Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
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Brief Summary
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This study will assess the use of risankizumab in adult patients with moderate to severe chronic plaque psoriasis and compare risankizumab to other commonly used biologics.

Official Title
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Multi-Country Prospective ObserVAtionaL, Cohort Study of Patients With Moderate to Severe Chronic PlaqUE Psoriasis (VALUE)

Conditions
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Chronic Plaque Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a specialist and presence of moderate to severe psoriasis symptoms according to physician's judgement at time of recruitment. Participant starting any approved treatment for psoriasis and physician's decision must be reached prior to recruitment in the study. Participant willing to continue with study documentation after cessation of therapy. Exclusion Criteria: Unwillingness or inability to comply with study requirements. Participation in an interventional clinical trial, concurrently or within the last 30 days. Participation in a post-market observational study (PMOS) or Registry is acceptable.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants treated with Risankizumab<br>Treatment decision independently made of study enrollment | |
| Participants treated with other approved biological therapies<br>Treatment decision independently made of study enrollment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 90 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. | From Month 4 to 3 years | 
| Time to first treatment change | Identify time to first treatment change including discontinuation, dose escalation and dosing interval shortening | From Week 0 (Baseline) to first treatment change | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first treatment change rate | Time to first treatment change including discontinuation, dose escalation and dose interval shortening. | At 1 year, 2 year, and 3 year | 
| Percentage of participants who achieved Static Physicians Global Assessment (sPGA) 0/1 or sPGA 0 | The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. sPGA scores demonstrate overall psoriatic disease with a lower score indicating less body coverage. The assessment is considered static which refers to the patients disease state at the time of the assessments, without comparison to any of the patient's previous disease states, whether at Baseline or at a previous visit. | Monthly for up to 3 years | 
| Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75, 90, or 100 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. Each threshold will be analyzed separately. | Monthly for up to 3 years | 
| Percentage of participants who achieved Absolute PASI<=5, <=3 or <=1 | Used to assess the benefit of psoriasis therapy. Each threshold will be analyzed separately. | Monthly for up to 3 years | 
| Time to achieve sPGA 0/1 or sPGA 0 | The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. | Up to 3 years | 
| Time to achieve PASI 75, 90,or 100 | PASI 75, 90, or 100 defined as at least a 75%/ 90%/ 100% reduction in PASI relative to Week 0 (Baseline). Each threshold will be analyzed separately. | Up to 3 years | 
| Percentage of participants who achieve sPGA 0/1 or sPGA 0 at 4 Months and maintained the response status at 1 Year, 2 Years and 3 Years without increasing the dose or shortening the dose interval | Percentage of participants who achieve sPGA 0/1 or sPGA 0 at 4 Months and maintained the response status at 1 Year, 2 Years and 3 Years without increasing the dose or shortening the dose interval. | At 4 months to 1 year, 2 years, and 3 years | 
| Percentage of participants who achieved PASI 90 or PASI 100 at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval | Percentage of participants who achieved PASI 90 or PASI 100 demonstrating a 90 or 100% reduction in PASI at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval. | At 4 months and 1 year, 2 years, and 3 years | 
| Change in PASI | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. | From Week 0 to up to 3 years | 
| Change in Body Surface Area (BSA) | BSA can be used to quantify the severity of psoriasis. A decrease in BSA affected by psoriasis indicates improvement. | From Week 0 to up to 3 years | 
| Change in Dermatology Quality of Life Index (DLQI) Score | The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool. The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much). | From Week 0 to up to 3 years | 
| Percentage of participants who achieve DLQI 0/1 | The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool. The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. The higher the DLQI score, the more quality of life is impaired. | Monthly for up to 3 years | 
| Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score | The Treatment Satisfaction Questionnaire for Medication (TSQM) is a widely used generic measure to assess treatment satisfaction with their medication. This is a 100-point scale with higher scores indicating greater satisfaction with medication and provides scores on four scales - side effects, effectiveness, convenience and global satisfaction. | From Week 0 to up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Plaque Psoriasis Risankizumab Biologics Psoriasis Vulgaris