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HomeAlimentary Pharmacology & Therapeuticsindex/list_12208_1The Effectiveness of Either Ustekinumab or Vedolizumab in Patients With Crohn's Disease...

The Effectiveness of Either Ustekinumab or Vedolizumab in Patients With Crohn’s Disease Refractory to Anti-tumour Necrosis Factor

Abstract and Introduction

Abstract

Background: Ustekinumab and vedolizumab are commonly used after anti-tumour necrosis factor (TNF) failure in patients with Crohn’s disease (CD). No randomised controlled trial has compared these drugs.

Aims: To compare the effectiveness of ustekinumab and vedolizumab in CD patients refractory to anti-TNF.

Methods: From PubMed, EMBASE and the Cochrane Library, through March 27, 2021, we identified studies that compared ustekinumab and vedolizumab in patients with CD refractory to anti-TNF. The main outcomes were clinical remission and steroid-free clinical remission at weeks 14 and 52. Secondary outcomes were biological remission and treatment persistence. We computed pooled odds ratios (OR) and 95% confidence intervals (CI) using random effects meta-analysis.

Results: We identified 1513 reports. Among them, 38 studies were assessed for eligibility and five studies were included. All studies included were of high quality: four were retrospective and one was prospective. Among 1026 patients, 659 received ustekinumab and 367 received vedolizumab. At week 14, clinical remission (OR 1.36; 95%CI: 0.74–2.47; I 2 = 50%), steroid-free clinical remission (OR 1.24; 95%CI: 0.79–1.92; I 2 = 52%) and biological remission (OR 0.80; 95%CI: 0.50–1.28; I 2 = 0%) rates were similar between the two treatments. At week 52, ustekinumab was associated with higher rates of clinical remission (OR 1.87; 95% CI: 1.18–2.98; I 2 = 0%), steroid-free clinical remission (OR 1.56; 95% CI: 1.23–1.97; I 2 = 0%), biological remission (OR 1.86; 95% CI: 1.03–3.37; I 2 = 29%) and treatment persistence (OR 2.37; 95% CI: 1.56–3.62; I 2 = 0%).

Conclusion: In patients with CD refractory to anti-TNF, ustekinumab and vedolizumab are similarly effective in induction, but as maintenance treatment, ustekinumab appears to be more effective than vedolizumab.

Introduction

Anti-tumour necrosis factor (TNF) agents have proven their efficacy as induction and maintenance treatment in moderate to severe Crohn’s disease (CD).[1] More than 30% of patients are exposed to anti-TNF in the 5 years following CD diagnosis.[2,3] Approximately 13%-40% are primary non-responders to anti-TNF.[4] In those who respond, the annual risk of loss of response is approximately 20% with adalimumab and 13% with infliximab.[5–7] In addition, in the years following infliximab initiation, 13% of patients discontinued treatment because of adverse events.[8] Therefore, a substantial number of patients become non-responsive or intolerant to anti TNF.

After anti-TNF failure, vedolizumab and ustekinumab are currently available and commonly prescribed. Ustekinumab is a human monoclonal antibody targeting p40, a subunit that is common to interleukin (IL)-12 and IL-23. Vedolizumab is a humanised monoclonal antibody that binds the integrin α4β7, resulting in inhibition of T lymphocyte homing in the intestines. Randomised placebo-controlled trials have proven the efficacy of ustekinumab and of vedolizumab in anti-TNF-naïve and experienced CD patients,[9,10] but no head-to-head trial has compared these two drugs. Indirect comparisons and network meta-analyses of randomised trials have led to conflicting conclusions.[11–17] Recently, several observational studies have compared ustekinumab and vedolizumab, in patients with CD.[18–24]

The aim of this study was to compare the effectiveness of ustekinumab and vedolizumab in patients with CD refractory to anti-TNF in a systematic review of literature and meta-analysis.

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