An observational study in Plaque Psoriasis, sponsored by Almirall, S.A.. Completed at 41 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Almirall, S.A. · Observational
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.
Almirall, S.A. is the lead sponsor of 64 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult male and female patients with moderate-to-severe chronic plaque psoriasis.
Exclusion Criteria:
Participants will be treated with tildrakizumab who have participated in prior tildrakizumab studies
Drug: Tildrakizumab
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
This study was conducted at 41 study sites over 6 European countries (Austria, Belgium, France, Germany, Italy, and Netherlands) from 30 October 2019 to 02 May 2024.
| Milestone | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Started | 73 | 4 | 251 | 3 |
| Full analysis set (fas) population | 72 | 4 | 246 | 3 |
| Safety population | 73 | 4 | 251 | 3 |
| Resurface study participants | 55 | 4 | 0 | 0 |
| Non-resurface study participants | 18 | 0 | 0 | 0 |
| Completed | 59 | 2 | 183 | 1 |
| Not completed | 14 | 2 | 68 | 2 |
| Withdrew: Withdrawal by participants due to adverse event | 3 | 0 | 5 | 0 |
| Withdrew: Withdrawal by participants due to reasons unrelated to adverse event | 4 | 0 | 20 | 0 |
| Withdrew: Withdrawal by investigator due to adverse event | 1 | 1 | 6 | 0 |
| Withdrew: Investigator decision | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 4 | 0 | 10 | 0 |
| Withdrew: Other | 1 | 0 | 4 | 0 |
| Withdrew: Lack of efficacy | 1 | 1 | 22 | 2 |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 48 | 1.13 ± 2.06 | 1.63 ± 1.45 |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 96 | 1.23 ± 1.47 | 1.10 ± 1.56 |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 48 | -0.57 ± 2.14 | -0.78 ± 0.69 |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 96 | -0.62 ± 2.97 | -1.05 ± 1.48 |
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.
| correlation coefficient | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| 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 | 0.3888 (0.1260 to 0.5958) | 1.0000 (NA to NA) |
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.
| correlation coefficient | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| 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 | 0.5880 (0.3395 to 0.7536) | 1.0000 (NA to NA) |
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).
| percentage of participants | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| At Week 48: PASI 75 | 62.50 | 50.0 |
| At Week 48: PASI 90 | 42.50 | 25.0 |
| At Week 48: PASI 100 | 22.50 | 25.0 |
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).
| percentage of participants | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| At Week 96: PASI 75 | 47.50 | 25.0 |
| At Week 96: PASI 90 | 32.50 | 25.0 |
| At Week 96: PASI 100 | 22.50 | 25.0 |
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.
| percentage | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48 | 1.08 ± 2.42 | 2.25 ± 1.71 |
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.
| percentage | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96 | 1.11 ± 1.73 | 0.45 ± 0.64 |
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).
| percentage | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| Baseline of reSURFACE Study | 28.96 ± 14.18 | 28.00 ± 16.71 |
| Change at Week 48 | -24.63 ± 10.93 | -25.75 ± 16.94 |
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).
| percentage | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| Baseline of reSURFACE Study | 28.96 ± 14.18 | 28.00 ± 16.71 |
| Change at Week 96 | -26.65 ± 12.49 | -18.05 ± 11.24 |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| At Week 48: General | 0.75 ± 0.84 | 0.75 ± 0.50 |
| At Week 48: Nail | 0.17 ± 0.38 | 0.75 ± 0.50 |
| At Week 48: Scalp | 0.38 ± 0.69 | 0.93 ± 0.83 |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| At Week 96: General | 0.73 ± 0.74 | 0.50 ± 0.71 |
| At Week 96: Nail | 0.24 ± 0.52 | 0.50 ± 0.71 |
| At Week 96: Scalp | 0.23 ± 0.50 | 1.00 ± 1.41 |
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).
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| Baseline (reSURFACE Studies): General | 3.36 ± 0.53 | 3.00 ± 0.00 |
| Change at Week 48: General | -2.67 ± 0.91 | -2.25 ± 0.50 |
| Baseline (Current study): Nail | 0.40 ± 0.81 | 0.50 ± 0.58 |
| Change at Week 48: Nail | -0.10 ± 0.72 | 0.25 ± 0.50 |
| Baseline (Current study): Scalp | 0.39 ± 0.81 | 1.50 ± 1.03 |
| Change at Week 48: Scalp | -0.09 ± 0.88 | -0.58 ± 0.56 |
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).
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg |
|---|---|---|
| Baseline (reSURFACE Studies): General | 3.36 ± 0.53 | 3.00 ± 0.00 |
| Change at Week 96: General | -2.74 ± 0.86 | -2.50 ± 0.71 |
| Baseline (Current study): Nail | 0.40 ± 0.81 | 0.50 ± 0.58 |
| Change at Week 96: Nail | 0.05 ± 0.83 | 0.00 ± 0.00 |
| Baseline (Current study): Scalp | 0.39 ± 0.81 | 1.50 ± 1.03 |
| Change at Week 96: Scalp | 0.08 ± 0.36 | -0.15 ± 0.21 |
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.
| score on a scale | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 52 | 1.30 ± 1.84 | 2.00 ± NA |
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.
| score on a scale | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Scroe at Week 100 | 1.37 ± 1.73 | 4.80 ± NA |
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.
| score on a scale | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52 | -11.39 ± 6.77 | -14.20 ± NA |
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.
| score on a scale | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 100 | -11.36 ± 6.88 | -11.40 ± NA |
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.
| correlation coefficient | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| 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 | 0.2562 (0.1024 to 0.3966) | NA (NA to NA) |
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.
| correlation coefficient | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| 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 | 0.4172 (0.2703 to 0.5431) | NA (NA to NA) |
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).
| percentage of participants | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| At Week 52: PASI 75 | 79.73 | 100 |
| At Week 52: PASI 90 | 63.51 | 0.0 |
| At Week 52: PASI 100 | 43.92 | 0.0 |
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).
| percentage of participants | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| At Week 100: PASI 75 | 77.37 | 0 |
| At Week 100: PASI 90 | 62.04 | 0 |
| At Week 100: PASI 100 | 35.77 | 0 |
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.
| percentage | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52 | 1.70 ± 4.83 | 0.60 ± NA |
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.
| percentage | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100 | 1.49 ± 2.67 | 2.00 ± NA |
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.
| percentage | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 52 | -13.97 ± 12.99 | -20.40 ± NA |
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.
| percentage | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 100 | -14.63 ± 12.85 | -19.00 ± NA |
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.
| score on a scale | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| At Week 52: General | 0.76 ± 0.76 | 1.00 ± NA |
| At Week 52: Nail | 0.33 ± 0.61 | 0.00 ± NA |
| At Week 52: Scalp | 0.34 ± 0.61 | 0.00 ± NA |
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.
| score on a scale | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| At Week 100: General | 0.80 ± 0.75 | 2.00 ± NA |
| At Week 100: Nail | 0.28 ± 0.61 | 0.00 ± NA |
| At Week 100: Scalp | 0.34 ± 0.60 | 0.00 ± NA |
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.
| score on a scale | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| Change at Week 52: General | -1.81 ± 1.02 | -3.00 ± NA |
| Change at Week 52: Nail | -0.60 ± 1.02 | — |
| Change at Week 52: Scalp | -1.55 ± 1.21 | — |
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.
| score on a scale | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|
| Change at Week 100: General | -1.75 ± 0.97 | -2.00 ± NA |
| Change at Week 100: Nail | -0.72 ± 1.13 | — |
| Change at Week 100: Scalp | -1.49 ± 1.16 | — |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| At Week 48 | 0.815 ± 1.705 | 4.500 ± 6.364 | — | — |
| At Week 96 | 1.095 ± 2.116 | 1.000 ± 1.414 | — | — |
| At Week 52 | — | — | 1.650 ± 2.739 | 1.000 ± NA |
| At Week 100 | — | — | 1.632 ± 2.906 | 1.000 ± NA |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Change at Week 48 | -1.224 ± 3.077 | 3.500 ± 4.950 | — | — |
| Change at Week 96 | -1.132 ± 2.801 | 0.500 ± 0.707 | — | — |
| Change at Week 52 | — | — | -9.693 ± 6.800 | -21.000 ± NA |
| Change at Week 100 | — | — | -10.059 ± 7.154 | -21.000 ± NA |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| At Week 48 | 0.900 ± 1.830 | 5.000 ± 7.071 | — | — |
| At Week 96 | 1.245 ± 2.487 | 1.000 ± 1.414 | — | — |
| At Week 52 | — | — | 1.846 ± 3.143 | 1.000 ± NA |
| At Week 100 | — | — | 1.940 ± 3.447 | 1.000 ± NA |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Change at Week 48 | -1.365 ± 3.227 | 3.900 ± 5.515 | — | — |
| Change at Week 96 | -1.305 ± 2.923 | 0.500 ± 0.707 | — | — |
| Change at Week 52 | — | — | -10.382 ± 7.264 | -21.000 ± NA |
| Change at Week 100 | — | — | -10.457 ± 7.711 | -21.000 ± NA |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Itch | 0.78 ± 1.58 | 0.45 ± 0.64 | 0.91 ± 1.46 | 3.00 ± NA |
| Pain | 0.65 ± 1.94 | 0.10 ± 0.14 | 0.41 ± 1.07 | 1.00 ± NA |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Change at Week 96: Itch | -0.29 ± 0.91 | -1.40 ± 1.98 | — | — |
| Change at Week 96: Pain | 0.11 ± 1.99 | -0.05 ± 0.07 | — | — |
| Change at Week 100: Itch | — | — | -3.98 ± 2.79 | -6.00 ± NA |
| Change at Week 100: Pain | — | — | -2.35 ± 2.87 | -3.00 ± NA |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| At Week 96: Effectiveness | 88.21 ± 19.61 | 91.65 ± 11.81 | — | — |
| At Week 96: Side Effects | 100.00 ± 0.00 | 100.00 ± 0.00 | — | — |
| At Week 96: Convenience | 90.24 ± 14.36 | 91.65 ± 11.81 | — | — |
| At Week 96: Global Satisfaction | 90.25 ± 14.88 | 89.30 ± 15.13 | — | — |
| At Week 100: Effectiveness | — | — | 85.30 ± 20.53 | 72.20 ± NA |
| At Week 100: Side Effects | — | — | 99.31 ± 4.81 | 100.00 ± NA |
| At Week 100: Convenience | — | — | 86.85 ± 15.90 | 100.00 ± NA |
| At Week 100: Global | — | — | 86.68 ± 17.73 | 71.40 ± NA |
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.
| score on a scale | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| At Week 96: Effectiveness | 1.38 ± 0.59 | 1.00 ± 0.00 | — | — |
| At Week 96: Tolerability | 1.08 ± 0.27 | 1.00 ± 0.00 | — | — |
| At Week 100: Effectiveness | — | — | 1.36 ± 0.58 | 2.00 ± NA |
| At Week 100: Tolerability | — | — | 1.16 ± 0.39 | 2.00 ± NA |
Number of participants who added concomitant medications were reported.
| Participants | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Number of Participants Who Added Concomitant Medications | 33 | 3 | 116 | 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.
| kilogram | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Change up to Week 96 | -0.50 ± 3.90 | 10.00 ± NA | — | — |
| Change up to Week 100 | — | — | 0.98 ± 5.11 | 1.20 ± NA |
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.
| centimeter | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Change at Week 96: Waist Circumference | 1.13 ± 6.70 | — | — | — |
| Change at Week 96: Hip Circumference | 1.75 ± 4.88 | — | — | — |
| Change at Week 100: Waist Circumference | — | — | -1.00 ± 7.89 | — |
| Change at Week 100: Hip Circumference | — | — | 0.47 ± 9.38 | — |
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.
| ratio | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Change at Week 96 | -0.001 ± 0.067 | — | — | — |
| Change at Week 100 | — | — | -0.016 ± 0.117 | — |
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.
