Table 2.

Infliximab in either Crohn’s disease or ulcerative colitis

Study	Number of patients	Treatment schedule	Primary end-point	Response to treatment
Accent I88	n = 573 active CD	5 mg/kg single infusion 5 or 10 mg/kg maintenance for those responded	CDAI > 70 points 2 weeks response clinical remission 54 weeks	58% 28.3% and 38.4% respectively vs 13.6% of placebo
Accent II93	n = 306 Fistulizing CD	5 mg/kg for those who responded	Week 54 absence of fistulas	36%
Ruggiero160	n = 24 patients with ileocolonic resection	iv 5 mg/kg for 12 months vs placebo	Endoscopic and histologic recurrence at 1 year	91% and 27.3% (Infliximab) vs 84.6% and 84.6% (placebo)
Colombel94	n = 508 patients with moderate-severe CD	5 mg infliximab/kg at weeks 0, 2, and 6 and then every 8 weeks plus daily oral placebo vs 2.5 mg oral azathioprine/kg daily plus a placebo infusion vs combination of the 2 drugs.	Corticosteroid-free clinical remission at week 26	56.8% (IFX plus AZ) vs 44.4% (IFX + placebo) vs 30.0% (AZ) (significant differences)
Kohn99	n = 83 patients with severe UC	Infliximab 5 mg/kg iv (1 or more infusions)	Short-term outcome: colectomy/death 2 months after the first infusion. Long-term outcome: survival free from colectomy	15% underwent colectomy after first infusion (greater rates in patients receiving only 1 infusion)
ACT 1 and ACT 2 studies96	n = 364 patients with UC and Mayo score 6–12	Placebo vs infliximab (5 or 10 mg/kg) at weeks 0, 2, and 6, then 5 mg/kg/8 weeks through week 46 (ACT 1) or through week 22 (ACT 2)	Response: drop of Mayo >3 rectal bleeding: 0–1
			ACT 1
			Response week 8	69%
			Response week 54	45%
			ACT 2
			Response week 8	64%
			Response week 30	31%

Abbreviations: AZ, azathioprine; CD, Crohn’s disease; CDAI, Crohn’s disease activity index; IFX, infliximab; UC, ulcerative colitis.