Introduction: Vedolizumab (VDZ) is approved to treat both Crohn's disease (CD) and ulcerative colitis (UC), and has a favorable safety profile. Its effectiveness and safety in the peri-operative setting is unknown. We describe our experience with VDZ in inflammatory bowel disease (IBD) patients (pts) who underwent abdominal surgery. Methods: We reviewed the medical records of pts at our tertiary center who received VDZ within 2 months prior to IBD-associated abdominal surgery from August 2014 to March 2016. Type of surgery, concomitant medications and any reported adverse events (AEs) and serious AEs (SAEs) after surgery were recorded from three different time points: post-surgical hospitalization, 4 weeks post-op and 6 months post-op. Standard clinical trial definitions of AEs were used. We also conducted a case-control analysis comparing pts receiving VDZ to patients receiving infliximab pre-operatively, matched based on Montreal classification, surgery type and age at surgery. Statistical analysis using Fisher's exact test was performed.Table 1: Rates of Adverse Events, Serious Adverse Events, and Infectious Complications in IBD Patients Receiving Vedolizumab.Results: 23 pts were included (14 CD, 9 UC) for the cohort analysis, including 19 who had ostomy creation and 4 with bowel resection and anastomosis. 2/23, 7/23 and 6/14 pts experienced a SAE in the hospital post-operatively, by 4 weeks or by 6 months, respectively. SAEs included intra-abdominal abscess (n=4), small bowel obstruction (n=4), and mesenteric thrombosis (n=1) (Table). Rates of infectious complications experienced by our cohort were 8.7% (n=2) during post-surgical hospitalization, 13.0% (n=3) within the 4 weeks and 28.6% (n=4) by 6 months (Figure 1). Infectious complications included wound infection, intra-abdominal/anorectal/urogenital abscess, sepsis, urogenital infection and C. difficile infection. The case control analysis compared 12 pts receiving VDZ to 20 pts receiving infliximab. Although there were numerically more infectious complications with infliximab, no statistically significant differences were seen in serious adverse events or infectious complications at all time points (Figure 2).Figure 1Figure 2Conclusion: We describe the AEs of IBD pts receiving VDZ peri-operatively, and perform a case-control analysis comparing these pts to those who receive anti-TNF therapy. No differences regarding SAEs or infectious complications were seen in the case control analysis when VDZ was compared to infliximab. The main limitations of this study are the retrospective setting and the small sample size.
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Aelvoet et al. (2016) studied this question.