Trial Outcomes & Findings for A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis (NCT NCT03718299)
NCT ID: NCT03718299
Last Updated: 2023-02-23
Results Overview
The Psychological General Well-Being scale is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients. The values reported are change in score from baseline.
COMPLETED
PHASE4
55 participants
baseline, week 28 and week 52
2023-02-23
Participant Flow
Participant milestones
| Measure |
Tildrakizumab 100 mg
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Tildrakizumab 100 mg
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis
Baseline characteristics by cohort
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 15.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 28 and week 52Population: The intent-to-treat (ITT) population
The Psychological General Well-Being scale is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients. The values reported are change in score from baseline.
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale
Baseline
|
78 score on a scale
Standard Deviation 14
|
|
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale
Week 28
|
3.7 score on a scale
Standard Deviation 12.36
|
|
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale
Week 52
|
8.0 score on a scale
Standard Deviation 14.06
|
SECONDARY outcome
Timeframe: baseline, weeks 4, 8, 12, 16, 40, 64Population: The intent-to-treat (ITT) population
The Psychological General Well-Being scale is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients. The values reported are change in score from baseline.
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time
Baseline
|
78.1 score on a scale
Standard Deviation 14.06
|
|
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time
Week 4
|
4.2 score on a scale
Standard Deviation 10.40
|
|
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time
Week 8
|
4.2 score on a scale
Standard Deviation 12.33
|
|
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time
Week 12
|
4.5 score on a scale
Standard Deviation 13.56
|
|
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time
Week 16
|
5.3 score on a scale
Standard Deviation 13.36
|
|
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time
Week 40
|
5.6 score on a scale
Standard Deviation 12.48
|
|
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time
Week 64
|
5.6 score on a scale
Standard Deviation 14.14
|
SECONDARY outcome
Timeframe: week 64The DLQI is a self-administered and user-friendly validated questionnaire used to measure the health-related quality of life of adult patients suffering from a skin disease. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment. Higher scores mean greater impairment of patient's QoL. The DLQI or Dermatology Life Quality Index measures patient's quality of life. The score ranges from 0 to 30. Lower scores indicate less impairment in quality of life
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=45 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Improvement in Quality of Life Measured by Change From Baseline in Dermatology Life Quality Index Over Time
|
-8.0 score on a scale
Standard Deviation 5.18
|
SECONDARY outcome
Timeframe: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64Population: The intent-to-treat (ITT) population
The DLQI is a self-administered and user-friendly validated questionnaire used to measure the health-related quality of life of adult patients suffering from a skin disease. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment. Higher scores mean greater impairment of patient's QoL. The DLQI or Dermatology Life Quality Index measures patient's quality of life. The score ranges from 0 to 30. Lower scores indicate less impairment in quality of life. For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100.
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
Baseline
|
1.8 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
Week 4
|
18.2 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
Week 8
|
36.5 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
Week 12
|
42.3 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
Week 16
|
51.9 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
Week 28
|
52.8 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
Week 40
|
58.3 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
Week 52
|
56.3 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
Week 64
|
62.2 Percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64Population: The intent-to-treat (ITT) population
The DLQI is a self-administered and user-friendly validated questionnaire used to measure the health-related quality of life of adult patients suffering from a skin disease. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment. Higher scores mean greater impairment of patient's QoL. The DLQI or Dermatology Life Quality Index measures patient's quality of life. The score ranges from 0 to 30. Lower scores indicate less impairment in quality of life. For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100.
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
Baseline
|
13 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
Week 4
|
56.4 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
Week 8
|
84.6 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
Week 12
|
86.5 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
Week 16
|
88.9 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
Week 28
|
94.3 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
Week 40
|
91.7 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
Week 52
|
89.6 Percentage of subjects
|
|
Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
Week 60
|
93.3 Percentage of subjects
|
SECONDARY outcome
Timeframe: baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64Population: The intent-to-treat (ITT) population
The DLQI is a self-administered and user-friendly validated questionnaire used to measure the health-related quality of life of adult patients suffering from a skin disease. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment. Higher scores mean greater impairment of patient's QoL. The DLQI or Dermatology Life Quality Index measures patient's quality of life. The score ranges from 0 to 30. Lower scores indicate less impairment in quality of life. For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline
Week 4
|
44.4 Percentage of subjects
|
|
Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline
Week 8
|
61.9 Percentage of subjects
|
|
Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline
Week 12
|
69.0 Percentage of subjects
|
|
Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline
Week 16
|
75.0 Percentage of subjects
|
|
Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline
Week 28
|
81.4 Percentage of subjects
|
|
Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline
Week 40
|
87.5 Percentage of subjects
|
|
Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline
Week 52
|
82.5 Percentage of subjects
|
|
Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline
Week 64
|
78.9 Percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 28, 40, 52, and 64Population: The intent-to-treat (ITT) population
The percent BSA affected with psoriasis will be estimated at each study visit. The investigator may use the estimate that 1% BSA is equivalent to the area of the subject's closed hand (palm with fingers held together).
