants With Difficult to Treat SitesMean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit-17.49 Units on a scaleStandard Deviation 6.204
Etanercept: Participants Without Difficult to Treat SitesMean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit-19.39 Units on a scaleStandard Deviation 4.604
p-value: 0.09t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Etanercept: Participants With Difficult to Treat SitesMean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12-15.66 Units on a scaleStandard Deviation 6.299
Etanercept: Participants Without Difficult to Treat SitesMean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12-17.39 Units on a scaleStandard Deviation 5.442
p-value: 0.02t-test, 2 sided
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Etanercept: Participants With Difficult to Treat SitesMean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4Baseline24.6 Units on a scaleStandard Deviation 4.303
Etanercept: Participants With Difficult to Treat SitesMean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4Change at Month 4-5.75 Units on a scaleStandard Deviation 5.306
Etanercept: Participants Without Difficult to Treat SitesMean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4Baseline24.42 Units on a scaleStandard Deviation 4.014
Etanercept: Participants Without Difficult to Treat SitesMean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4Change at Month 4-7.56 Units on a scaleStandard Deviation 5.797
p-value: 0.01t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Etanercept: Participants With Difficult to Treat SitesMean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit-23.78 Percent BSAStandard Deviation 17.799
Etanercept: Participants Without Difficult to Treat SitesMean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit-24.4 Percent BSAStandard Deviation 16.876
p-value: 0.41t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Etanercept: Participants With Difficult to Treat SitesMean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12-19.13 Percent BSAStandard Deviation 17.451
Etanercept: Participants Without Difficult to Treat SitesMean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12-18.93 Percent BSAStandard Deviation 16.555
p-value: 0.07t-test, 2 sided
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Etanercept: Participants With Difficult to Treat SitesMean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4Baseline28.1 Percent BSAStandard Deviation 19.603
Etanercept: Participants With Difficult to Treat SitesMean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4Change at Month 4-6.79 Percent BSAStandard Deviation 17.472
Etanercept: Participants Without Difficult to Treat SitesMean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4Baseline29.21 Percent BSAStandard Deviation 18.757
Etanercept: Participants Without Difficult to Treat SitesMean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4Change at Month 4-6.38 Percent BSAStandard Deviation 17.012
p-value: 0.35t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Etanercept: Participants With Difficult to Treat SitesMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit-19.79 Units on scaleStandard Deviation 7.922
Etanercept: Participants Without Difficult to Treat SitesMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit-18.42 Units on scaleStandard Deviation 9.472
p-value: <0.05t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Etanercept: Participants With Difficult to Treat SitesMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12-17.68 Units on a scaleStandard Deviation 7.934
Etanercept: Participants Without Difficult to Treat SitesMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12-16.16 Units on a scaleStandard Deviation 9.334
p-value: <0.05t-test, 2 sided
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Etanercept: Participants With Difficult to Treat SitesMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4Baseline24.68 Units on a scaleStandard Deviation 9.023
Etanercept: Participants With Difficult to Treat SitesMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4Change at Month 4-8.22 Units on a scaleStandard Deviation 9.224
Etanercept: Participants Without Difficult to Treat SitesMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4Baseline21.46 Units on a scaleStandard Deviation 10.621
Etanercept: Participants Without Difficult to Treat SitesMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4Change at Month 4-6.22 Units on a scaleStandard Deviation 10.572
p-value: 0.31t-test, 2 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Etanercept: Participants With Difficult to Treat SitesDermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline24.50 Units on scaleStandard Deviation 4.438
Etanercept: Participants With Difficult to Treat SitesDermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 416.63 Units on scaleStandard Deviation 6.303
Etanercept: Participants With Difficult to Treat SitesDermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 126.6 Units on scaleStandard Deviation 4.5
Etanercept: Participants Without Difficult to Treat SitesDermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline24.94 Units on scaleStandard Deviation 2.838
Etanercept: Participants Without Difficult to Treat SitesDermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 421.19 Units on scaleStandard Deviation 6.886
Etanercept: Participants Without Difficult to Treat SitesDermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 1211.3 Units on scaleStandard Deviation 7.2
Comparison: Comparison between Baseline and Month 4p-value: 0.0001t-test, 2 sided
Comparison: Comparison between Baseline and Month 12p-value: 0.0001t-test, 2 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Etanercept: Participants With Difficult to Treat SitesPercent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline27.56 Percent BSAStandard Deviation 19.03
Etanercept: Participants With Difficult to Treat SitesPercent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 420.06 Percent BSAStandard Deviation 11.706
Etanercept: Participants With Difficult to Treat SitesPercent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 128.7 Percent BSAStandard Deviation 6.8
Etanercept: Participants Without Difficult to Treat SitesPercent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline32.84 Percent BSAStandard Deviation 21.324
Etanercept: Participants Without Difficult to Treat SitesPercent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 431.74 Percent BSAStandard Deviation 21.892
Etanercept: Participants Without Difficult to Treat SitesPercent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 1211.1 Percent BSAStandard Deviation 8.9
Comparison: Comparison between Baseline and Month 4p-value: 0.0001t-test, 2 sided
Comparison: Comparison between Baseline and Month 12p-value: 0.0001t-test, 2 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Etanercept: Participants With Difficult to Treat SitesPsoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline21.980 Units on scaleStandard Deviation 10.0055
Etanercept: Participants With Difficult to Treat SitesPsoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 414.520 Units on scaleStandard Deviation 8.8686
Etanercept: Participants With Difficult to Treat SitesPsoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 124.8 Units on scaleStandard Deviation 3.9
Etanercept: Participants Without Difficult to Treat SitesPsoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline22.458 Units on scaleStandard Deviation 12.6765
Etanercept: Participants Without Difficult to Treat SitesPsoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 421.717 Units on scaleStandard Deviation 15.8263
Etanercept: Participants Without Difficult to Treat SitesPsoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 129.7 Units on scaleStandard Deviation 6.4
Comparison: Comparison between Baseline and Month 4p-value: 0.0001t-test, 2 sided
Comparison: Comparison between Baseline and Month 12p-value: 0.0001t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026