Treatment-naïve patients showed consistent results with the overall study population that was observed in the ASCLEPIOS I and II trials.
An evaluation of a subgroup population of treatment-naïve patients with relapsing-remitting multiple sclerosis (RRMS) from the phase 3 ASCLEPIOS I and II trials (NCT02792218 and NCT02792231) demonstrated low absolute relapse rates (ARRs), very low MRI lesion activity, and prolonged time to disability worsening with treatment with ofatumumab (Kesimpta; Novartis) compared with teriflunomide (Aubagio; Sanofi).1
The poster was presented at MS Virtual 2020, the 8th joint ECTRIMS-ACTRIMS meeting, September 11–13, 2020, by Stephen L. Hauser, MD, director, UCSF Weill Institute for Neurosciences, and co-chair, steering committee for the ASCLEPIOS I and II studies.
Hauser and colleagues assessed key efficacy and safety outcomes in 615 newly diagnosed (within 3 years before screening), treatment-naïve (no prior disease-modifying therapy [DMT] use) patients who received ofatumumab or teriflunomide as a first-line therapy.
They found that compared to teriflunomide, treatment with ofatumumab reduced ARR by 50.3% (0.09 vs 0.18; P <.001), 3-month confirmed disability worsening (3mCDW) risk by 38% (10.1% vs 12.8%; P = .065), and 6-month CDW (6mCDW) by 46% (5.9% vs 10.4%; P = .044). The treatment was also superior in reducing gadolinium enhancing T1 lesions per scan by 95.4% (0.02 vs 0.39; P <.001) and new/enlarging T2 lesions/year by 82.0% (0.86 vs 4.78; P <.001).
In total, 84.7% of patients who received ofatumumab experienced treatment-emergent adverse events (TEAEs) compared to 86.0% of teriflunomide-treated patients. Notably, serious AEs were found in 7.0% and 5.3% of groups, respectively.
Investigators reported no cases of malignancies in the newly diagnosed subgroup, randomized to either drug. Both ofatumumab (56.1%) and teriflunomide (56.5%) had comparable rates of infection, with no opportunistic infections reported. Serious infection rates were 1.9% and 0.7% in the ofatumumab and teriflunomide groups, respectively.
Hauser and colleagues concluded that ofatumumab is the first high efficacy DMT that can be self-administered at home. In fact, more than 70% of RMS patients self-injected at home after their 4th injection and 98.8% of patients complied with injections of ofatumumab.
Ofatumumab was granted market approval by the FDA for the treatment of relapsing forms of MS in adults, including clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive MS in August.2
Approval for the fully human anti-CD20 monoclonal antibody was supported by data from the same ASCLEPIOS I and II studies, which featured more than 1800 patients. Full results of the trials showed that ARRs for patients with MS were reduced by 51% (ofatumumab: 0.11; teriflunomide: 0.22; difference, −0.11; 95% CI, −0.16 to −0.06; P <.001) and 58% (ofatumumab: 0.10; teriflunomide: 0.25; difference, −0.15; 95% CI, −0.20 to −0.09; P <.001) in those who received ofatumumab in the ACLEPIOS I and II trials, respectively, with both differences achieving statistical significance (P <.001 for both).3