Psoriasis
Conditions
Keywords
Psoriasis, Quality of life
Brief summary
Primary objective * To evaluate the quality of life of Adalimumab treated patients over a period of 12 months Secondary objectives * To evaluate the long-term efficacy of Adalimumab in patients with moderate to severe chronic plaque psoriasis as prescribed by the dermatologists in day-to-day clinical practice and in accordance with the terms of the European marketing authorization. * To evaluate changes in patients quality of life according to treatment response over a 12-month period * To observe and assess the 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.
Detailed description
The aim of this post-marketing observational study in adult patients with moderate to severe chronic plaque psoriasis is to obtain further data on patient's Quality of Life and assess the impact of Adalimumab treatment on patient's quality of life in conditions of day-to-day clinical practice in Greece. This study will further assess the relationship between clinical outcomes and patient-reported outcomes. As this is an observational study, Abbott will not provide the study drug. Humira will be prescribed according to the routine medical practice. The participating physicians are free to determine the appropriate therapy for each patient and make treatment choices as deemed clinically necessary. The Dermatology Life Quality Index (DLQI) will be used to assess patient quality of life. The Dermatology Life Quality Index (DLQI) total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The Dermatology Life Quality Index (DLQI) has well-established reliability and validity as determined in several studies. Moreover, it is frequently used in clinical trials of psoriasis. The physician's global assessment of disease severity (PGA) will be used to measure patients' disease status at the time of assessment. It is a 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). Complementary, European Quality of Life-5 Dimensions health questionnaire (EQ5D) will be used as a measure of health outcome. This is applicable to a wide range of health conditions and treatments and it provides a simple descriptive profile and a single index value for health status. Health economic data will be collected by using European Quality of Life-5 Dimensions health questionnaire (EQ5D) questionnaire and data regarding patients hospitalisation due to psoriasis. Hospitalisation data will be collected 6 months before the period and throughout the observation period. Moreover, this study will observe the current medical practice in prescribing Adalimumab in Greece and more detailed data on prescription behavior will be collected. Guidelines have been developed in order to ensure that the new class of therapy (biologic agents) is introduced in a systematic and planned way to achieve the greatest possible benefit to people with psoriasis and to facilitate safe and effective prescribing. However, many issues are not fully addressed, such as recommendation regarding the amount of time for wash out of previous antipsoriatic drugs and combination therapies. Such issues remain at the discretion of the healthcare professional. Since this is an observational study the patient will be treated in accordance with the physician's usual and customary medical practice. Thus, the following information regarding the use of Adalimumab will be collected * the previous systemic treatment history will be recorded including previous biological therapies that patient received, if any, * wash out periods prior to initiating Adalimumab therapy, if any * reasons for stopping previous treatment, * combination of Adalimumab with other topical or systemic antipsoriatic agents, if applicable Furthermore, demographic data of patients suffering from psoriasis in Greece will be collected (age, gender, ethnicity) and disease data such as duration of the disease, involvement of nails or joints, geographic distribution of the disease in Greece will be collected.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with moderate to severe chronic plaque psoriasis who are newly prescribed Humira (adalimumab) therapy (have never been treated with adalimumab before) and for whom the treating physician has made the decision that they are eligible for treatment with adalimumab in accordance with the terms of the local marketing authorization * Patients with moderate to severe chronic plaque psoriasis for whom Adalimumab is indicated and has been prescribed according to the current approved local SPC as long as the first administration of adalimumab is not older than two months and they have not had dose interruptions since the initiation of adalimumab, and the Investigator can provide all the needed source documentation including a completed DLQI questionnaire at the start of Adalimumab treatment. * Patient age ≥ 18 * Patient is willing to consent to data being collected and provided to Abbott
Exclusion criteria
* Patients who meet contraindications as outlined in the latest version of the local approved SPC * Patients who participate in another clinical/observational study * Patients who are not willing to sign an Informed Consent Form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of Dermatology Life Quality Index (DLQI) Scores | 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores | 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12) | 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. |
| 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 | 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12) | 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. |
| Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12) | 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. |
| Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores | 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12) | 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. |
| 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 | 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. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Psoriasis All eligible patients with psoriasis treated with Adalimumab | 500 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Adverse event and consent withdrawal | 1 |
| Overall Study | Adverse event and disease exacerbation | 1 |
| Overall Study | Disease exacerbation | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lack of efficacy/disease exacerbation | 1 |
| Overall Study | Other | 54 |
Baseline characteristics
| Characteristic | Patients With Psoriasis |
|---|---|
| Age, Customized >=18 years | 500 participants |
| Region of Enrollment Greece | 500 participants |
| Regions of Greece Attica | 266 Participants |
| Regions of Greece Central Greece | 16 Participants |
| Regions of Greece Central Macedonia | 71 Participants |
| Regions of Greece Crete | 41 Participants |
| Regions of Greece East Macedonia and Thrace | 20 Participants |
| Regions of Greece Epirus | 2 Participants |
| Regions of Greece Ionian Islands | 4 Participants |
| Regions of Greece North Aegean | 8 Participants |
| Regions of Greece Peloponnese | 16 Participants |
| Regions of Greece South Aegean | 2 Participants |
| Regions of Greece Thessaly | 18 Participants |
| Regions of Greece West Greece | 33 Participants |
| Regions of Greece West Macedonia | 3 Participants |
| Sex: Female, Male Female | 190 Participants |
| Sex: Female, Male Male | 310 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 500 |
| serious Total, serious adverse events | 11 / 500 |
Outcome results
Primary
Mean Change of Dermatology Life Quality Index (DLQI) Scores
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.
