An observational study in Psoriasis, sponsored by Janssen-Cilag S.p.A.. Completed at 38 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Janssen-Cilag S.p.A. · Observational
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 356 is above the median of 200 across 396 observational studies indexed under Psoriasis.
Browse Psoriasis studies →Janssen-Cilag S.p.A. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Outpatients with facial and/or genital psoriasis, receiving guselkumab treatment as standard of care (SOC) in clinical practice, will be observed. The primary data source for the study will be the medical records of each participating participant.
Participants included in the study:
Exclusion Criteria:
Participants will be excluded from the study if they:
Participants with moderate facial psoriasis who are being treated with guselkumab in real world practice will be observed in this study.
Drug: Guselkumab
Participants with moderate genital psoriasis who are being treated with guselkumab in real world practice will be observed in this study.
Drug: Guselkumab
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.
Also known as: Tremfya
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.
Time frame: 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.
Time frame: 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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 52
Plan to share: No
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Janssen-Cilag S.p.A.