Patients started on vedolizumab within 4 weeks of resection had a significantly lower likelihood of CD recurrence than those on placebo.
Geert D’Haens, MD, PhD
Academic Medical Center University of Amsterdam
The REPREVIO trial was intended to establish whether treatment with vedolizumab starting shortly after an ileocolonic resection would have a beneficial effect on the recurrence of Crohn’s disease. The randomized, multicenter, placebo-controlled study included 80 postoperative patients who either received placebo or 300 mg vedolizumab every 8 weeks until week 24, whereby a video-recorded ileocolonoscopy was performed. “We included patients who had somewhat of a high risk of endoscopic recurrence,” Geert D’Haens, MD, PhD, of Acagastdemic Medical Center University of Amsterdam explained.
The study cohort had a median age of 36, nearly half of the participants were women, and the median disease duration was 8-9 years. About one-third of the patients had a history of one or more prior resections and approximately 48% had previously been treated with TNF antagonists. “Patients in the vedolizumab group had a 77.8% chance of having a lower Rutgeerts score (RS) than patients in the placebo group (P<0.0001),” Dr. D’Haens revealed as the result of the primary endpoint. When evaluating the secondary endpoint of having a low (RS i0-i2a) or high (RS i2b-i4) risk for recurrence, the likelihood of a low risk was 77% for vedolizumab and 38% for placebo (P=0.0004). Importantly, endoscopic remission was found in 1/37 versus 18/43 patients in the placebo versus the vedolizumab arm, respectively (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 examine in studies of much longer duration,” Dr. D’Haens added.
No new signals were detected in REPREVIO.
In his conclusion, Dr. D’Haens highlighted that starting vedolizumab within 4 weeks of ileocolonic resection is highly effective to reduce incidence and severity of postoperative relapse in patients with increased risk of recurrence.
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