Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP

Study Overview
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Brief Summary
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This is a multicenter, centrally registered observational study without a control group. This observational study is a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during the observation period (52 weeks after the start of treatment with this drug) in pediatric patients with psoriasis vulgaris, psoriatic arthritis, or pustular psoriasis who received this drug.

Detailed Description
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For patients who discontinued or completed this drug before the end of the observation period, the investigator will record adverse events that occurred within 30 days after the day following the last administration of this drug, or the day of discontinuation of the survey (the day when discontinuation of the survey was judged), whichever is later, in the CRF. If a patient withdraws consent, information will be collected during the observation period up to the date of consent withdrawal.

Official Title
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A Special Drug Use-results Survey to Evaluate the Safety and Efficacy of Subcutaneous Administration of Cosentyx in Pediatric Patients With Psoriasis Vulgaris, Psoriatic Arthritis, or Pustular Psoriasis

Conditions
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Psoriasis Vulgaris, Psoriatic Arthritis, Pustular Psoriasis

Intervention / Treatment
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* Other: Cosentyx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have obtained written consent from their legally acceptable representative to cooperate in this survey before the start of treatment with this drug Patients aged less than 18 years at the start of treatment with this drug Patients newly treated with this drug for any of the following diseases: Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis Exclusion Criteria: Prior treatment with this drug Participation in an interventional study (e.g., a clinical trial) at the time of starting this drug.

Ages Eligible for Study
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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 |
| --- | --- |
| Cosentyx<br>Cosentyx for Subcutaneous Injection | Other: Cosentyx<br>* There is no treatment allocation. Patients administered Cosentyx by prescription that have started before inclusion of the patient into the study will be enrolled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events | Incidence of SAEs will be collected | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects with psoriasis vulgaris and psoriatic arthritis: IGA mod 2011 with 0 or 1 response | Investigator's Global Assessment (IGA) rating scale is: 0 - no signs of psoriasis. Postinflammatory hyperpigmentation may be present. - Normal to pink lesions, no thickening, focal scaling absent or minimal - Pink to pale red lesions, minimal to mild thickening, and mainly fine scaling. - Clearly distinguishable erythema of dull red to bright red, clearly distinguishable to moderate thickening, moderate scaling. - Light red to dark red lesions, high thickness with hard margins, high/rough scaling covering almost all or all lesions. | Baseline, week 4, week 12, week 24 and week 52 | 
| Subjects with psoriasis vulgaris and psoriatic arthritis: PASI 75/90/100 response | Psoriasis Area and Severity Index (PASI) 75/90 response is defined as ≥ 75%, ≥ 90% improvement (reduction) in PASI score compared to Baseline. PASI 100 response means no sign of body psoriasis. | Baseline, week 4, week 12, week 24 and week 52 | 
| All patients: Change from baseline in CDLQI | Children's Dermatology Life Quality Index (CDLQI) is a global dermatology disability index designed to assess health-related quality of life in pediatric patients and consists of 10 questions about symptoms and feelings, leisure, school and holidays, personal relationships, sleep, and treatment. The total CDLQI score is the sum of 10 questions and ranges from 0   30. Higher scores indicate more impairment of health-related quality of life. | Baseline, week 4, week 12, week 24 and week 52 | 
| Subjects with psoriatic arthritis: Change from baseline in C-HAQ | Childhood Health Assessment Questionnaire (C-HAQ) is used to assess the QOL of patients with psoriatic arthritis. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other activities. Higher scores mean worse quality of life. | Baseline, week 4, week 12, week 24 and week 52 | 
| Subjects with psoriatic arthritis: Change from baseline in JADAS -27 | Juvenile Arthritis Disease Activity Score (JADAS) score will be used to assess disease activity in patients with juvenile idiopathic arthritis including psoriatic arthritis. The investigator will assess each of the 4 components of the JADAS for patients with psoriatic arthritis (Rater's Global Assessment, Patient's or guardian's global assessment, Number of active arthritis and CRP) and record the results in the CRF. JADAS-27 is the sum of the 4 scores (0   57). | Baseline, week 4, week 12, week 24 and week 52 | 
| Subjects with pustular psoriasis: Change from Baseline in the Japanese Dermatological Association (JDA) Severity Index | The investigator will determine the severity based on the areas of erythema with pustules, areas of erythema (total), areas of edema, fever, WBC count, CRP, and serum albumin. The total score in the severity index is divided into 0   17 points (1   6 = mild, 7   10 = moderate, 11   17 = severe). | Baseline, week 4, week 12, week 24 and week 52 | 
| Subjects with pustular psoriasis: General improvement in GPP | GPP: Generalized Pustular Psoriasis The investigator will assess the General improvement rating (Responder, partial-responder, non-responder, aggravated, indeterminate) of pustular psoriasis symptoms at each observation time point compared to the start of treatment with this drug. | Baseline, week 4, week 12, week 24 and week 52 | 
| Incidence of adverse events and adverse drug reactions | Incidence of AEs and ADRs will be collected | 52 weeks | 
| Incidence of adverse events and adverse reactions included in the safety specifications | Important identified risks or important potential risks specified in the Risk Management Plan at the time of planning the surveillance were determined to be identified in the surveillance. The following items were set as the safety specifications for the surveillance: Serious infections Neutrophil count decreased Hypersensitivity Reactions inflammatory bowel disease Erythroderma (exfoliative dermatitis) Malignancies Cardiovascular/cerebrovascular events Tuberculosis Events related to suicide/self-injury | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIS, psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, Japan, Cosentyx, pediatric