Chronic Plaque Psoriasis
Conditions
Keywords
Chronic Plaque Psoriasis Risankizumab Biologics Psoriasis Vulgaris
Brief summary
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 90 | From Month 4 to 3 years | 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. |
| Time to first treatment change | From Week 0 (Baseline) to first treatment change | Identify time to first treatment change including discontinuation, dose escalation and dosing interval shortening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75, 90, or 100 | Monthly for up to 3 years | 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. |
| Percentage of participants who achieved Absolute PASI<=5, <=3 or <=1 | Monthly for up to 3 years | Used to assess the benefit of psoriasis therapy. Each threshold will be analyzed separately. |
| Time to achieve sPGA 0/1 or sPGA 0 | Up to 3 years | 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. |
| Time to achieve PASI 75, 90,or 100 | Up to 3 years | 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. |
| 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 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. |
| Time to first treatment change rate | At 1 year, 2 year, and 3 year | Time to first treatment change including discontinuation, dose escalation and dose interval shortening. |
| Change in PASI | From Week 0 to up to 3 years | 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. |
| Change in Body Surface Area (BSA) | From Week 0 to up to 3 years | BSA can be used to quantify the severity of psoriasis. A decrease in BSA affected by psoriasis indicates improvement. |
| Change in Dermatology Quality of Life Index (DLQI) Score | From Week 0 to up to 3 years | 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). |
| Percentage of participants who achieve DLQI 0/1 | Monthly for up to 3 years | 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. |
| Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score | From Week 0 to up to 3 years | 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. |
| 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 | At 4 months and 1 year, 2 years, and 3 years | 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. |
| Percentage of participants who achieved Static Physicians Global Assessment (sPGA) 0/1 or sPGA 0 | Monthly for up to 3 years | 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. |
Countries
Argentina, Australia, Austria, Canada, Colombia, Czechia, France, Germany, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Romania, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom
Outcome results
None listed