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

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)

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Tildrakizumab

• Study Type: Observational
• Enrollment (Actual): 331

Contacts and Locations

Study Locations

• Austria
  • Baden, Austria
    • Investigator Site 1
  • Vienna, Austria
    • Investigator Site 2
• Belgium
  • Brussels, Belgium
    • Investigator Site 1
  • Charleroi, Belgium
    • Investigator Site 2
  • Genk, Belgium
    • Investigator Site 3
  • Ghent, Belgium
    • Investigator Site 4
  • Herstal, Belgium
    • Investigator Site 5
  • Jette, Belgium
    • Investigator Site 6
  • Lede, Belgium
    • Investigator Site 7
  • Leuven, Belgium
    • Investigator Site 8
  • Mons, Belgium
    • Investigator Site 9
• France
  • Nice, France
    • Investigational Site 1
  • Poitiers, France
    • Investigator Site 2
• Germany
  • Augsburg, Germany
    • Investigational Site 1
  • Berlin, Germany
    • Investigational Site 2
  • Bochum, Germany
    • Investigational Site 3
  • Cologne, Germany
    • Investigational site 10
  • Erlangen, Germany
    • Investigational Site 4
  • Greifswald, Germany
    • Investigational Site 5
  • Halle, Germany
    • Investigational Site 7
  • Hamburg, Germany
    • Investigational Site 6
  • Kiel, Germany
    • Investigational Site 8
  • Kiel, Germany
    • Investigational Site 9
  • Lübeck, Germany
    • Investigational site 11
  • Merzig, Germany
    • Investigational site 13
  • München, Germany
    • Investigational site 12
  • Oberursel, Germany
    • Investigational site 14
  • Quedlinburg, Germany
    • Investigational site 15
• Italy
  • Arezzo, Italy
    • Investigational Site 1
  • Brescia, Italy
    • Investigational Site 2
  • Catania, Italy
    • Investigational Site 3
  • Florence, Italy
    • Investigational Site 4
  • Genova, Italy
    • Investigational Site 5
  • Lecce, Italy
    • Investigational Site 6
  • Modena, Italy
    • Investigational Site 7
  • Roma, Italy
    • Investigational site 10
  • Roma, Italy
    • Investigational site 11
  • Roma, Italy
    • Investigational Site 8
  • Roma, Italy
    • Investigational Site 9
  • Rozzano, Italy
    • Investigational site 12
• Netherlands
  • Breda, Netherlands
    • Investigational Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult male and female patients with moderate-to-severe chronic plaque psoriasis.

Description

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®.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score 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.	At Week 48
Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score 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.	At Week 96
Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 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.	Baseline (current study), Week 48
Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 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.	Baseline (current study), Week 96
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	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.	At 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	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.	At Week 96
Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses 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).	At Week 48
Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses 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).	At Week 96
Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48	The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.	At Week 48
Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96	The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.	At Week 96
Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 48	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).	Baseline (Day 0 of reSURFACE Studies), Week 48 (Current study)
Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 96	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).	Baseline (Day 0 of reSURFACE Studies), Week 96 (Current Study)
Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores 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.	At Week 48
Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores 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.	At Week 96
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	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).	Baseline (Day 0 of reSURFACE Studies for General and current study for Nail and Scalp), Week 48 (Current Study)
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	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).	Baseline (Day 0 of reSURFACE Studies for General and current study for Nail and Scalp), Week 96 (Current study)
Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Score 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.	At Week 52
Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Scroe 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.	At Week 100
Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score 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. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	Baseline (current study), Week 52
Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score 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. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	Baseline (current study), Week 100
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	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.	At Week 52
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	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.	At Week 100
Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses 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).	At Week 52
Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses 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).	At Week 100
Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52	The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.	At Week 52
Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100	The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.	At Week 100
Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at 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.	Baseline (current study), Week 52
Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at 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.	Baseline (current study), Week 100
Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores 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.	At Week 52
Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores 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.	At Week 100
Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores 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. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	Baseline (current study), Week 52
Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores 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. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	Baseline (current study), Week 100

