APNEE Study: A Challenge to Identify Patients Treated with Dupilumab for Chronic Rhinosinusitis with Nasal Polyps (CRSWNP) in Real-Life Settings in France
Author(s)
Papon JF1, Mortuaire G2, Antoniali L3, Vataire AL3, Darnal E3, Karam P4
1Hôpital Bicêtre, Kremlin-Bicêtre, Paris, France, 2CHU de Lille, Lille, Hauts-de-France, France, 3Sanofi, Gentilly, Paris, France, 4Pierre Karam Conseil Santé, Ecully, France
Presentation Documents
OBJECTIVES: A real-life study, based on SDNS (Système National des Données de Santé – National Health Data System), was set up to characterize patients treated with dupilumab for chronic rhinosinusitis with nasal polyps (CRSwNP) in France between 2021 and 2023. The SNDS encompasses all the French population requiring medical care. The objective of APNEE project is to clearly identify the patients actually treated for CRSwNP, as opposed to other medical conditions wherein dupilumab is also prescribed (i.e. atopic dermatitis (AD) and asthma).
METHODS: Four experts (2 rhinologic surgeons and 2 methodologists) were joined to design an algorithm aiming to precisely identify CRSwNP patients treated with dupilumab between 2021 and 2023. This algorithm was also submitted to a dermatologist and a pneumologist to improve the exclusion criteria for patients treated with biologics for asthma and AD.
RESULTS: During the study period, 13,000 patients with ≥1 delivery of dupilumab-300mg were identified (51.2% male). Patients were classified according to their prior treatment and medical examinations as reported. To make sure that data collected were specific of CRSwNP patients, the occurrence of nasal endoscopy to control the mucosal response after the initiation of dupilumab was retrieved. In doing so, 2,300 patients with CRSwNP treated with dupilumab were expected to be rightfully selected.
CONCLUSIONS: The algorithm designed in the APNEE study seems to be robust to identify dupilumab-treated patients for CRSwNP. Meanwhile, it is tricky to implement a universal algorithm available for all population-based studies. A disease-specific algorithm conceived with clinical experts is mandatory for each study according to the objectives and the population targeted.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
RWD60
Topic
Real World Data & Information Systems, Study Approaches
Topic Subcategory
Health & Insurance Records Systems
Disease
Biologics & Biosimilars, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)