Long-Term Treatment Effect With Tildrakizumab in Participants With Plaque Psoriasis

Time to relapse is defined as the time interval between the last administration of Tildrakizumab and the relapse of psoriasis in days.

The PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease).

The PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Change from baseline will be calculated by subtracting post-dose value from baseline value.

The BSA is a numerical score used to measure the total area of the body affected by psoriasis. The palm method will be applied: the participant's palm, including the five digits is used as a reference (representing approximately 1% of the total body surface area) and is used to repeatedly cover the lesions on the body. The investigator totals the number of palms required and then estimates the percentage (%) in each of the four body regions: head (including scalp) and neck (10%); upper extremities (20%); trunk (30%); and lower extremities (40%).

The BSA is a numerical score used to measure the total area of the body affected by psoriasis. The palm method will be applied: the participant's palm, including the five digits is used as a reference (representing approximately 1% of the total body surface area) and is used to repeatedly cover the lesions on the body. The investigator totals the number of palms required and then estimates the percentage (%) in each of the four body regions: head (including scalp) and neck (10%); upper extremities (20%); trunk (30%); and lower extremities (40%). Change from baseline will be calculated by subtracting post-dose value from baseline value.

DLQI is a questionnaire to evaluate the impact on participant's quality of life due to psoriasis. It is composed of 10 items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 (no effect at all on participant's life) to 30 (extremely large effect on participant's life), with lower scores indicating better quality of life.

The DLQI-R is a scoring modification for the DLQI to better evaluate not relevant responses on the DLQI that could lead to underestimation of the impact on quality of life. DLQI-R is a scoring modification involves multiplying the original DLQI score by a conversion factor that increases with the number of not relevant responses.

DLQI is a questionnaire to evaluate the impact on participant's quality of life due to psoriasis. It is composed of 10 items related to symptoms, feelings, daily activities, leisure, working/studying activities, personal relationships \& opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores \& ranges from 0 (no effect at all on participant's life) to 30 (extremely large effect on participant's life), with lower scores indicating better quality of life. Change from baseline will be calculated by subtracting post-dose value from baseline value.

DLQI-R is a scoring modification for the DLQI to better evaluate not relevant responses on the DLQI that could lead to underestimation of the impact on quality of life. DLQI-R, a scoring modification involves multiplying the original DLQI score by a conversion factor that increases with the number of not relevant responses. Change from baseline will be calculated by subtracting post-dose value from baseline value.

The PGA is used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score.

The PGA is used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score. Change from baseline will be calculated by subtracting post-dose value from baseline value.

The nPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe nail psoriasis lesions. Only in participants with nail involvement the nPGA assessment will be performed.

The nPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe nail psoriasis lesions. Only in participants with nail involvement the nPGA assessment will be performed. Change from baseline will be calculated by subtracting post-dose value from baseline value.

The scPGA score is used to assess the average severity of scalp psoriasis lesions. The scPGA is also 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe scalp psoriasis lesions. Only in participants with scalp involvement, the scPGA assessment will be performed.

The scPGA score is used to assess the average severity of scalp psoriasis lesions. The scPGA is also 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe scalp psoriasis lesions. Only in participants with scalp involvement, the scPGA assessment will be performed. Change from baseline will be calculated by subtracting post-dose value from baseline value.

Both Pain-NRS and Pruritus-NRS are a unidimensional segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain or pruritus. The 11-point numeric scale of NRS ranges from 0 to 10, describing pain severity extremes scale 0 (no pain) to 10 (worst imaginable pain) and pruritus-severity extremes scale 0 (no pruritis) to 10 (worst imaginable pruritus), where higher scores indicates worse pain and pruritus.

Both Pain-NRS and Pruritus-NRS are a unidimensional segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain or pruritus. The 11-point numeric scale of NRS ranges from 0 to 10, describing pain severity extremes scale 0 (no pain) to 10 (worst imaginable pain) and pruritus-severity extremes scale 0 (no pruritis) to 10 (worst imaginable pruritus), where higher scores indicates worse pain and pruritus. Change from baseline will be calculated by subtracting post-dose value from baseline value.

An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, or is life threatening, or requires in participant hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is any other medically important event.

Physical Examination includes measuring height, weight, body mass index, waist circumference (cm), and waist hip ratio.

Following vital signs with clinically significant observation will be measured as safety variables: diastolic and systolic blood pressure, heart rate, respiratory rate and body temperature. Change from baseline will be calculated by subtracting post-dose value from baseline value.

Clinically Significant hematology and biochemical parameters will be assessed. Change from baseline will be calculated by subtracting post-dose value from baseline value.