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Changes From Baseline in Percent Affected Body Surface Area
Baseline
|
14.5 Percent BSA
Standard Deviation 11.54
|
|
Changes From Baseline in Percent Affected Body Surface Area
Week 4
|
-2.9 Percent BSA
Standard Deviation 5.70
|
|
Changes From Baseline in Percent Affected Body Surface Area
Week 8
|
-8.7 Percent BSA
Standard Deviation 11.89
|
|
Changes From Baseline in Percent Affected Body Surface Area
Week 12
|
-10.1 Percent BSA
Standard Deviation 12.09
|
|
Changes From Baseline in Percent Affected Body Surface Area
Week 16
|
-10.9 Percent BSA
Standard Deviation 11.57
|
|
Changes From Baseline in Percent Affected Body Surface Area
Week 28
|
-10.9 Percent BSA
Standard Deviation 12.74
|
|
Changes From Baseline in Percent Affected Body Surface Area
Week 40
|
-11.3 Percent BSA
Standard Deviation 12.93
|
|
Changes From Baseline in Percent Affected Body Surface Area
Week 52
|
-11.5 Percent BSA
Standard Deviation 12.79
|
|
Changes From Baseline in Percent Affected Body Surface Area
Week 64
|
-12.7 Percent BSA
Standard Deviation 11.88
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 28, 40, 52, and 64Population: The intent-to-treat (ITT) population
The sPGA is used to determine the overall severity of psoriasis lesions at a given time point. Its score ranges from 0 to 5 with higher scores indicating greater severity.
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Change From Baseline in Static Physician's Global Assessment
Baseline
|
3.2 score on a scale
Standard Deviation 0.56
|
|
Change From Baseline in Static Physician's Global Assessment
Week 4
|
-1.1 score on a scale
Standard Deviation 0.71
|
|
Change From Baseline in Static Physician's Global Assessment
Week 8
|
-1.8 score on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Static Physician's Global Assessment
Week 12
|
-2.0 score on a scale
Standard Deviation 1.08
|
|
Change From Baseline in Static Physician's Global Assessment
Week 16
|
-1.9 score on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Static Physician's Global Assessment
Week 28
|
-2.0 score on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Static Physician's Global Assessment
Week 40
|
-2.2 score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Static Physician's Global Assessment
Week 52
|
-2.1 score on a scale
Standard Deviation 1.07
|
|
Change From Baseline in Static Physician's Global Assessment
Week 64
|
-2.2 score on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: weeks 4, 8, 12, 16, 28, 40, 52, 64Population: The intent-to-treat (ITT) population
The metric of BSA x sPGA is a multiplication of the percentage BSA covered and the sPGA score. The scale range for the sPGA is 0 to 5. The scale range for BSA in this study was \>=3% (inclusion criterion), which means that it has to be at least 3%, and it can be as high as 100% hypothetically. So the minimum score for sPGA x BSA = 0, and the maximum score is 5 x 100 = 500. So the range for sPGA x BSA in this study was 0 to 500. The BSA has a range of 0% to 100% where higher percentages indicate a worse outcome or worse disease The sPGA has a range of 0 (clear) to 5 (severe) where higher values indicate a worse outcome or worse disease. sPGA is used to determine the overall severity of psoriasis lesions at a given time point. Its score ranges from 0 to 5. BSA covered is reported as percent of body surface area covered. Total score for BSA x sPGA ranges from 0 to 500 with higher scores indicating greater severity.
