1. Ublituximab in relapsing forms of multiple sclerosis: a profile of its use.
- Author
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Blair, Hannah A.
- Subjects
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THERAPEUTIC use of monoclonal antibodies , *MULTIPLE sclerosis , *DRUG approval , *DRUG efficacy , *BRAIN , *INTRAVENOUS therapy , *CLINICAL trials , *MONOCLONAL antibodies , *DISEASE relapse , *RISK assessment , *BUTYRIC acid , *CROTON oil - Abstract
Ublituximab (BRIUMVITM), an anti-CD20 immunoglobulin G1 monoclonal antibody, is a promising new treatment option for patients with relapsing forms of multiple sclerosis (MS). Ublituximab is approved in the USA and the EU for the treatment of adult patients with relapsing forms of MS. Following a starting dose of 150 mg infused over 4 h, ublituximab is conveniently administered twice-yearly as a short (1 h) intravenous infusion. In phase 3 clinical trials in patients with relapsing MS, ublituximab was more effective than oral teriflunomide at reducing annualized relapse rates and numbers of brain lesions over a period of 96 weeks. However, ublituximab did not result in a significantly lower risk of worsening of disability. Ublituximab had an acceptable tolerability profile in clinical trials. The most commonly reported adverse events were infusion-related reactions (IRRs), which occurred in almost half of ublituximab recipients. However, the majority of IRRs were of mild to moderate severity, occurred after the first dose and decreased in frequency with subsequent dosing. Plain language summary: Multiple sclerosis (MS) is a chronic illness whereby the body's immune system causes damage to the brain and spinal cord. Most patients with MS have a relapsing-remitting form of the disease, where symptoms flare for a period of time and then ease. Ublituximab (BRIUMVITM) is a monoclonal antibody approved for treating adults with relapsing forms of MS. Of convenience to patients, ublituximab is given intravenously once every 6 months after initial dosing and can be infused rapidly (over 1 h). In clinical trials, ublituximab recipients were half as likely to have a relapse and had fewer areas of inflammation in the brain than patients receiving oral teriflunomide. However, ublituximab did not significantly reduce the risk of worsening disability. Ublituximab had an acceptable safety profile in clinical trials. Nearly half of patients receiving ublituximab had mild to moderate infusion-related reactions that became less frequent with later infusions. Thus, ublituximab is a promising new treatment option for patients with relapsing forms of MS. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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