A Study to Assess Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Participants With Moderate-To-Severe Plaque Psoriasis

Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Patients With Moderate-To-Severe Plaque Psoriasis in Real-World Settings in China

The purpose of this study is to achieve a better understanding of clinical characteristics, treatment patterns and clinical outcomes of participants with moderate-to-severe plaque psoriasis (PsO) as well as their unmet medical needs and disease burden in real-world setting in China.

Study Overview

• Status: Completed
• Conditions: Psoriasis

• Study Type: Observational
• Enrollment (Actual): 3506

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Local Institution - 0002
  • Jiangsu
    • Nanjing, Jiangsu, China, 210042
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of participants experiencing moderate-to-severe plaque PsO, who have at least one clinical visit (either outpatient or inpatient visit) between 1st January 2018 and 31st December 2021.

Description

Inclusion Criteria:

• Diagnosis of moderate-to-severe plaque PsO either confirmed by a dermatologist or meeting criteria of: BSA ≥ 3% or PASI ≥ 3 or Dermatology Life Quality Index (DLQI) ≥ 6.

Exclusion Criteria:

• Participating in Randomized controlled trial (RCT) between 1st January 2018 and 31st December 2021, if there was any.
• Diagnosis of erythrodermic psoriasis, pustular psoriasis or guttate psoriasis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Moderate-to-severe Plaque PsO; Participants experiencing moderate-to-severe plaque PsO, who have had at least one clinical visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Distribution of demographic characteristics: Age	Baseline
Distribution of demographic characteristics: Sex	Baseline
Distribution of clinical characteristics: Height	Baseline
Distribution of clinical characteristics: Weight	Baseline
Distribution of clinical characteristics: Body Mass Index (BMI)	Baseline
Distribution of clinical characteristics: Disease duration	Baseline
Distribution of clinical characteristics: Severity of PsO	Baseline
Distribution of clinical characteristics: Comorbidities	Baseline
Treatment patterns: Drug categories treated during study period	Up to 4 Years
Treatment patterns: Drug names treated during study period	Up to 4 Years
Treatment patterns: Medication dosage	Up to 4 Years
Treatment patterns: Drug's administration frequency	Up to 4 Years
Treatment patterns: Reason for treatment change during study period	Up to 4 Years
Treatment patterns: Treatment duration of each drug during study period	Up to 4 Years
Treatment patterns: Treatment sequence	Up to 4 Years
Treatment patterns: Change of treatment pattern	Up to 4 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants achieving Body Surface Area of <3% during study period		Up to 4 Years
Psoriasis Area and Severity (PASI) Index		Up to 4 Years
Number of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period		Up to 4 Years
Healthcare resource utilization (HCRU)	HCRU will include visit date, visit type, cost, inpatient visits, outpatient visits, length of stay, and direct medical cost.	Up to 4 Years
Evaluation of patient reported outcome measure: Patients' global assessment of disease activity (PtGA)	PtGA of psoriasis is an indicator of disease severity of PsO measured using a single-item, five- point scale ranging from 0 (clear) to 4 (severe). Category labels include 'clear', 'almost clear', 'mild', 'moderate' and 'severe'.	Up to 4 Years
Evaluation of patient reported outcome measure: Dermatology life quality index (DLQI)	DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. Each item has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30 and higher scores indicate greater HRQoL impairment.	Up to 4 Years
Evaluation of patient reported outcome measure: EQ-5D-3L	The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension, participant is asked to choose one of the 3 levels (no problems, some problems, and extreme problems) to indicate his/her health state. This decision results into a 1-digit number and the digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state.	Up to 4 Years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Moderate to Severe Plaque PsO
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: IM011-206