OP012 Perioperative use of vedolizumab is not associated with short-term postoperative infectious complications in patients with ulcerative colitis undergoing (procto)colectomy with ileal pouch-anal anastomosis

Abstract

Background: Vedolizumab, a bowel focused anti-adhesion molecule, is effectively used in patients with Crohn's disease (CD) and ulcerative colitis (UC). Preoperative use of vedolizumab has recently been associated with increased risk of short-term postoperative infectious complications. We assessed this risk in a single-center cohort of patients with UC undergoing (procto)colectomy with ileal pouch-anal anastomosis (IPAA). Method(s): A chart review was performed in all patient undergoing (procto)colectomy with IPAA between September 2006 (initiation of vedolizumab in clinical trials) and September 2016. Patients receiving an investigational medical product besides vedolizumab within 14 weeks of (procto)colectomy or receiving a permanent ileostomy were excluded. Short-term postoperative infectious complications were evaluated within 30 days after (procto)colectomy and included pouch related complications, surgical site infections, and infections outside the surgical site. The comprehensive complication index (CCI) was calculated based on all events reported within 30 days of (procto)colectomy. Result(s): We identified 170 patients undergoing (procto)colectomy (46% female, median age 38 years, median disease duration 6 years). Thirty-four patients (20%) received vedolizumab within 14 weeks, 60 (35%) received anti-TNF within 8 weeks, 32 (19%) received a moderate-to-high dose (>=20 mg/day) of prednisone, and 71 (42%) received no therapy at time of (procto)colectomy (Figure 1). Surgery was laparoscopyassisted in 131 patients (77%). Pouch construction was performed at first stage in 47 patients (28%), more frequent in patients with dysplasia/cancer (85% vs. 13%, p<0.001), and less frequent in patients under vedolizumab (9% vs. 32%, p=0.005), anti-TNF (15% vs. 35%, p=0.006), or steroids (0% vs. 34%, p<0.001). In multivariate analysis, the only risk factor for short-term postoperative infectious and overall complications was the construction of the pouch at first stage [Odds ratio 2.40 (95%CI 1.18-4.90), p=0.016 and 3.11 (1.52-6.40), p=0.002, respectively]. As shown in Figure 2, no significant difference could be observed between different treatment categories and development of short-term postoperative complications. Also the CCI and postoperative hospitalization stay were comparable between each treatment category, and only elevated in patients undergoing pouch construction at first stage [20.9 (0.0-30.8) vs. 0.0 (0.0-20.9), p=0.001, and 11 (9-17) vs. 7 (5-10) days, p<0.001, respectively]. Conclusion(s): In this large single-center cohort of patient with UC undergoing IPAA surgery, perioperative use of vedolizumab was not associated with short-term postoperative (infectious) complications. However, in patients under biological therapy or moderateto-high dose of steroids pouch construction should be postponed to a second stage of surgery. (Figure Presented).