Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Safety and Clinical Outcomes of an Equine-derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States.
Abstract: Botulism is a rare, life-threatening paralytic illness. Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine) (BAT) manufactured by Emergent BioSolutions Canada Inc is an equine-derived heptavalent botulinum antitoxin product indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A-G in adults and pediatric patients. BAT product was US-licensed in 2013. In the United States, from October 2014 through July 2017, safety and clinical outcomes data were collected under a registry for patients treated with BAT product. Registry patients had a median age of 51 years (range, 32 days to 92 years). Among 162 patients, 7 (4.3%) experienced BAT product-related serious adverse events, including 1 (0.6%) report each of pneumonia, pneumonia aspiration, ventricular tachycardia, upper gastrointestinal hemorrhage, anaphylactic reaction, acute kidney injury, and acute myocardial infarction. Thirty-one (19.1%) patients had 41 BAT product-related adverse events. Six (3.7%) deaths were reported in the registry. All deaths were attributed to the underlying illness and were assessed as unlikely related to BAT product. Among 113 (69.8%) patients with a final diagnosis of botulism, those treated early (≤2 days) spent fewer days in the hospital (5 vs 15.5 days), in the intensive care unit (ICU) (4 vs 12 days), and on mechanical ventilation (6 vs 14.5 days) than those treated late (>2 days), respectively. BAT product was well tolerated in patients. Treatment with BAT product at ≤2 days of symptom onset was associated with shorter hospital and ICU stays, and shorter duration and need for mechanical ventilation, showing clinical benefit associated with early treatment.
© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.
Publication Date: 2019-06-19 PubMed ID: 31209461DOI: 10.1093/cid/ciz515Google Scholar: Lookup
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- Journal Article
- Research Support
- U.S. Gov't
- P.H.S.
Summary
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The research article discusses the safety and treatment outcomes of an antitoxin, specifically developed for botulism, a rare but severe paralytic illness. The product, manufactured by Emergent BioSolutions, has been used on patients in the United States, and the article presents data collected over a span of three years, highlighting the efficacy and adverse reactions to the treatment.
Safety outcomes with the Botulism Antitoxin
- Among 162 patients, 7 or 4.3% experienced serious adverse events related to the Botulism Antitoxin (BAT) product. These adverse events include pneumonia, pneumonia aspiration, ventricular tachycardia, upper gastrointestinal hemorrhage, anaphylactic reaction, acute kidney injury, and acute myocardial infarction.
- Overall, 31 patients (19.1%) had a total of 41 BAT product-related adverse events.
- However, the BAT was generally well tolerated among patients despite these adverse events.
Death incidences and link to the BAT product
- Of the 162 patients, there were 6 reported deaths (3.7%).
- However, it was noted that these deaths were not directly linked to the use of the BAT but were rather attributed to the patients’ underlying illnesses.
Effectiveness of early treatment with the BAT product
- Data showed that patients diagnosed with botulism who received BAT treatment early (within 2 days of symptom onset) experienced shorter hospital stays, shorter durations in the Intensive Care Unit (ICU), and less time on mechanical ventilation.
- Specifically, patients who were treated early spent five days in the hospital compared to 15.5 days for those treated late; four days in the ICU versus 12 days for later treatments, and were on mechanical ventilation for six days versus 14.5 days for later treatments.
- This finding supports the clinical benefits associated with early treatment using the BAT product.
Cite This Article
APA
Richardson JS, Parrera GS, Astacio H, Sahota H, Anderson DM, Hall C, Babinchak T.
(2019).
Safety and Clinical Outcomes of an Equine-derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States.
Clin Infect Dis, 70(9), 1950-1957.
https://doi.org/10.1093/cid/ciz515 Publication
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Researcher Affiliations
- Clinical Research Department, Emergent BioSolutions Canada, Inc., Winnipeg.
- Pharmacovigilance Department, Emergent BioSolutions Canada, Inc., Winnipeg.
- Pharmacovigilance Department, Emergent BioSolutions Canada, Inc., Winnipeg.
- Biostatistics Department, Emergent BioSolutions Canada, Inc., Winnipeg.
- Biostatistics Department, Emergent BioSolutions Canada, Inc., Winnipeg.
- Clinical Research Department, Emergent BioSolutions Canada, Inc., Winnipeg.
- Medical Affairs Department, Emergent BioSolutions, Inc., Gaithersburg, Maryland.
MeSH Terms
- Adult
- Animals
- Botulinum Antitoxin / therapeutic use
- Botulinum Toxins
- Botulism / diagnosis
- Botulism / drug therapy
- Canada
- Child
- Horses
- Humans
- Time Factors
- United States
Citations
This article has been cited 21 times.- Machamer JB, Vazquez-Cintron EJ, Stenslik MJ, Pagarigan KT, Bradford AB, Ondeck CA, McNutt PM. Neuromuscular recovery from botulism involves multiple forms of compensatory plasticity. Front Cell Neurosci 2023;17:1226194.
- Harris RA, Tchao C, Prystajecky N, Weedmark K, Tcholakov Y, Lefebvre M, Austin JW. Foodborne Botulism, Canada, 2006-2021(1). Emerg Infect Dis 2023 Sep;29(9):1730-7.
- Barker D, Han X, Wang E, Dagley A, Anderson DM, Jha A, Weaver SC, Julander J, Nykiforuk C, Kodihalli S. Equine Polyclonal Antibodies Prevent Acute Chikungunya Virus Infection in Mice. Viruses 2023 Jun 29;15(7).
