Tolerability of subcutaneous ofatumumab with long-term exposure in relapsing multiple sclerosis - Université de Lille
Article Dans Une Revue Multiple Sclerosis Journal - Experimental, Translational and Clinical Année : 2023

Tolerability of subcutaneous ofatumumab with long-term exposure in relapsing multiple sclerosis

Résumé

Background Ofatumumab is approved for treating relapsing multiple sclerosis (RMS). Examining tolerability will enable understanding of its risk–benefit profile. Objective Report the tolerability profile of ofatumumab in RMS during treatment of up to 4 years and the effect of pre-medication. Methods Cumulative data from the overall safety population included patients taking continuous ofatumumab or being newly switched from teriflunomide. Injection-related reactions (IRRs) by incidence and severity, and post-marketing surveillance data, with an exposure of 18,530 patient-years, were analyzed. Results Systemic IRRs affected 24.7% of patients (487/1969) in the overall safety population; most (99.2% [483/487]) were mild (333/487) to moderate (150/487) in Common Terminology Criteria for Adverse Events severity; most systemic IRRs occurred after first injection. Local-site IRRs affected 11.8% (233/1969) and most (99.6% [232/233]) were mild/moderate. Incidence and severity of systemic and localized IRRs were similar between continuous and newly switched patients across repeated injections. Systemic IRR incidence and severity were not substantially affected by steroidal or non-steroidal pre-medication. Post-marketing surveillance identified no new tolerability issues. Conclusion Ofatumumab is well tolerated, displays a consistent safety profile during continuous use or after switching from teriflunomide and does not require pre-medication. This enables home management of RMS with a high-efficacy treatment.
Fichier principal
Vignette du fichier
kramer-et-al-2023-tolerability-of-subcutaneous-ofatumumab-with-long-term-exposure-in-relapsing-multiple-sclerosis.pdf (1019.35 Ko) Télécharger le fichier
Origine Fichiers éditeurs autorisés sur une archive ouverte

Dates et versions

hal-04792741 , version 1 (20-11-2024)

Licence

Identifiants

Citer

John Kramer, Ralf Linker, David Paling, Adam Czaplinski, Olaf Hoffmann, et al.. Tolerability of subcutaneous ofatumumab with long-term exposure in relapsing multiple sclerosis. Multiple Sclerosis Journal - Experimental, Translational and Clinical, 2023, Multiple Sclerosis Journal - Experimental, Translational and Clinical, 9 (4), pp.20552173231203816. ⟨10.1177/20552173231203816⟩. ⟨hal-04792741⟩

Collections

UNIV-LILLE
0 Consultations
0 Téléchargements

Altmetric

Partager

More