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.
Study Type
OBSERVATIONAL
Enrollment
150
Novartis Investigative Site
Badalona, Barcelona, Spain
RECRUITINGNovartis Investigative Site
Barcelona, Spain
RECRUITINGNovartis Investigative Site
Madrid, Spain
RECRUITINGNumber 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 years
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 years
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 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.
Novartis Pharmaceuticals
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Málaga, Spain
RECRUITINGTime frame: 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: * 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 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): * 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
Time frame: 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: * Low risk: FIB-4 \< 1.30 * Intermediate risk: 1.30 ≤ FIB-4 ≤ 2.67 * High risk: FIB-4 \> 2.67
Time frame: 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: * Low risk: APRI \< 0.50 * Intermediate risk: 0.50 ≤ APRI ≤ 1.50 * High risk: APRI \> 1.50
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
AST Level
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
ALT Level
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
Platelet Count
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 12 and 24 months