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

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

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

Study Overview

• Status: Completed
• Conditions: Palmoplantar Pustulosis
• Intervention / Treatment: Other: No intervention

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 276

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan, 010-8543
    • Akita University Hospital
  • Bunkyō City, Japan, 113 8431
    • Juntendo University Hospital
  • Fukuoka, Japan, 812 8582
    • Kyushu University Hospital
  • Fukushima, Japan, 960 1295
    • Fukushima Medical University Hospital
  • Hamamatsu, Japan, 431-3192
    • Hamamatsu University Hospital
  • Hirakata, Japan, 573 1191
    • Kansai Medical University Hospital
  • Hiroshima, Japan, 731-0293
    • Hiroshima City Asa Citizens Hospital
  • Hiroshima, Japan, 733-0032
    • Seiwakai Hiroshima Clinic
  • Hokkaido, Japan, 060-0033
    • JR Sapporo Hospital
  • Hyōgo, Japan, 6751392
    • Kita-harima Medical Center
  • Itabashi Ku, Japan, 173 8606
    • Teikyo University Hospital
  • Kita-ku, Japan, 700-8511
    • Okayama Saiseikai General Hospital
  • Kochi, Japan, 780-8522
    • Chikamori Hospital
  • Kochi, Japan, 783-8505
    • Kochi Medical School Hospital
  • Kofu, Japan, 400-8506
    • Yamanashi Prefectural Central Hospital
  • Kurashiki-shi, Japan, 710-8522
    • Kurashiki Medical Center
  • Kurume, Japan, 830-0011
    • Kurume University Hospital
  • Kuwana, Japan, 511 0061
    • Kuwana City Medical Center
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Kyoto, Japan, 612-8555
    • National Hospital Organization Kyoto Medical Center
  • Matsumoto, Japan, 390 8621
    • Shinshu University Hospital
  • Meguro-ku, Japan, 153-8515
    • Toho University Medical Center, Ohashi Hospital
  • Nagoya, Japan, 467 8602
    • Nagoya City University Hospital
  • Nishinomiya, Japan, 663-8501
    • The Hospital of Hyogo College of Medicine
  • Okayama, Japan, 700 8558
    • Okayama University Hospital
  • Sapporo, Japan, 060-8648
    • Hokkaido University Hospital
  • Sasebo, Japan, 857 1195
    • Sasebo Chuo Hospital
  • Sendai, Japan, 980 8574
    • Tohoku University Hospital
  • Shinjuku-ku, Japan, 160-8582
    • Keio University Hospital
  • Takamatsu, Japan, 760 0017
    • Takamatsu Red Cross Hospital
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 193-0998
    • Tokyo Medical University Hachioji Medical Center
  • Tokyo, Japan, 104 8560
    • St. Luke's International Hospital
  • Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
  • Tōon, Japan, 791-0295
    • Ehime University Hospital
  • Yokosuka, Japan, 238 8558
    • Yokosuka Kyosai Hospital
  • Ōita, Japan, 879-5593
    • Oita University Hospital
  • Ōsaka-sayama, Japan, 589-8511
    • Kindai University Hospital
  • Ōtsu, Japan, 520-2192
    • Shiga University of Medical Science Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participants observed in this study newly initiated/will be newly initiating a systemic therapy for their PPP/pustulotic arthro-osteitis (PAO) - either as their first systemic therapy or as a switch from, or an addition to a previous therapy, having had an inadequate response and/or intolerant to prior PPP/PAO therapy. Participants will be treated in accordance with routine clinical practice in Japan in the outpatient specialist care setting.

Description

Inclusion Criteria:

• Must have a confirmed diagnosis of palmoplantar pustulosis (PPP) and/or pustulotic arthro-osteitis (PAO) in accordance with local clinical practice
• Has previously been prescribed treatment for PPP/PAO
• A decision has been made by the treating physician and the participant to commence treatment with a systemic PPP/PAO 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants With Palmoplantar pustulosis (PPP); 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; 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.

What is the study measuring?

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 4.5 Years
Percentage of Participants Ceasing Their 'Index Systemic' Therapy	Percentage of participants ceasing their 'index systemic' therapy will be reported.	Up to 4.5 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 4.5 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
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 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 4.5 Years
Percentage of Participants Ceasing a Concurrent Systemic Treatment to their 'Index Systemic' Therapy	Percentage of participants ceasing a concurrent systemic treatment to their 'index systemic' therapy will be reported.	Baseline and Every 6 Months Up to 4.5 Years
Time to Addition of a Concurrent Systemic Treatment to 'Index Systemic' Therapy	Time to addition of a concurrent systemic treatment to 'index systemic' therapy will be reported.	Baseline and Every 6 Months Up to 4.5 Years
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.	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.	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.	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.	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.	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.	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.	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.	Baseline and Every 6 Months Up to 4.5 Years
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.	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 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.	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.	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).	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.	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.	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.	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.	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.	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.	Up to 4.5 Years

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutical K.K.
• Investigators: Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): December 27, 2025
• Study Completion (Actual): December 27, 2025

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis
• Other Study ID Numbers: CR108811; CNTO1959PAP4001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No