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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Minato-ku, Tokyo, Japan, 1070052
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

120 participants, from 2 to 4 institutes which have a central role of psoriasis therapy in Japan, will be entered into the study if they started systemic treatment after 01/01/2017 and followed until either 12/31/2020, death, or lost to follow-up, whichever occurs first.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort 1; Participants with psoriasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): October 8, 2021
• Study Completion (Actual): October 8, 2021

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Psoriasis; Observational; Japan; Retrospective
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: IM011-166