Added benefit of raxibacumab to antibiotic treatment of inhalational anthrax

Antimicrobial Agents and Chemotherapy

Volumn 59, Issue 2, 2015, Pages 1145-1151

  Migone, Thi Sau ^a,c   Bolmer, Sally ^a,d   Zhong, John ^a,e   Corey, Al ^a   Vasconcelos, Daphne ^b   Buccellato, Matthew ^b   Meister, Gabriel ^b  

^a GLAXOSMITHKLINE   (United States)

^b BATTELLE MEMORIAL INSTITUTE   (United States)

^c Igenica Inc   (United States)

^d Independent Researcher   (United States)

^e BIOGEN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LEVOFLOXACIN; NEUTRALIZING ANTIBODY; RAXIBACUMAB; TOXIN; ANTIINFECTIVE AGENT; MONOCLONAL ANTIBODY;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANTHRAX; ANTIBIOTIC THERAPY; ANTIBODY TITER; ARTICLE; AUTOPSY; BACILLUS ANTHRACIS; BACTEREMIA; CONTROLLED STUDY; DEATH; DISEASE COURSE; DRUG BLOOD LEVEL; DRUG EFFICACY; DYING; FEMALE; HISTOPATHOLOGY; IMMUNE RESPONSE; IMMUNOGENICITY; MALE; MAXIMUM PLASMA CONCENTRATION; MICROSCOPY; MINIMUM INHIBITORY CONCENTRATION; MINIMUM PLASMA CONCENTRATION; NONHUMAN; PRIORITY JOURNAL; SURVIVAL; SURVIVAL RATE; SURVIVAL TIME; SURVIVOR; TREATMENT DURATION; ANIMAL; RABBIT; RESPIRATORY TRACT INFECTIONS;

ANIMALS; ANTHRAX; ANTI-BACTERIAL AGENTS; ANTIBODIES, MONOCLONAL; FEMALE; LEVOFLOXACIN; MALE; RABBITS; RESPIRATORY TRACT INFECTIONS;

EID: 84921926656     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.04606-14     Document Type: Article

References (22)

