Psoriasis
Conditions
Brief summary
The main purpose of this study is to describe how well Guselkumab works after switching from Ustekinumab in participants with moderate to severe psoriasis in a routine clinical setting. A long-term skin disease that causes red, scaly and sometimes painful, itchy patches on the skin.
Interventions
None listed
Sponsors
Janssen-Cilag Kft.
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 being treated with Ustekinumab (either the originator or its biosimilar) and who are medically indicated to switch to Guselkumab, or for whom this switch is medically indicated, based on the current and valid national psoriasis (PsO) therapeutic protocol * Participants who, based on the Investigator's decision, should initiate treatment with Guselkumab * Participants must sign an informed consent form (ICF) allowing for data collection and source data verification in accordance with local requirements
Exclusion criteria
* Contraindication or hypersensitivity to Guselkumab or any other ingredient in the injection solution * Pregnancy or breastfeeding * Currently enrolled in an interventional study * Currently enrolled in an observational study sponsored or managed by a Janssen company * Previous use of guselkumab in any indication in participant history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Absolute Psoriasis Area Severity Index (aPASI) <=3 at Week 20 Following Switch from Ustekinumab to Guselkumab | At Week 20 | Percentage of participants achieving aPASI less than or equal to (\<=) 3 at Week 20 following the switch from Ustekinumab to Guselkumab will be reported. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab | At Baseline | Participants switching treatment and reason for switching treatment from Ustekinumab or biosimilars to Guselkumab will be reported. |
| Reason for Guselkumab Discontinuation | Up to Week 52 | Number of participants discontinuing guselkumab and reason for guselkumab discontinuation if happens during the study will be reported. |
| Number of Participants with Specific Psoriatic Comorbidities | At Baseline | Specific psoriatic comorbidities at baseline will be reported. |
| Number of Participants with Adverse Events (AE) | Up to Week 52 | An AE is any untoward medical occurrence in a participant administered with a pharmaceutical product. An AE does not necessarily have a causal relationship with the treatment. |
| Clinical Characteristics: Severity of Psoriasis | At Baseline | Severity of psoriasis (mild, moderate, severe) in participants starting guselkumab treatment will be reported. |
| Clinical Characteristics: Affected Areas | At Baseline | Affected areas (anogenital, nail, scalp, palmoplantar), in participants starting guselkumab treatment will be reported. |
| Percentage of Participants Achieving aPASI <= 3 at Weeks 4, 12, 36 and 52 | At Weeks 4, 12, 36 and 52 | Percentage of participants achieving aPASI \<= 3 will be reported. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. |
| Percentage of Participants Achieving >= 75% Improvement in PASI (PASI 75) at Weeks 4, 12, 20, 36 and 52 | At Weeks 4, 12, 20, 36 and 52 | Participants with an absolute percentage improvement of at least 75% will be considered having achieved PASI 75 at Weeks 4, 12, 20, 36 and 52. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. |
| Percentage of Participants Achieving >= 90% Improvement in PASI (PASI 90) at Weeks 4, 12, 20, 36, and 52 | At Weeks 4, 12, 20, 36 and 52 | Participants with an absolute percentage improvement of at least 90% will be considered having achieved PASI 90 at Weeks 4, 12, 20, 36 and 52. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. |
| Percentage of Participants Achieving 100% Improvement in PASI (PASI 100) at Weeks 4, 12, 20, 36, and 52 | At Weeks 4, 12, 20, 36 and 52 | Participants with an absolute percentage improvement of 100% will be considered having achieved PASI 100 at Weeks 4, 12, 20, 36 and 52. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. |
| Absolute Changes in PASI Score from Baseline up to Weeks 4, 12, 20, 36 and 52 | Baseline up to Weeks 4, 12, 20, 36 and 52 | Absolute changes in PASI scores from baseline to Weeks 4, 12, 20, 36 and 52 will be reported. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. |
| Absolute Changes in Body Surface Area (BSA) Score from Baseline up to Weeks 4, 12, 20, 36 and 52 | Baseline up to Weeks 4, 12, 20, 36 and 52 | Absolute changes in BSA scores from baseline upto Weeks 4, 12, 20, 36 and 52 will be reported. BSA indicates the percentage of the total body surface area affected by psoriasis. For small-spotted psoriasis lesions, healthy skin between the lesions is not included in the assessment. BSA ranges from 0-100 in which the maximum value is 100. |
| Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) <=5 at Weeks 4, 12, 20, 36 and 52 | At Weeks 4, 12, 20, 36 and 52 | DLQI is a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question is evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. Scores from all 10 questions are added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants. |
| Percentage of Participants Achieving Dermatology Life Quality Index Relevant (DLQI-R) <=5 at Weeks 4, 12, 20, 36 and 52 | At Weeks 4, 12, 20, 36 and 52 | The DLQI-R is calculated by summing the scores of all answered items on the 10-question DLQI questionnaire (each scored 0-3), excluding those marked as "not relevant" (NRR). The total DLQI-R score ranges from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants. |
| Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52 | At Weeks 4, 12, 20, 36 and 52 | DLQI is a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question is evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. Scores from all 10 questions are added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants. |
