Clinical effectiveness of golimumab in Crohn’s disease: an observational study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG)

Figures & data

Table 1. Baseline demographics and clinical characteristics, according to the Montreal classification, of patients with Crohn’s disease who were treated with golimumab.

	Crohn’s disease (n = 94)
Male, no. (%)	40 (42.6)
Disease duration in years, median (IQR)	8 (3–15)
Smoking status, no. (%)
Smoker	14 (14.9)
Non-smoker	75 (79.8)
Data missing	5 (5.3)
Age at diagnosis, no. (%)
≤16 years (A1)	19 (20.2)
17–40 years (A2)	56 (59.6)
>40 years (A3)	19 (20.2)
Behaviour, no. (%)
Non-stricturing, non-penetrating (B1)	56 (59.6)
Stricturing (B2)	16 (17.0)
Penetrating (B3)	21 (22.3)
Data missing	1 (1.0)
+ Perianal disease	20 (21.3)
Location, no. (%)
Ileum (L1)	9 (9.6)
Colon (L2)	36 (38.3)
Ileocolonic (L3)	49 (52.1)
+ Upper gastrointestinal (L4)	7 (7.4)
Concomitant medication, no. (%)
Corticosteroids	14 (14.9)
Immunomodulators^a	39 (41.5)
Previous anti-TNF treatment, no. (%)
≥1	91 (96.8)
≥2	62 (66.0)
≥3	7 (7.4)
Reason for termination of last anti-TNF treatment, no. (%)
Inadequate response	55 (60.4)
Intolerance	27 (29.7)
Other reason	9 (9.9)
Previous surgery ≥1, no. (%)	34 (36.2)
CRP mg/L, median (IQR)	5.0 (2.0–16.3)

IQR: interquartile range; anti-TNF: anti-tumor necrosis factor; CRP: C-reactive protein.

a Including azathioprine, 6-mercaptopurine, and methotrexate.

Figure 1. Cumulative probability of staying on treatment with golimumab.

Table 2. Predictors of drug discontinuation at 12 weeks.

Variables	Univariate analysis				Multivariate analysis
	n	Events	HR (95% CI)	p-value	n	Events	HR (95% CI)	p-value
Sex (female)	54	11	2.90 (0.81–10.41)	.10	52	11	6.59 (1.04–41.62)	.05
Age at baseline (years)
<28	31	2	Reference		28	2	Reference
28–43	31	3	1.64 (0.27–9.81)	.59	29	3	0.46 (0.05–4.60)	.51
>43	32	9	5.00 (1.08–23.17)	.04	32	9	4.19 (0.70–24.98)	.12
Disease location
Ileum (L1)	9	2	1.40 (0.30–6.60)	.67	9	2	0.98 (0.12–7.82)	.99
Colon (L2)	36	4	0.83 (0.46–1.51)	.54	33	4	0.63 (0.27–1.47)	.29
Ileocolonic (L3)	49	8	Reference		47	8	Reference
Perianal disease	20	4	1.52 (0.48–4.83)	.48	19	4	1.21 (0.25–5.75)	.81
Smoking status (current smoker)^a	14	1	0.37 (0.05–2.81)	.33	14	1	0.15 (0.02–1.43)	.10
Previous surgery	34	7	1.76 (0.62–5.02)	.29	32	7	7.52 (1.12–50.36)	.04
Concomitant immunomodulators	39	3	0.38 (0.11–1.35)	.13	34	3	0.45 (0.09–2.19)	.32
Concomitant corticosteroids	14	5	3.33 (1.11–9.93)	.03	14	5	5.70 (1.13–28.68)	.04
>1 previous anti-TNF therapy	62	11	1.99 (0.56–7.13)	.29	60	11	1.53 (0.32–7.47)	.60
C-reactive protein (CRP) at baseline
CRP <2 mg/L	23	2	Reference		21	2	Reference
CRP 2–5 mg/L	25	4	1.88 (0.34–10.26)	.47	24	4	0.67 (0.08–5.75)	.72
CRP 5.1–16 mg/L	23	1	0.49 (0.05–5.44)	.56	22	1	0.24 (0.02–3.27)	.28
CRP >16 mg/L	23	7	4.08 (0.85–19.65)	.08	22	7	4.19 (0.51–34.25)	.18

n: number of patients; HR: hazard ratio; CI: confidence interval; anti-TNF: anti-tumor necrosis factor.

^a Smoking status at baseline was available for 89 patients.

The bold values represent the significant values (p < 0.05).

Table 3. Predictors of drug discontinuation at the most recent follow-up.

Variables	Univariate analysis				Multivariate analysis
	n	Events	HR (95% CI)	p-value	n	Events	HR (95% CI)	p-value
Sex (female)	54	42	1.81 (1.05–3.11)	.03	52	41	2.24 (1.19–4.23)	.01
Age at baseline (years)
<28	31	20	Reference		28	18	Reference
28–43	31	21	0.84 (0.45–1.57)	.59	29	20	0.70 (0.33–1.48)	.35
>43	32	20	0.91 (0.49–1.70)	.77	32	20	1.05 (0.50–2.22)	.90
Disease location
Ileum (L1)	9	4	0.79 (0.28–2.25)	.65	9	4	0.74 (0.23–2.39)	.62
Colon (L2)	36	22	1.04 (0.78–1.38)	.82	33	20	0.92 (0.65–1.31)	.65
Ileocolonic (L3)	49	35	Reference		47	34	Reference
Perianal disease	20	12	0.82 (0.44–1.55)	.55	19	11	0.71 (0.32–1.56)	.39
Smoking status (current smoker)^a	14	11	1.12 (0.58–2.17)	.73	14	11	0.92 (0.44–1.91)	.82
Previous surgery	34	25	0.99 (0.59–1.67)	.98	32	24	1.27 (0.65–2.46)	.49
Concomitant immunomodulators	39	24	0.81 (0.49–1.36)	.43	34	21	0.78 (0.41–1.47)	.43
Concomitant corticosteroids	14	12	2.37 (1.25–4.49)	.01	14	12	2.60 (1.17–5.79)	.02
>1 previous anti-TNF therapy	62	43	1.39 (0.79–2.43)	.26	60	41	1.45 (0.75–2.79)	.27
C-reactive protein (CRP) at baseline
CRP <2 mg/L	23	14	Reference		21	13	Reference
CRP 2–5 mg/L	25	17	1.19 (0.59–2.42)	.63	24	17	1.36 (0.58–3.18)	.48
CRP 5.1–16 mg/L	23	13	0.91 (0.42–1.98)	.82	22	12	0.78 (0.33–1.87)	.58
CRP >16 mg/L	23	17	1.64 (0.81–3.34)	.17	22	16	1.69 (0.67–4.22)	.26

n: number of patients; HR: hazard ratio; CI: confidence interval; anti-TNF: anti-tumor necrosis factor.

^a Smoking status at baseline was available for 89 patients.

The bold values represent the significant values (p < 0.05).