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Abstract Details

Achievement of Improved Post-Intervention Status in Patients with Generalized Myasthenia Gravis Treated with Ravulizumab during the CHAMPION MG Study
Autoimmune Neurology
S5 - Autoimmune Neurology: NMOSD and MG, a Focus on Treatment Trials (2:24 PM-2:36 PM)
008
To determine whether ravulizumab treatment enables patients with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis (AChR Ab+ gMG) to achieve the Myasthenia Gravis Foundation of America Post-Intervention Status (MGFA-PIS) of “improved”, with or without achieving minimal manifestation status (MMS).

The 26-week, phase 3, randomized, double-blind, placebo-controlled CHAMPION MG study demonstrated the efficacy and safety of ravulizumab in patients with AChR Ab+ gMG. Patients who completed the randomized controlled period (RCP) could receive ravulizumab in an open-label extension (OLE); blinding to original treatment was maintained.
In a prespecified exploratory analysis, modified MGFA-PIS (improved and achieved MMS, improved without MMS, unchanged, worsened) was assessed at Week 26 (patients who completed the RCP with Week 26 MGFA-PIS data) and Week 60 (patients who received ≥1 ravulizumab dose during the OLE with Week 60 MGFA-PIS data) relative to RCP baseline. A proportional-odds cumulative logit model (cumulated across categories starting from best outcome) was used to analyze outcomes at Week 26, with treatment as a fixed categorical effect and adjusting for geographic region (estimated odds ratio [OR] >1 indicates beneficial treatment effect).
At Week 26, improved status with and without MMS, respectively, was achieved by 25.6% (20/78) and 21.8% (17/78) of ravulizumab-treated patients, and by 9.9% (8/81) and 22.2% (18/81) of patients who received placebo (adjusted OR: 2.236, 95% confidence interval: 1.210, 4.130; p=0.01). At Week 60, improved status, with/without MMS, was achieved by 33.9% (19/56)/32.1% (18/56) of patients who continued ravulizumab treatment and 31.6% (18/57)/42.1% (24/57) of patients who switched from placebo to ravulizumab.
Ravulizumab-treated patients were more likely than those receiving placebo to achieve MGFA-PIS of improved, with or without MMS. The increase in the proportion of patients achieving MGFA-PIS of improved, with or without MMS, with continued treatment, suggests that longer-term treatment may be needed for some patients to achieve this status. 
Authors/Disclosures
Srikanth Muppidi, MD, FAAN
PRESENTER 		Dr. muppidi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. muppidi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for argenx. Dr. muppidi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB/Ra Pharma. Dr. muppidi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizont Pharma. Dr. muppidi has received publishing royalties from a publication relating to health care.
Pushpa Narayanaswami, MD, MBBS, FAAN (Beth Israel Deaconess Medical Center) Dr. Narayanaswami has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB. Dr. Narayanaswami has received personal compensation in the range of $0-$499 for serving as a Consultant for CVS. Dr. Narayanaswami 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. Narayanaswami has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Narayanaswami has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx USA. Dr. Narayanaswami 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. Narayanaswami has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Dr. Narayanaswami has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for NMD pharma. Dr. Narayanaswami has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD-Serono (Merck usa). Dr. Narayanaswami has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Immuneabs. Dr. Narayanaswami has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Viridian. Dr. Narayanaswami has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cabaletta-Bio. Dr. Narayanaswami has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunovant. Dr. Narayanaswami 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. Dr. Narayanaswami 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. Narayanaswami has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Muscle and Nerve, Wiley. Dr. Narayanaswami 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 Neurology. Dr. Narayanaswami has stock in Dr. Reddys laboratories. Dr. Narayanaswami has stock in Doximity. The institution of Dr. Narayanaswami has received research support from Alexion. The institution of Dr. Narayanaswami has received research support from NIH. Dr. Narayanaswami has received publishing royalties from a publication relating to health care. Dr. Narayanaswami has a non-compensated relationship as a Member, Medical and Scientific Council with Myasthenia Gravis Foundation of America that is relevant to AAN interests or activities. Dr. Narayanaswami has a non-compensated relationship as a Member, Finance Committee with AANEM that is relevant to AAN interests or activities.
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.
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.
Kimiaki Utsugisawa, MD, PhD (Hanamaki General Hospital) Dr. Utsugisawa 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. Utsugisawa 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 pharma. Dr. Utsugisawa has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen pharma. Dr. Utsugisawa has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Viela Bio. Dr. Utsugisawa has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Chugai. Dr. Utsugisawa has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mitsubisi Tanabe pharma. Dr. Utsugisawa has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Utsugisawa has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for argenx. Dr. Utsugisawa has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion phama. Dr. Utsugisawa has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Japan Blood Products Organization. Dr. Utsugisawa has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB.
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.
Kathleen Beasley, PharmD (Alexion Pharmaceuticals) Dr. Beasley has received personal compensation for serving as an employee of Alexion, AstraZeneca Rare Disease. Dr. Beasley has received stock or an ownership interest from Alexion, AstraZeneca Rare Disease.
No disclosure on file
James F. Howard, Jr., MD, FAAN (The University of North Carolina, Dept of Neurology, CB 7025) 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.