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.
Study Type
OBSERVATIONAL
Enrollment
240
National Taiwan University Hospital /ID# 230017
Taipei City, Taipei, Taiwan
National Taiwan University Hospital - Hsinchu branch /ID# 238432
Hsinchu, Taiwan
Hualien Tzu Chi Hospital /ID# 238431
Hualien City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 230016
Kaohsiung City, Taiwan
China Medical University Hospital /ID# 229961
Taichung, Taiwan
National Cheng Kung University Hospital /ID# 253776
Tainan, Taiwan
Taipei Medical University Hospital /ID# 230018
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 253775
Taoyuan City, Taiwan
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.
Time frame: Week 24
Time of First Treatment Change
Time of first treatment change is defined as any treatment change including discontinuation, dose escalation and dosing interval shortening.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 108
Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis
BSA affected by psoriasis as assessed by the Investigator.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years Medical Chart Review Prior to Enrollment
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