A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany (DELPHIN)

Study Overview
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Brief Summary
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The purpose of this observational study is to describe the effectiveness of deucravacitinib treatment and quality of life in adults with moderate-to-severe plaque psoriasis in routine clinical practice in Germany over a 5-year period

Official Title
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Deucravacitinib in Routine Clinical Practice: A 5-year, Multicenter, Prospective, Non-Interventional Cohort Study to Evaluate Effectiveness and Quality of Life in Patients With Moderate-to-Severe Plaque Psoriasis in Germany (DELPHIN)

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Deucravacitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a physician-reported diagnosis of moderate-to-severe plaque psoriasis initiating deucravacitinib according to approved label in the European Union The decision upon treatment with deucravacitinib must have been made before enrollment and independently of this non-interventional observational study Patient is at least 18 years of age at the time of treatment decision Patient provided written informed consent to participate in the study Exclusion Criteria: Any contraindications according to the approved deucravacitinib Summary of Product Characteristics Prior treatment with deucravacitinib Simultaneous participation in an interventional clinical trial for moderate-to-severe psoriasis

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 |
| --- | --- |
| Moderate-to-severe plaque psoriasis<br> | Drug: Deucravacitinib<br>* Non-interventional observational study of patients receiving treatment with commercially available deucravacitinib 6 mg once daily according to the Summary of Product Characteristics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 at Week 24 or nearest visit |  | Approximately 24 weeks after treatment initiation (data to be collected at visit nearest to this timepoint) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of deucravacitinib treatment measured by the number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 and ≤ 6 |  | 5 years | 
| Effectiveness of deucravacitinib treatment measured by the number of participants who achieve Psoriasis Area Severity Index (PASI) 75/90/100 |  | 5 years | 
| Effectiveness of deucravacitinib treatment measured by the number of participants who achieved static Physician's Global Assessment (sPGA) 0/1 and change in sPGA over time |  | 5 years | 
| Effectiveness of deucravacitinib treatment measured by body surface area (BSA) affected by psoriasis and changes in BSA from baseline and over time |  | 5 years | 
| Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the genital area |  | 5 years | 
| Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the intertriginous areas | Including but not limited to axilla, popliteal fossa, inguinal, genital, submammary, anal region | 5 years | 
| Effectiveness of deucravacitinib treatment in sensitive body areas measured by palmoplantar psoriasis Physician's Global Assessment (pp-PGA) for the palmoplantar area |  | 5 years | 
| Effectiveness of deucravacitinib treatment in sensitive body areas measured by target Nail Psoriasis Severity Index (NAPSI) for the nails |  | 5 years | 
| Effectiveness of deucravacitinib treatment in sensitive body areas measured by scalp-specific Physician's Global Assessment (ss-PGA) for the scalp |  | 5 years | 
| Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)-9 |  | 5 years | 
| Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the persistence of deucravacitinib therapy | Time from therapy initiation until discontinuation visualized using Kaplan-Meier methods | 5 years | 
| Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by reasons for therapy discontinuation | Discontinuation of deucravacitinib defined as a treatment interruption of >90 days with or without resumption of deucravacitinib treatment, with or without start of a follow-up therapy | 5 years | 
| Patient-reported outcomes measured by the Dermatology Life Quality Index (DLQI) |  | 5 years | 
| Patient-reported outcomes evaluating pruritus measured by the Itch Numeric Rating Scale (NRS) |  | 5 years | 
| Patient-reported outcomes measured by the Patient Benefit Index standard version (PBI-S) |  | 5 years |