Infliximab plus azathioprine for steroid-dependent Crohn's disease patients: a randomized placebo-controlled trial.
OBJECTIVE
The aim of this study was to evaluate the usefulness of short-term infliximab combined with azathioprine (AZA) or 6-mercaptopurine (6-MP) in steroid-dependent Crohn's disease patients.


METHODS
Patients with active disease despite prednisone given for more than 6 months were eligible and were stratified as follows: the failure stratum consisted of patients receiving AZA/6-MP at a stable dose for more than 6 months, and the naive stratum consisted of patients not treated previously with AZA/6-MP. Patients were randomized to infliximab 5 mg/kg or placebo at weeks 0, 2, and 6. All patients were treated with AZA/6-MP maintained at a stable dose throughout the 52 weeks of the study. The primary end point was remission off steroids at week 24.


RESULTS
Among the 113 enrolled patients (55 in the failure stratum), 57 were assigned to infliximab. At week 24, the success rate (intent-to-treat analysis) was higher in the infliximab group than in the placebo group (57% vs 29%; P = .003); at weeks 12 and 52, the corresponding rates were 75% vs 38% (P < .001) and 40% vs 22% (P = .04), respectively. In each stratum, the success rate was significantly higher in the infliximab group at weeks 12 and 24, and a trend was found at week 52. In the failure stratum, only 27% of the patients in the infliximab group were still in remission off steroids, compared with 52% in the naive stratum. Steroid resistance was less common and the cumulative dose of prednisone was lower in the infliximab group.


CONCLUSIONS
Infliximab plus AZA/6-MP is more effective than AZA/6-MP alone in steroid-dependent Crohn's disease patients.
Lémann
Marc
M
Department of Gastroenterology, Hôpital Saint-Louis, Paris, France.
Mary
Jean-Yves
JY
Duclos
Bernard
B
Veyrac
Michel
M
Dupas
Jean-Louis
JL
Delchier
Jean Charles
JC
Laharie
David
D
Moreau
Jacques
J
Cadiot
Guillaume
G
Picon
Laurence
L
Bourreille
Arnaud
A
Sobahni
Iradj
I
Colombel
Jean-Frederic
JF
D000893:Anti-Inflammatory Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001379:Azathioprine / Q000627:therapeutic use*; D003113:Colonoscopy; D003424:Crohn Disease / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab; D011241:Prednisone / Q000009:adverse effects* / Q000627:therapeutic use; D019966:Substance-Related Disorders / Q000209:etiology*; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab; D001379:Azathioprine; D011241:Prednisone