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time
Week 4
|
-21.1 score on a scale
Standard Deviation 27.47
|
|
Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time
Week 8
|
-37.1 score on a scale
Standard Deviation 42.52
|
|
Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time
Week 12
|
-38.1 score on a scale
Standard Deviation 43.36
|
|
Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time
Week 16
|
-39.9 score on a scale
Standard Deviation 41.74
|
|
Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time
Week 28
|
-37.8 score on a scale
Standard Deviation 45.28
|
|
Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time
Week 40
|
-38.2 score on a scale
Standard Deviation 44.48
|
|
Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time
Week 52
|
-40.0 score on a scale
Standard Deviation 44.33
|
|
Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time
Week 64
|
-43.3 score on a scale
Standard Deviation 41.86
|
SECONDARY outcome
Timeframe: baseline, weeks 4,16, 28 and 52Population: The intent-to-treat (ITT) population
The PASI is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI analyzes the four regions of the body (head, trunk, upper and lower limbs). It ranges from 0 to 72 with higher scores indicating greater severity.
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time
Baseline
|
11.6 score on a scale
Standard Deviation 7.12
|
|
Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time
Week 4
|
-5.1 score on a scale
Standard Deviation 4.60
|
|
Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time
Week 16
|
-9.3 score on a scale
Standard Deviation 7.03
|
|
Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time
Week 28
|
-9.4 score on a scale
Standard Deviation 6.95
|
|
Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time
Week 52
|
-10.0 score on a scale
Standard Deviation 7.32
|
SECONDARY outcome
Timeframe: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64Population: The intent-to-treat (ITT) population
The Itch-Numerical Rating Scale (I-NRS) is a simple, 11-point self-administered numeric rating scale. A score of 0 indicates no itch and score of 10 indicates indicates worst imaginable itch
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Change From Baseline in Itch-Numeric Rating Scale
Baseline
|
6.6 score on a scale
Standard Deviation 2.57
|
|
Change From Baseline in Itch-Numeric Rating Scale
Week 4
|
-1.7 score on a scale
Standard Deviation 2.47
|
|
Change From Baseline in Itch-Numeric Rating Scale
Week 8
|
-2.8 score on a scale
Standard Deviation 3.11
|
|
Change From Baseline in Itch-Numeric Rating Scale
Week 12
|
-3.0 score on a scale
Standard Deviation 3.22
|
|
Change From Baseline in Itch-Numeric Rating Scale
Week 16
|
-3.8 score on a scale
Standard Deviation 2.84
|
|
Change From Baseline in Itch-Numeric Rating Scale
Week 28
|
-3.8 score on a scale
Standard Deviation 3.12
|
|
Change From Baseline in Itch-Numeric Rating Scale
Week 40
|
-3.7 score on a scale
Standard Deviation 2.99
|
|
Change From Baseline in Itch-Numeric Rating Scale
Week 52
|
-4.1 score on a scale
Standard Deviation 3.06
|
|
Change From Baseline in Itch-Numeric Rating Scale
Week 64
|
-4.4 score on a scale
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 28, 40, 52, and 64Population: The intent-to-treat (ITT) population
The Scaling-NRS (S-NRS) is a simple, 11-point self-administered numeric rating scale that is administered at each visit. A score of 0 represents 'no scaling' and a score of 10, indicates 'worst scaling imaginable'.
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Change From Baseline in Scaling-Numeric Rating Scale
Baseline
|
7.0 score on a scale
Standard Deviation 2.33
|
|
Change From Baseline in Scaling-Numeric Rating Scale
Week 4
|
-2.6 score on a scale
Standard Deviation 2.38
|
|
Change From Baseline in Scaling-Numeric Rating Scale
Week 8
|
-4.1 score on a scale
Standard Deviation 3.03
|
|
Change From Baseline in Scaling-Numeric Rating Scale
Week 12
|
-4.3 score on a scale
Standard Deviation 2.95
|
|
Change From Baseline in Scaling-Numeric Rating Scale
Week 16
|
-4.5 score on a scale
Standard Deviation 2.54
|
|
Change From Baseline in Scaling-Numeric Rating Scale
Week 28
|
-4.7 score on a scale
Standard Deviation 2.78
|
|
