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This is an ethics-approved, multi-national, multi-site Phase IV, 1-cohort prospective observational study. The main purpose of this study is to assess the effect of tildrakizumab on the overall wellbeing in patients with moderate-to-severe psoriasis using the 5-item World Health Organization Wellbeing Index (WHO-5) questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tildrakizumab | Patients diagnosed with moderate-to-severe plaque psoriasis who require systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor in real-world clinical practice, following the routine clinical practice on each patient country, will be observed for 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tildrakizumab | Drug | As provided in real world clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score | Baseline and Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score | Baseline; 16 and 28 weeks; 12, 18 months after baseline visit | |
| Change from Baseline in Physician's Satisfaction Questionnaire Score | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of patients with moderate-to-severe plaque psoriasis who need systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor treatment in real-world clinical practice.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haut- und Laserzentrum Freising | Freising | Bavaria | 85354 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42146323 | Derived | Mrowietz U, Sommer R, Reguiai Z, Gerdes S, Dauden E, Weger W, Maul JT, Naldi L, Ghislain PD, Laws PM, De Jong EMGJ, Mburu S, Koscielny V, Massana E, Sapena V, Domenech A, Kasujee I, Augustin M. Patient-Reported Well-Being in Value-Based Routine Care in Psoriatic Disease Using Tildrakizumab: 2-Year Data of the Phase IV POSITIVE Study. Psoriasis (Auckl). 2026 May 12;16:590189. doi: 10.2147/PTT.S590189. eCollection 2026. | |
| 40605963 |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000598434 | tildrakizumab |
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| Change from Baseline in FamilyPso Questionnaire Score | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit |
| Change From Baseline in Dermatology Life Quality Index-Relevant (DLQI-R) Score | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit |
| Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit |
| Change From Baseline in Treatment-related Patient Benefit Index 2.0 (PBI 2.0) Score | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit |
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) Score | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit |
| Skin Manifestations Distribution (Patient's Grid/Heat Map) | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit |
| Change from Baseline in Numerical Rating Scale (NRS) Scores for Itch, Pain, Joint Pain and Fatigue | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit |
| Change from Baseline in Psoriasis Area and Severity Index (PASI) Score | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit |
| Number of Patients Compliance to Sociodemographic Characteristics and Clinical Characteristics | From Baseline up to 24 months |
| Number of Patients With Treatment-emergent Adverse Events (TEAE) | From Baseline up to 24 months |
| Derived |
| Mrowietz U, Sommer R, Gerdes S, Reguiai Z, Weger W, Dauden E, Maul JT, Ghislain PD, Laws PM, Naldi L, De Jong E, Mburu S, Koscielny V, Massana E, Domenech A, Gaarn du Jardin K, Kasujee I, Augustin M. Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study. Psoriasis (Auckl). 2025 Jun 28;15:243-259. doi: 10.2147/PTT.S526748. eCollection 2025. |
| 36792337 | Derived | Augustin M, Sommer R, Dauden E, Laws P, de Jong E, Fabbrocini G, Naldi L, Navarini A, Lambert J, Reguiai Z, Gerdes S, Massana E, Obis T, Kasujee I, Mrowietz U. Patient-reported well-being in value-based care using tildrakizumab in a real-world setting: protocol of a multinational, phase IV, 1-cohort prospective observational study (the POSITIVE study). BMJ Open. 2023 Feb 15;13(2):e060536. doi: 10.1136/bmjopen-2021-060536. |