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Abstract Details

Infection Risk in Patients with Complement-Mediated Neurological Disorders Receiving Eculizumab: Findings from Two Phase 3 Studies and Their Extensions in Aquaporin-4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (AQP4+ NMOSD) and Acetylcholine-Receptor Antibody-Positive Refractory Generalized Myasthenia Gravis (AChR+ gMG)
Autoimmune Neurology
P14 - Poster Session 14 (8:00 AM-9:00 AM)
15-008

To review, in two complement-mediated neurological disorders, the risk of infection in patients treated with eculizumab versus placebo, with or without concomitant immunosuppressant therapy (IST).  

PREVENT (NCT01892345) and REGAIN (NCT01997229) were phase 3, randomized, double-blind studies with open-label extensions (NCT02003144 [interim data] and NCT02301624), comparing the safety and efficacy of eculizumab and placebo in patients with AQP4+ NMOSD and AChR+ gMG, respectively.

Patients were randomized to eculizumab (maintenance dose, 1200 mg/2 weeks) or placebo, with stable-dose concomitant ISTs permitted. We report pooled post hoc infection data from these studies and for subgroups determined by number of ISTs (0, 1, 2 or ≥3 ISTs) used at baseline.

Rates (per 100 patient-years [PY]) and types of infection were similar in eculizumab and placebo groups. In patients with NMOSD, rates/100PY and %(n/N) were: no ISTs, 192.1, 77.1%(27/35) versus 192.2, 61.5%(8/13); 1 IST, 183.6, 72.7%(40/55) versus 154.1, 63.6%(14/22); 2 ISTs, 195.1, 80.9%(38/47) versus 266.7, 83.3%(10/12); no patients used ≥3 ISTs. For patients with gMG: no ISTs, 238.2, 100.0%(2/2) versus 305.6, 50.0%(1/2); 1 IST, 230.6, 82.9%(34/41) versus 253.1, 50.0%(9/18); 2 ISTs, 171.7, 91.0%(71/78) versus 192.5, 58.5%(24/41); ≥3 ISTs, 98.0, 50.0%(1/2) versus 100.1, 50.0%(1/2). For serious infections in the NMOSD and gMG groups and for patients receiving eculizumab versus placebo, respectively: no ISTs, 1.4, 2.9%(1/35) versus 8.0, 7.7%(1/13) and none observed; 1 IST, 13.9, 14.5%(8/55) versus 7.0, 9.1%(2/22) and 16.3, 24.4%(10/41) versus 34.5, 5.6%(1/18); 2 ISTs, 15.1, 27.7%(13/47) versus 47.6, 25.0%(3/12) and 13.4, 21.8%(17/78) versus 24.1, 12.2%(5/41); ≥3 ISTs, for gMG, 14.0, 50.0%(1/2) versus 0.0, 0.0%(0/2).

In these neurologic indications, the overall risk and the types of infections were similar in eculizumab and placebo groups, regardless of concomitant IST use. These findings are consistent with the established safety profile for eculizumab in other indications.
Authors/Disclosures
Todd D. Levine, MD (Honor Health)
PRESENTER 		Dr. Levine has received personal compensation for serving as an employee of CND life sciences . Dr. Levine has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Nufactor. Dr. Levine has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for PNA. Dr. Levine has or had stock in CND Life Sciences.Dr. Levine has or had stock in Corinthian reference lab.
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.
Celia Oreja Guevara Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for sanofi. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for roche. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for merck. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for merck. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for roche. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for sanofi. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for novartis. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for viatris. Celia Oreja Guevara has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for biogen. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for bms. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for jannsen.
No disclosure on file
Roger Kaprielian Roger Kaprielian has nothing to disclose.
No disclosure on file
Marcus Yountz, MD, FÂ鶹´«Ã½Ó³»­ (BlueRock Therapeutics) Dr. Yountz has received personal compensation for serving as an employee of Alexion, AstraZeneca Rare Disease. Dr. Yountz has stock in AstraZeneca.
James F. Howard, Jr., MD, FÂ鶹´«Ã½Ó³»­ (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 Â鶹´«Ã½Ó³»­ 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 Â鶹´«Ã½Ó³»­ interests or activities.