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Ofatumumab versus Teriflunomide in Multiple Sclerosis
Stephen L Hauser1, Amit Bar-Or1, Jeffrey A Cohen1
1From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).
Ofatumumab significantly reduced relapse rates in multiple sclerosis patients compared to teriflunomide. This subcutaneous anti-CD20 antibody offers a new treatment option for relapsing multiple sclerosis.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system.
- Ofatumumab is a subcutaneous anti-CD20 monoclonal antibody that depletes B cells.
- Teriflunomide is an oral pyrimidine synthesis inhibitor reducing T-cell and B-cell activation.
Purpose of the Study:
- To compare the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis.
- To evaluate the relative effects of these two distinct therapeutic mechanisms on MS disease activity.
Main Methods:
- Two double-blind, double-dummy, phase 3 randomized controlled trials (ASCLEPIOS I and II).
- Patients with relapsing MS received subcutaneous ofatumumab or oral teriflunomide for up to 30 months.
- Primary endpoint: annualized relapse rate. Secondary endpoints included disability progression, MRI lesion activity, and neurofilament light chain levels.
Main Results:
- Ofatumumab demonstrated significantly lower annualized relapse rates compared to teriflunomide in both trials (0.11 vs. 0.22 and 0.10 vs. 0.25).
- Ofatumumab showed a trend towards reduced disability worsening and improved disability (though not statistically significant for improvement).
- MRI outcomes and serum neurofilament light chain levels favored ofatumumab, while brain volume change was similar. Injection-related reactions were more common with ofatumumab.
Conclusions:
- Ofatumumab is associated with significantly lower annualized relapse rates than teriflunomide in patients with relapsing multiple sclerosis.
- Ofatumumab represents a promising therapeutic option for managing relapsing MS, with distinct efficacy and safety profiles compared to teriflunomide.
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