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

ABSTRACT:

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 Ter

SUBMITTER: Kramer J 

PROVIDER: S-EPMC10566276 | biostudies-literature | 2023 Oct-Dec

REPOSITORIES: biostudies-literature