Psoriasis
Conditions
Keywords
Japan, Observational, Psoriasis, Retrospective
Brief summary
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment patterns: Status of phototherapy combination with systemic treatment | Up to 4 years |
| 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 |
| Distribution of participant background at first visit: Age | At Baseline |
| Distribution of participant background at first visit: Sex | At Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 4 years | 75% reduction in the Psoriasis Area and Severity Index score (PASI 75) |
| Mean number of drug changes until participants achieve PASI 90 during study period | Up to 4 years | 90% reduction in the Psoriasis Area and Severity Index score (PASI 90) |
| Mean number of drug changes until participants achieve PASI 100 during study period | Up to 4 years | 100% reduction in the Psoriasis Area and Severity Index score (PASI 100) |
| 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 | — |
| Distribution of comorbidities that affect treatment choice and change | Up to 4 years | — |
Countries
Japan
Outcome results
None listed