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

NCT05650060 | Completed

• 1 other identifier: CAIN457ATH01
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Keywords

secukinumab,; psoriasis,; effectiveness,; real-world,; Thailand

Outcome Measures

Primary Outcomes (28)

• 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

Study Arms (1)

Secukinumab

all patients with psoriasis who received secukinumab

Drug: Secukinumab

Interventions

Secukinumab DRUG

all patients with psoriasis who received secukinumab

Secukinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study was a retrospective medical chart review study. It collected the characteristics of patients who received secukinumab for the treatment of moderate to severe plaque psoriasis as the primary objective.

You may qualify if:

• 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

You may not qualify if:

• \- Patients diagnosed with other forms of psoriasis other than plaque-type

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Bangkok, Thailand

Location

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: January 20, 2021
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)