| kilogram per square meter (kg/m^2) | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Change at Week 96 | -0.18 ± 1.21 | 2.70 ± NA | — | — |
| Change at Week 100 | — | — | 0.31 ± 1.80 | 0.40 ± NA |
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.
| millimeter of mercury (mmHg) | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Change at Week 96: Systolic BP | 3.88 ± 15.62 | -5.00 ± NA | — | — |
| Change at Week 96: Diastolic BP | 1.52 ± 12.05 | -4.00 ± NA | — | — |
| Change at Week 100: Systolic BP | — | — | -3.73 ± 14.03 | — |
| Change at Week 100: Diastolic BP | — | — | -2.50 ± 12.52 | — |
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.
| Participants | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Do you limit yourself in calorie intake? : Yes | 6 | 0 | 17 | 0 |
| Do you limit yourself in calorie intake? : No | 35 | 2 | 117 | 1 |
| Do you limit yourself in calorie intake? : Missing | 31 | 2 | 112 | 2 |
| Do you follow any other kind of diet? : Vegetarian | 1 | 0 | 0 | 0 |
| Do you follow any other kind of diet? : Other | 3 | 0 | 1 | 1 |
| Do you follow any other kind of diet? : No | 37 | 2 | 133 | 0 |
| Do you follow any other kind of diet? : Missing | 31 | 2 | 112 | 2 |
| Do you have any food intolerance? : Celiac disease | 0 | 0 | 1 | 0 |
| Do you have any food intolerance? : Lactose intolerance | 1 | 0 | 5 | 0 |
| Do you have any food intolerance? : Fructose malabsorption | 1 | 0 | 2 | 0 |
| Do you have any food intolerance? : Other | 1 | 1 | 0 | 0 |
| Do you have any food intolerance? : No | 38 | 1 | 128 | 1 |
| Do you have any food intolerance? : Missing | 31 | 2 | 112 | 2 |
| Do you have any food allergy? : Fish | 0 | 0 | 1 | 0 |
| Do you have any food allergy? : Edible nuts / Nuts | 0 | 0 | 1 | 0 |
| Do you have any food allergy? : Milk | 0 | 0 | 2 | 0 |
| Do you have any food allergy? : Other | 1 | 0 | 4 | 0 |
| Do you have any food allergy? : No | 40 | 2 | 127 | 1 |
| Do you have any food allergy? : Missing | 31 | 2 | 112 | 2 |
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.
| Participants | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| What kind of physical activity do you perform? : Workout (e.g. aerobic activity) | 15 | 0 | 41 | 0 |
| What kind of physical activity do you perform? : Weight training (exercises in the gym) | 2 | 0 | 14 | 0 |
| What kind of physical activity do you perform? : Stretch exercise e.g. Yoga | 3 | 0 | 9 | 0 |
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.
| minutes per month | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Change at Week 96: Workout - Exercise Time | 560.0 ± 944.5 | — | — | — |
| Change at Week 96: Weight Training- Exercise Time | 180.0 ± NA | — | — | — |
| Change at Week 96: Stretch Exercise - Exercise Time | 120.0 ± 84.9 | — | — | — |
| Change at Week 100: Workout - Exercise Time | — | — | 8.8 ± 1291.3 | — |
| Change at Week 100: Weight Training- Exercise Time | — | — | 200.0 ± 319.0 | — |
| Change at Week 100: Stretch Exercise - Exercise Time | — | — | 164.0 ± 282.6 | — |
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.
| millimoles per liter (MMOL/L) | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Change at Week 96: Total Cholesterol | 0.050 ± NA | — | — | — |
| Change at Week 96: HDL-c | -0.100 ± NA | — | — | — |
| Change at Week 96: TG | 0.580 ± NA | — | — | — |
| Change at Week 100: Total Cholesterol | — | — | 0.580 ± 0.492 | — |
| Change at Week 100: HDL-c | — | — | 0.225 ± 0.174 | — |
| Change at Week 100: LDL-c | — | — | 0.178 ± 0.180 | — |
| Change at Week 100: TG | — | — | 0.450 ± 1.323 | — |
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.
| nanomoles per liter (NMOL/L) | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Change at Week 100 | — | — | 1.825 ± 14.398 | — |
Number of participants withdrawn from the study due to any reason were reported.
