A Study of Treatment Patterns and Clinical Outcomes of Psoriasis in Japan

Study Overview
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Brief Summary
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The purpose of this study is to understand current real-world treatment patterns and clinical outcomes, reasons for switching treatment, and participant characteristics using each systemic psoriasis treatment in Japan.

Official Title
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Treatment Patterns and Outcomes Study for Psoriasis (PSO) in Japan

Conditions
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Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of psoriasis Can be followed for at least 2 years Treated with any of the following systemic therapy for psoriasis at time of follow-up start: Tumor Necrosis Factor (TNF) inhibitors (infliximab, adalimumab, and certolizumab pegol), Interleukin (IL)-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate Exclusion Criteria: Enrolled in any clinical trials for psoriasis in their follow-up period Developed psoriatic arthritis, guttate psoriasis, erythrodermic psoriasis, and pustular psoriasis at time of start date Treated with any of the following systemic therapy before they were diagnosed with psoriasis: TNF inhibitors (infliximab, adalimumab, and certolizumab pegol), IL-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate

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 |
| --- | --- |
| Cohort 1<br>Participants with psoriasis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of participant background at first visit: Age |  | At Baseline | 
| Distribution of participant background at first visit: Sex |  | At Baseline | 
| Distribution of participant background at first visit: Duration with psoriasis |  | At Baseline | 
| Distribution of participant background at first visit: Comorbidities |  | At Baseline | 
| Distribution of participant background at first visit: Current status of phototherapy |  | At Baseline | 
| Treatment patterns: Drug names treated during study period |  | Up to 4 years | 
| Treatment patterns: Drug categories treated during study period |  | Up to 4 years | 
| Treatment patterns: Number of treatment changes during study period |  | Up to 4 years | 
| Treatment patterns: Treatment duration of each drug during study period |  | Up to 4 years | 
| Treatment patterns: Duration between withdrawal of one drug and start of a new drug during study period |  | Up to 4 years | 
| Treatment patterns: Adverse event (AE) at time of withdrawal of some drug |  | Up to 4 years | 
| Treatment patterns: Psoriasis area severity index (PASI) at time of withdrawal |  | Up to 4 years | 
| Treatment patterns: PASI at time of start of a new drug |  | Up to 4 years | 
| Treatment patterns: PASI improvement from start of one drug to withdrawal of other drug |  | Up to 4 years | 
| Treatment patterns: Reason for treatment change during study period |  | Up to 4 years | 
| Treatment patterns: Status of phototherapy combination with systemic treatment |  | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of comorbidities that affect treatment choice and change |  | Up to 4 years | 
| Distribution of AEs that affect treatment choice and change |  | Up to 4 years | 
| Mean number of drug changes until participants achieve PASI 75 during study period | 75% reduction in the Psoriasis Area and Severity Index score (PASI 75) | Up to 4 years | 
| Mean number of drug changes until participants achieve PASI 90 during study period | 90% reduction in the Psoriasis Area and Severity Index score (PASI 90) | Up to 4 years | 
| Mean number of drug changes until participants achieve PASI 100 during study period | 100% reduction in the Psoriasis Area and Severity Index score (PASI 100) | Up to 4 years | 
| Total period until participants achieve PASI 75 during study period |  | Up to 4 years | 
| Total period until participants achieve PASI 90 during study period |  | Up to 4 years | 
| Total period until participants achieve PASI 100 during study period |  | Up to 4 years | 
| Mean period of participants achieve PASI 75 by each systemic treatment |  | Up to 4 years | 
| Mean period of participants achieve PASI 90 by each systemic treatment |  | Up to 4 years | 
| Mean period of participants achieve PASI 100 by each systemic treatment |  | Up to 4 years | 
| Description of relationship between the reasons for treatment change and period of withdrawal |  | Up to 4 years | 
| Efficacy after re-start treatment measured by PASI |  | Up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Japan, Observational, Psoriasis, Retrospective