Beneficial effect of early, post-operative vedolizumab on endoscopic recurrence in CD

When started within the first months of ileocolonic resection, vedolizumab significantly decreased the likelihood of a Crohn’s disease (CD) relapse. After 6 months, patients with early vedolizumab treatment demonstrated higher rates of endoscopic remission in the randomised, placebo-controlled REPREVIO trial.

“We know that vedolizumab, which we have used for a long time for inflammatory bowel disease, inhibits lymphocyte trafficking to the gut; so, we were thinking: if we give this drug immediately after surgery, perhaps we can prevent the occurrence of recurrent lesions endoscopically. Therefore, we performed a placebo-controlled trial,” Prof. Geert D’Haens (Academic Medical Center University of Amsterdam, the Netherlands) explained the aim of this study [1]. The REPREVIO trial (EudraCT 2015-000555-24) comprised 80 post-operative patients, who received either a placebo or 300 mg of vedolizumab, every 8 weeks until week 24, and who had undergone a video-recorded ileocolonoscopy. “We included patients who had somewhat of a high risk of endoscopic recurrence,” Prof. D’Haens specified.

The median age of the study cohort was 36 years, nearly half of the participants were women, and the median disease duration was 8–9 years. Approximately one-third of the participants had a history of 1 or more prior resections and approximately 48% had previously been treated with TNF antagonists.

“Participants in the vedolizumab group had a 77.8% chance of having a lower Rutgeerts score (RS) than participants in the placebo group (P<0.0001),” Prof. D’Haens revealed the result of the primary endpoint. When evaluating the secondary endpoint of having a low risk (RS i0-i2a) or high risk (RS i2b-i4) of recurrence, the likelihood of a low risk was 77% for vedolizumab and 38% for placebo (P=0.0004). Importantly, endoscopic remission was observed in 1/37 versus 18/43 participants in the placebo arm versus the vedolizumab arm (P<0.001). “Intriguingly, we did not observe a difference in clinical relapse, and we know that the endoscopic lesions precede clinical recurrence by a long time, so that is something you can only study in studies of much longer duration,” Prof. D’Haens added. Regarding safety, no new signals were detected in REPREVIO.

In conclusion, Prof. D’Haens highlighted that starting vedolizumab within 4 weeks of ileocolonic resection is highly effective in reducing the incidence and severity of post-operative relapses in patients with an increased risk of recurrence.

1. D’Haens G. Prevention of postoperative recurrence of Crohn’s disease with vedolizumab: First results of the prospective placebo-controlled randomised trial REPREVIO. OP14, ECCO 2023, 1–4 March, Copenhagen, Denmark.

Posted on 4 May, 202315 February, 2024