The Efficacy of Crotalidae Polyvalent Immune Fab (Ovine) Antivenom Versus Placebo Plus Optional Rescue Therapy on Recovery From Copperhead Snake Envenomation:

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Presentation transcript:

The Efficacy of Crotalidae Polyvalent Immune Fab (Ovine) Antivenom Versus Placebo Plus Optional Rescue Therapy on Recovery From Copperhead Snake Envenomation: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Charles J. Gerardo, MD, MHS, Eugenia Quackenbush, MD, Brandon Lewis, DO, S. Rutherfoord Rose, PharmD, Spencer Greene, MD, MS, Eric A. Toschlog, MD, Nathan P. Charlton, MD, Michael E. Mullins, MD, Richard Schwartz, MD, David Denning, MD, Kapil Sharma, MD, Kurt Kleinschmidt, MD, Sean P. Bush, MD, Samantha Ryan, BS, Maria Gasior, MD, Victoria E. Anderson, MPH, Eric J. Lavonas, MD Annals of Emergency Medicine Volume 70, Issue 2, Pages 233-244.e3 (August 2017) DOI: 10.1016/j.annemergmed.2017.04.034 Copyright © 2017 American College of Emergency Physicians Terms and Conditions

Figure 1 Patient flow. The unblinded investigational pharmacist at the investigative site accessed the Interactive Response Technology system to receive the treatment arm assignment for the subject. Only the unblinded pharmacy personnel had access to the treatment assignment to facilitate preparation of the study intervention. The subject, the investigator, and investigative site personnel remained blinded to the treatment assignment. Annals of Emergency Medicine 2017 70, 233-244.e3DOI: (10.1016/j.annemergmed.2017.04.034) Copyright © 2017 American College of Emergency Physicians Terms and Conditions

Figure 2 Supportive outcomes: recovery in copperhead envenomation patients treated initially with FabAV or placebo. A, PSFS scores. B, DASH scores. C, LEFS scores. D, Grip strength. E, NPRS scores. F, PROMIS PF-10 scores. G, Time to return to normal function in copperhead envenomation patients treated with FabAV or placebo. Error bars=95% confidence interval for each treatment group. The 95% confidence interval for the difference between treatment groups is analyzed with pooled standard error and is narrower. DASH: A lower score indicated better function; best possible score is 0. LEFS: A higher score indicated better function; best possible score is 80. Grip strength: A value of 0 kg was imputed for subjects unable to perform the test. NPRS: A lower score indicated less pain; range of possible scores is 0 to 10. PROMIS PF-10: A higher score indicated better quality of life; US population mean score is 50. Sample sizes: DASH (B) and grip strength (D): N=17 for the FabAV group and N=12 for placebo; LEFS (C): N=28 for the FabAV group and N=17 for placebo. All other assessments (A, E to G): N=45 for the FabAV group and N=29 for the placebo group. PSFS, Patient-Specific Functional Scale; DASH, Disorders of the Arm, Shoulder, and Hand; LEFS, Lower Extremity Functional Scale; NPRS, numeric pain rating scale. Annals of Emergency Medicine 2017 70, 233-244.e3DOI: (10.1016/j.annemergmed.2017.04.034) Copyright © 2017 American College of Emergency Physicians Terms and Conditions

Figure 2 Supportive outcomes: recovery in copperhead envenomation patients treated initially with FabAV or placebo. A, PSFS scores. B, DASH scores. C, LEFS scores. D, Grip strength. E, NPRS scores. F, PROMIS PF-10 scores. G, Time to return to normal function in copperhead envenomation patients treated with FabAV or placebo. Error bars=95% confidence interval for each treatment group. The 95% confidence interval for the difference between treatment groups is analyzed with pooled standard error and is narrower. DASH: A lower score indicated better function; best possible score is 0. LEFS: A higher score indicated better function; best possible score is 80. Grip strength: A value of 0 kg was imputed for subjects unable to perform the test. NPRS: A lower score indicated less pain; range of possible scores is 0 to 10. PROMIS PF-10: A higher score indicated better quality of life; US population mean score is 50. Sample sizes: DASH (B) and grip strength (D): N=17 for the FabAV group and N=12 for placebo; LEFS (C): N=28 for the FabAV group and N=17 for placebo. All other assessments (A, E to G): N=45 for the FabAV group and N=29 for the placebo group. PSFS, Patient-Specific Functional Scale; DASH, Disorders of the Arm, Shoulder, and Hand; LEFS, Lower Extremity Functional Scale; NPRS, numeric pain rating scale. Annals of Emergency Medicine 2017 70, 233-244.e3DOI: (10.1016/j.annemergmed.2017.04.034) Copyright © 2017 American College of Emergency Physicians Terms and Conditions

Figure 3 Opioid analgesic use in the previous 24 hours in copperhead envenomation patients treated initially with FabAV or placebo. Proportion of subjects who reported using an opioid analgesic (including tramadol) to treat snakebite-related pain in the 24 hours before each assessment. Sample size: FabAV, N=45; placebo, N=29. Annals of Emergency Medicine 2017 70, 233-244.e3DOI: (10.1016/j.annemergmed.2017.04.034) Copyright © 2017 American College of Emergency Physicians Terms and Conditions