Abstract Details

Title Long-term Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis

Topic Multiple Sclerosis

Presentation(s) S14 - MS Therapeutics (4:06 PM-4:18 PM)

Poster/Presentation
Number 004

Background

Ofatumumab, a fully-human anti-CD20 monoclonal antibody with a 20 mg subcutaneous monthly dosing regimen, is approved for treating RMS in adults. Previously published data demonstrated that ofatumumab treatment up to 30 months had a favorable safety profile and was generally well-tolerated. Longer-term safety of ofatumumab in RMS patients continues to be monitored.

Objective

To assess the long-term safety and tolerability of ofatumumab treatment in patients with relapsing multiple sclerosis (RMS).

Design/Methods

Patients completing the core ASCLEPIOS I/II, APOLITOS and APLIOS clinical trials could enter ALITHIOS, an ongoing, open-label, umbrella extension trial. Here, we analyze the cumulative data for up to 4 years of ofatumumab treatment (data cutoff: 25-Sep-2021) in the overall (N=1969), continuous (ofatumumab in core+extension; N=1292) and newly-switched (teriflunomide core and ofatumumab extension; N=677) groups. The proportion of patients with treatment-emergent adverse events (AEs), serious AEs, serious infections including opportunistic infections, and malignancies will be assessed. Laboratory parameters including neutrophils, lymphocytes, and serum immunoglobulin (Ig) G and IgM levels will be analyzed.

Results

In data reported from ALITHIOS with a cut-off of 29-Jan-2021, representing ofatumumab treatment for up to ~3.5 years, 83.8% of patients had ≥1 AEs (exposure-adjusted incidence rate [EAIR], 148.7) and 9.7% had ≥1 serious AEs (EAIR, 4.8) with a low incidence of serious infections (2.9%; EAIR, 1.4) and malignancies (0.6%; EAIR, 0.3). Updated safety data representing continuous ofatumumab treatment for up to 4 years will be presented, focusing on the incidence of serious infections including opportunistic infections, incidence of malignancies, and deaths. The long-term trend of IgG/IgM levels and their association with serious infections will also be investigated.

Conclusions

Safety findings for up to 3.5 years showed ofatumumab treatment to be well-tolerated with no new safety risks identified. This additional safety data will help confirm ofatumumab’s longer-term safety profile and provide further confidence to the MS community.

Authors/Disclosures
Stephen L. Hauser, MD (UCSF Weill Institute for Neurosciences) PRESENTER	Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NGM Bio. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BD. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pheno Therapeutics. Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Accure. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alector. Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Annexon. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Neurona. Dr. Hauser has a non-compensated relationship as a Clinical Trial/Primary Investigator with Roche that is relevant to AAN interests or activities. Dr. Hauser has a non-compensated relationship as a Clinical Trial/Primary Investigator with Novartis that is relevant to AAN interests or activities.
Anne H. Cross, MD, FAAN (Washington University School of Medicine)	Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech / F. Hoffman la Roche. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizon Pharmaceuticals. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen . Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb . Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Octave. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as an officer or member of the Board of Directors for Consortium of MS Centers. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN. The institution of Dr. Cross has received research support from Genentech. Dr. Cross has received intellectual property interests from a discovery or technology relating to health care.
Kevin Winthrop	No disclosure on file
Heinz Wiendl, MD, FAAN (University of Muenster)	Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Johnson&Johnson / Janssen. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Idorsia. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NexGen. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Worldwide Clinical Trials. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BD. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gossamer Bio. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for LTS. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sangamo. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz-Hexal. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cellerys. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dianthus. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Toleranzia. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Uniqure. The institution of Dr. Wiendl has received research support from Biogen. The institution of Dr. Wiendl has received research support from Roche. The institution of Dr. Wiendl has received research support from Deutsche Forschungsgemeinschaft. The institution of Dr. Wiendl has received research support from European Union. The institution of Dr. Wiendl has received research support from Argenx. The institution of Dr. Wiendl has received research support from CSL Behring. The institution of Dr. Wiendl has received research support from Merck. The institution of Dr. Wiendl has received research support from UCB. Dr. Wiendl has received publishing royalties from a publication relating to health care. Dr. Wiendl has received publishing royalties from a publication relating to health care.
Jacqueline A. Nicholas, MD (OhioHealth Riverside Methodist Hospital)	Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squib. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Greenwich Biosciences. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Vielo Bio. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Nicholas has received research support from Novartis. The institution of Dr. Nicholas has received research support from Biogen. The institution of Dr. Nicholas has received research support from Genentech. The institution of Dr. Nicholas has received research support from PCORI. Dr. Nicholas has a non-compensated relationship as a Physician with National MS Society that is relevant to AAN interests or activities. Dr. Nicholas has a non-compensated relationship as a Physician with Siegal Rare Neuroimmune Association that is relevant to AAN interests or activities.
Sven G. Meuth (Uniklinik Düsseldorf, Klinik für Neurologie)	Sven G. Meuth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck. Sven G. Meuth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Almirall. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TEVA. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche.
Paul S. Giacomini, MD (Montreal Neurological Institute)	Dr. Giacomini has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Innodem Neurosciences. Dr. Giacomini has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Giacomini has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for F. Hoffmann- La Roche. Dr. Giacomini has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Giacomini has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Giacomini has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Giacomini has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Giacomini has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for F. Hoffmann-La Roche. Dr. Giacomini has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Giacomini has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Giacomini has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Giacomini has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for F. Hoffman-La Roche. Dr. Giacomini has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Giacomini has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. Dr. Giacomini has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi.
Francesco Sacca, MD (University Federico II)	Dr. Sacca has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Sacca has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lexeo. Dr. Sacca has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genpharm. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medpharma. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Madison Pharma. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zai Lab. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dianthus. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Reata. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. The institution of Dr. Sacca has received research support from AIFA. The institution of Dr. Sacca has received research support from FARA.
Ronald Zielman (Novartis)	No disclosure on file
Ayan Das Gupta (Novartis Healthcare)	Ayan Das Gupta has received personal compensation for serving as an employee of Novartis Health Care Pvt. Ltd.
Xixi Hu	No disclosure on file
	No disclosure on file
Roseanne Sullivan (novartis)	Roseanne Sullivan has received personal compensation for serving as an employee of Novartis Pharmaceuticals. Roseanne Sullivan has stock in Novartis Pharmaceuticals.
Virginia DeLasHeras	Virginia DeLasHeras has received personal compensation for serving as an employee of NOVARTIS.
Wendy Su	Prof. Su has received personal compensation for serving as an employee of Novartis. Prof. Su has received stock or an ownership interest from Novartis.
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	The institution of Dr. Kappos has received research support from Bayer. The institution of Dr. Kappos has received research support from Biogen. The institution of Dr. Kappos has received research support from Genentech. The institution of Dr. Kappos has received research support from Genzyme. The institution of Dr. Kappos has received research support from Janssen. The institution of Dr. Kappos has received research support from Merck Serono. The institution of Dr. Kappos has received research support from Minoryx. The institution of Dr. Kappos has received research support from Novartis. The institution of Dr. Kappos has received research support from Roche. The institution of Dr. Kappos has received research support from Sanofi. The institution of Dr. Kappos has received research support from Santhera. The institution of Dr. Kappos has received research support from Swiss MS Society, Swiss National Research Foundation, European Union, Roche Research Foundation, Innosuisse. The institution of Dr. Kappos has received research support from Shionogi. The institution of Dr. Kappos has received research support from Japan Tobacco. The institution of Dr. Kappos has received research support from Auriga Vision AG. The institution of Dr. Kappos has received research support from EMD Serono. The institution of Dr. Kappos has received research support from Glaxo Smith Kline. The institution of Dr. Kappos has received research support from Wellmera AG. The institution of Dr. Kappos has received research support from Eli Lilly (Suisse) SA. The institution of Dr. Kappos has received research support from Bristol Myers Squibb. The institution of Dr. Kappos has received research support from Celltrion Inc. Dr. Kappos has received intellectual property interests from a discovery or technology relating to health care.