Abstract Details

Title Ravulizumab for the Treatment of Generalized Myasthenia Gravis: Timing of Response

Topic Autoimmune Neurology

Presentation(s) P1 - Poster Session 1 (8:00 AM-9:00 AM)

Poster/Presentation
Number 6-004

Objective To assess the timing of first response to ravulizumab in patients with generalized myasthenia gravis (gMG) in the CHAMPION MG study.

Background

The phase 3 CHAMPION MG study (NCT03920293) demonstrated that ravulizumab is an effective and well-tolerated treatment for anti-acetylcholine receptor antibody-positive (AChR Ab+) gMG. Endpoints for primary data analysis were assessed at Week 26 of the randomized controlled period (RCP); responses at earlier timepoints have not been examined.

Design/Methods Data were included from patients with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score of ≥6 at ravulizumab initiation who received ravulizumab in the RCP or in the open-label extension. Cumulative MG-ADL response rates at various timepoints after ravulizumab initiation were evaluated. Time to first response (improvement in MG-ADL total score ≥3 points) after ravulizumab initiation was also assessed, using the Kaplan–Meier product-limit method.

Results The analysis included 139 patients who were treated with ravulizumab for up to 60 weeks. Cumulative proportions of patients achieving MG-ADL response by Weeks 2, 4, 12, 26, and 60 were 45.3%, 55.4% 66.2%, 75.5%, and 82.0%, respectively. Median (interquartile range) time to first MG-ADL response was 29.0 (170.0) days.

Conclusions

Cumulative response rates indicate that first response was achieved by almost half of patients after one ravulizumab infusion (by Week 2) and by two-thirds of patients by Week 12; however, some patients (15.8%) achieved a first response after longer treatment. Median time to first response to ravulizumab treatment in patients with AChR Ab+ gMG was approximately 4 weeks.

Authors/Disclosures
Ali A. Habib, MD (University of California, Irvine) PRESENTER	Dr. Habib has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Habib has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for argenx. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Habib has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Habib has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech/Roche. Dr. Habib has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NMD Pharma. Dr. Habib has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizon/ Amgen. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Grifols. Dr. Habib has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Kyverna. Dr. Habib has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Jansen/Johnson & Johnson. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMDSerono/Merck. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NIH/NINDS. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunis Biomedical. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hoffman-La Roche. Dr. Habib 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. Habib has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Habib has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for argenx. Dr. Habib has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Jansen/Joohnson & Johnson. The institution of Dr. Habib has received research support from Alexion. The institution of Dr. Habib has received research support from Horizon/Amgen. The institution of Dr. Habib has received research support from Immunovant. The institution of Dr. Habib has received research support from UCB. The institution of Dr. Habib has received research support from argenx. The institution of Dr. Habib has received research support from CabalettaBio. The institution of Dr. Habib has received research support from Regeneron. The institution of Dr. Habib has received research support from Arcellx. The institution of Dr. Habib has received research support from Novartis. The institution of Dr. Habib has received research support from EMDSerono/Merck. The institution of Dr. Habib has received research support from Cour Pharmaceuticals.
Michael G. Benatar, MBChB, DPhil, FAAN (University of Miami)	Dr. Benatar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Benatar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Arrowhead. Dr. Benatar has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Benatar has received personal compensation in the range of $0-$499 for serving as a Consultant for Annexon. Dr. Benatar has received personal compensation in the range of $0-$499 for serving as a Consultant for UniQure. Dr. Benatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Benatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cartesian. Dr. Benatar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizon. Dr. Benatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Benatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Benatar has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for CorEvitas. Dr. Benatar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Canopy. Dr. Benatar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alaunos. Dr. Benatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Prilenia. Dr. Benatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Benatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alector. Dr. Benatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Benatar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Benatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Woolsey. Dr. Benatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Dr. Benatar has received intellectual property interests from a discovery or technology relating to health care.
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 Amgen. Dr. Vu has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NMD Pharma. 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 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 $500-$4,999 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 $50,000-$99,999 for serving on a Speakers Bureau for Alexion. Dr. Vu has received personal compensation in the range of $5,000-$9,999 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.
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.
Shahram Attarian, MD, PhD (CHU La Timone Aix Marseille University)	Prof. Attarian 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, Pfizer LFB, Alnylam Biogen Argenx, UCB Alexion, Astrazenica, Amicus, Janssen, Novartis, Roche. Prof. Attarian has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for SANOFI, Biogen,Alnylam, Argenx, USB, Alexion Astrazenica, Janssen, Roche, Amgen. The institution of Prof. Attarian has received research support from National Institut of Health .
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.
	No disclosure on file
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.
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 argenx . 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 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 $10,000-$49,999 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 $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cartesian 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 NMD Pharma. 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 H. Lundbeck A/S. 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 Seismic Therapeutics. 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 UCB Pharma. 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 Vor Biopharma. 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 $10,000-$49,999 for serving on a Speakers Bureau for MJH LifeSci. Dr. Howard has or had stock in Johnson & Johnson dividends.Dr. Howard has or had stock in Pfizer dividends. An immediate family member of Dr. Howard has or had stock in GlaxoSmithKline dividends.Dr. Howard has or had stock in Bristol Myer Squbb dividends.Dr. Howard has or had stock in AbbieVie Inc. 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 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. The institution of Dr. Howard has received research support from Merck EMD Serono. 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.

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