Clinical trial: The safety and short-term efficacy of recombinant cholera toxin B subunit in the treatment of active Crohn's disease

Alimentary Pharmacology and Therapeutics

Volumn 31, Issue 3, 2010, Pages 387-395

  Stal P ^a   Befrits, R ^a   ROnnblom A ^b   Danielsson, A ^c   Suhr, O ^c   Stahlberg D ^d   Brinkberg Lapidus, A ^a   LOfberg R ^a  

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^b UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^c UMEÅ UNIVERSITY HOSPITAL   (Sweden)

^d ERSTA HOSPITAL   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

CHOLERA TOXIN B SUBUNIT;

ABDOMINAL PAIN; ADULT; ARTHRALGIA; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CROHN DISEASE; DISEASE SEVERITY; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; FEMALE; HUMAN; LOOSE FECES; MALE; MULTICENTER STUDY; NAUSEA; PRIORITY JOURNAL; PRURITUS; REMISSION; RHINOPHARYNGITIS; SCORING SYSTEM; VOMITING;

ADOLESCENT; ADULT; AGED; CHOLERA TOXIN; CONFIDENCE INTERVALS; CROHN DISEASE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; MALE; MIDDLE AGED; RISK ASSESSMENT; TREATMENT OUTCOME; YOUNG ADULT;

EID: 73549112203     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2009.04185.x     Document Type: Article

References (18)

1. Podolsky D. Inflammatory bowel disease. N Engl J Med 2002 347 : 417 429.
2. Lapidus A. Crohn's disease in Stockholm County during 1990-2001: an epidemiological update. World J Gastroenterol 2006 12 : 75 81.
3. Zareie M, Singh PK, Irvine EJ, et al. Monocyte/macrophage activation by normal bacteria and bacterial products: implications for altered epithelial function in Crohn's disease. Am J Pathol 2001 158 : 1101 1109.
4. Marks DJB, Segal AW. Innate immunity in inflammatory bowel disease: a disease hypothesis. J Pathol 2008 214 : 260 266.
5. Parronchi P, Romagnani P, Annunziato F, et al. Type 1 T-helper cell predominance and IL-12 expression in the gut of patients with Crohn's disease. Am J Pathol 1997 150 : 823 832.
6. Lycke N. The mechanism of cholera toxin adjuvanticity. Res Immunol 1997 148 : 504 520.
7. Neurath MF, Finotto S, Glimcher LH. The role of Th1/Th2 polarization in mucosal immunity. Nature Med 2002 8 : 567 573.
8. Boirivant M, Fuss IJ, Ferroni L, et al. Oral administration of recombinant cholera toxin subunit B inhibits IL-12-mediated murine experimental (trinitrobenzene sulfonic acid) colitis. J Immunol 2001 166 : 3522 3532.
9. Coccia EM, Remoli MF, Di Giacinto C, et al. Cholera toxin subunit B inhibits IL-12 and IFN-gamma production and signaling in experimental colitis and Crohn′s disease. Gut 2005 54 : 1558 1564.
10. Wypij D. Binomial distribution. In : Armitage P, Colton T, eds. Encyclopedia of Biostatistics, Vol. 1. Chichester, UK : John Wiley and Sons, 1998 359 363.
11. Stanford M, Whittall T, Bergmeier LA, et al. Oral tolerization with peptide 336-351 linked to cholera toxin B subunit in preventing relapses of uveitis in Behcet's disease. Clin Exp Immunol 2004 137 : 201 208.
12. Burkart V, Kim YE, Hartmann B, et al. Cholera toxin B pretreatment of macrophages and monocytes diminishes their proinflammatory responsiveness to lipopolysaccharide. J Immunol 2002 168 : 1730 1737.
13. Szabo SJ, Jacobson NG, Dighe AS, et al. Developmental commitment to the Th2 lineage by extinction of IL-12 signaling. Immunity 1995 2 : 665 675.
14. Davidson NJ, Hudak SA, Lesley RE, et al. IL-12, but not IFN-gamma, plays a major role in sustaining the chronic phase of colitis in IL-10-deficient mice. J Immunol 1998 161 : 3143 3149.
15. Fuss IJ, Marth T, Neurath MF, et al. Anti-interleukin 12 treatment regulates apoptosis of Th1 T cells in experimental colitis in mice. Gastroenterology 1999 117 : 1078 1088.
16. Neurath MF, Fuss I, Kelsall BL, et al. Antibodies to interleukin 12 abrogate established experimental colitis in mice. J Exp Med 1995 182 : 1281 1290.
17. Simpson SJ, Shah S, Comiskey M, et al. T cell-mediated pathology in two models of experimental colitis depends predominantly on the interleukin 12/Signal transducer and activator of transcription (Stat)-4 pathway, but is not conditional on interferon gamma expression by T cells. J Exp Med 1998 187 : 1225 1234.
18. Aman AT, Fraser S, Merritt EA, et al. A mutant cholera toxin B subunit that binds GM1- ganglioside but lacks immunomodulatory or toxic activity. Proc Natl Acad Sci U S A 2001 98 : 8536 8541.