The maker of ofatumumab (OMB157; Novartis, Basel, Switzerland) has announced results of 2 head-to-head phase 3 clinical studies (ASCLEPIOS I and II [NCT02792218 and NCT02792231]). In both studies, individuals with relapsing-remitting multiple sclerosis (RRMS) who were treated with ofatumumab had significantly greater reductions in annualized relapse rate (ARR) compared with those treated with teriflunomide (Aubagio; Sanofi Genzyme, Cambridge, MA). Treatment with ofatumumab also delayed time to confirmed disability progression.
The manufacturer will present data from these studies at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place September 11–13, 2019, in Stockholm, Sweden. Submission of a new drug application to the Food and Drug Administration (FDA) is expected before the end of 2019.
“It is clear that early initiation of highly effective treatment for MS improves long-term outcomes, and there is a high need for potent, safe, and convenient therapy that can be used to treat MS from the start,” said Stephen L. Hauser, MD, director of the UCSF Weill Institute for Neurosciences. “The results from ASCLEPIOS are wonderful news for patients who would like to take an effective B-cell therapy with low requirement for monitoring, avoiding visits to an infusion center.”
Ofatumumab is an investigational fully human anti-CD20 monoclonal antibody (mAb) that is self-administered monthly as a subcutaneous injection that inducing B-cell lysis and depletion.
In these twin flexible-duration (up to 30 months) randomized trials, 1,882 participants, age 18-55 years, with RRMS and Expanded Disability Status Scale (EDSS) scores of 0 to 5.5. Other secondary endpoints measured included number of gadolinium-enhancing T1 lesions, number of new or enlarging T2 lesions, serum neurofilament light chain (NfL) levels, and rate of brain volume loss.