Post-Marketing Surveillance Study of Adalimumab in Pediatric Chronic Severe Plaque Psoriasis Patients in Korea

Study Overview
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Brief Summary
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The objective of this study is to evaluate the real world safety and effectiveness of adalimumab (Humira) for the treatment of Korean patients with pediatric chronic severe plaque psoriasis under a routine treatment practice.

Official Title
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Post-Marketing Surveillance Study of Adalimumab (Humira) for Pediatric Chronic Severe Plaque Psoriasis Patients According to the Standard for Re-Examination of New Drugs

Conditions
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Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adolescents who are diagnosed with pediatric chronic severe plaque psoriasis. Prior to participating in the study, adalimumab treatment was determined according to clinical judgement of the physician. Participants (or legal representative) who voluntarily agreed to participate in this study and signed informed consent. Exclusion Criteria: Participants with contraindication to adalimumab as listed in the approved Korean label. Participants with prior treatment with adalimumab.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric participants with chronic severe plaque psoriasis<br>Participants with chronic severe plaque psoriasis receiving adalimumab in routine clinical practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Reported Any Treatment Emergent Serious Adverse Events (TESAE) OR Drug Reactions | An adverse event (AE) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relations. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. | Day 0 (informed consent) to up to 70 days following the last administration of Humira | 
| Percentage of Participants Who Reported Any Unexpected Treatment Emergent Adverse Events OR Drug Reactions | An adverse event (AE) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relations. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. Unexpected adverse events are the ones that do not appear on the label of the drug. | Day 0 (informed consent) to up to 70 days following the last administration of Humira | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Reported Any Treatment Emergent Non-Serious Adverse Event OR Drug Reaction | An adverse event (AE) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relations. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. | Day 0 (informed consent) to up to 70 days following the last administration of Humira | 
| Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 From Baseline | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. | Up to approximately 40 days | 
| Percentage of Participants Achieving PASI 90 From Baseline | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-90 responders are the participants who achieved at least a 90% reduction (improvement) from baseline in PASI score. | Up to approximately 40 days | 
| Percentage of Participants Achieving PASI 100 From Baseline | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-100 responders are the participants who achieved at least a 100% reduction (improvement) from baseline in PASI score. | Up to approximately 40 days | 
| Change in Body Surface Area (BSA) from Baseline | BSA affected by psoriasis is assessed by the Investigator. | Up to approximately 40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-marketing, Adalimumab, Humira, Pediatric, Chronic severe plaque psoriasis, Psoriasis