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RISK OF POSTOPERATIVE COMPLICATIONS AMONG ULCERATIE COLITIS PATIENTS TREATED PREOPERATIVELY WITH VEDOLIZUMAB. A MATCHED CASE-CONTROL STUDY
Jeong Yeon Kim, Karen Zaghiyan, Phillip Fleshner*
Division of Colorectal Surgery, Cedars-Sinai, Los Angeles, CA
BACKGROUND
Although biologic agents have revolutionized the medical management of severe ulcerative colitis (UC), many patients still require colectomy. Vedolizumab, a biologic agent directed toward gut-specific α4β7 integrins, has recently been used to treat UC. There is considerable controversy regarding the potential adverse effects of vedolizumab on outcomes of ileal pouch-anal anastomosis (IPAA) in UC. The aim of this study was to evaluate 30-day postoperative morbidity in UC patients undergoing IPAA treated with vedolizumab prior to surgery.
METHODS
A prospectively maintained database evaluating the role of clinical, serologic and genetic markers with clinical phenotypes in UC was queried for patients treated with vedolizumab prior to surgery. Selected patients were then matched 1:3:3 into 3 preoperative treatment groups based on age, gender and number of stages (two vs. three) need to complete IPAA: a) vedolizumab, b) anti-tumor necrosis factor (anti-TNF), and c) no biologics. Demographic information, characteristics of the disease and its treatment, and perioperative outcomes were tabulated. 30-day postoperative complications among patient groups were compared using univariate and multivariable analysis. Postoperative ileus (POI) was defined clinically as nausea, vomiting, or abdominal distention requiring regression or cessation of diet, placement of nasogastric tube, or intravenous nutrition without a clear mechanical obstruction identified radiologically or surgically.
RESULTS
Of 315 patients undergoing IPAA between 2007 and 2017, 153 patients were matched by age, gender, and number of stages to complete IPAA: 25 treated with vedolizumab, 74 treated with anti-TNF and 54 treated with no biologics. The 3 patient groups were well-matched in other characteristics including onset age, disease duration, family history of inflammatory bowel disease and presence of extra-intestinal disease. The overall incidence of 30-day postoperative complications was not different among patients treated preoperatively with vedolizumab, anti-TNFs, or no biologics (44.0% vs. 44.6% vs. 31.3%; p=0.67). Although univariate analysis showed no significant difference between patient cohorts in surgical site infection (p=0.20) and readmission rate (p=0.36), POI was significantly more common among patients treated with vedolizumab (n=9; 36%) compared to patients treated with anti-TNF (n=12; 16.2%) or no biologics (n=5; 9.3%) (p=0.013). Multivariable analysis showed that vedolizumab treatment prior to surgery was an independent risk factor for POI (OR: 1.3, 95% CI; 1.10-1.54; p=.003).
CONCLUSION
Although not influencing overall 30-day postoperative complications, preoperative vedolizumab increases the incidence of POI after IPAA for UC. This observation may reflect the gut specific effects of vedolizumab on tissue level inflammatory pathways involved in POI.
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