Severe plaque psoriasis Skin and Connective Tissue Diseases
Conditions
Interventions
This non-interventional study will be conducted in patients with psoriasis by dermatologists across up to 40 centers according to routine clinical practice and provisions of the National Therapeutic P
Sponsors
Terapia S.A. a SUN PHARMA Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients (>18 years) diagnosed with severe psoriasis 2. Eligible for Tildrakizumab (Ilumetri®) treatment according to SmPC and National Therapeutic Protocol and for whom decision of Tildrakizumab (Ilumetri®) prescription was done before enrolment in the study
Exclusion criteria
Exclusion criteria: 1. Patients who are not fulfilling the inclusion criteria according to the product SmPC and National Therapeutic Protocol 2. Patients participating in other trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving PASI 75, defined as 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) after treatment at week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients achieving PASI 75, defined as 75% reduction (improvement) in the PASI score after treatment at week 52 and end of study visit 2. Proportion of patients maintaining PASI 75 response, defined as the percentage of patients which continue to meet 75% reduction (improvement) in the PASI score after treatment at week 52 and end of study visit 3. Percentage of subjects achieving PASI 90 measured using the PASI 90% reduction (improvement) in the PASI score after treatment at week 28, 52 and end of study visit 4. Percentage of subjects achieving PASI 100 measured using the PASI 100% reduction (improvement) in the PASI score after treatment at week 28, 52 and end of study visit. 5. Special areas scores in patients with scalp psoriasis if applicable, measured using the Psoriasis Scalp Severity Index (PSSI) at baseline, week 28, 52 and end of study visit 6. Special areas scores for palm and sole psoriasis if applicable, measured using the Erythema, Scaling, Induration, Fissuring Scale (ESIFS) at baseline, week 28, 52 and end of study visit 7. Special areas score in patients with nail psoriasis if applicable, measured using the Nail Psoriasis Severity Index (NAPSI) at baseline, week 28, 52 and end of study visit 8. Absolute PASI score measured at baseline, week 28, 52 and end of study visit 9. Percentage of subjects with adverse events, drug-related treatment-emergent adverse events and change from baseline in laboratory parameters as specified in National Therapeutic Protocol, measured using AE forms at each study visit 10. DLQI score measured using the Dermatology Life Quality Index (DLQI) questionnaire at baseline, week 16, 28, 52 and end of study visit | — |
Countries
Romania
Contacts
Public ContactAlina Iordache
Outcome results
None listed