Real-world confirmed effectiveness and safety of ustekinumab in patients with ulcerative colitis

What is it about?

This study is the most comprehensive systematic review and meta-analysis of real-world evidence evaluating the outcomes of ustekinumab for moderate-to-severe UC. The first relevant observation is the high complexity and refractoriness of patients receiving ustekinumab in the real-life setting: 92% of patients were biologic experienced, 61% had previously failed both an anti-TNF and vedolizumab (biologic dual-refractory), and 16% had been exposed to any biologic and tofacitinib. Our meta-analysis showed pooled remission rates after induction of almost 45% at both weeks 8 and 12–16, in line with those reported for tofacitinib in the real world. In the long term, our pooled clinical remission rates were almost 50% at months 6 and 12, roughly similar to the reported efficacy of vedolizumab maintenance in the real-world. Ustekinumab showed an acceptable safety profile.

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Why is it important?

Strict inclusion criteria used in randomised controlled trials (RCTs) can limit the patient population and generalisability of trial results to clinical practice. The results of this meta-analysis of observational studies confirm the effectiveness of ustekinumab in a highly treatment-refractory population of patients with active moderate-to-severe UC. The acceptable safety data presented here support the positive long-term benefit–risk profile of ustekinumab in the treatment of UC.

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