Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom vs Placebo in Recovery from Copperhead Snakebite Trial

Michael E. Mullins, Charles J. Gerardo, Sean P. Bush, S. Rutherfoord Rose, Spencer Greene, Eugenia B. Quackenbush, Brandon Lewis, Victoria E. Anderson, Kurt C Kleinschmidt, Richard B. Schwarz, Nathan P. Charlton, Eric A. Toschlog, Kapil Sharma, David A. Denning, Eric J. Lavonas

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Objective To compare the incidence of hypersensitivity reactions following copperhead envenomation treated with Fab antivenom (FabAV) or placebo. Methods Patients with copperhead snakebites received treatment and follow-up in a prospective, randomized, double-blind, placebo-controlled trial of FabAV or placebo. The treatment allocation ratio was 2:1 (FabAV:placebo). All of the included patients received at least one dose of study treatment. We reviewed all treatment-emergent adverse events (AEs) using a previously published scale to classify likely hypersensitivity reactions as mild, moderate, or severe. Results We enrolled 74 patients at 13 sites. Forty-five patients received FabAV, and 29 patients received placebo. Five FabAV patients and 4 placebo patients had moderate envenomations; the rest were mild. Twenty-five FabAV patients and 8 placebo patients had at least 1 AE. Mild skin reactions occurred in 11 (24%) FabAV patients (pruritis, urticaria, rash, ecchymosis, erythema) and 1 (3%) placebo patient (pruritis). Moderate gastrointestinal AEs occurred in 7 (16%) FabAV patients (nausea, vomiting, constipation, diarrhea, oral paresthesia) and in 2 (7%) placebo patients (nausea). Respiratory AEs occurred in 3 (7%) FabAV patients (dyspnea, pulmonary embolism, nasal congestion, sneezing) and no placebo patients. Hypotension occurred in 1 patient in each group. Conclusions In a randomized controlled trial of FabAV for copperhead bites, the incidence of hypersensitivity reactions was low. Most reactions were mild skin reactions.

Original languageEnglish (US)
Pages (from-to)716-720
Number of pages5
JournalSouthern Medical Journal
Volume111
Issue number12
DOIs
StatePublished - Dec 1 2018

Fingerprint

Agkistrodon
Antivenins
Snake Bites
Placebos
Hypersensitivity
Crotalidae Polyvalent immune Fab
Pruritus
Nausea
Ecchymosis
Sneezing
Skin

Keywords

  • Agkistrodon contortrix
  • antivenom
  • copperhead
  • hypersensitivity
  • snakebite

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Mullins, M. E., Gerardo, C. J., Bush, S. P., Rose, S. R., Greene, S., Quackenbush, E. B., ... Lavonas, E. J. (2018). Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom vs Placebo in Recovery from Copperhead Snakebite Trial. Southern Medical Journal, 111(12), 716-720. https://doi.org/10.14423/SMJ.0000000000000902

Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom vs Placebo in Recovery from Copperhead Snakebite Trial. / Mullins, Michael E.; Gerardo, Charles J.; Bush, Sean P.; Rose, S. Rutherfoord; Greene, Spencer; Quackenbush, Eugenia B.; Lewis, Brandon; Anderson, Victoria E.; Kleinschmidt, Kurt C; Schwarz, Richard B.; Charlton, Nathan P.; Toschlog, Eric A.; Sharma, Kapil; Denning, David A.; Lavonas, Eric J.

In: Southern Medical Journal, Vol. 111, No. 12, 01.12.2018, p. 716-720.

