A Double-Blind Randomized Controlled Trial of Infliximab Associated with Prednisolone in Acute Alcoholic Hepatitis

Hepatology

Volumn 39, Issue 5, 2004, Pages 1390-1397

  Naveau, Sylvie ^a,b,i   Chollet Martin, Sylvie ^c   Dharancy, Sébastien ^d   Mathurin, Philippe ^d   Jouet, Pauline ^b   Piquet, Marie Astrid ^e   Davion, Thierry ^f   Oberti, Fédéric ^g   Broët, Philippe ^h   Emilie, Dominique ⁱ  

^a HÔPITAL ANTOINE BÉCLÈRE   (France)

^b ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^c BICHAT HOSPITAL   (France)

^d LILLE UNIVERSITY HOSPITAL   (France)

^e CAEN UNIVERSITY HOSPITAL   (France)

^f Hopital du Docteur Schaffner de Lens   (France)

^g ANGERS UNIVERSITY HOSPITAL   (France)

^h HÔPITAL PAUL BROUSSE   (France)

ⁱ INSERM   (France)

Author keywords

[No Author keywords available]

Indexed keywords

INFLIXIMAB; PREDNISOLONE; TUMOR NECROSIS FACTOR ALPHA;

ACUTE DISEASE; ADULT; ALCOHOL LIVER DISEASE; ARTICLE; ASCITES CELL; BRAIN DISEASE; CELL FUNCTION; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG EFFECT; DRUG EFFICACY; DRUG INFUSION; FEMALE; FOLLOW UP; FRANCE; GASTROINTESTINAL HEMORRHAGE; HEADACHE; HUMAN; HYPERGLYCEMIA; INFECTION; LIVER FIBROSIS; LUNG EDEMA; MADDREY SCORE; MALE; MORTALITY; NEUTROPHIL; PRIORITY JOURNAL; PROBABILITY; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SERUM SICKNESS; SERUM SICKNESS LIKE REACTION; SIDE EFFECT; SUBCUTANEOUS DRUG LEAKAGE; VOMITING;

EID: 2342502025     PISSN: 02709139     EISSN: None     Source Type: Journal    
DOI: 10.1002/hep.20206     Document Type: Article

References (35)