Change From Baseline in Scaling-Numeric Rating Scale
Week 40
|
-4.5 score on a scale
Standard Deviation 2.86
|
|
Change From Baseline in Scaling-Numeric Rating Scale
Week 52
|
-4.6 score on a scale
Standard Deviation 2.86
|
|
Change From Baseline in Scaling-Numeric Rating Scale
Week 64
|
-4.6 score on a scale
Standard Deviation 2.89
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 28, 40, 52, and 64Population: The intent-to-treat (ITT) population
The P-NRS is a simple, 11-point self-administered numeric rating scale. A score of 0 indicates no pain. A score of 10 indicates worst pain imaginable
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Change From Baseline in Pain-Numeric Rating Scale
Baseline
|
3.8 score on a scale
Standard Deviation 3.22
|
|
Change From Baseline in Pain-Numeric Rating Scale
Week 4
|
-1.2 score on a scale
Standard Deviation 2.65
|
|
Change From Baseline in Pain-Numeric Rating Scale
Week 8
|
-1.8 score on a scale
Standard Deviation 3.18
|
|
Change From Baseline in Pain-Numeric Rating Scale
Week 12
|
-1.8 score on a scale
Standard Deviation 2.88
|
|
Change From Baseline in Pain-Numeric Rating Scale
Week 16
|
-2.2 score on a scale
Standard Deviation 2.88
|
|
Change From Baseline in Pain-Numeric Rating Scale
Week 28
|
-2.3 score on a scale
Standard Deviation 3.05
|
|
Change From Baseline in Pain-Numeric Rating Scale
Week 40
|
-2.3 score on a scale
Standard Deviation 2.48
|
|
Change From Baseline in Pain-Numeric Rating Scale
Week 52
|
-2.5 score on a scale
Standard Deviation 2.76
|
|
Change From Baseline in Pain-Numeric Rating Scale
Week 64
|
-2.8 score on a scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: weeks 4, 8, 12, 16, 28, 40, 52, and 64Population: The intent-to-treat (ITT) population
The Itch-Numerical Rating Scale (I-NRS) is a simple, 11-point self-administered numeric rating scale. A score of 0 indicates no itch and score of 10 indicates indicates worst imaginable itch. For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Proportion of Patients With Itch Score of 0
Baseline
|
1.8 Percentage of participants
|
|
Proportion of Patients With Itch Score of 0
Week 4
|
3.6 Percentage of participants
|
|
Proportion of Patients With Itch Score of 0
Week 8
|
11.3 Percentage of participants
|
|
Proportion of Patients With Itch Score of 0
Week 12
|
22.2 Percentage of participants
|
|
Proportion of Patients With Itch Score of 0
Week 16
|
16.7 Percentage of participants
|
|
Proportion of Patients With Itch Score of 0
Week 28
|
20.8 Percentage of participants
|
|
Proportion of Patients With Itch Score of 0
Week 40
|
22.9 Percentage of participants
|
|
Proportion of Patients With Itch Score of 0
Week 52
|
22.9 Percentage of participants
|
|
Proportion of Patients With Itch Score of 0
Week 64
|
24.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 28, 40, 52, and 64Population: The intent-to-treat (ITT) population
The Scaling-NRS (S-NRS) is a simple, 11-point self-administered numeric rating scale that is administered at each visit. A score of 0 represents 'no scaling' and a score of 10, indicates 'worst scaling imaginable'. For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Proportion of Patients With Scaling Score of 0
Baseline
|
0 percentage of participants
|
|
Proportion of Patients With Scaling Score of 0
Week 4
|
3.6 percentage of participants
|
|
Proportion of Patients With Scaling Score of 0
Week 8
|
20.8 percentage of participants
|
|
Proportion of Patients With Scaling Score of 0
Week 12
|
16.7 percentage of participants
|
|
Proportion of Patients With Scaling Score of 0
Week 16
|
20.4 percentage of participants
|
|
Proportion of Patients With Scaling Score of 0
Week 28
|
22.6 percentage of participants
|
|
Proportion of Patients With Scaling Score of 0
Week 40
|
22.9 percentage of participants
|
|
Proportion of Patients With Scaling Score of 0
Week 52
|
25.0 percentage of participants
|
|
Proportion of Patients With Scaling Score of 0
Week 64
|
17.8 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 28, 40, 52, and 64Population: The intent-to-treat (ITT) population
The P-NRS is a simple, 11-point self-administered numeric rating scale. A score of 0 indicates no pain. A score of 10 indicates worst pain imaginable. For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100.
