Anti-adhesion therapies and the rule of 3 for rare events

American Journal of Gastroenterology

Volumn 108, Issue 12, 2013, Pages 1831-1832

  Govani, Shail M ^a   Waljee, Akbar K ^a   Higgins, Peter D R ^a  

^a UNIVERSITY OF MICHIGAN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ETROLIZUMAB; MONOCLONAL ANTIBODY; NATALIZUMAB; PF 00547659; UNCLASSIFIED DRUG; VEDOLIZUMAB;

CLINICAL TRIAL; CROHN DISEASE; DRUG INDUSTRY; ENTERITIS; HUMAN; MORTALITY; NONHUMAN; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; REVIEW; RISK FACTOR;

ANTIBODIES, MONOCLONAL, HUMANIZED; CELL MIGRATION INHIBITION; CROHN DISEASE; HUMANS; LEUKOENCEPHALOPATHY, PROGRESSIVE MULTIFOCAL; RISK ASSESSMENT; RISK FACTORS;

EID: 84889638316     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1038/ajg.2013.141     Document Type: Review

References (13)

1. Tavazzi EE, Ferrante PP, Khalili KK. Progressive multifocal leukoencephalopathy: An unexpected complication of modern therapeutic monoclonal antibody therapies. Clin Microbiol Infect 2011; 17 : 1776-80.
2. Keene DL, Legare C, Taylor E et al. Monoclonal antibodies and progressive multifocal leukoencephalopathy. Can J Neurol Sci 2011; 38 : 565-71.
3. Milch C, Wyant T, Xu J et al. Vedolizumab does not reduce the CD4+: CD8+ ratio in the CSF of healthy volunteers. Inflammatory Bowel Diseases 2011; 17 : S54.
4. Fedyk E, Csizmadia V, Shyu W et al. The gastrointestinal-selective biologic vedolizumab does not impair immune surveillance of the central nervous system in non-human primates. Inflammatory Bowel Diseases 2011; 17 : S4.
5. Miller DH, Khan OA, Sheremata WA et al. A controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2003; 348 : 15-23.
6. Sandborn WJ, Colombel J - F, Enns R et al. Natalizumab induction and maintenance therapy for Crohn's disease. N Engl J Med 2005; 353 : 1912.
7. FDA Drug Safety Communication. New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizmab) [Internet]. fda.gov 2012 [cited 6 March 2013]; Available from: Http://www.fda.gov/Drugs/ DrugSafety/ucm288186.htm.
8. Hanley JA, Lippman-Hand A. If nothing goes wrong, is everything all right JAMA 1983; 249 : 1743-5.
9. Louis TA. Confi dence Intervals for a binomial parameter after observing no successes. Am Stat 1981; 35 : 154.
10. Jovanovic BD, Levy PS. A look at the rule of three. Am Stat 1997; 51 : 137-9.
11. Walsh N. Biologic Works Ulcerative Colitis [Internet], medpagetoday.com 2012; [cited 21 January 2013]; Available from: Http://www.medpagetoday.com/ MeetingCoverage/DDW/32913.
12. Parikh A, Paolino J, Fedyk ER et al. No association between vedolizumab exposure and serum JC virus levels. 6th Congress of European Crohn's and Colitis Organization. 2011.
13. Newman TB. If almost nothing goes wrong, is almost everything all right Interpreting small numerators. JAMA 1995; 274 : 1013.