Semaglutide 2.4 mg in French people living with Class 3 obesity and comorbidities: Baseline characteristics and real-world safety data - 27/02/25
, Judith Aron-Wisnewsky c, d, David Jacobi e, Karine Clément c, d, Martine Laville a, Cyril Gauthier f, François Pattou g, Julie Molleville h, Melissa Akerib i, Lysiane Jubin j, Blandine Gatta-Cherifi k, Bénédicte Gaborit l, m, Emilie Montastier n, o, Fabien Stenard p, Claire Carette q, Najate Achamrah r, Antoine Avignon s, Sébastien Czernichow jfor the
SEMAFEAP Study Group†
Highlights |
• | The burden of obesity and its consequences is increasing worldwide |
• | Semaglutide 2.4 mg early access program (EAP) was the 1st EAP for obesity in France. |
• | The inclusion of 9000 people in the EAP over 1 year show a high unmet medical need |
• | No new safety signals were identified in this population, based on real-world data |
• | Further real-world data will clarify its role in multimodal management of obesity |
Abstract |
Aim |
- To describe baseline characteristics and safety data of real-world use of semaglutide 2.4 mg.
Methods |
- Patients with a body mass index (BMI) ≥40 kg/m2 and at least one of the following treated weight-related comorbidities (WRC: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease) were eligible to receive treatment through Temporary Utilization Authorization (TUA: March to June 2022) or Early Access Program (EAP: July 2022 to October 2023). Data were collected according to Health Authorities’ requirements. Only descriptive statistics were used.
Results |
- Overall, 5,797 (62.8%) treatment requests were sent by sites specialized in obesity management. In total, 478 and 8,568 patients were treated within TUA and EAP cohorts respectively, with mean follow-up durations of 1.2 and 4.5 months, respectively. Mean (SD) BMI was 48.9 (9.7) and 47.0 (7.4) kg/m2, respectively. Age ranged from 18 to 81 years. In the EAP, 57.4%, 26.5%, 12.3% and 3.7% of patients had 1, 2, 3 and 4 WRC. In addition, 15.5% had type 2 diabetes, 18.1% reported depression and 15.4% had osteoarthritis. In the EAP, 247 (2.9%) patients discontinued treatment after a median time of 2.8 months (IQR: 1.2–5.1), mainly due to adverse events (AEs) (47.0%). During TUA, 3 patients discontinued due to AEs. Pancreatitis was reported in 7 cases overall.
Conclusion |
- The high number of treatment prescriptions in a short period highlights the high unmet medical need. No new safety concerns were identified in this population with severe obesity treated in a real-world setting.
Le texte complet de cet article est disponible en PDF.Keywords : Early access, Obesity, Real-world data, Safety, Semaglutide
Abbreviations : cTUA, EAP, ANSM, HAS
Plan
Vol 51 - N° 3
Article 101625- mai 2025 Retour au numéro
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