Observational Study of Tildrakizumab in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Tildrakizumab

• Registration Number: NCT04203693
• Lead Sponsor: Almirall, S.A.

Brief Summary

The observational, non-interventional study will assess the efficacy, safety, prescription and utilization patterns of Tildrakizumab in participants with moderate to severe plaque psoriasis in routine clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-30
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-18
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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®.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1: Tildrakizumab Treated Participants	Tildrakizumab	Participants will be treated with tildrakizumab who have participated in prior tildrakizumab studies
Cohort 2: Newly Tildrakizumab Prescribed Participants	Tildrakizumab	Participants will be newly prescribed tildrakizumab (a prescription has occurred independently of the enrolment in the study)

Primary Outcome Measures

Name	Time	Method
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	Week 96	PASI is used to assess the lesion severity and affected area due to psoriasis. Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses.
Cohort 1: Percentage of Participants who maintaining Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 96	Week 96	PASI is a combined assessment of lesion severity and affected area into a single score.
Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) at Week 100	Week 100	PASI is a combined assessment of lesion severity and affected area into a single score.
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 48	Week 48	PASI is used to assess the lesion severity and affected area due to psoriasis. Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses.
Cohort 1: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48	Week 48	BSA is a numerical score used to measure the total area of the body affected by psoriasis.
Cohort 1: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96	Week 96	BSA is a numerical score used to measure the total area of the body affected by psoriasis.
Cohort 1: Change from Baseline in Body Surface Area Affected by Psoriasis at Week 96	Baseline (Day 0) and Week 96	BSA is a numerical score used to measure the total area of the body affected by psoriasis.
Cohort 1: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail, Scalp) at Week 96	Baseline (Day 0) and Week 96	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body. PGA of psoriasis in general, at nail and scalp will be graded from 0 (none/clear) to 4 (severe).
Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) at Week 52	Week 52	PASI is a combined assessment of lesion severity and affected area into a single score.
Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 48	Week 48	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body.
Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 96	Week 96	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body.
Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) at Week 48	Week 48	PASI is a combined assessment of lesion severity and affected area into a single score.
Cohort 1: Change From Baseline in Psoriasis Area and Severity Index at Week 96	Baseline (Day 0) and Week 96	PASI is a combined assessment of lesion severity and affected area into a single score.
Cohort 1: Change from Baseline in Body Surface Area Affected by Psoriasis at Week 48	Baseline (Day 0) and Week 48	BSA is a numerical score used to measure the total area of the body affected by psoriasis.
Cohort 1: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail, Scalp) at Week 48	Baseline (Day 0) and Week 48	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body. PGA of psoriasis in general, at nail and scalp will be graded from 0 (none/clear) to 4 (severe).
Cohort 2: Change From Baseline in Psoriasis Area and Severity Index at Week 52	Baseline (Week 0) and Week 52	PASI is a combined assessment of lesion severity and affected area into a single score.
Cohort 2: Correlation between absolute Psoriasis Area and Severity Index scores and Dermatology Life Quality Index adjusted for not relevant responses at Week 52	Week 52	PASI is used to assess the lesion severity and affected area due to psoriasis. Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses.
Cohort 2: Correlation between absolute Psoriasis Area and Severity Index scores and Dermatology Life Quality Index adjusted for not relevant responses at Week 100	Week 100	PASI is used to assess the lesion severity and affected area due to psoriasis. Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses.
Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) at Week 96	Week 96	PASI is a combined assessment of lesion severity and affected area into a single score.
Cohort 1: Change From Baseline in Psoriasis Area and Severity Index at Week 48	Baseline (Day 0) and Week 48	PASI is a combined assessment of lesion severity and affected area into a single score.
Cohort 1: Percentage of Participants who maintaining Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 48	Week 48	PASI is a combined assessment of lesion severity and affected area into a single score.
Cohort 2: Change From Baseline in Psoriasis Area and Severity Index at Week 100	Baseline (Week 0) and Week 100	PASI is a combined assessment of lesion severity and affected area into a single score.
