Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Efficacy of Early Ofatumumab vs Late Switch From Teriflunomide: Subgroup Analysis of the ALITHIOS Open-label Extension Study by Previous Disease-Modifying Therapy Exposure and Age
Multiple Sclerosis
P6 - Poster Session 6 (5:30 PM-6:30 PM)
3-016
In ASCLEPIOS I/II (NCT02792218/NCT02792231), OMB (fully human anti-CD20 monoclonal antibody) reduced annualized relapse rate (ARR), MRI lesion activity, and delayed disability worsening vs TER. Patients entering ALITHIOS (NCT03650114) continued OMB or switched from TER to OMB.
To compare clinical and MRI outcomes in patients with relapsing multiple sclerosis initiating ofatumumab (OMB) in the phase 3 ASCLEPIOS I/II study (core) vs switching from teriflunomide (TER) to OMB in ALITHIOS (open-label extension), according to age and number of previous disease-modifying therapies (DMTs).
Cumulative clinical and MRI outcomes (ARR, time to 3- or 6-month confirmed disability worsening [3/6mCDW], number of gadolinium-enhancing [Gd+] T1 lesions, annualized T2 lesion rate) were analyzed in patients who received and continued OMB (OMB-OMB) and patients who switched from TER to OMB (TER-OMB) according to number of previous DMTs (0, 1, 2, >2, any) and age (≤40y, >40y).
946/936 received OMB/TER in the core and 690/677 continued/switched to OMB in the open-label extension. ARR was significantly reduced by 68.3-76.6% in the TER-OMB group and reduced by 39.9-65.1% in the OMB-OMB group in the open-label extension. Lowest mean ARR was achieved in the OMB-OMB group for patients with ≤1 previous DMT (0.046-0.049). Switching to or continuing OMB was associated with a reduced risk of 3/6mCDW, with the greatest benefit observed in OMB-OMB patients with ≤1 DMT or age ≤40y. Near complete suppression of T1 Gd+ activity was observed in the TER-OMB group (90.00-100% across all subgroups) and sustained in the OMB-OMB group. New/enlarging T2 lesions showed a similar, though delayed, suppression in the TER-OMB group. Incidence of adverse events was consistent with ASCLEPIOS I/II.

Switching from TER to OMB reduced clinical and MRI disease activity across all previous DMT and age subgroups, particularly for younger patients and those treated with ≤1 DMT, highlighting the importance of earlier treatment initiation.

Authors/Disclosures
Heinz Wiendl, MD, FAAN (University of Muenster)
PRESENTER
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.
Jeffrey A. Cohen, MD (Cleveland Clinic) Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Convelo. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FiND. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for INMune. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celltrion. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sage.
Ralf Gold, MD (Neurologische Universitaetsklinik) Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Gold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer Vital. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai Pharamaceuticals. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for SAGE Publishers. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Novartis. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Biogen. The institution of Dr. Gold has received research support from Novartis. The institution of Dr. Gold has received research support from Biogen.
Jerome De Seze Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma.
Derrick Robertson, MD Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Greenwich Biosciences. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Janssen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi Genzyme. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mallinckrodt. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Robertson has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Biogen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Robertson has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Genentech. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for PRIME CME. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Janssen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Horizon. Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TG Therapeutics. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for McVeigh. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Mccumber. Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Goodis. The institution of Dr. Robertson has received research support from Biogen. The institution of Dr. Robertson has received research support from EMD Serono. The institution of Dr. Robertson has received research support from Jansenn. The institution of Dr. Robertson has received research support from Genentech. The institution of Dr. Robertson has received research support from Patient-Centered Outcomes Research Institute. The institution of Dr. Robertson has received research support from Novartis. The institution of Dr. Robertson has received research support from Sanofi Genzyme. The institution of Dr. Robertson has received research support from TG Therapeutics. The institution of Dr. Robertson has received research support from Prime. The institution of Dr. Robertson has received research support from Greenwich Biosciences. The institution of Dr. Robertson has received research support from Atara Biotherapeutics. The institution of Dr. Robertson has received research support from CorEvitas. The institution of Dr. Robertson has received research support from Anokion. The institution of Dr. Robertson has received research support from UCB Biosciences. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Consortium of Multiple Sclerosis Centers. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Multiple Sclerosis Association of America.
Sibyl E. Wray, MD (Hope Neurology) Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Wray 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. Wray 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/Celgene. Dr. Wray 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. Wray 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. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Roche/Genentech. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi/Genzyme. The institution of Dr. Wray has received research support from Biogen. The institution of Dr. Wray has received research support from Atara Biotherapeutics. The institution of Dr. Wray has received research support from Bristol Myers Squibb/Celgene. The institution of Dr. Wray has received research support from Novartis. The institution of Dr. Wray has received research support from Roche/Genentech. The institution of Dr. Wray has received research support from Sanofi/Genzyme. The institution of Dr. Wray has received research support from TG Therapeutics. The institution of Dr. Wray has received research support from EMD Serono. The institution of Dr. Wray has received research support from Pharmaceuticals Corp..
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
Amin Azmon No disclosure on file
Miriam King No disclosure on file
No disclosure on file
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.