Vedolizumab outcomes compared in early versus late active Crohn's disease.
Geert R D'Haens, MD; Mark Löwenberg, MD; Filip Baert, MD; Peter Bossuyt, MD; Tamás Molnár, MD; Frank Hoentjen, MD; et al.
January 8, 2026
- The Lancet Gastroenterology & Hepatology
- The Lancet Gastroenterology & Hepatology, Volume 11, Issue 1, Pages 12–21
- 10.1016/S2468-1253(25)00233-X
Evidence before this study
We searched PubMed and Embase with the following keywords: “Crohn's disease”, “vedolizumab” and “biological naïve”. This resulted in 85 studies, of which eight were real-world retrospective studies and three were meta-analyses. In GEMINI 2, the phase 3 the registration trial for vedolizumab in Crohn's disease, the clinical response rate was 31·4% at week 6, but endoscopy was not conducted. Among responders, clinical remission rates ranged from 36·4% to 39·0% at week 52. According to a real-world study, clinical remission rates after 2 years were 74·2% in biologic-naive patients with Crohn's disease. All studies showed that vedolizumab treatment was effective and safe in biologic-naive patients. However, no studies have compared biologic-naive and biologic-experienced patients. Besides early intervention with vedolizumab, anti-TNF treatment with infliximab and adalimumab in a top-down approach previously showed superior outcomes compared to step-up strategies. Recently, the results of a retrospective multicentre study were published, showing significantly higher transmural healing rates, assessed by magnetic resonance enterography, in 154 patients receiving early treatment with infliximab, adalimumab, ustekinumab, or vedolizumab.
Added value of this study
To the best of our knowledge, this is the first study to investigate the ability of vedolizumab to promote clinical, endoscopic, and histological remission in patients with early and late active Crohn's disease over a 1-year period. This study shows that patients with early Crohn's disease are significantly more likely to reach clinical and endoscopic remission at both weeks 26 and 52 with vedolizumab than are patients with late Crohn's disease (31·4% vs 8·6%). Moreover, the frequency of serious adverse events was significantly lower among patients with early Crohn's disease than among those with late Crohn's disease (3·5% vs 26·4%).
Implications of all the available evidence
Our results, based on a stringent co-primary endpoint, show that vedolizumab is a safe and highly effective treatment option for patients with early moderate to severe Crohn's disease. Based on these outcomes, vedolizumab could be considered as a favourable treatment option for patients with biologic-naive Crohn's disease with a short disease duration.
