A double-blind randomized controlled trial of infliximab associated with prednisolone in acute alcoholic hepatitis

• DOI: 10.1002/hep.20206
• Publication Date: 2004-04-26T23:02:10Z
• Authors: Sylvie Naveau; Sylvie Chollet-Ma...; Sébastien Dharancy; Philippe Mathurin; Pauline Jouet; Marie-Astrid Piquet; Thierry Davion; Frédéric Oberti; Philippe Broët; Dominique Emilie
• Keywords: Alcoholic Hepatitis; Prednisolone

Tumor necrosis factor-α (TNF-α) may contribute to the progression of acute alcoholic hepatitis (AAH). The aim this study was evaluate efficacy an association infliximab and prednisolone at reducing 2-month mortality rate among patients with severe AAH. Patients AAH (Maddrey score ≥32) were randomly assigned group A receiving intravenous infusions (10 mg/kg) in weeks 0, 2, 4; or B a placebo same times. All received (40 mg/day) for 28 days. Blood neutrophil functional capacities monitored over After randomization 36 patients, seven from three died within 2 months. probability being dead months higher (not significant [NS]) (39% ± 11%) than (18% 9%). stopped by follow-up committee sponsor (Assistance Publique-Hôpitaux de Paris). frequency infections ( P < .002). This difference potentially related significantly lower ex vivo stimulation capacity neutrophils. There no differences between two groups terms Maddrey scores any time point. In conclusion, 10 mg/kg be harmful because high prevalence infections. (Hepatology 2004;39:1390-1397.)