Study to Assess the Change in Disease State When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Taiwan

Study Overview
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Brief Summary
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Psoriasis (PsO) is a chronic, disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques and is associated with high burden of illness that results in a negative impact on long-term health outcomes including quality of life (QoL). The main objective of this study is to characterize the durability of response of risankizumab compared to other biologics measured by the Psoriasis Area and Severity Index (PASI) 90 response in adult participants with moderate to severe chronic plaque psoriasis who are either new or have used a biological treatment in the past. Risankizumab is a drug approved for the treatment of moderate-to-severe plaque psoriasis. Participants who are prescribed risankizumab or other comparator drugs in the real world setting are enrolled in this study. Data from a total of approximately 240 participants; 160 using risankizumab and 80 using other biologics will be evaluated across Taiwan. Participants will receive subcutaneous risankizumab injection or or other biologic as prescribed by their physician. Data from these participants will be collected for approximately 2 years. There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by questionnaire.

Official Title
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Prospective Observational Cohort Study of Patients With Moderate to Severe Chronic Plaque Psoriasis in Taiwan

Conditions
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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 t at the time of recruitment. Initiating an approved biologic treatment for psoriasis as per regulatory and reimbursement policy in Taiwan. Physician's decision with any of the above-mentioned treatments must have been reached prior to and independently of recruitment in the study. Treatments prescribed in accordance to both the product monograph, regulatory and reimbursement policies in Taiwan. Exclusion Criteria: - Participation in an interventional clinical trial, concurrently or within the last 30 days. Participation in another PMOS or Registry is acceptable.

Ages Eligible for Study
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Minimum Age: 20 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 Receiving Risankizumab<br>Participants will receive risankizumab as prescribed by their physician. | |
| Participants Receiving All Other Biologics<br>Participants will receive all other biologics as prescribed by their physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants who Achieved Psoriasis Area and Severity Index (PASI) 90 | The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree. | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of First Treatment Change | Time of first treatment change is defined as any treatment change including discontinuation, dose escalation and dosing interval shortening. | Up to Week 108 | 
| The Percentage of Participants who Achieved PASI 75 | The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree. | Up to Week 108 | 
| The Percentage of Participants who Achieved PASI 90 | The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree. | Up to Week 108 | 
| The Percentage of Participants who Achieved PASI 100 | The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 100% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree. | Up to Week 108 | 
| Percentage of Participants who Achieved Absolute PASI<=5 | The absolute PASI is used to assess the benefit of psoriasis therapy, with a higher score indicating a greater percent reduction. | Up to Week 108 | 
| Percentage of Participants who Achieved Absolute PASI<=3 | The absolute PASI is used to assess the benefit of psoriasis therapy, with a higher score indicating a greater percent reduction. | Up to Week 108 | 
| Percentage of Participants who Achieved Absolute PASI<=1 | The absolute PASI is used to assess the benefit of psoriasis therapy, with a higher score indicating a greater percent reduction. | Up to Week 108 | 
| The Percentage of Participants who Achieved Dermatology Life Quality Index (DLQI) 0/1 | DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 where the higher the score, the more the quality of life is impaired. | Up to Week 108 | 
| Time to Achieved PASI 75 | The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree. | Up to Week 108 | 
| Time to Achieved PASI 100 | The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 100% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree. | Up to Week 108 | 
| Time to Achieved PASI 90 | The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree. | Up to Week 108 | 
| The Percentage of Participants who Achieved PASI 90 at 24 Weeks and Maintained the Response Without Changing the Indicated Dose or Dosing Interval | The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree. | Up to Week 108 | 
| Change from Baseline in PASI | The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree. | Up to Week 108 | 
| Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis | BSA affected by psoriasis as assessed by the Investigator. | Up to Week 108 | 
| Change from Baseline in DLQI | DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 where the higher the score, the more the quality of life is impaired. | Up to Week 108 | 
| Number of Participants with Adverse Events (AE) | An AE is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. | Up to Week 108 | 
| Time to Reach Absolute PASI 10 After Withdraw from Latest Biologic Therapy | The absolute PASI is used to assess the benefit of psoriasis therapy, with a higher score indicating a greater percent reduction. | Up to 5 years Medical Chart Review Prior to Enrollment | 
| Time to Reach Loss of PASI 50 After Withdraw from Latest Biologic Therapy | The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 50% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree. | Up to 5 years Medical Chart Review Prior to Enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Risankizumab, Skyrizi, Plaque Psoriasis