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Abstract Details

Long-term Safety and Efficacy of Nipocalimab: Approximately Two Years Follow-up Results From the Open-label Extension Phase of Vivacity-MG3 Study
Neuromuscular and Clinical Neurophysiology (EMG)
P9 - Poster Session 9 (5:00 PM-6:00 PM)
9-019
To assess the long-term safety and efficacy of nipocalimab in patients with generalized myasthenia gravis (gMG) from the ongoing Vivacity-MG3 (NCT04951622) open-label extension (OLE) phase. 
In patients with gMG, long-term sustained symptom control remains an important treatment goal. In a broad population of autoantibody-positive patients with gMG, nipocalimab (neonatal Fc-receptor blocker), has demonstrated substantial improvement from baseline in MG-Activities of Daily Living (MG-ADL) scores over 24 weeks (W) in double-blind (DB) phase and over 60W of OLE phase of Vivacity-MG3 study. Results with additional follow-up are presented up to Week 96 of OLE of nipocalimab treatment. 
In Vivacity-MG3, adult patients with gMG (Myasthenia Gravis Foundation of America Class II-IV), inadequately controlled (MG-ADL≥6) on standard-of-care (SOC) therapy, were randomized 1:1 to nipocalimab+SOC or placebo+SOC in 24W DB phase, followed by an option to enter the OLE phase. Efficacy and safety were evaluated in seropositive (anti-AChR positive, anti-MuSK positive, and/or anti-LRP4 positive) patients who received ≥1 dose of study treatment.
In the seropositive efficacy analysis set (N=137) during OLE, total duration of treatment (median [range]) for placebo/nipocalimab (n=66) and nipocalimab/nipocalimab (n=71) groups was 69.1W (8–128) and 62.1W (8–128) respectively. The mean (SD) change-from-baseline (CFB) in MG-ADL scores from DB baseline for those who reached 96W of treatment with placebo/nipocalimab and nipocalimab/nipocalimab groups was –6.69 (3.39) and –6.47 (4.62), and CFB in Quantitative Myasthenia Gravis (QMG) scores was –5.81 (4.11) and –5.97 (4.97) respectively. The mean (SD) percent CFB in IgG for placebo/nipocalimab group was –63.24 (14.31) and for nipocalimab/nipocalimab group was –64.06 (12.91). No new safety concerns were reported in OLE phase. 
In autoantibody-positive patients with gMG, long-term treatment with nipocalimab demonstrated sustained disease control through the 24-week phase 3 Vivacity-MG3 study and the 96-week OLE (120 weeks total).
Authors/Disclosures
Constantine Farmakidis, MD, FAAN
PRESENTER 		Dr. Farmakidis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Farmakidis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for J&J. Dr. Farmakidis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Muscular Dystrophy Association.
Carlo Antozzi, MD Dr. antozzi 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. antozzi 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. antozzi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for argenx. Dr. antozzi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Johnson Johnson.
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.
Sindhu Ramchandren No disclosure on file
Richard J. Nowak, MD (Yale University School of Medicine) Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion . Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for argenx. Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Nowak has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunovant . Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cabaletta Bio . Dr. Nowak has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cour Pharma. Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janseen . The institution of Dr. Nowak has received research support from UCB. The institution of Dr. Nowak has received research support from Alexion . The institution of Dr. Nowak has received research support from Janseen. The institution of Dr. Nowak has received research support from Immunovant . The institution of Dr. Nowak has received research support from argenx. The institution of Dr. Nowak has received research support from Amgen. Dr. Nowak has a non-compensated relationship as a Member of the Board of Directors with Myasthenia Gravis Foundation of America (MGFA) that is relevant to AAN interests or activities.
Vera Bril, MD (Toronto General Hospital) Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CSL. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Grifols. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Octapharma. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Powell Mansfield. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Akcea. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ionis. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Momenta (now J&J). Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NovoNordisk. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Dr. Bril 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. Bril 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. Bril has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Akcea. Dr. Bril 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. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alnylam. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CSL. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. The institution of Dr. Bril has received research support from UCB. The institution of Dr. Bril has received research support from Argenx. The institution of Dr. Bril has received research support from Momenta (now J&J). The institution of Dr. Bril has received research support from Immunovant. The institution of Dr. Bril has received research support from Alexion. The institution of Dr. Bril has received research support from Takeda. The institution of Dr. Bril has received research support from Grifols. The institution of Dr. Bril has received research support from CSL. The institution of Dr. Bril has received research support from Octapharma. The institution of Dr. Bril has received research support from Akcea. The institution of Dr. Bril has received research support from Ionis. The institution of Dr. Bril has received research support from Viela Bio (now Horizon). Dr. Bril has received intellectual property interests from a discovery or technology relating to health care.
Jan L. De Bleecker, MD, PhD, FAAN (Neurology/University Hospital) Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ArgNX. Dr. De Bleecker has received personal compensation in the range of $0-$499 for serving as a Consultant for Biogen. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson and Johnson. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. De Bleecker has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for CSL Behring. Dr. De Bleecker has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. De Bleecker has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. De Bleecker has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for CSL Behring. Dr. De Bleecker 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. De Bleecker has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Alnylam. Dr. De Bleecker has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen pharmaceuticals. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amicus. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abcuro.
Huan Yang (Neurology, Xiangya Hospital, Central South University, Changsha, China) No disclosure on file
Eduard Minks (First Department of Neurology, Faculty of Medicine, Masaryk University and St. Anne’s Hospital, Brno, Czech Republic) Eduard Minks has nothing to disclose.
Jin-Sung Park, MD, PhD Prof. Park has nothing to disclose.
Mariusz P. Grudniak, MD, PhD Dr. Grudniak has nothing to disclose.
Marek Smilowski, MD, PhD Dr. Smilowski has nothing to disclose.
Teresa Sevilla Teresa Sevilla has nothing to disclose.
Sarah Hoffmann, MD, PhD Prof. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Prof. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Prof. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Prof. Hoffmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Prof. Hoffmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Argenx. Prof. Hoffmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Prof. Hoffmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Grifols. The institution of Prof. Hoffmann has received research support from Janssen. The institution of Prof. Hoffmann has received research support from Argenx.
Kumaraswamy Sivakumar, MD, MRCP Dr. Sivakumar has nothing to disclose.
Panna Sanga, MBBS Dr. Sanga has received personal compensation for serving as an employee of Johnson & Johnson . Dr. Sanga has stock in Johnson & Johnson .
Ibrahim Turkoz (Janssen R&D) Ibrahim Turkoz has received personal compensation for serving as an employee of Johnson and Johnson. Ibrahim Turkoz has stock in Johnson and Johnson.
Yaowei Zhu, PhD (Janssen Research & Development, LLC) Dr. Zhu has received personal compensation for serving as an employee of Johnson & Johnson.
Marie Fitzgibbon, PhD Dr. Fitzgibbon has stock in Johnson & Johnson.
Michel Burcklen, PhD Mr. Burcklen has received personal compensation for serving as an employee of Johnson & Johnson. Mr. Burcklen has stock in Johnson & Johnson.