Trial Outcomes & Findings for Greek Study of the Quality of Life in Patients With Psoriasis Treated With Adalimumab (NCT NCT01077128)
NCT ID: NCT01077128
Last Updated: 2014-02-21
Results Overview
DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
Recruitment status
COMPLETED
Target enrollment
500 participants
Primary outcome timeframe
12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)
Results posted on
2014-02-21
Participant Flow
Participant milestones
| Measure |
Patients With Psoriasis
All eligible patients with psoriasis treated with Adalimumab
|
|---|---|
|
Overall Study
STARTED
|
500
|
|
Overall Study
COMPLETED
|
433
|
|
Overall Study
NOT COMPLETED
|
67
|
Reasons for withdrawal
| Measure |
Patients With Psoriasis
All eligible patients with psoriasis treated with Adalimumab
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Disease exacerbation
|
1
|
|
Overall Study
Adverse event and consent withdrawal
|
1
|
|
Overall Study
Adverse event and disease exacerbation
|
1
|
|
Overall Study
Lack of efficacy/disease exacerbation
|
1
|
|
Overall Study
Other
|
54
|
Baseline Characteristics
Greek Study of the Quality of Life in Patients With Psoriasis Treated With Adalimumab
Baseline characteristics by cohort
| Measure |
Patients With Psoriasis
n=500 Participants
All eligible patients with psoriasis treated with Adalimumab
|
|---|---|
|
Age, Customized
>=18 years
|
500 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
190 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
310 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
500 participants
n=5 Participants
|
|
Regions of Greece
Attica
|
266 Participants
n=5 Participants
|
|
Regions of Greece
Central Macedonia
|
71 Participants
n=5 Participants
|
|
Regions of Greece
Crete
|
41 Participants
n=5 Participants
|
|
Regions of Greece
West Greece
|
33 Participants
n=5 Participants
|
|
Regions of Greece
East Macedonia and Thrace
|
20 Participants
n=5 Participants
|
|
Regions of Greece
Thessaly
|
18 Participants
n=5 Participants
|
|
Regions of Greece
Central Greece
|
16 Participants
n=5 Participants
|
|
Regions of Greece
Peloponnese
|
16 Participants
n=5 Participants
|
|
Regions of Greece
North Aegean
|
8 Participants
n=5 Participants
|
|
Regions of Greece
Ionian Islands
|
4 Participants
n=5 Participants
|
|
Regions of Greece
West Macedonia
|
3 Participants
n=5 Participants
|
|
Regions of Greece
South Aegean
|
2 Participants
n=5 Participants
|
|
Regions of Greece
Epirus
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)Population: Participants with available data at each time point
DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
Outcome measures
| Measure |
Patients With Psoriasis- Month 1
n=491 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 4
n=467 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 8
n=443 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 12
n=432 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Attica
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Central Greece
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Central Macedonia
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Crete
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- East Macedonia/Thrace
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Epirus
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Ionian Islands
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- North Aegean
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Peloponnese
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- South Aegean
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Thessaly
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- West Greece
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- West Macedonia
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 4
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 8
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 12
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Baseline
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 1
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 4
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 8
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 12
All eligible patients with psoriasis treated with Adalimumab
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change of Dermatology Life Quality Index (DLQI) Scores
|
4.9 units on a scale
Standard Deviation 6.3
|
9.3 units on a scale
Standard Deviation 7.3
|
11.3 units on a scale
Standard Deviation 7.8
|
12.1 units on a scale
Standard Deviation 7.8
|
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SECONDARY outcome
Timeframe: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)Population: Participants with available data at each time point
The Physician's Global Assessment of disease severity (PGA) was used to measure participants' disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores was recorded.
Outcome measures
| Measure |
Patients With Psoriasis- Month 1
n=491 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 4
n=470 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 8
n=445 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 12
n=433 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Attica
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Central Greece
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Central Macedonia
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Crete
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- East Macedonia/Thrace
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Epirus
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Ionian Islands
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- North Aegean
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Peloponnese
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- South Aegean
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Thessaly
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- West Greece
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- West Macedonia
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 4
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 8
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 12
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Baseline
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 1
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 4
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 8
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 12
All eligible patients with psoriasis treated with Adalimumab
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores
|
66.2 Percentage of patients improving
|
95.1 Percentage of patients improving
|
97.5 Percentage of patients improving
|
97.9 Percentage of patients improving
|
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SECONDARY outcome
Timeframe: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)Population: Participants with available data at each time point
The average change in the Dermatology Life Quality Index (DLQI) score during the 12-month study was analyzed by the Physician's Global Assessment of disease severity (PGA) response and also by geographical location of study participants. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life. . In this table, a higher number means a greater improvement in the participants' quality of life.
