A Randomized, Double-Blind, Placebo-Controlled Trial of a Highly Purified Equine F(ab)2 Antibody Black Widow Spider Antivenom

Dart, Richard C.; Bogdan, Gregory M.; Heard, Kennon; Bartelson, Becki Bucher; García-Ubbelohde, Walter; Bush, Sean P.; Arnold, Tom; Clark, Richard; Hendey, Gregory W.; Holstege, Christopher P.; Spradley, Elizabeth A.

doi:10.1016/j.annemergmed.2012.10.008

Cited by 24 publications

(12 citation statements)

References 22 publications

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“…13 A small phase II study of black widow spider antivenom versus placebo found no significant benefit of antivenom over placebo. 12 Taken together, these results suggested that antivenom might be no more effective than placebo and provided sufficient doubt to warrant a placebo-controlled trial.…”

Section: Introductionmentioning

confidence: 86%

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Randomized Controlled Trial of Intravenous Antivenom Versus Placebo for Latrodectism: The Second Redback Antivenom Evaluation (RAVE-II) Study

Isbister¹,

Page²,

Buckley³

et al. 2014

Annals of Emergency Medicine

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1 Randomized controlled trial of intravenous antivenom versus placebofor latrodectism: the second redback antivenom evaluation (RAVE-II) study. AbstractObjective: Latrodectism is the most important spider envenomation syndrome worldwide.There remains considerable controversy over antivenom treatment. We aimed to investigate whether antivenom resulted in resolution of pain and systemic effects in patients with latrodectism given standardized analgesia.Methods: In a multicentre randomized placebo-controlled trial of redback spider antivenom for latrodectism, 224 patients (>7yr) with a redback spider-bite and severe pain with or without systemic effects were randomized to receive normal saline (placebo) or antivenom, after receiving standardized analgesia. The primary outcome was a clinically significant reduction in pain 2 hours after trial medication compared to baseline. A second primary outcome for the subgroup with systemic features of envenomation was resolution of systemic features at 2 hours. Secondary outcomes were improved pain at 4 and 24 hours, resolution of systemic features at 4 hours, administration of opioid analgesics or unblinded antivenom after 2 hours and adverse reactions.Results: Two hours after treatment, 26/112 patients (23%) from the placebo arm had a clinically significant improvement in pain versus 38/112 (34%) from the antivenom arm (difference in favor of antivenom 10.7%;95%CI:−1.1% to +22.6%;p=0.10). Systemic 2 effects resolved after two hours in 9/41 patients (22%) in the placebo arm and 9/35 (26%) in the antivenom arm (difference 3.8%;95%CI:−15% to +23%;p=0.79). There was no significant difference in any secondary outcome between antivenom and placebo. Acute systemic hypersensitivity reactions occurred in 4/112 (3.6%) patients given antivenom.Conclusions: The addition of antivenom to standardized analgesia in patients with latrodectism, did not significantly improve pain or systemic effects.

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Section: Introductionmentioning

confidence: 86%

“…1 Three randomized controlled trials of antivenom for latrodectism have been published. 2,11,12 Two previous trials in Australia both reported no difference between intravenous and intramuscular antivenom. 2,11 These were unexpected outcomes because it 4 was assumed that intravenous antivenom would be more effective.…”

Section: Introductionmentioning

confidence: 99%

Randomized Controlled Trial of Intravenous Antivenom Versus Placebo for Latrodectism: The Second Redback Antivenom Evaluation (RAVE-II) Study

Isbister¹,

Page²,

Buckley³

et al. 2014

Annals of Emergency Medicine

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“…We identified three placebo-controlled randomised trials [52,53,54] and two no-placebo randomised comparator trials [4,27] of antivenom for Latrodectism (Table 3). …”

Section: Clinical Studies Of Antivenom Effectivenessmentioning

confidence: 99%

“…Dart et al (2013) [53] conducted a multi-centre randomised, placebo-controlled clinical trial in patients at least 10 years old with moderate to severe latrodectism following black-widow spider bite. Subjects had to present for treatment within 72-h of symptom onset with a clinical diagnosis of latrodectism made by an investigator and an independent physician.…”

Section: Clinical Studies Of Antivenom Effectivenessmentioning

confidence: 99%

Treatments for Latrodectism—A Systematic Review on Their Clinical Effectiveness

Ryan

Buckley

Graudins

2017

Toxins

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Latrodectism or envenomation by widow-spiders is common and clinically significant worldwide. Alpha-latrotoxin is the mammalian-specific toxin in the venom that results in toxic effects observed in humans. Symptoms may be incapacitating and include severe pain that can persist for days. The management of mild to moderate latrodectism is primarily supportive while severe cases have variously been treated with intravenous calcium, muscle relaxants, widow-spider antivenom and analgesic opioids. The object of this systematic review is to examine the literature on the clinical effectiveness of past and current treatments for latrodectism. MEDLINE, EMBASE and Google Scholar were searched from 1946 to December 2016 to identify clinical studies on the treatment of latrodectism. Studies older than 40 years and not in English were not reviewed. There were only two full-publications and one abstract of placebo-controlled randomised trials on antivenom use for latrodectism. Another two randomised comparative trials compared the route of administration of antivenom for latrodectism. There were fourteen case series (including two abstracts), fourteen case reports and one letter investigating drug treatments for latrodectism with the majority of these also including antivenom for severe latrodectism. Antivenom with opioid analgesia is often the major treatment reported for latrodectism however; recent high quality evidence has cast doubt on the clinical effectiveness of this combination and suggests that other treatments need to be investigated.

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“…9% in 1989) and serum sickness (33%) prior to reducing the speed of administration, which reduced the total adverse event rate to less than 3% [130]. Equine derived F(ab ) 2 black widow antivenins have been developed and are being tested [131]. An Australian study of 95 cases of redback spider antivenin F(ab ) 2 yielded 4 cases of anaphylaxis (4.2%) and a serum sickness rate of 9.3% [132].…”

Section: Efficacy and Safety Of Modern Polyclonal Immunoglobulin Prodmentioning

confidence: 99%

Benefits of using heterologous polyclonal antibodies and potential applications to new and undertreated infectious pathogens

Dixit

Herz²,

Dalton

et al. 2016

Vaccine

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A Randomized, Double-Blind, Placebo-Controlled Trial of a Highly Purified Equine F(ab)2 Antibody Black Widow Spider Antivenom

Cited by 24 publications

References 22 publications

Randomized Controlled Trial of Intravenous Antivenom Versus Placebo for Latrodectism: The Second Redback Antivenom Evaluation (RAVE-II) Study

Randomized Controlled Trial of Intravenous Antivenom Versus Placebo for Latrodectism: The Second Redback Antivenom Evaluation (RAVE-II) Study

Treatments for Latrodectism—A Systematic Review on Their Clinical Effectiveness

Benefits of using heterologous polyclonal antibodies and potential applications to new and undertreated infectious pathogens

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