Safety of perioperative treatment with biologics in patients with inflammatory bowel disease undergoing bowel surgery: Experience from a large urban center.

Background and aimsRisks of peri- and postoperative complications after bowel surgery in patients with inflammatory bowel disease (IBD) receiving biologics are still discussed controversially. We therefore addressed the safety of different biologics that were applied in our IBD center before surgery.MethodsData of IBD patients who underwent bowel resections between 2012 and 2022 at our hospital were analyzed retrospectively. Exposure to biologics was defined by receiving biologics within 12 weeks before resective abdominal surgery. Safety considerations included minor complications, such as infections and wound healing disorders and major complications, e.g., anastomotic insufficiency or abscess formation.ResultsA total of 447 IBD patients (334 with Crohn's disease, 113 with ulcerative colitis), 51.9% female, were included and followed for a median follow-up of 45 months [range 0-113]. A total of 73.9% (326/447) were undergoing medical treatment at date of surgery, 61.5% (275/447) were treated with biologics within 3 months and 42.3% (189/447) within 4 weeks before surgery. Most surgeries (97.1%) were planned electively and 67.8% were performed laparoscopically. Major and minor complications occurred in 20.8% (93/447) of patients. Serious complications were rare: Six patients had acute postoperative bleeding, one CD patient developed peritonitis and two CD patients died postoperatively. After adjusting for age, disease duration, disease activity, Montreal classification, and medical treatment at date of surgery, no significant differences were observed regarding complications and exposure to biologics.ConclusionsThis retrospective single center study of 447 IBD patients goes to demonstrate that perioperative use of biologics is not associated with a higher risk of complications

Impact of Immunotherapies on SARS-CoV-2-Infections and Other Respiratory Tract Infections during the COVID-19 Winter Season in IBD Patients

Background. COVID-19 represents one of the most significant medical problems of our time. Aims. This study is focused on the question whether patients with inflammatory bowel disease (IBD) who receive immunotherapies are more vulnerable to respiratory tract infections and SARS-CoV-2 infections in comparison to medical staff, as a cohort with an increased infection risk, and to the general population in a COVID-19 hotspot. Methods. We analysed data regarding respiratory tract infections that were collected in our IBD registry and compared them with corresponding data from medical employees in our associated Isarklinikum hospital and from the healthy general population in Munich, Germany, over the same time frame in April and June 2020. Patients were tested for SARS-CoV-2 immunoglobulins (Ig). Results. Symptoms of respiratory tract infections occurred equally frequent in IBD patients with immunotherapies as compared to those without. Older age (>49 years), TNF-inhibitor, and ustekinumab treatment showed a significantly protective role in preventing respiratory tract symptomatic COVID-19 infections that occurred in 0.45% of all our 1.091 IBD patients. Of those, 1.8% were positive for SARS-CoV-2 Ig, identically to the general population of Munich with also 1.8% positivity. Whilst more than 3% of all COVID-19 subjects of the general population died during the first wave, none of our IBD patients died or needed referral to the ICU or oxygen treatment. Conclusions. In our study, IBD patients are as susceptible to respiratory tract infections or SARS-CoV-2 as the normal population. There is no evidence of an association between IBD therapies and increased risk of COVID-19. Interestingly, a reduced rate of COVID-19 deaths in IBD patients, the majority on immunomodulator therapy, was observed, compared to the general population. Therefore, no evidence was found to suggest that IBD medication should be withheld, and adherence should be encouraged to prevent flares. In addition to older age (>49 years), TNF inhibitors and ustekinumab show a protective role in preventing respiratory tract infections. In addition, these results add to the growing evidence that supports further investigation of TNF inhibitors as a possible treatment in the early course of severe COVID-19

