Psoriasis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Janssen-Cilag Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have a confirmed diagnosis of moderate-to-severe plaque psoriasis requiring systemic treatment * Participants who are currently treated with Ustekinumab (either the originator or its biosimilar) and who are medically indicated to switch to Guselkumab * Participants who, based on the Investigator's decision, should initiate treatment with Guselkumab * Participants must understand and be willing and able to answer patient-reported outcomes (PROs) * Must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
Exclusion criteria
* Contraindication or hypersensitivity to Guselkumab or any ingredient in the injection solution/liquid * Pregnancy or breastfeeding * Currently enrolled in an interventional study * Currently enrolled in an observational study sponsored or managed by a Janssen company
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) Score Less Than or Equal to (<=) 3 after Switching to Guselkumab at Week 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a PASI Score <= 3 after Switching to Guselkumab at Weeks 12 and 52 | 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. |
| 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 | 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. |
| Percentage of Participants Achieving 100% Improvement in PASI Score (PASI 100) from Baseline at Weeks 12, 28 and 52 | 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. |
| Number of Participants with Absolute PASI Course from Baseline to Week 52 | Baseline up to Week 52 | Absolute PASI course refers to how a participant's absolute PASI score changes over time during treatment. |
| Absolute Change from Baseline In PASI Scores at Week 52 | Baseline up to 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. |
| Relative Change from Baseline In PASI Score at Week 52 | Baseline up to 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. |
| Absolute Change from Baseline in Body Surface Area (BSA) Score at Week 52 | Baseline up to 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. |
| Relative Change from Baseline in BSA Score at Week 52 | Baseline up to 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. |
| Absolute Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 52 | Baseline up to 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. |
| Relative Change from Baseline in DLQI Score at Week 52 | Baseline up to 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. |
| Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 12, 28, and 52 | 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. |
| Absolute Change from Baseline in World Health Organization-5 (WHO-5) Well-Being Index Questionnaire Score at Week 52 | Baseline up to 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. |
| Relative Change from Baseline in WHO-5 Well-Being Index Questionnaire Score at Week 52 | Baseline up to 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. |
| Absolute Change From Baseline in Worst Itch Numeric Rating Scores (WI-NRS) at Week 52 | Baseline up to 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. |
| Relative Change from Baseline in WI-NRS at Week 52 | Baseline up to 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. |
| Absolute Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI: PSO) Scores at Week 52 | Baseline up to 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. |
| Relative Change from Baseline in WPAI:PSO Scores at Week 52 | Baseline up to 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. |
| Absolute Change from Baseline in Anogenital Physician's Global Assessment (PGA) Score at Week 52 | Baseline up to 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. |
| Percentage of Participants Achieving Anogenital PGA Score of 0 at Weeks 12, 28, and 52 | 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. |
| Absolute Change from Baseline in Palmoplantar PGA Score at Week 52 | Baseline up to 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. |
| Percentage of Participants Achieving Palmoplantar PGA Score of 0 at Weeks 12, 28, and 52 | 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. |
| Absolute Change from Baseline in Scalp PGA Score at Week 52 | Baseline up to 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. |
| Percentage of Participants Achieving Scalp PGA Score of 0 at Weeks 12, 28, and 52 | 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. |
| Absolute Change from Baseline in Scalp Itch Numeric Rating Scales (NRS) at Week 52 | Baseline up to 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. |
| Relative Change from Baseline in Scalp Itch NRS at Week 52 | Baseline up to 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. |
| Relative Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 52 | Baseline up to 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. |
| Percentage of Participants Achieving NAPSI Score of 0 at Weeks 12, 28, and 52 | 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. |
| Demographic Characteristics: Age | Baseline | Participant's age at the time of starting guselkumab treatment will be reported. |
| Demographic Characteristics: Sex | Baseline | Sex (male, female) of participants at the time of starting guselkumab treatment will be reported. |
| Demographic Characteristics: Weight | Baseline | Weight of participants at the time of starting guselkumab treatment will be reported. |
| Demographic Characteristics: Height | Baseline | Height of participants at the time of starting guselkumab treatment will be reported. |
| Clinical Characteristics: Time Since Psoriasis Diagnosis | Baseline up to Week 52 | Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported. |
| Clinical Characteristics: Prior Treatments for Moderate to Severe Psoriasis | Baseline | Prior treatments for moderate-to-severe psoriasis, including start and stop dates in participants starting guselkumab treatment will be reported. |
| Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab | Baseline | Participants switching treatment and reason for switching treatment from Ustekinumab or biosimilars to Guselkumab will be reported. |
| Treatment Patterns: Dose of the Treatment | Up to Week 52 | Patterns of treatment (dose) with Guselkumab during the observational period will be reported. |
| Treatment Patterns: Frequency of the Treatment | Up to Week 52 | Patterns of treatment (frequency) with Guselkumab during the observational period will be reported. |
| Number of Participants with Specific Psoriatic Comorbidities | Baseline | Specific psoriatic comorbidities at baseline will be reported. |
| Number of Participants with Other Comorbidities | Baseline | Other comorbidities at baseline will be reported. |
| Number of Participants Receiving Concomitant Medications for Specific Psoriatic Comorbidities | Up to Week 52 | Concomitant medications for specific psoriatic comorbidities during the observational period will be reported. |
Countries
Austria
Contacts
STUDY_DIRECTORJanssen- Cilag Pharma Clinical Trial
Janssen- Cilag Pharma
Outcome results
None listed