Recent advancement in the understanding of the pathophysiology of inflammatory bowel disease has seen an expansion in therapeutic options. Vedolizumab, a selective α4β7 inhibitor, and ustekinumab, an IL 12/23 p40 inhibitor, have provided the much‐awaited out‐of‐class alternatives for patients who have failed or who are intolerant to anti‐Tumor Necrosis Factor (TNF) therapy. However, questions remain as to how we may best use these novel therapeutic agents. We evaluate the evidence available from randomized controlled trials and postmarketing cohort studies and discuss their safety, efficacy, and limitations, in relation to anti‐TNF therapy, in optimizing the treatment outcomes.

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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.

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