Editorial: Is vedolizumab the preferred biologic therapy for biologic-naïve patients with ulcerative colitis?

Real-world data complement randomised controlled trials (RCTs) by providing insights into treatment effectiveness, safety and utilisation patterns in diverse populations, offering a broader perspective on the impact of interventions. To date, a relatively large amount of real-world data has been reported regarding vedolizumab.^1-5

In retrospective studies,^{1, 2} prior exposure to a tumour necrosis factor (TNF) antagonist was associated with a reduced probability of achieving clinical and endoscopic remission in patients with ulcerative colitis (UC) who were treated with vedolizumab. Another study³ found that although the incidence of loss of response (LOR) to vedolizumab was comparable in anti-TNF-naÏive and exposed patients, those who experienced LOR to anti-TNF agents before vedolizumab were almost twice as likely to experience LOR to vedolizumab. In a large retrospective study (EVOLVE),⁴ first-line biologic therapy in biologic-naive patients with UC indicated that vedolizumab and anti-TNF agents were equally effective at controlling clinical symptoms. Nevertheless, rates of treatment persistence at two years were higher in patients treated with vedolizumab. Real-world data from the PANIC study⁵ found that first-line vedolizumab had significantly longer persistence than first-line infliximab. First-line vedolizumab persistence was significantly longer than second-line vedolizumab, but first-line infliximab persistence was not statistically significantly different from second-line infliximab. Based on these results, vedolizumab should be considered as the first-line biological agent for UC.

The study by Bokemeyer et al⁶ has added new real-world data regarding the effectiveness of vedolizumab. To date, this is the largest real-world study on this issue. Although it was not a randomized controlled trial, it utilised propensity-score-adjusted analysis, a statistical method that minimises bias related to patient characteristics. This study prospectively compared the effectiveness of vedolizumab and anti-TNF agents in patients with UC who were biologic-naïve at the end of the induction period and during maintenance treatment at one and two years. After achieving similar effectiveness to anti-TNF agents during the induction period, vedolizumab demonstrated significantly higher remission rates than anti-TNF agents after two years. These findings support the use of vedolizumab as a first-line biologic in UC. One limitation of this study is that biomarkers and endoscopic findings were not evaluated in all patients, which prevented a rigorous comparison of these end points.

When considering this issue and integrating the findings of this study⁶ with previous research, it can be concluded that vedolizumab is the preferred biologic therapy for biologic-naïve patients with UC. While both vedolizumab and anti-TNF agents demonstrated efficacy, there remains a subset of patients who do not respond to these medications. Thus, it is imperative to establish an optimal treatment algorithm for UC, including the selection of alternative therapies for non-response.

Takayuki Yamamoto: Conceptualization (lead); data curation (lead); formal analysis (lead); funding acquisition (equal); investigation (lead); methodology (equal); project administration (lead); resources (lead); software (lead); supervision (equal); validation (lead); visualization (lead); writing – original draft (lead); writing – review and editing (lead).

This article is linked to Bokemeyer et al paper. To view this article, visit https://doi.org/10.1111/apt.17616