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