Psoriasis
Conditions
Keywords
Moderate to Severe Plaque PsO
Brief summary
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Distribution of demographic characteristics: Sex | Baseline |
| Distribution of clinical characteristics: Height | Baseline |
| Distribution of clinical characteristics: Weight | Baseline |
| 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 |
| Distribution of clinical characteristics: Body Mass Index (BMI) | Baseline |
| Distribution of demographic characteristics: Age | Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Up to 4 Years | HCRU will include visit date, visit type, cost, inpatient visits, outpatient visits, length of stay, and direct medical cost. |
| Evaluation of patient reported outcome measure: Patients' global assessment of disease activity (PtGA) | Up to 4 Years | 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'. |
| Evaluation of patient reported outcome measure: Dermatology life quality index (DLQI) | Up to 4 Years | 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. |
| Evaluation of patient reported outcome measure: EQ-5D-3L | Up to 4 Years | 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. |
Countries
China
Outcome results
None listed