Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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This study was a non-interventional, retrospective study collecting data from hospital medical records. Approximately 200 adult patients with moderate to severe plaque psoriasis who were treated with secukinumab from hospitals in Thailand that participated in this study were expected for data collection.

Detailed Description
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The study was performed in 7 study sites in Thailand and planned to involve approximately 200 medical records. At each study site, patients who were treated with secukinumab or had ever been treated with secukinumab for moderate to severe plaque psoriasis were included for screening by chronological order starting from the most recent date (April 2021) to September 2017. This was to include the most recent clinical practice in the study. The data of patients diagnosed with moderate-to-severe chronic plaque-type psoriasis who received secukinumab in real clinical practice at least 1 dose were collected. The medical records were reviewed to collect the data from the date of the first diagnosis of psoriasis till the most recent dose of secukinumab. The data of secukinumab use and clinical outcome (PASI score) were collected at 4 and 16 weeks after first dose initiation and at the most recent dose of secukinumab. The total number of secukinumab injections at the 3-time points were collected. An index date was defined for each patient. The first secukinumab injection observed in the medical records was considered the index date for the exploratory endpoint.

Official Title
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The Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis in Real-world Practice in Thailand

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Secukinumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female aged ≥ 18 years at index date Previous diagnosis of moderate to severe plaque psoriasis as hospital record with available baseline PASI at index date (date 0 to date -7 prior index date) Initiated treatment with secukinumab for moderate to severe plaque psoriasis during September 2017-April 2021 Exclusion Criteria: - Patients diagnosed with other forms of psoriasis other than plaque-type

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Secukinumab<br>all patients with psoriasis who received secukinumab | Drug: Secukinumab<br>* all patients with psoriasis who received secukinumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age information was reported. | Baseline | 
| Gender | Gender information was reported. | Baseline | 
| Number of patients with Reimbursement scheme | Reimbursement scheme information was reported. | Baseline | 
| Weight | Weight information was reported. | During 3 months pre-baseline | 
| Height | Height information was reported. | During 3 months pre-baseline | 
| BMI | BMI information was reported. | During 3 months pre-baseline | 
| Co-morbidities | Crohn's Disease Diabetes Mellitus Dyslipidemia Hypertension Inflammatory Bowel Disease Latent Tuberculosis Psoriatic Arthritis (PsA) | During 12 months pre-baseline | 
| Psoriasis Area and Sensitivity Index (PASI) score | Psoriasis Area and Severity Index (PASI) is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). | During 4 weeks pre-baseline | 
| Percentage of Body Surface Area (BSA) involvement | Percentage of Body Surface Area (BSA) involvement was reported. | During 4 weeks pre-baseline | 
| Disease Life Quality Index (DLQI) score | The Dermatology Life Quality Index (DLQI) is a simple, self-administered and user-friendly validated questionnaire. The DLQI is designed to measure the health-related quality of life of adult patients suffering from a skin disease. The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of psoriasis on quality of life. The DLQI was rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30 and higher scores indicate more severe impact on quality of life. | During 4 weeks pre-baseline | 
| Date of first symptom of psoriasis (PSO) / year | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| Date of psoriasis diagnosis / year | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| Duration of psoriasis diagnosis | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| Date of first systemic treatment/ year | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| Date of first biologic agent/year | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| Duration of topical therapy | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| History of topical therapy | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| Duration of systemic therapy | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| History of systemic therapy | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| Duration of biologic therapy | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| History of biologic therapy | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| Date of PsA diagnosis/year | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| Duration of PsA diagnosis | To describe the PSO treatment history | Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) | 
| Number of patients with baseline PSO treatment | Topical Therapies Topical corticosteroid Coal tar Salicylic acid Vitamin D analogues Anthralin Calcineurin inhibitors Others Oral systemic therapies Methotrexate Acitretin Retinoid Cyclosporine Azathioprine Hydroxyurea Leflunomide Sulfasalazine Others Biologic therapy Infliximab Etanercept Ustekinumab Brodalumab Guselkumab Ixekizumab Others | During 12 months pre-baseline | 
| Duration since the discontinuation of the latest biological agents | Secukinumab therapy | Baseline | 
| Medication use concomitant to index secukinumab prescription | Secukinumab therapy | Baseline | 
| Treatment pattern with secukinumab | Secukinumab therapy | Baseline | 
| Treatment duration since the first dosing till the most recent dosing | Secukinumab therapy | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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secukinumab,, psoriasis,, effectiveness,, real-world,, Thailand