Skip to content

Study to Evaluate the Efficacy of Enbrel as a Biological Treatment in Moderate to Severe Plaque Psoriasis Patients

Efficacy of Etanercept in Iraqi Patients With Moderate to Severe Psoriasis: 5 Years Data From Local Registry.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04398732
Enrollment
486
Registered
2020-05-21
Start date
2020-07-05
Completion date
2020-10-01
Last updated
2021-11-01

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 Iraqi patients with moderate to severe psoriasis on Enbrel treatment with regards to efficacy, treatment regimen adherence and patient characterization (i.e. age, gender, smoking status) using data from the Dermatologists in Baghdad Teaching Hospital registry

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

* Confirmed diagnosis of moderate to severe plaque psoriasis receiving etanercept treatment for a minimum duration of 1 year. * Age ≥18 years old. * No history of using a biological treatment, other than etanercept, for treatment of moderate to severe plaque psoriasis or any other reason.

Exclusion criteria

* Etanercept use for treatment moderate to severe plaque psoriasis less than 1 year duration. * Previous use of other biological treatments for any reason

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 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.
Change From Baseline in Percent Body Surface Area (BSA) at Month 12Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 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.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 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.

Secondary

MeasureTime frameDescription
Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 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 in DLQI score between participants adherent and not adherent to treatment at Baseline, Month 4 and 12.
Percent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 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 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. % BSA for body region=total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for 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 in % BSA between participants adherent and not adherent to treatment at Baseline, Month 4 and 12.
Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 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 in PASI score between participants adherent and not adherent to treatment at Baseline, Month 4 and 12.

Other

MeasureTime frameDescription
Change From Baseline in Percent Body Surface Area (BSA) at Month 4Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 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.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 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.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 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.

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 for treatment of moderate to severe plaque psoriasis at dermatology center in the Baghdad teaching hospital were included in the study. Available data of maximum 5 years were evaluated in approximately 2.8 months of this retrospective, observational study.

Participants by arm

ArmCount
Etanercept
Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world 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 for approximately 2.8 months in this study.
486
Total486

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyParticipants Who Did Not Meet Entrance Criteria50

Baseline characteristics

CharacteristicEtanercept
Age, Continuous32.5 years
STANDARD_DEVIATION 10.6
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
240 Participants
Sex: Female, Male
Male
246 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

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.

Time frame: Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)

Population: Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
EtanerceptChange From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12-17.2 units on a scaleStandard Deviation 5.632051136
Comparison: Statistical analysis was performed on change from baseline in DLQI at Month 12.p-value: 0.0001Student's t-test
Primary

Change From Baseline in Percent Body Surface Area (BSA) 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 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.

Time frame: Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)

Population: Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
EtanerceptChange From Baseline in Percent Body Surface Area (BSA) at Month 12-21 Percent BSAStandard Deviation 17.12191578
Comparison: Statistical analysis was performed on change from Baseline in percent BSA at Month 12.p-value: 0.0001Student's t-test
Primary

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.

Time frame: Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)

Population: Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
EtanerceptChange From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12-16.44 units on a scaleStandard Deviation 9.062008607
Comparison: Statistical analysis was performed on change from baseline in PASI at Month 12.p-value: 0.0001Student's t-test
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 in DLQI score between participants adherent and not adherent to treatment at Baseline, Month 4 and 12.

Time frame: Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)

Population: Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, Number Analyzed signifies participants evaluable at specific time points.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptDermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline24.50 units on a scaleStandard Deviation 4.438
EtanerceptDermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 416.6 units on a scaleStandard Deviation 6.3
EtanerceptDermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 126.6 units on a scaleStandard Deviation 4.5
Etanercept: Participants Not Adherent to TreatmentDermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline24.94 units on a scaleStandard Deviation 2.838
Etanercept: Participants Not Adherent to TreatmentDermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 421.1 units on a scaleStandard Deviation 6.8
Etanercept: Participants Not Adherent to TreatmentDermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 1211.3 units on a scaleStandard Deviation 7.2
Comparison: Baselinep-value: 0.42Student's t-test
Comparison: Month 4p-value: 0.0001Student's t-test
Comparison: Month 12p-value: 0.0001Student's t-test
Secondary

Percent Body Surface Area (BSA) 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 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. % BSA for body region=total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for 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 in % BSA between participants adherent and not adherent to treatment at Baseline, Month 4 and 12.

Time frame: Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)

Population: Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, Number Analyzed signifies participants evaluable at specific time points.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPercent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline27.56 Percent BSAStandard Deviation 19.03
EtanerceptPercent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 420.1 Percent BSAStandard Deviation 11.7
EtanerceptPercent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 128.7 Percent BSAStandard Deviation 6.8
Etanercept: Participants Not Adherent to TreatmentPercent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline32.84 Percent BSAStandard Deviation 21.324
Etanercept: Participants Not Adherent to TreatmentPercent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 431.7 Percent BSAStandard Deviation 21.8
Etanercept: Participants Not Adherent to TreatmentPercent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 1211.1 Percent BSAStandard Deviation 8.9
Comparison: Baselinep-value: 0.036Student's t-test
Comparison: Month 4p-value: 0.0001Student's t-test
Comparison: Month 12p-value: 0.0001Student's t-test
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 in PASI score between participants adherent and not adherent to treatment at Baseline, Month 4 and 12.

Time frame: Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)

Population: Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, Number Analyzed signifies participants evaluable at specific time points.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPsoriasis Area and Severity Index (PASI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline21.980 units on a scaleStandard Deviation 10.0055
EtanerceptPsoriasis Area and Severity Index (PASI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 414.5 units on a scaleStandard Deviation 8.8
EtanerceptPsoriasis 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 a scaleStandard Deviation 3.9
Etanercept: Participants Not Adherent to TreatmentPsoriasis Area and Severity Index (PASI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentBaseline22.458 units on a scaleStandard Deviation 12.6765
Etanercept: Participants Not Adherent to TreatmentPsoriasis Area and Severity Index (PASI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to TreatmentMonth 421.7 units on a scaleStandard Deviation 15.8
Etanercept: Participants Not Adherent to TreatmentPsoriasis 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 a scaleStandard Deviation 6.4
Comparison: Baselinep-value: 0.72Student's t-test
Comparison: Month 4p-value: 0.0001Student's t-test
Comparison: Month 12p-value: 0.0001Student's t-test
Other Pre-specified

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.

Time frame: Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)

Population: Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
EtanerceptChange From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4-7.3 units on a scaleStandard Deviation 5.70876519
Comparison: Statistical analysis was performed on change from baseline in DLQI at Month 4.p-value: 0.0001Student's t-test
Other Pre-specified

Change From Baseline in Percent Body Surface Area (BSA) 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 = 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.

Time frame: Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)

Population: Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
EtanerceptChange From Baseline in Percent Body Surface Area (BSA) at Month 4-6.8 Percent BSAStandard Deviation 17.39310208
Comparison: Statistical analysis was performed on change from Baseline in percent BSA at Month 4.p-value: 0.0001Student's t-test
Other Pre-specified

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.

Time frame: Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)

Population: Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
EtanerceptChange From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4-6.64 units on a scaleStandard Deviation 10.35036231
Comparison: Statistical analysis was performed on change from baseline in PASI at Month 4.p-value: 0.0001Student's t-test

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