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Abstract Details

Long-term Efficacy and Safety of Ravulizumab, a Long-acting Terminal Complement Inhibitor, in Adults with Anti-Acetylcholine Receptor Antibody-Positive Generalized Myasthenia Gravis: Results from the Phase 3 CHAMPION MG Open-label Extension
Autoimmune Neurology
S25 - Autoimmune Neurology 2: Clinical Trials and Treatment (4:18 PM-4:30 PM)
005
To evaluate the long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive (AChR Ab+) generalized myasthenia gravis (gMG).
The long half-life of the terminal complement C5 inhibitor ravulizumab allows maintenance dosing every 8 weeks. The 26-week, double-blind, randomized, placebo-controlled phase (RCP) of the CHAMPION MG study demonstrated ravulizumab’s efficacy and favorable safety profile in patients with AChR Ab+ gMG. Patients who completed the RCP could receive ravulizumab in the ongoing open-label extension (OLE; NCT03920293).

In the OLE, patients receive intravenous ravulizumab (blind induction or bridging dose for those previously receiving placebo or ravulizumab, respectively, then 3000–3600 mg according to body weight every 8 weeks) for up to 4 years. Assessments include Myasthenia Gravis-Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) total scores and safety evaluations.

This interim analysis included data for 79 patients (38 received ravulizumab, 41 received placebo in the RCP) who entered the OLE at least 26 weeks before data cut-off. Improvements in MG-ADL score achieved by ravulizumab-treated patients in the RCP were maintained: least squares (LS) mean change from RCP baseline at Week 52 of -4.2 (95% confidence interval [CI] -5.7, -2.7; p<0.0001). Patients who switched from placebo in the RCP to ravulizumab in the OLE showed rapid improvement in MG-ADL score, which was maintained through 26 weeks (LS mean change from OLE baseline at Week 26 of the OLE: -2.4, 95% CI -3.8, -0.9; p<0.01). Improvements in QMG score were maintained in patients continuing ravulizumab in the OLE and scores improved from OLE baseline in patients switching to ravulizumab. Ravulizumab was well tolerated; no cases of meningococcal infection were reported.

Ravulizumab, administered every 8 weeks, demonstrated sustained improvements in symptoms and was well tolerated for up to 1 year in adults with AChR Ab+ gMG.

