A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with plaque psoriasis.

Official Title
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A Real-world, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib Versus Apremilast in Adults With Plaque Psoriasis - North American Region

Conditions
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Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been diagnosed with plaque psoriasis by a dermatologist Newly initiating an eligible medication for enrollment (i.e., deucravacitinib, apremilast) Actively enrolled in the CorEvitas Psoriasis Registry and have documented consent to allow copies of information from the registry be used for research purposes Exclusion Criteria: Currently participating in an interventional clinical trial (does not include observational registry or study)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants that have initiated deucravacitinib | |
| Cohort 2<br>Participants that have initiated apremilast | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body surface area (BSA) |  | At baseline and every 6 months up to 60 months or treatment discontinuation | 
| Investigator global assessment (IGA) response 0/1 |  | Up to 60 months | 
| Dermatology life quality index (DLQI) response 0/1 |  | Up to 60 months | 
| Time from date of treatment initiation to date of discontinuation |  | Up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 75 percent improvement in Psoriasis area and severity index (PASI) score |  | At baseline and every 6 months up to 60 months or treatment discontinuation | 
| PASI score response ≤ 5 |  | At baseline to follow-up, up to 60 months | 
| PASI score response ≤ 3 |  | At baseline to follow-up, up to 60 months | 
| National psoriasis foundation (NPF) acceptable body surface area (BSA) response |  | At baseline to follow-up, up to 60 months | 
| NPF target BSA response |  | At baseline to follow-up, up to 60 months | 
| Change in investigator global assessment (IGA) score |  | Up to 60 months | 
| Change in dermatology life quality index (DLQI) response |  | At baseline to follow-up, up to 60 months | 
| Change in DLQI response ≤5 |  | At baseline to follow-up, up to 60 months | 
| Change in visual analog scale (VAS): Itch response |  | At baseline to follow-up, up to 60 months | 
| Change in VAS: Skin Pain response |  | At baseline to follow-up, up to 60 months | 
| Change in VAS: Fatigue Response |  | At baseline to follow-up, up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real-world, Deucravacitinib, Observational