S2 Data -

Background and aimsRisks of peri- and postoperative complications after bowel surgery in patients with inflammatory bowel disease (IBD) receiving biologics are still discussed controversially. We therefore addressed the safety of different biologics that were applied in our IBD center before surgery.MethodsData of IBD patients who underwent bowel resections between 2012 and 2022 at our hospital were analyzed retrospectively. Exposure to biologics was defined by receiving biologics within 12 weeks before resective abdominal surgery. Safety considerations included minor complications, such as infections and wound healing disorders and major complications, e.g., anastomotic insufficiency or abscess formation.ResultsA total of 447 IBD patients (334 with Crohn’s disease, 113 with ulcerative colitis), 51.9% female, were included and followed for a median follow-up of 45 months [range 0–113]. A total of 73.9% (326/447) were undergoing medical treatment at date of surgery, 61.5% (275/447) were treated with biologics within 3 months and 42.3% (189/447) within 4 weeks before surgery. Most surgeries (97.1%) were planned electively and 67.8% were performed laparoscopically. Major and minor complications occurred in 20.8% (93/447) of patients. Serious complications were rare: Six patients had acute postoperative bleeding, one CD patient developed peritonitis and two CD patients died postoperatively. After adjusting for age, disease duration, disease activity, Montreal classification, and medical treatment at date of surgery, no significant differences were observed regarding complications and exposure to biologics.ConclusionsThis retrospective single center study of 447 IBD patients goes to demonstrate that perioperative use of biologics is not associated with a higher risk of complications.</div

Patient characteristics.

A total of 447 IBD patients (334 CD, 113 UC, 232 females, 51.9%) were included in this observational retrospective trial. Almost two thirds of all IBD patients (61.52%, n = 275, (214 CD, 61 UC)) had direct exposure to biologic treatment within 12 weeks to CD related surgery. Median follow-up overall was 45 months [range 0–113]. Remission or mild disease activity at date of CD related surgery was documented in only one quarter of IBD patients (25.7%, n = 97/377) whereas 74.3% of all patients (n = 280/377) had moderate to severe disease activity at date of surgery. For description of disease location and disease behavior, the Montreal classification was used [20]. With 73.9% of all patients (n = 326/447), most patients had any treatment at date of surgery with 275 patients receiving biologic treatment (61.5%). A total of 97 patients (21.7%) received corticosteroids at date of surgery. No significant differences were observed between the subgroups with respect to patients’ characteristics.</p

S1 Data -

Background and aimsRisks of peri- and postoperative complications after bowel surgery in patients with inflammatory bowel disease (IBD) receiving biologics are still discussed controversially. We therefore addressed the safety of different biologics that were applied in our IBD center before surgery.MethodsData of IBD patients who underwent bowel resections between 2012 and 2022 at our hospital were analyzed retrospectively. Exposure to biologics was defined by receiving biologics within 12 weeks before resective abdominal surgery. Safety considerations included minor complications, such as infections and wound healing disorders and major complications, e.g., anastomotic insufficiency or abscess formation.ResultsA total of 447 IBD patients (334 with Crohn’s disease, 113 with ulcerative colitis), 51.9% female, were included and followed for a median follow-up of 45 months [range 0–113]. A total of 73.9% (326/447) were undergoing medical treatment at date of surgery, 61.5% (275/447) were treated with biologics within 3 months and 42.3% (189/447) within 4 weeks before surgery. Most surgeries (97.1%) were planned electively and 67.8% were performed laparoscopically. Major and minor complications occurred in 20.8% (93/447) of patients. Serious complications were rare: Six patients had acute postoperative bleeding, one CD patient developed peritonitis and two CD patients died postoperatively. After adjusting for age, disease duration, disease activity, Montreal classification, and medical treatment at date of surgery, no significant differences were observed regarding complications and exposure to biologics.ConclusionsThis retrospective single center study of 447 IBD patients goes to demonstrate that perioperative use of biologics is not associated with a higher risk of complications.</div

A-E. Multivariate logistic regression on the development of post-operative complications, included the following parameters: Biologics within 12 weeks of surgery, age, disease duration, disease activity (remission/mild and moderate/severe), disease behaviour (Montreal classification), corticosteroid treatment perioperatively, including concomitant steroid treatment.

A-E. Multivariate logistic regression on the development of post-operative complications, included the following parameters: Biologics within 12 weeks of surgery, age, disease duration, disease activity (remission/mild and moderate/severe), disease behaviour (Montreal classification), corticosteroid treatment perioperatively, including concomitant steroid treatment.</p

Surgery outcome and complications.

Table 2 shows the surgery outcome in patients overall and in subgroups of patients with exposure to biologic treatment within 3 months of surgery in comparison with surgery outcome in patients without exposure to biologic treatment.</p