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

Time to Ceasing of a Concurrent Systemic Treatment to 'Index Systemic' Therapy

Time to ceasing of a concurrent systemic treatment to 'index systemic' therapy will be reported.

Time frame: Baseline and Every 6 Months Up to 4.5 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.

Time frame: Baseline and Every 6 Months Up to 4.5 Years

Percentage of Participants Adding a Concurrent Non-Systemic Therapy to their 'Index Systemic' Therapy

Percentage of participants adding a concurrent non-systemic therapy to their 'index systemic' therapy will be reported.

Time frame: Baseline and Every 6 Months Up to 4.5 Years

Percentage of Participants Ceasing a Concurrent Non-Systemic Therapy to their 'Index Systemic' Therapy

Percentage of participants ceasing a concurrent non-systemic therapy to their 'index systemic' therapy will be reported.

Time frame: Baseline and Every 6 Months Up to 4.5 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.

Time frame: Every 6 Months Up to 4.5 Years

Time to Commencement of First Subsequent Systemic Therapy From Baseline

Time to commencement of first subsequent systemic therapy from baseline will be reported.

Time frame: Baseline and Every 6 Months Up to 4.5 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.

Time frame: Every 6 Months Up to 4.5 Years

Time to Commencement of Second Subsequent Systemic Therapy From Baseline

Time to commencement of second subsequent systemic therapy from baseline will be reported.

Time frame: Baseline and Every 6 Months Up to 4.5 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.

Time frame: 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.

Time frame: Baseline

Mean and Distribution of Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline

Mean and distribution of HAQ-DI scores at baseline will be reported. The Disability Index of the Health Assessment Questionnaire (HAQ-DI) assesses the functional status of the participant. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area where lower scores are indicative of better functioning.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and Every 6 Months Up to 4.5 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.

Time frame: Baseline and Every 6 Months Up to 4.5 Years

Change from Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Score

The PPPASI assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, and left sole, which account for 20 percent (%), 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.

Time frame: Baseline and Every 6 Months Up to 4.5 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).

Time frame: Baseline and Every 6 Months Up to 4.5 Years

Change in Primary Location of Pain

Change in primary location of pain will be reported.

Time frame: Baseline and Every 6 Months Up to 4.5 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.

Time frame: Baseline and Every 6 Months Up to 4.5 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.

Time frame: Baseline and Every 6 Months Up to 4.5 Years

Change from Baseline in HAQ-DI Index Score

Change from baseline in HAQ-DI score will be reported. The HAQ-DI assesses the functional status of the participant. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area where lower scores are indicative of better functioning.

Time frame: Baseline and Every 6 Months Up to .4.5 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.

Time frame: Baseline and Every 6 Months Up to 4.5 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.

Time frame: Up to 4.5 Years