1. Perrot S, Beaugrand M. Le traitement de l'hépatite alcoolique. Une revue des essais randomisés. Gastroenterol Clin Biol 1988;12:521-531.
2. Naveau S. Mechanisms of the inflammatory reaction implicated in acute experimental alcoholic hepatitis. Gastroenterol Clin Biol 2001;25:137-143.
3. Tilg H, Diehl AM. Cytokines in alcoholic and nonalcoholic steatohepatitis. N Engl J Med 2000;343:1467-1476.
4. Iimuro Y, Gallucci RM, Luster MI, Kono H, Thurman RG. Antibodies to tumor necrosis factor alpha attenuate hepatic necrosis and inflammation caused by chronic exposure to ethanol in the rat. HEPATOLOGY 1997;26:1530-1537.
5. Christensen E. Alcoholic hepatitis-glucocorticoids or not? J Hepatol 2002;547-548.
6. Daures JP, Peray P, Bones P, Blanc P, Youfsi A, Michel H, et al. Place de la corticothérapie dans le traitement des hépatites alcooliques aigues. Résultats d'une métaanalyse. Gastroenterol Clin Biol 1991;15:223-228.
7. Reynolds TB, Benhamou JP, Blake J, Naccarato R, Orrego H. Treatment of alcoholic hepatitis. Gastroenterol Int 1989;2:208-216.
8. Imperial TF, Mc Cullough AJ. Do corticosteroids reduce mortality from alcoholic hepatitis? Ann Intern Med 1990;113:299-307.
9. Mathurin P, Mendenhall CL, Carithers RL Jr, Ramond MJ, Maddrey WC, Carstide P, et al. Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis (AH): individual data analysis of the last three randomized placebo controlled double blind trials of corticosteroids in severe AH. J Hepatol 2002;36:480-487.
10. Mc Cullough AJ, O'Connor JFB. Alcoholic liver disease: proposed recommendations for the American college of gastroenterology. J Am Gastroenterol 1998;93:2022-2036.
11. Poynard T, Thabut D, Chryssostalis A, Tareb J, Ratziu V. Anti-tumor necrosis factor-alpha therapy in severe alcoholic hepatitis: are large randomized trials still possible? J Hepatol 2003;38:518-520.
12. Taïeb J, Mathurin P, Elbim C, Cluzel P, Arce-Vicioso M, Bernard B, et al. Blood neutrophil functions cytokine release in severe alcoholic hepatitis: effects of corticoids. J Hepatol 2000;32:579-586.
13. Carithers RL, Herlong HF, Diehl AM, Show EW, Combes B, Fallon HJ, et al. Methylprednisolone therapy in patients with severe alcoholic hepatitis. A randomized multicenter trial. Ann Intern Med 1989:110:685-690.
14. Review by an international group, alcoholic liver disease morphological manifestations. Lancet 1981;1:707-711.
15. Present DH, Rutgeerts P, Targan S, Hanaver SB, Mayer L, Van Hogezand RA, et al. Infliximab for the treatment of fistulas in patients with Crohn disease. N Engl J Med 1999;340:1398-1405.
16. Onrust SV, Lamb HM. Infliximab A review of its use in Crohn's disease and rheumatoid arthritis. Biodrugs 1998;10:397-422.
17. Sandborn WJ, Hanaver SB. Antitumor necrosis factor therapy for inflammatoty bowel disease: a review of agents, pharmacology, clinical results, and safety. Inflamm Bowel Dis 1999;5:119-133.
18. Wagner C, Mace K, De Woody K. Infliximab treatment benefits correlate with pharmacodynamic parameters in Crohn's disease patients [Abstract]. Digestion 1998;59(Suppl 3):1252.
19. Guarner C, Runyon BA. Spontaneous bacterial peritonitis: pathogenesis, diagnosis and management. Gastroenterologist 1995;3:311-328.
20. Whithead J, Stratton I. Group sequential clinical trials with triangular continuation region. Biometrics 1983;39:227-236.
21. Kittelson JM, Emerson SS. A unifying family of groups sequential test designs. Biometrics 1999;55:874-882.
22. Spahr L, Rubbia-Brandt L, Frossard J. Combination of steroids with infliximab or placebo in severe alcoholic hepatitis: a randomized controlled pilot study. J Hepatol 2002;37:448-456.
23. Tilg H, Jalan R, Kaser A, Davies NA, Offher FA, Hodges SJ, et al. Antitumor necrosis factor-alpha monoclonal antibody therapy in severe alcoholic hepatitis. J Hepatol 2003;38:419-425.
24. Khorus A, Stahnke L, Mac Clain CJ, Logan G, Allen JL. Circulating tumor necrosis factor, interleukin-1 and interleukine-6 concentrations in chronic alcoholic patients. HEPATOLOGY 1991;13:267-276.
25. Nielsen OH, Brynskov J, Bendzen K. Circulating and mucosal concentrations of tumor necrosis factor and inhibitor(s) in chronic inflammatory bowel disease. Dan Med Bull 1993;40:247-249.
26. Lipsky PE, Van Der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study group. N Engl J Med 2000;343:1594-1602.
27. Dinarello CA. Anti-cytokine therapeutics and infections. Vaccine 2003;21(Suppl 2):S24-S34.
28. Kroesen S, Widmer AF, Tyndall A, Hasler P. Serious bacterial infections in patients with rheumatoid arthritis under anti-TNF-alpha therapy. Rheumatology (Oxford) 2003;42:617-621.
29. Keane J, Gershon S, Wix RP, Mirabile-Levens E, Kasznica J, Schwieterman WD, et al. Tuberculosis associated with infliximab, a tumor necrosis factor α-neutralizing agent. N Engl J Med 2001;345:1098-1104.
30. Colombel JF, Loftus EV, Tremaine WJ, Egan LJ, Harmsen WS, Schleck CD, et al. The safety profile of infliximab in patients with Crohn's disease: the Mayo Clinic experience inn 500 patients. Gastroenterology 2004;126:19-31.
31. Nakada MT, Tam SH, Woulfe DS, Casper KA, Swerlick RA, Ghrayeb J. Neutralization of TNF bye the antibody cA2 reveals differential regulation of adhesion molecule expression on TNF-activated endothelial cells. Cell Adhes Commun 1998;5:491-503.
32. Lugering A, Schmidt M, Lugering N, Pauels HG, Domschke W, Kucharzik T. Infliximab induces apoptosis in monocytes from patients with chronic active Crohn's disease by using a caspase-dependent pathway. Gastroenterology 2001;121:1145-1157.
33. Eissner G, Kirchner S, Linder H, Kolch W, Janosch P, Grell M, et al. Reverse signaling through transmembrane TNF confers resistance to lipopolysaccharide in human monocytes and macrophages. J Immunol 2000;164:6193-6198.
34. phox is a common event of priming of human neutrophils by TNF-α and granulocyte-macrophage colony-stimulating factor. J Immunol 2003;171:4392-4398.
35. Runyon BA. Bacterial infections in patients with cirrhosis. J Hepatol 1993;18:271-272.