The investigational therapy ofatumumab demonstrated positive results in patients with relapsing multiple sclerosis (RMS), according to new data from a pair of phase 3 studies.

Results from both studies, ASCLEPIOS I and II, were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). If approved, ofatumumab will be the first B-cell therapy for patients with RMS that can be started and managed in a monthly self-administered injection at home, according to Novartis.

The ASCLEPIOS I and II studies evaluated the safety and efficacy of ofatumumab 20 mg monthly subcutaneous injections compared with teriflunomide (Aubagio) 14 mg oral tablets taken once daily in adults with RMS. The studies included 1882 patients with MS, between the ages of 18 and 55 years, with an Expanded Disability Status Scale (EDSS) score between 0 and 5.5.

According to the results:
 
  • Patients treated with ofatumumab had an annualized relapse rate (ARR) of 0.11 and 0.10 compared with teriflunomide (ARR of 0.22 and 0.25) in ASCLEPIO I and II, respectively, corresponding to a reduction in ARR by 50.5% and 58.8% with ofatumumab.
  • Ofatumumab showed highly significant suppression of both gadolinium (Gd)+ T1 lesions and new or enlarging T2 lesions compared with teriflunomide.
  • Ofatumumab showed a relative risk reduction of 34.4% (p=0.002) in a 3-month confirmed disability progression (CDP) and 32.5% (p=0.012) in 6-month CDP versus teriflunomide in pre-specified pooled analyses.

In addition, the researchers determined that ofatumumab delivered efficacy with a favorable safety profile, according to Novartis.

“It is clear that early initiation of highly effective treatment for MS improves long-term outcomes, and there is great need for potent, safe, and convenient therapy that can be used to treat MS from the start,” professor Stephen L. Hauser, MD, director of the UCSF Weill Institute for Neurosciences, said in a statement. “The results from ASCLEPIOS are wonderful news for patients who would like to take an extremely effective B-cell therapy with low requirement for monitoring, avoiding visits to an infusion center.”

Reference

Novartis Phase III ASCLEPIOS trial demonstrate robust efficacy of ofatumumab in patients with relapsing multiple sclerosis [news release]. Novartis. https://www.novartis.com/news/media-releases/novartis-phase-iii-asclepios-trials-demonstrate-robust-efficacy-ofatumumab-patients-relapsing-multiple-sclerosis. Accessed September 13, 2019.