Vedolizumab Reduces Postoperative Crohn’s Disease Recurrence

TOPLINE:

Vedolizumab treatment within 4 weeks of ileocolonic resection outperformed placebo in preventing postoperative endoscopic recurrence of Crohn’s disease in patients with at least one risk factor for recurrence, the REPREVIO trial found.

METHODOLOGY:

• Researchers conducted the multicenter REPREVIO trial to evaluate the efficacy and safety of vedolizumab, an α4β7 integrin antibody, in preventing the recurrence of Crohn’s disease in patients who underwent ileocolonic resection and had at least one risk factor for recurrence, such as active smoking, perforating complications, previous exposure to tumor necrosis factor (TNF) antagonists, or previous resections.
• Patients with Crohn’s disease were randomly assigned to receive either 300 mg of intravenous vedolizumab (n = 43; median age, 36 years; 44.2% women) or placebo (n = 37; median age, 36 years; 48.6% women) within 4 weeks of surgery (week 0) and then at weeks 8, 16, and 24. Endoscopic assessment was performed at 26 weeks.
• The primary endpoint was the between-group distribution of modified Rutgeerts scores (ranging from i0 [less severe] to i4 [more severe]) for postoperative recurrence of Crohn’s disease at week 26.
• The secondary endpoints included severe endoscopic recurrence (modified Rutgeerts score ≥ i2b), any endoscopic recurrence (modified Rutgeerts score > i0), clinical recurrence, the incidence and severity of histologic recurrence indicative of inflammation, adverse events, and serious adverse events.

TAKEAWAY:

• Compared with placebo, vedolizumab resulted in a 77.8% probability of achieving a lower modified Rutgeerts score at 26 weeks (P
• The proportion of patients with severe endoscopic recurrence was significantly lower in the vedolizumab group than in the placebo group (23.3% vs 62.2%; P = .0004).
• The vedolizumab group also had a lower incidence of any endoscopic recurrence than the placebo group (58.1% vs 97.3%; P
• Serious adverse events were reported in 7% of patients in the vedolizumab group and 5.4% of patients in the placebo group, but no correlation was found between these events and serum concentrations of vedolizumab.

IN PRACTICE:

“Vedolizumab treatment prevented postoperative recurrence of Crohn’s disease following ileocolonic resection and should be considered as a prophylactic treatment in individuals with risk factors for recurrence,” the study authors concluded.

“As the first randomized controlled trial to show that vedolizumab reduces postoperative endoscopic recurrence, REPREVIO provides an evidence base for an alternative biologic class to anti-TNF drugs in this setting. This finding could be of particular benefit in people who have previously not responded, lost response, or are intolerant to anti-TNF therapies or in whom anti-TNF therapy is contraindicated,” wrote Robert J. Mulligan and Christopher A. Lamb, Newcastle University, Newcastle upon Tyne, England, in a related comment.

SOURCE:

This study, led by Geert D’Haens, MD, Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, the Netherlands, was published online in The Lancet Gastroenterology & Hepatology.

LIMITATIONS:

This study’s limitations included a small sample size, relatively short follow-up duration, and absence of stratification based on histopathology.

DISCLOSURES:

This study was supported by Takeda Nederland, which provided vedolizumab and placebo. Several study authors and the commentary authors disclosed serving as consultants or advisory board members; receiving research funding or grants, lecture fees, speaker honoraria, consulting fees, personal fees, or support for traveling and/or attending meetings; or owning stock or stock options in Takeda or other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.