Psoriasis
Conditions
Brief summary
This is a Phase 4 multicenter, uncontrolled open-label study design. There will be a total of 10 study visits at Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Week 28, Week 40, Week 52 and Week 64, with subjects receiving tildrakizumab injections at Week 0, Week 4, Week 16, Week 28, Week 40, and Week 52. The total study duration will be approximately 64 weeks, excluding a screening period.
Interventions
DRUGInjections of tildrakizumab
given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects are non-immunocompromised males or females 18 years of age or older. 2. Subjects have ≥3% total body surface area plaque psoriasis. 3. Subjects are candidates for phototherapy or systemic therapy. 4. Subject must be diagnosed at least 6 months prior to entering the study. 5. Females must be surgically sterile, postmenopausal for \>5 years, or using a highly effective form of birth control (\<1% failure rate), for at least 30 days prior to test article exposure, with a negative serum pregnancy test.
Exclusion criteria
1. Subject is pregnant, lactating, or is planning to become pregnant during the study. 2. Subject is younger than 18 years of age. 3. Subjects with uncontrolled mental illness or active suicidal ideations based on baseline mental health questionnaire of choice. 4. Subject is known, or suspected of being unable to comply with the study protocol, in the opinion of the investigator. 5. Subject is currently enrolled in an investigational drug or device study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale | baseline, week 28 and week 52 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time | baseline, weeks 4, 8, 12, 16, 40, 64 | 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. |
| Improvement in Quality of Life Measured by Change From Baseline in Dermatology Life Quality Index Over Time | week 64 | 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 |
| Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1 | baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64 | 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. |
| Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5 | Baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 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. |
| Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline | baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 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 |
| Changes From Baseline in Percent Affected Body Surface Area | Weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 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). |
| Change From Baseline in Static Physician's Global Assessment | Weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 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. |
| Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time | weeks 4, 8, 12, 16, 28, 40, 52, 64 | 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. |
| Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time | baseline, weeks 4,16, 28 and 52 | 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. |
| Change From Baseline in Scaling-Numeric Rating Scale | Weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 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'. |
| Change From Baseline in Pain-Numeric Rating Scale | Weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 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 |
| Proportion of Patients With Itch Score of 0 | weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 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 |
| Proportion of Patients With Scaling Score of 0 | Weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 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 |
| Proportion of Patients With Pain Score of 0 | Weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 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. |
| Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time | baseline, weeks 16, 28, 40, 52, 64 | 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). |
| Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time | baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64 | 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 |
| Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales | weeks 4, 8, 12, 16, 28, 40, 52, 64 | 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'. |
| Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale | weeks 4, 8, 12, 16, 28, 40, 52, 64 | 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'. |
| Change From Baseline in Itch-Numeric Rating Scale | baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64 | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent AEs | baseline, weeks 4, 8, 12, 16, 28, 40, 52,,64 | The reported values are entered in the 'Other Adverse events' section |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tildrakizumab 100 mg Injections of tildrakizumab: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52 | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Tildrakizumab 100 mg |
|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 15.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 52 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 29 / 55 |
| serious Total, serious adverse events | 4 / 55 |
Outcome results
Primary
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale
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.
Time frame: baseline, week 28 and week 52
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
Comparison: Week 52p-value: <0.001t-test, 2 sided
Secondary
Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
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'.
Time frame: weeks 4, 8, 12, 16, 28, 40, 52, 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale | Baseline | 2.7 score on a scale | Standard Deviation 2.33 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale | Week 40 | 5.9 score on a scale | Standard Deviation 3 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
p-value: <0.001t-test, 2 sided
Secondary
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
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
Time frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 13.7 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 18.4 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
Comparison: Treatment Satisfaction Questionnaire for Medication over time- Effectiveness
Comparison: Treatment Satisfaction Questionnaire for Medication over time-Side Effectsp-value: <0.001Exact binomial test
Comparison: Treatment Satisfaction Questionnaire for Medication over time - Convenience
Comparison: Treatment Satisfaction Questionnaire for Medication over time - Global Satisfaction
Secondary
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
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'.
