Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT05650060
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
- 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
- Patients diagnosed with other forms of psoriasis other than plaque-type
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Secukinumab Secukinumab all patients with psoriasis who received secukinumab
- Primary Outcome Measures
Name Time Method Duration of topical therapy Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
Age Baseline Age information was reported.
Date of first symptom of psoriasis (PSO) / year Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
Date of psoriasis diagnosis / year Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
BMI During 3 months pre-baseline BMI information was reported.
Co-morbidities During 12 months pre-baseline * Crohn's Disease
* Diabetes Mellitus
* Dyslipidemia
* Hypertension
* Inflammatory Bowel Disease
* Latent Tuberculosis
* Psoriatic Arthritis (PsA)Duration of psoriasis diagnosis Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
Date of first biologic agent/year Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
Weight During 3 months pre-baseline Weight information was reported.
Disease Life Quality Index (DLQI) score During 4 weeks pre-baseline 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.
Date of first systemic treatment/ year Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
Treatment pattern with secukinumab Baseline Secukinumab therapy
Number of patients with Reimbursement scheme Baseline Reimbursement scheme information was reported.
Height During 3 months pre-baseline Height information was reported.
Psoriasis Area and Sensitivity Index (PASI) score During 4 weeks pre-baseline 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).
Date of PsA diagnosis/year Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
Gender Baseline Gender information was reported.
Percentage of Body Surface Area (BSA) involvement During 4 weeks pre-baseline Percentage of Body Surface Area (BSA) involvement was reported.
Duration of PsA diagnosis Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
Medication use concomitant to index secukinumab prescription Baseline Secukinumab therapy
Treatment duration since the first dosing till the most recent dosing Baseline Secukinumab therapy
History of topical therapy Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
History of systemic therapy Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
Duration of biologic therapy Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
History of biologic therapy Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
Duration since the discontinuation of the latest biological agents Baseline Secukinumab therapy
Duration of systemic therapy Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment) To describe the PSO treatment history
Number of patients with baseline PSO treatment During 12 months pre-baseline 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Investigative Site
🇹🇭Bangkok, Thailand