J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website http://www.jocmr.org

Original Article

Volume 10, Number 2, April 2017, pages 92-99

Discontinuation of Scheduled Infliximab in Crohn’s Patients With Clinical Remission: A Retrospective Single-Center Study

**Table 1.** Characteristics of the Included Patients
Characteristics	CD patients (n = 106)
CRP: C-reactive protein; Alb: albumin; WBC: white blood cell; Hb: hemoglobin; Hct: hematocrit; AZA: azathioprine; CDAI: Crohn’s disease activity index; SD: standard deviation; IQR: interquartile range.
Male, n (%)	72 (67.9)
Active smoker, n (%)	3 (2.8)
Age (years) at diagnosis, mean (SD)	26.6 (9.5)
Montreal classification
Age (years) at diagnosis, n (%)
≤ 16 years (A1)	10 (9.4)
17 - 40 years (A2)	83 (78.3)
> 40 years (A3)	13 (12.3)
Disease site, n (%)
Ileum (L1)	36 (34.0)
Colon (L2)	7 (6.6)
Ileocolon (L3)	63 (59.4)
Disease behavior, n (%)
Inflammatory (B1)	55 (51.9)
Stricturing (B2)	41 (38.7)
Penetrating (B3)	10 (9.4)
Perianal disease, n (%)	28 (26.4)
Extraintestinal manifestations, n (%)	10 (9.4)
Disease duration (m), n (%)
≤ 18	84 (79.2)
> 18	22 (20.8)
Gastrointestinal surgery before infusion, n (%)	27 (25.5)
Therapeutic regimen, n (%)
Step-up	30 (28.3)
Top-down	76 (71.7)
CRP level at week 0/30, median (IQR)	9.9 (3.0 - 38.9)/1.49 (0.48 - 6.11)
Alb level at week 0/30, median (IQR)	37.7 (33.7 - 41.6)/42.3 (39.2 - 45.7)
WBC level at week 0/30, median (IQR)	7.12 (5.91 - 8.92)/5.57 (4.83 - 6.58)
Hb level at week 0/30, median (IQR)	115.0 (101.0 - 130.3)/129.0 (117.5 - 143.0)
Hct level at week 0/30, median (IQR)	36.6 (32.7 - 40.5)/39.3 (35.9 - 43.2)
CDAI at week 0/30, median (IQR)	213.5 (160.0 - 265.3)/64.5 (39.8 - 90.5)
AZA at IFX discontinuation, n (%)	77 (72.6)

Table 1. Characteristics of the Included Patients

Characteristics

CD patients (n = 106)

CRP: C-reactive protein; Alb: albumin; WBC: white blood cell; Hb: hemoglobin; Hct: hematocrit; AZA: azathioprine; CDAI: Crohn’s disease activity index; SD: standard deviation; IQR: interquartile range.

Male, n (%)

72 (67.9)

Active smoker, n (%)

3 (2.8)

Age (years) at diagnosis, mean (SD)

26.6 (9.5)

Montreal classification

Age (years) at diagnosis, n (%)

≤ 16 years (A1)

10 (9.4)

17 - 40 years (A2)

83 (78.3)

> 40 years (A3)

13 (12.3)

Disease site, n (%)

Ileum (L1)

36 (34.0)

Colon (L2)

7 (6.6)

Ileocolon (L3)

63 (59.4)

Disease behavior, n (%)

Inflammatory (B1)

55 (51.9)

Stricturing (B2)

41 (38.7)

Penetrating (B3)

10 (9.4)

Perianal disease, n (%)

28 (26.4)

Extraintestinal manifestations, n (%)

10 (9.4)

Disease duration (m), n (%)

≤ 18

84 (79.2)

> 18

22 (20.8)

Gastrointestinal surgery before infusion, n (%)

27 (25.5)

Therapeutic regimen, n (%)

Step-up

30 (28.3)

Top-down

76 (71.7)

CRP level at week 0/30, median (IQR)

9.9 (3.0 - 38.9)/1.49 (0.48 - 6.11)

Alb level at week 0/30, median (IQR)

37.7 (33.7 - 41.6)/42.3 (39.2 - 45.7)