1. Holty JE, Bravata DM, Liu H, Olshen RA, McDonald KM, Owens DK. 2006. Systematic review: a century of inhalational anthrax cases from 1900 to 2005. Ann Intern Med 144:270-280. http://dx.doi.org/10.7326/0003 -4819-144-4-200602210-00009.
2. Inglesby TV, O'Toole T, Henderson DA, Bartlett JG, Ascher MS, Eitzen E, Friedlander AM, Gerberding J, Hauer J, Hughes J, McDade J, Osterholmn MT, Parker G, Perl TM, Russell PK, Tonat K. 2002. Anthrax as a biological weapon, 2002: updated recommendations for management. JAMA 287:2236-2252. http://dx.doi.org/10.1001/jama.287 .17.2236.
3. Jernigan DB, Raghunathan PL, Bell BP, Brechner R, Bresnitz EA, Butler JC, Cetron M, Cohen M, Doyle T, Fischer M, Greene C, Griffith KS, Guarner J, Hadler JL, Hayslett JA, Meyer R, Petersen LR, Phillips M, Pinner R, Popovic T, Quinn CP, Reefhuis J, Reissman D, Rosenstein N, Schuchat A, Shieh W-J, Siegal L, Swerdlow DL, Tenover FC, Traeger M, Ward JW, Weisfuse I, Wiersma S, Yewskey K, Zaki S, Ashford DA, Perkins BA, Ostroff S, Hughes J, Fleming D, Koplan JP, Gerberding JL, National Anthrax Epidemiologic Investigation Team. 2002. Investigation of bioterrorism-related anthrax, United States, 2001: epidemiologic findings. Emerg Infect Dis 8:1019-1028. http://dx.doi.org/10.3201/eid 0810.020353.
4. Jernigan JA, Stephens DS, Ashford DA, Omenaca C, Topiel MS, Galbraith M, Tapper M, Fisk TL, Zaki S, Popovic T, Meyer RF, Quinn CP, Harper SA, Fridkin SK, Sejvar JJ, Shepard CW, McConnell M, Guarner J, Shieh, W-J, Malecki JM, Gerberding JL, Hughes JM, Perkins BA, Members of the Anthrax Bioterrorism Investigation Team. 2001. Bio-terrorism-related inhalational anthrax: the first 10 cases reported in the United States. Emerg Infect Dis 7:933-944. http://dx.doi.org/10.3201 /eid0706.010604.
5. Dixon TC, Meselson M, Guillemin J, Hanna PC. 1999. Anthrax. N Engl J Med 341:815-826. http://dx.doi.org/10.1056/NEJM199909093411107.
6. Ascenzi P, Visca P, Ippolito G, Spallarossa A, Bolognesi M, Montecucco C. 2002. Anthrax toxin: a tripartite lethal combination. FEBS Lett 531: 384-388. http://dx.doi.org/10.1016/S0014-5793(02)03609-8.
7. Artenstein AW, Opal SM. 2012. Novel approaches to the treatment of systemic anthrax. Clin Infect Dis 54:1148-1161. http://dx.doi.org/10 .1093/cid/cis017.
8. Subramanian GM, Cronin PW, Poley G, Weinstein A, Stoughton S, Zhong J, Ou Y, Zmuda JF, Osborn BL, Freimuth WW. 2005. A phase 1 study of PAmAb, a fully human monoclonal antibody against Bacillus anthracis protective antigen, in healthy volunteers. Clin Infect Dis 41:12-20. http://dx.doi.org/10.1086/430708.
9. Maynard JA, Maassen CB, Leppla SH, Brasky K, Patterson JL, Iverson BL, Georgiou G. 2002. Protection against anthrax toxin by recombinant antibody fragments correlates with antigen affinity. Nat Biotechnol 20: 597-601. http://dx.doi.org/10.1038/nbt0602-597.
10. Fritz DL, Jaax NK, Lawrence WB, Davis KJ, Pitt ML, Ezzell JW, Friedlander AM. 1995. Pathology of experimental inhalation anthrax in the rhesus monkey. Lab Invest 73:691-702.
11. Twenhafel NA, Leffel E, Pitt ML. 2007. Pathology of inhalational anthrax infection in the African green monkey. Vet Pathol 44:716-721. http://dx .doi.org/10.1354/vp.44-5-716.
12. Vasconcelos D, Barnewall R, Babin M, Hunt R, Estep J, Nielsen C, Carnes R, Carney J. 2003. Pathology of inhalation anthrax in cynomolgus monkeys (Macaca fascicularis). Lab Invest 83:1201-1209. http://dx.doi .org/10.1097/01.LAB.0000080599.43791.01.
13. Zaucha GM, Pitt LM, Estep J, Ivins BE, Friedlander AM. 1998. The pathology of experimental anthrax in rabbits exposed by inhalation and subcutaneous inoculation. Arch Pathol Lab Med 122:982-992.
14. Migone T-S, Subramanian GM, Zhong J, Healey LM, Corey A, Devalaraja M, Lo L, Ullrich S, Zimmerman J, Chen A, Lewis M, Meister G, Gillum K, Sanford D, Mott J, Bolmer S. 2009. Raxibacumab for the treatment of inhalational anthrax. N Engl J Med 361:135-144. http://dx .doi.org/10.1056/NEJMoa0810603.
15. Friedlander AM, Welkos SL, Pitt MLM, Ezzell JW, Worsham PL, Rose KJ, Ivins BE, Lowe JR, Howe GB, Mikesell P, Lawrence WB. 1993. Postexposure prophylaxis against experimental inhalational anthrax. J Infect Dis 167:1239-1243. http://dx.doi.org/10.1093/infdis/167.5.1239.
16. Yee SB, Hatkin JM, Dyer DN, Orr SA, Pitt MLM. 2010. Aerosolized Bacillus anthracis infection in New Zealand white rabbits: natural history and intravenous LVX treatment. Comp Med 60:461-468.
17. Corey A, Migone T-S, Bolmer S, Fiscella M, Ward C, Chen C, Meister G. 2013. Bacillus anthracis protective antigen kinetics in inhalation sporechallenged untreated or levofloxacin/raxibacumab-treated New Zealand white rabbits. Toxins (Basel) 5:120-138. http://dx.doi.org/10.3390/toxins 5010120.
18. Hering D, Thompson W, Hewetson J, Little S, Norris S, Pace-Templeton J. 2004. Validation of the anthrax lethal toxin neutralization assay. Biologicals 32:17-27. http://dx.doi.org/10.1016/j.biologicals.2003 .09.003.
19. Corey AE. 2013. Protective antigen kinetics and raxibacumab pharmacokinetics explain survival in the rabbit model of inhalational anthrax, abstr T3185. Abstr Annu Meet Am Assoc Pharm Scientists.
20. Janssen Pharmaceuticals Inc. August 2013. LevaquinUS label. Janssen Pharmaceuticals Inc, Titusville, NJ. http://www.accessdata.fda.gov/drugsatfda -docs/label/2013/020634s065,020635s071,021721s032lbl.pdf.
21. Davies B, Morris T. 1993. Physiological parameters in laboratory animals and humans. Pharm Res 10:1093-1095. http://dx.doi.org/10.1023/A:101 8943613122.
22. th ed. National Academies Press, Washington, DC.