Biologic-naïve patients with CD: real-world data from EVOLVE Expansion

A real-world analysis of clinical effectiveness and safety of vedolizumab and ustekinumab offers a perspective on these treatments for biologic-naïve patients with moderate to severe Crohn’s disease (CD).

The multicentre, retrospective EVOLVE Expansion (NCT05056441) study, presented by Prof. Marc Ferrante (KU Leuven, Belgium), spanned across Australia, Belgium, and Switzerland, and included 623 biologic-naïve patients with CD who initiated treatment with vedolizumab (n=347) or ustekinumab (n=276) and had a minimum of 6 months of follow-up [1]. The study aimed to delineate the position of vedolizumab and ustekinumab within the treatment algorithm, as their roles as first-line biologic treatments in patients with CD are currently unclear. It evaluated clinical outcomes, safety, and healthcare resource utilisation.

The results of this 3-year study showed that the clinical response and remission rates were similar among patients treated with either vedolizumab or ustekinumab over 36 months. However, a noteworthy finding was the higher cumulative rate of mucosal healing in patients treated with vedolizumab, becoming statistically significant from the 1-year follow-up mark. At 24 months, the mucosal healing rates for vedolizumab and ustekinumab were 83.2% and 70.2% respectively (P=0.02), and at 36 months, they were 91.3% and 87.4% (P=0.02). In contrast, treatment persistence rates were better in the ustekinumab group, reaching 80.3% at 36 months compared with 70.6% for the vedolizumab group (P=0.03).

In terms of safety, no differences in serious adverse events between the 2 groups were detected. However, there were significantly more serious infections in the vedolizumab group, albeit the absolute numbers were still very low. “In conclusion, this real-world data show that clinical response and remission rates are similar for bio-naïve patients starting treatment with vedolizumab or ustekinumab. Over the 3 years, mucosal healing was higher with vedolizumab, despite a higher incidence of serious infections,” Prof. Ferrante summarised. Further investigation will be crucial in refining the understanding of these findings and their implications for treatment selection in clinical practice.

1. Ferrante M, et al. Real-world clinical effectiveness and safety of vedolizumab and ustekinumab in biologic-naïve patients with Crohn’s disease: results from the EVOLVE Expansion study. Lecture 16, DDW 2023, 6–9 May, Chicago, IL, USA.

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