Treatment of Inflammatory Bowel Disease with Biologics

16

Table 2.1

Summary of efficacy for induction and maintenance clinical trials of anti-TNF

α medications in UC

Anti-TNF

α^

medication

Authors, date

Study summary

Study population, sample size

Dosing information

Clinical response

Clinical remission and mucosal improvement

Infliximab

Rutgeerts et al. [

15

]

Induction (ACT 1)

364 TNF-naïve patients with moderate-to-severe active UC

Placebo or infliximab 5 mg/kg or 10 mg/kg IV at weeks 0, 2, and 6 and then every 8 weeks through week 46

Clinical response at week 8 occurred in 69% of patients on 5 mg/kg, 61% of patients on 10 mg/kg, and 37% of patients on placebo (

P < 0.001

for both comparisons with placebo)

Clinical remission at week 8 occurred in 38.8% of patients on 5 mg/kg, 32% of patients on 10 mg/kg, and 14.9% of patients on placebo (

P

 < 0.001,

P = 0.002, respectively)Mucosal improvement at weeks 8, 30, and 54 occurred in significantly more patients in the infliximab groups than in the placebo groups (

P < 0.001 for

all comparisons)

Induction (ACT 2)

364 TNF-naïve patients with moderate-to-severe active UC

Placebo or infliximab 5 mg/kg or 10 mg/kg IV at weeks 0, 2, and 6 and then every 8 weeks through week 22

Clinical response at week 8 occurred in 64% of patients on 5 mg/kg, 69% of patients on 10 mg/kg, and 29% of patients on placebo (

P < 0.001

for both comparisons with placebo)

Clinical remission at week 8 occurred in 33.9% of patients on 5 mg/kg, 27.5% of 10 mg/kg, and 5.7% of patients on placebo (

P < 0.001 for

both comparisons to placebo)Mucosal improvement at weeks 8 and 30 occurred in significantly more patients in the infliximab groups than in the placebo groups (

P^

≤

 0.009 for

all comparisons)

K. Clark-Snustad et al.