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Proportion of Patients With Pain Score of 0
Baseline
|
12.7 Percentage of participants
|
|
Proportion of Patients With Pain Score of 0
Week 4
|
21.8 Percentage of participants
|
|
Proportion of Patients With Pain Score of 0
Week 8
|
34.0 Percentage of participants
|
|
Proportion of Patients With Pain Score of 0
Week 12
|
48.1 Percentage of participants
|
|
Proportion of Patients With Pain Score of 0
Week 16
|
40.7 Percentage of participants
|
|
Proportion of Patients With Pain Score of 0
Week 28
|
50.9 Percentage of participants
|
|
Proportion of Patients With Pain Score of 0
Week 40
|
54.2 Percentage of participants
|
|
Proportion of Patients With Pain Score of 0
Week 52
|
52.1 Percentage of participants
|
|
Proportion of Patients With Pain Score of 0
Week 64
|
48.9 Percentage of participants
|
SECONDARY outcome
Timeframe: baseline, weeks 16, 28, 40, 52, 64Population: The intent-to-treat (ITT) population
The WPAI is a validated, subject-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to general health or a specific health problem. WPAI surveys were analyzed based on published algorithms to determine the following: current employment status, absenteeism, presenteeism, total activity impairment , and total work productivity impairment. Each WPAI score is expressed as impairment percentages (0-100), with higher scores indicating greater impairment (worse outcomes).
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Baseline (Total Activity Impairment)
|
29.5 score on a scale
Standard Deviation 26.56
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 16 (Total Activity Impairment)
|
-20.8 score on a scale
Standard Deviation 21.47
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 28 (Total Activity Impairment)
|
-24.7 score on a scale
Standard Deviation 25.47
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 40 (Total Activity Impairment)
|
-26.9 score on a scale
Standard Deviation 24.33
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 52 (Total Activity Impairment)
|
-20.8 score on a scale
Standard Deviation 28.57
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 64 Total Activity Impairment)
|
-27.8 score on a scale
Standard Deviation 22.85
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Baseline (Total Work Productivity Impairment)
|
20.9 score on a scale
Standard Deviation 22.21
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 16 (Total Work Productivity Impairment)
|
-13.7 score on a scale
Standard Deviation 21.02
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 28 (Total Work Productivity Impairment)
|
-14.5 score on a scale
Standard Deviation 20.45
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 40 (Total Work Productivity Impairment)
|
17.1 score on a scale
Standard Deviation 19.33
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 52 (Total Work Productivity Impairment)
|
-16.4 score on a scale
Standard Deviation 22.42
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 64 (Total Work Productivity Impairment)
|
-19.4 score on a scale
Standard Deviation 20.81
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Baseline (Absenteeism)
|
1.1 score on a scale
Standard Deviation 5.66
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 16 (Absenteeism)
|
0.5 score on a scale
Standard Deviation 3.85
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 28 (Absenteeism)
|
-0.3 score on a scale
Standard Deviation 1.93
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 40 (Absenteeism)
|
-0.4 score on a scale
Standard Deviation 2.00
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 52 (Absenteeism)
|
-0.4 score on a scale
Standard Deviation 2.00
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 64 (Absenteeism)
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Baseline (Presenteeism)
|
20.5 score on a scale
Standard Deviation 21.67
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 16 (Presenteeism)
|
-14.0 score on a scale
Standard Deviation 20.47
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 28 (Presenteeism)
|
-14.2 score on a scale
Standard Deviation 20.31
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 40 (Presenteeism)
|
-16.8 score on a scale
Standard Deviation 19.22
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 52 (Presenteeism)
|
-16.1 score on a scale
Standard Deviation 22.31
|
|
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Week 64 (Presenteeism)
|
-19.4 score on a scale
Standard Deviation 20.81
|
SECONDARY outcome
Timeframe: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64Population: The intent-to-treat (ITT) population
The TSQM is a general measure of treatment satisfaction with medication, suitable for use across a wide variety of medication types and illness conditions. The 14-item TSQM Version 1.4 is a reliable and valid instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. The TSQM domain scores range from 0-100 with higher scores representing higher satisfaction on that domain
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 4 (Effectiveness)
|
59.5 score on a scale
Standard Deviation 17.03
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 8 (Effectiveness)
|
70.8 score on a scale
Standard Deviation 23.12
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 12 (Effectiveness)
|
71.0 score on a scale
Standard Deviation 22.65
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 16 (Effectiveness)
|
73.9 score on a scale
Standard Deviation 17.39
