Plaque Psoriasis
Conditions
Keywords
Ilumetri®, Tildrakizumab, Moderate to severe plaque psoriasis
Brief summary
The observational, non-interventional study will assess the efficacy, safety, prescription and utilization patterns of Tildrakizumab in participants with moderate to severe plaque psoriasis in routine clinical practice.
Interventions
DRUGTildrakizumab
The study physicians will choose the treatment independently of the enrolment in the study according to routine care.
Sponsors
Almirall, S.A.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 52 | Baseline (current study), Week 52 | The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration. |
| Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 100 | Baseline (current study), Week 100 | The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration. |
| Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 52 | At Week 52 | The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. |
| Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 100 | At Week 100 | The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. |
| Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 52 | Baseline (current study), Week 52 | The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration. |
| Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 100 | Baseline (current study), Week 100 | The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration. |
| Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 48 | At Week 48 | The PASI was calculated by assessing four body regions: head (10 percent \[%\] of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. |
| Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 96 | At Week 96 | The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis. |
| Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 48 | At Week 48 | PASI 75 and 90 defined as percentage of participants who achieved \>=75% and \>=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who have achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case). |
| Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 96 | At Week 96 | PASI 75 and 90 defined as percentage of participants who achieved \>=75% and \>=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case). |
| Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48 | At Week 48 | The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. |
| Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96 | At Week 96 | The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. |
| Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 48 | Baseline (Day 0 of reSURFACE Studies), Week 48 (Current study) | The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline value of reSURFACE Studies was used to calculate change at Week 48 of current study. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab \[reSURFACE\] clinical trials). |
| Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 96 | Baseline (Day 0 of reSURFACE Studies), Week 96 (Current Study) | The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline value of reSURFACE Studies was used to calculate change at Week 96 of current study. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab \[reSURFACE\] clinical trials). |
| Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 48 | At Week 48 | The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. |
| Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 96 | At Week 96 | The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. |
| Cohort 1: Change From Baseline (reSURFACE Studies for General and Current Study for Nail and Scalp) in Physician's Global Assessment (PGA) Score at Week 48 | Baseline (Day 0 of reSURFACE Studies for General and current study for Nail and Scalp), Week 48 (Current Study) | The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline value of reSURFACE Studies was used to calculate change for "General" at Week 48 of current study. For "Nail" and "Scalp", Baseline value of current study was used to calculate change. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab \[reSURFACE\] clinical trials). |
| Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 96 | At Week 96 | The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. |
| Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 48 | Baseline (current study), Week 48 | PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration. |
| Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 96 | Baseline (current study), Week 96 | PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration. |
| Cohort 1: Change From Baseline (reSURFACE Studies for General and Current Study for Nail and Scalp) in Physician's Global Assessment (PGA) Score at Week 96 | Baseline (Day 0 of reSURFACE Studies for General and current study for Nail and Scalp), Week 96 (Current study) | The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline value of reSURFACE Studies was used to calculate change for "General" at Week 96 of current study. For "Nail" and "Scalp", Baseline value of current study was used to calculate change. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab \[reSURFACE\] clinical trials). |
| Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 52 | At Week 52 | The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. |
| Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Scroe at Week 100 | At Week 100 | The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. |
| Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52 | Baseline (current study), Week 52 | The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration. |
| Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 100 | Baseline (current study), Week 100 | The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration. |
| Cohort 2: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 52 | At Week 52 | The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis. |
| Cohort 2: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 100 | At Week 100 | The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis. |
| Cohort 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 | At Week 48 | The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis. |
| Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 52 | At Week 52 | PASI 75 and 90 defined as percentage of participants who achieved \>=75% and \>=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who have achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case). |
| Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 100 | At Week 100 | PASI 75 and 90 defined as percentage of participants who achieved \>=75% and \>=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case). |
| Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52 | At Week 52 | The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. |
| Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100 | At Week 100 | The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Physical Activity at Week 96 for Cohort 1 and Week 100 for Cohort 2 | Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100 | 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. |
| Change From Baseline in Lipid Profile (Lipoprotein-a) at Week 96 for Cohort 1 and Week 100 for Cohort 2 | Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100 | 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. |
| Number of Participants Withdrawn From the Study | Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100 | Number of participants withdrawn from the study due to any reason were reported. |
| Number of Participants With Reason for Tildrakizumab Dosage Change | Cohort 1: At Week 84; Cohort 2: At Week 100 | Number of participants with reasons of tildrakizumab change (100 mg or 200 mg) were reported. |
| Drug Survival | Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100 | 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. |
| Participants Adherence as Assessed by Time to Study Discontinuation | Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100 | Time to study discontinuation was defined as: (first dosing date to the study completion date or decided to discontinue date)/30.5. |
| Absolute Dermatology Life Quality Index (DLQI) Score at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2 | Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100 | 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. |
| Change From Baseline in Absolute Dermatology Life Quality Index (DLQI) Score at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2 | Cohort 1: Baseline (current study), Week 48 and Week 96; Cohort 2: Baseline (current study), Week 52 and Week 100 | 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. |
| Absolute Dermatology Life Quality Index Score Adjusted for Not Relevant Responses (DLQI-R) at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2 | Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100 | 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. |
| Change From Baseline in Dermatology Life Quality Index Score Adjusted for Not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2 | Cohort 1: Baseline (current study), Week 48 and Week 96; Cohort 2: Baseline (current study), Week 52 and Week 100 | 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. |
| Itch and Pain Visual Analogue Scales (VAS) Scores at Week 96 for Cohort 1 and Week 100 for Cohort 2 | Cohort 1: At Week 96; Cohort 2: At Week 100 | 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. |
| Change From Baseline in Itch and Pain Visual Analogue Scales (VAS) Scores at Week 96 for Cohort 1 and Week 100 for Cohort 2 | Cohort 1: At Week 96; Cohort 2: At Week 100 | 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. |
| Absolute Scores of Participant's Satisfaction With Tildrakizumab Therapy as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 96 for Cohort 1 and Week 100 for Cohort 2 | Cohort 1: At Week 96; Cohort 2: At Week 100 | 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. |
| Absolute Scores of Physician's Satisfaction With Tildrakizumab Therapy for Effectiveness and Tolerability at Week 96 for Cohort 1 and Week 100 for Cohort 2 | Cohort 1: At Week 96; Cohort 2: At Week 100 | 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. |
| Number of Participants Who Added Concomitant Medications | Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100 | Number of participants who added concomitant medications were reported. |
| Change From Baseline in Body Weight up to Week 96 for Cohort 1 and Week 100 for Cohort 2 | Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100 | Change from baseline in 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. |
| Change From Baseline in Waist and Hip Circumference at Week 96 for Cohort 1 and Week 100 for Cohort 2 | Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100 | Change from baseline in 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. |
| Change From Baseline in Waist/Hip Ratio at Week 96 for Cohort 1 and Week 100 for Cohort 2 | Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100 | 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. |
| Change From Baseline in Body Mass Index (BMI) at Week 96 for Cohort 1 and Week 100 for Cohort 2 | Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100 | Change from baseline in 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. |
| Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 96 for Cohort 1 and Week 100 for Cohort 2 | Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100 | 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. |
| Number of Participants With Responses to Questions About Food Intake | Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100 | 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. |
| Number of Participants With Responses to Physical Activity Questionnaire | Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100 | 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. |
| Change From Baseline in Lipid Profiles at Week 96 for Cohort 1 and Week 100 for Cohort 2 | Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100 | Change from baseline in lipid 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. |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands
Contacts
STUDY_DIRECTORStudy Director
Almirall, S.A.
Participant flow
Recruitment details
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.
Pre-assignment details
A total of 331 participants were enrolled in two cohorts. Cohort 1 included participants who completed tildrakizumab clinical trials (reSURFACE and non-reSURFACE Studies) and Cohort 2 included newly tildrakizumab prescribed participants.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47.7 years STANDARD_DEVIATION 13.91 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 73 | 0 / 4 | 2 / 251 | 0 / 3 |
| other Total, other adverse events | 0 / 73 | 2 / 4 | 21 / 251 | 2 / 3 |
| serious Total, serious adverse events | 5 / 73 | 0 / 4 | 12 / 251 | 2 / 3 |
Outcome results
None listed