Trial Outcomes & Findings for Study To Evaluate The Impact Of Difficult To Treat Sites On Biological Response In Moderate-To-Severe Plaque Psoriasis(PsO). (NCT NCT04428411)
NCT ID: NCT04428411
Last Updated: 2021-10-25
Results Overview
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.
COMPLETED
486 participants
Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
2021-10-25
Participant Flow
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.
Participant milestones
| Measure |
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 milligrams \[mg\] 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.
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|---|---|
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Overall Study
STARTED
|
486
|
|
Overall Study
Participants With Difficult to Treat Sites
|
397
|
|
Overall Study
Participants Without Difficulty to Treat Sites
|
89
|
|
Overall Study
Participants Adherent to Treatment
|
417
|
|
Overall Study
Participants Not Adherent to Treatment
|
69
|
|
Overall Study
COMPLETED
|
372
|
|
Overall Study
NOT COMPLETED
|
114
|
Reasons for withdrawal
| Measure |
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 milligrams \[mg\] 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.
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|---|---|
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Overall Study
Lost to Follow-up
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114
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Etanercept
n=486 Participants
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.
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|---|---|
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Age, Continuous
|
32.5 Years
STANDARD_DEVIATION 10.6 • n=486 Participants
|
|
Sex: Female, Male
Female
|
246 Participants
n=486 Participants
|
|
Sex: Female, Male
Male
|
240 Participants
n=486 Participants
|
|
Disease duration
|
10.6 Years
STANDARD_DEVIATION 6.4 • n=486 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Difficult to Treat Sites
n=397 Participants
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) and had sites difficult to treat.
|
Etanercept: Participants Without Difficult to Treat Sites
n=89 Participants
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) and did not have sites difficult to treat.
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|---|---|---|
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Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4
Baseline
|
28.1 Percent BSA
Standard Deviation 19.603
|
29.21 Percent BSA
Standard Deviation 18.757
|
|
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
|
-6.38 Percent BSA
Standard Deviation 17.012
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Difficult to Treat Sites
n=344 Participants
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) and had sites difficult to treat.
|
Etanercept: Participants Without Difficult to Treat Sites
n=78 Participants
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) and did not have sites difficult to treat.
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|---|---|---|
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Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12
|
-19.13 Percent BSA
Standard Deviation 17.451
|
-18.93 Percent BSA
Standard Deviation 16.555
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Difficult to Treat Sites
n=300 Participants
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) and had sites difficult to treat.
|
Etanercept: Participants Without Difficult to Treat Sites
n=72 Participants
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) and did not have sites difficult to treat.
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|---|---|---|
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Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit
|
-23.78 Percent BSA
Standard Deviation 17.799
|
-24.4 Percent BSA
Standard Deviation 16.876
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Difficult to Treat Sites
n=397 Participants
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) and had sites difficult to treat.
|
Etanercept: Participants Without Difficult to Treat Sites
n=89 Participants
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) and did not have sites difficult to treat.
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|---|---|---|
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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
|
24.42 Units on a scale
Standard Deviation 4.014
|
|
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
|
-7.56 Units on a scale
Standard Deviation 5.797
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Difficult to Treat Sites
n=344 Participants
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) and had sites difficult to treat.
|
Etanercept: Participants Without Difficult to Treat Sites
n=78 Participants
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) and did not have sites difficult to treat.
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|---|---|---|
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Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12
|
-15.66 Units on a scale
Standard Deviation 6.299
|
-17.39 Units on a scale
Standard Deviation 5.442
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Difficult to Treat Sites
n=300 Participants
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) and had sites difficult to treat.
|
Etanercept: Participants Without Difficult to Treat Sites
n=72 Participants
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) and did not have sites difficult to treat.
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|---|---|---|
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Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit
|
-17.49 Units on a scale
Standard Deviation 6.204
|
-19.39 Units on a scale
Standard Deviation 4.604
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Difficult to Treat Sites
n=397 Participants
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) and had sites difficult to treat.
|
Etanercept: Participants Without Difficult to Treat Sites
n=89 Participants
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) and did not have sites difficult to treat.
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|---|---|---|
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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
|
21.46 Units on a scale
Standard Deviation 10.621
|
|
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
|
-6.22 Units on a scale
Standard Deviation 10.572
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Difficult to Treat Sites
n=344 Participants
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) and had sites difficult to treat.
|
Etanercept: Participants Without Difficult to Treat Sites
n=78 Participants
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) and did not have sites difficult to treat.
|
|---|---|---|
|
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
|
-16.16 Units on a scale
Standard Deviation 9.334
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Difficult to Treat Sites
n=300 Participants
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) and had sites difficult to treat.
|
Etanercept: Participants Without Difficult to Treat Sites
n=72 Participants
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) and did not have sites difficult to treat.
|
|---|---|---|
|
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit
|
-19.79 Units on scale
Standard Deviation 7.922
|
-18.42 Units on scale
Standard Deviation 9.472
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Difficult to Treat Sites
n=417 Participants
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) and had sites difficult to treat.
|
Etanercept: Participants Without Difficult to Treat Sites
n=69 Participants
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) and did not have sites difficult to treat.
|
|---|---|---|
|
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 19.030
|
32.84 Percent BSA
Standard Deviation 21.324
|
|
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
|
31.74 Percent BSA
Standard Deviation 21.892
|
|
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
|
11.1 Percent BSA
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Difficult to Treat Sites
n=417 Participants
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) and had sites difficult to treat.
|
Etanercept: Participants Without Difficult to Treat Sites
n=69 Participants
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) and did not have sites difficult to treat.
|
|---|---|---|
|
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
|
24.94 Units on scale
Standard Deviation 2.838
|
|
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
|
21.19 Units on scale
Standard Deviation 6.886
|
|
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
|
11.3 Units on scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Difficult to Treat Sites
n=417 Participants
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) and had sites difficult to treat.
|
Etanercept: Participants Without Difficult to Treat Sites
n=69 Participants
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) and did not have sites difficult to treat.
|
|---|---|---|
|
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
|
22.458 Units on scale
Standard Deviation 12.6765
|
|
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
|
21.717 Units on scale
Standard Deviation 15.8263
|
|
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
|
9.7 Units on scale
Standard Deviation 6.4
|
Adverse Events
Etanercept
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER