Plaque Psoriasis
Conditions
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
Interventions
DRUGDeucravacitinib
Non-interventional observational study of patients receiving treatment with commercially available deucravacitinib 6 mg once daily according to the Summary of Product Characteristics
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
* 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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 measured by the number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 and ≤ 6 | 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 | — |
| Effectiveness of deucravacitinib treatment in sensitive body areas measured by scalp-specific Physician's Global Assessment (ss-PGA) for the scalp | 5 years | — |
Countries
Germany
Outcome results
None listed