STOCKHOLM — The results of the identically designed ASCLEPIOS I and II phase 3 trials evaluating the effect of ofatumumab versus teriflunomide in participants with relapsing multiple sclerosis (MS) were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held September 11-13, 2019 in Stockholm, Sweden.
Ofatumumab, the first fully human, anti-CD20 monoclonal antibody, was developed and tested through 2 double-blind, double-dummy, parallel-group, active comparator-controlled, multicenter trials to assess the efficacy and safety of the drug compared with teriflunomide in patients with relapsing MS. Participants were 18 to 55 years of age, had an Expanded Disability Status Scale score of 0 to 5.5 at screening, and had experienced one of the following: positive gadolinium-enhancing (Gd+) magnetic resonance imaging scan in the year before randomization, 1 or more relapses in the past year, or 2 or more relapses in the past 2 years.
Participants (n=1881) in 37 countries were randomly assigned 1:1 to receive oral teriflunomide 14 mg once daily, or subcutaneous injections of ofatumumab 20 mg once every 4 weeks (after an initial loading regiment of 20 mg injections on day 1, 7, and 14), for up to 30 months. Both studies had flexible durations with study termination according to pre-specified criteria occurring in the blinded core treatment epoch.
The primary end point was annualized relapse rate. Key secondary end points included serum neurofilament light chain levels, 6-month confirmed disability improvement (CDI), 3- and 6-month confirmed disability worsening (CDW), and magnetic resonance imaging-related outcomes. Tolerability and safety were also assessed.
Investigators predicted that the end of study (EOS) could be planned for early July 2019 because the protocol-defined EOS criteria were based on blinded data for both studies and were powered to 90% for the primary end point. Both studies also combined to 90% for 3-month CDW and to 80% for 6-month CDW. Researchers presented top line results for safety and efficacy.
Study investigators concluded, “The results of these large controlled Phase 3 trials will elucidate the therapeutic potential of ofatumumab 20 mg, the first B-cell therapy that is subcutaneous and self-administered every 4 weeks, in RMS patients.”
Disclosure: This study was supported by Novartis Pharma AG, Basel, Switzerland. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Hauser SL, Bar-Or A, Cohen J, et al. Efficacy and safety of ofatumumab versus teriflunomide in relapsing multiple sclerosis: results of the phase 3 ASCLEPIOS I and II trials. Presented at: The 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis and the 24th Annual Conference of Rehabilitation in MS; September 11-13; Stockholm, SE. Abstract 336.