| Participants | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Number of Participants Withdrawn From the Study | 14 | 2 | 68 | 2 |
Number of participants with reasons of tildrakizumab change (100 mg or 200 mg) were reported.
| Participants | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| At Week 84: Lack of Effectiveness | 0 | — | — | — |
| At Week 84: Other | 1 | — | — | — |
| At Week 100: Lack of Effectiveness | — | — | 2 | — |
| At Week 100: Other | — | — | 2 | — |
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.
| months | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Drug Survival | 20.365 ± 4.965 | 20.100 ± 5.418 | 20.087 ± 6.975 | 13.003 ± 9.751 |
Time to study discontinuation was defined as: (first dosing date to the study completion date or decided to discontinue date)/30.5.
| months | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Participants Adherence as Assessed by Time to Study Discontinuation | 21.338 ± 4.377 | 21.133 ± 4.571 | 20.853 ± 6.042 | 13.803 ± 9.127 |
Collected over Cohort 1: Baseline (current study) up to Week 108; Cohort 2: Baseline (current study) up to Week 112. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: Tildrakizumab 100 mg | 1/73 (1.4%) | 5/73 (6.8%) | 0/73 (0%) |
| Cohort 1: Tildrakizumab 200 mg | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Cohort 2: Tildrakizumab 100 mg | 2/251 (0.8%) | 12/251 (4.8%) | 21/251 (8.4%) |
| Cohort 2: Tildrakizumab 200 mg | 0/3 (0%) | 2/3 (66.7%) | 2/3 (66.7%) |
| Event | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| CholangitisHepatobiliary disorders | 0/73 | 0/4 | 0/251 | 1/3 |
| Multiple sclerosisNervous system disorders | 0/73 | 0/4 | 0/251 | 1/3 |
| Nervous system disorderNervous system disorders | 1/73 | 0/4 | 0/251 | 0/3 |
| SyncopeInjury, poisoning and procedural complications | 1/73 | 0/4 | 0/251 | 0/3 |
| Myocardial infarctionCardiac disorders | 1/73 | 0/4 | 0/251 | 0/3 |
| DeathGeneral disorders | 1/73 | 0/4 | 0/251 | 0/3 |
| Adenocarcinoma of the cervixNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/73 | 0/4 | 0/251 | 0/3 |
| Septic shockInfections and infestations | 0/73 | 0/4 | 2/251 | 0/3 |
| HypercholesterolaemiaMetabolism and nutrition disorders | 0/73 | 0/4 | 2/251 | 0/3 |
| Ankle fractureInjury, poisoning and procedural complications | 0/73 | 0/4 | 1/251 | 0/3 |
| Event | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg |
|---|---|---|---|---|
| Herpes zosterInfections and infestations | 0/73 | 0/4 | 1/251 | 1/3 |
| Fibrous histiocytomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/73 | 0/4 | 1/251 | 1/3 |
| DepressionPsychiatric disorders | 0/73 | 1/4 | 0/251 | 0/3 |
| PsoriasisSkin and subcutaneous tissue disorders | 0/73 | 1/4 | 0/251 | 0/3 |
| COVID-19Infections and infestations | 0/73 | 0/4 | 19/251 | 0/3 |
Safety population included all participants for whom it was known that they had at least one tildrakizumab dose during the study duration.
| Age, Continuous(years) | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg | Total |
|---|---|---|---|---|---|
| Mean | 51.8 ± 11.99 | 48.0 ± 15.34 | 46.4 ± 14.21 | 55.7 ± 14.57 | 47.7 ± 13.91 |
| Sex: Female, Male(Participants) | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg | Total |
|---|---|---|---|---|---|
| Female | 16 | 0 | 91 | 0 | 107 |
| Male | 57 | 4 | 160 | 3 | 224 |
| Race and Ethnicity Not Collected(Participants) | Cohort 1: Tildrakizumab 100 mg | Cohort 1: Tildrakizumab 200 mg | Cohort 2: Tildrakizumab 100 mg | Cohort 2: Tildrakizumab 200 mg | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
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Almirall, S.A.