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	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	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.	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	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. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	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	Itch and pain of the skin were assessed by the participants on visual analogue scales (VAS) score ranged from 0 to 100, where 0 represented the best possible condition ("no itching" and "no skin pain", respectively) and 100 the worst possible condition ("worst itch imaginable" and "severe skin pain", respectively). Higher score indicates worse outcome.	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	Itch and pain of the skin were assessed by the participants on visual analogue scales (VAS) score ranged from 0 to 100, where 0 represented the best possible condition ("no itching" and "no skin pain", respectively) and 100 the worst possible condition ("worst itch imaginable" and "severe skin pain", respectively). Higher score indicates worse outcome. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	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	TSQM Version 1.4 was used to determine participant´s satisfaction with the tildrakizumab (Ilumetri®) therapy. This questionnaire was comprised of 14 items which represented the following four domains:(1) Effectiveness (3 items, Question [Q]1-Q3); (2) Side effects (5 items, Q4-Q8); (3) Convenience (3 items, Q9-Q11); (4) Global satisfaction (3 items, Q12-Q14). TSQM scores for the each domain ranged from 0 to 100, higher scores indicate greater satisfaction.	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	The effectiveness and tolerability of tildrakizumab (Ilumetri®) were rated on a 4-point scale ranging over 1 to 4, where 1 = "very good", 2 = "good", 3 = "acceptable" and 4 = "bad". The higher score means no or bad satisfaction.	Cohort 1: At Week 96; Cohort 2: At Week 100
Number of Participants Who Added Concomitant Medications	Number of participants who added concomitant medications were reported.	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	Change from baseline in body weight at Week 96 for Cohort 1 and Week 100 for Cohort 2 was reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	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	Change from baseline in waist and hip circumference at Week 96 for Cohort 1 and Week 100 for Cohort 2 were reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100
Change From Baseline in Waist/Hip Ratio at Week 96 for Cohort 1 and Week 100 for Cohort 2	Change from baseline in waist/hip ratio at Week 96 for Cohort 1 and Week 100 for Cohort 2 were reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	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	Change from baseline in BMI at Week 96 for Cohort 1 and Week 100 for Cohort 2 were reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	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	Change from baseline in systolic and diastolic BP at Week 96 for Cohort 1 and Week 100 for Cohort 2 were reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100
Number of Participants With Responses to Questions About Food Intake	Participants were asked to complete a simple questionnaire regarding their food intake, which included the following questions: 1. Do you limit yourself in calorie intake; 2. Do you follow any other kind of diet; 3. Do you have any food intolerance; 4. Do you have any food allergy.	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	Participants were asked to complete a simple questionnaire regarding their physical activity i.e. Workout (e.g. aerobic activity), Weight training (exercises in the gym) and Stretch exercise e.g. Yoga. Number of participants With Responses to Physical Activity Questionnaire were reported.	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	Exercise time of workout, weight training and stretch exercise was calculated in total minutes per month as: Minutes of exercise per day * Number of days in the month. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	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	Change from baseline in lipid profiles (total cholesterol, high-density lipoprotein cholesterol [HDL-c], low-density lipoprotein cholesterol [LDL-c], Triglycerides [TG]) at Week 96 for Cohort 1 and Week 100 for Cohort 2 were reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	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	Change from baseline in lipid profile (lipoprotein-a) at Week 96 for Cohort 1 and Week 100 for Cohort 2 were reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.	Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100
Number of Participants Withdrawn From the Study	Number of participants withdrawn from the study due to any reason were reported.	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	Number of participants with reasons of tildrakizumab change (100 mg or 200 mg) were reported.	Cohort 1: At Week 84; Cohort 2: At Week 100
Drug Survival	Drug survival was defined as the time to study drug discontinuation. The time to discontinuation of the study drug (months) was measured from the (first dosing date to the last dosing date)/30.5.	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	Time to study discontinuation was defined as: (first dosing date to the study completion date or decided to discontinue date)/30.5.	Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Investigators: Study Director: Study Director, Almirall, S.A.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): May 2, 2024
• Study Completion (Actual): May 2, 2024

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Moderate to severe plaque psoriasis; Ilumetri®; Tildrakizumab
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; tildrakizumab
• Other Study ID Numbers: NIS Study M-14745-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No