Plaque Psoriasis
Conditions
Brief summary
This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast.
Interventions
DRUGDeucravacitinib
According to the product label
DRUGApremilast
According to the product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Japanese adult participants aged 18 years old or older * Physician-reported diagnosis of plaque psoriasis * Newly initiating deucravacitinib or apremilast according to the label * Participants who have signed informed consent
Exclusion criteria
* Participants currently participating in or planning to participate in an interventional clinical trial * Patients enrolled in deucravacitinib post-marketing surveillance study (ClinicalTrial.gov ID: NCT05633264) * Previous treatment experience with the treatment of interest (e.g. patients who have history of apremilast will not be eligible to be enrolled in apremilast arm of the study and similar for deucravacitinib)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib. | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) | 1 month, 3 months, 6 months and every 6 months up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
Countries
Japan
Contacts
Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain NCT # and Site #.
Outcome results
None listed