N/A
N=331
Observational Study of Tildrakizumab in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT04203693 ↗Enrolled (actual)
331
Serious AEs
5.7%
Results posted
Mar 2026
Primary outcome: Primary: Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 48 — 1.13; 1.63 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tildrakizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Almirall, S.A.
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 48 |
1.13; 1.63 | — |
| PRIMARY Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 96 |
1.23; 1.10 | — |
| PRIMARY Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 48 |
-0.57; -0.78 | — |
| PRIMARY Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 96 |
-0.62; -1.05 | — |
| PRIMARY Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) Scores at Week 48 |
0.3888; 1.0000 | — |
| PRIMARY Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 96 |
0.5880; 1.0000 | — |
| PRIMARY Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 48 |
62.50; 50.0; 42.50; 25.0; 22.50; 25.0 | — |
| PRIMARY Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 96 |
47.50; 25.0; 32.50; 25.0; 22.50; 25.0 | — |
| PRIMARY Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48 |
1.08; 2.25 | — |
| PRIMARY Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96 |
1.11; 0.45 | — |
| PRIMARY Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 48 |
28.96; 28.00; -24.63; -25.75 | — |
| PRIMARY Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 96 |
28.96; 28.00; -26.65; -18.05 | — |
| PRIMARY Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 48 |
0.75; 0.75; 0.17; 0.75; 0.38; 0.93 | — |
| PRIMARY Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 96 |
0.73; 0.50; 0.24; 0.50; 0.23; 1.00 | — |
| PRIMARY Cohort 1: Change From Baseline (reSURFACE Studies for General and Current Study for Nail and Scalp) in Physician's Global Assessment (PGA) Score at Week 48 |
3.36; 3.00; -2.67; -2.25; 0.40; 0.50 | — |
| PRIMARY Cohort 1: Change From Baseline (reSURFACE Studies for General and Current Study for Nail and Scalp) in Physician's Global Assessment (PGA) Score at Week 96 |
3.36; 3.00; -2.74; -2.50; 0.40; 0.50 | — |
| PRIMARY Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 52 |
1.30; 2.00 | — |
| PRIMARY Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Scroe at Week 100 |
1.37; 4.80 | — |
| PRIMARY Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52 |
-11.39; -14.20 | — |
| PRIMARY Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 100 |
-11.36; -11.40 | — |
| PRIMARY Cohort 2: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 52 |
0.2562; NA | — |
| PRIMARY Cohort 2: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 100 |
0.4172; NA | — |
| PRIMARY Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 52 |
79.73; 100; 63.51; 0.0; 43.92; 0.0 | — |
| PRIMARY Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 100 |
77.37; 0; 62.04; 0; 35.77; 0 | — |
| PRIMARY Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52 |
1.70; 0.60 | — |
| PRIMARY Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100 |
1.49; 2.00 | — |
| PRIMARY Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 52 |
-13.97; -20.40 | — |
| PRIMARY Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 100 |
-14.63; -19.00 | — |
| PRIMARY Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 52 |
0.76; 1.00; 0.33; 0.00; 0.34; 0.00 | — |
| PRIMARY Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 100 |
0.80; 2.00; 0.28; 0.00; 0.34; 0.00 | — |
| PRIMARY Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 52 |
-1.81; -3.00; -0.60; -1.55 | — |
| PRIMARY Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 100 |
-1.75; -2.00; -0.72; -1.49 | — |
| SECONDARY Absolute Dermatology Life Quality Index (DLQI) Score at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2 |
0.815; 4.500; 1.095; 1.000; 1.650; 1.000 | — |
| SECONDARY Change From Baseline in Absolute Dermatology Life Quality Index (DLQI) Score at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2 |
