A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
This study aims to examine the retention rate of secukinumab in adult patients with plaque psoriasis (with or without psoriatic arthritis \[PsA\]) and metabolic dysfunction-associated steatotic liver disease (MASLD) in routine clinical practice in Spain, as well as hepatic biomarker trajectories. The study will use electronic medical record (EMR) data from multiple Spanish hospitals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a first recorded secukinumab prescription between 01 January 2021 and 31 December 2023.
Patients aged ≥18 years at index date.
Patients with no prior secukinumab exposure in available EMR history.
Secukinumab must be patient's first-, second-, or third-line biologic therapy for psoriasis/psoriatic arthritis (PsA).
Disqualifiers
Patients with evidence of MASLD absence.
Patients with malignant liver disease.
Patients with a history of liver transplantation.
Patients with alcohol use disorder.
Trial population
Adult patients with plaque psoriasis (with or without PsA) and confirmed MASLD initiating secukinumab as first-, second-, or third-line biologic therapy during routine clinical practice in Spain.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Secukinumab Cohort
Trial outcomes
Primary outcomes
1
Number of Definitive Discontinuation Events Per Patient-Year
Definitive discontinuation is defined as the date of first documentation of secukinumab discontinuation or biologic switch, whichever is recorded first.
Time frame
Up to 5 yearsSecondary outcomes
1
Cumulative Incidence of Treatment Discontinuation Due to Lack of Response
Discontinuation due to lack of response is defined as the first documentation of secukinumab discontinuation or biologic switch due to lack of response or similar assessment, whichever is recorded first
Time frame
Up to 5 years2
Proportion of Patients who Achieve a Psoriasis Area and Severity Index (PASI) 100
PASI is a combined assessment of lesion severity and affected area into a single score. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a maximum of 72.0. The body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area multiplied by the area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A PASI 100 response corresponds to complete clearing of psoriasis (PASI = 0).
Time frame
12 and 24 months3
Proportion of Patients who Achieve a PASI Score ≤ 3
PASI is a combined assessment of lesion severity and affected area into a single score. The body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area multiplied by the area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a maximum of 72.0.
Time frame
12 and 24 months4
Cumulative Incidence of a ≥20% Relative Increase in Fibrosis-4 Index (FIB-4) From Baseline
FIB-4 is a non-invasive tool used to assess liver fibrosis. The FIB-4 score is calculated using age, aspartate aminotransferase (AST) level, alanine aminotransferase (ALT) level, and platelet count. FIB-4 fibrosis risk categories: * Low risk: FIB-4 \< 1.30 * Intermediate risk: 1.30 ≤ FIB-4 ≤ 2.67 * High risk: FIB-4 \> 2.67
Time frame
Baseline up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov