Combination of steroids with infliximab or placebo in severe alcoholic hepatitis: a randomized controlled pilot study.

BACKGROUND/AIMS: The aim of this study is to evaluate the tolerance and effects of infliximab combined with steroids in severe alcoholic hepatitis (AH).

METHODS

Twenty patients with biopsy-proven severe AH (Maddrey's score>32) received prednisone 40 mg/day for 28 days and either infliximab 5mg/kg IV (group A) or placebo (group B) at day 0. Histology, plasma interleukin-6 (IL-6) and interleukin-8 (IL-8) were measured at baseline and at day 10.

RESULTS

Infliximab was well tolerated. Histology showed no significant changes. At day 28, Maddrey's score significantly improved in group A (39 (32-53) to 12 (7-52), P<0.05 vs. baseline) but not in group B (44 (33-50) to 22 (2-59), P=NS). At day 10, IL-6 and IL-8 decreased in group A (25 pg/ml (10-85 pg/ml) to 4.5 pg/ml (2-25 pg/ml); 301 pg/ml (107-1207 pg/ml) to 14 6 pg/ml (25-252 pg/ml), P<0.01, P<0.05 vs. baseline, respectively). In group B, changes were not significant (38 pg/ml (13-116 pg/ml) to 16 pg/ml (4-128); 315 pg/ml (26-1698 pg/ml) to 110 pg/ml (27-492 pg/ml)).

CONCLUSIONS

In severe AH, infliximab was well tolerated and associated with significant improvement in Maddrey's score at day 28. Although the size of this study does not allow comparison between groups, these promising results should encourage larger trials assessing the effects of this therapy on survival.