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The main aim of this study is to assess the effects of switching from another biologic to tildrakizumab on patient-reported outcomes and to assess psoriasis intensity, patient's quality of life prior and after switching and the individual rationales for switching biologics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tildrakizumab | Participants who have been prescribed tildrakizumab to manage moderate-to-severe plaque psoriasis according to summary of product characteristic (SmPC) in routine clinical practice settings will be observed prospectively for up to 28 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tildrakizumab | Drug | As provided in real-world clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score | TSQM 11-item scale is derived from the TSQM version 1.4, which comprises four domains: global satisfaction, medication effectiveness, convenience, and side effects with scores at each domain ranging from 0 to 100. Higher scores indicating greater satisfaction and lower scores reflecting room for improvement. | Baseline, Week 28 |
| World Health Organisation Well-Being Index (WHO-5) Score | The WHO-5 consists of 5-items that measure current mental well-being. Each item is rated on 6-point Likert scale, ranging from 0 (at no the time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. | Baseline up to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in absolute Psoriasis Area and Severity Index (PASI) Score | The PASI is a measure of psoriasis and psoriatic arthritis severity that will be assessed at baseline and all follow-up visits for participants with psoriasis or psoriatic arthritis. This common clinical measure selects a representative area of psoriasis for each body region. The intensity of redness, thickness, and scaling of the psoriasis is assessed by the clinician. PASI scores range from 0 to 72, with higher scores indicating worse symptoms. |
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Inclusion Criteria:
Written informed consent.
>=18 years of age.
Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFα antagonist, IL12/23 antagonist, IL17 antagonist).
Switch to tildrakizumab due to:
Treatment with tildrakizumab planned in the frame of clinical practice.
Exclusion Criteria:
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Adult male and female participants with moderate to severe plaque psoriasis will be observed in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Regional Medical Affairs | Contact | +43 0 15953960 | medicalat@almirall.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gesundheitszentrum Citypark Graz | Recruiting | Graz | Styria | 8010 | Austria |
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| Baseline, Week 4, 16 and 28 |
| Change from Baseline in Physician's Global Assessment (PGA) Score | The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema. | Baseline, Week 4, 16 and 28 |
| Change from Baseline in Dermatology Life Quality Index (DLQI) Score | The DLQI consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life. Each item is scored on a 4-point Likert scale (0 = 'not at all / not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). DLQI scores range from 0 to 30, with higher scores indicating worse quality of life. | Baseline, Week 4, 16 and 28 |
| Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab | At Baseline |
| 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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