Outcome measures
| Measure |
Patients With Psoriasis- Month 1
n=325 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 4
n=444 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 8
n=433 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 12
n=423 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Attica
n=237 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Central Greece
n=16 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Central Macedonia
n=65 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Crete
n=34 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- East Macedonia/Thrace
n=20 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Epirus
n=2 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Ionian Islands
n=1 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- North Aegean
n=7 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Peloponnese
n=10 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- South Aegean
n=2 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Thessaly
n=15 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- West Greece
n=21 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- West Macedonia
n=2 Participants
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 4
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 8
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 12
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Baseline
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 1
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 4
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 8
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 12
All eligible patients with psoriasis treated with Adalimumab
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change in the Dermatology Life Quality Index (DLQI) Score by Physician's Global Assessment of Disease Severity (PGA) Response Groups and by Geographical Region
|
6.3 units on a scale
Standard Deviation 6.5
|
9.6 units on a scale
Standard Deviation 7.1
|
11.5 units on a scale
Standard Deviation 7.7
|
12.3 units on a scale
Standard Deviation 7.8
|
12.9 units on a scale
Standard Deviation 8.5
|
14.9 units on a scale
Standard Deviation 7.2
|
12.3 units on a scale
Standard Deviation 6.4
|
11.2 units on a scale
Standard Deviation 6.7
|
10.6 units on a scale
Standard Deviation 6.1
|
2.0 units on a scale
Standard Deviation 0.0
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19.0 units on a scale
|
11.0 units on a scale
Standard Deviation 7.7
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6.8 units on a scale
Standard Deviation 4.7
|
15.0 units on a scale
Standard Deviation 4.2
|
9.5 units on a scale
Standard Deviation 7.7
|
8.7 units on a scale
Standard Deviation 7.2
|
12.5 units on a scale
Standard Deviation 2.1
|
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)Population: Participants with available data at each time point
EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome. It has two components: 1. the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and 2. the EQ-5D VAS. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either "problem" or "no problem" with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively.
Outcome measures
| Measure |
Patients With Psoriasis- Month 1
n=500 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 4
n=491 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 8
n=469 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 12
n=445 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Attica
n=433 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Central Greece
n=500 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Central Macedonia
n=491 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Crete
n=469 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- East Macedonia/Thrace
n=445 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Epirus
n=432 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Ionian Islands
n=500 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- North Aegean
n=491 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Peloponnese
n=468 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- South Aegean
n=445 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Thessaly
n=433 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- West Greece
n=500 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- West Macedonia
n=491 Participants
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 4
n=469 Participants
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 8
n=445 Participants
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 12
n=431 Participants
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Baseline
n=500 Participants
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 1
n=491 Participants
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 4
n=467 Participants
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 8
n=445 Participants
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 12
n=433 Participants
All eligible patients with psoriasis treated with Adalimumab
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Reporting "No Problem" on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)
|
74.6 Percentage of patients with no problem
|
66.2 Percentage of patients with no problem
|
90.2 Percentage of patients with no problem
|
91.5 Percentage of patients with no problem
|
90.8 Percentage of patients with no problem
|
81.2 Percentage of patients with no problem
|
84.3 Percentage of patients with no problem
|
92.1 Percentage of patients with no problem
|
95.3 Percentage of patients with no problem
|
94.2 Percentage of patients with no problem
|
66.2 Percentage of patients with no problem
|
77.8 Percentage of patients with no problem
|
90.2 Percentage of patients with no problem
|
92.1 Percentage of patients with no problem
|
94.5 Percentage of patients with no problem
|
56.2 Percentage of patients with no problem
|
73.1 Percentage of patients with no problem
|
87.2 Percentage of patients with no problem
|
90.3 Percentage of patients with no problem
|
93.3 Percentage of patients with no problem
|
20.8 Percentage of patients with no problem
|
36.9 Percentage of patients with no problem
|
53.7 Percentage of patients with no problem
|
67.6 Percentage of patients with no problem
|
73.0 Percentage of patients with no problem
|
SECONDARY outcome
Timeframe: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)Population: Participants with available data at each time point
EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome. It has two components: 1. the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and 2. the EQ-5D VAS. EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either "problem" or "no problem" with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively.
