Prospective Observational Cohort Study of Patients With Moderate to Severe Chronic Plaque Psoriasis in Taiwan
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psoriasis
- Sponsor
- AbbVie
- Enrollment
- 240
- Locations
- 8
- Primary Endpoint
- The Percentage of Participants who Achieved Psoriasis Area and Severity Index (PASI) 90
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
The Percentage of Participants who Achieved Psoriasis Area and Severity Index (PASI) 90
Time Frame: Week 24
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.
Secondary Outcomes
- Percentage of Participants who Achieved Absolute PASI<=3(Up to Week 108)
- Time to Achieved PASI 100(Up to Week 108)
- Time of First Treatment Change(Up to Week 108)
- Percentage of Participants who Achieved Absolute PASI<=1(Up to Week 108)
- Time to Achieved PASI 75(Up to Week 108)
- The Percentage of Participants who Achieved PASI 75(Up to Week 108)
- The Percentage of Participants who Achieved PASI 90(Up to Week 108)
- Percentage of Participants who Achieved Absolute PASI<=5(Up to Week 108)
- Time to Achieved PASI 90(Up to Week 108)
- The Percentage of Participants who Achieved PASI 100(Up to Week 108)
- Change from Baseline in PASI(Up to Week 108)
- Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis(Up to Week 108)
- The Percentage of Participants who Achieved Dermatology Life Quality Index (DLQI) 0/1(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(Up to Week 108)
- Change from Baseline in DLQI(Up to Week 108)
- Number of Participants with Adverse Events (AE)(Up to Week 108)
- Time to Reach Absolute PASI 10 After Withdraw from Latest Biologic Therapy(Up to 5 years Medical Chart Review Prior to Enrollment)
- Time to Reach Loss of PASI 50 After Withdraw from Latest Biologic Therapy(Up to 5 years Medical Chart Review Prior to Enrollment)