(6-MP, AZA)]. Concomitant stable doses of oral aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted. In both studies, patients were randomized to receive either placebo, 5 mg/kg Remicade, or 10 mg/kg Remicade at weeks 0, 2, 6, 14 and 22, and in ACT 1 at weeks 30, 38 and 46. Corticosteroid taper was permitted after week 8.
Table 8
Effects on clinical response, clinical remission and mucosal healing at Weeks 8 and 30.
Combined data from ACT 1 & 2.
Placebo
Infliximab
5 mg/kg
10 mg/kg
Combined
Subjects randomized
244
242
242
484
Percentage of subjects in clinical response and in sustained clinical response
Clinical response at Week 8a
33.2%
66.9%
65.3%
66.1%
Clinical response at Week 30a
27.9%
49.6%
55.4%
52.5%
Sustained response
(clinical response at both Week 8 and Week 30)a
19.3%
45.0%
49.6%
47.3%
Percentage of subjects in clinical remission and sustained remission
Clinical remission at Week 8a
10.2%
36.4%
29.8%
33.1%
Clinical remission at Week 30a
13.1%
29.8%
36.4%
33.1%
Sustained remission
(in remission at both Week 8 and Week 30)a
5.3%
19.0%
24.4%
21.7%
Percentage of subjects with mucosal healing
Mucosal healing at Week 8a
32.4%
61.2%
60.3%
60.7%
Mucosal healing at Week 30a
27.5%
48.3%
52.9%
50.6%
a: p < 0.001, for each infliximab treatment group vs. placebo
The efficacy of Remicade through week 54 was assessed in the ACT 1 study.
At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p<0.001). Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p<0.001 and 46.1% vs. 18.2%, p<0.001, respectively). The proportions of patients in sustained response and sustained remission at week 54 were greater in the combined infliximab treatment group than in the placebo treatment group (37.9% vs. 14.0%, p<0.001; and 20.2% vs. 6.6%, p<0.001, respectively).
A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p < 0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT1 data).
The pooled data analysis from the ACT 1 and ACT 2 studies and their extensions, analysed from baseline through 54 weeks, demonstrated a reduction of ulcerative colitis related hospitalisations and surgical procedures with infliximab treatment. The number of ulcerative colitis-related hospitalisations was significantly lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years: 21 and 19 vs 40 in the placebo group; p=0.019 and p=0.007, respectively). The number of ulcerative colitis-related surgical procedures was also lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of surgical procedures per 100 subject-years: 22 and 19 vs 34; p=0.145 and p=0.022, respect |
