Metabolic Dysfunction-Associated Steatotic Liver Disease, Plaque Psoriasis
Conditions
Keywords
Plaque psoriasis, MASLD Hepatic Biomarkers Trajectories
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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). * Patients with documented administration per Summary of Product Characteristics dosing recommendations (SmPC). * Patients with confirmed plaque psoriasis with or without PsA. * Patients with at least one cardiometabolic risk factor. * Patients with a confirmed MASLD diagnosis. * Patients with baseline laboratory data available.
Exclusion criteria
* Patients with evidence of MASLD absence. * Patients with malignant liver disease. * Patients with a history of liver transplantation. * Patients with alcohol use disorder. * Patients with other chronic liver diseases. * Patients with diseases or treatments which cause thrombocytopenia. * Patients with decompensated cirrhosis. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Definitive Discontinuation Events Per Patient-Year | Up to 5 years | Definitive discontinuation is defined as the date of first documentation of secukinumab discontinuation or biologic switch, whichever is recorded first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AST Level | Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months | — |
| ALT Level | Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months | — |
| Platelet Count | Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months | — |
| Correlation Between Changes in FIB-4 and Changes in PASI | Baseline to 12 and 24 months | Associations between changes in the level of liver fibrosis (FIB-4) and changes in the severity of psoriasis (PASI) will be explored using Spearman correlations. |
| Correlation Between Changes in APRI and Changes in PASI | Baseline to 12 and 24 months | Associations between changes in the level of liver fibrosis (APRI) and changes in the severity of psoriasis (PASI) will be explored using Spearman correlations. |
| Cumulative Incidence of Treatment Discontinuation Due to Lack of Response | Up to 5 years | 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 |
| Proportion of Patients who Achieve a Psoriasis Area and Severity Index (PASI) 100 | 12 and 24 months | 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). |
| Proportion of Patients who Achieve a PASI Score ≤ 3 | 12 and 24 months | 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. |
| Cumulative Incidence of a ≥20% Relative Increase in Fibrosis-4 Index (FIB-4) From Baseline | Baseline up to 5 years | 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 |
| Proportion of Patients With a Shift in Fibrosis Category | Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months | FIB-4 and aspartate aminotransferase to platelet ratio index (APRI) are non-invasive tools used to assess liver fibrosis. The scores are calculated using age, AST level, ALT level, and platelet count FIB-4 fibrosis risk categories (patients aged ≥35 years): * Low risk: FIB-4 \< 1.30 * Intermediate risk: 1.30 ≤ FIB-4 ≤ 2.67 * High risk: FIB-4 \> 2.67 APRI risk categories (patients aged \<35 years): * Low risk: APRI \< 0.50 * Intermediate risk: 0.50 ≤ APRI ≤ 1.50 * High risk: APRI \> 1.50 |
| APRI Score | Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months | APRI is a non-invasive tool used to assess liver fibrosis. The APRI score is calculated using AST level and platelet count APRI risk categories: * Low risk: APRI \< 0.50 * Intermediate risk: 0.50 ≤ APRI ≤ 1.50 * High risk: APRI \> 1.50 |
| FIB-4 Score | Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months | FIB-4 is a non-invasive tool used to assess liver fibrosis. The FIB-4 score is calculated using age, AST level, 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 |
Countries
Spain
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed