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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05650060
• Other study ID #: CAIN457ATH01
• Status: Completed
• Start date: January 20, 2021
• Est. completion date: December 23, 2021

Study information

• Verified date: April 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: December 23, 2021
• Est. primary completion date: December 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Secukinumab
all patients with psoriasis who received secukinumab

Locations

Country	Name	City	State
Thailand	Novartis Investigative Site	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	Age information was reported.	Baseline
Primary	Gender	Gender information was reported.	Baseline
Primary	Number of patients with Reimbursement scheme	Reimbursement scheme information was reported.	Baseline
Primary	Weight	Weight information was reported.	During 3 months pre-baseline
Primary	Height	Height information was reported.	During 3 months pre-baseline
Primary	BMI	BMI information was reported.	During 3 months pre-baseline
Primary	Co-morbidities	Crohn's Disease; Diabetes Mellitus; Dyslipidemia; Hypertension; Inflammatory Bowel Disease; Latent Tuberculosis; Psoriatic Arthritis (PsA)	During 12 months pre-baseline
Primary	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
Primary	Percentage of Body Surface Area (BSA) involvement	Percentage of Body Surface Area (BSA) involvement was reported.	During 4 weeks pre-baseline
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	Duration since the discontinuation of the latest biological agents	Secukinumab therapy	Baseline
Primary	Medication use concomitant to index secukinumab prescription	Secukinumab therapy	Baseline
Primary	Treatment pattern with secukinumab	Secukinumab therapy	Baseline
Primary	Treatment duration since the first dosing till the most recent dosing	Secukinumab therapy	Baseline