A Real-world Study to Assess Safety and Effectiveness of Secukinumab in Pediatric Plaque Psoriasis Patients in China

Novartis Pharmaceuticals42 enrolled

Overview

This was a non-interventional, prospective, multi-center real world setting study, aiming to provide safety and effectiveness data in Chinese pediatric patients with moderate to severe plaque psoriasis treated with Cosentyx® for up to 52 weeks.

Patients who were about to initiate Cosentyx® or had started Cosentyx® within the last 4 weeks and met the eligibility criteria were enrolled. Patients were followed via routine visits in real clinical practice up to 52 weeks. Data from medical records, including safety and effectiveness information of Cosentyx® (e.g., AE, SAE, physical examinations, laboratory tests, disease assessments, etc.) were collected at each visit. No additional study visits, examinations, laboratory tests or procedures were mandated throughout the study.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Interventions

CosentyxOTHER

Prospective observational cohort study. There was treatment allocation.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients meeting all of the following criteria are eligible for inclusion in this study: * Written assent and informed consent must be obtained as per local regulations prior to any study procedures. * Diagnosed with moderate to severe plaque psoriasis. * Initiating treatment with Cosentyx® or having started Cosentyx® treatment within the last 4 weeks in routine clinical practice, and its prescription is independent of this study. * Aged 6 to less than 18 years at the time they are prescribed Cosentyx®. * Have valid PASI and IGA mod 2011 score at the time they are prescribed Cosentyx®. Exclusion Criteria: Patients meeting any of the following criteria are not eligible for inclusion in this study: * Patients previously treated with other biologics. * Patients participating in other clinical trials or who previously participated in clinical trials within 30 days before Cosentyx® initiation or a period of 5 half-lives of the investigational drug, whichever is longer. * Patients in conditions which in the judgment of the clinical investigator renders the patient unsuitable for the study.

Locations (7)

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Shijiazhuang, Hebei, China

Novartis Investigative Site

Zhengzhou, Henan, China

Novartis Investigative Site

Shenyang, Liaoning, China

Outcomes

Primary Outcomes

AEs/SAEs/AESIs type and frequency

Adverse events (AEs)/ Serious adverse events (SAEs)/Adverse events of special interest (AESIs).

Time frame: 52 weeks

Secondary Outcomes

Percentage of patients who achieved PASI 75 response

Percentage of participants who achieve 75% reduction in the Psoriasis Area and Severity Index (PASI) score compared to baseline. A PASI score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).

Time frame: Week 12

Percentage of patients who achieved IGA mod 2011 0 or 1 response

The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and is not compared with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

Time frame: Week 12

Percentage of patients who achieved PASI 90/100 response

Percentage of participants who achieve 90/100% reduction in the Psoriasis Area and Severity Index (PASI) score compared to baseline. A PASI score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).

Time frame: Week 12

Percentage of patients who achieved PASI 75/90/100 response/IGA mod 2011 0 or 1 response over time

Percentage of participants who achieve 75/90/100% reduction in the Psoriasis Area and Severity Index (PASI) score compared to baseline. A PASI score is a tool used to measure the severity and extent of psoriasis. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and is not compared with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

Data from ClinicalTrials.gov

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