Time frame: weeks 4, 8, 12, 16, 28, 40, 52, 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales | Week 28 (Improvement in Symptoms) | 8.0 score on a scale | Standard Deviation 2.3 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 2.8 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 2.3 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 1.7 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales | Week 8 (Side Effects) | 9.0 score on a scale | Standard Deviation 1.5 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
Comparison: Improvement in Symptoms
Comparison: Speed of Symptom Improvement
Comparison: Frequency of Taking Medication
Comparison: Side Effects
Secondary
Change From Baseline in Itch-Numeric Rating Scale
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
Time frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | Change From Baseline in Itch-Numeric Rating Scale | Baseline | 6.6 score on a scale | Standard Deviation 2.57 |
| Tildrakizumab 100 mg | Change From Baseline in Itch-Numeric Rating Scale | Week 4 | -1.7 score on a scale | Standard Deviation 2.47 |
| Tildrakizumab 100 mg | Change From Baseline in Itch-Numeric Rating Scale | Week 8 | -2.8 score on a scale | Standard Deviation 3.11 |
| Tildrakizumab 100 mg | Change From Baseline in Itch-Numeric Rating Scale | Week 12 | -3.0 score on a scale | Standard Deviation 3.22 |
| Tildrakizumab 100 mg | Change From Baseline in Itch-Numeric Rating Scale | Week 16 | -3.8 score on a scale | Standard Deviation 2.84 |
| Tildrakizumab 100 mg | Change From Baseline in Itch-Numeric Rating Scale | Week 28 | -3.8 score on a scale | Standard Deviation 3.12 |
| Tildrakizumab 100 mg | Change From Baseline in Itch-Numeric Rating Scale | Week 40 | -3.7 score on a scale | Standard Deviation 2.99 |
| Tildrakizumab 100 mg | Change From Baseline in Itch-Numeric Rating Scale | Week 52 | -4.1 score on a scale | Standard Deviation 3.06 |
| Tildrakizumab 100 mg | Change From Baseline in Itch-Numeric Rating Scale | Week 64 | -4.4 score on a scale | Standard Deviation 2.66 |
p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline in Pain-Numeric Rating Scale
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
Time frame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | Change From Baseline in Pain-Numeric Rating Scale | Baseline | 3.8 score on a scale | Standard Deviation 3.22 |
| Tildrakizumab 100 mg | Change From Baseline in Pain-Numeric Rating Scale | Week 4 | -1.2 score on a scale | Standard Deviation 2.65 |
| Tildrakizumab 100 mg | Change From Baseline in Pain-Numeric Rating Scale | Week 8 | -1.8 score on a scale | Standard Deviation 3.18 |
| Tildrakizumab 100 mg | Change From Baseline in Pain-Numeric Rating Scale | Week 12 | -1.8 score on a scale | Standard Deviation 2.88 |
| Tildrakizumab 100 mg | Change From Baseline in Pain-Numeric Rating Scale | Week 16 | -2.2 score on a scale | Standard Deviation 2.88 |
| Tildrakizumab 100 mg | Change From Baseline in Pain-Numeric Rating Scale | Week 28 | -2.3 score on a scale | Standard Deviation 3.05 |
| Tildrakizumab 100 mg | Change From Baseline in Pain-Numeric Rating Scale | Week 40 | -2.3 score on a scale | Standard Deviation 2.48 |
| Tildrakizumab 100 mg | Change From Baseline in Pain-Numeric Rating Scale | Week 52 | -2.5 score on a scale | Standard Deviation 2.76 |
| Tildrakizumab 100 mg | Change From Baseline in Pain-Numeric Rating Scale | Week 64 | -2.8 score on a scale | Standard Deviation 2.75 |
p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline in Scaling-Numeric Rating Scale
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'.
Time frame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | Change From Baseline in Scaling-Numeric Rating Scale | Week 28 | -4.7 score on a scale | Standard Deviation 2.78 |
| Tildrakizumab 100 mg | Change From Baseline in Scaling-Numeric Rating Scale | Baseline | 7.0 score on a scale | Standard Deviation 2.33 |
| Tildrakizumab 100 mg | Change From Baseline in Scaling-Numeric Rating Scale | Week 4 | -2.6 score on a scale | Standard Deviation 2.38 |
| Tildrakizumab 100 mg | Change From Baseline in Scaling-Numeric Rating Scale | Week 8 | -4.1 score on a scale | Standard Deviation 3.03 |
| Tildrakizumab 100 mg | Change From Baseline in Scaling-Numeric Rating Scale | Week 12 | -4.3 score on a scale | Standard Deviation 2.95 |
| Tildrakizumab 100 mg | Change From Baseline in Scaling-Numeric Rating Scale | Week 16 | -4.5 score on a scale | Standard Deviation 2.54 |
| Tildrakizumab 100 mg | Change From Baseline in Scaling-Numeric Rating Scale | Week 40 | -4.5 score on a scale | Standard Deviation 2.86 |
| Tildrakizumab 100 mg | Change From Baseline in Scaling-Numeric Rating Scale | Week 52 | -4.6 score on a scale | Standard Deviation 2.86 |
| Tildrakizumab 100 mg | Change From Baseline in Scaling-Numeric Rating Scale | Week 64 | -4.6 score on a scale | Standard Deviation 2.89 |
p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline in Static Physician's Global Assessment
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.
