marc lémann,* jean–yves mary,‡ bernard duclos,§ michel - IG-IBD

April 2006 INFLIXIMAB AND AZATHIOPRINE 1057
Figure 1. Flow chart of patients
randomized in the trial. The figures
in parentheses correspond
to the number of patients in the
naive stratum and the failure
stratum, respectively.
Characteristics of the 113 enrolled patients are
shown in Table 1. Comparability of the 2 treatment
groups was verified for all clinical characteristics, except
for the percentage of patients with active perianal
lesions, the CDAI level in failure stratum, and the
duration of steroid treatments in the naive stratum.
Efficacy
The numbers of patients available for efficacy
evaluation at weeks 12, 24, and 52 are shown in Figure
1. At week 24, the percentage of success (CDAI 150
and off steroids) was significantly higher in the infliximab
group than in the placebo group (57% vs 29%;
OR, 3.3; 95% CI, 1.5–7.4; P .003); the corresponding
rates were 75% vs 38% (OR, 4.9; 95% CI, 2.2–11.0; P
.001) at week 12, and 40% vs 22% (OR, 2.4; 95% CI,
1.0–5.7; P .04) at week 52 (Figure 2).
There was no significant interaction between treatment
and stratum (P .10; .32, and .82 at weeks 12,
24, and 52, respectively). The comparison of infliximab
and placebo in each stratum is indicated in Figure 3. In
the naive stratum, at week 24, the percentage of success
was significantly higher in the infliximab group than in
the placebo group (63% vs 32%; OR, 3.7; 95% CI,
1.1–11.3; P .02); the corresponding rates were 83% vs
41% (OR, 7.1; 95% CI, 2.1–24.9; P .009) at week 12,
and 52% vs 32%; (OR, 2.3; 95% CI, .7–6.9; P .14)
at week 52. In the failure stratum, the success rate also
was higher in the infliximab group than in the placebo
group at week 24 (50% vs 26%; OR, 2.9; 95% CI,
.9–9.3; P .08) and at week 12 (64% vs 34%; OR, 3.4;
95% CI, 1.1–10.3; P .03); a trend was found at week
52 (27% vs 12%; OR, 2.8; 95% CI, .6–12.4; P .16).
These results must be considered cautiously because of
the absence of demonstrable interaction.
Steroid resistance was less common in the infliximab
group than in the placebo group (5% vs 23%;
OR, 5.1; 95% CI, 1.3–19.2; P .01). The median
cumulative dose (interquartile range) of prednisone
was lower in the infliximab group at 1110 mg/24 wk
(630–1720 mg/24 wk) vs 1870 mg/24 wk (1110–
2710 mg/24 wk) (P .002). The median (interquartile
range) of the side-effect steroid score, however,