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 28 (Effectiveness)
|
76.5 score on a scale
Standard Deviation 19.93
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 40 (Effectiveness)
|
78.4 score on a scale
Standard Deviation 16.01
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 52 (Effectiveness)
|
78.7 score on a scale
Standard Deviation 16.89
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 64 (Effectiveness)
|
79.5 score on a scale
Standard Deviation 20.06
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 4 (Convenience)
|
83.3 score on a scale
Standard Deviation 15.89
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 8 (Convenience)
|
85.1 score on a scale
Standard Deviation 14.33
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 12 (Convenience)
|
86.9 score on a scale
Standard Deviation 13.70
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 16 (Convenience)
|
84.0 score on a scale
Standard Deviation 12.57
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 28 (Convenience)
|
85.1 score on a scale
Standard Deviation 13.42
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 40 (Convenience)
|
85.6 score on a scale
Standard Deviation 13.93
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 52 (Convenience)
|
85.2 score on a scale
Standard Deviation 13.58
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 64 (Convenience)
|
82.2 score on a scale
Standard Deviation 16.35
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 4 (Global Satisfaction)
|
72.7 score on a scale
Standard Deviation 18.55
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 8 (Global Satisfaction)
|
77.5 score on a scale
Standard Deviation 21.19
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 12 (Global Satisfaction)
|
77.4 score on a scale
Standard Deviation 20.89
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 16 (Global Satisfaction)
|
79.4 score on a scale
Standard Deviation 16.69
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 28 (Global Satisfaction)
|
80.5 score on a scale
Standard Deviation 17.78
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 40 (Global Satisfaction)
|
81.4 score on a scale
Standard Deviation 15.15
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 52 (Global Satisfaction)
|
81.7 score on a scale
Standard Deviation 18.40
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 64 (Global Satisfaction)
|
81.9 score on a scale
Standard Deviation 20.47
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 4 (Side Effects)
|
70.8 score on a scale
Standard Deviation 14.61
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 8 (Side Effects)
|
78.1 score on a scale
Standard Deviation 18.75
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 12 (Side Effects)
|
73.4 score on a scale
Standard Deviation 11.83
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 16 (Side Effects)
|
68.8 score on a scale
Standard Deviation 6.25
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 28 (Side Effects)
|
81.3 score on a scale
Standard Deviation 10.83
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 40 (Side Effects)
|
81.3 score on a scale
Standard Deviation 6.25
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 52 (Side Effects)
|
77.1 score on a scale
Standard Deviation 9.55
|
|
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Week 64 (Side Effects)
|
79.2 score on a scale
Standard Deviation 3.61
|
SECONDARY outcome
Timeframe: weeks 4, 8, 12, 16, 28, 40, 52, 64Population: The intent-to-treat (ITT) population
The Tildrakizumab Overall Satisfaction Scale is an 11-point simple, self-administered numeric rating scale. Subjects indicate their overall satisfaction by circling the integer that best describes their experience on a scale. A score of 0 indicates 'not satisfied' and 10 indicates 'extremely satisfied'.
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 4 (Improvement in Symptoms)
|
6.0 score on a scale
Standard Deviation 2.36
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 8 (Improvement in Symptoms)
|
7.6 score on a scale
Standard Deviation 2.44
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 12 (Improvement in Symptoms)
|
7.7 score on a scale
Standard Deviation 2.45
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 16 (Improvement in Symptoms)
|
8.0 score on a scale
Standard Deviation 2.03
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 28 (Improvement in Symptoms)
|
8.0 score on a scale
Standard Deviation 2.30
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 40 (Improvement in Symptoms)
|
8.4 score on a scale
Standard Deviation 1.85
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 52 (Improvement in Symptoms)
|
8.4 score on a scale
Standard Deviation 2.15
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 64 (Improvement in Symptoms)
|
8.7 score on a scale
Standard Deviation 2.01
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 4 (Speed of Symptom Improvement)
|
5.9 score on a scale
Standard Deviation 2.39
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 8 (Speed of Symptom Improvement)
|
7.5 score on a scale
Standard Deviation 2.55
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 12 (Speed of Symptom Improvement)
|
7.2 score on a scale
Standard Deviation 2.80
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 16 (Speed of Symptom Improvement)
|
7.7 score on a scale
Standard Deviation 2.15
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 28 (Speed of Symptom Improvement)
|
7.8 score on a scale
Standard Deviation 2.44
