SAFETY OF PERIOPERATIVE BIOLOGICS IN PATIENTS WITH IBD UNDERGOING RESECTIVE BOWEL SURGERY: THE MUNICH IBD CENTER EXPERIENCE

Abstract

Abstract BACKGROUND AND AIMS The risk of biologics in the peri-operative setting in IBD is still discussed controversially. Recently, the large prospective PUCCINI trial could demonstrate that direct exposure to TNF-blockers within 12 weeks before abdominal surgery was not associated with a higher risk of infectious complications. However, in daily clinical practice experiences on biological treatment perioperatively are limited. In our current retrospective trial, we addressed the safety of different biologicals in a peri-operative setting. METHODS Eligible IBD patients in this single center study were recruited from our Munich IBD center between January 2012 and May 2022, who underwent bowel surgery at our Department of Surgery. Direct exposure to biologics was defined as exposure to biologics within 12 weeks before abdominal surgery. To evaluate safety, the postoperative outcome focused on minor complications, defined as infectious complications, wound healing complications and major complications, defined as insufficiency of the anastomosis and abscess formation at the surgery site postoperatively. RESULTS A total of 447 IBD patients (334 CD/113 UC, 51.9% female) were included and were followed for a median time of 45 months [range 0-113]. Median age was 44 years [19-89], median age at diagnosis was 24 years [5-84] and median age at surgery was 41 years [16/85]. Median disease duration until surgery was 11 years [0-47]. With 74.3%, the majority of IBD patients had moderate to severe IBD disease activity at date of surgery. A total of 73.9% (326/447) had medical treatment at date of surgery, 61.5% (275/447) were treated with biologics within 3 months before surgery and 42.3% (189/447) had biologics within 4 weeks before surgery. Overall, 36.9% of patients (164/447) received infliximab, 13.0% (58/447) adalimumab, 1.1% (6/447) golimumab, 5.8% (26/447) vedolizumab, 6.5% (29/447) ustekinumab, perioperatively. The majority of surgeries was planned electively (97.1%, 434/447), and performed laparoscopically (67.8%, 303/447). Minor and major postoperative complications occurred in 20.8% (93/447) of patients. Serious complications were observed in a total of 9 patients, six patients had acute bleeding complications postoperatively, 1 patient developed peritonitis and 2 CD patients died postoperatively, one with and one without biologics. No significant differences regarding complications and safety were observed between patients with versus without biologic treatment. Interestingly, CD patients with direct exposure to biologics were more likely to undergo minimal-invasive surgery (63.1%, 135/214) than patients without exposure (28.3%, 34/120, p<0.05). CONCLUSIONS This retrospective single center study of 447 IBD patients could demonstrate that biologic treatment before sugery, even within 4 weeks, is not associated with a higher risk of complications.