Jason S Richardson1, Geraldine S Parrera2, Hugo Astacio2, Harpreet Sahota3, Deborah M Anderson3, Christine Hall1, Tim Babinchak4. 1. Clinical Research Department, Emergent BioSolutions Canada, Inc., Winnipeg. 2. Pharmacovigilance Department, Emergent BioSolutions Canada, Inc., Winnipeg. 3. Biostatistics Department, Emergent BioSolutions Canada, Inc., Winnipeg. 4. Medical Affairs Department, Emergent BioSolutions, Inc., Gaithersburg, Maryland.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Patrick M McNutt; Edwin J Vazquez-Cintron; Luis Tenezaca; Celinia A Ondeck; Kyle E Kelly; Mark Mangkhalakhili; James B Machamer; Christopher A Angeles; Elliot J Glotfelty; Jaclyn Cika; Cesar H Benjumea; Justin T Whitfield; Philip A Band; Charles B Shoemaker; Konstantin Ichtchenko Journal: Sci Transl Med Date: 2021-01-06 Impact factor: 17.956
Authors: James B Machamer; Edwin J Vazquez-Cintron; Sean W O'Brien; Kyle E Kelly; Amber C Altvater; Kathleen T Pagarigan; Parker B Dubee; Celinia A Ondeck; Patrick M McNutt Journal: Mol Med Date: 2022-06-03 Impact factor: 6.376
Authors: Martin Amezcua; Ricardo S Cruz; Alex Ku; Wilfred Moran; Marcos E Ortega; Nicholas T Salzameda Journal: ACS Med Chem Lett Date: 2021-01-27 Impact factor: 4.345
Authors: Deborah M Anderson; Veena R Kumar; Diana L Arper; Eliza Kruger; S Pinar Bilir; Jason S Richardson Journal: PLoS One Date: 2019-11-07 Impact factor: 3.240
Authors: Doris M Snow; Kathryn Riling; Angie Kimbler; Yero Espinoza; David Wong; Khanh Pham; Zachary Martinez; Carl N Kraus; Fraser Conrad; Consuelo Garcia-Rodriguez; Ronald R Cobb; James D Marks; Milan T Tomic Journal: Antimicrob Agents Chemother Date: 2019-10-07 Impact factor: 5.191
Authors: Geraldine S Parrera; Hugo Astacio; Priya Tunga; Deborah M Anderson; Christine L Hall; Jason S Richardson Journal: Toxins (Basel) Date: 2021-12-27 Impact factor: 4.546