- Shi DY, Lu JS, Mao YY, Liu FJ, Wang R, Du P, Yu S, Yu YZ, Yang ZX. Characterization of a novel tetravalent botulism antitoxin based on receptor-binding domain of BoNTs. Appl Microbiol Biotechnol 2023 May;107(10):3205-3216.
- Peñuelas M, Guerrero-Vadillo M, Valdezate S, Zamora MJ, Leon-Gomez I, Flores-Cuéllar Á, Carrasco G, Díaz-García O, Varela C. Botulism in Spain: Epidemiology and Outcomes of Antitoxin Treatment, 1997-2019. Toxins (Basel) 2022 Dec 20;15(1).
- Ben David A, Barnea A, Torgeman A, Diamant E, Dor E, Schwartz A, Rosen O, Caspi N, Saraf M, Lerer E, Adar Y, Lupo E, Toister E, Zichel R. Immunologic and Protective Properties of Subunit- vs. Whole Toxoid-Derived Anti-Botulinum Equine Antitoxin. Vaccines (Basel) 2022 Sep 14;10(9).
- Patel EN, Lin L, Sneller MM, Eubanks LM, Tepp WH, Pellett S, Janda KD. Investigation of Salicylanilides as Botulinum Toxin Antagonists. ACS Infect Dis 2022 Aug 12;8(8):1637-1645.
- Machamer JB, Vazquez-Cintron EJ, O'Brien SW, Kelly KE, Altvater AC, Pagarigan KT, Dubee PB, Ondeck CA, McNutt PM. Antidotal treatment of botulism in rats by continuous infusion with 3,4-diaminopyridine. Mol Med 2022 Jun 3;28(1):61.
- Beliveau M, Anderson D, Barker D, Kodihalli S, Simard E, Hall C, Richardson JS. Exposure-Response Modeling and Simulation to Support Human Dosing of Botulism Antitoxin Heptavalent Product. Clin Pharmacol Ther 2022 Jul;112(1):171-180.
- Sakari M, Laisi A, Pulliainen AT. Exotoxin-Targeted Drug Modalities as Antibiotic Alternatives. ACS Infect Dis 2022 Mar 11;8(3):433-456.
- Parrera GS, Astacio H, Tunga P, Anderson DM, Hall CL, Richardson JS. Use of Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) (BAT(®)) in Clinical Study Subjects and Patients: A 15-Year Systematic Safety Review. Toxins (Basel) 2021 Dec 27;14(1).
- Tharmalingam T, Han X, Wozniak A, Saward L. Polyclonal hyper immunoglobulin: A proven treatment and prophylaxis platform for passive immunization to address existing and emerging diseases. Hum Vaccin Immunother 2022 Apr 29;18(2):1886560.
- Amezcua M, Cruz RS, Ku A, Moran W, Ortega ME, Salzameda NT. Discovery of Dipeptides as Potent Botulinum Neurotoxin A Light-Chain Inhibitors. ACS Med Chem Lett 2021 Feb 11;12(2):295-301.
- McNutt PM, Vazquez-Cintron EJ, Tenezaca L, Ondeck CA, Kelly KE, Mangkhalakhili M, Machamer JB, Angeles CA, Glotfelty EJ, Cika J, Benjumea CH, Whitfield JT, Band PA, Shoemaker CB, Ichtchenko K. Neuronal delivery of antibodies has therapeutic effects in animal models of botulism. Sci Transl Med 2021 Jan 6;13(575).
- Vazquez-Cintron E, Machamer J, Ondeck C, Pagarigan K, Winner B, Bodner P, Kelly K, Pennington MR, McNutt P. Symptomatic treatment of botulism with a clinically approved small molecule. JCI Insight 2020 Jan 30;5(2).
- Anderson DM, Kumar VR, Arper DL, Kruger E, Bilir SP, Richardson JS. Cost savings associated with timely treatment of botulism with botulism antitoxin heptavalent product. PLoS One 2019;14(11):e0224700.
- Snow DM, Riling K, Kimbler A, Espinoza Y, Wong D, Pham K, Martinez Z, Kraus CN, Conrad F, Garcia-Rodriguez C, Cobb RR, Marks JD, Tomic MT. Safety and Pharmacokinetics of a Four Monoclonal Antibody Combination Against Botulinum C and D Neurotoxins. Antimicrob Agents Chemother 2019 Sep 9;63(12).
- Barker D, Gillum KT, Niemuth NA, Kodihalli S. Therapeutic efficacy of equine botulism heptavalent antitoxin against all seven botulinum neurotoxins in symptomatic guinea pigs. PLoS One 2019;14(9):e0222670.
- O'Brien SW, Gregg BM, Bollapragada A, McNutt PM. Combined treatment with antitoxin and 3,4-diaminopyridine improves survival outcomes after lethal botulinum neurotoxin challenge. Mol Med 2025 Jul 28;31(1):270.
- Prygiel M, Mosiej E, Wdowiak K, Zasada AA. Passive Immunisation in the Treatment of Infectious Diseases Related to Highly Potent Bacterial Toxins. Biomedicines 2024 Dec 23;12(12).
- McClintic WT, Chandler ZD, Karchalla LM, Ondeck CA, O'Brien SW, Campbell CJ, Jacobson AR, McNutt PM. Aminopyridines Restore Ventilation and Reverse Respiratory Acidosis at Late Stages of Botulism in Mice. J Pharmacol Exp Ther 2024 Jan 17;388(2):637-646.
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