Effect of Modulen vs budesonide on clinical response and mucosal healing in Crohn’s patients

Table 1 Demographic and parameters of two groups, mean ± SD/n (%)

	Modulen group	Budesonide group	P value
Number of patients	21	9
Gender			0.22
Female	15 (71)	4 (44)
Male	6 (29)	5 (56)
Age, years	34.7 ± 12.9	39.9 ± 15.8	0.35
BMI	25.0 ± 4.8	27.5 ± 5.6	0.22
Non-smokers	14/19 (73.7)	7/8 (87.5)	0.63
Time from diagnosis, months	2.28 ± 1.23	2.33 ± 1.66	0.93
SB/colon involvement			NA
SB only (L1)	17 (81)	8 (88.9)
SB + colon (L3)	4 (19)	1 (11.1)
Previous surgery	1	1	NA
No previous treatment	21 (100)	9 (100)	NA
Baseline CDAI (range)	216.8 ± 78.2 (40-387)	191.4 ± 60.6 (88-279)	0.39
Baseline IBDQ (range)	129.9 ± 31.6 (86-201)	149.3 ± 35.8 (98-218)	0.15
Baseline Lewis score (median with IQR)	477.5 (337-951)	412 (337-1379)	0.91
Baseline total inflammatory score (median with IQR range)	745 (365-1229)	637 (476-1264)	0.91
Baseline stenosis score	1 patient-2352	1 patient-2352	NA
Baseline SES-CD	1 patient-6	4 patients with average 75	NA
Baseline total symptoms score	4.61 ± 1.99	3.72 ± 1.83	0.26
Baseline calprotectin score, μg/mg (median with IQR range)	59 (25-121.5)	336 (84-697)	0.055
Baseline hemoglobin, g/dL	13.9 ± 1.6	13.4 ± 1.3	0.39
Baseline CRP level (median with IQR range)	1.65 (0.5-4.40)	3.6 (1.15-15.6)	0.14

Median with interquartile range was evaluated if the distribution of values was asymmetric. IQR: Interquartile range; NA: Not applicable; BMI: Body mass index; SB: Small bowel; CDAI: Crohn’s disease activity index; IBDQ: Inflammatory bowel disease questionnaire; SES-CD: Simple endoscopic score for Crohn’s disease; CRP: C-reactive protein.

Table 2 Intention for treat analysis in the Modulen group (21 patients), mean ± SD

	Baseline	End of I month of treatment	End of II months of treatment	Follow-up	P value
Weight (kg)	70.8 ± 13.9	72.4 ± 14.05	69.4 ± 12.4	74.3 ± 12.6	0.761; 0.802; 0.523
CDAI	216.8 ± 78.2	117.6 ± 98.8	126.5 ± 93.5	141.0 ± 106.72	0.0041; 0.0072; 0.0353
IBDQ	129.9 ± 31.6	165.2 ± 33.7	161.9 ± 35.9	158.8 ± 31.3	0.0081; 0.0142; 0.0233
Lewis score (median with IQR)	477.5 (337-951)	NA	322.5 (0-505.75)	NA	0.56
Total inflammatory score (median with IQR)	745 (365-1229)	NA	322.5 (0-865.8)	NA	0.035
I tertile (median with IQR)	0 (0-337)	NA	0 (0-168.3)	NA	0.63
II tertile (median with IQR)	67.5 (0-519)	NA	0 (0-35.8)	NA	0.17
III tertile (median with IQR)	337 (315-730)	NA	322.5 (0-505.8)	NA	0.26
Total symptom score (range)	4.61 ± 1.99	2.46 ± 2.00	2.30 ± 2.04	2.50 ± 1.95	0.0081; 0.0042; 0.013
Calprotectin (μg/mg) (median with IQR)	59 (25-121.5)	34 (14-70)	39.4 (29.5-91.0)	34 (14.3-110)	0.131; 0.502; 0.443
Hemoglobin (d/dL)	13.9 ± 1.6	14.51 ± 1.50	14.59 ± 1.32	14.53 ± 1.31	0.311; 0.272; 0.313
CRP (median with IQR)	1.65 (0.5-4.4)	1.0 (0.5-4.3)	3.8 (0.5-8.2)	1.4 (0.7-13.0)	0.511; 0.932; 0.883
Compliance for Modulen (portions)	NA	2.9 ± 0.91	2.60 ± 1.14	NA	NA

¹P baseline vs end of I month of treatment.

