A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effectiveness profile of guselkumab used in a real-life setting in participants with moderate facial and/or genital psoriasis. Effectiveness will be evaluated using the static Physicians Global Assessment (sPGA) for the facial region and the sPGA for the genital region.

Official Title
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Observational Study on GUselkumab: Effectiveness and Impact on quaLity of LIfe in naïVE or Bio Experienced Patients With Regional (Facial and Genital) Psoriasis (GULLIVER Study)

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Guselkumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants included in the study: must have a first or confirmed diagnosis of psoriasis, requiring systemic treatment with significant involvement (defined as a Static Physician's Global Assessment [sPGA] score greater than or equal to [>=] 3) involving the facial and/or genital regions must have started treatment according to the approved indication as described in the current version of summary of product characteristics (SmPC) of the product approved in Italy. Enrollment may occur at any time after the first injection of guselkumab but before completion of the next visit at week 4 or 12 as scheduled according to common clinical practice must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements Exclusion Criteria: Participants will be excluded from the study if they: have any contraindication to the use of guselkumab, as stated in the current SmPC of the product approved in Italy received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of guselkumab treatment are currently enrolled in another clinical trial or investigational study are currently enrolled in an observational study sponsored or managed by a Janssen company participant unable to read, to write, to understand and sign the informed consent form (ICF)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Facial Psoriasis<br>Participants with moderate facial psoriasis who are being treated with guselkumab in real world practice will be observed in this study. | Drug: Guselkumab<br>* Participants with moderate facial and/or genital psoriasis treated with guselkumab (as prescribed by their physician) in real world practice will be observed in this study.<br>* Other names: Tremfya;|
| Participants with Genital Psoriasis<br>Participants with moderate genital psoriasis who are being treated with guselkumab in real world practice will be observed in this study. | Drug: Guselkumab<br>* Participants with moderate facial and/or genital psoriasis treated with guselkumab (as prescribed by their physician) in real world practice will be observed in this study.<br>* Other names: Tremfya;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) and at Least a 2-grade Improvement for the Facial Region | The sPGA for the facial region is a physician global rating of psoriasis severity, which evaluates plaque thickness, scaling and erythema, at a given point in time. The sPGA comprises a 6-point rating scale from 0 to 5 where 0 = clear, 1 = minimal/ almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. | Week 52 | 
| Percentage of Participants Achieving a sPGA Score of Clear (0) or Almost Clear (1) and at Least a 2-grade Improvement for the Genital Region | The sPGA for the genital region is a physician global ratings of psoriasis severity, which evaluates plaque thickness, scaling and erythema, at a given point in time. The sPGA comprises a 6-point rating scale from 0 to 5 where 0 = clear, 1 = minimal/ almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a sPGA Score of Clear (0) or Almost Clear (1) and at least a 2-grade Improvement for the Facial Region | The sPGA for the facial region is a physician global rating of psoriasis severity, which evaluates plaque thickness, scaling and erythema, at a given point in time. The sPGA comprises a 6-point rating scale from 0 to 5 where 0 = clear, 1 = minimal/ almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. | Week 12, Week 28 | 
| Percentage of Participants Achieving a sPGA Score of Clear (0) or Almost Clear (1) and at least a 2-grade Improvement for the Genital Region | The sPGA for the genital region is a physician global rating of psoriasis severity, which evaluates plaque thickness, scaling and erythema, at a given point in time. The sPGA comprises a 6-point rating scale from 0 to 5 where 0 = clear, 1 = minimal/ almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. | Week 12, Week 28 | 
| Change from Baseline in the Dermatology Quality of life Index (DLQI) Total Score for the Facial Region | The DLQI is a 10-item questionnaire that measures the impact of skin disease on participants' quality of life. Each question is evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate greater impact on quality of life. The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30 where 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate greater impact on quality of life of participants. | Baseline, Week 12, Week 28, Week 52 | 
| Change from Baseline in the DLQI Total Score for the Genital Region | The DLQI is a 10-item questionnaire that measures the impact of skin disease on participants' quality of life. Each question is evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate greater impact on quality of life. The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30 where 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate greater impact on quality of life of participants. | Baseline, Week 12, Week 28, Week 52 | 
| Change from Baseline in the SF-36 Physical Component Summary (PCS) Score for the Facial Region | The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Each item is scored on a scale of 0 to 100. Worst value is 0 and best value is 100. | Baseline, Week 12, Week 28, Week 52 | 
| Change from Baseline in the SF-36 PCS Score for the Genital Region | The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Each item is scored on a scale of 0 to 100. Worst value is 0 and best value is 100. | Baseline, Week 12, Week 28, Week 52 | 
