Ustekinumab for Crohn’s disease: a nationwide real-life cohort study from Finland (FINUSTE)

Figures & data

Figure 1. Map presenting study participants at represented hospital district in Finland including the number of patients treated with ustekinumab.

Table 1. Baseline patient characteristics and phenotype.

Characteristic	n	Mean (SD)
Age, years	48	42.2 (14.9)
Weight (kg)	48	72.2 (21.6)
Height^a (cm)	40	170.5 (9.0)
Disease duration, years	48	13.9 (10.3)
	n	%
Gender, male	22	45.8
Smoking
Yes	14	29.2
No	29	60.4
Prior smoking	5	10.4
Prior CD-related surgery	30	62.5
Intestinal resections	25	83
Fistula/abscess operation	5	17
Montreal classification
Age at diagnosis
A1	9	18.8
A2	29	60.4
A3	10	20.8
Location
L1 or L1 + L4	10	20.8
L2	13	27.1
L3/ L3 + L4 or L4	21/4	43.8/8.3
Behaviour
B1	14	29.2
B2	25	52.1
B3	9	18.8
Perianal	16	33.3
Comorbidities^b	6	12.5

^a Height: data for 40 patients available.

^b Ankylosing spondylitis, psoriasis, hidradenitis suppurativa.

Table 2. Treatment history and concomitant drug use at baseline.

	n	%
Prior biologic treatment	46	95.8
Adalimumab	32	66.7
Infliximab	41	85.4
Vedolizumab	21	43.8
1 prior biologic	12	25.0
2 prior biologics	20	41.7
3 prior biologics	14	29.2
Concomitant drug treatment	35	72.9
Corticosteroids	23	47.9
Methotrexate	8	16.7
5-aminosalicylic acid	10	20.8
Thiopurines	8	16.7

Figure 2. Flow-chart of ustekinumab (UST) treatment in the FINUSTE study population. A total of 48 Crohn’s disease patients received intravenous (iv) UST treatment at induction. Six patients (12.5%) lacked primary response or discontinued for other reasons. Forty-two patients (87.5%) continued UST treatment at 16 weeks. Two patients (4.2%) discontinued treatment due to lack of response after 16 weeks. Forty patients (83.3%) maintained UST at the end of follow-up, including 5 UST dose intensified patients and 35 not intensified.

Figure 3. UST persistence (%) among Crohn’s disease patients presented in Kaplan–Meier rates.

Figure 4. Concomitant drug use during ustekinumab treatment for Crohn’s disease (CD) at baseline, at 16 weeks, and at end of follow-up. Given are the total number of patients still using UST and the proportion of patients for the relevant CD treatment at specific time period. In parenthesis are the numbers of patients with available data. *Indicates statistically significant difference compared to baseline; p < .05.

Figure 5. Box and whiskers plot showing upper-lower extreme and median changes in (a) the Simple Endoscopic Score for Crohn’s disease (SES-CD), (b) modified Harvey–Bradshaw index (mHBI), (c) faecal calprotectin (fCal) and (d) C-reactive protein (CRP), at baseline, at 16 weeks and at end of follow-up of Crohn’s disease patients treated with ustekinumab. In parenthesis are the numbers of patients with available data at each timepoint. *Indicate statistically significant difference compared to baseline; p < .05.

Table 3. Clinical parameters during the study follow-up among UST users: median, (IQR, 25th–75th percentile).

Parameter	Baseline n = 48	16 weeks n = 48	p Value (vs. baseline)	End of follow-up n = 32	p Value (vs. baseline)
Haemoglobin, g/l	134 (120–143) n = 48	133 (122–139) n = 46	p = 0.84	138 (129–148) n = 32	p = 0.43
Leukocytes, E9/l	8.6 (7.0–11.8) n = 48	7.7 (5.7–10.4) n = 46	p = .003*	7.5 (6.7–10.2) n = 32	p =.07
Platelets, E9/l	334 (284–449) n = 48	324 (297–427) n = 45	p = 0.43	315 (267–400) n = 32	p = 0.26
P-Albumin, g/l	33 (29–37) n = 34	34 (29–36) n = 32	p = 0.79	33 (29–36) n = 13	p = 0.91
C-reactive protein, mg/l	11 (5–19) n = 48	8 (2–15) n = 46	p = 0.17	8 (4–14) n = 30	p =.02*
Faecal calprotectin, µg/g	643 (219–1390) n = 37	472 (194–974) n = 29	p = 0.48	561 (118–1150) n = 19	p =.06
SES-CD	12 (7–15) n = 17	3 (0–6) n = 11	p =.009*	3 (0–4) n = 6	p =.09
mHBI	9 (3–13) n = 35	3 (1–7) n = 24	p =.0001*	4 (0–8) n = 21	p =.001*

mHBI: modified Harvey–Bradshaw index; SES-CD: simple endoscopic score for Crohn’s disease. * = statistically significant change from baseline. n = number of patients with available data.

Figure 6. Proportion of ustekinumab treated Crohn’s disease patients with response, remission and clinical benefit at week 16 and at end of follow-up.