Time frame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | Change From Baseline in Static Physician's Global Assessment | Baseline | 3.2 score on a scale | Standard Deviation 0.56 |
| Tildrakizumab 100 mg | Change From Baseline in Static Physician's Global Assessment | Week 4 | -1.1 score on a scale | Standard Deviation 0.71 |
| Tildrakizumab 100 mg | Change From Baseline in Static Physician's Global Assessment | Week 8 | -1.8 score on a scale | Standard Deviation 0.94 |
| Tildrakizumab 100 mg | Change From Baseline in Static Physician's Global Assessment | Week 12 | -2.0 score on a scale | Standard Deviation 1.08 |
| Tildrakizumab 100 mg | Change From Baseline in Static Physician's Global Assessment | Week 16 | -1.9 score on a scale | Standard Deviation 0.8 |
| Tildrakizumab 100 mg | Change From Baseline in Static Physician's Global Assessment | Week 28 | -2.0 score on a scale | Standard Deviation 1.05 |
| Tildrakizumab 100 mg | Change From Baseline in Static Physician's Global Assessment | Week 40 | -2.2 score on a scale | Standard Deviation 1 |
| Tildrakizumab 100 mg | Change From Baseline in Static Physician's Global Assessment | Week 52 | -2.1 score on a scale | Standard Deviation 1.07 |
| Tildrakizumab 100 mg | Change From Baseline in Static Physician's Global Assessment | Week 64 | -2.2 score on a scale | Standard Deviation 1 |
p-value: <0.001t-test, 2 sided
Secondary
Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time
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.
Time frame: weeks 4, 8, 12, 16, 28, 40, 52, 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
p-value: <0.001t-test, 2 sided
Secondary
Changes From Baseline in Percent Affected Body Surface Area
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).
Time frame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | Changes From Baseline in Percent Affected Body Surface Area | Baseline | 14.5 Percent BSA | Standard Deviation 11.54 |
| Tildrakizumab 100 mg | Changes From Baseline in Percent Affected Body Surface Area | Week 4 | -2.9 Percent BSA | Standard Deviation 5.7 |
| Tildrakizumab 100 mg | Changes From Baseline in Percent Affected Body Surface Area | Week 8 | -8.7 Percent BSA | Standard Deviation 11.89 |
| Tildrakizumab 100 mg | Changes From Baseline in Percent Affected Body Surface Area | Week 12 | -10.1 Percent BSA | Standard Deviation 12.09 |
| Tildrakizumab 100 mg | Changes From Baseline in Percent Affected Body Surface Area | Week 16 | -10.9 Percent BSA | Standard Deviation 11.57 |
| Tildrakizumab 100 mg | Changes From Baseline in Percent Affected Body Surface Area | Week 28 | -10.9 Percent BSA | Standard Deviation 12.74 |
| Tildrakizumab 100 mg | Changes From Baseline in Percent Affected Body Surface Area | Week 40 | -11.3 Percent BSA | Standard Deviation 12.93 |
| Tildrakizumab 100 mg | Changes From Baseline in Percent Affected Body Surface Area | Week 52 | -11.5 Percent BSA | Standard Deviation 12.79 |
| Tildrakizumab 100 mg | Changes From Baseline in Percent Affected Body Surface Area | Week 64 | -12.7 Percent BSA | Standard Deviation 11.88 |
p-value: <0.001t-test, 2 sided
Secondary
Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time
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.
Time frame: baseline, weeks 4,16, 28 and 52
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 4.6 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
p-value: <0.001t-test, 2 sided
Secondary
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
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).
