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• W3096780775 abstract "Fab antivenom (FabAV) halts progression of venom-induced tissue injury and improves recovery in copperhead snakebite. It is unknown if F(ab’)2 does as well. A prior study comparing F(ab’)2AV with FabAV included copperhead snakebite patients and made assessments of the initial and maintenance control of the envenomation syndrome. In copperhead snakebite, these assessments primarily evaluate the control of tissue injury. The objective of this study is to compare control of tissue injury in copperhead snakebite patients treated with F(ab’)2 versus Fab antivenom. We performed a post hoc analysis of the copperhead envenomated patients in a prospective, multicenter, blinded, randomized, controlled trial (RCT) comparing F(ab’)2AV to FabAV approved by the Institutional Review Board at each site and registered at ClinicalTrials.gov, #00636116. In this analysis, only patients with copperhead snakebite as determined by the investigator and with clinical signs of envenomation were evaluated. Patients were randomized to one of three arms with the initial control and maintenance study drugs as follows: 1) F(ab’)2/placebo 2) F(ab’)2/F(ab’)2 3) Fab/Fab. The primary outcome of this analysis is the number of repeat doses required to obtain initial control. Additional outcomes include the time from antivenom administration to initial control and the number of patients requiring additional doses after maintenance. Control of the envenomation syndrome was evaluated after start of antivenom, after each dose, and on days 5, 8, and 15. We performed a non-inferiority analysis of the combined F(ab’)2AV group with the FabAV group assuming a meaningful difference in the proportion of patients receiving repeat initial control doses or unscheduled post maintenance doses of 20%, and a meaningful difference in time to initial control of >1 hr. Of the 121 enrolled patients in the original trial, 21 (13 F(ab’)2AV, 8 FabAV) had definitive copperhead envenomation. Mean age was 43.9 (SD 21.4) years with a male predominance of 86%. Baseline snakebite severity score and time to antivenom were similar between F(ab’)2AV and FabAV groups. One (8%) F(ab’)2AV and 2 (25%) FabAV patients required repeat initial dosing, difference = 17%, 95% CI (-18, 57). One (8%) F(ab’)2AV and 1(13%) FabAV patients required additional doses after maintenance, difference = 5% ,95% CI (-27, 45). Median time to initial control was 2.7 IQR (2.0, 9.3) hours and 3.5 IQR (2.0, 7.4) for F(ab’)2AV and FabAV respectively, difference - 0.7 hours, 95% CI (-0.9, 2.6). Repeat initial dosing and time to initial control met the post hoc non-inferiority assumptions, whereas additional doses after maintenance did not. See figure. A rigorous RCT comparing F(ab’)2 and Fab antivenom was performed and included a small subgroup of copperhead snakebite patients. A meaningful difference was determined in a post hoc manner and this exploratory analysis indicated that the available measures of the control of tissue injury were not statistically different between the two groups. Further work is required to verify these findings." @default.
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• W3096780775 date "2020-10-01" @default.
• W3096780775 modified "2023-10-18" @default.
• W3096780775 title "72 Post Hoc Analysis of the RCT Comparing F(ab’)2to Fab Antivenom: Control of Venom-induced Tissue Injury in Copperhead Snakebite Patients" @default.
• W3096780775 doi "https://doi.org/10.1016/j.annemergmed.2020.09.082" @default.
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