A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany (DELPHIN)
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Moderate-to-severe plaque psoriasis
|
Drug: Deucravacitinib
Non-interventional observational study of patients receiving treatment with commercially available deucravacitinib 6 mg once daily according to the Summary of Product Characteristics
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 [5 years]
Including but not limited to axilla, popliteal fossa, inguinal, genital, submammary, anal region
- 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 [5 years]
Time from therapy initiation until discontinuation visualized using Kaplan-Meier methods
- Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by reasons for therapy discontinuation [5 years]
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
- 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]
Eligibility Criteria
Criteria
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
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Patient is at least 18 years of age at the time of treatment decision
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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
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Simultaneous participation in an interventional clinical trial for moderate-to-severe psoriasis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dermatologische Spezial- und Schwerpunktpraxis Selters | Selters | Rhineland-Palatinate | Germany |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- IM011-250