Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis

• Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis¹
   
• ASCLEPIOS I and II demonstrated significant reductions in risk of relapses, confirmed disability worsening and profound reduction of active or new brain lesions¹
   
• The US Food and Drug Administration and European Medicines Agency are currently reviewing ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults
   
• If approved, ofatumumab will be the first B-cell therapy that can be self-administered at home and has the potential to become a first-choice treatment for use in RMS patients 

The digital press release with multimedia content can be accessed here:

Basel, August 5, 2020 — Novartis today announced that The New England Journal of Medicine (NEJM) published the positive results from the ASCLEPIOS I and II studies evaluating the safety and efficacy of ofatumumab (OMB157) 20 mg monthly subcutaneous injections versus teriflunomide 14 mg oral tablets taken once daily in adults with relapsing forms of multiple sclerosis (RMS). Both studies met the primary endpoints where ofatumumab showed a significant reduction in the number of confirmed relapses, evaluated as the annualized relapse rate (ARR)¹.

“ASCLEPIOS I and II demonstrate the efficacy and safety of ofatumumab and its potential to become a first-choice treatment option that offers RMS patients the flexibility as they continue to live their lives,” said Krishnan Ramanathan, Neuroscience Global Program Head at Novartis. “Ofatumumab is a testament to our commitment to advance science and investigate potential treatments that reimagine care and address significant unmet needs at all parts of the RMS journey.”

Results from the ASCLEPIOS I and II studies showed that compared with teriflunomide, ofatumumab:

• Significantly reduced the ARR by 51% (0.11 vs 0.22) and 58% (0.10 vs 0.25) in ASCLEPIOS I and II, respectively (P<.001 in both studies) (primary endpoints)¹
• Showed a relative risk reduction of 34% (P=.002) in 3-month confirmed disability worsening (CDW) and 32% (P=.01) in 6-month CDW in a pre-specified meta-analysis, as defined in ASCLEPIOS (disability-related secondary endpoints)¹
• Showed significant reduction of both gadolinium enhancing (Gd+) T1 lesions with a 97% and 94% relative reduction in ASCLEPIOS I and II, respectively, (both P<.001), and an 82% and 85% relative reduction in new or enlarging T2 lesions in ASCLEPIOS I and II, respectively (both P<.001) (MRI-related secondary endpoints)¹
• Showed superiority in reducing neuroaxonal damage in both studies, as measured by neurofilament light chain (NfL) serum concentrations (biomarker secondary endpoint)¹; axonal loss, which begins at disease onset, is a detrimental consequence of central nervous system (CNS) inflammation and is a major determinant of irreversible neurological disability in MS patients²
• Demonstrated a favorable trend in rate of 6-month confirmed disability improvement (CDI) events but did not reach significance (disability-related secondary endpoint)¹
• Showed the annual rate of brain volume loss was not significantly different (MRI-related secondary endpoint)¹
• Demonstrated an overall safety profile similar to teriflunomide, the frequency of serious infections and neoplasms was similar across both treatment groups. Injection-related reactions, nasopharyngitis, headache, injection-site reactions, upper respiratory tract infection and urinary tract infection were the most commonly observed adverse events across both treatment groups, occurring in ≥10% of patients^1,3

“The ASCLEPIOS studies found that ofatumumab produced a significant reduction in new inflammation, as well as fewer clinical relapses and progression events,” said Professor Stephen L. Hauser, Director of the UCSF Weill Institute for Neurosciences and co-chair of the steering committee for the ASCLEPIOS I and II studies. “A separate post hoc analysis demonstrated that nearly 9 out of 10 patients experienced no evidence of disease activity in the second year of treatment⁴. Ofatumumab represents a potential new option for RMS patients with greater efficacy compared to teriflunomide, a comparable safety profile, and the convenience of once monthly self-administration without the need for infusions."