Authors/Disclosures
James F. Howard, Jr., MD, FAAN (The University of North Carolina, Dept of Neurology, CB 7025)
PRESENTER
Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for arenx . Dr. Howard has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Regeneron Pharmaceuticals. Dr. Howard 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 Pharmaceuticals. Dr. Howard has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AMGEN (Horizon Therapeutics). Dr. Howard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi US. Dr. Howard 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. Howard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven Ltd. Dr. Howard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CorEvitas. Dr. Howard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck EMD Serono. Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Academic CME. Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for PeerView CME. Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Platform Q CME. Dr. Howard has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Zai Laboratories. Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Medscape CME. Dr. Howard has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for MJH LifeSci. Dr. Howard has stock in General Electric dividends. Dr. Howard has stock in Johnson & Johnson dividends. Dr. Howard has stock in Pfizer dividends. An immediate family member of Dr. Howard has stock in GlaxoSmithKline dividends. An immediate family member of Dr. Howard has stock in GE Healthcare dividends. Dr. Howard has stock in Viatris. The institution of Dr. Howard has received research support from Alexion Pharmaceuticals. The institution of Dr. Howard has received research support from argenx . The institution of Dr. Howard has received research support from UCB Biosciences. The institution of Dr. Howard has received research support from NIH. The institution of Dr. Howard has received research support from Centers for Disease Control/Research Triangle Institute. The institution of Dr. Howard has received research support from Duke University (DCRI). The institution of Dr. Howard has received research support from Cartestian Therapeutics. The institution of Dr. Howard has received research support from NMD Pharma. The institution of Dr. Howard has received research support from Ad Scientiam. Dr. Howard has a non-compensated relationship as a Scientific Advisiory Board member, Committee member with Myasthenia Gravis Foundation of America that is relevant to AAN interests or activities. Dr. Howard has a non-compensated relationship as a Committee member with American Assoc Neuromuscular and Electrodiagnostic Medicine that is relevant to AAN interests or activities.
Tuan H. Vu, MD (University of South Florida) Dr. Vu has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Dianthus. Dr. Vu has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ImmunAbs. Dr. Vu 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. Vu 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. Vu has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Vu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen (Horizon). Dr. Vu has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Johnson & Johnson. Dr. Vu has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Vu has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for CSL Behring. Dr. Vu has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Argenx. The institution of Dr. Vu has received research support from CSL Behring. The institution of Dr. Vu has received research support from Alexion. The institution of Dr. Vu has received research support from RA Pharma/UCB. The institution of Dr. Vu has received research support from Mass Gen Hospital/Healy Platform Study. The institution of Dr. Vu has received research support from ARGENX. The institution of Dr. Vu has received research support from Horizon/Amgen. The institution of Dr. Vu has received research support from Woolsey Pharma. The institution of Dr. Vu has received research support from CSL Behring. The institution of Dr. Vu has received research support from Cartesian Therapeutics. The institution of Dr. Vu has received research support from Janssen/Johnson & Johnson. The institution of Dr. Vu has received research support from Immunovant. The institution of Dr. Vu has received research support from Regeneron. The institution of Dr. Vu has received research support from Dianthus. The institution of Dr. Vu has received research support from COUR.
Renato Mantegazza, MD Dr. Mantegazza has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Mantegazza has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Mantegazza has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for argenx. Dr. Mantegazza has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Mantegazza has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for SERB. The institution of Dr. Mantegazza has received research support from Alpine Immune Sciences, Inc.
No disclosure on file
Masahisa Katsuno (Nagoya University) Masahisa Katsuno has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Chugai. Masahisa Katsuno has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Masahisa Katsuno has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sumitomo Pharma. Masahisa Katsuno has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Takeda. Masahisa Katsuno has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Viatris. The institution of Masahisa Katsuno has received research support from Sumitomo Pharma. The institution of Masahisa Katsuno has received research support from Nihon Mediphysics.
Rasha Aguzzi (Alexion) No disclosure on file
Nishi Rampal, MD (Yale University) Dr. Rampal has received personal compensation for serving as an employee of Amgen. Dr. Rampal has received personal compensation for serving as an employee of Horizon Therapeutics. Dr. Rampal has stock in Amgen. Dr. Rampal has stock in Horizon Therapeutics.
Andreas Meisel (Charité Universitätsmedizin Berlin) Andreas Meisel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Andreas Meisel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for argenx. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Adivo. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Andreas Meisel has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for argenx. The institution of Andreas Meisel has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Andreas Meisel has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Andreas Meisel has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for argenx. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Pfizer/BMS. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Boehringer. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Axunio. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Desitin. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genpharm. The institution of Andreas Meisel has received research support from Alexion. The institution of Andreas Meisel has received research support from argenx. The institution of Andreas Meisel has received research support from Octapharma. The institution of Andreas Meisel has received research support from Deutsche Myasthenie Gesellschaft. The institution of Andreas Meisel has received research support from Deutsche Forschungsgemeinschaft . The institution of Andreas Meisel has received research support from Bundesministerium für Wissenschaft und Forschung. The institution of Andreas Meisel has received research support from Leducq Foundation. The institution of Andreas Meisel has received research support from Einstein Stiftung Berlin. Andreas Meisel has received publishing royalties from a publication relating to health care. Andreas Meisel has received publishing royalties from a publication relating to health care. Andreas Meisel has a non-compensated relationship as a Chairman, Medical Advisory Board with Deutsche Myasthenie Gesellschaft that is relevant to AAN interests or activities. Andreas Meisel has a non-compensated relationship as a Chairman with Berliner Schlaganfall Gesellschaft that is relevant to AAN interests or activities.