²P baseline vs end of II months of treatment.

³P baseline vs end of follow up of treatment.

IQR: Interquartile range; NA: Not applicable; CDAI: Crohn’s disease activity index; IBDQ: Inflammatory bowel disease questionnaire; CRP: C-reactive protein.

Table 3 Per-protocol analysis in the Modulen group (11 patients)

	Baseline	End of I month of treatment	End of II months of treatment	Follow-up	P value
Weight (kg) (median with IQR)	63 (58.5-79.5)	65 (58.8-83.5)	65 (58-82)	77 (61-84)	0.151; 0.732; 0.183
CDAI (median with IQR)	182 (150-261)	78 (66-165)	120 (57-150)	111 (50-219)	0.0211; 0.0412; 0.113
IBDQ (median with IQR)	142 (116-170)	173.5 (138-195.8)	169 (126-201)	157 (127-199)	0.051; 0.0162; 0.0743
Lewis score (median with IQR)	337 (329-1147)	NA	322.5 (0-505.8)	NA	0.027
Total inflammatory score (median with IQR)	745 (337-1399)	NA	322.5 (0-865.8)	NA	0.027
I tertile (median with IQR)	0 (0-337)	NA	0 (0-168)	NA	0.28
II tertile (median with IQR)	143 (0-618)	NA	0 (0-35.75	NA	0.043
III tertile (median with IQR)	337 (308-618)	NA	322 (0-505)	NA	0.34
Total symptom score (median with IQR)	4.75 (1.75-5.25)	2.06 (0.75-3.31)	2.38 (0.75-4.0)	2.25 (1.0-4.63)	0.0751; 0.0912; 0.0663
Calprotectin (μg/mg) (median with IQR)	82 (22.7-118.0)	36.5 (13.5-76.9)	39.4 (29.5-91.0)	34 (14.3-110)	0.0511; 0.162; 0.593
Hemoglobin (d/dL) (median with IQR)	14.3 (13.9-15.6)	14.7 (14.0-15.6)	14.8 (13.9-15.3)	14.4 (13.9-15.5)	0.681; 0.372; 0.193
CRP (median with IQR)	3.5 (0.5-5.2)	1.0 (0.5-4.3)	3.8 (0.5-8.2)	1.4 (0.7-13.0)	0.861; 0.772; 0.333
Compliance for Modulen, portions (median with IQR)	NA	3.0 (2-3.9)	2.8 (1.5-3.7)	NA	NA

¹P baseline vs end of I month of treatment.

²P baseline vs end of II months of treatment.

³P baseline vs end of follow up of treatment.

IQR: Interquartile range; NA: Not applicable; CDAI: Crohn’s disease activity index; IBDQ: Inflammatory bowel disease questionnaire; CRP: C-reactive protein.

Table 4 Intention for treat analysis in the budesonide group (9 patients), mean ± SD

	Baseline	End of I month of treatment	End of II months of treatment	Follow-up	P value
Weight (kg)	82.9 ± 17.3	80.8 ± 18.3	78.5 ± 14.6	75.8 ± 15.6	0.811; 0.692; 0.473
CDAI	191.4 ± 60.6	113.6 ± 75.3	152.4 ± 75.9	103.6 ± 83.1	0.0421; 0.352; 0.0633
IBDQ	149.3 ± 35.8	173.9 ± 30.4	164.4 ± 29.1	173.7 ± 27.8	0.151; 0.382; 0.153
Lewis score (median with IQR)	412 (337-1379)	NA	337 (0-1690)	NA	0.56
Total inflammatory score (median with IQR)	637 (476-1264)	NA	674 (0-809)	NA	0.75
I tertile (median with IQR)	143 (67.5-393.5)	NA	135 (0-337)	NA	0.59
II tertile (median with IQR)	0 (0-236)	NA	0 (0-337)	NA	1.00
III tertile (median with IQR)	337 (240-574)	NA	337 (0-412)	NA	0.79
Total symptom score	3.72 ± 1.83	2.45 ± 1.59	3.21 ± 2.48	2.96 ± 2.22	0.221; 0.652; 0.453
Calprotectin (μg/mg) (median with IQR)	336 (84-697)	77.7 (15-358)	14 (8.7-46.65)	15 (13.4-61)	0.0221; 0.0082; 0.0133
Hemoglobin (g/dL)	13.4 ± 1.28	14.03 ± 1.67	13.87 ± 1.89	13.99 ± 1.64	0.381; 0.542; 0.453
CRP (median with IQR)	3.6 (1.15-15.6)	1.2 (0.53-2.77)	1.0 (0.5-3.0)	1.0 (0.5-2)	0.081; 0.102; 0.203

¹P baseline vs end of I month of treatment.

²P baseline vs end of II months of treatment.

³P baseline vs end of follow up of treatment.

IQR: Interquartile range; NA: Not applicable; CDAI: Crohn’s disease activity index; IBDQ: Inflammatory bowel disease questionnaire; CRP: C-reactive protein.

Table 5 Per-protocol analysis in the budesonide group (7 patients)

	Baseline	End of I month of treatment	End of II months of treatment	Follow-up	P value
Weight (kg) (median with IQR)	85.2 (66.4-90.25)	82.75 (66.3-91.5)	82.5 (66.25-91.25)	83.5 (66.3-91.3)	0.461; 0.342; 0.213
CDAI (median with IQR)	216 (151-267)	89 (39.8-89.0)	180 (78.5-227.5)	69 (28-171)	0.0071; 0.502; 0.0443
IBDQ (median with IQR)	159 (133-171)	179 (167-204)	152 (149-183)	169 (152-195)	0.191; 0.22; 0.183
Lewis score (median with IQR)	412 (337-1690)	NA	337 (0-1690)	NA	0.14
Total inflammatory score (median with IQR)	637 (472-1124)	NA	674 (0-809)	NA	0.23
I tertile (median with IQR)	143 (0-450)	NA	135 (0-337)	NA	0.36
II tertile (median with IQR)	0 (0-337)	NA	0 (0-337)	NA	0.66
III tertile (median with IQR)	337 (143-412)	NA	337 (0-412)	NA	0.29
Total symptom score (median with IQR)	3.75 (1.68-5.25)	2.43 (0.18-3.63)	3.25 (0.94-5.50)	2.87 (2.0-5.25)	0.481; 0.52; 0.43
Calprotectin score (μg/mg) (median with IQR)	336 (47.35-671.0)	17 (10.75-113.85)	14 (8.7-46.65)	15 (13-61)	0.0541; 0.052; 0.0513
Hemoglobin, d/dL (median with IQR)	13.7 (12.1-14.45)	14.6 (12.2-15.65)	13.8 (11.85-15.15)	14.4 (12.3-15.4)	0.0371; 0.182; 0.0143
CRP (median with IQR)	3.2 (1.0-13.6)	1.0 (0.5-2.9)	1.0 (0.5-3)	1.0 (0.5-2)	0.0171; 0.0172; 0.0383

¹P baseline vs end of I month of treatment.

²P baseline vs end of II months of treatment.

³P baseline vs end of follow up of treatment.

IQR: Interquartile range; NA: Not applicable; CDAI: Crohn’s disease activity index; IBDQ: Inflammatory bowel disease questionnaire; CRP: C-reactive protein.