-1.224; 3.500; -1.132; 0.500; -9.693; -21.000 | — |
| SECONDARY Absolute Dermatology Life Quality Index Score Adjusted for Not Relevant Responses (DLQI-R) at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2 |
0.900; 5.000; 1.245; 1.000; 1.846; 1.000 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index Score Adjusted for Not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2 |
-1.365; 3.900; -1.305; 0.500; -10.382; -21.000 | — |
| SECONDARY Itch and Pain Visual Analogue Scales (VAS) Scores at Week 96 for Cohort 1 and Week 100 for Cohort 2 |
0.78; 0.45; 0.91; 3.00; 0.65; 0.10 | — |
| SECONDARY Change From Baseline in Itch and Pain Visual Analogue Scales (VAS) Scores at Week 96 for Cohort 1 and Week 100 for Cohort 2 |
-0.29; -1.40; 0.11; -0.05; -3.98; -6.00 | — |
| SECONDARY Absolute Scores of Participant's Satisfaction With Tildrakizumab Therapy as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 96 for Cohort 1 and Week 100 for Cohort 2 |
88.21; 91.65; 100.00; 100.00; 90.24; 91.65 | — |
| SECONDARY Absolute Scores of Physician's Satisfaction With Tildrakizumab Therapy for Effectiveness and Tolerability at Week 96 for Cohort 1 and Week 100 for Cohort 2 |
1.38; 1.00; 1.08; 1.00; 1.36; 2.00 | — |
| SECONDARY Number of Participants Who Added Concomitant Medications |
33; 3; 116; 2 | — |
| SECONDARY Change From Baseline in Body Weight up to Week 96 for Cohort 1 and Week 100 for Cohort 2 |
-0.50; 10.00; 0.98; 1.20 | — |
| SECONDARY Change From Baseline in Waist and Hip Circumference at Week 96 for Cohort 1 and Week 100 for Cohort 2 |
1.13; 1.75; -1.00; 0.47 | — |
| SECONDARY Change From Baseline in Waist/Hip Ratio at Week 96 for Cohort 1 and Week 100 for Cohort 2 |
-0.001; -0.016 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) at Week 96 for Cohort 1 and Week 100 for Cohort 2 |
-0.18; 2.70; 0.31; 0.40 | — |
| SECONDARY Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 96 for Cohort 1 and Week 100 for Cohort 2 |
3.88; -5.00; 1.52; -4.00; -3.73; -2.50 | — |
| SECONDARY Number of Participants With Responses to Questions About Food Intake |
6; 0; 17; 0; 35; 2 | — |
| SECONDARY Number of Participants With Responses to Physical Activity Questionnaire |
15; 0; 41; 0; 2; 0 | — |
| SECONDARY Change From Baseline in Physical Activity at Week 96 for Cohort 1 and Week 100 for Cohort 2 |
560.0; 180.0; 120.0; 8.8; 200.0; 164.0 | — |
| SECONDARY Change From Baseline in Lipid Profiles at Week 96 for Cohort 1 and Week 100 for Cohort 2 |
0.050; -0.100; 0.580; 0.580; 0.225; 0.178 | — |
| SECONDARY Change From Baseline in Lipid Profile (Lipoprotein-a) at Week 96 for Cohort 1 and Week 100 for Cohort 2 |
1.825 | — |
| SECONDARY Number of Participants Withdrawn From the Study |
14; 2; 68; 2 | — |
| SECONDARY Number of Participants With Reason for Tildrakizumab Dosage Change |
0; 1; 2; 2 | — |
| SECONDARY Drug Survival |
20.365; 20.100; 20.087; 13.003 | — |
| SECONDARY Participants Adherence as Assessed by Time to Study Discontinuation |
21.338; 21.133; 20.853; 13.803 | — |
Summary
The observational, non-interventional study will assess the efficacy, safety, prescription and utilization patterns of Tildrakizumab in participants with moderate to severe plaque psoriasis in routine clinical practice.
Eligibility Criteria
Inclusion Criteria
- Written informed consent form.
- Age >= 18years.
- Moderate to severe chronic plaque psoriasis diagnosis.
- Participants who have participated in Tildrakizumab (Ilumetri®) clinical trials (Cohort 1) OR participants who, according to the physician's therapeutic decision, should start the treatment with Tildrakizumab (Ilumetri®) (Cohort 2).
Exclusion Criteria
- Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study.
- Participants meeting any of the exclusion criteria specified in the summary of product characteristics (SmPC) of Ilumetri®.
Data sourced from ClinicalTrials.gov (NCT04203693). 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.