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.

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Psoriasis

Dermatology

Immune system conditions

A Non-interventional, Multi-centric, Single Country Observational Study to Assess the Safety and Effectiveness of Guselkumab After Ustekinumab (Originator or Biosimilar) in Moderate to Severe Psoriasis Patients in Clinical Routine

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 >=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 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.

Absolute PASI course refers to how a participant's absolute PASI score changes over time during treatment.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Participant's age at the time of starting guselkumab treatment will be reported.

Sex (male, female) of participants at the time of starting guselkumab treatment will be reported.

Weight of participants at the time of starting guselkumab treatment will be reported.

Height of participants at the time of starting guselkumab treatment will be reported.

Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported.

Prior treatments for moderate-to-severe psoriasis, including start and stop dates in participants starting guselkumab treatment will be reported.

Participants switching treatment and reason for switching treatment from Ustekinumab or biosimilars to Guselkumab will be reported.

Patterns of treatment (dose) with Guselkumab during the observational period will be reported.

Patterns of treatment (frequency) with Guselkumab during the observational period will be reported.

Specific psoriatic comorbidities at baseline will be reported.

Other comorbidities at baseline will be reported.

Concomitant medications for specific psoriatic comorbidities during the observational period will be reported.

Participants with moderate-to-severe psoriasis who are candidates for systemic treatment (according to the Guselkumab label) and who are medically indicated to switch from Ustekinumab or its biosimilar to Guselkumab can be included in this study. Only data available per clinical practice will be collected within this study.

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.

LKH-Univ. Klinikum Graz

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 >=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 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.

Absolute PASI course refers to how a participant's absolute PASI score changes over time
during treatment.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Sex (male, female) of participants at the time of starting guselkumab treatment will be
reported.

Time since psoriasis diagnosis (years), in participants starting guselkumab treatment
will be reported.

Prior treatments for moderate-to-severe psoriasis, including start and stop dates in
participants starting guselkumab treatment will be reported.

Participants switching treatment and reason for switching treatment from Ustekinumab or
biosimilars to Guselkumab will be reported.

Patterns of treatment (dose) with Guselkumab during the observational period will be
reported.

Patterns of treatment (frequency) with Guselkumab during the observational period will be
reported.

Concomitant medications for specific psoriatic comorbidities during the observational
period will be reported.

Participants with moderate-to-severe psoriasis who are candidates for systemic treatment
(according to the Guselkumab label) and who are medically indicated to switch from
Ustekinumab or its biosimilar to Guselkumab can be included in this study. Only data
available per clinical practice will be collected within this study.

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Trials at a glance

Trials at a glance

Eligibility criteria