Crohn’s disease, fatigue, and infliximab: Is there a role for cytokines in the pathogenesis of fatigue?

Table 1 Demographic and clinical characteristics of the patients

Clinical characteristics	Included CD patients (n = 14)
Age (yr) (mean ± SD)	32.2 (± 8.6)
Disease duration (yr) (median; range)	7.5 (1-28)
Gender male (n)	5
Refractory, clinical active luminal disease (n)	9
Active (draining) fistulae (n)	5
Medication use
Mesalamine (n) (range)	9 (1.5-3 g/d)
Azathioprine (n) (range)	12 (25-175 mg/d)
Prednisone (n) (range)	5 (10-50 mg/d)
Infliximab naïve (n)	8

Table 2 Decrease in general fatigue score and CDAI score after infusion mean ± SEM

t/D	General fatigue		CDAI score
	Placebo	Infliximab	Placebo	Infliximab
D 3	3.5 ± 1.1b	2.4 ± 1.5
D 7	3.5 ± 1.1b	3.5 ± 1.6a	40 ± 10.6b	63 ± 18.9b
D 14	1.9 ± 1.1	2.6 ± 1.2a	39 ± 13.3a	65 ± 27.1a
D 21	.	3.6 ± 1.4a		72 ± 28.9a
D 28	.	3.8 ± 1.4a		68 ± 36.2

^aP≤ 0.05,

^bP≤ 0.01 vs baseline. CDAI: Crohn’s disease activity index.

Table 3 Effect of infliximab on IBDQ and CES-D scores, and IL-18, CRP mean ± SEM

	Placebo infusion		Infliximab infusion
Parameters	Baseline	d 14	Baseline	d 14	d 28
Total IBDQ (range 32-224)	138.6 ± 9.4				179.4 ± 6.7a
Systemic symptoms (range 5-35)	19.9 ± 5.9				25.1 ± 1.6b
CES-D (range 0-60)	20.4 ± 9.4	17.0 ± 2.9	17.0 ± 2.9	14.0 ±2.4	11.3 ± 2.2b
IL-18 (ng/L)	37.1 ± 6.4	37.3 ± 6.5	37.3 ± 6.5	27.4 ± 5.2c	26.6 ± 3.8e
CRP (mg/L)	21.4 ± 6.2	21.9 ± 6.3	21.9 ± 6.3	9.1 ± 1.4d	8.7 ± 0.8e

^aP≤ 0.005;

^bP≤ 0.01 between baseline (before infliximab infusion) and 4 wk after infliximab infusion;

^cP≤ 0.005;

^eP≤ 0.05 between baseline and 2 or 4 wk after infliximab infusion. IBDQ: Inflammatory Bowel Disease Questionnaire; CES-D: Center for Epidemiological Studies Depression scale; IL-18: Interleukin 18; CRP: C-reactive protein.