Time frame: 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)
Population: Participants with available data at each time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Psoriasis- Month 1 | Mean Change of Dermatology Life Quality Index (DLQI) Scores | 4.9 units on a scale | Standard Deviation 6.3 |
| Patients With Psoriasis- Month 4 | Mean Change of Dermatology Life Quality Index (DLQI) Scores | 9.3 units on a scale | Standard Deviation 7.3 |
| Patients With Psoriasis- Month 8 | Mean Change of Dermatology Life Quality Index (DLQI) Scores | 11.3 units on a scale | Standard Deviation 7.8 |
| Patients With Psoriasis- Month 12 | Mean Change of Dermatology Life Quality Index (DLQI) Scores | 12.1 units on a scale | Standard Deviation 7.8 |
Secondary
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
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.
Time frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Psoriasis- Month 1 | 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 | 500 Participants |
Secondary
Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores
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.
Time frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Population: Participants with available data at each time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Psoriasis- Month 1 | 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 |
| Patients With Psoriasis- Month 4 | Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores | 25.9 units on a scale | Standard Deviation 20.5 |
| Patients With Psoriasis- Month 8 | Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores | 31.8 units on a scale | Standard Deviation 23.3 |
| Patients With Psoriasis- Month 12 | Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores | 35.9 units on a scale | Standard Deviation 22.4 |
Secondary
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
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.
Time frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Population: Participants with available data at each time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Psoriasis- Month 1 | 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 |
| Patients With Psoriasis- Month 4 | 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 | 9.6 units on a scale | Standard Deviation 7.1 |
| Patients With Psoriasis- Month 8 | 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 | 11.5 units on a scale | Standard Deviation 7.7 |
| Patients With Psoriasis- Month 12 | 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 | 12.3 units on a scale | Standard Deviation 7.8 |
| DLQI Score Change Baseline to Month 12- Attica | 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 | 12.9 units on a scale | Standard Deviation 8.5 |
| DLQI Score Change Baseline to Month 12- Central Greece | 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 | 14.9 units on a scale | Standard Deviation 7.2 |
| DLQI Score Change Baseline to Month 12- Central Macedonia | 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 | 12.3 units on a scale | Standard Deviation 6.4 |
| DLQI Score Change Baseline to Month 12- Crete | 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 | 11.2 units on a scale | Standard Deviation 6.7 |
| DLQI Score Change Baseline to Month 12- East Macedonia/Thrace | 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 | 10.6 units on a scale | Standard Deviation 6.1 |
| DLQI Score Change Baseline to Month 12- Epirus | 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 | 2.0 units on a scale | Standard Deviation 0 |
| DLQI Score Change Baseline to Month 12- Ionian Islands | 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 | 19.0 units on a scale | — |
| DLQI Score Change Baseline to Month 12- North Aegean | 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 | 11.0 units on a scale | Standard Deviation 7.7 |
| DLQI Score Change Baseline to Month 12- Peloponnese | 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 | 6.8 units on a scale | Standard Deviation 4.7 |
| DLQI Score Change Baseline to Month 12- South Aegean | 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 | 15.0 units on a scale | Standard Deviation 4.2 |
| DLQI Score Change Baseline to Month 12- Thessaly | 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 | 9.5 units on a scale | Standard Deviation 7.7 |
| DLQI Score Change Baseline to Month 12- West Greece | 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 | 8.7 units on a scale | Standard Deviation 7.2 |
| DLQI Score Change Baseline to Month 12- West Macedonia | 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 | 12.5 units on a scale | Standard Deviation 2.1 |
Secondary
Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)
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.
Time frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Population: Participants with available data at each time point
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Psoriasis- Month 1 | 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 |
| Patients With Psoriasis- Month 4 | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 66.2 Percentage of patients with no problem |
| Patients With Psoriasis- Month 8 | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 90.2 Percentage of patients with no problem |
| Patients With Psoriasis- Month 12 | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 91.5 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- Attica | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 90.8 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- Central Greece | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 81.2 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- Central Macedonia | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 84.3 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- Crete | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 92.1 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- East Macedonia/Thrace | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 95.3 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- Epirus | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 94.2 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- Ionian Islands | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 66.2 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- North Aegean | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 77.8 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- Peloponnese | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 90.2 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- South Aegean | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 92.1 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- Thessaly | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 94.5 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- West Greece | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 56.2 Percentage of patients with no problem |
| DLQI Score Change Baseline to Month 12- West Macedonia | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 73.1 Percentage of patients with no problem |
| EQ5D- Pain/Discomfort- Month 4 | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 87.2 Percentage of patients with no problem |
| EQ5D- Pain/Discomfort- Month 8 | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 90.3 Percentage of patients with no problem |
| EQ5D- Pain/Discomfort- Month 12 | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 93.3 Percentage of patients with no problem |
| EQ5D- Anxiety/Depression- Baseline | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 20.8 Percentage of patients with no problem |
| EQ5D- Anxiety/Depression- Month 1 | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 36.9 Percentage of patients with no problem |
| EQ5D- Anxiety/Depression- Month 4 | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 53.7 Percentage of patients with no problem |
| EQ5D- Anxiety/Depression- Month 8 | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 67.6 Percentage of patients with no problem |
| EQ5D- Anxiety/Depression- Month 12 | Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) | 73.0 Percentage of patients with no problem |
Secondary
Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores
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.
Time frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Population: Participants with available data at each time point
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Psoriasis- Month 1 | 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 |
| Patients With Psoriasis- Month 4 | Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores | 95.1 Percentage of patients improving |
| Patients With Psoriasis- Month 8 | Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores | 97.5 Percentage of patients improving |
| Patients With Psoriasis- Month 12 | Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores | 97.9 Percentage of patients improving |