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

Abstract

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. 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.

Long‐term effectiveness and persistence rate of ustekinumab dose intensification in a South East Asian inflammatory bowel disease center

“…A previous study on the experience of UST in Singapore showed favorable outcomes, comparable to western populations. 9 In this study, we showed that DI was effective in 38% of both CD and UC patients in our cohort. This echo published data, which showed that DI was effective in about 40-50% of IBD patients.…”

Real-World Evidence of the Effectiveness and Safety of Ustekinumab for the Treatment of Crohn’s Disease: Systematic Review and Meta-Analysis of Observational Studies

“…A total of 63 studies (including 8529 patients) met the inclusion criteria and were finally included in the systematic review and meta-analysis ( Figure 1 ) [ 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , ...…”

“…Only one study focused exclusively on naïve patients [ 55 ], and in three studies, prior biologic exposure was not reported. Only three studies (4.8%) included paediatric patients [ 54 , 59 , 63 ] ( Table 1 ).…”

Landscape of inflammatory bowel disease in Singapore

“…In 2020, a study trial involving 22 Singapore-Asia cohort demonstrated that the safety and efficacy of ustekinumab were comparable to Western data. 25 Even more recently, tofacitinib (Janus kinase inhibitor) was also granted local regulatory approval in 2021 for moderate to active UC patients that had inadequate/lost response or intolerant to either conventional therapy or a biologic agent.…”

“…In addition, other new IBD treatment includes ustekinumab (a monoclonal antibody targeting IL-12 and IL-23) that had obtained the Health Science Authority regulatory approval in February 2018 for the treatment of moderate to severely active CD adult patients that had failed or intolerant to immunomodulators or corticosteroids. In 2020, a study trial involving 22 Singapore-Asia cohort demonstrated that the safety and efficacy of ustekinumab were comparable to Western data [ 25 ]. Even more recently, tofacitinib (Janus kinase inhibitor) was also granted local regulatory approval in 2021 for moderate to active UC patients that had inadequate/lost response or intolerant to either conventional therapy or a biologic agent.…”