Clinical monitoring: infliximab biosimilar CT-P13 in the treatment of Crohn’s disease and ulcerative colitis

Figures & data

Table 1. Baseline patient demographics and clinical characteristics.

Number of patients (men/women)
CD	30 (14/16)
UC	22 (15/7)
	Men	Women
Age before therapy, median (range)	37 (19.0–71.0)	39 (18.0–61.0)
Age at diagnosis, median (range)	30 (14.0–58.0)	28.5 (13.0–55.0)
Disease activity, median (range)
Mayo score	4 (0.0–10.0)	8 (0.0–9.0)
CDAI	186 (0.0–345.0)	283 (0.0–400.0)
CRP, median (range)	28 (0.0–85.0)	11 (0.0–57.0)
Weight, median (range)	80 (55.0–168.0)	63 (45.0–97.0)
Site of disease in CD, n (%)	All patients
Small intestine	23 (76.7)
Colon	22 (73.3)
Perianal fistula	9 (30.0)
Other types of fistula	2 (6.7)
Previous treatment, n (%)
5-aminosalicylates	47 (90.4)
Oral corticosteroids	46 (88.5)
Azathioprine	39 (75.0)
Others	10 (19.2)
Concomitant treatment, n (%)
5-aminosalicylates	40 (76.9)
Oral corticosteroids (low dose)	14 (26.9)
Azathioprine	29 (55.8)
Others	4 (7.7)

CD: Crohn’s disease; CDAI: Crohn’s Disease Activity Index; CRP: C-reactive protein; UC: ulcerative colitis.

Table 2. Montreal classification in CD patients at enrolment (total number of patients = 30).

	n
A – age at diagnosis, years
A1 (<16)	2
A2 (17–40)	20
A3 (>40)	8
L – localisation at diagnosis
L1 (ileal)	3
L2 (colonic)	5
L3 (ileocolonic)	22
L4 indicator (upper gastrointestinal tract)	1
B – behaviour
B1 (nonstricturing, nonpenetrating)	22
B2 (stricturing)	6
B3 (penetrating)	2
p indicator (perianal disease)	9

CD: Crohn’s disease.

Table 3. Montreal classification in UC patients at enrolment (total number of patients = 22).

	n
E – extent
E1 (proctitis)	1
E2 (left-sided colitis)	9
E3 (pancolitis)	12
S – severity
S0 (clinical remission)	0
S1 (mild)	3
S2 (moderate)	17
S3 (severe)	2

UC: ulcerative colitis.

Figure 1. Median disease activity scores at baseline and after 14 weeks of treatment with CT-P13. (A) Crohn’s Disease Activity Index (CDAI) score in patients with Crohn’s disease. (B) Mayo score in patients with ulcerative colitis.

Figure 2. Median levels of C-reactive protein (CRP) at baseline and after 14 weeks of treatment with CT-P13 in patients with inflammatory bowel disease.

Figure 3. Median weight at baseline and after 14 weeks of treatment with CT-P13 in patients with inflammatory bowel disease.