WBC level at week 0/30, median (IQR)

7.12 (5.91 - 8.92)/5.57 (4.83 - 6.58)

Hb level at week 0/30, median (IQR)

115.0 (101.0 - 130.3)/129.0 (117.5 - 143.0)

Hct level at week 0/30, median (IQR)

36.6 (32.7 - 40.5)/39.3 (35.9 - 43.2)

CDAI at week 0/30, median (IQR)

213.5 (160.0 - 265.3)/64.5 (39.8 - 90.5)

AZA at IFX discontinuation, n (%)

77 (72.6)

**Table 2.** Univariate Analysis of Factors Associated With Relapse
Variables	Relapses/total	P value	Hazard ratio	95% CI
CRP: C-reactive protein; Alb: albumin; Hb: hemoglobin; AZA: azathioprine; CI: confidence interval. Male patients < 130 g/L, female patients < 115 g/L. *Male patients < 0.4, female patients < 0.35.
Sex
Female	18/34	0.605	1
Male	41/72		1.158	0.664 - 2.017
Disease duration (months)
≤ 18	42/84	0.072	1
> 18	17/22		1.679	0.954 - 2.955
Age at diagnosis
≤ 16 years (A1)	3/10	0.071	1
17 - 40 years (A2)	46/83	0.266	1.942	0.603 - 6.255
> 40 years (A3)	10/13	0.045	3.763	1.032 - 13.719
Location
Ileum (L1)	22/36	0.267	1
Colon (L2)	5/7	0.185	1.944	0.728 - 5.188
Ileocolon (L3)	32/63	0.660	0.885	0.513 - 1.525
Upper GI (L4)	0/0
Behavior
Inflammatory (B1)	25/55	0.094	1
Stricturing (B2)	27/41	0.081	1.624	0.942 - 2.800
Penetrating (B3)	7/10	0.070	2.171	0.937 - 5.027
Perianal disease
No	45/78	0.888	1
Yes	14/28		0.957	0.524 - 1.751
Extraintestinal manifestation
No	52/96	0.168	1
Yes	7/10		1.746	0.790 - 3.858
Therapeutic regimen
Top-down	37/76	0.027	1
Step-up	22/30		1.820	1.070 - 3.093
Combine therapy
No	48/86	0.624	1
Yes	11/20		1.179	0.611 - 2.272
CD-related surgery before infusion
No	39/79	0.049	1
Yes	20/27		1.718	1.002 - 2.947
Biologic variables at week 0
Low Hb level* (n = 106)
No	14/38	0.004	1
Yes	45/68		2.419	1.325 - 4.416
Low Hct level** (n = 106)
No	17/41	0.020	1
Yes	42/65		1.955	1.112 - 3.438
CRP level (mg/L) (n = 101)
≤ 5	20/37	0.898	1
> 5	36/64		1.036	0.600 - 1.791
Alb level (g/L) (n = 102)
≥ 40	15/38	0.027	1
< 40	41/64		1.955	1.081 - 3.535
Biologic variables at week 30
Low Hb level* (n = 105)
No	33/66	0.277	1
Yes	25/39		1.335	0.793 - 2.245
Low Hct level** (n = 105)
No	28/62	0.009	1
Yes	30/43		1.992	1.188 - 3.341
CRP level (mg/L) (n = 93)
≤ 5	30/68	0.000	1
> 5	21/25		3.479	1.979 - 6.114
Alb level (g/L) (n = 99)
≥ 40	27/66	0.000	1
< 40	26/33		2.717	1.567 - 4.711
AZA after IFX discontinuation
No	14/29	0.109	1
Yes	45/77		1.644	0.896 - 3.018

Table 2. Univariate Analysis of Factors Associated With Relapse

Variables

Relapses/total

P value

Hazard ratio

95% CI

CRP: C-reactive protein; Alb: albumin; Hb: hemoglobin; AZA: azathioprine; CI: confidence interval. *Male patients < 130 g/L, female patients < 115 g/L. **Male patients < 0.4, female patients < 0.35.

Sex

Female

18/34

0.605

Male

41/72

1.158

0.664 - 2.017

Disease duration (months)

≤ 18

42/84

0.072

> 18

17/22

1.679

0.954 - 2.955

Age at diagnosis

≤ 16 years (A1)

3/10

0.071

17 - 40 years (A2)

46/83

0.266

1.942

0.603 - 6.255

> 40 years (A3)

10/13

0.045

3.763

1.032 - 13.719

Location

Ileum (L1)

22/36

0.267

Colon (L2)

5/7

0.185

1.944

0.728 - 5.188

Ileocolon (L3)

32/63

0.660

0.885

0.513 - 1.525

Upper GI (L4)

0/0

Behavior

Inflammatory (B1)

25/55

0.094

Stricturing (B2)

27/41

0.081

1.624

0.942 - 2.800

Penetrating (B3)

7/10

0.070

2.171

0.937 - 5.027

Perianal disease

45/78

0.888

Yes

14/28

0.957

0.524 - 1.751

Extraintestinal manifestation

52/96

0.168

Yes

7/10

1.746

0.790 - 3.858

Therapeutic regimen

Top-down

37/76

0.027

Step-up

22/30

1.820

1.070 - 3.093

Combine therapy

48/86

0.624

Yes

11/20

1.179

0.611 - 2.272

CD-related surgery before infusion

39/79

0.049

Yes

20/27

1.718

1.002 - 2.947

Biologic variables at week 0

Low Hb level* (n = 106)

14/38

0.004

Yes

45/68

2.419

1.325 - 4.416

Low Hct level** (n = 106)

17/41

0.020

Yes

42/65

1.955

1.112 - 3.438

CRP level (mg/L) (n = 101)

≤ 5

20/37

0.898

> 5

36/64

1.036

0.600 - 1.791

Alb level (g/L) (n = 102)

≥ 40

15/38

0.027

< 40

41/64

1.955

1.081 - 3.535

Biologic variables at week 30

Low Hb level* (n = 105)

33/66

0.277

Yes

25/39

1.335

0.793 - 2.245

Low Hct level** (n = 105)

28/62

0.009

Yes

30/43

1.992

1.188 - 3.341

CRP level (mg/L) (n = 93)

≤ 5

30/68

0.000

> 5

21/25

3.479

1.979 - 6.114

Alb level (g/L) (n = 99)

≥ 40

27/66

0.000

< 40

26/33

2.717

1.567 - 4.711

AZA after IFX discontinuation

14/29

0.109

Yes

45/77

1.644

0.896 - 3.018

**Table 3.** Multivariable Cox Model
Variables	P value	Hazard ratio	95% CI
After univariate analysis, variables with P < 0.05 were included in the multivariable Cox model. CRP: C-reactive protein; Alb: albumin; CI: confidence interval.
CD-related surgery before infusion	0.013	2.671	1.230 - 5.798
Step-up therapeutic regimen	0.035	2.073	1.054 - 4.080
Low Hb level at week 0	0.116	2.183	0.825 - 5.779
Low Hct level at week 0	0.439	0.678	0.253 - 1.817
Low Alb level at week 0	0.022	3.431	1.196 - 9.846
Low Hct level at week 30	0.531	1.258	0.613 - 2.582
High CRP level at week 30	0.007	2.643	1.310 - 5.332
Low Alb level at week 30	0.819	0.916	0.434 - 1.935

Table 3. Multivariable Cox Model

Variables

P value

Hazard ratio

95% CI

After univariate analysis, variables with P < 0.05 were included in the multivariable Cox model. CRP: C-reactive protein; Alb: albumin; CI: confidence interval.

CD-related surgery before infusion

0.013

2.671

1.230 - 5.798

Step-up therapeutic regimen

0.035

2.073

1.054 - 4.080

Low Hb level at week 0

0.116

2.183

0.825 - 5.779

Low Hct level at week 0

0.439

0.678

0.253 - 1.817

Low Alb level at week 0

0.022

3.431

1.196 - 9.846

Low Hct level at week 30

0.531

1.258

0.613 - 2.582

High CRP level at week 30

0.007

2.643

1.310 - 5.332

Low Alb level at week 30

0.819

0.916

0.434 - 1.935