2023 American Academy of Neurology Abstract Website

Jeffrey Cohen¹, Stephen Hauser², Anne Cross³, Kevin Winthrop⁴, Heinz Wiendl⁵, Jacqueline Nicholas⁶, Sven Meuth⁷, Paul Giacomini⁸, Francesco Sacca⁹, Ronald Zielman¹⁰, Ayan Das Gupta¹¹, Xixi Hu¹², Roseanne Sullivan¹², Virginia DeLasHeras¹³, Ludwig Kappos¹⁴
¹Department of Neurology, Mellen MS Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA, ²UCSF Weill Institute for Neurosciences, University of California, San Francisco, CA, USA, ³Washington University School of Medicine, Saint Louis, MO, USA, ⁴Public Health and Preventive Medicine, Division of Infectious Diseases, Oregon Health and Sciences University, Portland, OR, USA, ⁵University of Muenster, Muenster, Germany, ⁶OhioHealth Multiple Sclerosis Center, Columbus, OH, USA, ⁷Department of Neurology, Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany, ⁸Department of Neurology and Neurosurgery, Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada, ⁹NSRO Department, University “Federico II” of Naples, Naples, Italy, ¹⁰Novartis Pharma B.V., Amsterdam, The Netherlands, ¹¹Novartis Healthcare Pvt. Ltd., Hyderabad, India, ¹²Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, ¹³Novartis Pharma AG, Basel, Switzerland, ¹⁴Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) and MS Center, Departments of Head, Spine and Neuromedicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland

Objective:

To assess the longer-term safety and tolerability of ofatumumab treatment for up to 5 years in people living with relapsing multiple sclerosis (RMS).

Background:

Previously reported safety data from ALITHIOS open-label extension study for up to 4 years demonstrated that extended treatment with ofatumumab continues to show a favorable safety and tolerability profile in RMS participants.

Design/Methods:

Participants completing core ASCLEPIOS I/II, APOLITOS and APLIOS clinical trials may enter ALITHIOS. We previously reported cumulative safety data for up to 4 years of ofatumumab treatment in the overall (N=1969), continuous (ofatumumab in core+extension; N=1292) and newly-switched (teriflunomide in core/ofatumumab in extension; N=677) groups. Safety data for up to 5 years of ofatumumab treatment in the same study population will be presented at the congress. Proportion of participants with treatment-emergent adverse events (AEs), serious AEs (SAEs), injection-related reactions (IRRs), serious infections including opportunistic infections, malignancies, COVID-19 outcomes, serum immunoglobulin (Ig)G and IgM levels and their association with serious infections will be analyzed.

Results:

In the previously reported 4-year safety data (cut-off: 25-Sep-2021), 86.2% had ≥1 AEs (exposure-adjusted incidence rate/100 patient-years [EAIR], 135.1) and 12.3% had ≥1 SAEs (EAIR, 5.0) with low incidence of serious infections (4.0%; EAIR, 1.5) and malignancies (0.9%; EAIR, 0.3). Majority (99.2%) of reported IRRs were mild-to-moderate in severity. Most COVID-19 cases were non-serious (90.2%) and majority (98.4%) were recovered. Mean serum IgG levels remained stable and >LLN (5.65 g/L). Mean serum IgM levels decreased over time but remained >LLN (0.40 g/L). Safety data for up to 5 years will be presented at the congress.

Conclusions:

Previously reported safety findings for up to 4 years showed ofatumumab treatment to be well tolerated with no new safety risks identified. Additional safety data for up to 5 years will help inform physicians on the longer-term safety profile of ofatumumab in people living with RMS.