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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab Cohort | Adult patients with plaque psoriasis (with or without PsA) and MASLD initiating secukinumab in routine clinical practice in Spain. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 5 years |
| Proportion of Patients who Achieve a Psoriasis Area and Severity Index (PASI) 100 |
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Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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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). |
| 12 and 24 months |
| 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. | 12 and 24 months |
| 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:
| Baseline up to 5 years |
| Proportion of Patients With a Shift in Fibrosis Category | 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):
APRI risk categories (patients aged <35 years):
| Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months |
| FIB-4 Score | 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:
| Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months |
| APRI Score | 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:
| Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months |
| 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 | 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. | Baseline to 12 and 24 months |
| Correlation Between Changes in APRI and Changes in PASI | Associations between changes in the level of liver fibrosis (APRI) and changes in the severity of psoriasis (PASI) will be explored using Spearman correlations. | Baseline to 12 and 24 months |