The following article is part of conference coverage from the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event. Neurology Advisor‘s staff will be reporting breaking news associated with research conducted by leading experts in neurology. .
Ofatumumab was found to have greater efficacy than teriflunomide for the treatment of patients with newly diagnosed relapsing multiple sclerosis (RMS), according to study results presented at the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event, held September 11-13, 2020.
Study researchers aimed to evaluate the benefit-risk profile of ofatumumab in trials comparing the efficacy and safety of ofatumubab to teriflunomid in patients with MS (ASCLEPIOS I/II trials; ClinicalTrials.gov Identifiers: NCT02792218 and NCT02792231, respectively). To do so, study researchers assessed the safety and efficacy of ofatumumab and teriflunomide in a subgroup of 615 patients with RMS diagnosed within the past 3 years.
Participants (median age, 36 years; median MS duration, 0.35 years) had not previously been treated with disease-modifying therapy. Patients received either ofatumumab or teriflunomide for first-line treatment as part of the ASCLEPIOS I/II trials.
Patients receiving ofatumumab vs teriflunomide had reductions in: annualized relapse rate (0.09 vs 0.18, respectively; P <.001; 50.3% reduction), 3-month confirmed worsening (10.1% vs 12.8%, respectively; P =.065; 38% reduction), 6-month confirmed worsening (5.9% vs 10.4%, respectively; P =.044; 46% reduction), gadolinium-enhanced T1 lesions (0.02 vs 0.39, respectively; P <.001; 95.4% reduction), and in the annual rate of new or enlarged T2 lesions (0.86 vs 4.78; P <.001; 82.0% reduction).
A total of 84.7% and 86.0% of participants receiving ofatumumab and teriflunomide, respectively, reported experiencing treatment-emergent adverse events, and 7.0% and 5.3% of patients, respectively reported serious adverse events.
Infection rates were comparable in the 2 treatment groups. Serious infection rates were 1.9% and 0.7% in patients receiving ofatumubab and teriflunomide, respectively. Additionally, study researchers observed no opportunistic infections. There was an imbalance of systemic injection reactions only for the first injection between patients receiving ofatumumab and teriflunomide with placebo injections. These reactions which occurred at the study site were mild-to-moderate (>70% of participants injected themselves at home after the fourth injection). Compliance of participants in the ofatumumab group was 98.8%.
The study investigators concluded that ofatumubab was “the first high efficacy [disease-modifying therapy] that can be self-administered at home” and that it “showed superior efficacy vs teriflunomide in newly diagnosed, treatment-naïve patients with low absolute relapse rates, very low [magnetic resonance imaging] lesion activity and prolonged time to disability worsening, consistent with the overall study population.”
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Gartner J, Hauser S, Bar-Or A, et al. Benefit-risk of ofatumumab in treatment-naïve early relapsing multiple sclerosis patients. Presented at: 8th Joint American Committee for Treatment and Research in Multiple Sclerosis and European Committee for Treatment and Research in Multiple Sclerosis MSVirtual2020 event; September 11-13, 2020; Presentation P0192.