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

1058 LEMANN ET AL GASTROENTEROLOGY Vol. 130, No. 4
Table 1. Baseline Characteristics of the Patients Enrolled in the Trial According to Study Treatment and Stratum
was not different in the 2 treatment groups at 2.0 (.0–4.0)
vs 2.0 (1.0–4.0) at week 6 (P .65), 2.0 (.0–3.0) vs 1.0
(.0–3.0) at week 12 (P .91), and 1.0 (.0–2.0) vs .5
(.0–1.8) at week 24 (P .42). There was no significant
interaction between treatment and stratum.
Factors associated with success at week 24 in the
multivariate logistic regression analysis were a low CDAI
at baseline (OR, 4.5; 95% CI, 1.5–13.7; P .005), a
Failure stratum Naive stratum
Placebo n 29 Infliximab n 26 P Placebo n 27 Infliximab n 31 P
Sex (female) a 69 69 .95 43 39 .75
Age, yb 29 (23–33) 26 (22–37) .52 26 (22–36) 27 (22–38) .79
Disease duration, yb Disease location
7 (3–11) 5 (4–10) .97 4 (1–8) 3 (1–6) .60
a
Small bowel 11 20 .37 15 35 .74
Colon 50 32 26 13
Both 39 48 59 52
Active perianal diseasea 14 35 .07 7 32 .02
CDAIb 181 (154–259) 240 (219–281) .02 112 (42–262) 146 (90–244) .48
Duration of steroids, mob 16 (9–36) 25 (13–36) .20 15 (9–52) 9 (7–22) .03
Steroid dose, mg/dayb 30 (20–40) 33 (20–46) .32 25 (20–40) 25 (20–40) .85
Steroid dose, mg/kg/dayb .5 (.3–.7) .6 (.4–.8) .25 .4 (.3–.6) .4 (.3–.6) .77
Duration of AZA/6-MP, mob 21 (10–44) 27 (10–33) .95 0 0 -
Dosage of AZA, c mg/kg/dayb 2.4 (2.1–2.6) 2.3 (2.0–2.5) .27 2.2 (2.0–2.4) 2.2 (2.0–2.4) .94
Dosage of AZA, c mg/dayb 150 (125–150) 125 (100–150) .39 125 (100–150) 150 (125–150) .20
CDEISb (n 52) 9 (6–15) d 9 (4–14) e .63 6 (3–14) f 11 (5–16) g .50
C-reactive protein, b mg/L 8 (4–35) 19 (4–47) h .63 17 (7–31) i 20 (10–30) .36
a Percent of patients; 2 test.
b Median (interquartile range); Mann–Whitney U test.
c All patients were treated with AZA.
d n 17.
e n 9.
f n 14.
g n 12.
h n 25.
i n 26.
young age (OR, 5.9; 95% CI, 1.8–19.6; P .002), the
absence of small-bowel involvement (OR, 4.3; 95% CI,
1.5–12.2; P .004), and a long duration of steroids
before entry (OR, 5.5; 95% CI, 1.3–22.5; P .01).
After adjusting for these factors, infliximab still was
superior to placebo (OR, 5.7; 95% CI, 2.0–15.9; P
.001) and no interaction between treatment and strata
could be seen (P .63).
Figure 2. Percent of patients in
clinical remission and off steroids
at weeks 12, 24 (primary
end point), and 52 (follow-up
evaluation). The figures below
the bars correspond to the number
of patients analyzed at each
date. □, AZA/6-MP placebo;
, AZA/6-MP infliximab 5
mg/kg.