A Study to Assess Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Participants With Moderate-To-Severe Plaque Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to achieve a better understanding of clinical characteristics, treatment patterns and clinical outcomes of participants with moderate-to-severe plaque psoriasis (PsO) as well as their unmet medical needs and disease burden in real-world setting in China.

Official Title
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Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Patients With Moderate-To-Severe Plaque Psoriasis in Real-World Settings in China

Conditions
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Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of moderate-to-severe plaque PsO either confirmed by a dermatologist or meeting criteria of: BSA ≥ 3% or PASI ≥ 3 or Dermatology Life Quality Index (DLQI) ≥ 6. Exclusion Criteria: Participating in Randomized controlled trial (RCT) between 1st January 2018 and 31st December 2021, if there was any. Diagnosis of erythrodermic psoriasis, pustular psoriasis or guttate psoriasis.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Moderate-to-severe Plaque PsO<br>Participants experiencing moderate-to-severe plaque PsO, who have had at least one clinical visit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of demographic characteristics: Age |  | Baseline | 
| Distribution of demographic characteristics: Sex |  | Baseline | 
| Distribution of clinical characteristics: Height |  | Baseline | 
| Distribution of clinical characteristics: Weight |  | Baseline | 
| Distribution of clinical characteristics: Body Mass Index (BMI) |  | Baseline | 
| Distribution of clinical characteristics: Disease duration |  | Baseline | 
| Distribution of clinical characteristics: Severity of PsO |  | Baseline | 
| Distribution of clinical characteristics: Comorbidities |  | Baseline | 
| Treatment patterns: Drug categories treated during study period |  | Up to 4 Years | 
| Treatment patterns: Drug names treated during study period |  | Up to 4 Years | 
| Treatment patterns: Medication dosage |  | Up to 4 Years | 
| Treatment patterns: Drug's administration frequency |  | Up to 4 Years | 
| Treatment patterns: Reason for treatment change during study period |  | Up to 4 Years | 
| Treatment patterns: Treatment duration of each drug during study period |  | Up to 4 Years | 
| Treatment patterns: Treatment sequence |  | Up to 4 Years | 
| Treatment patterns: Change of treatment pattern |  | Up to 4 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants achieving Body Surface Area of <3% during study period |  | Up to 4 Years | 
| Psoriasis Area and Severity (PASI) Index |  | Up to 4 Years | 
| Number of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period |  | Up to 4 Years | 
| Healthcare resource utilization (HCRU) | HCRU will include visit date, visit type, cost, inpatient visits, outpatient visits, length of stay, and direct medical cost. | Up to 4 Years | 
| Evaluation of patient reported outcome measure: Patients' global assessment of disease activity (PtGA) | PtGA of psoriasis is an indicator of disease severity of PsO measured using a single-item, five- point scale ranging from 0 (clear) to 4 (severe). Category labels include 'clear', 'almost clear', 'mild', 'moderate' and 'severe'. | Up to 4 Years | 
| Evaluation of patient reported outcome measure: Dermatology life quality index (DLQI) | DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. Each item has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30 and higher scores indicate greater HRQoL impairment. | Up to 4 Years | 
| Evaluation of patient reported outcome measure: EQ-5D-3L | The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension, participant is asked to choose one of the 3 levels (no problems, some problems, and extreme problems) to indicate his/her health state. This decision results into a 1-digit number and the digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state. | Up to 4 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate to Severe Plaque PsO