Ublituximab Associated With Significant Reduction in MS Disease Activity, Focal Lesions
Study participants received 3 ublituximab infusions on day 1, day 15, and week 24.
|The following article is part of conference coverage from the 2018 Annual Meeting of the Consortium of Multiple Sclerosis Centers in Nashville, Tennesssee. Neurology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from CMSC 2018.|
The chimeric monoclonal antibody ublituximab is well-tolerated by individuals with relapsing multiple sclerosis and leads to significant reductions in clinical disease activity and focal inflammatory lesions, including a complete elimination of gadolinium (Gd)-enhancing lesions, according to research presented at the 32nd Annual Meeting of the Consortium of Multiple Sclerosis Centers, held May 30-June 2, 2018, in Nashville, Tennessee.
TG1101-RMS201 was a multicenter, placebo-controlled, phase 2, 52-week study designed to evaluate the optimal infusion and safety of ublituximab for relapsing multiple sclerosis.
Study participants received 3 ublituximab infusions on day 1, day 15, and week 24. The volume of T1 hypointense lesions and T2 lesions and the number of Gd-enhancing lesions were assessed using magnetic resonance imaging scans of the brain at baseline, before ublituximab treatment at week 24 and at week 48. Preliminary results had been analyzed for 31 participants up to week 24. Baseline data on T1 Gd-enhancing lesions showed 73 total (mean, 2.4 ± 4.0), which were reduced to 0 by week 24 (P =.003). In the same time period, participants showed an 8.1% (P =.01) reduction in T2 lesion volume and a 6.6% (P =.04) reduction in T1 hypointense lesion volume.
“Ublituximab is well tolerated, and 6-month data show potent B-cell depletion and robust efficacy on MRI end points,” the study investigators concluded. “Additionally, infusion times as low as 1 hour and lower dose infusions, relative to other anti-CD20s, provide a convenience benefit for patients.”
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Inglese M, Petracca M, Cocozza S, et al. 6-Month results from a phase 2 multicenter study of ublituximab, a novel glycoengineered anti-cd20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis, demonstrates complete elimination of gadolinium-enhancing lesions. Presented at: 2018 CMSC Annual Meeting. May 30-June 2, 2018; Nashville, Tennessee. Abstract DX62.