Research output: Contribution to journalArticle

Mullins, ME, Gerardo, CJ, Bush, SP, Rose, SR, Greene, S, Quackenbush, EB, Lewis, B, Anderson, VE, Kleinschmidt, KC, Schwarz, RB, Charlton, NP, Toschlog, EA, Sharma, K, Denning, DA & Lavonas, EJ 2018, 'Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom vs Placebo in Recovery from Copperhead Snakebite Trial', Southern Medical Journal, vol. 111, no. 12, pp. 716-720. https://doi.org/10.14423/SMJ.0000000000000902
Mullins, Michael E. ; Gerardo, Charles J. ; Bush, Sean P. ; Rose, S. Rutherfoord ; Greene, Spencer ; Quackenbush, Eugenia B. ; Lewis, Brandon ; Anderson, Victoria E. ; Kleinschmidt, Kurt C ; Schwarz, Richard B. ; Charlton, Nathan P. ; Toschlog, Eric A. ; Sharma, Kapil ; Denning, David A. ; Lavonas, Eric J. / Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom vs Placebo in Recovery from Copperhead Snakebite Trial. In: Southern Medical Journal. 2018 ; Vol. 111, No. 12. pp. 716-720.
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abstract = "Objective To compare the incidence of hypersensitivity reactions following copperhead envenomation treated with Fab antivenom (FabAV) or placebo. Methods Patients with copperhead snakebites received treatment and follow-up in a prospective, randomized, double-blind, placebo-controlled trial of FabAV or placebo. The treatment allocation ratio was 2:1 (FabAV:placebo). All of the included patients received at least one dose of study treatment. We reviewed all treatment-emergent adverse events (AEs) using a previously published scale to classify likely hypersensitivity reactions as mild, moderate, or severe. Results We enrolled 74 patients at 13 sites. Forty-five patients received FabAV, and 29 patients received placebo. Five FabAV patients and 4 placebo patients had moderate envenomations; the rest were mild. Twenty-five FabAV patients and 8 placebo patients had at least 1 AE. Mild skin reactions occurred in 11 (24{\%}) FabAV patients (pruritis, urticaria, rash, ecchymosis, erythema) and 1 (3{\%}) placebo patient (pruritis). Moderate gastrointestinal AEs occurred in 7 (16{\%}) FabAV patients (nausea, vomiting, constipation, diarrhea, oral paresthesia) and in 2 (7{\%}) placebo patients (nausea). Respiratory AEs occurred in 3 (7{\%}) FabAV patients (dyspnea, pulmonary embolism, nasal congestion, sneezing) and no placebo patients. Hypotension occurred in 1 patient in each group. Conclusions In a randomized controlled trial of FabAV for copperhead bites, the incidence of hypersensitivity reactions was low. Most reactions were mild skin reactions.",
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AU - Gerardo, Charles J.

AU - Bush, Sean P.

AU - Rose, S. Rutherfoord

AU - Greene, Spencer

AU - Quackenbush, Eugenia B.

AU - Lewis, Brandon

AU - Anderson, Victoria E.

AU - Kleinschmidt, Kurt C

AU - Schwarz, Richard B.

AU - Charlton, Nathan P.

AU - Toschlog, Eric A.

AU - Sharma, Kapil

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AU - Lavonas, Eric J.

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N2 - Objective To compare the incidence of hypersensitivity reactions following copperhead envenomation treated with Fab antivenom (FabAV) or placebo. Methods Patients with copperhead snakebites received treatment and follow-up in a prospective, randomized, double-blind, placebo-controlled trial of FabAV or placebo. The treatment allocation ratio was 2:1 (FabAV:placebo). All of the included patients received at least one dose of study treatment. We reviewed all treatment-emergent adverse events (AEs) using a previously published scale to classify likely hypersensitivity reactions as mild, moderate, or severe. Results We enrolled 74 patients at 13 sites. Forty-five patients received FabAV, and 29 patients received placebo. Five FabAV patients and 4 placebo patients had moderate envenomations; the rest were mild. Twenty-five FabAV patients and 8 placebo patients had at least 1 AE. Mild skin reactions occurred in 11 (24%) FabAV patients (pruritis, urticaria, rash, ecchymosis, erythema) and 1 (3%) placebo patient (pruritis). Moderate gastrointestinal AEs occurred in 7 (16%) FabAV patients (nausea, vomiting, constipation, diarrhea, oral paresthesia) and in 2 (7%) placebo patients (nausea). Respiratory AEs occurred in 3 (7%) FabAV patients (dyspnea, pulmonary embolism, nasal congestion, sneezing) and no placebo patients. Hypotension occurred in 1 patient in each group. Conclusions In a randomized controlled trial of FabAV for copperhead bites, the incidence of hypersensitivity reactions was low. Most reactions were mild skin reactions.

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