Plaque psoriasis
Conditions
Interventions
None listed
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for this study, patients will be required to meet all of the following criteria at the time of consent: - Be aged 18 years old or older - Physician-reported diagnosis of plaque psoriasis - Be newly initiating DEUC or APR according to the label - Patients who have signed informed consent
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: - Patients currently participating in or planning to participate in an interventional clinical trial - Patients enrolled in DEUC Post Marketing Surveillance (PMS; ClinicalTrial.gov ID: NCT05633264) - Previous treatment experience with the treatment of interest (e.g. patients who have history of APR will not be eligible to be enrolled in APR arm of the study and similar for DEUC)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the real-world effectiveness of DEUC in terms of: 1. Skin clearance a. Change in Body Surface Area (BSA) from baseline to follow-up b. Physician's Global Assessment (PGA) 0/1 response at follow-up c. Absolute Psoriasis Area and Severity Index (PASI) <=2 response at follow-up 2. Health-related quality of life (HRQoL) - Dermatology Life Quality Index (DLQI) 0/1 response at follow-up 3. Drug survival of DEUC - Time from therapy initiation until discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes 1. To compare the effectiveness of DEUC and APR regarding: a. Skin clearance i) Change in BSA from baseline to follow-up ii) PGA 0/1 response at follow-up iii) Absolute PASI <=2 response at follow-up b. HRQoL - DLQI 0/1 response at follow-up c. Drug survival - Time from therapy initiation until discontinuation 2. To describe patients initiating DEUC or APR regarding demographics, disease characteristics, and medical history 3. Additional DEUC effectiveness measures regarding: a. PGA change b. DLQI <=5; change in DLQI c. PASI 75 response, PASI 90 response, absolute PASI score <=3, 5 d. National Psoriasis Foundation (NPF) Acceptable BSA: BSA <=3% or BSA75 and Target response (BSA <=1%) e. Severity score in the hard-to-treat areas (scalp, nail, palmoplantar) i). Scalp specific PGA (ss-PGA) 0/1 ii). PGA-Fingernail (PGA-F) 0/1 iii). Palmoplantar PGA (pp-PGA) 0/1 4. Additional comparative effectiveness of DEUC and APR measures regarding: a. PGA change b. DLQI <=5; change in DLQI c. PASI 75 response, PASI 90 response, absolute PASI score <=3, 5 d. NPF Acceptable BSA: BSA <=3% or BSA75 and Target response (BSA <=1%) e. Severity score in the hard-to-treat areas (scalp, nail, palmoplantar) i). ss-PGA 0/1 ii). PGA-F 0/1 iii). pp-PGA 0/1 Exploratory outcomes 1. To describe the development of psoriatic arthritis in patients taking DEUC and APR 2. To describe the frequency of adverse events (AEs) and serious AEs for DEUC 3. To describe treatment changes (e.g., switching, subsequent treatment, discontinuation, resumption, and reasons for discontinuation/switching) in DEUC and APR 4. To compare change in 100-point Visual Analog Scale in DEUC and APR a. Itch b. Skin pain 5. To compare change in PGA x BSA in DEUC and APR 6. To evaluate treatment satisfaction in DEUC using TSQM-9 7. To evaluate the gastro-intestinal intolerance during the initiatio | — |
Countries
Japan
Contacts
Public ContactYuki Murabayashi
Mebix, Inc. Research Promotion Headquarters
Outcome results
None listed