Long-term Ofatumumab Treatment Over 6 Years Did Not Increase the Risk of Serious Infections
Heinz Wiendl1, Sven Meuth2, Gabriel Pardo3, Scott Zamvil4, lbolya Boer5, Alit Bhatt6, Min Wu7, Xixi Hu7, Valentine Jehl5, Roseanne Sullivan7, Xavier Montalban8, Jeffrey Cohen9
1Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany, 2Department of Neurology, Medical Faculty, Heinrich-Heine-University, Dusseldorf, Germany, 3Oklahoma Medical Research Foundation, OK, USA, 4UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, CA, USA, 5Novartis Pharma AG, Basel, Switzerland, 6Novartis Healthcare Pvt. Ltd., Hyderabad, India, 7Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 8Department of Neurology/Neuroimmunology, Centre d'Esclerosi Multiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona, Spain, 9Department of Neurology, Mellen MS Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA
Objective:
To evaluate the risk of serious infections (SIs) with ofatumumab treatment over a period of 6 years (cutoff date: Sep 25, 2023) in people with relapsing multiple sclerosis (pwRMS).
Background:
Ofatumumab treatment up to 6 years showed a favorable safety and tolerability profile, with no new safety signals identified in pwRMS.
Design/Methods:
Participants who received ≥1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS or ALITHIOS were included. Their data from the first dose were analyzed for SIs by risk categories including upper, lower, and unspecified respiratory tract infections (RTls) (excluding COVID-19), COVID-19, appendicitis, urinary tract infections (UTls), herpes viral infections, and others.
Time-adjacent SIs (concurrent or ≤3 days apart) of the same nature (i.e., same risk category) were counted as a single infection episode. The annualized rate of SIs was estimated by negative binomial regression model, with cumulative infection count per patient in the year as a response variable, year as factor, and time at risk as an offset variable.
Results:
Of 1969 participants in this analysis (cumulative exposure, 8042.7 patient years [PYs]), 115 participants (5.84%) had 130 SIs over 6 years; 103 (5.23%) had 1 SI, and 12 (0.61%) had multiple SIs. Of these 12 participants, 9 (0.46%) had 2 SIs and 3 (0.15%) had 3 SIs. Most common SIs were COVID-19 (n=49; 2.49%), UTI (n=16; 0.81%), lower RTI (n=16; 0.81%), and appendicitis (n=15; 0.76%). The annualized rates (95% Cl) of SIs excluding COVID-19, were low throughout 6 years of treatment (year 1, 0.013 [0.008-0.021]; year 2, 0.010 [0.006-0.017]; year 3, 0.011 [0.006-0.018); year 4, 0.006 [0.003-0.013); year 5, 0.007 [0.003-0.017); and year 6, 0.010 [0.004-0.025]).
Conclusions:
The results show that long-term use of ofatumumab did not increase the risk of SIs over 6 years, supporting the favorable long-term safety profile of ofatumumab in pwRMS.
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