Comparative effectiveness of gonadotropins used for ovarian stimulation during assisted reproductive technologies (ART) in France: A real-world observational study from the French nationwide claims database (SNDS).
Cumulative live birth
France
HP-hMG
Live birth
Real-world data
r-hFSH
Journal
Best practice & research. Clinical obstetrics & gynaecology
ISSN: 1532-1932
Titre abrégé: Best Pract Res Clin Obstet Gynaecol
Pays: Netherlands
ID NLM: 101121582
Informations de publication
Date de publication:
Jun 2023
Jun 2023
Historique:
received:
25
10
2022
accepted:
19
12
2022
medline:
5
6
2023
pubmed:
28
1
2023
entrez:
27
1
2023
Statut:
ppublish
Résumé
This comparative non-interventional study using data from the French National Health Database (Système National des Données de Santé) investigated real-world (cumulative) live birth outcomes following ovarian stimulation, leading to oocyte pickup with either originator recombinant human follicle-stimulating hormone (r-hFSH) products (alfa or beta), r-hFSH alfa biosimilars, or urinaries including mainly HP-hMG (menotropins), and marginally u-hFSH-HP (urofollitropin). Using data from 245,534 stimulations (153,600 women), biosimilars resulted in a 19% lower live birth (adjusted odds ratio (OR) 0.81, 95% confidence interval (CI) 0.76-0.86) and a 14% lower cumulative live birth (adjusted hazard ratio (HR) 0.86, 95% CI 0.82-0.89); and urinaries resulted in a 7% lower live birth (adjusted OR 0.93, 95% CI 0.90-0.96) and an 11% lower cumulative live birth (adjusted HR 0.89, 95% CI 0.87-0.91) versus originator r-hFSH alfa. Results were consistent across strata (age and ART strategy), sensitivity analysis using propensity score matching, and with r-hFSH alfa and beta as the reference group.
Identifiants
pubmed: 36707343
pii: S1521-6934(22)00189-4
doi: 10.1016/j.bpobgyn.2022.102308
pii:
doi:
Substances chimiques
Biosimilar Pharmaceuticals
0
Follicle Stimulating Hormone
9002-68-0
Follicle Stimulating Hormone, Human
0
Gonadotropins
0
Types de publication
Journal Article
Observational Study
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
102308Informations de copyright
Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest MG has received fees from Merck Healthcare KGaA, Darmstadt, Germany, as a medical expert for this study, and lecture fees from Merck KGaA, Darmstadt, Germany, MSD, Ferring, IBSA, Gedeon Richter, Theramex, General Electric, Novartis, Besins Healthcare. I-CD has received fees from Merck Healthcare KGaA, Darmstadt, Germany, as a medical expert for this study, and lecture fees from Merck KGaA, Darmstadt, Germany, MSD, Ferring, IBSA, Gedeon Richter, and Theramex. FR and EH are employees of HEVA, Lyon, France. LL, FP, SP, and CC-B are employees of Merck Santé, Lyon, France, an affiliate of Merck KGaA, Darmstadt, Germany. PV, JES, and TDH are employees of Merck Healthcare KGaA, Darmstadt Germany. CH is an employee of Merck KGaA, Darmstadt Germany. MB has received fees from Merck Healthcare KGaA, Darmstadt, Germany, as a medical expert for this study, and lecture fees from Merck KGaA, Darmstadt, Germany.