Observational Study of Tildrakizumab in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
The observational, non-interventional study will assess the efficacy, safety, prescription and utilization patterns of Tildrakizumab in participants with moderate to severe plaque psoriasis in routine clinical practice.

Official Title
-----------------
Observational Study to Assess the Effectiveness, Safety Profile and Real-life Prescribing and Utilization Patterns of Tildrakizumab (Ilumetri®) in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice. (SAIL)

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: Tildrakizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent form. Age >= 18years. Moderate to severe chronic plaque psoriasis diagnosis. Participants who have participated in Tildrakizumab (Ilumetri®) clinical trials (Cohort 1) OR participants who, according to the physician's therapeutic decision, should start the treatment with Tildrakizumab (Ilumetri®) (Cohort 2). Exclusion Criteria: Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study. Participants meeting any of the exclusion criteria specified in the summary of product characteristics (SmPC) of Ilumetri®.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: Tildrakizumab Treated Participants<br>Participants will be treated with tildrakizumab who have participated in prior tildrakizumab studies | Drug: Tildrakizumab<br>* The study physicians will choose the treatment independently of the enrolment in the study according to routine care.<br>|
| Cohort 2: Newly Tildrakizumab Prescribed Participants<br>Participants will be newly prescribed tildrakizumab (a prescription has occurred independently of the enrolment in the study) | Drug: Tildrakizumab<br>* The study physicians will choose the treatment independently of the enrolment in the study according to routine care.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) at Week 48 | PASI is a combined assessment of lesion severity and affected area into a single score. | Week 48 | 
| Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) at Week 96 | PASI is a combined assessment of lesion severity and affected area into a single score. | Week 96 | 
| Cohort 1: Change From Baseline in Psoriasis Area and Severity Index at Week 48 | PASI is a combined assessment of lesion severity and affected area into a single score. | Baseline (Day 0) and Week 48 | 
| Cohort 1: Change From Baseline in Psoriasis Area and Severity Index at Week 96 | PASI is a combined assessment of lesion severity and affected area into a single score. | Baseline (Day 0) and Week 96 | 
| Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index Scores and Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) at Week 48 | PASI is used to assess the lesion severity and affected area due to psoriasis. Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses. | Week 48 | 
| Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index Scores and Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) at Week 96 | PASI is used to assess the lesion severity and affected area due to psoriasis. Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses. | Week 96 | 
| Cohort 1: Percentage of Participants who maintaining Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 48 | PASI is a combined assessment of lesion severity and affected area into a single score. | Week 48 | 
| Cohort 1: Percentage of Participants who maintaining Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 96 | PASI is a combined assessment of lesion severity and affected area into a single score. | Week 96 | 
| Cohort 1: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48 | BSA is a numerical score used to measure the total area of the body affected by psoriasis. | Week 48 | 
| Cohort 1: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96 | BSA is a numerical score used to measure the total area of the body affected by psoriasis. | Week 96 | 
| Cohort 1: Change from Baseline in Body Surface Area Affected by Psoriasis at Week 48 | BSA is a numerical score used to measure the total area of the body affected by psoriasis. | Baseline (Day 0) and Week 48 | 
| Cohort 1: Change from Baseline in Body Surface Area Affected by Psoriasis at Week 96 | BSA is a numerical score used to measure the total area of the body affected by psoriasis. | Baseline (Day 0) and Week 96 | 
| Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 48 | PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body. | Week 48 | 
| Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 96 | PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body. | Week 96 | 
| Cohort 1: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail, Scalp) at Week 48 | PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body. PGA of psoriasis in general, at nail and scalp will be graded from 0 (none/clear) to 4 (severe). | Baseline (Day 0) and Week 48 | 
| Cohort 1: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail, Scalp) at Week 96 | PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body. PGA of psoriasis in general, at nail and scalp will be graded from 0 (none/clear) to 4 (severe). | Baseline (Day 0) and Week 96 | 
| Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) at Week 52 | PASI is a combined assessment of lesion severity and affected area into a single score. | Week 52 | 
| Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) at Week 100 | PASI is a combined assessment of lesion severity and affected area into a single score. | Week 100 | 
| Cohort 2: Change From Baseline in Psoriasis Area and Severity Index at Week 52 | PASI is a combined assessment of lesion severity and affected area into a single score. | Baseline (Week 0) and Week 52 | 
| Cohort 2: Change From Baseline in Psoriasis Area and Severity Index at Week 100 | PASI is a combined assessment of lesion severity and affected area into a single score. | Baseline (Week 0) and Week 100 | 
