Ublituximab-xiiy (Briumvi)

Multiple sclerosis (MS) is a chronic disease affecting the central nervous system (CNS). It is characterized by triad of inflammation, demyelination, and scarring of the central nervous system and manifests as pathological (immune-mediated CNS demyelination and axonal injury) and clinical (exacerbations, disability progression) dissemination in time and space. MS has been categorized into four types: clinically isolated syndrome (CIS), relapsing-remitting (RRMS), secondary progressive (SPMS), and primary progressive (PPMS). The most common type is RRMS, which is characterized by acute attacks followed by periods of remission. An initial attack may present as a clinically isolated syndrome (CIS); individuals presenting with this syndrome are high risk for subsequent conversion to clinically definite MS (CDMS) when coupled with MRI lesions consistent with MS. Although a cure for MS remains elusive, several treatment options slow the progression of the disease and reduce the frequency of relapses. Ublituximab-xiiy is monoclonal antibody that is used to reduce the frequency of relapses and delay the accumulation of physical disability in patients with RRMS. It exerts its physiologic effects through binding to CD20 on the surface of B lymphocytes which results in antibody-dependent and complement-mediated cell lysis. Ublituximab is Food and Drug administration (FDA) approved for the treatment of relapsing forms of MS to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. The efficacy of ublituximab for the treatment of relapsing multiple sclerosis was compared to teriflunomide in two randomized, double-blind trials. Subjects were required to have at least one relapse in the prior year, 2 relapses in the previous 2 years, or the presence of a T1 gadolinium-enhancing lesion in the previous year. The subjects were also required to have an Expanded disability status scale score from 0 to 5.5 at baseline. In both trials, ublituximab significantly reduced annualized MS relapse rates compared to teriflunomide (Study 1, 0.076 vs 0.188, relative reduction = 59%;Study 2, 0.091 vs 0.178, RR=49%). The proportion of patients with 12-week confirmed disability progression was also reduced in the subjects treated with ublituximab as compared to teriflunomide (5.2% vs 5.9%, risk reduction=16%). The mean number of T1 gadolinium- enhancing lesions per MRI and number of new or enlarging T2 lesions were significantly reduced for subjects treated with ublituximab as compared to teriflunomide. The most common adverse reactions that occurred were infusion reactions, upper and lower respiratory tract infections, herpes infections, extremity pain, insomnia, and fatigue <a id="