Traitements systémiques du psoriasis et événements cardiovasculaires à partir des données du SNDS

Objectif(s) de la recherche et intérêt pour la santé publique

Finalité de l'étude

Objectifs poursuivis

Domaines médicaux investigués

Bénéfices attendus

Titre du projet : SYSCARE-France : Analyse comparative du risque de survenue d’événements cardiovasculaires majeurs associés aux traitements systémiques du psoriasis : une étude en vie réelle utilisant le Système National des Données de Santé (SNDS)

Public Health Relevance
Psoriasis affects approximately 1.5 to 3 million people in France and is now recognized as a systemic inflammatory disease associated with an increased risk of major cardiovascular events (MCEs) such as myocardial infarction, stroke, heart failure, and cardiovascular mortality. The increasing use of systemic treatments, including biotherapies and small molecules, raises questions about their long-term cardiovascular safety. Current data from clinical trials are limited and do not reflect real-world practice, hence the need for real-world studies to guide therapeutic strategies, improve patient care, and prevent avoidable cardiovascular complications.

Objectives and Methodology
The primary objective of the SYSCARE-France study is to compare the risk of major MCEs in adult patients with psoriasis initiating different systemic treatments (conventional agents, biotherapies, apremilast). Secondary objectives include: (i) estimating the incidence rates of major CVDs and their components; (ii) comparing risk profiles across therapeutic classes; (iii) identifying high-risk subgroups; and (iv) exploring mediating factors influencing the relationship between treatments and CVDs. This is a longitudinal, retrospective cohort study based on data from the French National Health Data System (SNDS). The design is based on an active comparator of new users, with longitudinal follow-up of patients from treatment initiation until the occurrence of CVD, treatment change, death, or the end of the observation period. Statistical analyses will include Cox models, structural marginal models (IPTW), and sensitivity analyses to strengthen the robustness of the results.

Study Population and Expected Impact
The cohort will include approximately 80,000 to 100,000 adult patients with psoriasis, identified in the SNDS between 2010 and 2025. Inclusion criteria are based on a confirmed diagnosis of psoriasis (≥2 vitamin D analog dispensations or ICD-10 code L40) and initiation of systemic treatment. Key exclusion criteria include a recent history of major CVD, concomitant inflammatory diseases, recent cancers, and participation in a clinical trial. The expected results aim to optimize prescriptions by identifying the safest treatments, reduce cardiovascular morbidity and mortality, inform clinical guidelines, and support public health policies. This project will fully leverage the strengths of the SNDS to produce robust data that can be directly translated into clinical practice and useful to health authorities.