Cohort 2: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52	Week 52	BSA is a numerical score used to measure the total area of the body affected by psoriasis.
Cohort 2: Change from Baseline in Percent Body Surface Area Affected by Psoriasis (BSA) at Week 100	Baseline and Week 100	BSA is a numerical score used to measure the total area of the body affected by psoriasis.
Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (Scores of General, Nail and Scalp) at Week 52	Baseline (Day 0) and Week 52	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body.
Cohort 2: Percentage of Participants who Achieved Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 100	Week 100	PASI is a combined assessment of lesion severity and affected area into a single score.
Cohort 2: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100	Week 100	BSA is a numerical score used to measure the total area of the body affected by psoriasis.
Cohort 2: Change from Baseline in Percent Body Surface Area Affected by Psoriasis (BSA) at Week 52	Baseline and Week 52	BSA is a numerical score used to measure the total area of the body affected by psoriasis.
Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) at Week 52	Week 52	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body.
Cohort 2: Percentage of Participants who Achieved Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 52	Week 52	PASI is a combined assessment of lesion severity and affected area into a single score.
Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) at Week 100	Week 100	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body.
Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (Scores of General, Nail and Scalp) at Week 100	Baseline (Day 0) and Week 100	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Lipid Profiles up to EOS	Baseline (Day 0) to Week 96/100 (EOS)	Serum lipid will be assessed, if available
Change from Baseline in Waist and hip Circumference at EOS/ET	Baseline (Day 0) and Week 96/100 (EOS)/ET	Change in waist and hip circumference will be assessed.
Change from Baseline in Itch and Pain Visual Analogue Scales Scores	Baseline (Day 0) to Week 96/100	Itch and pain of the skin will be assessed by the participant on visual analogue scales (VAS).
Number of participants who Used Concomitant Medications From Baseline at Week 48 and 96 for Cohort 1 and Week 52 and 100 for Cohort 2	Cohort 1: Baseline (Day 0), Week 48 and Week 96; Cohort 2: Baseline, Week 52 and Week 100	Concomitant topical, photo- or systemic anti-psoriatic and non-psoriasis therapy will be assessed.
Change from Baseline in Body Mass Index (BMI) at EOS/ET	Baseline (Day 0) and Week 96/100 (EOS)/ET	Change in BMI will be assessed.
Change from Baseline in Blood Pressure at EOS/ET	Baseline (Day 0) and Week 96/100 (EOS)/ET	Change in Blood Pressure will be assessed.
Absolute Dermatology Life Quality Index and Dermatology Life Quality Index Adjusted for not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2	Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100	Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses.
Itch and Pain Visual Analogue Scales (VAS) Scores	Baseline (Day 0) to Week 96/100	Itch and pain of the skin will be assessed by the participant on visual analogue scales (VAS).
Change from Baseline in Food Intake up to EOS/ET	Baseline (Day 0) to Week 96/100 (EOS)/ET	Participants will be asked to complete a simple questionnaire regarding their food intake.
Number of Participant's With Adherence to Treatment up to EOS/ET	Baseline (Day 0) to Week 96/100 (EOS)/ET	Number of Participant's who adhere to the treatment will be assessed.
Change from Baseline in Absolute Dermatology Life Quality Index and Dermatology Life Quality Index Adjusted for not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2	Cohort 1: Baseline (Day 0), Week 48 and Week 96; Cohort 2: Baseline, Week 52 and Week 100	Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses.
Change from Baseline in Body Weight at End of study (EOS)/End of treatment (ET)	Baseline (Day 0) and Week 96/100 (EOS)/ET	Change in the body weight measurement will be assessed.
Change from Baseline in Physical Activity up to EOS/ET	Baseline (Day 0) to Week 96/100 (EOS)/ET	Participants will be asked to complete a simple questionnaire regarding their physical activity.
Number of Participants Withdraw From the Study Overtime	Baseline (Day 0) to Week 96/100 (EOS)	Participants who discontinue treatment prior to the regular end of the observation period.
Number of Participants who Underwent Dose Change up to EOS/ET	Baseline (Day 0) to Week 96/100 (EOS)/ET	The number of participants who underwent dose change (100 mg or 200 mg).
Drug Survival up to EOS/ET	Baseline (Day 0) to Week 96/100 (EOS)/ET	Drug survival is defined as the time from initiation of therapy to discontinuation.

Trial Locations

Locations (14)

Investigational site 1; 🇳🇱 Breda, Netherlands

Investigational site 5; 🇮🇹 Roma, Italy

Investigational site 13; 🇩🇪 Berlin, Germany

Investigator Site 1; 🇦🇹 Wien, Austria

Investigational site 7; 🇮🇹 Genova, Italy

Investigational site 2; 🇮🇹 Roma, Italy

Investigational site 3; 🇮🇹 Modena, Italy

Investigational site 4; 🇮🇹 Parma, Italy

Investigational site 6; 🇮🇹 Catania, Italy

Investigational site 12; 🇩🇪 Oberursel, Germany

Investigational site 10; 🇩🇪 Berlin, Germany

Investigational site 11; 🇩🇪 Berlin, Germany

Investigational site 8; 🇩🇪 Erlangen, Germany

Investigational site 9; 🇩🇪 Greifswald, Germany