Michael E Mullins1, Charles J Gerardo1, Sean P Bush1, S Rutherfoord Rose1, Spencer Greene1, Eugenia B Quackenbush1, Brandon Lewis1, Victoria E Anderson1, Kurt C Kleinschmidt1, Richard B Schwarz1, Nathan P Charlton1, Eric A Toschlog1, Kapil Sharma1, David A Denning1, Eric J Lavonas1. 1. From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.
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%) placebopatients (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.
RCT Entities:
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.
Authors: Eric J Lavonas; Randy I Burnham; John Schwarz; Eugenia Quackenbush; Brandon Lewis; S Rutherfoord Rose; Spencer Greene; Eric A Toschlog; Nathan P Charlton; Michael E Mullins; Richard Schwartz; David Denning; Kapil Sharma; Kurt Kleinschmidt; Sean P Bush; Victoria E Anderson; Adit A Ginde; Charles J Gerardo Journal: J Med Toxicol Date: 2019-09-03
Authors: Charles J Gerardo; Elizabeth Silvius; Seth Schobel; John C Eppensteiner; Lauren M McGowan; Eric A Elster; Allan D Kirk; Alexander T Limkakeng Journal: Front Immunol Date: 2021-03-15 Impact factor: 7.561