Endoscopic response to tumor necrosis factor inhibitors predicts long term benefits in Crohn’s disease

Table 1 Patient’s demographic characteristics (n = 62) n (%)

Patient’s demographic characteristics (n = 62)
Female, n (%)	31 (50)
Age at inclusion, mean (min-max)	39 (18-72)
Disease duration (yr), mean (min-max)	9 (0-33)
Location
Terminal ileum	32 (52)
Colonic	15 (24)
Ileocolonic	15 (24)
Associated upper involvement	3 (5)
Phenotype
Inflammatory	39 (63)
Stricturing	14 (22)
Penetrating	9 (15)
Associated structuring + penetrating	4 (7)
Perianal disease	16 (26)
Current smokers	19 (31)
Anti-TNFdrug used
Infliximab	34 (55)
Adalimumab	28 (45)
Prior anti-TNF exposure	16 (26)
Immunomodulators at baseline	53 (86)
Steroids at baseline	13 (21)
Previous CD surgery	9 (15)

TNF: Tumor necrosis factor; CD: Crohn’s disease.

Table 2 Biological, pharmacokinetic, clinical and endoscopic data at baseline and during follow up

	Baseline, n = 62	Week 14, n = 59	P value (week 14- baseline)	Week 46, n = 56	P value (week 46- baseline)
CDAI, median (IQR)	201 (114-236)	60 (28-94)	P < 0.001	53 (26-94)	P < 0.001
CDEIS, median (IQR)	6.7 (5-11.3)	3.2 (0.8-5)	P < 0.001	3.0 (0.2-4.4)	P < 0.001
CRP mg/dL, median (IQR)	0.66 (0,16-1.72)	0.2 (0.03-0.71)	P = 0.125	0.19 (0.03-0.76)	P < 0.05
Hemoglobin g/L, median (IQR)	127 (113-140)	135 (121-141)	P < 0.05	134 (123-143)	P < 0.05
Albumin g/L, median (IQR)	41 (40-43)	43 (40-45)	P < 0.05	43 (40-45)	P < 0.05
Serum TNF-alpha pg/mL, median (IQR)	5.5 (3.3-8)	20 (11-36)	P < 0.001	17 (8.25-30)	P < 0.001
Fecal Calprotectin μg/g, median (IQR)	1044 (685-1800)	610 (209-1646)	P < 0.05	940 (233-1747)	P < 0.05
Infliximab μg/mL, median (IQR)	0 (0-0)	3.1 (1.2-5.6)	P < 0.001	1.8 (1-6.6)	P < 0.001
ATIs, % patients (n)	8 (5/62)	3 (1/34)	P = 0.327	13 (4/32)	P = 0.230
Adalimumab μg/mL, median (IQR)	0 (0-0)	8.9 (5.6-12)	P < 0.001	9.9 (7-12)	P < 0.001
ATAs, % patients (n/total)	10 (6/62)	0 (0/25)	P = 0.117	4.1 (1/24)	P = 0.408

IQR: Interquartile range; CRP= C reactive protein; TNF-alpha: Tumor necrosis factor alpha; ATIs: Anti-infliximab antibodies; ATAs: Anti-adalimumab antibodies; CDAI: Crohn’s Disease Activity Index; CDEIS: Crohn’s Disease Endoscopic Index of Severity.

Table 3 Sensitivity and specificity of variables at week 14 as predictors of long-term mucosal healing

Variable	Sensitivity	Specificity
CDEIS < 3	69	67
CDEIS < 4	62	78
80% reduction of CDEIS (baseline to week 14)	59	91
Endoscopic response at week 14	85	66
Endoscopic remission at week 14	59	85

CDEIS: Crohn’s Disease Endoscopic Index of Severity.

Table 4 Diagnostic accuracy of 80% Crohn’s Disease Endoscopic Index of Severity reduction at week 14 for the diagnosis of long-term mucosal healing

			Mucosal healing at week 46
			No	Yes
≥ 80% reduction in CDEIS at week 14 from baseline	No	n (%)	32 (74.4)	11(25.6)
	Yes	n (%)	3 (15.8)	16 (84.2)

CDEIS: Crohn’s Disease Endoscopic Index of Severity.

Table 5 Comparison between 50 and 80% Crohn’s Disease Endoscopic Index of Severity reduction from baseline to week 14 as predictors of long-term mucosal healing

CDEIS reduction	Sensitivity (95%CI)	Specificity (95%CI)	PPV (95%CI)	NPV (95%CI)	LR+ (95%CI)	LR- (95%CI)
50%	85 (66%-96%)	66 (48%-81%)	66 (54%-76%)	85 (69%-93%)	2.5 (1.5-4)	0.23 (0.09-0.57)
80%	59 (39%-77%)	91 (77%-98%)	84 (63%-94%)	74 (65%-82%)	6.9 (2.24-21)	0.45 (0.28-0.72)

CDEIS: Crohn's Disease Endoscopic Index of Severity; CI: Confidence interval; PPV: Positive predictive value; NPV: Negative predictive value; LR+: Positive likelihood ratio; LR-: Negative likelihood ratio.