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
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
| Gender, male | 14 (63.6%) |
| Smoking | |
| Nonsmoker | 16 (72.7%) |
| Ex-smoker | 3 (13.6%) |
| Smoker | 3 (13.6%) |
| Duration of disease (years), median (IQR) | 9.5 (3–12.25) |
| Montreal classification | |
| Age | |
| A1: ≤16 | 6 (27.3%) |
| A2: 17–40 | 12 (54.5%) |
| A3: >40 | 4 (18.2%) |
| Location | |
| L1: ileal | 5 (22.7%) |
| L2: colonic | 3 (13.6%) |
| L3: ileocolonic | 12 (54.5%) |
| L3+L4 (upper GI) | 2 (9.1%) |
| Behaviour | |
| B1: inflammatory | 6 (27.3%) |
| B2: stricturing | 8 (36.4%) |
| B3: fistulising | 8 (36.4%) |
| Perianal involvement | 6 (27.3%) |
| History of bowel surgery | 12 (54.5%) |
| Biologic experienced | 19 (86.4%) |
| Number of baseline biologic(s) | |
| 0 | 3 (13.6%) |
| 1 | 8 (36.4%) |
| 2 | 9 (40.9%) |
| 3 | 2 (9.1%) |
| Baseline concomitant medications | |
| Immunomodulator | 13 (59.1%) |
| Steroid | 6 (27.3%) |
| Immunomodulator + steroid | 4 (18.2%) |
| Baseline ( | Week 14 ( | Week 24 ( | Week 54 ( | |
| 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) |
| CRP | 6.9 (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% |
| SFR | 60.0% | 78.9% | 83.3% | 75.0% |
| Global physician assessment | 9.1% | 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.