Chinese Psoriasis Real World Evidence Research

Study Overview
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Brief Summary
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This research is a multicenter,observational study under real world settings in patients diagnosed as psoriasis by dermatologist in the clinic. As patient's choice of medication should be fully respected, all the patients can choose the treatments they prefer, like phototherapy, traditional systemic therapy or biologics. And the study was conducted to compare the effectiveness among different choices of medication in Chinese psoriasis patients.

Detailed Description
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Psoriasis is a chronic, recurrent inflammatory disease which is caused by heredity, environment and other factors. The typical clinical manifestation are erythematosquamous lesions, and the disease can progress to involve several organs. In view of its complex pathogenesis, there exists various of treatment of psoriasis like traditional systemic drugs and biologics. This study is an observational, multi-centre study based on real-world evidence. Inclusion criteria is the patients who visit the clinic diagnosed psoriasis by the dermatologist. There existed no exclusion criteria. Information were most collected by a phone application called Psoriasis New World. Primary outcome measure is the percentage of patients who achieved a PASI reduction of 100% (PASI 100). And Psoriasis Area and Severity Index includes scores of erythema, infiltration and desquamation, weighted by area of involvement in each regions (head and neck, upper extremities, trunk, lower extremities), with higher PASI scores indicating worse condition. Also, static Physician Global Assessment (sPGA), static Investigator Global Assessment (sIGA), Body surface area (BSA) and Dermatology Life Quality Index (DLQI) are measured to assess the severity of psoriasis and the change of the disease condition. It is important to monitor all the Adverse Events (AEs) over the whole study. In addition, the laboratory examinations of patients such as liver function are also collected.

Official Title
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A Real World Evidence Study in Chinese Psoriasis Patients

Conditions
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Psoriasis

Intervention / Treatment
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* Other: NIS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all the patients diagnosed as psoriasis by dermatologist in clinic. Exclusion Criteria: None
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 |
| --- | --- |
| Psoriasis<br>This is a non-interventional study (NIS). All the patients diagnosed as psoriasis by the dermatologists in the clinic are included in this study no matter what kind of treatment they adopt. | Other: NIS<br>* This is a non-interventional study (NIS).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients who achieved a PASI reduction of 100% (PASI 100) | Psoriasis Area and Severity Index includes scores of erythema, infiltration and desquamation, weighted by area of involvement in each regions (head and neck, upper extremities, trunk, lower extremities), with higher PASI scores indicating worse condition. The percentage of patients who achieved a PASI reduction of 100% (PASI 100) will be measured. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients who achieved a PASI reduction of 100% (PASI 100) | PASI100 represents complete clearance. | 6 months and 12 months | 
| The percentage of patients who achieved a PASI reduction of 75% (PASI 75) | PASI75 response is the percentage of participants who achieved at least a 75% reduction from baseline in PASI score. | 6 months and 12 months | 
| The percentage of patients who achieved a PASI reduction of 50% (PASI 50) | PASI50 response is the percentage of participants who achieved at least a 50% reduction from baseline in PASI score. | 6 months and 12 months | 
| static Physician Global Assessment (sPGA) = 0 | static Physician Global Assessment (sPGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4. | 6 months and 12 months | 
| static Investigator Global Assessment (sIGA) = 0 | static Investigator Global Assessment (sIGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4. | 6 months and 12 months | 
| Body surface area (BSA) | The percentage of BSA represents the area of involvement, which can be estimated by the entire palm of the patient. | 6 months and 12 months | 
| Dermatology Life Quality Index (DLQI) =0 | The Dermatology Life Quality Index (DLQI) is a questionnaire used to measure the impact of a skin disease. | 6 months and 12 months | 
| Adverse Events (AEs) | Number of patients with adverse events | Up to 12 months | 
| Visual Analog Scale (VAS) | Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 10. The higher score is, the greater discomfortableness participant has. | 6 months and 12 months |