1. In this double-blind, randomized phase 3 trial, patient treated with ofatumumab had a lower annualized relapse rate in multiple sclerosis compared to those treated with teriflunomide
2. The ofatumumab treatment group had less disability worsening, improved number of enhancing lesions per MRI scans, and lower serum neurofilament light chains levels. However, no differences in brain volume was found
Evidence Rating Level: 1 (Excellent)
Study Rundown: Ofatumumab is a CD-20 antibody that selectively depletes B cells while teriflunomide targets both the B and T-cell populations. This trial aimed to evaluate the efficacy and safety of injectable ofatumumab compared to oral teriflunomide in patients with multiple sclerosis. It was determined that treatment with ofatumumab reduced the annualized relapse rate compared to teriflunomide. Ofatumumab treatment was also associated with improved secondary endpoints such as less Expanded Disability Status Scale score regressions at 3 and 6 months but no significant improvement events were shown. MRI detected lesions and serum neurofilament light chain levels were improved in the ofatumumab group compared to the teriflunomide group. The main safety profile difference was an increased incidence of injection-related reactions in the ofatumumab group. This study was limited by the follow-up time as long term adverse events such as the development of neoplasms and mortality differences were not adequately assessed. Taken together, this study demonstrated that ofatumumab is a superior alternative to oral teriflunomide in the treatment of multiple sclerosis with some minor increases in the incidence of injected related reactions.
In-Depth [randomized controlled trial]: This was a 1.6 year, double-blind, double-dummy phase 3 trial with two identical trials with a total of 946 patients with multiple sclerosis with a relapsing-remitting course or a secondary progressive course. Ages of patients ranged from 18 to 55 years. Patients were randomly assigned 1:1 to receive ofatumumab or oral teriflunomide with appropriate placebos. The primary efficacy endpoint demonstrated that ofatumumab improved the adjusted annualized relapse rate (-0.11 [95% CI -0.16 to -0.06], p <0.001) in trial 1 and trial 2 (-0.15 [95% CI -0.20 to -0.09], p <0.001). Secondary endpoints showed less disability worsening events at 3 months (HR 0.66 [95% CI 0.50 to 0.86]), at 6 months (HR 0.68 [95% cI 0.50 to 0.92]) but no improvements at 6 months (HR 1.35 [95% CI 0.95 to 1.92]) in the ofatumamab group. Furthermore, MRI detected lesions and serum neurofilament light chain concentrations were significantly lower on ofatumumab compared to teriflunomide. Brain volume change was not significantly different between groups. Serious adverse events were reported in 9% of ofatumumab patients and 8% of teriflunomide patients. Injection-related systemic reactions were reported in 20% of ofatumumab patients and 15% of placebo injections while injection-site reactions occurred in 11% and 6% respectively.
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