Landmark IBD trials · Summary of an original articleLancet Gastroenterol Hepatol 2025;10:26–33

REPREVIOCD · Surgery

Vedolizumab to prevent postoperative recurrence of Crohn's disease (REPREVIO): a multicentre, double-blind, randomised, placebo-controlled trial

D'Haens G, et al.

Lancet Gastroenterol Hepatol 2025 · PMID 39571587 (PubMed, opens in a new tab) · doi 10.1016/S2468-1253(24)00317-0 (full paper, opens in a new tab)

Figure 1. Endoscopic recurrence 26 weeks after ileocolonic resection (modified Rutgeerts score, central reading). The primary endpoint compared the whole distribution of scores, so its result is a probability, not a rate.

Outcome at week 26	Vedolizumab (n=43)	Placebo (n=37)	Effect (95% CI)
Modified Rutgeerts score, whole distribution (primary) (primary endpoint)	—	—	Probability of a lower score with vedolizumab 77.8% (66.4–86.3); P<0.0001
Severe endoscopic recurrence (≥i2b)	10/43 (23.3%)	23/37 (62.2%)	Difference −38.9% (−56.0 to −17.3); P=0.0004
Serious adverse events	3/43 (7.0%)	2/37 (5.4%)	—

A probability of 50% would mean no difference between the groups.

Source: D'Haens 2025, abstract (patients who received at least one dose).

Structured abstract

BackgroundEndoscopic recurrence is common in the first year after ileocolonic resection. Anti-TNF prophylaxis was the main option; whether gut-selective vedolizumab prevents recurrence had not been tested against placebo.

MethodsMulticentre, double-blind, randomised, placebo-controlled trial (13 hospitals in France, Italy, the Netherlands and Spain). 84 patients. Primary endpoint: Distribution of modified Rutgeerts scores at week 26 (video-recorded, central reading).

ResultsPrimary result. Probability of a lower modified Rutgeerts score with vedolizumab than placebo: 77.8% (95% CI 66.4–86.3); P<0.0001.

Take-homeStarting vedolizumab within 4 weeks of ileocolonic resection reduces early endoscopic recurrence in patients at risk.

Table 1. Trial at a glance

Patients	84
Population	Adults with Crohn's disease after ileocolonic resection with at least one risk factor for recurrence, randomised within 4 weeks of surgery. 80 received study drug (43 vedolizumab, 37 placebo).
Comparison	Vedolizumab 300 mg IV vs placebo at weeks 0, 8, 16 and 24
Drugs	vedolizumab
Classes	Anti-integrin
Published	D'Haens G, et al. Lancet Gastroenterol Hepatol 2025;10:26–33.

Key points

Severe endoscopic recurrence (modified Rutgeerts ≥i2b) at week 26: 23.3% (10/43) vs 62.2% (23/37); difference −38.9% (95% CI −56.0 to −17.3); P=0.0004.
Serious adverse events: 7.0% (3/43) vedolizumab vs 5.4% (2/37) placebo.
Gives a randomised option for postoperative prophylaxis in patients for whom an anti-TNF is unsuitable.

Limitations

Small trial with a 26-week endpoint; clinical recurrence and longer-term outcomes were not assessed.
No comparison with anti-TNF prophylaxis.
Funded by Takeda Nederland.

Commentary

REPREVIO adds vedolizumab to the options for preventing postoperative recurrence, alongside anti-TNF therapy (PREVENT). Endoscopic monitoring 6 to 12 months after surgery, as in POCER, is still needed.

Journal club

PopulationAdults with Crohn's disease after ileocolonic resection with at least one risk factor for recurrence, randomised within 4 weeks of surgery. 80 received study drug (43 vedolizumab, 37 placebo).

InterventionVedolizumab 300 mg IV

ComparisonPlacebo at weeks 0, 8, 16 and 24

Primary outcomeDistribution of modified Rutgeerts scores at week 26 (video-recorded, central reading).

Design

Multicentre, double-blind, randomised, placebo-controlled trial (13 hospitals in France, Italy, the Netherlands and Spain). 84 patients.

Primary result. Probability of a lower modified Rutgeerts score with vedolizumab than placebo: 77.8% (95% CI 66.4–86.3); P<0.0001.

Validity and applicability

Small trial with a 26-week endpoint; clinical recurrence and longer-term outcomes were not assessed.
No comparison with anti-TNF prophylaxis.
Funded by Takeda Nederland.

Where it sits now

Starting vedolizumab within 4 weeks of ileocolonic resection reduces early endoscopic recurrence in patients at risk.

PREVENT (2016): In patients at increased risk, postoperative infliximab roughly halves endoscopic recurrence but did not significantly reduce clinical recurrence by week 76, so endoscopic monitoring is still needed.
POCER (2015): After resection, treating by risk and scoping at 6 months with step-up for recurrence beats drug prophylaxis alone; this is why we do a postoperative colonoscopy.
SPICY (2024): Removing more mesentery at primary ileocolic resection did not reduce 6-month endoscopic recurrence, and leaks were numerically more common.
LIR!C (2017): For limited (40 cm or less), non-stricturing terminal ileal Crohn's disease that has failed conventional therapy, laparoscopic resection is a reasonable alternative to starting an anti-TNF.

Questions for discussion

The primary endpoint was the probability of a lower score rather than a recurrence rate. What are the advantages and drawbacks of that choice?
With no anti-TNF comparator, when would you choose vedolizumab rather than an anti-TNF after resection?
The endpoint was at 26 weeks. What follow-up would you want before relying on vedolizumab prophylaxis?

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