Maintenance of remission with infliximab in inflammatory bowel disease: Efficacy and safety long-term follow-up

Table 1 Demographic and clinical characteristics of the study population

Clinical characteristics	IBD (CD + UC)	Crohn’s disease	Ulcerative colitis
n	50	40	10
Gender (M/F)	23/27	18/22	4/6
Age (yr)1	47.7 ± 15.6	45.4 ± 17.9	52.7 ± 8.9
Median disease duration (yr)	10.8	9.2	9.3
(range)	(0.3-22.2)	(0.3-22.2)	(2.1-15.1)
Disease activity (T0)1	N/A	245.0 ± 99.3 (CDAI)2	12.9 ± 2.8 (CAI)
Site of disease n (%):
Small bowel/pouch		13 (32.5)
Large bowel		4 (10)	10
Ileum-colon		23 (57.5)
Steroid therapy at enrolment (%) (≥ 0.7 mg/kg per day)	39 (78)	30 (75)	9 (90)
Concomitant medications n (%):
Salicylates	29	21 (52.5)	8 (80)
6-MP/azathioprine	31	28 (70)	3 (30)
Antibiotics	25	24 (60)	1 (10)

¹Mean ± SD;

²5 steroid-dependent patients had baseline Crohn's disease activity index (CDAI) < 150; CAI: Clinical activity index; T0: Baseline time; N/A: Not applicable.

Table 2 Efficacy profile of maintenance protocol

	IBD (CD + UC)		Crohn's disease		Ulcerative colitis
IFX infusions total number	637		493		144
Median number (range)	15 (4-25)		15 (4-25)		14.5 (6-22)
Median duration (mo) of IFX therapy (range)	27 (4-64)		27 (4-64)		24.5 (6-46)
No. patients maintaining remission with IFX (%)	41/50	82	32/40	80	9/10	90
Median duration (mo) of remission during IFX treatment (range)	25 (4-59)		25.5 (4-59)		25 (6-46)
No. patients discontinuing therapy during clinical remission (%)	13/38	34	9/29	31	4/9	44
Median duration (mo) of remission after treatment discontinuation (range)	15.5 (4-30)		16 (5-30)		6.5 (4-16)
No. patients on corticosteroids1 during maintenance with IFX (%)	1/50	2	10/40	25	1/10	10

¹Median corticosteroid dose ≤ 0.25 mg/kg per day.

Table 3 Summary of IFX related adverse events

Adverse event	IBD (CD + UC)	Crohn’s disease	Ulcerative colitis
Acute infusion reaction (%) (Mild, moderate, severe)	3/50 (6)	3/40 (7.5)	0
Delayed infusion reaction (%) (Serum sickness-like)	1/50 (2)	1/40 (2.5)	0
Opportunistic infection (%)	9/50 (18)	8/40 (20) 5 HSV 1 VZV 2 atypical pneumoniae	1/10 (10) 1 HSV
Lymphoproliferative diseases	0	0	0
Malignant disorder (%)	3/50 (6)	2/40 (5)	1/10 (10)

HSV: Herpes simplex virus; VZV: Varicella-zoster virus.

Table 4 Clinical characteristics of patients developing malignant disorders during IFX treatment

Patients	1	2	3
Gender	F	F	F
Disease	Ulcerative colitis	Crohn’s disease	Crohn’s disease
Disease duration (yr)	22	3	3
Site of disease	Left colon	Ileum-colon	Ileum-colon
Type of neoplasia (TNM)	Breast cancer (T2mN3M0)	Gastric cancer (T2aN0M0)	Endometrial cancer (T1cN0M0)
Concomitant medication	Azathioprine	Azathioprine/cyprofloxacine/metronidazole	Azathioprine/ cyprofloxacine/ metronidazole
N. IFX infusions	13	6	10
Months since first IFX infusion	21	24	14

TNM: Tumour, nodes, metastasis.