The purpose of this study is to assess the effectiveness and safety of guselkumab following a switch from ustekinumab or an ustekinumab biosimilar in participants with moderate to severe psoriasis, a chronic inflammatory skin disease characterized by erythematous, scaly plaques that may be associated with pain and pruritus, in routine clinical practice.
Study Type
OBSERVATIONAL
Enrollment
200
LKH-Univ. Klinikum Graz
Graz, Austria
RECRUITINGPercentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) Score Less Than or Equal to (<=) 3 after Switching to Guselkumab at Week 28
The PASI is a standardized scoring method for assessing and grading the severity of a participant's psoriasis. PASI yields a numeric score ranging from 0 (skin completely free of symptoms) to 72 (maximum expression of psoriasis), with higher scores indicating more severe psoriasis.
Time frame: At Week 28
Percentage of Participants Achieving a PASI Score <= 3 after Switching to Guselkumab at Weeks 12 and 52
The PASI is a standardized scoring method for assessing and grading the severity of a participant's psoriasis. PASI yields a numeric score ranging from 0 (skin completely free of symptoms) to 72 (maximum expression of psoriasis), with higher scores indicating more severe psoriasis.
Time frame: At Weeks 12 and 52
Percentage of Participants Achieving a Greater Than or Equal to (>=) 90 Percent (%) Improvement in PASI Score (PASI 90) from Baseline at Weeks 12, 28 and 52
Percentage of participants achieving \>=90% improvement in PASI score at Weeks 12, 28 and 52 will be reported. PASI yields a numeric score ranging from 0 (skin completely free of symptoms) to 72 (maximum expression of psoriasis), with higher scores indicating more severe psoriasis.
Time frame: At Weeks 12, 28 and 52
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI 100) from Baseline at Weeks 12, 28 and 52
Percentage of participants achieving 100% improvement in PASI score from baseline at Weeks 12, 28 and 52 will be reported. PASI yields a numeric score ranging from 0 (skin completely free of symptoms) to 72 (maximum expression of psoriasis), with higher scores indicating more severe psoriasis.
Time frame: At Weeks 12, 28 and 52
Number of Participants with Absolute PASI Course from Baseline to Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Absolute PASI course refers to how a participant's absolute PASI score changes over time during treatment.
Time frame: Baseline up to Week 52
Absolute Change from Baseline In PASI Scores at Week 52
PASI yields a numeric score ranging from 0 (skin completely free of symptoms) to 72 (maximum expression of psoriasis), with higher scores indicating more severe psoriasis. Absolute changes in PASI scores, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Relative Change from Baseline In PASI Score at Week 52
PASI yields a numeric score ranging from 0 (skin completely free of symptoms) to 72 (maximum expression of psoriasis), with higher scores indicating more severe psoriasis. Relative changes in PASI scores, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Absolute Change from Baseline in Body Surface Area (BSA) Score at Week 52
BSA indicates the percentage of the total body surface area affected by psoriasis. The maximum value for BSA is 100. Absolute changes in BSA scores from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Relative Change from Baseline in BSA Score at Week 52
BSA indicates the percentage of the total body surface area affected by psoriasis. The maximum value for BSA is 100. Relative changes in BSA scores from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Absolute Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 52
DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. Absolute changes in DLQI scores, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Relative Change from Baseline in DLQI Score at Week 52
DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. Relative changes in DLQI scores, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 12, 28, and 52
DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. Percentage of participants achieving DLQI score of 0 or 1 at Weeks 12, 28, and 52 will be reported.
Time frame: At Weeks 12, 28 and 52
Absolute Change from Baseline in World Health Organization-5 (WHO-5) Well-Being Index Questionnaire Score at Week 52
WHO-5 is a self-report measure comprising 5 items about psychological well-being. All items are answered on a 5-point Likert scale that ranges from 0 (at no time) to 4 (all of the time). A higher score indicates more pronounced psychological well-being. Absolute changes in WHO-5 scores, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Relative Change from Baseline in WHO-5 Well-Being Index Questionnaire Score at Week 52
WHO-5 is a self-report measure comprising 5 items about psychological well-being. All items are answered on a 5-point Likert scale that ranges from 0 (at no time) to 4 (all of the time). A higher score indicates more pronounced psychological well-being. Relative changes in WHO-5 scores, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Absolute Change From Baseline in Worst Itch Numeric Rating Scores (WI-NRS) at Week 52
The WI-NRS is a single-item, patient-reported questionnaire designed to measure an individual's "worst itch" over the past 24 hours on an 11-point rating scale, where 0 represents "no itch" and 10 represents "the worst itching imaginable." A higher score indicates worse itch. Absolute changes in worst itch numeric rating scale (WI-NRS) scores, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Relative Change from Baseline in WI-NRS at Week 52
The WI-NRS is a single-item, patient-reported questionnaire designed to measure an individual's "worst itch" over the past 24 hours on an 11-point rating scale, where 0 represents "no itch" and 10 represents "the worst itching imaginable." A higher score indicates worse itch. Relative changes in worst itch numeric rating scale (WI-NRS) scores, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Absolute Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI: PSO) Scores at Week 52
WPAI is a 6-item instrument designed to measure impairments in work and activities over the past 7 days. WPAI outcomes are expressed as percentages of impairment, with higher percentages indicating greater impairment and reduced productivity, meaning worse outcomes. Absolute changes in WPAI: PSO scores, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Relative Change from Baseline in WPAI:PSO Scores at Week 52
WPAI is a 6-item instrument designed to measure impairments in work and activities over the past 7 days. WPAI outcomes are expressed as percentages of impairment, with higher percentages indicating greater impairment and reduced productivity, meaning worse outcomes. Relative changes in WPAI: PSO scores, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Absolute Change from Baseline in Anogenital Physician's Global Assessment (PGA) Score at Week 52
The Anogenital PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. In participants with anogenital psoriasis at baseline, absolute changes in Anogenital PGA score, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Percentage of Participants Achieving Anogenital PGA Score of 0 at Weeks 12, 28, and 52
The Anogenital PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. In participants with anogenital psoriasis at baseline, the percentage of participants achieving anogenital PGA Score of 0 at Weeks 12, 28, and 52 will be reported.