| Change from Baseline in the SF-36 Mental Component Summary (MCS) Score for the Facial Region | The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Each item is scored on a scale of 0 to 100. Worst value is 0 and best value is 100. | Baseline, Week 12, Week 28, Week 52 | 
| Change from Baseline in the SF-36 MCS Score for the Genital Region | The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Each item is scored on a scale of 0 to 100. Worst value is 0 and best value is 100. | Baseline, Week 12, Week 28, Week 52 | 
| Change from Baseline in Pain/Itch/Discomfort Visual Analogue Scale (VAS) Scores for the Facial Region | Each VAS is a patient-rated assessment designed to evaluate the intensity of pain, itch or discomfort on a linear scale of 0-100. Operationally, each VAS is represented by a 100 mm horizontal line anchored by extreme descriptors at each end, where 0 = No Symptom and 100 = Worst Symptom Imaginable. | Baseline, Week 12, Week 28, Week 52 | 
| Change from Baseline in Pain/Itch/Discomfort VAS Scores for the Genital Region | Each VAS is a patient-rated assessment designed to evaluate the intensity of pain, itch or discomfort on a linear scale of 0-100. Operationally, each VAS is represented by a 100 mm horizontal line anchored by extreme descriptors at each end, where 0 = No Symptom and 100 = Worst Symptom Imaginable. | Baseline, Week 12, Week 28, Week 52 | 
| Change from Baseline in Redness/Scaling/Thickness VAS Scores for the Facial Region | Each VAS is a patient-rated assessment designed to evaluate the intensity of redness, scaling, and thickness on a linear scale of 0-100. Operationally, each VAS is represented by a 100 mm horizontal line anchored by extreme descriptors at each end, where 0 = No Sign and 100 = Worst Sign Imaginable. | Baseline, Week 12, Week 28, Week 52 | 
| Change from Baseline in Redness/Scaling/Thickness VAS Scores for the Genital Region | Each VAS is a patient-rated assessment designed to evaluate the intensity of redness, scaling, and thickness on a linear scale of 0-100. Operationally, each VAS is represented by a 100 mm horizontal line anchored by extreme descriptors at each end, where 0 = No Sign and 100 = Worst Sign Imaginable. | Baseline, Week 12, Week 28, Week 52 | 
| Percentage of Participants Achieving an Overall sPGA Score of Clear (0) or Almost Clear (1) and at least a 2-grade Improvement Among Participants with an Overall sPGA Score greater than or equal to (>=) 3 at baseline | The overall sPGA is defined as physician global rating of psoriasis severity, which evaluates plaque thickness, scaling and erythema, at a given point in time. The sPGA comprises a 6-point rating scale from 0 to 5 where 0 = clear, 1 = minimal/ almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. | Baseline, Week 12, Week 28, Week 52 | 
| Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 100 Response Among Participants with a PASI Score >10 at Baseline | The PASI is a tool to assess and grade the severity of psoriasis and response to therapy. In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status. A PASI 100 response is defined as 100 percent (%) improvement in PASI score from baseline. | Baseline, Week 12, Week 28, Week 52 | 
| Percentage of Participants Achieving a PASI 90 Response Among Participants with a PASI Score >10 at Baseline | The PASI is a tool to assess and grade the severity of psoriasis and response to therapy. In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status. A PASI 90 response is defined as >=90% improvement in PASI score from baseline. | Baseline, Week 12, Week 28, Week 52 | 
| Percentage of Participants Achieving a PASI 75 Response Among Participants with a PASI Score >10 at Baseline | The PASI is a tool to assess and grade the severity of psoriasis and response to therapy. In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status. A PASI 75 response is defined as >=75% improvement in PASI score from baseline. | Baseline, Week 12, Week 28, Week 52 | 
| Mean Percent Change in PASI Score from Baseline | The PASI is a tool to assess and grade the severity of psoriasis and response to therapy. In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status. Mean percent change from baseline in PASI score will be assessed. | Baseline, Week 12, Week 28, Week 52 | 
| Mean Change in Percent Body Surface Area (BSA) from Baseline in Participants with BSA >10% at Baseline | BSA affected by psoriasis of <5% is considered mild psoriasis, 5-10% moderate psoriasis, and >10% severe psoriasis. | Baseline, Week 12, Week 28, Week 52 | 
| Percentage of Participants Achieving an Absolute PASI Score of Less Than (<) 3 Among Participants with a PASI Score of >10 at Baseline | The PASI is a tool to assess and grade the severity of psoriasis and response to therapy. In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status. Percentage of participants who achieve an absolute PASI score <3 will be assessed. | Baseline, Week 12, Week 28, Week 52 | 
| Treatment Satisfaction Questionnaire for Medication (TSQM-9) | The TSQM-9 is a 9-item generic participant-reported outcome instrument to assess participants' satisfaction with medication and covers domains of effectiveness, convenience and global satisfaction. The instrument is scored by domain with scores ranging from 0-100, where a lower score indicates lower satisfaction. | Week 52 | 
| Persistency with Guselkumab | Persistency with treatment is defined as duration of time from initiation to last dose of therapy, as well as the percentage of participants still on treatment at the end of the observation period. | Up to Week 52 | 
| Narrative Plots at Enrollment and Week 52 | Participants will be invited to fill in two narrative plots; one at the enrollment visit and one at the week 52 visit. | Baseline (at enrollment) and Week 52 | 
| Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facial, Genital