P381 Use of ustekinumab in Crohn’s disease: Singapore largest single-centre experience

H.H. Shim1, S.C. Kong1, W.C. Ong2, T.G. Lim2, P.W. Chan1

1Gastroenterology and Hepatology, Singapore General Hospital, Singapore, Singapore, 2Singapore General Hospital, Pharmacy, Singapore, Singapore

Background

Ustekinumab is the latest therapeutic option for Crohn’s disease (CD). Efficacy and safety outcomes of its use in the Asia CD population, however, have not been reported.

Methods

Patients with CD who received minimum 14 weeks of UST were included. The primary outcome was the percentage of patients who achieved remission by global physician assessment, GPA [defined by Steroid Free Remission (Harvey Bradshaw Index ≤4 and absence of systemic corticosteroid), stool calprotectin <250 μg/g and CR p < 5mg/l] at baseline, weeks 14, 24 and 54. Secondary outcomes included steroid-free remission, normalisation of CRP (<5mg/l), mucosal healing (absence of mucosal ulceration), transmural healing (absence of disease activity on CT/MR enterography); and adverse events including infection, infusion reaction, malignancy and surgery.

Results

Twenty-two patients were included in this study (Table 1). 22.7%, 50% and 55.6% of patients achieved remission by GPA at weeks 14, 24 and 54 respectively (Table 2). Two (2/5.40%) patients achieved mucosal healing with the median time to scope of 12 (IQR 4.5–15) months. Three (3/7, 42.9%) patients achieved transmural healing with the median time to scan of 8 (IQR 5–11) months. Reported on-treatment infection included pharyngitis, adenovirus, norovirus diarrhoea, dental abscess, shingles and cutaneous Mycobacterium abscessus. Four had surgery during the follow-up. No cases of an infusion reaction or malignancy were reported.

Table 1. Baseline demographics

N = 22, n (%)
Gender, male14 (63.6%)
Smoking
Nonsmoker16 (72.7%)
Ex-smoker3 (13.6%)
Smoker3 (13.6%)
Duration of disease (years), median (IQR)9.5 (3–12.25)
Montreal classification
Age
A1: ≤166 (27.3%)
A2: 17–4012 (54.5%)
A3: >404 (18.2%)
Location
L1: ileal5 (22.7%)
L2: colonic3 (13.6%)
L3: ileocolonic12 (54.5%)
L3+L4 (upper GI)2 (9.1%)
Behaviour
B1: inflammatory6 (27.3%)
B2: stricturing8 (36.4%)
B3: fistulising8 (36.4%)
Perianal involvement6 (27.3%)
History of bowel surgery12 (54.5%)
Biologic experienced19 (86.4%)
Number of baseline biologic(s)
03 (13.6%)
18 (36.4%)
29 (40.9%)
32 (9.1%)
Baseline concomitant medications
Immunomodulator13 (59.1%)
Steroid6 (27.3%)
Immunomodulator + steroid4 (18.2%)

Table 2. Efficacy outcomes

Baseline (n = 22)Week 14 (n = 22)Week 24 (n = 18)Week 54 (n = 9)
HBI*3(1–5)1(0–4)1(0–3)0(0–4)
Stool calprotectin*1000 (228–1000)826 (330–1000)336 (32–902)43 (38–44)
CRP6.9 (4.0–45.5)7.0 (2.1–10.0)4.8 (1.4–25)3.9 (1.7–28)
Normalisation of CRP (<5 mg/l)31.8%31.8%44.4%55.6%
SFR60.0%78.9%83.3%75.0%
Global physician assessment9.1%22.7%50%55.6%

*Median (IQR).

Conclusion

Efficacy and safety profile of ustekinumab in local patients with CD is comparable to their western counterpart in this first real-world Asia cohort.