Time frame: baseline, weeks 16, 28, 40, 52, 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
Comparison: Total Activity Impairmentp-value: <0.001t-test, 2 sided
Comparison: Total Work Productivity Impairmentp-value: <0.001t-test, 2 sided
Secondary
Improvement in Quality of Life Measured by Change From Baseline in Dermatology Life Quality Index Over Time
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
Time frame: week 64
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tildrakizumab 100 mg | 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 |
p-value: <0.001t-test, 2 sided
Secondary
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time
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.
Time frame: baseline, weeks 4, 8, 12, 16, 40, 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 10.4 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
| Tildrakizumab 100 mg | 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 |
p-value: 0.011t-test, 2 sided
Secondary
Proportion of Patients With Itch Score of 0
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
Time frame: weeks 4, 8, 12, 16, 28, 40, 52, and 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tildrakizumab 100 mg | Proportion of Patients With Itch Score of 0 | Baseline | 1.8 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Itch Score of 0 | Week 4 | 3.6 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Itch Score of 0 | Week 8 | 11.3 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Itch Score of 0 | Week 12 | 22.2 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Itch Score of 0 | Week 16 | 16.7 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Itch Score of 0 | Week 28 | 20.8 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Itch Score of 0 | Week 40 | 22.9 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Itch Score of 0 | Week 52 | 22.9 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Itch Score of 0 | Week 64 | 24.4 Percentage of participants |
95% CI: [12.9, 39.5]
Secondary
Proportion of Patients With Pain Score of 0
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.
Time frame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tildrakizumab 100 mg | Proportion of Patients With Pain Score of 0 | Baseline | 12.7 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Pain Score of 0 | Week 4 | 21.8 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Pain Score of 0 | Week 8 | 34.0 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Pain Score of 0 | Week 12 | 48.1 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Pain Score of 0 | Week 16 | 40.7 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Pain Score of 0 | Week 28 | 50.9 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Pain Score of 0 | Week 40 | 54.2 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Pain Score of 0 | Week 52 | 52.1 Percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Pain Score of 0 | Week 64 | 48.9 Percentage of participants |
95% CI: [33.7, 64.2]
Secondary
Proportion of Patients With Scaling Score of 0
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
Time frame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tildrakizumab 100 mg | Proportion of Patients With Scaling Score of 0 | Baseline | 0 percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Scaling Score of 0 | Week 4 | 3.6 percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Scaling Score of 0 | Week 8 | 20.8 percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Scaling Score of 0 | Week 12 | 16.7 percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Scaling Score of 0 | Week 16 | 20.4 percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Scaling Score of 0 | Week 28 | 22.6 percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Scaling Score of 0 | Week 40 | 22.9 percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Scaling Score of 0 | Week 52 | 25.0 percentage of participants |
| Tildrakizumab 100 mg | Proportion of Patients With Scaling Score of 0 | Week 64 | 17.8 percentage of participants |
95% CI: [8, 32.1]
Secondary
Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline
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
Time frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tildrakizumab 100 mg | Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline | Week 4 | 44.4 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline | Week 8 | 61.9 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline | Week 12 | 69.0 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline | Week 16 | 75.0 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline | Week 28 | 81.4 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline | Week 40 | 87.5 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline | Week 52 | 82.5 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline | Week 64 | 78.9 Percentage of subjects |
95% CI: [62.7, 90.4]
Secondary
Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
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.
Time frame: Baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5 | Baseline | 13 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5 | Week 4 | 56.4 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5 | Week 8 | 84.6 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5 | Week 12 | 86.5 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5 | Week 16 | 88.9 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5 | Week 28 | 94.3 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5 | Week 40 | 91.7 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5 | Week 52 | 89.6 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5 | Week 60 | 93.3 Percentage of subjects |
95% CI: [81.7, 98.6]
Secondary
Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
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.
Time frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64
Population: The intent-to-treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1 | Baseline | 1.8 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1 | Week 4 | 18.2 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1 | Week 8 | 36.5 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1 | Week 12 | 42.3 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1 | Week 16 | 51.9 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1 | Week 28 | 52.8 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1 | Week 40 | 58.3 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1 | Week 52 | 56.3 Percentage of subjects |
| Tildrakizumab 100 mg | Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1 | Week 64 | 62.2 Percentage of subjects |
95% CI: [46.5, 76.2]
Other Pre-specified
Treatment-emergent AEs
The reported values are entered in the 'Other Adverse events' section
Time frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52,,64