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Clinical Trials/NCT04203693
NCT04203693
Completed
Not Applicable

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)

Almirall, S.A.41 sites in 6 countries331 target enrollmentOctober 30, 2019
InterventionsTildrakizumab

Overview

Phase
Not Applicable
Intervention
Tildrakizumab
Conditions
Plaque Psoriasis
Sponsor
Almirall, S.A.
Enrollment
331
Locations
41
Primary Endpoint
Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 48
Status
Completed
Last Updated
2 months ago

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.

Registry
clinicaltrials.gov
Start Date
October 30, 2019
End Date
May 2, 2024
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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®.

Arms & Interventions

Cohort 1: Tildrakizumab Treated Participants

Participants will be treated with tildrakizumab who have participated in prior tildrakizumab studies

Intervention: Tildrakizumab

Cohort 2: Newly Tildrakizumab Prescribed Participants

Participants will be newly prescribed tildrakizumab (a prescription has occurred independently of the enrolment in the study)

Intervention: Tildrakizumab

Outcomes

Primary Outcomes

Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 48

Time Frame: At Week 48

The PASI was calculated by assessing four body regions: head (10 percent \[%\] of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.

Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 96

Time Frame: At Week 96

The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.

Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 48

Time Frame: Baseline (current study), Week 48

PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 96

Time Frame: Baseline (current study), Week 96

PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) Scores at Week 48

Time Frame: At Week 48

The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.

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

Time Frame: At Week 96

The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.

Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 48

Time Frame: At Week 48

PASI 75 and 90 defined as percentage of participants who achieved \>=75% and \>=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who have achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).

Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 96

Time Frame: At Week 96

PASI 75 and 90 defined as percentage of participants who achieved \>=75% and \>=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).

Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48

Time Frame: At Week 48

The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.

Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96

Time Frame: At Week 96

The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.

Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 48

Time Frame: Baseline (Day 0 of reSURFACE Studies), Week 48 (Current study)

The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline value of reSURFACE Studies was used to calculate change at Week 48 of current study. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab \[reSURFACE\] clinical trials).

Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 52

Time Frame: At Week 52

The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.

Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 96

Time Frame: Baseline (Day 0 of reSURFACE Studies), Week 96 (Current Study)

The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline value of reSURFACE Studies was used to calculate change at Week 96 of current study. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab \[reSURFACE\] clinical trials).

Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 48

Time Frame: At Week 48

The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.

Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 96

Time Frame: At Week 96

The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.

Cohort 1: Change From Baseline (reSURFACE Studies for General and Current Study for Nail and Scalp) in Physician's Global Assessment (PGA) Score at Week 48

Time Frame: Baseline (Day 0 of reSURFACE Studies for General and current study for Nail and Scalp), Week 48 (Current Study)

The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline value of reSURFACE Studies was used to calculate change for "General" at Week 48 of current study. For "Nail" and "Scalp", Baseline value of current study was used to calculate change. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab \[reSURFACE\] clinical trials).

Cohort 1: Change From Baseline (reSURFACE Studies for General and Current Study for Nail and Scalp) in Physician's Global Assessment (PGA) Score at Week 96

Time Frame: Baseline (Day 0 of reSURFACE Studies for General and current study for Nail and Scalp), Week 96 (Current study)

The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline value of reSURFACE Studies was used to calculate change for "General" at Week 96 of current study. For "Nail" and "Scalp", Baseline value of current study was used to calculate change. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab \[reSURFACE\] clinical trials).

Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Scroe at Week 100

Time Frame: At Week 100

The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.

Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52

Time Frame: Baseline (current study), Week 52

The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 100

Time Frame: Baseline (current study), Week 100

The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

Cohort 2: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 52

Time Frame: At Week 52

The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.

Cohort 2: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 100

Time Frame: At Week 100

The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.

Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 52

Time Frame: At Week 52

PASI 75 and 90 defined as percentage of participants who achieved \>=75% and \>=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who have achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).

Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 100

Time Frame: At Week 100

PASI 75 and 90 defined as percentage of participants who achieved \>=75% and \>=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).

Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52

Time Frame: At Week 52

The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.

Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100

Time Frame: At Week 100

The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.

Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 52

Time Frame: Baseline (current study), Week 52

The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 100

Time Frame: Baseline (current study), Week 100

The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 52

Time Frame: At Week 52

The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.

Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 100

Time Frame: At Week 100

The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.

Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 52

Time Frame: Baseline (current study), Week 52

The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 100

Time Frame: Baseline (current study), Week 100

The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

Secondary Outcomes

  • Change From Baseline in Waist/Hip Ratio at Week 96 for Cohort 1 and Week 100 for Cohort 2(Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100)
  • Absolute Dermatology Life Quality Index (DLQI) Score at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2(Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100)
  • Change From Baseline in Absolute Dermatology Life Quality Index (DLQI) Score at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2(Cohort 1: Baseline (current study), Week 48 and Week 96; Cohort 2: Baseline (current study), Week 52 and Week 100)
  • Absolute Dermatology Life Quality Index Score Adjusted for Not Relevant Responses (DLQI-R) at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2(Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100)
  • Change From Baseline in Dermatology Life Quality Index Score Adjusted for Not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2(Cohort 1: Baseline (current study), Week 48 and Week 96; Cohort 2: Baseline (current study), Week 52 and Week 100)
  • Itch and Pain Visual Analogue Scales (VAS) Scores at Week 96 for Cohort 1 and Week 100 for Cohort 2(Cohort 1: At Week 96; Cohort 2: At Week 100)
  • Change From Baseline in Itch and Pain Visual Analogue Scales (VAS) Scores at Week 96 for Cohort 1 and Week 100 for Cohort 2(Cohort 1: At Week 96; Cohort 2: At Week 100)
  • Absolute Scores of Participant's Satisfaction With Tildrakizumab Therapy as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 96 for Cohort 1 and Week 100 for Cohort 2(Cohort 1: At Week 96; Cohort 2: At Week 100)
  • Absolute Scores of Physician's Satisfaction With Tildrakizumab Therapy for Effectiveness and Tolerability at Week 96 for Cohort 1 and Week 100 for Cohort 2(Cohort 1: At Week 96; Cohort 2: At Week 100)
  • Number of Participants Who Added Concomitant Medications(Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100)
  • Change From Baseline in Body Weight up to Week 96 for Cohort 1 and Week 100 for Cohort 2(Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100)
  • Change From Baseline in Waist and Hip Circumference at Week 96 for Cohort 1 and Week 100 for Cohort 2(Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100)
  • Change From Baseline in Body Mass Index (BMI) at Week 96 for Cohort 1 and Week 100 for Cohort 2(Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100)
  • Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 96 for Cohort 1 and Week 100 for Cohort 2(Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100)
  • Number of Participants With Responses to Questions About Food Intake(Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100)
  • Number of Participants With Responses to Physical Activity Questionnaire(Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100)
  • Change From Baseline in Physical Activity at Week 96 for Cohort 1 and Week 100 for Cohort 2(Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100)
  • Change From Baseline in Lipid Profiles at Week 96 for Cohort 1 and Week 100 for Cohort 2(Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100)
  • Change From Baseline in Lipid Profile (Lipoprotein-a) at Week 96 for Cohort 1 and Week 100 for Cohort 2(Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100)
  • Number of Participants Withdrawn From the Study(Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100)
  • Number of Participants With Reason for Tildrakizumab Dosage Change(Cohort 1: At Week 84; Cohort 2: At Week 100)
  • Drug Survival(Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100)
  • Participants Adherence as Assessed by Time to Study Discontinuation(Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100)

Study Sites (41)

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