Efficacy of ANTHRASIL (Anthrax Immune Globulin Intravenous (Human)) in rabbit and nonhuman primate models of inhalational anthrax: Data supporting approval under animal rule.

Article

作者: Meister, Gabriel ; Comer, Jason ; Toth, Derek ; Kammanadiminti, Srinivas ; Kodihalli, Shantha ; Carnelley, Trevor

To meet the requirements of the Animal Rule, the efficacy of monotherapy with ANTHRASIL® (Anthrax Immune Globulin Intravenous (Human)) for inhalational anthrax was evaluated in blinded studies using rabbit and nonhuman primate models. Animals in both studies were randomized to treatment groups exposed to ~ 200 LD50 Bacillus anthracis (Ames strain) spores by the aerosol route to induce inhalational anthrax. Rabbits (N = 50/group) were treated with either 15 U/kg ANTHRASIL or a volume-matching dose of IGIV after disease onset as determined by the detection of bacterial toxin in the blood. At the end of the study, survival rates were 2% (1 of 48) in the IGIV control group, and 26% (13 of 50) in the ANTHRASIL-treated group (p = 0.0009). Similarly, ANTHRASIL was effective in cynomolgus monkeys (N = 16/group) when administered therapeutically after the onset of toxemia, with 6% survival in the IGIV control and a dose-related increase in survival of 36%, 43%, and 70% with 7.5, 15 or 30 U/kg doses of ANTHRASIL, respectively. These studies formed the basis for approval of ANTHRASIL by FDA under the Animal Rule.

2017-12-01·Intensive Care Medicine Experimental

Anthrax immune globulin improves hemodynamics and survival during B. anthracis toxin-induced shock in canines receiving titrated fluid and vasopressor support

Article

作者: Suffredini, Dante A ; Li, Yan ; Solomon, Steven B ; Sun, Junfeng ; Remy, Kenneth E ; Moayeri, Mahtab ; Jaswal, Dharmvir ; Eichacker, Peter Q ; Cui, Xizhong ; Fitz, Yvonne ; Leppla, Stephen

BACKGROUNDAlthough anthrax immune globulin (AIG) improved survival in antibiotic-treated Bacillus anthracis-challenged animal models, whether it adds to the benefit of conventional hemodynamic support for B. anthracis toxin-associated shock is unknown.METHODSWe therefore tested AIG in sedated, mechanically ventilated canines challenged with 24-h B. anthracis lethal and edema toxin infusions and supported for 96 h with a previously demonstrated protective regimen of titrated normal saline and norepinephrine.RESULTSCompared to controls, proportional survival (%) was increased with AIG treatment started 4 h before (33 vs. 100%, n = 6 each) or 2 h (17 vs. 86%, n = 6 and 7 respectively) or 5 h (0 vs. 67%, n = 3 each) after the start of toxin (p ≤ 0.05) and overall [3 survivors of 15 controls (20%) vs. 14 of 16 AIG animals (88%); p = 0.006]. Averaged across treatment times, AIG increased blood pressure at 48 h and decreased norepinephrine requirements at 72 h (p ≤ 0.02), increased left ventricular ejection fraction at 48 and 72 h (p ≤ 0.02), and increased urine output and decreased net fluid balance at 72 and 96 h (p ≤ 0.04). AIG also reduced acidosis and renal and hepatic injury markers between 24 and 96 h.CONCLUSIONSThese findings further support AIG's potential benefit for patients with B. anthracis infection and developing toxin-associated shock.

2017-01-01·Emerging Infectious Diseases2区 · 医学

Analysis of Anthrax Immune Globulin Intravenous with Antimicrobial Treatment in Injection Drug Users, Scotland, 2009–2010

2区 · 医学

ArticleOA

作者: Booth, Malcolm ; McConnell, Paul ; Cui, Xizhong ; Hendricks, Katherine ; Judd, Owen ; Quinn, Conrad P. ; Bower, William A. ; Shadomy, Sean ; Eichacker, Peter Q. ; Boyer, Anne E. ; Bothma, Pieter ; Sun, Junfeng ; Donaldson, Lindsay ; Nolen, Leisha D.

We studied anthrax immune globulin intravenous (AIG-IV) use from a 2009-2010 outbreak of Bacillus anthracis soft tissue infection in injection drug users in Scotland, UK, and we compared findings from 15 AIG-IV recipients with findings from 28 nonrecipients. Death rates did not differ significantly between recipients and nonrecipients (33% vs. 21%). However, whereas only 8 (27%) of 30 patients at low risk for death (admission sequential organ failure assessment score of 0-5) received AIG-IV, 7 (54%) of the 13 patients at high risk for death (sequential organ failure assessment score of 6-11) received treatment. AIG-IV recipients had surgery more often and, among survivors, had longer hospital stays than did nonrecipients. AIG-IV recipients were sicker than nonrecipients. This difference and the small number of higher risk patients confound assessment of AIG-IV effectiveness in this outbreak.

100 项与炭疽人免疫球蛋白（泰邦生物）相关的药物交易

登录后查看更多信息