Ofatumumab Reduces New MRI Lesions in Relapsing Multiple Sclerosis
Ofatumumab was shown to suppress new brain MRI lesions in patients with RMS.
In patients with relapsing forms of multiple sclerosis (RMS), ofatumumab decreases the number of new magnetic resonance imaging (MRI) gadolinium-enhancing lesions after 12 weeks of treatment, according to study results published in Neurology.
The study (ClinicalTrials.gov Identifier: NCT01457924) included participants with RMS (n=232) who were randomly assigned to receive 3 mg, 30 mg, or 60 mg of ofatumumab every 12 weeks; ofatumumab 60 mg ofatumumab every 4 weeks; or placebo for a 24-week treatment period.
The specified primary end point was the cumulative number of new gadolinium-enhancing lesions at week 12 assessed via brain MRI. The researchers also assessed relapses and safety/tolerability. Participants' CD19+ peripheral blood B-lymphocyte counts were measured.
Compared with the placebo group, all ofatumumab dose groups had a 65% reduction in the cumulative number of new lesions (P <.001). A post hoc analysis that excluded weeks 1 to 4 estimated a ≥90% lesion reduction for all cumulative ofatumumab doses ≥30 mg compared with placebo at week 12.
Participants showed a dose-dependent CD19 B-cell depletion, but complete depletion was not necessary for a significant treatment effect.
The most common adverse event reported by participants was injection-related reactions (52% ofatumumab, 15% placebo). These events occurred most commonly after the first dose and diminished with subsequent dosing.
“Our findings thus support investigation of low-dose subcutaneous ofatumumab in longer-term efficacy studies in RRMS,” the researchers wrote.
Clinical trial NCT01457924 was sponsored by GlaxoSmithKline. Refer to original publication for full list of disclosures.
Bar-Or A, Grove RA, Austin DJ, et al. Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis. [published online April 25, 2018]. Neurology. doi:10.1212/WNL.0000000000005516