Evaluation of “top-down” treatment of early Crohn’s disease by double balloon enteroscopy

Table 1 Baseline characteristics

	Group I	Group II	All patients	P value
	(n = 38)	(n = 39)	(n = 77)
Age at onset (yr), median (IQR)	24 (19-28)	27 (19-32)	25 (19-31)	0.259
Male sex, n (%)	22 (57.9)	25 (64.1)	47 (61.0)	0.577
Median disease duration (wk, IQR)	10 (4-20)	10 (4.5-18)	10 (4-20)	0.854
CDAI, median (IQR)	280 (247-347)	274 (258-340)	279 (251-346)	0.699
CDEIS, mean (SD)	13.7 ± 4.4	13.2 ± 4.0	13.5 ± 4.1	0.708

CDAI: Crohn’s Disease Activity Index; CDEIS: Crohn’s Disease Endoscopic Index of Severity.

Table 2 Efficacy results n (%)

	Group I	Group II	P value
	(n = 38)	(n = 39)
Patients with clinical remission
Week 2	10 (26.3)	1 (2.6)	0.003
Week 6	25 (65.8)	11 (28.2)	0.001
Week 14	27 (71.1)	21 (53.84)	0.119
Week 22	27 (71.1)	18 (46.2)	0.027
Week 30	26 (68.4)	17 (43.6)	0.028
Week 54	27 (71.1)	22 (56.4)	0.182
Week 102	31 (81.5)	27 (69.2)	0.209
Median clinical remission time (wk)	6.8	14.2	0.009
Patients with MH at week 30	17 (44.7)	7 (17.9)	0.011
Patients with deep remission at week 30	17 (44.7)	7 (17.9)	0.011
Endoscopic response at week 30 (decrease in CDEIS score > 5)	30 (78.9)	19 (48.7)	0.006
Endoscopic remission at week 30 (CDEIS score < 6)	23 (60.5)	12 (30.8)	0.009
Complete endoscopic remission at week 30 (CDEIS score < 3)	14 (36.8)	8 (20.5)	0.113
Patients with MH at week 54	20 (52.6)	14 (35.9)	0.139
Patients with deep remission at week 54	20 (52.6)	14 (35.9)	0.139
Endoscopic response at week 54 (decrease in CDEIS score > 5)	32 (84.2)	30 (77.0)	0.420
Endoscopic remission at week 54 (CDEIS score < 6)	31 (81.6)	29 (74.4)	0.445
Complete endoscopic remission at week 54 (CDEIS score < 3)	18 (47.4)	18 (46.2)	0.915
Patients with MH at week 102	22 (57.9)	15 (38.5)	0.088
Patients with deep remission at week 102	22 (57.9)	15 (38.5)	0.088
Maximum tolerated dose of azathioprine (mg/kg) , mean (SD)	1.73 ± 0.18	1.71 ± 0.19	0.748

MH: Mucosal healing; CDEIS: Crohn’s Disease Endoscopic Index of Severity.

Table 3 Safety data n (%)

	Group I	Group II	All patients	P value
	(n = 38)	(n = 39)	(n = 77)
Patients with any adverse events	34 (89.5)	33 (84.6)	77 (87.0)	0.737
Adverse events leading to discontinuation of study drug	5 (13.2)	4 (10.3)	9 (11.7)	0.663
Infusion reaction	5 (13.2)	-	-	-
Serum-sickness-like reactions	0	-	-	-
Infection	4 (10.5)	4 (10.3)	8 (10.4)	1.000
Headache	6 (15.8)	7 (17.9)	13 (16.9)	1.000
Nausea	6 (15.8)	9 (23.1)	15 (19.5)	0.420
Abdominal pain	7 (18.4)	11 (28.2)	18 (23.4)	0.310
Acute pancreatitis	1 (2.6)	0	1 (1.3)	0.494
Alopecia	0	1 (2.6)	1 (1.3)	1.000
Amenorrhea	2 (5.3)	1 (2.6)	3 (3.9)	0.615
Elevation of transaminase	1 (2.6)	1 (2.6)	2 (2.6)	1.000
Leukopenia	7 (18.4)	9 (23.1)	16 (20.8)	0.615
Tuberculosis	0	0	0	-
Colon cancer	0	0	0	-
Hematologic cancer	0	0	0	-
Death	0	0	0	-