A Registry Study of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan

Study Overview
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Brief Summary
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The purpose of this study is to describe the treatment patterns of participants receiving systemic treatment for of palmoplantar pustulosis (PPP) in Japan.

Detailed Description
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This is a retrospective study where the historical data on PPP therapy will also be used prior to Visit 1 (baseline).

Official Title
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Registry of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan

Conditions
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Palmoplantar Pustulosis

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have a confirmed diagnosis of palmoplantar pustulosis (PPP) in accordance with local clinical practice Has previously been prescribed treatment for PPP A decision has been made by the treating physician and the participant to commence treatment with a systemic PPP therapy, having been deemed to have an inadequate response to previous therapy (New users are defined as those participants to commence treatment on baseline visit date. Existing users are defined as those who commenced treatment prior to the baseline visit since 01 November 2019.) Must sign a participation agreement/informed consent form allowing data collection and source data verification in accordance with local requirements Exclusion Criteria: Are receiving, or have received within the past 3 months, anti-inflammatory or analgesic systemic therapy such as oral corticosteroid, disease modifying antirheumatic drug (DMARDs), non-steroidal anti-inflammatory drugs, opioids, phosphodiesterase 4 (PDE4) inhibitor, or biologics for any other indication (for example, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and asthma) Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point Participation in an investigational study Participation in another observational study for guselkumab (including a post marketing surveillance study) If the only treatment they have received for PPP has been antibiotics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants With Palmoplantar pustulosis (PPP)<br>Participants treated with a new systemic therapy for their PPP, having had an inadequate response to a prior PPP therapy either as their first systemic therapy or as a switch from, or addition to, a previous systemic therapy will be observed. Participants will be treated in accordance with routine clinical practice in Japan in the outpatient specialist care setting. The primary data source for this study will be the medical records of each participant. | Other: No intervention<br>* No intervention will be administered as a part of this study. Both retrospective and prospective data will be collected. The retrospective data will be collected through participant charts and prospective data will be collected in accordance with clinical practice at the participant's clinic visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who remain on their 'index systemic' therapy | Percentage of participants who remain on their 'index systemic' therapy will be reported. | Up to 5 Years | 
| Percentage of Participants Ceasing Their 'Index Systemic' Therapy | Percentage of participants ceasing their 'index systemic' therapy will be reported. | Up to 5 Years | 
| Time to Cessation of Index Systemic Therapy From Baseline | Time to cessation of index systemic therapy from baseline will be reported. | Baseline, Up to 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Receiving Each 'Index Systemic' Therapy | Percentage of participants receiving each 'Index Systemic' therapy will be reported. | Baseline | 
| Percentage of Participants Adding a Concurrent Systemic Treatment to their 'Index Systemic' Therapy | Percentage of participants adding a concurrent systemic treatment to their 'index systemic' therapy will be reported. | Baseline and Every 6 Months Up to 5 Years | 
| Percentage of Participants Changing the Dosage of their 'Index Systemic' Therapy | Percentage of participants changing the dosage of their 'index systemic' therapy will be reported. | Baseline and Every 6 Months Up to 5 Years | 
| Percentage of Participants Switching to a First Subsequent Systemic Therapy Within the Follow-up Period | Percentage of participants switching to a first subsequent systemic therapy within the follow-up period will be reported. | Every 6 Months Up to 5 Years | 
| Time to Commencement of First Subsequent Systemic Therapy From Baseline | Time to commencement of first subsequent systemic therapy from baseline will be reported. | Baseline and Every 6 Months Up to 5 Years | 
| Percentage of Participants Switching to a Second Subsequent Systemic Therapy Within the Follow-up Period | Percentage of participants switching to a second subsequent systemic therapy within the follow-up period will be reported. | Every 6 Months Up to 5 Years | 
| Time to Commencement of Second Subsequent Systemic Therapy From Baseline | Time to commencement of second subsequent systemic therapy from baseline will be reported. | Baseline and Every 6 Months Up to 5 Years | 
| Percentage of Participants Changing Their Concurrent Non-Systemic Therapy Within the Follow-up Period | Percentage of participants changing their concurrent non-systemic therapy within the follow-up period will be reported. | Every 6 Months Up to 5 Years | 
| Mean and Distribution of Dermatology Life Quality Index (DLQI) Scores at Baseline | Mean and distribution of DLQI scores at baseline will be reported. DLQI instrument consists of 10 questions covering six domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life. | Baseline | 
| Mean and Distribution of European Quality of Life (EuroQol) Group, 5-Dimension, 5-Level (EQ-5D-5L) Scores at Baseline | Mean and distribution of EQ-5D-5L scores at baseline will be reported. EQ-5D-5L is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. A lower score indicates worse health. | Baseline | 
| Mean and Distribution of Work Productivity and Activity Impairment: General Health (WPAI:GH) Scores at Baseline | Mean and distribution of WPAI:GH scores at baseline will be reported. WPAI:GH questionnaire is a validated instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. It consists of 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. | Baseline | 
| Percentage of Participants with a Physician's Global Assessment (PGA) Score of 1 or Less (0 or 1) | Percentage of participants with a PGA score of 1 or less (0 or 1) will be reported. The PGA is used to determine the participant's overall palmoplantar pustulosis lesions at a given time point. Overall lesions will be graded based on the scale where, 0 = clear;1 = almost clear; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Very severe. | Baseline and Every 6 Months Up to 5 Years | 
| Change From Baseline in PGA Score | Change From baseline in PGA score will be reported. The PGA is used to determine the participant's overall palmoplantar pustulosis lesions at a given time point. Overall lesions will be graded based on the scale where, 0 = clear;1 = almost clear; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Very severe. | Baseline and Every 6 Months Up to 5 Years | 
| Change From Baseline in Pain Visual Analogue Scale (Pain-VAS) Score | Change from baseline in Pain-VAS score will be reported. Pain-VAS is used to measure subjective pain status. It is a unilateral scale anchored at 0 (no pain) and 10 (worst pain imaginable). | Baseline and Every 6 Months Up to 5 Years | 
| Change in Primary Location of Pain | Change in primary location of pain will be reported. | Baseline and Every 6 Months Up to 5 Years | 
| Change From Baseline in DLQI Score | Change from baseline in DLQI score will be reported. DLQI instrument consists of 10 questions covering six domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life. | Baseline and Every 6 Months Up to 5 Years | 
| Change From Baseline in EQ5D-5L Index Score | Change from baseline in EQ5D-5L index score will be reported. The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. | Baseline and Every 6 Months Up to 5 Years | 
| Change from baseline in Work Productivity and Activity Impairment questionnaire (WPAI) | Change from baseline in WPAI will be reported. WPAI questionnaire is a validated instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. The higher the score the greater impact on productivity. | Baseline and Every 6 Months Up to 5 Years | 
| Percentage of Participants with Adverse Events (AEs) and serious Adverse Events (SAEs) | Percentage of participants with adverse events and serious Adverse Events will be reported. An adverse event is any untoward medical occurrence in a participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. | Up to 5 Years |