Infliximab therapy for moderately severe Crohn’s disease and ulcerative colitis: a retrospective comparison over 6 years

Figures & data

Table 1 Demographic features of 71 patients with Crohn’s disease (CD) and 26 with idiopathic ulcerative colitis (UC). Data are listed for time-dependent variables as prior to infliximab (IFX) infusion. “General” refers to any time up to 1 month pre-IFX. Marginally significant differences were noted for fistulae by disease type (exact P = 0.06) and surgery before IFX by disease type (exact P = 0.09). No other differences were statistically significant

	Crohn’s disease (n = 71)	Idiopathic ulcerative colitis (n = 26)
	Mean (SD)
Age	38.9 (13.1)	38.4 (13.9)
Time to disease (years before IFX)	8.7 (8.1)	6.3 (6.4)
	n (%)
Gender
Female	35 (49%)	14 (54%)
Male	36 (51%)	12 (46%)
Location
Small bowel only (in CD)	19 (27%)	n/a
Terminal ileum and colon (in CD)	29 (41%)	n/a
Colon only (in CD)	23 (32%)	n/a
Left-sided only (in UC)	n/a	8 (31%)
Pancolitis (in UC)	n/a	16 (62%)
Pouchitis (in UC)	n/a	2 (8%)
Fistulae	15 (21%)	1 (4%)a
Level of medical therapy (0–5)
General pre-IFX^b
0: None	16 (23%)	8 (31%)
1: 5-Aminosalacylic acid	10 (14%)	5 (19%)
2: Prednisone	40 (56.3%)	13 (50%)
3: Azathioprine/6-mercaptopurine or methotrexate	26 (36.6%)	8 (30.8%)
4: Cyclosporine or mycophenylate mofetil	1 (1%)	0 (0%)
5: Biologic therapy	2 (3%)	1 (4%)
1 month pre-IFX
0: None	7 (10%)	1 (4%)
2: Prednisone	46 (64.8%)	23 (88.5%)
3: Azathioprine/6-mercaptopurine or methotrexate	59 (83.1%)	21 (80.1%)
Surgical therapy, general pre-IFX	17 (24%)	2 (8%)

Notes:

a One patient, 6 years after colectomy for UC, developed a rectovaginal fistula. Despite suspicion of CD as the true nature of cause, no radiological or histological evidence was found to support CD. She was considered to have pouchitis.

b Treatment levels are not mutually exclusive.

Table 2 Laboratory values for patients with Crohn’s disease (CD) or idiopathic ulcerative colitis (UC). Values are listed as during a general period, 1 month prior to infliximab (IFX) infusion, and general after IFX infusion. Sample sizes are noted for each statistic. Mean values are provided. Bracketed values represent SD

Laboratory values	General pre-IFX		1 month pre-IFX		General post-IFX
	CD	UC	CD	UC	CD	UC
Hgb (g/L)	n = 43 126.6 (19.2)	n = 14 120.7 (13.2)	n = 66 129.1^a (18.1)	n = 26 120.0^a (18.3)	n = 60 135.1 (19.1)	n = 23 133.9 (16.7)
WBC (x10E9)	n = 43 8.9 (3.9)	n = 13 7.8 (2.8)	n = 66 13.7 (40.4)	n = 26 9.9 (4)	n = 60 8.4 (3.8)	n = 23 19.2 (58.2)
Platelets (x10E9)	n = 43 329.7 (92.5)	n = 13 357.5 (168.7)	n = 66 340.8 (115.7)	n = 26 366.8 (94.5)	n = 60 291.3 (104.4)	n = 23 310.7 (129.1)
MPV (fL)	n = 40 9.1 (2.1)	n = 12 9.5 (1.7)	n = 65 9.8 (3.4)	n = 22 9.2 (1.8)	n = 58 10.7 (4.2)	n = 21 9.6 (2.4)
Lymph number (x10E9)	n = 41 14.9 (11.3)	n = 14 17.5 (17.3)	n = 62 12.5 (12)	n = 24 12.5 (13.2)	n = 54 16.1^a (14.3)	n = 23 24.1 (16.5)
CRP (mg/L)	n = 4 27.3 (37)	n = 1 23 (n/a)	n = 11 45.9 (106.8)	n = 5 51.9 (85.3)	n = 15 8.5 (12.6)	n = 7 25.3 (42.3)
Albumin (g/L)	n = 24 37.6 (9.2)	n = 7 40.4 (3.6)	n = 38 39.7 (6.8)	n = 14 35.6 (17.1)	n = 32 39.8 (8.4)	n = 11 39.1 (10.4)
TIBC (μmol/L)	n = 23 59.2 (13.3)	n = 7 52.9 (11.1)	n = 50 55.3 (12.6)	n = 18 49.7 (13.1)	n = 42 59.6 (11.8)	n = 17 56.9 (7.7)
Ferritin (μg/L)	n = 22 45.3 (36)	n = 9 39.7 (24.4)	n = 50 67.7 (68.5)	n = 23 94.3 (183.3)	n = 45 71.2 (81.3)	n = 18 42.2 (41.7)

Note:

a Statistically significant difference between CD and UC 1 month pre-IFX (P < 0.02 from a Kruskal–Wallis test).

Abbreviations: CRP, C-reactive protein; Hgb, hemoglobin; MPV, mean platelet volume; TIBC, total iron-binding capacity; WBC, white blood cell count.

Table 3 Characteristics of infliximab treatment for patients with Crohn’s disease (CD) and idiopathic ulcerative colitis (UC)

	Crohn’s disease (n = 71)	Idiopathic ulcerative colitis (n = 26)
Indications, n (%)
Severe disease only	55 (77.5%)	21 (80.8%)
Fistula only	11 (15.5%)	1 (3.8%)
Both severe disease and fistula	4 (5.6%)	0 (0%)
Other	1 (1.4%)	4 (15.4%)
Start dose
5 mg/kg	69 (97.2%)	25 (96.2%)
4 mg/kg	1 (1.4%)	0 (0%)
Unknown	1 (1.4%)	1 (3.8%)
Total dose (mg) per patient, median (25th percentile, 75th percentile)	350 (300, 400)	400 (300, 400)
Infusions per patient, mean (SD)^a	14.1 (11.2)	8.6 (7.1)
Total infusions for all patients with each disease	999	215

Note:

a A statistical difference was noted only for the number of infusions per patient with CD > UC (P = 0.03 from a Kruskal–Wallis test).

Figure 1 The distribution of the number of infusions (by year) and year of start of IFX treatment by disease group are shown (N = 97). Some patients who were tracked at infusion centers during the period of interest of the study began therapy earlier (also described in Methods).

Abbreviations: CD, Crohn’s disease; IFX, infliximab; UC, ulcerative colitis.

Figure 2 Length of treatment for CD and/or UC is shown for the duration of the observational period of 76 months (log-rank P = 0.5; n = 97).

Abbreviations: CD, Crohn’s disease; UC, ulcerative colitis.

Table 4 Summary of therapeutic failures (primary and Grade A), adjustment requirements (Grade B), or ongoing therapy without primary or Grade A failure

	Crohn’s disease (n = 71)	Idiopathic ulcerative colitis (n = 26)
Primary failure:
No	55	19
Yes	12 (17% of 71)^§	5 (19% of 26)^§
Missing	4	2
Grade A failure among patients without primary failure:	n = 55	n = 19
No	43	17
Yes*	10 (18% of 55)^§§	2 (11% of 19)
Missing	2	0
Grade B failure among patients without primary or Grade A failures:	n = 43	n = 17
No	28	9
Yes	15 (35% of 43)^†	8 (47% of 17)^‡
Ongoing therapy without primary or Grade A failures among all patients:
No	5	1
Yes	38 (54% of 71)	16 (62% of 26)

Notes:

* Only five patients, all with CD, had both Grade B and Grade A failures and had to stop therapy subsequently.

§ One patient required surgery.

§§ Five patients required surgery.

† Four of these patients stopped treatment.

‡ One patient stopped treatment.

Figure 3 Survival analysis of CD (N = 9/52) and UC (N = 2/19) patients who developed Grade A failure (need to stop infliximab for medical reasons and alter therapy). Only patients who did not have primary failure were included, and three patients were missing sufficient data.

Abbreviations: CD, Crohn’s disease; UC, ulcerative colitis.

Figure 4 Survival analysis CD (N = 24/52) and UC (N = 10/19) patients who developed Grade A failure and/or Grade B failure (need to alter frequency or dose of infliximab therapy). Only patients who did not have primary failure were included, and three patients were missing data.

Abbreviations: CD, Crohn’s disease; UC, ulcerative colitis.