| Cohort 2: Correlation between absolute Psoriasis Area and Severity Index scores and Dermatology Life Quality Index adjusted for not relevant responses at Week 52 | PASI is used to assess the lesion severity and affected area due to psoriasis. Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses. | Week 52 | 
| Cohort 2: Correlation between absolute Psoriasis Area and Severity Index scores and Dermatology Life Quality Index adjusted for not relevant responses at Week 100 | PASI is used to assess the lesion severity and affected area due to psoriasis. Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses. | Week 100 | 
| Cohort 2: Percentage of Participants who Achieved Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 52 | PASI is a combined assessment of lesion severity and affected area into a single score. | Week 52 | 
| Cohort 2: Percentage of Participants who Achieved Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 100 | PASI is a combined assessment of lesion severity and affected area into a single score. | Week 100 | 
| Cohort 2: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52 | BSA is a numerical score used to measure the total area of the body affected by psoriasis. | Week 52 | 
| Cohort 2: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100 | BSA is a numerical score used to measure the total area of the body affected by psoriasis. | Week 100 | 
| Cohort 2: Change from Baseline in Percent Body Surface Area Affected by Psoriasis (BSA) at Week 52 | BSA is a numerical score used to measure the total area of the body affected by psoriasis. | Baseline and Week 52 | 
| Cohort 2: Change from Baseline in Percent Body Surface Area Affected by Psoriasis (BSA) at Week 100 | BSA is a numerical score used to measure the total area of the body affected by psoriasis. | Baseline and Week 100 | 
| Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) at Week 52 | PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body. | Week 52 | 
| Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) at Week 100 | PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body. | Week 100 | 
| Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (Scores of General, Nail and Scalp) at Week 52 | PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body. | Baseline (Day 0) and Week 52 | 
| Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (Scores of General, Nail and Scalp) at Week 100 | PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body. | Baseline (Day 0) and Week 100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Dermatology Life Quality Index and Dermatology Life Quality Index Adjusted for not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2 | Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses. | Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100 | 
| Change from Baseline in Absolute Dermatology Life Quality Index and Dermatology Life Quality Index Adjusted for not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2 | Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses. | Cohort 1: Baseline (Day 0), Week 48 and Week 96; Cohort 2: Baseline, Week 52 and Week 100 | 
| Itch and Pain Visual Analogue Scales (VAS) Scores | Itch and pain of the skin will be assessed by the participant on visual analogue scales (VAS). | Baseline (Day 0) to Week 96/100 | 
| Change from Baseline in Itch and Pain Visual Analogue Scales Scores | Itch and pain of the skin will be assessed by the participant on visual analogue scales (VAS). | Baseline (Day 0) to Week 96/100 | 
| Number of participants who Used Concomitant Medications From Baseline at Week 48 and 96 for Cohort 1 and Week 52 and 100 for Cohort 2 | Concomitant topical, photo- or systemic anti-psoriatic and non-psoriasis therapy will be assessed. | Cohort 1: Baseline (Day 0), Week 48 and Week 96; Cohort 2: Baseline, Week 52 and Week 100 | 
| Change from Baseline in Body Weight at End of study (EOS)/End of treatment (ET) | Change in the body weight measurement will be assessed. | Baseline (Day 0) and Week 96/100 (EOS)/ET | 
| Change from Baseline in Waist and hip Circumference at EOS/ET | Change in waist and hip circumference will be assessed. | Baseline (Day 0) and Week 96/100 (EOS)/ET | 
| Change from Baseline in Body Mass Index (BMI) at EOS/ET | Change in BMI will be assessed. | Baseline (Day 0) and Week 96/100 (EOS)/ET | 
| Change from Baseline in Blood Pressure at EOS/ET | Change in Blood Pressure will be assessed. | Baseline (Day 0) and Week 96/100 (EOS)/ET | 
| Change from Baseline in Food Intake up to EOS/ET | Participants will be asked to complete a simple questionnaire regarding their food intake. | Baseline (Day 0) to Week 96/100 (EOS)/ET | 
| Change from Baseline in Physical Activity up to EOS/ET | Participants will be asked to complete a simple questionnaire regarding their physical activity. | Baseline (Day 0) to Week 96/100 (EOS)/ET | 
| Change from baseline in Lipid Profiles up to EOS | Serum lipid will be assessed, if available | Baseline (Day 0) to Week 96/100 (EOS) | 
| Number of Participants Withdraw From the Study Overtime | Participants who discontinue treatment prior to the regular end of the observation period. | Baseline (Day 0) to Week 96/100 (EOS) | 
| Number of Participants who Underwent Dose Change up to EOS/ET | The number of participants who underwent dose change (100 mg or 200 mg). | Baseline (Day 0) to Week 96/100 (EOS)/ET | 
| Drug Survival up to EOS/ET | Drug survival is defined as the time from initiation of therapy to discontinuation. | Baseline (Day 0) to Week 96/100 (EOS)/ET | 
| Number of Participant's With Adherence to Treatment up to EOS/ET | Number of Participant's who adhere to the treatment will be assessed. | Baseline (Day 0) to Week 96/100 (EOS)/ET | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ilumetri®, Tildrakizumab, Moderate to severe plaque psoriasis