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 40 (Speed of Symptom Improvement)
|
8.4 score on a scale
Standard Deviation 1.75
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 52 (Speed of Symptom Improvement)
|
7.9 score on a scale
Standard Deviation 2.36
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 64 (Speed of Symptom Improvement)
|
8.3 score on a scale
Standard Deviation 2.30
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 4 (Frequency of Taking Medication)
|
7.8 score on a scale
Standard Deviation 2.05
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 8 (Frequency of Taking Medication)
|
8.4 score on a scale
Standard Deviation 1.75
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 12 (Frequency of Taking Medication)
|
8.2 score on a scale
Standard Deviation 2.08
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 16 (Frequency of Taking Medication)
|
8.2 score on a scale
Standard Deviation 2.19
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 28 (Frequency of Taking Medication)
|
8.3 score on a scale
Standard Deviation 2.24
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 40 (Frequency of Taking Medication)
|
8.8 score on a scale
Standard Deviation 2.12
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 52 (Frequency of Taking Medication)
|
8.8 score on a scale
Standard Deviation 2.12
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 64 (Frequency of Taking Medication)
|
9.1 score on a scale
Standard Deviation 1.70
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 4 (Side Effects)
|
8.6 score on a scale
Standard Deviation 2.14
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 8 (Side Effects)
|
9.0 score on a scale
Standard Deviation 1.50
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 12 (Side Effects)
|
9.2 score on a scale
Standard Deviation 1.48
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 16 (Side Effects)
|
9.2 score on a scale
Standard Deviation 1.52
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 28 (Side Effects)
|
9.1 score on a scale
Standard Deviation 1.54
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 40 (Side Effects)
|
9.3 score on a scale
Standard Deviation 1.59
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 52 (Side Effects)
|
9.5 score on a scale
Standard Deviation 1.22
|
|
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Week 64 (Side Effects)
|
9.6 score on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: weeks 4, 8, 12, 16, 28, 40, 52, 64Population: The intent-to-treat (ITT) population
The Patient Happiness with Psoriasis Control assessment is an 11-point simple, self- administered numeric rating scale ranging in score from 0 to 10 that is administered at each visit. Subjects indicate their overall happiness with psoriasis control by circling the integer that best describes their experience on a scale. A score of 0 indicates 'extremely unhappy'. A score of 10 indicates 'extremely happy'.
Outcome measures
| Measure |
Tildrakizumab 100 mg
n=55 Participants
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
Baseline
|
2.7 score on a scale
Standard Deviation 2.33
|
|
Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
Week 4
|
3.7 score on a scale
Standard Deviation 3.65
|
|
Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
Week 8
|
5.1 score on a scale
Standard Deviation 3.69
|
|
Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
Week 12
|
5.1 score on a scale
Standard Deviation 3.73
|
|
Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
Week 16
|
5.5 score on a scale
Standard Deviation 3.41
|
|
Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
Week 28
|
5.7 score on a scale
Standard Deviation 2.91
|
|
Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
Week 40
|
5.9 score on a scale
Standard Deviation 3.00
|
|
Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
Week 52
|
6.0 score on a scale
Standard Deviation 2.78
|
|
Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
Week 64
|
6.0 score on a scale
Standard Deviation 2.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, weeks 4, 8, 12, 16, 28, 40, 52,,64The reported values are entered in the 'Other Adverse events' section
Outcome measures
Outcome data not reported
Adverse Events
Tildrakizumab 100 mg
Serious adverse events
| Measure |
Tildrakizumab 100 mg
n=55 participants at risk
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
1.8%
1/55 • Week 64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
1.8%
1/55 • Week 64
|
|
Nervous system disorders
Ischaemic stroke
|
1.8%
1/55 • Week 64
|
|
Renal and urinary disorders
IgA nephropathy
|
1.8%
1/55 • Week 64
|
Other adverse events
| Measure |
Tildrakizumab 100 mg
n=55 participants at risk
Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.6%
2/55 • Week 64
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
2/55 • Week 64
|
|
Gastrointestinal disorders
Large intestine polyp
|
3.6%
2/55 • Week 64
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
2/55 • Week 64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
3.6%
2/55 • Week 64
|
|
Renal and urinary disorders
Haematuria
|
3.6%
2/55 • Week 64
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.5%
3/55 • Week 64
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.6%
2/55 • Week 64
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
12.7%
7/55 • Week 64
|
|
Vascular disorders
Hypertension
|
9.1%
5/55 • Week 64
|
Additional Information
Head-Clinical Development
Sun Pharmaceutical Industries Limited
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER