Combining biological therapies in patients with inflammatory bowel disease: a Finnish multi-centre study

Figures & data

Table 1. Baseline characteristics of 16 patients with IBD treated with biological combination therapy.

	n/median	%/(range)
Male	9	56
Age at diagnosis of IBD (years)	18	7–32
Biological treatment naive period from diagnosis (years)	3.5	0–16
Duration of treatment with biologics prior to combination treatment (years)	7	1–20
Duration of treatment with the first biologic prior to combination therapy (months)	9	0–52
Age at the initiation of combination therapy (years)	27	20–44
Smoker	1	6
Prior surgery for IBD (nonperianal)	9	56
EIM	7	44
IBD subtype
UC	1	6
CD	15	94
CD location (n = 15)
L2	1	7
L3	12	79
L4	1	7
L2 + L4	1	7
CD behaviour (n = 15)
B1	2	13
B2	9	60
B3	4	27
Perianal involvement (n = 15)	8	53
Prior biologic exposures
Infliximab	16	100
Adalimumab	15	94
Golimumab	2	13
Vedolizumab	13	81
Ustekinumab	13	81

Data expressed as absolute and relative frequencies and median.

IBD, inflammatory bowel disease; EIM, extraintestinal manifestation, CD, Crohn’s disease; UC, ulcerative colitis.

Table 2. Clinical characteristics of the 16 patients with IBD treated with 22 trials of biological combination therapy.

	n/median	%/(range)	Remission or partial response	Reduction in Cs use	Recovery of fistulas	Surgery during treatment	Infection during treatment
Follow-up (months)	9	2–31
Therapeutic trials
ADA + VEDO	5	23	2	1/3	0	1	1
ADA + USTE	8	36	5	0/1	1/1	3	0
GOLI + VEDO	2	9	0	2/3	0	0	0
GOLI + USTE	2	9	1	1/1	0	0	0
VEDO + USTE	5	23	1	0/2	1/2	1	2

Data expressed as absolute and relative frequencies and median.

IBD, Inflammatory bowel disease; Cs, Corticosteroid; ADA, adalimumab; VEDO, vedolizumab; USTE, ustekinumab; GOLI, golimumab.

Figure 1. Clinical outcomes of the 22 trials of biological combination therapy.

Figure 2. Changes in faecal calprotectin in follow-up.

Table 3. Changes in biochemical markers, clinical and endoscopic scores during follow-up.

	Baseline	4 months	p-value	12 months	p-value
		(+/- 4 weeks)		(+/- 4 weeks)
	Median (range)	Median (range)	baseline vs 4 months	Median (range)	baseline vs 12 months
Haemoglobin (g/L)	125 (92–159)	126 (92–149)	.455	133 (101–155)	.374
Albumin (g/L)	31 (22–41)	32 (21–41)	.972	36 (26–42)	.176
CRP (mg/L)	14 (0–63)	17 (0–130)		16 (0–72)	.063
Faecal Calprotectin (µg/g)	1818 (111–6000)	384 (222–3485)	.131	831 (15–3160)	.038
HBI	6 (1–10)	5 (0–10)	.128	4 (0–10)	.140
SES-CD	19 (10–32) 9*	16 (0–23) 5*		9 (5–14) 3*

Data expressed as median (range).

C-reactive protein, CRP; Partial Harvey–Bradshaw Index, HBI; Simple endoscopic score for Crohn’s disease, SES-CD. Due to the small number of patients p-value for SES-CD was not calculated. Number of patients*.

Table 4. Clinical characteristics and predictors to response to biological combination therapy in 22 trials.

	Response to treatment	%
Gender
Male	5/13	38
Female	4/9	44
Smoking status
Smoker	1/1	100
Non-smoker	7/19	37
Location of disease
L2	0/2	0
L3	9/18	50
L4	0/1	0
L2 + L4	0/1	0
Behaviour of disease
B1	2/4	50
B2	5/11	46
B3	2/7	29
Perianal disease	6/12	50
Prior surgery	4/9	44
Corticosteroid use prior to treatment	3/10	30
Concomitant Thiopurines	1/1	100
Concomitant Methotrexate	0/3	0

Data expressed as absolute and relative frequencies.