Time frame: At Weeks 12, 28 and 52
Absolute Change from Baseline in Palmoplantar PGA Score at Week 52
The Palmoplantar PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. In participants with palmoplantar psoriasis at baseline, absolute changes in Palmoplantar PGA score, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Percentage of Participants Achieving Palmoplantar PGA Score of 0 at Weeks 12, 28, and 52
The Palmoplantar PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. In participants with palmoplantar psoriasis at baseline, the percentage of participants achieving anogenital PGA score of 0 at Weeks 12, 28, and 52 will be reported.
Time frame: At Weeks 12, 28 and 52
Absolute Change from Baseline in Scalp PGA Score at Week 52
The Scalp PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. In participants with scalp psoriasis at baseline, absolute changes in Scalp PGA score, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Percentage of Participants Achieving Scalp PGA Score of 0 at Weeks 12, 28, and 52
The Scalp PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. In participants with scalp psoriasis at baseline, the percentage of participants achieving Scalp PGA score of 0 at Weeks 12, 28, and 52 will be reported.
Time frame: At Weeks 12, 28 and 52
Absolute Change from Baseline in Scalp Itch Numeric Rating Scales (NRS) at Week 52
The Scalp Itch NRS is a single-item, patient-reported questionnaire designed to measure an individual's "worst itch" over the past 24 hours on an 11-point rating scale, where 0 represents "no itch" and 10 represents "the worst itching imaginable." A higher score indicates more itch. In participants with scalp psoriasis at baseline, absolute changes in scalp itch Numeric Rating Scale (NRS) scores, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Relative Change from Baseline in Scalp Itch NRS at Week 52
The Scalp Itch NRS is a single-item, patient-reported questionnaire designed to measure an individual's "worst itch" over the past 24 hours on an 11-point rating scale, where 0 represents "no itch" and 10 represents "the worst itching imaginable." A higher score indicates more itch. In participants with scalp psoriasis at baseline, relative changes in scalp itch NRS scores, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Relative Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 52
The NAPSI is designed to evaluate the presence or absence of nail matrix and nail bed psoriasis in the four quadrants of 10 fingernails. Only participants with nail psoriasis at baseline will be evaluated using NAPSI. The worst affected nail will be selected for each participant at baseline, and this specific nail will be evaluated throughout the study, with a score ranging from 0-8 where higher scores indicate more severe nail psoriasis. In participants with nail psoriasis at baseline, relative changes in NAPSI score, from baseline to Week 52 will be reported.
Time frame: Baseline up to Week 52
Percentage of Participants Achieving NAPSI Score of 0 at Weeks 12, 28, and 52
The NAPSI is designed to evaluate the presence or absence of nail matrix and nail bed psoriasis in the four quadrants of 10 fingernails. Only participants with nail psoriasis at baseline will be evaluated using NAPSI. The worst affected nail will be selected for each participant at baseline, and this specific nail will be evaluated throughout the study, with a score ranging from 0-8 where higher scores indicate more severe nail psoriasis. In participants with nail psoriasis at baseline, the percentage of participants achieving NAPSI Score of 0 at Weeks 12, 28, and 52 will be reported.
Time frame: At Weeks 12, 28 and 52
Demographic Characteristics: Age
Participant's age at the time of starting guselkumab treatment will be reported.
Time frame: Baseline
Demographic Characteristics: Sex
Sex (male, female) of participants at the time of starting guselkumab treatment will be reported.
Time frame: Baseline
Demographic Characteristics: Weight
Weight of participants at the time of starting guselkumab treatment will be reported.
Time frame: Baseline
Demographic Characteristics: Height
Height of participants at the time of starting guselkumab treatment will be reported.
Time frame: Baseline
Clinical Characteristics: Time Since Psoriasis Diagnosis
Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported.
Time frame: Baseline up to Week 52
Clinical Characteristics: Prior Treatments for Moderate to Severe Psoriasis
Prior treatments for moderate-to-severe psoriasis, including start and stop dates in participants starting guselkumab treatment will be reported.
Time frame: Baseline
Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab
Participants switching treatment and reason for switching treatment from Ustekinumab or biosimilars to Guselkumab will be reported.
Time frame: Baseline
Treatment Patterns: Dose of the Treatment
Patterns of treatment (dose) with Guselkumab during the observational period will be reported.
Time frame: Up to Week 52
Treatment Patterns: Frequency of the Treatment
Patterns of treatment (frequency) with Guselkumab during the observational period will be reported.
Time frame: Up to Week 52
Number of Participants with Specific Psoriatic Comorbidities
Specific psoriatic comorbidities at baseline will be reported.
Time frame: Baseline
Number of Participants with Other Comorbidities
Other comorbidities at baseline will be reported.
Time frame: Baseline
Number of Participants Receiving Concomitant Medications for Specific Psoriatic Comorbidities
Concomitant medications for specific psoriatic comorbidities during the observational period will be reported.
Time frame: Up to Week 52