A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis

Almirall

Status: Enrolling

Conditions: Plaque Psoriasis

Treatments: Drug: Tildrakizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06030076

SW-ATCH

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent.

2. >=18 years of age.

3. Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFα antagonist, IL12/23 antagonist, IL17 antagonist).

4. Switch to tildrakizumab due to:

   1. primary or secondary treatment failure (PASI >= 3 or ΔPASI < 75 and/or DLQI > 5)
   2. adverse events, contraindication, intolerance
   3. patient wish (dosing regimen), lack of adherence, or other, including nonmedical reason

5. Treatment with tildrakizumab planned in the frame of clinical practice.

Exclusion criteria

1. Patient appears to be unwilling or unable to comply with the requirements of the study or who, in the opinion of the Investigator, should not participate in the study.
2. >=3 previous biologic treatments in the last 3 years.
3. Participation in a clinical trial simultaneous to participation in SW-ATCH.
4. Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance.
5. Patient dependent on the Investigator.
6. Previous treatment with Tildrakizumab.

Trial design

50 participants in 1 patient group

Tildrakizumab

Description:

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.

Treatment:

Drug: Tildrakizumab