Phase 4
Completed N=55
A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis
Source: ClinicalTrials.gov NCT03718299 ↗Enrolled (actual)
55
Serious AEs
7.3%
Results posted
Feb 2023
Primary outcomePrimary: Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale — 78; 3.7; 8.0 score on a scale — p=<0.001
◆ Published Evidence
Emerging
2citations · ~1 / year
Improvements in Psoriasis-Related Work Productivity with Tildrakizumab: Results from a Phase 4 Real-World Study in Patients with Moderate-to-Severe Plaque Psoriasis.
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.
Linked Publications
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Improvements in Psoriasis-Related Work Productivity with Tildrakizumab: Results from a Phase 4 Real-World Study in Patients with Moderate-to-Severe Plaque Psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale |
78; 3.7; 8.0 | <0.001 sig |
| SECONDARY Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time |
78.1; 4.2; 4.2; 4.5; 5.3; 5.6 | 0.011 sig |
| SECONDARY Improvement in Quality of Life Measured by Change From Baseline in Dermatology Life Quality Index Over Time |
-8.0 | <0.001 sig |
| SECONDARY Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1 |
1.8; 18.2; 36.5; 42.3; 51.9; 52.8 | — |
| SECONDARY Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5 |
13; 56.4; 84.6; 86.5; 88.9; 94.3 | — |
| SECONDARY Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline |
44.4; 61.9; 69.0; 75.0; 81.4; 87.5 | — |
| SECONDARY Changes From Baseline in Percent Affected Body Surface Area |
14.5; -2.9; -8.7; -10.1; -10.9; -10.9 | <0.001 sig |
| SECONDARY Change From Baseline in Static Physician's Global Assessment |
3.2; -1.1; -1.8; -2.0; -1.9; -2.0 | <0.001 sig |
| SECONDARY Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time |
-21.1; -37.1; -38.1; -39.9; -37.8; -38.2 | <0.001 sig |
| SECONDARY Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time |
11.6; -5.1; -9.3; -9.4; -10.0 | <0.001 sig |
| SECONDARY Change From Baseline in Itch-Numeric Rating Scale |
6.6; -1.7; -2.8; -3.0; -3.8; -3.8 | <0.001 sig |
| SECONDARY Change From Baseline in Scaling-Numeric Rating Scale |
7.0; -2.6; -4.1; -4.3; -4.5; -4.7 | <0.001 sig |
| SECONDARY Change From Baseline in Pain-Numeric Rating Scale |
3.8; -1.2; -1.8; -1.8; -2.2; -2.3 | <0.001 sig |
| SECONDARY Proportion of Patients With Itch Score of 0 |
1.8; 3.6; 11.3; 22.2; 16.7; 20.8 | — |
| SECONDARY Proportion of Patients With Scaling Score of 0 |
0; 3.6; 20.8; 16.7; 20.4; 22.6 | — |
| SECONDARY Proportion of Patients With Pain Score of 0 |
12.7; 21.8; 34.0; 48.1; 40.7; 50.9 | — |
| SECONDARY Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time |
29.5; -20.8; -24.7; -26.9; -20.8; -27.8 | <0.001 sig |
| SECONDARY Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time |
59.5; 70.8; 71.0; 73.9; 76.5; 78.4 | <0.001 sig |
| SECONDARY Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales |
6.0; 7.6; 7.7; 8.0; 8.0; 8.4 | — |
| SECONDARY Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale |
2.7; 3.7; 5.1; 5.1; 5.5; 5.7 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Subjects are non-immunocompromised males or females 18 years of age or older.
- Subjects have ≥3% total body surface area plaque psoriasis.
- Subjects are candidates for phototherapy or systemic therapy.
- Subject must be diagnosed at least 6 months prior to entering the study.
- 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
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject is younger than 18 years of age.
- Subjects with uncontrolled mental illness or active suicidal ideations based on baseline mental health questionnaire of choice.
- Subject is known, or suspected of being unable to comply with the study protocol, in the opinion of the investigator.
- Subject is currently enrolled in an investigational drug or device study.
Data sourced from ClinicalTrials.gov (NCT03718299) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.