| Percentage of Participants Achieving DLQI-R score of 0 or 1 at Weeks 4, 12, 20, 36 and 52 | At Weeks 4, 12, 20, 36 and 52 | The DLQI-R is calculated by summing the scores of all answered items on the 10-question DLQI questionnaire (each scored 0-3), excluding those marked as "not relevant" (NRR). The total DLQI-R score ranges from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants. |
| Absolute Changes in DLQI Scores from Baseline up to Weeks 4, 12, 20, 36 and 52 | Baseline up to Weeks 4, 12, 20, 36 and 52 | Absolute changes in DLQI scores from baseline to Week 4, 12, 20, 36 and 52 will be reported. DLQI is a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. The total DLQI score ranges from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants. |
| Absolute Changes in DLQI-R Scores from Baseline up to Weeks 4, 12, 20, 36 and 52 | Baseline up to Weeks 4, 12, 20, 36 and 52 | Absolute changes in DLQI-R scores from baseline to Week 4, 12, 20, 36 and 52 will be reported. The DLQI-R is calculated by summing the scores of all answered items on the 10-question DLQI questionnaire (each scored 0-3), excluding those marked as "not relevant" (NRR). The total DLQI-R score ranges from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants. |
| Absolute Change in Static Physician's Global Assessment of Genitalia (sPGA-G) Score Over Time | Baseline up to Weeks 4, 12, 20, 36 and 52 | In participants with anogenital psoriasis at baseline, absolute change in sPGA-G score over time will be reported. The sPGA-G describes the severity of psoriasis using 6 categories. Accordingly, the score ranges from 0-5, with higher scores indicating more severe psoriasis. |
| Percentage of Participants Achieving sPGA-G Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52 | At Weeks 4, 12, 20, 36 and 52 | In participants with anogenital psoriasis at baseline, the percentage of participants achieving sPGA-G score of 0 or 1 amongst the participants who had a \>= 2 sPGA-G score at baseline will be reported. The sPGA-G describes the severity of psoriasis using 6 categories. Accordingly, the score ranges from 0-5, with higher scores indicating more severe psoriasis. |
| Absolute Change in Physician´s Global Assessment of Hands and/or Feet (hf-PGA) Score Over Time | Baseline up to Weeks 4, 12, 20, 36 and 52 | In participants with palmoplantar psoriasis at baseline, absolute change in hf-PGA score over time will be reported. The hf-PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. |
| Percentage of Participants Achieving hf-PGA Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52 | At Weeks 4, 12, 20, 36 and 52 | In participants with palmoplantar psoriasis at baseline, percentage of participants achieving hf-PGA = 0 or 1 amongst the participants who had a \>= 2 hf-PGA at baseline will be reported. The hf-PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. |
| Absolute Change in Scalp-Specific Investigator Global Assessment (ss-IGA) Score Over Time | Baseline up to Weeks 4, 12, 20, 36, and 52 | In participants with scalp psoriasis at baseline, the absolute change in ss-IGA score over time will be reported. The ss-IGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. |
| Percentage of Participants Achieving ss-IGA Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52 | At Weeks 4, 12, 20, 36, and 52 | In participants with scalp psoriasis at baseline, the percentage of participants achieving ss-IGA of 0 or 1 amongst the participants who had a \>= 2 ss-IGA score at baseline will be reported. The ss-IGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis. |
| Absolute Change in Fingernail Physician's Global Assessment (PGA-F) Score Over Time | Baseline up to Weeks 4, 12, 20, 36, and 52 | In participants with fingernail psoriasis at baseline, absolute change in PGA-F score over time will be reported. The PGA-F describes the severity of psoriasis using 5 categories and consists of scores ranging from 0 (Clear), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Severe). Here, higher scores indicate more severity of psoriasis. |
| Percentage of Participants Achieving PGA-F Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52 | At Weeks 4, 12, 20, 36, and 52 | In participants with fingernail psoriasis at baseline, the percentage of participants achieving PGA-F score of 0 or 1 amongst participants who had a \>=2 PGA-F at baseline will be reported. The PGA-F describes the severity of psoriasis using 5 categories and consists of scores ranging from 0 (Clear), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Severe). Here, higher scores indicate more severity of psoriasis. |
| Demographic Characteristics: Age | At Baseline | Participant's age at the time of starting guselkumab treatment will be reported. |
| Demographic Characteristics: Sex | At Baseline | Sex (male, female) of participants at the time of starting guselkumab treatment will be reported. |
| Demographic Characteristics: Weight | At Baseline | Weight of participants at the time of starting guselkumab treatment will be reported. |
| Demographic Characteristics: Height | At Baseline | Height of participants at the time of starting guselkumab treatment will be reported. |
| Clinical Characteristics: Time Since Psoriasis Diagnosis | At Baseline | Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported. |
| Clinical Characteristics: Prior and Baseline Treatments for Moderate to Severe Psoriasis | At Baseline | Prior and baseline treatments for moderate-to-severe psoriasis, including start and stop dates (in years) in participants starting guselkumab treatment will be reported. |
| Clinical Characteristics: Time Since First Symptoms | At Baseline | Time since first symptoms (years), in participants starting guselkumab treatment will be reported. |
Countries
Hungary
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen-Cilag Kft. Clinical Trial
Janssen-Cilag Kft.
Outcome results
None listed