Outcome measures
| Measure |
Patients With Psoriasis- Month 1
n=491 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 4
n=470 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 8
n=445 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 12
n=433 Participants
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Attica
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Central Greece
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Central Macedonia
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Crete
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- East Macedonia/Thrace
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Epirus
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Ionian Islands
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- North Aegean
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Peloponnese
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- South Aegean
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Thessaly
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- West Greece
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- West Macedonia
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 4
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 8
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 12
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Baseline
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 1
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 4
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 8
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Anxiety/Depression- Month 12
All eligible patients with psoriasis treated with Adalimumab
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores
|
12.5 units on a scale
Standard Deviation 15.8
|
25.9 units on a scale
Standard Deviation 20.5
|
31.8 units on a scale
Standard Deviation 23.3
|
35.9 units on a scale
Standard Deviation 22.4
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SECONDARY outcome
Timeframe: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)An adverse event (AE) was defined as any untoward medical occurrence in a participant, which did not necessarily have a causal relationship with their treatment. Any worsening of a pre-existing condition or illness was considered an adverse event.
Outcome measures
| Measure |
Patients With Psoriasis- Month 1
n=500 Participants
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 4
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 8
All eligible patients with psoriasis treated with Adalimumab
|
Patients With Psoriasis- Month 12
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Attica
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Central Greece
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Central Macedonia
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Crete
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- East Macedonia/Thrace
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Epirus
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Ionian Islands
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- North Aegean
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Peloponnese
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- South Aegean
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- Thessaly
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- West Greece
All eligible patients with psoriasis treated with Adalimumab
|
DLQI Score Change Baseline to Month 12- West Macedonia
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 4
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 8
All eligible patients with psoriasis treated with Adalimumab
|
EQ5D- Pain/Discomfort- Month 12
All eligible patients with psoriasis treated with Adalimumab
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EQ5D- Anxiety/Depression- Baseline
All eligible patients with psoriasis treated with Adalimumab
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EQ5D- Anxiety/Depression- Month 1
All eligible patients with psoriasis treated with Adalimumab
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EQ5D- Anxiety/Depression- Month 4
All eligible patients with psoriasis treated with Adalimumab
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EQ5D- Anxiety/Depression- Month 8
All eligible patients with psoriasis treated with Adalimumab
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EQ5D- Anxiety/Depression- Month 12
All eligible patients with psoriasis treated with Adalimumab
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Assessment of Long Term Use and Safety of Adalimumab as Prescribed by the Dermatologist in a Normal Clinical Setting and in Accordance With the Terms of the European Marketing Authorization
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500 Participants
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Adverse Events
Patients With Psoriasis
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients With Psoriasis
n=500 participants at risk
All eligible patients with psoriasis treated with Adalimumab
|
|---|---|
|
Nervous system disorders
Dysarthria
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Nervous system disorders
Extradural haematoma
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Nervous system disorders
Hypoaesthesia
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Nervous system disorders
Paraplegia
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Nervous system disorders
Paresis
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Nervous system disorders
Spinal cord ischaemia
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Nervous system disorders
Spinal haematoma
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.40%
2/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
General disorders
Asthenia
|
0.40%
2/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
General disorders
Pyrexia
|
0.40%
2/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
General disorders
Chills
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
General disorders
Fatigue
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
General disorders
Oedema, peripheral
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Musculoskeletal and connective tissue disorders
Muscle contractions involuntary
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Vascular disorders
Ischaemic stroke
|
0.40%
2/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Vascular disorders
Transient ischaemic attack
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Endocrine disorders
Thyroiditis acute
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Investigations
Electromyogram abnormal
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
|
Surgical and medical procedures
Abortion induced
|
0.20%
1/500 • Data on adverse events were collected from study enrollment (Month 0) through Month 12.
|
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER